RIFINAH Coated tablet (2023)

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Περιεχόμενα

1. Name of the medicinal product

Rifinah 150/100 mg Tablets.

2. Qualitative and quantitative composition

Active substances (per tablet): Rifampicin 150 mg Isoniazid 100 mg Excipients with known effect (per tablet): Sucrose 110.06 mg For a full list of excipients, see section 6.1.

3. Pharmaceutical form

Coated tablet. Cyclamen, smooth, shiny, round, curved sugar coated tablet.

4.1. Therapeutic indications

Rifinah is indicated in the treatment of all forms of tuberculosis, including fresh, advanced and chronic cases.

4.2. Posology and method of administration

For oral administration. Another antituberculosis drug may be given concurrently with Rifinah until the susceptibility of the infecting organism to rifampicin and isoniazid has been confirmed. Adults ...

4.3. Contraindications

Rifinah is contraindicated in: patients who are hypersensitive to rifamycins or isoniazid or any of the excipients (see section 6.1); the presence of jaundice; concurrent treatment with the combination ...

4.4. Special warnings and precautions for use

Rifinah is a combination of 2 drugs, each of which has been associated with liver dysfunction. All tuberculosis patients should have pre-treatment measurements of liver function. Adults treated for tuberculosis ...

4.5. Interaction with other medicinal products and other forms of interaction

Interference with laboratory and diagnostic tests Therapeutic levels of rifampicin have been shown to inhibit standard microbiological assays for serum folate and Vitamin B12. Thus, alternative assay methods ...

4.6. Pregnancy and lactation

Pregnancy Rifampicin Rifampicin has been shown to be teratogenic in rodents when given in large doses. There are no well controlled studies with Rifinah in pregnant women. Although rifampicin has been ...

4.7. Effects on ability to drive and use machines

Isoniazid has been associated with vertigo, visual disorders and psychotic reactions (see section 4.8). Patients should be informed of these, and advised that if affected, they should not drive, operate ...

4.8. 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 ...

4.9. Overdose

Signs and Symptoms Rifampicin Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antimycobacterials, Combinations of drugs for treatment of tuberculosis ATC code: J04AM02 Rifampicin and isoniazid are active bactericidial antituberculosis drugs ...

5.2. Pharmacokinetic properties

Rifampicin Rifampicin is readily absorbed from the stomach and the duodenum. Peak serum concentrations of the order of 10 µg/ml occur about 2–4 hours after a dose of 10 mg/kg body weight on an empty stomach. ...

5.3. Preclinical safety data

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the Summary of Product Characteristics.

6.1. List of excipients

Tablet core: Sodium lauryl sulphate Calcium stearate Sodium carboxymethylcellulose Magnesium stearate Microcrystalline cellulose Magnesium carbonate – light Carnauba wax Colophony Beeswax white ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store below 25°C. If it proves necessary to open a blister pack, Rifinah should be dispensed in amber glass or plastic containers. Protect from moisture.

6.5. Nature and contents of container

Blister packs of 84 tablets (4 week calendar packs) in cardboard cartons. Blister material is PVC/PVDC and aluminium foil/PVC.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PTUK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

8. Marketing authorization number(s)

PL 04425/0041

9. Date of first authorization / renewal of the authorization

Date of First Authorisation: 15 December 1974 Date of latest renewal: 26 January 2005

10. Date of revision of the text

11 July 2023

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