Adalat LA 20 mg prolonged-release drugs
2. Qualitative and quantitative composition
Each prolonged-release tablet consists of 20 mg nifedipine.
Each pill includes a 10% overage of nifedipine to deliver the label declare.
For the entire listing of excipients, see segment 6.1.
Three. Pharmaceutical form
Prolonged-launch tablet.
Pink, spherical, convex extended-launch pill with a laser hollow on one facet and marked with Adalat 20.
4. Clinical particulars
4.1 Therapeutic symptoms
For the remedy of slight to moderate high blood pressure.
For the prophylaxis of persistent stable angina pectoris either as monotherapy or in mixture with a beta-blocker.
Four.2 Posology and technique of management
Posology
In slight to moderate high blood pressure, the endorsed initial dose is one 20 mg tablet as soon as-daily. If essential, the dosage can be accelerated according to individual necessities as much as a most of 90 mg once-daily.
For the prophylaxis of angina pectoris, the endorsed initial dose is one 30 mg tablet once-every day. The dosage can be elevated in step with individual necessities up to a most of ninety mg once-daily.
Patients in whom hypertension or anginal signs are controlled on Adalat capsules or Adalat retard can be adequately switched to Adalat LA. Prophylactic anti-anginal efficacy is maintained whilst patients are switched from different calcium antagonists such as diltiazem or verapamil to Adalat LA. Patients switched from other calcium antagonists ought to initiate remedy at the recommended preliminary dose of 30 mg Adalat LA as soon as-every day. Subsequent titration to a better dose can be initiated as warranted clinically.
Co-management with CYP 3A4 inhibitors or CYP 3A4 inducers may additionally bring about the advice to adapt the nifedipine dose or no longer to use nifedipine at all (see section four.Five).
Duration of remedy
Treatment may be persisted indefinitely.
Additional records on unique populations
Paediatric populace
The safety and efficacy of Adalat LA in kids underneath 18 years has no longer been hooked up. Currently available facts for the usage of nifedipine in high blood pressure are described in section five.1.
Elderly
Based on pharmacokinetic statistics for Adalat LA no dose edition in elderly human beings above sixty five years is essential.
Renal impairment
Based on pharmacokinetic statistics, no dosage adjustment is required in sufferers with renal impairment (see phase five.2).
Method of administration
Oral use
The tablets need to be swallowed whole with a glass of water, either without or with meals. The pills need to be taken at approximately 24-hour durations, i.E. On the equal time each day, preferably for the duration of the morning. Adalat LA capsules should be swallowed complete; never should they be bitten, chewed or broken up.
Adalat LA ought to not be interested by grapefruit juice (see phase four.5).
Four.3 Contraindications
Adalat LA ought to not be administered to sufferers with recognized allergy to the active substance, or to different dihydropyridines because of the theoretical threat of go-reactivity, or to any of the excipients indexed in phase four.4 and six.1.
Adalat LA must now not be used in instances of cardiogenic surprise, clinically good sized aortic stenosis, risky angina, or at some stage in or within one month of a myocardial infarction.
Adalat LA need to now not be used for the treatment of acute attacks of angina.
The protection of Adalat LA in malignant hypertension has not been mounted.
Adalat LA should now not be used for secondary prevention of myocardial infarction.
Owing to the length of movement of the system, Adalat LA have to not be administered to sufferers with hepatic impairment.
Adalat LA ought to no longer be administered to sufferers with a records of gastro-intestinal obstruction, oesophageal obstruction, or any diploma of reduced lumen diameter of the gastro-intestinal tract.
Adalat LA must now not be used in patients with a Kock pouch (ileostomy after proctocolectomy).
Adalat LA is contra-indicated in sufferers with inflammatory bowel disorder or Crohn's sickness.
Adalat LA need to not be administered concomitantly with rifampicin considering powerful plasma tiers of nifedipine might not be carried out owing to enzyme induction (see section 4.Five).
4.Four Special warnings and precautions for use
Adalat LA tablets ought to be swallowed entire; under no circumstances ought to they be bitten, chewed or broken up.
Caution need to be exercised in patients with hypotension as there may be a chance of similarly discount in blood stress and care need to be exercised in sufferers with very low blood strain (extreme hypotension with systolic blood strain less than ninety mm Hg).
