Dolocalma may be available in the countries listed below.
Metamizole magnesium (a derivative of Metamizole) is reported as an ingredient of Dolocalma in the following countries:
International Drug Name Search
In the US, Disulfiram (disulfiram systemic) is a member of the drug class drugs used in alcohol dependence and is used to treat Alcohol Dependence.
US matches:
Rec.INN
N07BB01,P03AA04
0000097-77-8
C10-H20-N2-S4
296
Alcohol withdrawal agent
Insecticide
Thioperoxydicarbonic diamide ([(H₂N)C(S)]₂S₂), tetraethyl-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Betanamin may be available in the countries listed below.
Pemoline is reported as an ingredient of Betanamin in the following countries:
International Drug Name Search
ExiFLAM may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Dimethyl Sulfoxide is reported as an ingredient of ExiFLAM in the following countries:
International Drug Name Search
Zyban is a brand name of bupropion, approved by the FDA in the following formulation(s):
A generic version of Zyban has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Zyban and have been approved by the FDA:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zyban. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
Extended Release Tablets
For Oral Use
Sular®(nisoldipine) is an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, C20H24N2O6, and has the structural formula:
Nisoldipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 388.4. Sular tablets comprise three layers: a top barrier layer, a middle layer containing nisoldipine, and a bottom barrier layer. The erodible barrier layers and the hydrogel middle layer provide for the controlled release of the drug. Sular tablets contain either 8.5, 17, 25.5 or 34 mg of nisoldipine for once-a-day oral administration.
Inactive ingredients in the formulation include: Hypromellose,hypromellose phthalate, lactose,glyceryl behenate, povidone, magnesium stearate, silicon dioxide,methacrylic acid copolymer, and sodium lauryl sulfate. Inactive ingredients in the film coating include: polydextrose, titanium dioxide, hypromellose, polyethylene glycol, iron oxide, and carnauba wax. Additionally, the 17 mg formulation contains FD&C Yellow #5.
Nisoldipine is a member of the dihydropyridine class of calcium channel antagonists (calcium ion antagonists or slow channel blockers) that inhibit the transmembrane influx of calcium into vascular smooth muscle and cardiac muscle. It reversibly competes with other dihydropyridines for binding to the calcium channel. Because the contractile process of vascular smooth muscle is dependent upon the movement of extracellular calcium into the muscle through specific ion channels, inhibition of the calcium channel results in dilation of the arterioles. In vitro studies show that the effects of nisoldipine on contractile processes are selective, with greater potency on vascular smooth muscle than on cardiac muscle. Although, like other dihydropyridine calcium channel blockers, nisoldipine has negative inotropic effects in vitro, studies conducted in intact anesthetized animals have shown that the vasodilating effect occurs at doses lower than those that affect cardiac contractility.
The effect of nisoldipine on blood pressure is principally a consequence of a dose-related decrease of peripheral vascular resistance. While nisoldipine, like other dihydropyridines, exhibits a mild diuretic effect, most of the antihypertensive activity is attributed to its effect on peripheral vascular resistance.
Nisoldipine pharmacokinetics are independent of the dose across the clicinal dosage range of 17 to 51 mg, with plasma concentrations proportional to dose. Nisoldipine accumulation, during multiple dosing, is predictable from a single dose. Nisoldipine is relatively well absorbed into the systemic circulation with 87% of the radiolabeled drug recovered in urine and feces. The absolute bioavailability of nisoldipine is about 5%. Nisoldipine's low bioavailability is due, in part, to pre-systemic metabolism in the gut wall, and this metabolism decreases from the proximal to the distal parts of the intestine. A pronounced food-effect is observed when Sular is administered with a high-fat meal resulting in an increased peak concentration (Cmax) of up to 245%. Total exposure (AUC) is decreased by 25%. As a result, Sular should be taken on an empty stomach (1 hour before or 2 hours after a meal).
Maximal plasma concentrations of nisoldipine are reached at 9.2 ± 5.1 hours. The terminal elimination half-life (reflecting post absorption clearance of nisoldipine) ranges from 13.7 ± 4.3 hours. After oral administration, the concentration of (+)-nisoldipine, the active enantiomer, is about 6 times higher than the inactive (-) -nisoldipine enantiomer. The plasma protein binding of nisoldipine is very high, with less than 1% unbound over the plasma concentration range of 100 ng/mL to 10 mcg/mL.
