RIFASYNT Hard gelatin capsule (2018)

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Περιεχόμενα

1. Name of the medicinal product

Rifasynt 150 mg capsules. Rifasynt 300 mg capsules.

2. Qualitative and quantitative composition

Each capsule contains either 150 mg or 300 mg of rifampicin. Excipients with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. Each 150mg capsule contains lactose ...

3. Pharmaceutical form

Rifasynt 150 mg: Hard gelatin capsules, scarlet – scarlet size 2, for oral administration. Rifasynt 300 mg: Hard gelatin capsules, scarlet – scarlet size 1, for oral administration.

4.1. Therapeutic indications

Tuberculosis: In combination with other active anti-tuberculosis drugs in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug-resistant cases. Rifasynt is also effective ...

4.2. Posology and method of administration

Posology Tuberculosis Rifasynt should be given with other effective anti-tuberculosis drugs to prevent the possible emergence of rifampicin-resistant strains of Mycobacteria. Adults The recommended single ...

4.3. Contraindications

Rifasynt is contraindicated in patients who have hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. have jaundice. are concurrently receiving saquinavir/indinavir ...

4.4. Special warnings and precautions for use

Rifampicin should be given under the supervision of a respiratory or other suitably qualified physician. Cautions should be taken in case of renal impairment if dose >600 mg/day. All tuberculosis patients ...

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

Cytochrome P-450 enzyme interaction Rifampicin is a potent inducer of certain cytochrome P-450 enzymes. Coadministration of rifampicin with other drugs that are also metabolised through these cytochrome ...

4.6. Pregnancy and lactation

Pregnancy At very high doses in animals rifampicin has been shown to have teratogenic effects. There are no well controlled studies with rifampicin in pregnant women. Although rifampicin has been reported ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8. Undesirable effects

Reactions occurring with either daily or intermittent dosage regimens include: Blood and lymphatic system disorders Rare: Disseminated intravascular coagulation has also been rarely reported. ...

4.9. Overdose

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

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antimycobacterials, antibiotics ATC code: J04AB02 Rifampicin is an active bactericidial antituberculosis drug which is particularly active against the rapidly growing ...

5.2. Pharmacokinetic properties

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

5.3. Preclinical safety data

Not applicable.

6.1. List of excipients

Rifasynt 150 mg capsules also contain lactose monohydrate, croscarmellose sodium and magnesium stearate. The capsule shells contain gelatin, erythrosine (E127), indigo carmine (E132) and titanium dioxide ...

6.2. Incompatibilities

None known.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C, in the original package, in order to be protected fromprotected from light.

6.5. Nature and contents of container

Capsules are available packed in aluminium foil – polyvinylchloride film blisters. Rifasynt 150mg caps: Cartons containing 8, 10 and 100 capsules are available. Rifasynt 300mg caps: Cartons ...

6.6. Special precautions for disposal and other handling

For oral administration only.

7. Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

8. Marketing authorization number(s)

Rifasynt 150mg caps: 8533 Rifasynt 300mg caps: 7238

9. Date of first authorization / renewal of the authorization

Rifasynt 150mg caps: 30/10/1982 Rifasynt 300mg caps: 14/12/1979

10. Date of revision of the text

17/12/2018

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