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Data Sheet

Adalat^® 10 / ADALAT^® 20

Bayer, Nifedipine

General Information

Qualitative and Quantitative Composition in terms of the active ingredient(s) per dosage form:

Adalat 10 - 1 tablet contains 10 mg nifedipine
Adalat 20 - 1 tablet contains 20 mg nifedipine

Pharmaceutical Form

Adalat 10 - film-coated tablets
Adalat 20 - film-coated tablets

Clinical Particulars

Indications

Treatment of coronary heart disease

• Chronic stable angina pectoris (angina of effort)
• Treatment of hypertension

Posology and Method of Administration

Recommended Usual Dose

As far as possible the treatment must be tailored to the needs of the individual according to the severity of the disease and the patient's response.

Depending on the clinical picture in each case, the basic dose must be introduced gradually. In patients with impaired liver function careful monitoring and, in severe cases, a dose reduction may be necessary.

Adalat 10 is particularly suitable for dose titration. Dose titration is recommended for hypertensives with severe cerebrovascular disease and for patients, who because of low body weight or multiple therapy with other antihypertensive drugs, are likely to have an excessive reaction to nifedipine. In addition, patients in whom side effects in response to the nifedipine treatment make a finer dose adjustment desirable should be individually stabilised with Adalat 10.

Unless otherwise prescribed, the following dosage guidelines apply for adults:

In Coronary Heart Disease:
Chronic stable angina pectoris (angina of effort)	1. Adalat 10 tablet twice daily (2 x 10 mg/day)
	1. Adalat 20 tablet twice daily (2 x 20 mg/day)
If higher dosages are necessary, the dose can be increased in stages up to maximum 60 mg daily.
In Hypertension:	1. Adalat 10 tablet twice daily (2 x 10 mg/day)
	1 Adalat 20 tablet twice daily (2 x 20 mg/day)
If higher dosages are necessary the dose can be increased in stages up to maximum 60 mg daily. Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see "interaction with other medicinal products and other forms of interaction".

Duration of Use

The attending doctor will determine the duration of use.

Because Adalat has a pronounced antiischemic and antihypertensive action, it should be discontinued gradually, particularly when high doses are used.

Method of Administration

Tablets are generally swallowed whole with a little liquid, independently of meals. Simultaneous food intake leads to delayed but not reduced absorption.

Grapefruit juice is to be avoided (see "interaction with other medicinal products and other forms of interaction").

Do not halve tablet.

The recommended dosage interval for Adalat 10 or Adalat 20 is about 12 hours and should not be less than 4 hours.

Contraindications

Adalat must not be used in cases of known hypersensitivity to nifedipine or to any of the excipients.

Nifedipine must not be used in pregnancy before week 20 and during breastfeeding. (See "Pregnancy and lactation").

Nifedipine must not be used in cases of cardiovascular shock.

Nifedipine must not be used in combination with rifampicin because efficient plasma levels of nifedipine may not be obtained due to enzyme induction. (See "interaction with other medicinal products and other forms of interaction").

Special Warnings and Precautions for Use

Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90 mm Hg), in cases of manifest heart failure and in the case of severe aortic stenosis.

There are no safety and efficacy data from well-controlled studies in pregnant women (see "Pregnancy and lactation").

Animal studies have shown a variety of embryotoxic, placentotoxic and foetotoxic effects when administered during and after the period of organogenesis (see "Preclinical safety data").

From the clinical evidence available a specific prenatal risk has not been identified. Although an increase in perinatal asphyxia, caesarean delivery as well as prematurity and intrauterine growth retardation have been reported. It is unclear whether these reports are due to the underlying hypertension, its treatment or to a specific drug effect.

The available information is inadequate to rule out adverse drug effects on the unborn and newborn child. Therefore any use in pregnancy after week 20 requires a very careful individual risk benefit assessment and should only be considered if all other treatment options are either not indicated or have failed to be efficacious.

Careful monitoring of blood pressure must be exercised, also when administered nifedipine with i.v. magnesium sulfate, owing to the possibility of an excessive fall in blood pressure which could harm both mother and foetus.

In patients with impaired liver function careful monitoring and, in severe cases, a dose reduction may be necessary.