Nisoldipine is highly metabolized; 5 major urinary metabolites have been identified. Although 60 - 80% of an oral dose undergoes urinary excretion, only traces of unchanged nisoldipine are found in urine. The major biotransformation pathway appears to be the hydroxylation of the isobutyl ester. A hydroxylated derivative of the side chain, present in plasma at concentrations approximately equal to the parent compound, appears to be the only active metabolite, and has about 10% of the activity of the parent compound. Cytochrome P450 enzymes are believed to play a major role in the metabolism of nisoldipine. The particular isoenzyme system responsible for its metabolism has not been identified, but other dihydropyridines are metabolized by cytochrome P450 IIIA4. Nisoldipine should not be administered with grapefruit juice, as this has been shown, in a study of 12 subjects, to interfere with nisoldipine metabolism, resulting in a mean increase in Cmax of about 3-fold (ranging up to about 7-fold) and AUC of almost 2-fold (ranging up to about 5-fold). A similar phenomenon has been seen with several other dihydropyridine calcium channel blockers.
Because renal elimination is not an important pathway, bioavailability and pharmacokinetics of Sular were not significantly different in patients with various degrees of renal impairment. Dosing adjustments in patients with mild to moderate renal impairment are not necessary.
Elderly patients have been found to have 2 to 3 fold higher plasma concentrations (Cmax and AUC) than young subjects. This should be reflected in more cautious dosing (See DOSAGE AND ADMINISTRATION).
In patients with liver cirrhosis given a dose bioequivalent to 8.5 mg Sular, plasma concentrations of the parent compound were 4 to 5 times higher than those in healthy young subjects. Lower starting and maintenance doses should be used in cirrhotic patients (See DOSAGE AND ADMINISTRATION).
The effect of gender or race on the pharmacokinetics of nisoldipine has not been investigated.
Hypertension does not significantly alter the pharmacokinetics of nisoldipine.
Administration of a single dose of nisoldipine leads to decreased systemic vascular resistance and blood pressure with a transient increase in heart rate. The change in heart rate is greater with immediate release nisoldipine preparations. The effect on blood pressure is directly related to the initial degree of elevation above normal. Chronic administration of nisoldipine results in a sustained decrease in vascular resistance and small increases in stroke index and left ventricular ejection fraction. A study of the immediate release formulation showed no effect of nisoldipine on the renin-angiotensin-aldosterone system or on plasma norepinephrine concentration in normals. Changes in blood pressure in hypertensive patients given Sular were dose related over the clinical dosage range.
Nisoldipine does not appear to have significant negative inotropic activity in intact animals or humans, and did not lead to worsening of clinical heart failure in three small studies of patients with asymptomatic and symptomatic left ventricular dysfunction. There is little information, however, in patients with severe congestive heart failure, and all calcium channel blockers should be used with caution in any patient with heart failure.
Nisoldipine has no clinically important chronotropic effects. Except for mild shortening of sinus cycle, SA conduction time and AH intervals, single oral doses up to 20 mg of immediate release nisoldipine did not significantly change other conduction parameters. Similar electrophysiologic effects were seen with single IV doses, which could be blunted in patients pre-treated with beta-blockers. Dose and plasma level related flattening or inversion of T-waves have been observed in a few small studies. Such reports were concentrated in patients receiving rapidly increased high doses in one study; the phenomenon has not been a cause of safety concern in large clinical trials.
The antihypertensive efficacy of Sular was studied in 5 double-blind, placebo-controlled, randomized studies, in which over 600 patients were treated with Sular as monotherapy and about 300 with placebo; 4 of the five studies compared 2 or 3 fixed doses while the fifth allowed titration from doses bioequivalent to 8.5 - 34 mg. Once daily administration of Sular produced sustained reductions in systolic and diastolic blood pressures over the 24 hour dosing interval in both supine and standing positions. The mean placebo-subtracted reductions in supine systolic and diastolic blood pressure at trough, 24 hours post-dose, in these studies, are shown below. Changes in standing blood pressure were similar:
| Sular | |||||
|---|---|---|---|---|---|
| Doses bioequivalent to: (mg/day) | 8.5 mg | 17 mg | 25.5 mg | 34 mg | 8.5-34 mg titrated |
| Systolic | 8 | 11 | 11 | 14 | 15 |
| Diastolic | 3 | 5 | 7 | 7 | 8 |
In patients receiving atenolol, supine blood pressure reductions with Sular doses bioequivalent to 17 and 34 mg once daily were 12/6 and 19/8 mm Hg, respectively. The sustained antihypertensive effect of Sular was demonstrated by 24 hour blood pressure monitoring and examination of peak and trough effects. The trough/peak ratios ranged from 70 to 100% for diastolic and systolic blood pressure. The mean change in heart rate in these studies was less than one beat per minute. In 4 of the 5 studies, patients received intial doses bioequivalent to 17-25.5 mg Sular without incident (excessive effects on blood pressure or heart rate). The fifth study started patients on lower doses of Sular.
