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SPC, UK: TILDIEM 60mg Modified-release tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tildiem 60mg Modified-Release Tablets.

Qualitative and quantitative composition

Each tablet contains 60mg of the active substance diltiazem hydrochloride. Also contains 125.5mg of lactose monohydrate and 28mg of hydrogenated castor oil. For a full list of excipients, see section 6.1. ...

Pharmaceutical form

Modified release tablet. White, round, biconvex tablets engraved withTILDIEM 60' or DILT 60 or DTZ 60 on one side.

Therapeutic indications

Prophylaxis and treatment of Angina Pectoris.

Posology and method of administration

Adults The usual dose is one tablet (60mg) three times daily. However, patient responses may vary and dosage requirements can differ significantly between individual patients. If necessary the divided ...

Contraindications

Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker. Severe bradycardia (less than 50 beats per minute). Left ventricular failure with pulmonary stasis. Lactation. ...

Special warnings and precautions for use

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Close observation is necessary in patients ...

Interaction with other medicinal products and other forms of interaction

Combination contraindicated for safety reasons Dantrolene (infusion) Lethal ventricular fibrillation is regularly observed in animals when intravenous verapamil and dantrolene are administered concomitantly. ...

Pregnancy and lactation

Pregnancy There are very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity (see section 5.3) in certain animal species (rat, mice, rabbit). ...

Effects on ability to drive and use machines

On the basis of reported adverse drug reactions, i.e. dizziness (common), malaise (common), the ability to drive and use machines could be altered. However, no studies have been performed.

Undesirable effects

The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known ...

Overdose

The clinical effects of acute overdose can involve pronounced hypotension leading to collapse and acute kidney injury, sinus bradycardia with or without isorhythmic dissociation, sinus arrest, atrioventricular ...

Pharmacodynamic properties

Pharmacotherapeutic group: Calcium channel blockers; Benzothiazepine derivatives ATC code: C08DB01 Tildiem is a calcium antagonist. It restricts the slow channel entry of calcium into the cell and so ...

Pharmacokinetic properties

Diltiazem hydrochloride is effective in angina, protecting the heart against ischaemia, vasodilating coronary arteries and reducing myocardial oxygen requirements. It is well tolerated and does not generally ...

Preclinical safety data

Pregnancy Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from 4 to 6 times (depending on species) the upper limit of the optimum dosage range in clinical ...

List of excipients

Lactose monohydrate Macrogol 6000 Hydrogenated castor oil Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/foil blister packs of 90 and 100 tablets. Securitainers, polypropylene body with polyethylene cap containing 50, 100 and 500 tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization number(s)

PL 04425/0640

Date of first authorization / renewal of the authorization

Date of first authorisation: 8 March 1984 Date of latest renewal: 23 September 2005

Date of revision of the text

18 March 2019

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