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RIFATER TABLETS

Active substance(s): ISONIAZID / PYRAZINAMIDE / RIFAMPICIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifater 50, 120,
300mg Tablets

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.

isoniazid, rifampicin, pyrazinamide

Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help
Important things you need to know about
Rifater Tablets
• It is very important that you take Rifater Tablets
exactly as your doctor has told you
• 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
• Rifater Tablets make all your body fluids an orange or
red colour. Do not worry - this is normal and not
harmful
• Take Rifater Tablets on an empty stomach. This means
at least 30 minutes before food or 2 hours after food
• While you are taking Rifater Tablets, you should not
eat cheese, skipjack tuna or drink red wine (see
‘Taking Rifater 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 the rest 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 your
pharmacist. This medicine has been prescribed for you.
Do not pass it to others. It may harm them, even if their
symptoms are the same as yours. If any of the side effects
gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
What is in this leaflet
1. What Rifater Tablets are and what they are used for
2. What you need to know before you take Rifater Tablets
3. How to take Rifater Tablets
4. Possible side effects
5. How to store Rifater Tablets
6. Contents of the pack and other information

1. What Rifater Tablets are and what
they are used for

i

Rifater Tablets contain three different medicines called
isoniazid, rifampicin and pyrazinamide. They all belong
to a group of medicines called anti-tuberculous drugs.
They work by killing the bacteria that cause tuberculosis.
Rifater Tablets are used to treat tuberculosis (also known
as TB).

2. What you need to know before you
take Rifater Tablets

Do not take Rifater Tablets if:
You are allergic (hypersensitive) to
isoniazid
rifampicin
pyrazinamide
any of the other ingredients of the Rifater Tablets (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
Rifater Tablets.
X
-

Warnings and precautions
Talk to your doctor or pharmacist before taking
Rifater Tablets
V You have liver problems
V 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 have or have ever had gout (pain or swelling in
the joints)
▲ You are coughing up blood
▲ You have epilepsy
▲ You have or have ever had mental health problems
(such as depression or schizophrenia)
▲ You feel numb or weak in your arms and legs
(peripheral neuropathy)
▲ You have an HIV infection
▲ You are under weight or malnourished
▲ You drink alcohol every day or you are an alcoholic
▲ You inject yourself with drugs
▲ You are a black or Hispanic woman
▲ You have a rare blood problem called ‘porphyria’
▲ You doctor has told you that your body takes a long
time to get rid of some drugs (you have a slow
acetylator status)
▲ You wear contact lenses. Taking Rifater Tablets 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 Rifater Tablets.

Other medicines and Rifater 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 Rifater Tablets can
affect the way some other medicines work. Also some
medicines can affect the way Rifater 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 Rifater Tablets
work less well:
• Antacids used for indigestion. Take Rifater Tablets at
least 1 hour before taking antacids
• Other medicines used for TB such as P-aminosalicyclic
acid (PAS) and cycloserine. PAS and Rifater 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, inflammation and gout 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
• Sulfinpyrazone - used for gout
Other medicines
• Medicines used for diabetes
• Medicines used to relax muscles before surgery
(anaesthetics) such as halothane
• Medicines used for erection problems such as
tadalafil
• Some medicines used for feeling sick or being sick
such as ondansetron and aprepitant
• Probenecid (used with a medicine called cidofovir
to stop kidney damage)
• Quinine - used for malaria
• Theophylline - used for wheezing or difficulty in
breathing
Taking Rifater Tablets with food and drink
If Rifater 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 Rifater Tablets do not have:
• Cheese
• Skipjack tuna or other tropical fish
• Red wine
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are
pregnant, plan to get pregnant or think you are pregnant.
Rifater 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 Rifater 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 Rifater
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 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 Rifater Tablets
Rifater Tablets contain:
• Sucrose: If you have been told by your doctor that
you can not tolerate some sugars, talk to your doctor
before taking Rifater Tablets
• Sodium: These tablets contains less than 1 mmol
sodium (23 mg) per daily dose and are essentially
‘sodium-free’.

3. How to take Rifater Tablets
Always take Rifater 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
• 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 B 6 during
treatment with Rifater Tablets, especially if you are
malnourished, elderly or a diabetic.
How much to take
The usual dose is:
Adults and the Elderly
• Between 3 and 6 tablets each day. The amount
depends on your body weight
• If you are elderly, your doctor may monitor your
treatment more closely
Children
This medicine is not recommended for use in
children.
If you take more Rifater Tablets than you should
If you take more Rifater 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 includes 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 Rifater 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 Rifater 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 Rifater
Tablets.

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. This 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).
• 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)
• Your stomach ulcer gets worse
• 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
• Being unable to concentrate, feeling nervous, irritable
or depressed
• Balance problems with dizziness (vertigo)
• 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:
• Acne
• Loss of appetite (anorexia)
• Headache
• Skin flushing or itching
• Painful, red, swollen joints
• Pain or discomfort when passing urine
• Irregular periods
• Constipation, diarrhoea, stomach discomfort or dry
mouth
• Breast enlargement in men
• Increased thirst, going to the toilet more often and
feeling tired. Your blood sugar may be high
• 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 Rifater 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. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Rifater Tablets
Keep this medicine in a safe place where children cannot
see or reach it.
Do not use Rifater 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. Store in the original container.
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.

6. Contents of the pack and other
information
What Rifater Tablets contain:
• Each tablet contains 50mg of isoniazid, 120mg of
rifampicin and 300mg of pyrazinamide. These are the
active ingredients
• The other ingredients are polyvinylpyrrolidone,
sodium carboxymethylcellulose, sodium lauryl
sulphate, calcium stearate, sucrose, acacia gum, talc,
light magnesium carbonate, kaolin, colloidal silicondioxide, aluminium hydroxide gel and colours
titanium dioxide (E171) and iron oxide (E172)
What Rifater Tablets look like and contents of the pack
The tablets are light pink, smooth, shiny, round and sugar
coated. Each pack contains 100 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 1984 - 2016

89029191

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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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