Patient race and gender did not influence the blood pressure lowering effect of Sular. Despite the higher plasma concentration of nisoldipine in the elderly, there was no consistent difference in their blood pressure response except that the lowest clinical dose was somewhat more effective than in non-elderly patients. No postural effect on blood pressure was apparent and there was no evidence of tolerance to the antihypertensive effect of Sular in patients treated for up to one year.
Sular is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Sular is contraindicated in patients with known hypersensitivity to dihydropyridine calcium channel blockers.
Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration and/or severity of angina, or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been established. In controlled studies of Sular in patients with angina this was seen about 1.5% of the time in patients given nisoldipine, compared with 0.9% in patients given placebo.
Because nisoldipine, like other vasodilators, decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of Sular is recommended. Close observation is especially important for patients already taking medications that are known to lower blood pressure. Although in most patients the hypotensive effect of Sular is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment.
Although acute hemodynamic studies of nisoldipine in patients with NYHA Class II-IV heart failure have not demonstrated negative inotropic effects, safety of Sular in patients with heart failure has not been established. Caution therefore should be exercised when using Sular in patients with heart failure or compromised ventricular function, particularly in combination with a beta-blocker.
Because nisoldipine is extensively metabolized by the liver and, in patients with cirrhosis, it reaches blood concentrations about 5 times those in normals, Sular should be administered cautiously in patients with severe hepatic dysfunction (See DOSAGE AND ADMINISTRATION).
Sular is an extended release tablet and should be swallowed whole. Tablets should not be chewed, divided or crushed. Sular should be taken on an empty stomach (1 hour before or 2 hours after a meal). Grapefruit juice, which has been shown to increase significantly the bioavailability of nisoldipine and other dihydropyridine type calcium channel blockers, should not be taken with Sular.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Sular is not known to interfere with the interpretation of laboratory tests.
A 30 to 45% increase in AUC and Cmax of nisoldipine was observed with concomitant administration of cimetidine 400 mg twice daily. Ranitidine 150 mg twice daily did not interact significantly with nisoldipine (AUC was decreased by 15 - 20%). No pharmacodynamic effects of either histamine H2 receptor antagonist were observed.
Sular is substrate of CYP3A4 and coadministration of Sular with any known inducer or inhibitor of CYP3A4 should be avoided in general.
Coadministration of phenytoin with a dose bioequivalent to 34mg Sular tablets in epileptic patients lowered the nisoldipine plasma concentrations to undetectable levels. Coadministration of Sular with phenytoin should be avoided and alternative antihypertensive therapy should be considered. Pharmacokinetic interactions between nisoldipine and beta-blockers (atenolol, propranolol) were variable and not significant. Propranolol attenuated the heart rate increase following administration of immediate release nisoldipine. The blood pressure effect of Sular tended to be greater in patients on atenolol than in patients on no other antihypertensive therapy. Quinidine at 648 mg bid decreased the bioavailability (AUC) of nisoldipine by 26%, but not the peak concentration. Immediate release nisoldipine increased plasma quinidine concentrations by about 20%. This interaction was not accompanied by ECG changes and its clinical significance is not known. No significant interactions were found between nisoldipine and warfarin of digoxin.