Adalat LA should no longer be used at some point of being pregnant unless the clinical condition of the female requires remedy with nifedipine. Adalat LA have to be reserved for girls with excessive hypertension who're unresponsive to standard therapy (see section 4.6).
Careful tracking of blood pressure need to be exercised when administering nifedipine with I.V. Magnesium sulfate, thanks to the opportunity of an excessive fall in blood stress, that can harm both mom and foetus. For further statistics concerning use in pregnancy, discuss with section 4.6.
Adalat LA isn't recommended for use for the duration of breast-feeding due to the fact nifedipine has been pronounced to be excreted in human milk and the results of nifedipine publicity to the little one aren't recognised (see section 4.6).
In patients with impaired liver function careful tracking and, in severe instances, a dose discount can be necessary.
Adalat LA may be utilized in combination with beta-blocking off pills and other antihypertensive sellers but the opportunity of an additive effect ensuing in postural hypotension ought to be borne in mind. Adalat LA will now not save you feasible rebound consequences after cessation of other antihypertensive therapy.
Adalat LA have to be used with caution in patients whose cardiac reserve is bad. Deterioration of coronary heart failure has occasionally been discovered with nifedipine.
Diabetic sufferers taking Adalat LA can also require adjustment in their manage.
In dialysis patients with malignant high blood pressure and hypovolaemia, a marked decrease in blood strain can arise.
Nifedipine is metabolised via the cytochrome P450 3A4 system. Drugs which can be recognised to both inhibit or to result in this enzyme device might also therefore alter the first pass or the clearance of nifedipine (see segment 4.Five).
Drugs, which can be recognized inhibitors of the cytochrome P450 3A4 system, and which may therefore lead to extended plasma concentrations of nifedipine include, for instance:
- macrolide antibiotics (e.G., erythromycin)
- anti-HIV protease inhibitors (e.G., ritonavir)
- azole antimycotics (e.G., ketoconazole)
- the antidepressants, nefazodone and fluoxetine
- quinupristin/dalfopristin
- valproic acid
- cimetidine
Upon co-administration with these drugs, the blood strain have to be monitored and, if necessary, a discount of the nifedipine dose must be considered.
As the outer membrane of the Adalat LA tablet is not digested, what seems to be the whole tablet can be visible in the rest room or associated with the patient's stools. Also, due to this, care have to be exercised while administering Adalat LA to patients, as obstructive symptoms can also occur. Bezoars can occur in very uncommon instances and might require surgical intervention
In single cases, obstructive signs have been defined without recognised history of gastrointestinal problems.
A false advantageous effect may be skilled while performing a barium evaluation x-ray.
For use in unique populations see phase 4.2.
Four.5 Interaction with other medicinal products and different varieties of interaction
Drugs that affect nifedipine
Nifedipine is metabolised through the cytochrome P450 3A4 device, positioned each inside the intestinal mucosa and inside the liver. Drugs that are recognized to either inhibit or to set off this enzyme system can also therefore regulate the first skip (after oral management) or the clearance of nifedipine (see Section four.Four).
The volume as well as the duration of interactions ought to be taken into account while administering nifedipine together with the subsequent pills:
Rifampicin: Rifampicin strongly induces the cytochrome P450 3A4 gadget. Upon co-management with rifampicin, the bioavailability of nifedipine is exceptionally decreased and as a consequence its efficacy weakened. The use of nifedipine in combination with rifampicin is therefore contraindicated (see Section four.Three).
Upon co-administration of acknowledged inhibitors of the cytochrome P450 3A4 machine, the blood stress have to be monitored and, if vital, a discount inside the nifedipine dose considered (see Sections 4.2 and 4.Four). In most of the people of those cases, no formal research to evaluate the potential for a drug interaction among nifedipine and the drug(s) listed have been undertaken, up to now.
Drugs growing nifedipine publicity:
- macrolide antibiotics (e.G., erythromycin)
- anti-HIV protease inhibitors (e.G., ritonavir)
- azole anti-mycotics (e.G., ketoconazole)
- fluoxetine
- nefazodone
- quinupristin/dalfopristin
- cisapride
- valproic acid
- cimetidine
- diltiazem
Upon co-administration of inducers of the cytochrome P450 3A4 system, the clinical response to nifedipine should be monitored and, if essential, an growth in the nifedipine dose considered. If the dose of nifedipine is multiplied in the course of co-management of each capsules, a reduction of the nifedipine dose need to be taken into consideration when the remedy is discontinued.