Adalat OROS modified release tablets are not bioequivalent to immediate release nifedipine capsules and tablets and patients should be carefully monitored if it is decided to switch between immediate release and modified release nifedipine or vice versa.

Nifedipine is metabolised via the cytochrome P450 3A4 system. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass or the clearance of nifedipine (see "interaction with other medicinal products and other forms of interaction").

Drugs, which are weak to moderate inhibitors of the cytochrome P450 3A4 system and therefore may lead to increased plasma concentrations of nifedipine are, e.g.:

• macrolide antibiotics (e.g., erythromycin),
• anti-HIV protease inhibitors (e.g., ritonavir),
• azole antimycotics (e.g., ketoconazole),
• the antidepressants nefazodone and fluoxetine,
• quinupristin/dalfopristin,
• sodium valproate,
• cimetidine.

Upon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction of the nifedipine dose should be considered.

Since this medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interaction with other Medicinal Products and other Forms of Interaction

Drugs that affect nifedipine

The blood pressure lowering effect of nifedipine may be potentiated by co-administration of other antihypertensive drugs.

When nifedipine is administered simultaneously with ß-receptor blockers the patient should be carefully monitored, since fairly severe hypotension can occur. Deterioration of heart failure is also known to develop in isolated cases.

Nifedipine is metabolised via the cytochrome P450 3A4 system, located both in the intestinal mucosa and in the liver. Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass (after oral administration) or the clearance of nifedipine.(See "special warnings and precautions for use")

The extent as well as the duration of interactions should be taken into account when administering nifedipine together with the following drugs:

Rifampicin
Rifampicin strongly induces the cytochrome P450 3A4 system. With co-administration of rifampicin, the bioavailability of nifedipine is distinctly reduced and thus its efficacy weakened. The use of nifedipine in combination with rifampicin is therefore contra-indicated. (See "Contraindications").

Upon co-administration of the following weak to moderate inhibitors of the cytochrome P450 3A4 system the blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered (see "Posology and method of administration").

Macrolide Antibiotics (e.g. erythromycin)

No interaction studies have been carried out between nifedipine and macrolide antibiotics. Certain macrolide antibiotics are known to inhibit the cytochrome P450 3A4 mediated metabolism of other drugs. Therefore the potential for an increase of nifedipine plasma concentrations with co-administration of both drugs cannot be excluded. (See "Special warnings and precautions for use").

Azithromycin, although structurally related to the class of macrolide antibiotic is void of CYP3A4 inhibition.

Anti-HIV protease inhibitors (e.g.ritonavir)

A clinical study investigating the potential of a drug interaction between nifedipine and certain anti-HIV protease inhibitors has not yet been performed. Drugs of this class are known to inhibit the cytochrome 450 3A4 system. In addition, drugs of this class have been shown to inhibit in vitro the cytochrome P450 3A4 mediated metabolism of nifedipine. When administered together with nifedipine, a substantial increase in plasma concentrations of nifedipine due to an increased absorption and decreased elimination cannot be excluded. (See "Special warnings and precautions for use").

Azole anti-mycotics (e.g ketoconazole)
A formal interaction study investigating the potential of a drug interaction between nifedipine and certain azole anti-mycotics has not yet been performed. Drugs of this class are known to inhibit the cytochrome P450 3A4 system. When administered orally together with nifedipine, a substantial increase in systemic bioavailability of nifedipine due to an increased absorption cannot be excluded. (See "Special warnings and precautions for use").

Fluoxetine
A clinical study investigating the potential of a drug interaction between nifedipine and fluoxetine has not yet been performed. Fluoxetine has been shown to inhibit in vitro the cytochrome P450 3A4 mediated metabolism of nifedipine. Therefore an increase of nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded. (See "Special warnings and precautions for use").

Nefazodone

A clinical study investigating the potential of a drug interaction between nifedipine and nefazodone has not yet been performed. Nefazodone is known to inhibit the cytochrome P450 3A4 mediated metabolism of other drugs. Therefore an increase of nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded. (See "Special warnings and precautions for use").

Quinupristin/Dalfopristin
Simultaneous administration of quinupristin/dalfopristin and nifedipine may lead to increased plasma concentrations of nifedipine. (See "Special warnings and precautions for use").