Dietary administration of nisoldipine to male and female rats for up to 24 months (mean doses up to 82 and 111 mg/kg/day, 16 and 19 times the maximum recommended human dose {MRHD} on a mg/m2 basis, respectively and female mice for up to 21 months (mean doses of up to 217 mg/kg/day, 20 times the MRHD on a mg/m2 basis) revealed no evidence of tumorigenic effect of nisoldipine. In male mice receiving a mean dose of 163 mg nisoldipine/kg/day (16 times the MRHD of 60 mg/day on a mg/m2 basis), an increased frequency of stomach papilloma, but still within the historical range, was observed. No evidence of stomach neoplasia was observed at lower doses (up to 58 mg/kg/day). Nisoldipine was negative when tested in a battery of genotoxicity assays including the Ames test and the CHO/HGRPT assay for mutagenicity and the in vivo mouse micronucleus test and in vitro CHO cell test for clastogenicity.
When administered to male and female rats at doses of up to 30 mg/kg/day (about 5 times the MRHD on a mg/m2 basis) nisoldipine had no effect on fertility.
Nisoldipine was neither teratogenic nor fetotoxic at doses that were not maternally toxic. Nisoldipine was fetotoxic but not teratogenic in rats and rabbits at doses resulting in maternal toxicity ( reduced maternal body weight gain). In pregnant rats, increased fetal resorption (postimplantation loss) was observed at 100 mg/kg/day and decreased fetal weight was observed at both 30 and 100 mg/kg/day. These doses are, respectively, about 5 and 16 times the MRHD when compared on a mg/m2 basis. In pregnant rabbits, decreased fetal and placental weights were observed at a dose of 30 mg/kg/day, about 10 times the MRHD when compared on a mg/m2 basis. In a study in which pregnant monkeys (both treated and control) had high rates of abortion and mortality, the only surviving fetus from a group exposed to a maternal dose of 100 mg nisoldipine/ kg/day (about 30 times the MRHD when compared on a mg/m2 basis) presented with forelimb and vertebral abnormalities not previously seen in control monkeys of the same strain. There are no adequate and well controlled studies in pregnant women. Sular should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether nisoldipine is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made to discontinue nursing, or to discontinue Sular, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of nisoldipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Patients over 65 are expected to develop higher plasma concentrations of nisoldipine. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
More than 6000 patients world-wide have received nisoldipine in clinical trials for the treatment of hypertension, either as the immediate release or the Sular extended release formulation. Of about 1,500 patients who received Sular in hypertension studies, about 55% were exposed for at least 2 months and about one third were exposed for over 6 months, the great majority at doses equivalent to 17 mg and above.
Sular is generally well-tolerated. In the U.S. clinical trials of Sular in hypertension, 10.9% of the 921 Sular patients discontinued treatment due to adverse events compared with 2.9% of 280 placebo patients. The frequency of discontinuations due to adverse experiences was related to dose, with a 5.4% and 10.9% discontinuation rate at the lowest and highest daily dose, respectively.
The most frequently occurring adverse experiences with Sular are those related to its vasodilator properties; these are generally mild and only occasionally lead to patient withdrawal from treatment. The table below, from U.S. placebo-controlled parallel dose response trials of Sular using doses across the clinical dosage range in patients with hypertension, lists all of the adverse events, regardless of the causal relationship to Sular, for which the overall incidence on Sular was both >1% and greater with Sular than with placebo.
| Adverse Event | Nisoldipine (%) (n=663) | Placebo (%) (n=280) |
|---|---|---|
| Only peripheral edema and possibly dizziness appear to be dose related. | ||
| Peripheral Edema | 22 | 10 |
| Headache | 22 | 15 |
| Dizziness | 5 | 4 |
| Pharyngitis | 5 | 4 |
| Vasodilation | 4 | 2 |
| Sinusitis | 3 | 2 |
| Palpitation | 3 | 1 |
| Chest Pain | 2 | 1 |
| Nausea | 2 | 1 |
| Rash | 2 | 1 |
| Adverse | Sular, dose bioequivalent to: | ||||
|---|---|---|---|---|---|
| Event | Placebo | 8.5mg | 17mg | 25.5mg | 34mg |
| (Rates in %) | N=280 | N=30 | N=170 | N=105 | N=139 |
| Peripheral Edema | 10 | 7 | 15 | 20 | 27 |
| Dizziness | 4 | 7 | 3 | 3 | 4 |
The common adverse events occurred at about the same rate in men as in women, and at a similar rate in patients over age 65 as in those under that age, except that headache was much less common in older patients. Except for peripheral edema and vasodilation, which were more common in whites, adverse event rates were similar in blacks and whites.