Drugs reducing nifedipine exposure:
- rifampicin (see above)
- phenytoin
- carbamazepine
- phenobarbital
Effects of nifedipine on other capsules
Nifedipine may increase the blood pressure lowering effect of concomitant implemented antihypertensives.
When nifedipine is administered simultaneously with ß-receptor blockers the patient have to be carefully monitored, since deterioration of heart failure is also known to expand in isolated instances.
Digoxin: The simultaneous administration of nifedipine and digoxin can also lead to decreased digoxin clearance and, as a result, an growth in the plasma digoxin degree. The affected person ought to therefore be subjected to precautionary assessments for symptoms of digoxin overdosage and, if vital, the glycoside dose need to be decreased.
Quinidine: Co-management of nifedipine with quinidine may additionally decrease plasma quinidine tiers, and after discontinuation of nifedipine, a awesome boom in plasma quinidine ranges can be found in person cases. Consequently, while nifedipine is both moreover administered or discontinued, tracking of the quinidine plasma concentration, and if important, adjustment of the quinidine dose are encouraged. Blood strain ought to be cautiously monitored and, if essential, the dose of nifedipine should be reduced.
Tacrolimus: Tacrolimus is metabolised through the cytochrome P450 3A4 machine. Published information suggest that the dose of tacrolimus administered concurrently with nifedipine may be decreased in character instances. Upon co-management of both pills, the tacrolimus plasma concentrations should be monitored and, if essential, a discount within the tacrolimus dose taken into consideration.
Drug meals interactions
Grapefruit juice inhibits the cytochrome P450 3A4 device. Administration of nifedipine together with grapefruit juice for this reason effects in expanded plasma concentrations and prolonged movement of nifedipine due to a reduced first skip metabolism or decreased clearance. As a result, the blood strain decreasing effect of nifedipine can be expanded. After regular intake of grapefruit juice, this impact might also ultimate for as a minimum 3 days after the final ingestion of grapefruit juice. Ingestion of grapefruit/grapefruit juice is consequently to be averted even as taking nifedipine (see Section 4.2).
Other kinds of interplay
Nifedipine can also growth the spectrophotometric values of urinary vanillylmandelic acid, falsely. However, HPLC measurements are unaffected.
4.6 Fertility, being pregnant and lactation
Pregnancy
Nifedipine should now not be used at some point of pregnancy unless the clinical situation of the female requires treatment with nifedipine (see section four.4).
In animal studies, nifedipine has been proven to produce embryotoxicity, foetotoxicity and teratogenicity (see section five.3).
There aren't any good enough nicely controlled studies in pregnant women.
From the medical proof to be had a selected prenatal threat has not been identified, although an increase in perinatal asphyxia, caesarean shipping, as well as prematurity and intrauterine growth retardation were pronounced. It is unclear whether those reports are because of the underlying hypertension, its remedy, or to a specific drug impact.
The available data is insufficient to rule out unfavorable drug results on the unborn and newborn toddler. Therefore any use in being pregnant requires a completely careful character risk benefit evaluation and should handiest be taken into consideration if all different treatment alternatives are either not indicated or have did not be efficacious.
Acute pulmonary oedema has been found whilst calcium channel blockers, among others nifedipine, had been used as a tocolytic agent all through being pregnant (see section 4.8), specially in cases of multiple pregnancy (twins or more), with the intravenous course and/or concomitant use of beta-2 agonists.
Breast-feeding
Nifedipine is excreted in the breast milk. The nifedipine concentration within the milk is nearly similar with mom serum awareness. For immediately release formulations, it is proposed to put off breast-feeding or milk expression for three to 4 hours after drug management to lower the nifedipine exposure to the little one (see section four.Four).
Fertility
In unmarried instances of in vitro fertilisation calcium antagonists like nifedipine were related to reversible biochemical adjustments within the spermatozoa's head phase that can bring about impaired sperm function. In the ones men who're again and again unsuccessful in fathering a child by using in vitro fertilisation, and where no different clarification may be determined, calcium antagonists like nifedipine need to be considered as viable causes.
4.7 Effects on ability to drive and use machines
Reactions to the drug, which vary in intensity from person to person, may also impair the potential to pressure or to function equipment (see Section 4.Eight). This applies particularly at the start of remedy, on changing the drugs and in combination with alcohol.
