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RIFINAH 150/100MG TABLETS

Active substance(s): ISONIAZID / RIFAMPICIN

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Blood Tests
Your doctor will need to check your blood before you take
this medicine. This will help your doctor know if any
changes happen to your blood after taking this medicine. If
you are aged 35 years or older, you will also need to have
monthly blood tests to check how your liver is working.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifinah 150/100mg
Coated Tablets
rifampicin - isoniazid

Other medicines and Rifinah 150/100mg
Tablets
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
you buy without a prescription, including herbal medicines.
This is because Rifinah 150/100mg Tablets can affect the way
some other medicines work. Also some medicines can affect
the way Rifinah 150/100mg Tablets work.
In particular, do not take this medicine, and tell your
doctor, if you are taking:
X Saquinavir or ritonavir used for HIV infection
The following medicines can make Rifinah 150/100mg
Tablets work less well:
• Antacids used for indigestion. Take Rifinah
150/100mg Tablets at least 1 hour before taking
antacids
• Other medicines used for TB such as
P-aminosalicyclic acid (PAS) and cycloserine. PAS and
Rifinah 150/100mg Tablets should be taken at least 8
hours apart
Tell your doctor if you are taking any of the following
medicines:
Heart and blood medicines
• Medicines for high blood pressure
• Medicines for heart problems or to control your
heartbeat
• Medicines used to thin the blood such as warfarin
• Medicines used to lower cholesterol
• Water tablets (diuretics) such as eplerenone
Mental health, epilepsy and motor neurone
medicines
• Medicines for thought disorders known as
‘antipsychotics’ such as haloperidol
• Medicines to calm or reduce anxiety (hypnotics,
anxiolytics)
• Medicines to help you sleep (barbiturates)
• Medicines used for epilepsy such as phenytoin and
carbamazepine
• Some medicines used for depression such as
amitriptyline and nortriptyline
• Riluzole - used for motor neurone disease
Medicines for infections and the immune system
• Some medicines used for an HIV infection such as
stavudine and zalcitabine
• Some medicines used for viral infections such as
indinavir, efavirenz, amprenavir, nelfinavir,
atazanavir, lopinavir and neviparine
• Medicines used for fungal infections
• Medicines used for bacterial infections (antibiotics)
• Medicines used for lowering your immune system
such as ciclosporin, sirolimus and tacrolimus
• Praziquantel - used for tapeworm infections
• Atovaquone - used for pneumonia
Hormone and cancer medicines
• Some hormone medicines (estrogen, systemic
hormones, progestogens) used for contraception or
some types of cancer such as ethinyloestradiol,
levonorgestrel or dydrogesterone
• Some hormone medicines (anti-estrogens) used for
breast cancer or endometriosis such as tamoxifen,
toremifene and gestrinone
• Some medicines used for cancer (cytotoxics) such as
imatinib
• Levothyroxine (thyroid hormone) used for thyroid
problems
• Irinotecan - used for cancer
Pain and inflammation medicines
• Non-steroidal anti-inflammatory drugs (NSAIDS) such
as etoricoxib, aspirin and indometacin
• Medicines used for pain such as codeine, morphine,
fentanyl or pethidine
• Corticosteroids used for inflammation such as
hydrocortisone, betamethasone and prednisolone
• Methadone - used for heroin withdrawal
Other medicines
• Medicines used for diabetes
• Medicines used to relax muscles before surgery
(anaesthetics) such as halothane
• Some medicines used for feeling sick or being sick
such as ondansetron and aprepitant
• Quinine - used for malaria
• Theophylline - used for wheezing or difficulty in
breathing
Taking Rifinah 150/100mg Tablets with food and drink
If Rifinah 150/100mg Tablets are taken with the food and
drink listed below you may experience headache, sweating,
flushing, fast, uneven or forceful heartbeat (palpitations),
dizziness, feel lightheaded or faint (due to low blood
pressure).
While taking Rifinah 150/100mg Tablets do not
have:
• Cheese
• Skipjack tuna or other tropical fish
• Red wine
Pregnancy, breast-feeding and fertility
Talk to your doctor before taking this medicine if you are
pregnant, plan to get pregnant or think you are pregnant.
Rifinah 150/100mg Tablets may make the contraceptive
“pill” work less well. This means you should change to a
different type of contraception. Instead, you must use a
reliable barrier method of contraception such as condoms
or the “coil” while taking Rifinah 150/100mg Tablets. If you
have any questions or are unsure about this talk to your
doctor or pharmacist.
You should not breast-feed if you are taking
Rifinah 150/100mg Tablets. This is because small
amounts may pass into the mothers’ milk. If you
are breast-feeding or planning to breast feed, talk
to your doctor or pharmacist before taking any
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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 cheese, skipjack tuna or drink red wine
(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 Tablet
3. How to take Rifinah 150/100mg Tablets
4. Possible side effects
5. How to store Rifinah 150/100mg Tablets
6. Contents of the pack and other information