The following adverse events occurred in ≤1% of all patients treated for hypertension in U.S. and foreign clinical trials, or with unspecified incidence in other studies. Although a causal relationship of Sular to these events cannot be established, they are listed to alert the physician to a possible relationship with Sular treatment.
Body As A Whole: cellulitis, chills, facial edema, fever, flu syndrome, malaise
Cardiovascular: atrial fibrillation, cerebrovascular accident, congestive heart failure, first degree AV block, hypertension, hypotension, jugular venous distension, migraine, myocardial infarction, postural hypotension, ventricular extrasystoles, supraventricular tachycardia, syncope, systolic ejection murmur, T wave abnormalities on ECG (flattening, inversion, nonspecific changes), venous insufficiency
Digestive: abnormal liver function tests, anorexia, colitis, diarrhea, dry mouth, dyspepsia, dysphagia, flatulence, gastritis, gastrointestinal hemorrhage, gingival hyperplasia, glossitis, hepatomegaly, increased appetite, melena, mouth ulceration
Endocrine: diabetes mellitus, thyroiditis
Hemic and Lymphatic: anemia, ecchymoses, leukopenia, petechiae
Metabolic and Nutritional: gout, hypokalemia, increased serum creatine kinase, increased nonprotein nitrogen, weight gain, weight loss
Musculoskeletal: arthralgia, arthritis, leg cramps, myalgia, myasthenia, myositis, tenosynovitis
Nervous: abnormal dreams, abnormal thinking and confusion, amnesia, anxiety, ataxia, cerebral ischemia, decreased libido, depression, hypesthesia, hypertonia, insomnia, nervousness, paresthesia, somnolence, tremor, vertigo
Respiratory: asthma, dyspnea, end inspiratory wheeze and fine rales, epistaxis, increased cough, laryngitis, pharyngitis, pleural effusion, rhinitis, sinusitis
Skin and Appendages: acne, alopecia, dry skin, exfoliative dermatitis, fungal dermatitis, herpes simplex, herpes zoster, maculopapular rash, pruritus, pustular rash, skin discoloration, skin ulcer, sweating, urticaria
Special Senses: abnormal vision, amblyopia, blepharitis, conjunctivitis, ear pain, glaucoma, itchy eyes, keratoconjunctivitis, otitis media, retinal detachment, tinnitus, watery eyes, taste disturbance, temporary unilateral loss of vision, vitreous floater
Urogenital: dysuria, hematuria, impotence, nocturia, urinary frequency, increased BUN and serum creatinine, vaginal hemorrhage, vaginitis.
The following postmarketing event has been reported very rarely in patients receiving Sular: systemic hypersensitivity reaction which may include one or more of the following; angioedema, shortness of breath, tachycardia, chest tightness, hypotension, and rash. A definite causal relationship with Sular has not been established. An unusual event observed with immediate release nisoldipine but not observed with Sular was one case of photosensitivity. Gynecomastia has been associated with the use of calcium channel blockers.
There is no experience with nisoldipine overdosage. Generally, overdosage with other dihydropyridines leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents and fluids. Clearance of nisoldipine would be expected to be slowed in patients with impaired liver function. Since nisoldipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.
The dosage of Sular must be adjusted to each patient's needs. Therapy usually should be initiated with 17 mg orally once daily, then increased by 8.5 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 17 to 34 mg once daily. Blood pressure response increases over the 8.5 - 34 mg daily dose range but adverse event rates also increase. Doses beyond 34 mg once daily are not recommended. Sular has been used safely with diuretics, ACE inhibitors, and beta-blocking agents. Patients over age 65, or patients with impaired liver function are expected to develop higher plasma concentrations of nisoldipine. Their blood pressure should be monitored closely during any dosage adjustment. A starting dose not exceeding 8.5 mg daily is recommended in these patient groups. Sular tablets should be administered orally once daily. Sular should be taken on an empty stomach (1 hour before or 2 hours after a meal). Grapefruit products should be avoided before and after dosing. Sular is an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.
Sular extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 25.5 mg and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:
| Strength | Color | Markings |
|---|---|---|
| 8.5 mg | Oyster | SCI 500 |
| 17 mg | Yellow Cream | SCI 501 |
| 25.5 mg | Mustard | SCI 502 |
| 34 mg | Burnt Orange | SCI 503 |
Sular Tablets are supplied in:
| Strength | NDC Code | |
|---|---|---|
| Bottles of 100 | 8.5 mg | 59630-500-10 |
| 17 mg | 59630-501-10 | |
| 25.5 mg | 59630-502-10 | |
| 34 mg | 59630-503-10 |
Protect from light and moisture. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers.