4.8 Undesirable results
Adverse drug reactions (ADRs) based on placebo-managed research with nifedipine sorted by using CIOMS III categories of frequency (scientific trial information base: nifedipine n = 2,661; placebo n = 1,486; reputation: 22 Feb 2006 and the ACTION examine: nifedipine n = 3,825; placebo n = three,840) are indexed beneath:
ADRs listed underneath "commonplace" had been observed with a frequency underneath 3% excluding oedema (9.9%) and headache (3.9%).
The frequencies of ADRs said with nifedipine-containing products are summarised in the table underneath. Within each frequency grouping, undesirable results are offered in order of lowering seriousness. Frequencies are defined as commonplace (≥1/one hundred to < 1/10), uncommon (≥ 1/1,000 to < 1/a hundred) and uncommon (≥ 1/10,000 to < 1/1,000). The ADRs identified only during the ongoing postmarketing surveillance, and for which a frequency could not be estimated, are listed under “Not known”.
System Organ Class (MedDRA)
Common
Uncommon
Rare
Not Known
Blood and Lymphatic System Disorders
Agranulocytosis
Leucopenia
Immune System Disorders
Allergic reaction
Allergic oedema/angioedema (incl. Larynx oedema*)
Pruritus
Urticaria
Rash
Anaphylactic/ anaphylactoid reaction
Psychiatric Disorders
Anxiety reactions
Sleep disorders
Metabolism and Nutrition Disorders
Hyperglycaemia
Nervous System Disorders
Headache
Vertigo
Migraine
Dizziness
Tremor
Par-/Dysaesthesia
Hypoaesthesia
Somnolence
Eye Disorders
Visual disturbances
Eye pain
Cardiac Disorders
Tachycardia
Palpitations
Chest pain
(Angina pectoris)
Vascular Disorders
Oedema (incl. Peripheral oedema)
Vasodilatation
Hypotension
Syncope
Respiratory, Thoracic and Mediastinal Disorders
Nosebleed
Nasal congestion
Dyspnoea
Pulmonary oedema**
Gastrointestinal Disorders
Constipation
Gastrointestinal and abdominal pain
Nausea
Dyspepsia
Flatulence
Dry mouth
Gingival hyperplasia
Bezoar
Dysphagia
Intestinal obstruction
Intestinal ulcer
Vomiting
Gastroesophageal sphincter insufficiency
Hepatobiliary Disorders
Transient increase in liver enzymes
Jaundice
Skin and Subcutaneous Tissue Disorders
Erythema
Toxic Epidermal Necrolysis
Photosensitivity allergic reaction
Palpable purpura
Musculoskeletal and Connective Tissue Disorders
Muscle cramps
Joint swelling
Arthralgia
Myalgia
Renal and Urinary Disorders
Polyuria
Dysuria
Reproductive System and Breast Disorders
Erectile dysfunction
General Disorders and Administration Site Conditions
Feeling unwell
Unspecific pain
Chills
* = may result in life-threatening outcome
**cases have been reported when used as tocolytic during pregnancy (see section 4.6)
In dialysis patients with malignant hypertension and hypovolaemia a distinct fall in blood pressure can occur as a result of vasodilation.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.Mhra.Gov.Uk/yellowcard.
4.9 Overdose
Symptoms
The following symptoms are observed in cases of severe nifedipine intoxication:
Disturbances of consciousness to the point of coma, a drop in blood pressure, tachycardia, bradycardia, hyperglycaemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary oedema.
Treatment
As far as treatment is concerned, elimination of nifedipine and the restoration of stable cardiovascular conditions have priority. Elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.
The benefit of gastric decontamination is uncertain.
1. Consider activated charcoal (50 g for adults, 1 g/kg for children) if the patient presents within 1 hour of ingestion of a potentially toxic amount.
Although it may seem reasonable to assume that late administration of activated charcoal may be beneficial for sustained release (SR, MR) preparations there is no evidence to support this.
2. Alternatively consider gastric lavage in adults within 1 hour of a potentially life-threatening overdose.
3. Consider further doses of activated charcoal every 4 hours if a clinically significant amount of a sustained release preparation has been ingested with a single dose of an osmotic laxative (e.G. Sorbitol, lactulose or magnesium sulphate).