1. What Rifinah 150/100mg Tablets are
and what they are used for

i

Rifinah 150/100mg Tablets contain two different medicines
called rifampicin and isoniazid. They both belong to a group
of medicines called anti-tuberculous drugs. They work by
killing the bacteria that cause tuberculosis.
Rifinah 150/100mg Tablets are used to treat tuberculosis
(also known as TB).

2. What you need to know before you take
Rifinah 150/100mg Tablets

Do not take Rifinah 150/100mg Tablets if:
X You are allergic (hypersensitive) to
- rifampicin
- isoniazid
- any of the other ingredients of the Rifinah
150/100mg Tablets (see Section 6: Contents of the pack
and other 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 Rifinah
150/100mg Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Rifinah 150/100mg Tablets
V You have liver problems
V You have any kidney problems and if you are having
more than 600mg rifampicin per day
V You have diabetes. Your diabetes may become more
difficult to control while taking this medicine
V You have epilepsy
V You have or have ever had mental health problems
(such as depression or schizophrenia)
V You feel numb or weak in your arms and legs
(peripheral neuropathy)
V You have an HIV infection
V You are underweight or malnourished
V You drink alcohol every day or you are an alcoholic
V You inject yourself with drugs
V You are a black or Hispanic woman
V You have a rare blood problem called ‘porphyria’
V Your doctor has told you that your body takes a long time to
get rid of some drugs (you have a slow acetylator status)
V You wear contact lenses. Taking Rifinah 150/100mg
Tablets may permanently stain soft contact lenses
V The person taking this medicine is a child
V 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 Rifinah 150/100mg Tablets.

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET
CODE:

89029011

DESCRIPTION:

RIFINAH 150/100 MG
VERSION:

4 a

OLD CODE:

DIMENSION mm:

89027257 148 x 420

89029011
(int. version 4)
COUNTRY:

COLOURS N°:

1

05 FEB 2016
LOGO VERSION:

UK

//

COLOUR 1:

REFLEX BLUE

MIN. FONT SIZE:

COLOUR 2:

9 pt.