Rx Only
Sular® is a trademark of
Shionogi Pharma, Inc.
©2010 Shionogi Pharma, Inc.
Manufactured for:
Shionogi Pharma, Inc.
Atlanta, GA 30328
By: SkyePharma Production SAS
38291 Saint Quentin-Fallavier, France
Made in France
SLG-PI-06 Rev 02/10
Code 34EP5986E
Printed in the United Kingdom
NDC: 59630-500-10
Extended Release
8.5 mg tablets
Sular®
(nisoldipine)
100 Tablets
Rx Only
NDC: 59630-501-10
Extended Release
17 mg tablets
Sular®
(nisoldipine)
100 Tablets
Rx Only
NDC: 59630-502-10
Extended Release
25.5 mg tablets
Sular®
(nisoldipine)
100 Tablets
Rx Only
NDC: 59630-503-10
Extended Release
34 mg tablets
Sular®
(nisoldipine)
100 Tablets
Rx Only
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020356 | 02/02/1995 | |
| Sular nisoldipine tablet, film coated, extended release | ||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020356 | 02/02/1995 | |
| Sular nisoldipine tablet, film coated, extended release | ||||||||||||
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Mycetin may be available in the countries listed below.
Chloramphenicol is reported as an ingredient of Mycetin in the following countries:
International Drug Name Search
Brimonal may be available in the countries listed below.
Brimonidine tartrate (a derivative of Brimonidine) is reported as an ingredient of Brimonal in the following countries:
International Drug Name Search
Disulfox may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Sulfadimethoxine sodium (a derivative of Sulfadimethoxine) is reported as an ingredient of Disulfox in the following countries:
International Drug Name Search
COVERSYL ARGININE 2.5 mg Tablets
COVERSYL ARGININE 5 mg Tablets
COVERSYL ARGININE 10 mg Tablets
perindopril arginine
COVERSYL ARGININE is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them.
COVERSYL ARGININE is used:
If any of the following apply to you please talk to your doctor before taking COVERSYL ARGININE:
You must tell your doctor if you think that you are (or might become) pregnant. COVERSYL ARGININE is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
COVERSYL ARGININE is not recommended for use in children and adolescents.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Treatment with COVERSYL ARGININE can be affected by other medicines. These include:
It is preferable to take COVERSYL ARGININE before a meal.
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will normally advise you to stop taking COVERSYL ARGININE before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of COVERSYL ARGININE. COVERSYL ARGININE is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. COVERSYL ARGININE is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
COVERSYL ARGININE usually does not affect alertness but dizziness or weakness due to low blood pressure may occur in certain patients. If you are affected in this way, your ability to drive or to operate machinery may be impaired.
COVERSYL ARGININE contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take COVERSYL ARGININE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow your tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will decide on the correct dose for you.
The usual dosages are as follows:
High blood pressure: the usual starting and maintenance dose is 5 mg once daily. After one month, this can be increased to 10 mg once a day if required. 10 mg a day is the maximum recommended dose for high blood pressure.
If you are 65 or older, the usual starting dose is 2.5 mg once a day. After a month this can be increased to 5 mg once a day and then if necessary to 10 mg once daily.
Heart failure: the usual starting dose is 2.5 mg once daily. After two weeks, this can be increased to 5 mg once a day, which is the maximum recommended dose for heart failure.
Stable coronary artery disease: the usual starting dose is 5 mg once daily. After two weeks, this can be increased to 10 mg once daily, which is the maximum recommended dose in this indication.
If you are 65 or older, the usual starting dose is 2.5 mg once a day. After a week this can be increased to 5 mg once a day and after a further week to 10 mg once daily.
If you take too many tablets, contact your nearest accident and emergency department or tell your doctor immediately. The most likely effect in case of overdose is low blood pressure which can make you feel dizzy or faint. If this happens, lying down with the legs raised can help.
It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of COVERSYL ARGININE, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
As the treatment with COVERSYL ARGININE is usually life-long, you should discuss with your doctor before stopping this medicinal product.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, COVERSYL ARGININE can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking the medicinal product at once and tell your doctor immediately:
In decreasing order of frequency, side effects can include:
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use COVERSYL ARGININE after the expiry date which is stated on the carton and bottle.
