Rifadin 300mg Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Rifampicin

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

J04AB; J04AB02

INN (International Name):

Rifampicin

Dosage:

300 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antibiotics; rifampicin

Authorization status:

Marketed

Authorization date:

1977-02-14

Patient Information leaflet

Internal
RIFADIN
®
300MG CAPSULES
_Rifampicin _
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP.
Read all of this leaflet carefully before you start taking this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
- If any side effects gets serious, or if you notice any side effect
not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Rifadin is and what it is used for
2. Before you take Rifadin
3. How to take Rifadin
4. Possible side effects
5. How to store Rifadin
6. Further information
1. WH
1. WHAT RIFADIN IS AND WHAT IT IS USED FOR
AT RIFADIN IS AND WHAT IT IS USED FOR
Rifadin 300mg Capsules are one of a group of medicines called
antibiotics. They are used to
treat tuberculosis (also known as TB), and are active against some
other organisms.
2. BEFORE YOU TAKE RIFADIN
2. BEFORE YOU USE RIFADIN
DO NOT TAKE RIFADIN IF:
- You are allergic (hypersensitive) to rifampicin or any of the other
ingredients.
- You have yellowing of the skin and eyes (jaundice).
- You are taking saquinavir or ritonavir for HIV infection (see
‘Taking other medicines’
section below).
Do not take if any of the above apply to you. If you are not sure,
talk to your doctor, nurse or
pharmacist before taking Rifadin.
WARNINGS AND PRECAUTIONS
INFORM YOUR DOCTOR IMMEDIATELY WHILE TAKING THIS MEDICINE
• If your symptoms of tuberculosis return or get worse (see 4.
Possible side effects)
• if you develop new or sudden worsening of shortness of breath,
possibly with a dry cough
or fever not responding to antibiotic treatment. These could be
symptoms of lung
inflammation (interstitial lung disease/pneumonitis) and can lead to
serious breathing
problems due to collection of fluid in the lungs and interfere with
normal breathing which can
lead to life threatening conditions
Inte

Summary of Product characteristics

Health Products Regulatory Authority
14 March 2024
CRN00DR74
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rifadin 300mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Rifampicin 300 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsule (Capsules).
Opaque, hard gelatin capsule with scarlet body and cap, marked R-300.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications for use:
Rifadin, used in combination with other active anti-tuberculosis
drugs, is indicated in the treatment of tuberculosis and certain
other mycobacterial infections.
Rifadin is active _in vitro_ at low concentrations against
Gram-positive organisms and _N. Gonorrhoea._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended Dosage
For oral administration.
The daily dose of Rifadin, calculated from the patient’s body
weight, should preferably be taken on an empty stomach at least
30 minutes before a meal or 2 hours after a meal to ensure rapid and
complete absorption.
Rifadin should be given with other effective anti-tuberculosis drugs
to prevent the possible emergence of rifampicin-resistant
strains of Mycobacteria.
_Adults_: The recommended single daily dose in tuberculosis is 450mg
to 600mg (10mg/kg bodyweight).
_Usual Daily dose_: Patients weighing less than 50kg – 450mg.
Patients weighing 50kg or more – 600mg.
_Children_: In children over 3 months, oral doses of 15 (10-20) mg/kg
bodyweight daily are recommended, although a total daily
dose should not exceed 600mg.
Impaired liver function:
A daily dose of 8mg/kg should not be exceeded in patients with
impaired liver function.
Use in the elderly:
Caution should be exercised in using Rifampicin in such patients
especially if there is evidence of liver function impairment.
4.3 CONTRAINDICATIONS
Rifadin is contra-indicated in the presence of jaundice, and in
patients who are hypersensitive to the rifamycins or any of the
excipients (see section 6.1).
Health Products Regulatory Authority
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