Rifinah 150mg/100mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Rifampicin; Isoniazid

זמין מ:

Sanofi

קוד ATC:

J04AM02

INN (שם בינלאומי):

Rifampicin; Isoniazid

כמות:

150mg ; 100mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 05010900; GTIN: 5015265300081

עלון מידע

TURN
OVER
_i_
IMPORTANT THINGS YOU KNOW NEED TO ABOUT
RIFINAH 150/100MG TABLETS
The name of your medicine is Rifinah 150/100mg Coated
Tablets (called Rifinah 150/100mg Tablets in this leaflet).
•
It is very important that you take Rifinah 150/100mg Tablets
exactly as your doctor has told you. There is a chance of you
having a severe and dangerous allergic reaction if you do not
take your tablets every day as you are told
•
You must keep taking it until your doctor tells you to stop.
•
If you are taking any other medicines, including medicines
you have bought from the pharmacy or shop, you must make
sure your doctor knows
•
Rifinah 150/100mg Tablets makes all of your body fluids an
orange or red colour. Do not worry - this is normal and not
harmful
•
Take Rifinah 150/100mg Tablets on an empty stomach. This
means at least 30 minutes before food or 2 hours after food
•
While you are taking Rifinah 150/100mg Tablets, you should
not eat matured cheeses, cured meat, some fish (like tuna,
salmon and mackerel) or drink wine and beer (see ‘Taking
Rifinah 150/100mg Tablets with food and drink’)
•
If you get a temperature, are sick, begin to feel more unwell,
lose your appetite or have yellowing of the skin, gums or
eyes, you must talk to your doctor straight away.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
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 only. Do not pass it to others. It
may harm them, even if their symptoms are the same as yours.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET:
1. What Rifinah 150/100mg Tablets are and what they are
used for
2. What you need to know before you take Rifinah 150/100mg
Tablets
3. How to take Rifinah 150/100mg Tablets
4. Possible side effects
5. How

מאפייני מוצר

OBJECT 1
RIFINAH 150MG/100MG TABLETS
Summary of Product Characteristics Updated 06-Aug-2019 | SANOFI
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Rifinah 150/100mg Tablets
2. Qualitative and quantitative composition
Active substances (per tablet):
Rifampicin 150mg
Isoniazid 100mg
Excipients with known effect (per tablet):
Sucrose 110.06mg
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated tablet
Cyclamen, smooth, shiny, round, curved sugar coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
Rifinah is indicated in the treatment of all forms of tuberculosis,
including fresh, advanced and chronic cases.
4.2 Posology and method of administration
For oral administration.
Another antituberculosis drug may be given concurrently with Rifinah
until the susceptibility of the infecting
organism to rifampicin and isoniazid has been confirmed.
_Adults:_ Patients should be given the following single daily dose
preferably on an empty stomach at least