The expiry date refers to the last day of that month.
Keep the bottle tightly closed in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
COVERSYL ARGININE 2.5 mg tablets are white, round, convex, film coated tablets.
COVERSYL ARGININE 5 mg tablets are light-green, rod-shaped film-coated tablets engraved with the Servier logo on one face and scored on both edges.
COVERSYL ARGININE 10 mg tablets are green, round, biconvex, film-coated tablets engraved with a heart on one face and the Servier logo on the other face.
The tablets are available in box of 5, 10, 14, 20, 30, 50, 60 (60 or 2 containers of 30), 90 (90 or 3 containers of 30), 100 (100 or 2 containers of 50), 120 (120 or 4 containers of 30) or 500 tablets (500 or 10 containers of 50).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Local contact:
Manufacturer
This leaflet was last revised in December 2009
Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or doctor at once.
Treating or preventing a lack of vitamins or minerals before, during, and after pregnancy and while breast-feeding. It may also be used for treating and preventing certain conditions as determined by your doctor.
Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate is a vitamin and mineral combination. It provides vitamins and minerals to the body to help meet nutritional requirements.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; darkened or green stools; diarrhea; nausea; stomach upset; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stools; stomach pain or cramping.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.
Store Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Prenatal Multivitamins and Minerals with Iron, Folic Acid, and L-Methylfolate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Amoxicilina Clav Ur may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilina Clav Ur in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicilina Clav Ur in the following countries:
International Drug Name Search
Boots Paracetamol and Codeine Tablets
This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.
This medicine contains two painkillers, Paracetamol and Codeine, which act to relieve pain.
It can be used for the short term treatment of acute moderate pain such as headache, migraine, toothache, period pain and rheumatic pains including muscle pains and backache that is not relieved by aspirin, ibuprofen or paracetamol alone.
This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.
You can take this medicine if you are breastfeeding.
If you are having any blood tests, stomach tests, or go into hospital, tell your doctor that you are taking this medicine.
Driving and using machines: Do not drive or use machines if you feel drowsy or dizzy after taking this medicine.
Do not drink alcohol (wine, beer, spirits) whilst taking this medicine.
Information about some of the ingredients: Ethyl hydroxybenzoate (E214), methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216) in this medicine may cause allergic reactions.
This medicine contains paracetamol.
Do not take with any other paracetamol-containing products.
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.
Check the foil is not broken before use. If it is, do not take that tablet.
Adults and children of 12 years and over: Take one or two tablets every 4 to 6 hours.
Don’t take more than 8 tablets in 24 hours.
If you have liver or kidney problems your doctor may tell you to take fewer tablets. If this applies to you follow your doctor’s instructions.
Swallow each tablet with water.
Do not take for more than 3 days. If you need to use this medicine for more than 3 days you must speak to your doctor or pharmacist.
Do not give to children under 12 years.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
If you take too many tablets: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.
This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
Most people will not have problems, but some people may have side effects when taking this medicine. If you have any unwanted side effects you should seek advice from your doctor, pharmacist or other healthcare professional.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0800 100 3352 (available between 10 am until 2 pm Monday to Friday) or fill in a paper form available from your local pharmacy.
If you get any of these serious side effects, stop taking the tablets. See a doctor at once:
These other effects are less serious. If they bother you talk to a pharmacist:
If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.
If you take this medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
Do not store above 25°C. Store in the original package.
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.
Use by the date on the end flap of the carton.
Each tablet contains Codeine Phosphate 8 mg, Paracetamol 500 mg, which are the active ingredients.
As well as the active ingredients, the tablets also contain potato starch, maize starch, talc, povidone, stearic acid, magnesium stearate, Nipasept (containing ethyl parahydroxybenzoate (E214), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)).
The pack contains 32 white tablets, with a broken breakline on one side and AB on the other side.
Manufactured for
by the Marketing Authorisation holder
Leaflet prepared December 2009
If you would like any further information about this medicine, please contact
Other formats
To request a copy of this leaflet in Braille, large print or audio please call free of charge:
0800198 5000 (UK only)
Please be ready to give the following information:
Product name: Boots Paracetamol and Codeine Tablets
Reference number: 17907/0162
This is a service provided by the Royal National Institute of Blind People.