Sodium Volproate

No formal studies have been performed to investigate the potential interaction between nifedipine and sodium volproate. As sodium volproate has been shown to increase the plasma concentrations of the structurally similar calcium channel blocker nimodipine due to enzyme inhibition, an increase in nifedipine plasma concentrations and hence an increase in efficacy cannot be excluded. (See "Special warnings and precautions for use").

Cimetidine
Due to its inhibition of cytochrome P450 3A4, cimetidine elevates the plasma concentrations of nifedipine and may potentiate the antihypertensive effect. (See "Special warnings and precautions for use").

Further studies

Cisapride
Simultaneous administration of cisapride and nifedipine may lead to increased plasma concentrations of nifedipine.

Cytochrome P450 3A4 system inducing anti-epileptic drugs, such as phenytoin, carbamazepine and phenobarbitone

Phenytoin induces the cytochrome P450 3A4 system. With co-administration of phenytoin, the bioavailability of nifedipine is reduced and its efficacy weakened. When both drugs are concomitantly administered, the clinical response to nifedipine should be monitored and, if necessary, an increase of the nifedipine dose considered. If the dose of nifedipine is increased during co-administration of both drugs, a reduction of the nifedipine dose should be considered when the treatment with phenytoin is discontinued.

No formal studies have been performed to investigate the potential interaction between nifedipine and carbamazepine or phenobarbitone. As both drugs have been shown to reduce the plasma concentrations of the structurally similar calcium channel blocker nimodipine due to enzyme induction, a decrease in nifedipine plasma concentrations and hence a decrease in efficacy cannot be excluded.

Effects of nifedipine on other drugs:

Blood pressure lowering drugs

Nifedipine may increase the blood pressure lowering effect of concomitant applied antihypertensives, such as:

• diuretics,
• β-blockers,
• ACE-inhibitors,
• AT-1 antagonists,
• other calcium antagonists,
• α-adrenergic blocking agents,
• PDE5 inhibitors,
• α-methyldopa.

When nifedipine is administered simultaneously with ß-receptor blockers the patient should be carefully monitored, since deterioration of heart failure is also known to develop in isolated cases.

Digoxin
The simultaneous administration of nifedipine and digoxin may lead to reduced digoxin clearance and hence an increase in plasma concentrations of digoxin. As a precaution therefore the patient should be checked for symptoms of digoxin overdosage and, if necessary, the dose should be reduced.

Quinidine
When nifedipine and quinidine have been administered simultaneously, occasionally lowered quinidine plasma concentrations have been observed. Also in some cases after the discontinuation of nifedipine a distinct increase in plasma concentrations of quinidine have been noted. For this reason, when nifedipine is either additionally administered or discontinued, monitoring of the quinidine plasma concentration and, if necessary, adjustment of the quinidine dose are recommended.

Tacrolimus
Tacrolimus has been shown to be metabolised via the cytochrome P450 3A4 system. Data recently published indicate that the dose of tacrolimus administered simultaneously with nifedipine may be reduced in individual cases. With co-administration the tacrolimus plasma concentrations should be monitored and, if necessary, a reduction in the tacrolimus dose considered.

Drug-food interactions:

Grapefruit juice

Grapefruit juice inhibits the cytochrome P450 3A4 system. Administration of nifedipine together with grapefruit juice thus results in elevated plasma concentrations and prolonged action of nifedipine due to a decreased first pass metabolism or reduced clearance. As a consequence, the blood pressure lowering effect may be increased. After regular intake of grapefruit juice this effect may last for at least 3 days after the last ingestion of grapefruit juice.

Ingestion of grapefruit / grapefruit juice is therefore to be avoided while taking nifedipine (see "Posology and method of administration").

Interactions Shown not to Exist

Ajmaline
Concomitant administration of nifedipine and ajmaline has no effect on the metabolism of ajmaline.

Aspirin
Concomitant administration of nifedipine and aspirin 100 mg has no effect on the pharmacokinetics of nifedipine. Co-administration of nifedipine does not alter the effect of aspirin 100 mg on the platelet aggregation and bleeding time.

Benazepril
Concomitant administration of nifedipine and benazepril has no effect on the pharmacokinetics of nifedipine.

