RIMACTANE Capsule (2019)
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Περιεχόμενα
1. Name of the medicinal product
Rimactane 300 mg Capsules.
2. Qualitative and quantitative composition
The active ingredient is 3-(4-Methyl-1-piperazinyliminomethyl) rifamycin SV.
One capsule contains 300 mg rifampicin Ph. Eur.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules.
Opaque, two-piece, hard gelatine capsule, reddish-brown in colour, marked with 'NG 300'.
4.1. Therapeutic indications
Rifampicin is a major drug in the management of tuberculosis (all forms) and certain opportunistic mycobacterial infections. It is effective in cases resistant to other anti-tuberculosis agents and...
4.2. Posology and method of administration
For the management of tuberculosis and certain opportunistic mycobacterial infections
Rifampicin must always be given in association with other anti-tuberculosis drugs, to prevent emergence of resi...
4.3. Contraindications
Rifampicin is contraindicated in patients who:
are hypersensitive to any of the rifamycins or to any of the excipients listed in section 6.1;
have jaundice;
are concurrently receiving saquinavir/ri...
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 tuberculosi...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacodynamic Interactions
When rifampicin is given concomitantly with the combination saquinavir/ritonavir, the potential for hepatotoxicity is increased. Therefore, concomitant use of Rifampici...
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 r...
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
The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%, Unknown (cannot be es...
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 o...
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Antimycobacterials, antibiotic
ATC code:
J04AB02
Mechanism of action
Rifampicin exerts, both
in vitro
and
in vivo
bactericidal effects on Mycobacterium tuberculosi...
5.2. Pharmacokinetic properties
Absorption
Rifampicin is rapidly and completely absorbed. Following a single dose taken on an empty stomach (600 mg) the peak serum concentrations (approx. 10 g/ml) are observed after about 2 hours...
5.3. Preclinical safety data
There is limited evidence as to the carcinogenic potential of rifampicin in animals. In female mice of a strain known to be susceptible to hepatomas, a significant increase in such tumours was obse...
6.1. List of excipients
The capsules contain:
Calcium stearate
Lactose
Titanium dioxide (E171)
Iron oxide red (E172)
Iron oxide yellow (E172)
Iron oxide black (E172)
Gelatine
Shellac glaze
Propylene glycol (E1520)...
6.2. Incompatibilities
None known.
6.3. Shelf life
Four years.
6.4. Special precautions for storage
Protect from moisture and heat (store below 30°C).
Medicines should be kept out of reach of children.
6.5. Nature and contents of container
The capsules are opaque, two-piece, hard gelatine capsule size 1, reddish-brown in colour, marked with the monogram NG on each half and the code 300, and come in securitainers of 100 and PVC/PE/PVd...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
8. Marketing authorization number(s)
PL 04520/0043
9. Date of first authorization / renewal of the authorization
1 February 2000
10. Date of revision of the text
17 October 2019
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