• Yellowing of the skin or whites of the eyes, or urine
getting darker and stools paler, fatigue, weakness,
malaise, loss of appetite, nausea or vomiting caused by
liver problems (hepatitis, may affect up to 1 in 100 people).
Talk to your doctor straight away if you notice any of
the following serious side effects:
• Mental problems with unusual thoughts and strange
visions (hallucinations)
• Severe watery diarrhoea that will not stop and you are
feeling weak and have a fever. This may be something
called ‘Pseudomembranous colitis’
• Your fits get worse or you start to have fits
• Flu-like symptoms including chills, fever, headache,
dizziness and bone pains
Tell your doctor as soon as possible if you have any of
the following side effects:
• Water retention (oedema) which may cause swollen face,
stomach, arms or legs
• Muscle weakness or pain or loss of muscle reflexes
• Dizziness, feel lightheaded and faint especially when
you stand or sit up quickly (due to low blood pressure)
• Swollen fingers, toes or ankles
• Balance problems with dizziness (vertigo)
• Being unable to concentrate, feeling nervous, irritable or
depressed
• Feeling very tired and weak or difficulty sleeping (insomnia)
• Unusual skin sensations such as feeling numb, tingling,
pricking, burning or creeping on the skin (paraesthesia)
• Short-term memory loss, anxiety, being less alert or
responsive
• Blurred or distorted eyesight
• Wasting of muscles or other body tissues
• Weight loss, night sweats and fever. These could be signs
of a blood condition called eosinophilia
• Feeling sick or being sick
Tell your doctor or pharmacist if any of the following
side effects get serious or lasts longer than a few days:
• Skin flushing or itching
• Irregular periods
• Constipation, diarrhoea, stomach discomfort or dry mouth
• Headache
• Loss of appetite (anorexia)
• Breast enlargement in men
• Increased thirst, going to the toilet more often and
feeling tired. Your blood sugar may be high
• Acne
• Inflammation of the blood vessels.
Other side effects you should discuss with your doctor if
you are concerned about them
• You notice an orange or reddish colour in your urine,
sweat, phlegm (sputum), saliva or tears. This is quite
common and you need not worry. However, the red
colour may permanently stain soft contact lenses. The
red colour in tears may last for some time after you have
stopped having Rifinah 150/100mg Tablets.
Blood tests
• A blood test may show changes in the way the liver is
working
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet.
United Kingdom
You can also report side effects directly via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard
Malta
You can also report side effects directly via ADR Reporting
www.medicinesauthority.gov.mt/
adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.

Driving and using machines
You may feel dizzy or faint, have problems with vision or
have other side effects that could affect your ability to drive
while taking this medicine. If this happens, do
not drive or use any tools or
machines.
Important information about some of the ingredients of
Rifinah 150/100mg Tablets
Rifinah 150/100mg Tablets contain:
• Sucrose: If you have been told by your doctor that you
cannot tolerate some sugars, talk to your doctor before
taking Rifinah 150/100mg Tablets
• Sodium: These tablets contain less than 1 mmol sodium
(23 mg) per daily dose and are essentially ‘sodium-free’.

3. How to take Rifinah 150/100mg Tablets
Always take Rifinah 150/100mg Tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Keep taking this medicine
• You must take the tablets every day for the whole time
the doctor has told you to take them
• Do not stop and start taking the tablets. This may
increase the risk of side effects and your TB will not be
treated properly
How to take the tablets
• Take this medicine by mouth
• Swallow the tablets whole, with a drink of water
• Take at least 30 minutes before a meal or 2 hours after a
meal. They are best taken at least 30 minutes before
breakfast
• Take all your tablets together each day, as a single dose
• Do not give this medicine to children
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your doctor
Your doctor may ask you to take Vitamin B6 during
treatment with Rifinah 150/100mg Tablets, especially if you
are malnourished, elderly or a diabetic.
How much to take
The usual dose is:
Adults and the Elderly weighing less than 50kg
• 3 tablets each day
• If you are elderly, your doctor may monitor your
treatment more closely
Adults and the Elderly weighing more than 50kg
• Rifinah 300/150mg Tablets are usually prescribed
Children
This medicine is not recommended for use in children.
If you take more Rifinah 150/100mg Tablets than you
should
If you take more Rifinah 150/100mg Tablets than you
should, tell a doctor or go to a hospital casualty department
straight away. Take the medicine pack with you. This is so
the doctor knows what you have taken.
You may feel sick (nausea), be sick (vomiting), have stomach
pain, itching or a headache. You may also feel tired, sleepy,
dizzy, light-headed, have blurred or strange visions
(hallucinations) and faint or feel faint. Other signs of taking
too much include swelling of the face, eyes or eyelids,
slurring of speech, difficulty breathing, fast heartbeat,
uneven heartbeats, fits and heart attack.
If you forget to take Rifinah 150/100mg Tablets
If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the
missed dose. Do not take a double dose to make up for the
forgotten tablets.
Tests
Taking Rifinah 150/100mg Tablets may affect the results of
some blood tests. In particular, tests for folate, vitamin B12
and liver function. If you are going to have a blood test, it is
important to tell your doctor that you are taking Rifinah
150/100mg Tablets.

