Rifadin 100 mg/5 ml Oral Suspension

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Rifampicin

Հասանելի է:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC կոդը:

J04AB; J04AB02

INN (Միջազգային անվանումը):

Rifampicin

Դոզան:

100 mg/5ml

Դեղագործական ձեւ:

Oral suspension

Ռեկվիզորի տեսակը:

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

Թերապեւտիկ տարածք:

Antibiotics; rifampicin

Լիազորման կարգավիճակը:

Not marketed

Հաստատման ամսաթիվը:

1977-02-23

Տեղեկատվական թերթիկ

RIFADIN
®
100MG/5ML
ORAL SUSPENSION
_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 get 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. WHAT RIFADIN IS AND WHAT IT IS
1. WHAT RIFADIN IS AND WHAT IT IS USED FOR E
D FOR
Rifadin 100mg/5ml Oral Suspension is one of a group of medicines
called antibiotics. It is
used to treat tuberculosis (also known as TB) and other similar types
of infection.
2. BEFORE YOU USE RIFADIN
2. BEFORE YOU TAKE 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
TAK

Ապրանքի հատկությունները

Health Products Regulatory Authority
14 March 2024
CRN00DR74
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rifadin 100 mg/5 ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose contains 100mg Rifampicin.
Excipients: Each 5ml also contains:
Sucrose 2000mg
Methy parahydroxybenzoate (E218) 6mg
Propyl parahydroxybenzoate (E216) 1.5mg
Sodium metabisulphite (E223) 5mg
Ethanol 4.78 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
Homogenous, dark red oral suspension with a pleasant raspberry odour.
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.
Health Products Regulatory Authority
1