4. Asymptomatic patients should be observed for at least 4 hours after ingestion and for 12 hours if a sustained release preparation has been taken.
Haemodialysis serves no purpose as nifedipine is not dialysable, but plasmapheresis is advisable (high plasma protein binding, relatively low volume of distribution).
Hypotension as a result of cardiogenic shock and arterial vasodilatation can be treated with calcium (10-20 ml of a 10 % calcium gluconate solution administered intravenously over 5-10 minutes). If the effects are inadequate, the treatment can be continued, with ECG monitoring. If an insufficient increase in blood pressure is achieved with calcium, vasoconstricting sympathomimetics such as dopamine or noradrenaline should be administered. The dosage of these drugs should be determined by the patient's response.
Symptomatic bradycardia may be treated with atropine, beta-sympathomimetics or a temporary cardiac pacemaker, as required.
Additional fluids should be administered with caution to avoid cardiac overload.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: selective calcium channel blockers with mainly vascular effect, dihydropyridine derivatives, ATC code: C08CA05
Nifedipine is a calcium antagonist of the 1,4-dihydropyridine type. Calcium antagonists reduce the transmembranal influx of calcium ions through the slow calcium channel into the cell. As a specific and potent calcium antagonist, nifedipine acts particularly on the cells of the myocardium and the smooth muscle cells of the coronary arteries and the peripheral resistance vessels. The main action of nifedipine is to relax arterial smooth muscle, both in the coronary and peripheral circulation. The Adalat LA tablet is formulated to achieve controlled delivery of nifedipine in a release profile sufficient to enable once-daily administration to be effective in clinical use.
In hypertension, the main action of nifedipine is to cause peripheral vasodilatation and thus reduce peripheral resistance. Nifedipine administered once-daily provides 24-hour control of raised blood pressure. Nifedipine causes reduction in blood pressure such that the percentage lowering is proportional to its initial level. In normotensive individuals, nifedipine has little or no effect on blood pressure.
In angina, Adalat LA reduces peripheral and coronary vascular resistance, leading to an increase in coronary blood flow, cardiac output and stroke volume, whilst decreasing after-load. Additionally, nifedipine dilates submaximally both clear and atherosclerotic coronary arteries, thus protecting the heart against coronary artery spasm and improving perfusion to the ischaemic myocardium. Nifedipine reduces the frequency of painful attacks and the ischaemic ECG changes irrespective of the relative contribution from coronary artery spasm or atherosclerosis.
In a multi-national, randomised, double-blind, prospective study involving 6321 hypertensive patients with at least one additional risk factor followed over 3 to 4.8 years, Adalat LA 30 and 60 (nifedipine GITS) were shown to reduce blood pressure to a comparable degree as a standard diuretic combination.
Paediatric population
Limited information on comparison of nifedipine with other antihypertensives is available for both acute hypertension and long-term hypertension with different formulations in different dosages. Antihypertensive effects of nifedipine have been demonstrated but dose recommendations, long term safety and effect on cardiovascular outcome remain unestablished. Pediatric dosing forms are lacking.
5.2 Pharmacokinetic properties
General characteristics:
Adalat LA tablets are formulated to provide nifedipine at an approximately constant rate over 24 hours. Nifedipine is released from the tablet at a zero-order rate by a membrane-controlled, osmotic push-pull process. The pharmacokinetic profile of this formulation is characterized by low peak-trough fluctuation. 0-24 hour plasma concentration versus time profiles at steady state are plateau-like, rendering the Adalat LA tablet appropriate for once-a-day administration.
The delivery rate is independent of gastrointestinal pH or motility. Upon swallowing, the biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the faeces as an insoluble shell.
Absorption
Orally administered nifedipine is almost completely absorbed in the gastro-intestinal tract. The systemic availability of orally administered nifedipine immediate release formulations (nifedipine capsules) is 45–56% owing to a first pass effect. At steady-state, the bioavailability of Adalat LA tablets ranges from 68-86% relative to Adalat capsules. Administration in the presence of food slightly alters the early rate of absorption but does not influence the extent of drug availability.
Distribution
Nifedipine is about 95% bound to plasma protein (albumin). The distribution half-life after intravenous administration has been determined to be 5 to 6 minutes.