Candesartan Cilexetil
Concomitant administration of nifedipine and candesartan cilexetil has no effect on the pharmacokinetics of either drug.

Debrisoquine
Concomitant administration of nifedipine and debrisoquine has no effect on the metabolic ratio of debrisoquine.

Doxazosin
Concomitant administration of nifedipine and doxazosin has no effect on the pharmacokinetics of nifedipine.

Irbesartan
Concomitant administration of nifedipine and irbesartan has no effect on the pharmacokinetics of irbesartan.

Omeprazole
Concomitant administration of nifedipine and omeprazole has no clinically relevant effect on the pharmacokinetics of nifedipine.

Orlistat
Concomitant administration of nifedipine and orlistat has no effect on the pharmacokinetics of nifedipine.

Pantoprazole
Concomitant administration of nifedipine and pantoprazole has no effect on the pharmacokinetics of nifedipine.

Ranitidine
Concomitant administration of nifedipine and ranitidine has no effect on the pharmacokinetics of nifedipine.

Rosiglitazone
Concomitant administration of nifedipine and rosiglitazone has no clinically relevant effect on the pharmacokinetics of nifedipine.

Talinolol
Concomitant administration of nifedipine and talinolol has no effect on the pharmacokinetics of nifedipine.

Triamterene Hydrochlorothiazide
Concomitant administration of nifedipine and triamterene hydrochlorothiazide has no effect on the pharmacokinetics of nifedipine.

Other forms of interaction:

Nifedipine may cause falsely increased spectrophotometric values of urinary vanillyl-mandelic acid. However, measurement with HPLC is unaffected.

Pregnancy and Lactation

Nifedipine is contraindicated in pregnancy before week 20 .(See" Contraindications")

There are no adequate and well controlled studies in pregnant women.

Nifedipine has been shown to produce teratogenic findings in rats, mice and rabbits, including digital anomalies, malformation of the extremities, cleft palates, cleft sternum and malformation of the ribs. Digital anomalies and malformation of the extremities are possibly a result of compromised uterine blood flow, but have also been observed in animals treated with nifedipine solely after end of the organogenesis period.

Nifedipine administration was associated with a variety of embryotoxic, placentotoxic and foetotoxic effects, including stunted foetuses (rats, mice, rabbits), small placentas and underdeveloped chorionic villi (monkeys), embryonic and foetal deaths (rats, mice, rabbits) and prolonged pregnancy/decreased neonatal survival (rats; not evaluated in other species). All of the doses associated with the teratogenic, embryotoxic or foetotoxic effects in animals were maternally toxic and several times the recommended maximum dose for humans.

In single cases of in vitro fertilisation calcium-antagonists like nifedipine have been associated with reversible biochemical changes in the spermatozoa's head section that may result in impaired sperm function. In those men who are repeatedly unsuccessful in fathering a child by in vitro fertilisation, and where no other explanation can be found, calcium-antagonists like nifedipine should be considered as possible causes.

Lactation

Nifedipine passes into the breast milk. As there is no experience of possible effects on infants, breastfeeding should first be stopped if nifedipine treatment becomes necessary during the breastfeeding period.

Effect on Ability to Drive and Use Machines

Reactions to the drug, which vary in intensity from individual to individual, can impair the ability to drive or to operate machinery. This applies particularly at the start of the treatment, on changing the medication and in combination with alcohol.

Undesirable Effects

Adverse drug reactions (ADRs) based on placebo-controlled studies with nifedipine sorted by CIOMS III categories of frequency (clinical trial data base: nifedipine n = 2,661; placebo n = 1,486; status: 22 Feb 2006 and the ACTION study: nifedipine n = 3,825; placebo n = 3,840) are listed below:

ADRs listed under "common" were observed with a frequency below 3% with the exception of oedema (9.9%) and headache (3.9%).

ADRs derived from post marketing reports (status: 15 Feb 2006) are printed in bold italic.