5. How to store Rifinah 150/100mg Tablets
Keep this medicine in a safe place where children cannot see
or reach it.
Do not use Rifinah 150/100mg Tablets after the expiry date
which is stated on the carton and blister packs. The expiry
date refers to the last day of that month.
Store below 25°C. Keep the blister in the outer carton,
protect from moisture.
Medicines should not be disposed of via waterwaste or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking and go to a hospital straight away if you
notice any of the following serious side effects:
• You have an allergic reaction. The signs may include: a
rash, swallowing or breathing problems, wheezing,
swelling of your lips, face, throat or tongue
• You get blistering, peeling, bleeding, scaling or fluid
filled patches on any part of your skin. This includes
your lips, eyes, mouth, nose, genitals, hands or feet. You
may have a serious skin problem
• You bruise more easily than usual. Or you may have a
painful rash of dark red spots under the skin which do
not go away when you press on them (purpura). This
could be because of a serious blood problem
• You have chills, tiredness, unusually pale skin colour,
shortness of breath, fast heartbeat or dark coloured
urine. These could be signs of a serious type of anaemia
• You have blood in your urine or an increase or decrease
in amount of urine you produce. You may also get
swelling, especially of the legs, ankles or feet. This may
be caused by serious kidney problems
• You have a sudden severe headache. This could be a
sign of bleeding in the brain
• Shortness of breath and wheezing
• You get confused, sleepy, cold clammy skin, shallow or
difficult breathing, a racing heartbeat or your skin is
paler than normal. These could be signs of shock
• You get more infections more easily than normal. Signs
include fever, sore throat or mouth ulcers. This could be
because you have a low number of white blood cells
• You have bleeding from your nose, ear, gums, throat,
skin or stomach. Signs may include a feeling of
tenderness and swelling in your stomach, purple spots
on your skin and black or tar-like stools
If you experience any of the following side effects
contact your doctor as soon as possible:
• Inflammation of the pancreas, which causes severe pain
in the abdomen and back (pancreatitis, frequency not
known).
• Severe extensive skin damage (separation of the epidermis
and superficial mucous membranes) (toxic epidermal
necrolysis, TEN, may affect up to 1 in 1,000 people).
• a drug reaction that causes rash, fever, inflammation of
internal organs, hematologic abnormalities and systemic
illness (DRESS syndrome, may affect up to 1 in 1,000 people).

6. Contents of the pack and other information
What Rifinah 150/100mg Tablets contain:
• Each tablet contains 150mg of rifampicin and 100mg of
isoniazid. These are the active ingredients
• The other ingredients are sodium lauryl sulphate, calcium
stearate, sodium carboxymethyl cellulose, magnesium
stearate, microcrystalline cellulose, acacia, gelatin, kaolin,
magnesium carbonate light, talc, titanium dioxide (E171),
colloidal silicon dioxide, polyvinylpyrollidone K30,
sucrose, carnauba wax, colophony, white beeswax, hard
paraffin, Erythrosine (E127).
What Rifinah 150/100mg Tablets look like and contents
of the pack
The tablets are cyclamen, smooth, shiny, round, curved and
sugar coated. Each pack contains 84 tablets.
Marketing Authorisation Holder
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi S.P.A.
Loc. Valcanello
03012 Anagni (FR)
ITALY
This leaflet does not contain all the information required
about your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in February 2016
© Sanofi 1974 - 2016
89029011

CROMinFOTO s.n.c.

Via G. Tartini, 2 - 2 0 1 5 8 - M I L A N O
Tel. 02.375787 • e-mail: crominfoto@tiscali.it

GRAFICA - FOTOCOMPOSIZIONE

AZIENDA CERTIFICATA UNI EN ISO 9001:2008

TYPE OF MATERIAL:

LEAFLET
CODE:

89029011

DESCRIPTION:

RIFINAH 150/100 MG
VERSION:

4 a

OLD CODE:

DIMENSION mm:

89027257 148 x 420

89029011
(int. version 4)
COUNTRY:

COLOURS N°:

1

05 FEB 2016
LOGO VERSION:

UK

//

COLOUR 1:

REFLEX BLUE

MIN. FONT SIZE:

COLOUR 2:

9 pt.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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