Rifadin 100mg/5ml syrup

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Rifampicin

Предлага се от:

Sanofi

АТС код:

J04AB02

INN (Международно Name):

Rifampicin

дозиране:

20mg/1ml

Лекарствена форма:

Oral suspension

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 05010900; GTIN: 5015265300050

Листовка

_I_
Rifadin Oral Suspension is used to treat the following bacterial
infections:
•
Tuberculosis (also known as TB) alongside other medicines
•
Leprosy alongside other medicines
•
Brucellosis alongside other medicines
•
Legionnaires Diseases alongside other medicines
•
Haemophilus Influenzae
•
Other serious bacterial infections
Rifadin Oral Suspension can also be used to stop the following
infections from developing:
•
Meningitis
•
Haemophilus Influenzae in children aged 4 years or younger
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFADIN ORAL SUSPENSION
DO NOT TAKE RIFADIN ORAL SUSPENSION IF:
X
You are allergic (hypersensitive) to
- rifampicin
-
any of the other ingredients of the Rifadin Oral Suspension (see
Section 6: Further information)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling
of your lips, face, throat or tongue
X
You have yellowing of the skin and eyes (jaundice)
X
You are taking saquinavir or ritonavir for an 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 or
pharmacist before taking Rifadin Oral Suspension.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING RIFADIN ORAL
SUSPENSION
▲
You have liver problems
▲
You have any kidney problems and if you are having more than 600mg
rifampicin per day
▲
You have diabetes. Your diabetes may become more difficult to control
while taking this
medicine
▲
You feel numb or weak in your arms and legs (peripheral neuropathy)
▲
You are under weight or malnourished
▲
You have a rare blood problem called ‘porphyria’
▲
You wear contact lenses. Taking Rifadin Oral Suspension may
permanently stain soft
contact lenses
▲
The person taking this medicine is a child
▲
You are aged 65 years or older
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before
taking Rifadin Oral Suspension.
BLOOD TESTS
Your doctor will need to check your bloo

Данни за продукта

OBJECT 1
RIFADIN 100MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 20-Feb-2018 | SANOFI
1. Name of the medicinal product
Rifadin 100mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Active substance (per 5ml dose)
Rifampicin 100 mg
Excipient with known effect (per 5ml dose)
Methyl-p-hydroxybenzoate
(E218)
Propyl-p-hydroxybenzoate
(E216)
Tween 80 (Polysorbate 80)
Sucrose
Sodium metabisulphite (E223)
6.0 mg
1.5 mg
0.75 mg
2000 mg
5.00 mg
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Raspberry coloured and flavoured suspension.
4. Clinical particulars
4.1 Therapeutic indications
Indications for use
_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. Rifadin is also effective against
most atypical strains of Mycobacteria.
_Leprosy_: In combination with at least one other active anti-leprosy
drug in the management of
multibacillary and paucibacillary leprosy to effect conversion of the
infectious state to a non-infectious
state.
_Other Infections_: In the treatment of Brucellosis, Legionnaires
Disease, and serious staphylococcal
infections. To prevent emergence of resistant strains of the infecting
organisms, Rifadin should be used in
combination with another antibiotic appropriate for the infection.
_Prophylaxis of meningococcal meningitis_: For the treatment of
asymptomatic carriers of _N. meningitidis_
to eliminate meningococci from the nasopharynx.
_Haemophilus influenzae_: For the treatment of asymptomatic carriers
of _H.influenzae_ and as
chemoprophylaxis of exposed children, 4 years of age or younger.
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 at least
30 minutes before a meal or 2 hours after a meal to ensure rapid and
complete absorption.
Tuberculosis:
Rifadin should be given with other