Common ≥1% to <10%	Uncommon ≥0.1% to <1%	Rare ≥0.01% to <0.1%	Very Rare <0.01%
	Allergic reaction Allergic oedema / angioedema (incl. larynx oedema*)	Pruritus Urticaria Rash	Anaphylactic/ anaphylactoid reaction
	Anxiety reactions Sleep disorders
Headache	Vertigo Migraine
	Dizziness Tremor
		Par-/Dysaesthesia
	Visual disturbances
	Tachycardia Palpitations
Oedema Vasodilatation	Hypotension Syncope
	Nasal congestion Nosebleed		Dyspnoea
Constipation	Gastrointestinal and abdominal pain Nausea Dyspepsia Flatulence Dry mouth	Gingival hyperplasia	Vomiting
	Transient increase in liver enzymes
	Erythema
	Muscle cramps Joint swelling
	Polyuria Dysuria
	Erectile dysfunction
Feeling unwell	Unspecific pain Chills

* = may result in life-threatening outcome

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, tachycardiac/bradycardiac heart rhythm disturbances, hyperglycaemia, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary oedema.

Management of Overdose in Man

As far as treatment is concerned, elimination of the active substance and the restoration of stable cardiovascular conditions have priority.

After oral ingestion thorough gastric lavage is indicated, if necessary in combination with irrigation of the small intestine.

Particularly in cases of intoxication with slow-release nifedipine formulations such as (Adalat 10, Adalat 20) elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.

Haemodialysis serves no purpose, as nifedipine is not dialysable, but plasmapheresis is advisable (high plasma protein binding, relatively low volume of distribution).

Bradycardiac heart rhythm disturbances may be treated symptomatically with ß-sympathomimetics, and in life-threatening bradycardiac disturbances of heart rhythm temporary pacemaker therapy can be advisable.

Hypotension as a result of cardiogenic shock and arterial vasodilation can be treated with calcium (10 - 20 ml of a 10 % calcium gluconate solution administered slowly i.v. and repeated if necessary). As a result, the serum calcium can reach the upper normal range to slightly elevated levels. If an insufficient increase in blood pressure is achieved with calcium, vasoconstricting sympathomimetics such as dopamine or noradrenaline are additionally administered. The dosage of these drugs is determined solely by the effect obtained.

Additional liquid or volume must be administered with caution because of the danger of overloading the heart.

Pharmacodynamic Properties

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. Nifedipine acts particularly on the cells of the myocardium and the smooth muscle cells of the coronary arteries and the peripheral resistance vessels.

In the heart nifedipine dilates the coronary arteries, especially the large conductance vessels, even in the free wall segment of partially stenosed areas. Further, nifedipine reduces the vascular smooth muscle tone in the coronary arteries and prevents vasospasm. The final result is an increased poststenotic blood flow and an increased oxygen supply. Parallel to this, nifedipine reduces the oxygen requirement by lowering peripheral resistance (afterload). With long-term use nifedipine can also prevent the development of new atherosclerotic lesions in the coronary arteries.

Nifedipine reduces the smooth muscle tone of the arterioles, thus lowering the increased peripheral resistance and consequently the blood pressure. At the beginning of the nifedipine treatment there may be a transient reflex increase in heart rate and thus in the cardiac output. However, this increase is not enough to compensate for the vasodilation. In addition nifedipine increases sodium and water excretion both in the short-term and long-term use. The blood-pressure-lowering effect of nifedipine is particularly pronounced in hypertensive patients.

In Raynaud's syndrome nifedipine can prevent or reduce digital vasospasm.

Pharmacokinetic Properties

Absorption

After oral administration nifedipine is rapidly and almost completely absorbed. The systemic availability of orally administered nifedipine is 45 - 56 % owing to a first pass effect. Maximum plasma and serum concentrations are reached at 1.5 to 4.2 hours with Adalat 10 and Adalat 20. Simultaneous food intake leads to delayed, but not reduced absorption.

Two Adalat 10 tablets were shown to be bioequivalent to one Adalat 20 tablet.

The following table shows the peak plasma concentrations (c_max) of Adalat 20 and the corresponding times (t_max):

Dose	cmax[mg/l]	tmax[h]
20mg	26 - 77	1.5 - 4.2

Distribution

Nifedipine is about 95 % bound to plasma protein (albumin). The distribution half-life after intravenous administration was 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 excreted in the form of its metabolites predominantly via the kidneys and about 5 - 15 % via the bile in the faeces. The unchanged substance is recovered only in traces (below 0.1 %) in the urine.