Biotransformation
After oral administration, nifedipine is metabolised in the gut wall and in the liver, primarily by oxidative processes. These metabolites show no pharmacodynamic activity. Nifedipine is eliminated in the form of its metabolites, predominantly via the kidneys, with approximately 5-15% being excreted via the bile in the faeces. Non-metabolised nifedipine can be detected only in traces (below 0.1%) in the urine.
Elimination
The terminal elimination half-life is 1.7 to 3.4 h in conventional formulations (nifedipine capsules). The terminal half-life following Adalat LA administration does not represent a meaningful parameter as a plateau-like plasma concentration is maintained during release from the tablets and absorption. After release and absorption of the last dose the plasma concentration finally declines with an elimination half-life as seen in conventional formulations.
Characteristics in patients:
There are no significant differences in the pharmacokinetics of nifedipine between healthy subjects and subjects with renal impairment. Therefore, dosage adjustment is not needed in these patients.
In patients with hepatic impairment, the elimination half-life is distinctly prolonged and the total clearance is reduced. Owing to the duration of action of the formulation, Adalat LA should not be administered in these patients.
5.3 Preclinical safety data
Preclinical data reveal no special hazards for humans based on conventional studies of single and repeated dose toxicity, genotoxicity and carcinogenic potential.
Following acute oral and intravenous administration of nifedipine in various animal species, the following LD50 (mg/kg) values were obtained:
Mouse:
Oral: 494 (421-572)*;
I.V.: 4.2 (3.8-4.6)*.
Rat:
Oral: 1022 (950-1087)*;
I.V.: 15.5 (13.7-17.5)*.
Rabbit
Oral: 250-500;
I.V.: 2-3.
Cat:
Oral: ~ 100;
I.V.: 0.5-8.
Dog:
Oral: > 250;
I.V.: 2-3.
* ninety five% self belief c program languageperiod.
In subacute and subchronic toxicity research in rats and dogs, nifedipine changed into tolerated without damage at doses of up to 50 mg/kg (rats) and 100 mg/kg (dogs) p.O. Over intervals of thirteen and four weeks, respectively. Following intravenous management, puppies tolerated as much as zero.1 mg/kg nifedipine for six days without harm. Rats tolerated every day intravenous management of 2.5 mg/kg nifedipine over a length of 3 weeks without damage.
In continual toxicity research in puppies with treatment lasting as much as twelve months, nifedipine was tolerated without harm at doses as much as and which include 100 mg/kg p.O. In rats, toxic consequences came about at concentrations above a hundred ppm in the feed (about five-7 mg/kg body weight).
In a carcinogenicity examine in rats (two years), there was no proof of a carcinogenic effect of nifedipine.
Nifedipine has been shown to produce teratogenic findings in rats, mice and rabbits, such as digital anomalies, malformation of the extremities, cleft palates, cleft sternum and malformation of the ribs.
Digital anomalies and malformation of the extremities are probably a result of compromised uterine blood float, but have also been observed in animals treated with nifedipine completely after the end of the organogenesis period.
Nifedipine management become associated with a variety of embryotoxic, placentotoxic and foetotoxic effects, such as stunted foetuses (rats, mice, rabbits), small placentas and underdeveloped chorionic villi (monkeys), embryonic and foetal deaths (rats, mice, rabbits) and prolonged being pregnant/reduced neonatal survival (rats; no longer evaluated in different species). The risk to humans can't be ruled out if a sufficiently excessive systemic exposure is performed, however, all of the doses associated with the teratogenic, embryotoxic or foetotoxic outcomes in animals were maternally toxic and were several instances the advocated maximum dose for human beings.
In in vitro and in vivo exams, nifedipine has no longer been related to mutagenic residences.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet Core
Polyethylene oxide
Hypromellose (5 cp)
Magnesium stearate
Sodium chloride
Ferric oxide, pink (E172)
Coating
Cellulose acetate
Macrogol (3350)
Hydroxypropylcellulose
Hypromellose (three cp)
Propylene glycol
Hypromellose (five cp)
Titanium dioxide (E171)
Ferric oxide, red (E172)
Polish and Print
Black ink for printing Opacode S-1-8106
(Contains: iron oxide black (E172) and Shellac)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
PP blister packs: four years
6.Four Special precautions for storage
Store inside the authentic field. The tablets need to be protected from robust mild.
6.5 Nature and contents of field
Blister packs composed of PP backed with aluminium foil, containing 28 capsules.
6.6 Special precautions for disposal and other managing
No additional information
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