Elimination

The terminal elimination half-life is 6 - 11 hours because of delayed absorption. No accumulation of the substance after the usual dose was reported during long-term treatment.

In cases of impaired kidney function no substantial changes have been detected in comparison with healthy volunteers.

In cases of impaired liver function the elimination half-life is distinctly prolonged and the total clearance is reduced. A dose reduction may be necessary in severe cases.

Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity and carcinogenic potential.

Acute Toxicity

Acute toxicity has been investigated in various animal species and the individual results are listed in the following table:

	LD50(mg/kg)
	oral	i.v.
Mouse	494 (421 - 572)*	4.2 (3.8 - 4.6)*
Rat	1022 (950 - 1087)*	15.5 (13.7 - 17.5)*
Rabbit	250 - 500	2 - 3
Cat	~ 100	0.5 - 8
Dog	> 250	2 - 3

* 95 % confidence level

Subacute and Subchronic Toxicity

Daily oral administration to rats (50 mg/kg body weight) and to dogs (100 mg/kg body weight) over periods of 13 and 4 weeks respectively were tolerated without toxic effects.

After parenteral (i.v.) administration dogs tolerated up to 0.1 mg/kg body weight/day for 6 days without damage. Daily i.v. administration of 2.5 mg/kg body weight in rats over a period of 3 weeks was also tolerated without signs of damage.

Chronic Toxicity

Dogs tolerated up to 100 mg/kg body weight as a daily oral dose over a period of 1 year without toxic damage. In rats toxic effects occurred at concentrations above 100 ppm in the feed (about 5-7 mg/kg body weight).

Carcinogenicity

A long-term study in rats (2 years) yielded no evidence of a carcinogenic effect of nifedipine.

Reproduction Toxicology

Nifedipine has been shown to produce teratogenic findings in rats, mice and rabbits, including digital anomalies, malformation of the extremities, cleft palates, cleft sternum, malformation of the ribs.

Digital anomalies and malformation of the extremities are possibly a result of compromised uterine blood flow, but have also been observed in animals treated with nifedipine solely after end of the organogenesis period.

Nifedipine administration was associated with a variety of embryotoxic, placentotoxic and foetotoxic effects, including stunted foetuses (rats, mice, rabbits), small placentas and underdeveloped chorionic villi (monkeys), embryonic and foetal deaths (rats, mice, rabbits) and prolonged pregnancy/decreased neonatal survival (rats; not evaluated in other species). All of the doses associated with the teratogenic, embryotoxic or foetotoxic effects in animals were maternally toxic and several times the recommended maximum dose for humans

(See "Pregnancy and lactation").

Mutagenicity

To assess the mutagenic effects the Ames test, the Dominant-lethal-test, and the Micronucleus-test were performed in the mouse. No evidence of a mutagenic effect of nifedipine could be found.

Pharmaceutical Particulars

List of Excipients

Hydroxypropyl methyl cellulose, lactose, polyethylene glycol 4000, magnesium stearate, maize starch, microcrystalline cellulose, polysorbate 80, iron oxide red (E 172/C.I.77491), titanium dioxide (E 171/C.I.77891).

Incompatibilities

None

Shelf-life

48 months from the date of manufacture, stored below 25°C.

Special Precautions for Storage

None

Special Precautions for Use

The active substance nifedipine is highly light-sensitive. Therefore the film-coated tablets must not be broken, as the protection against light due to the pigment film-coating is no longer guaranteed.

The light-sensitive active substance contained in the film-coated tablets is protected from light inside and outside its packaging. Nevertheless, tablets must only be removed from the packaging immediately before use.

Adalat 10 and Adalat 20 must not be used after the expiry date.

Nature and Contents of Container

Red PVC/foil strips of 10 tablets in boxes containing 60 tablets

Instruction for Use / Handling

None

Medicine Classification

Prescription Medicine

Name and Address

Bayer New Zealand Limited
3 Argus Place
Hillcrest

North Shore 0627
New Zealand

Date of Preparation

27 Feb 2007

Source: CCDS version 21 Dated:18 Sept 2006

® Trade Mark Bayer AG, Germany