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RIFINAH 300 TABLETS

Active substance(s): ISONIAZID / RIFAMPICIN

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Rifinah® 300 Tablets

0460
06.06.16[13]

(isoniazid, rifampicin)
PATIENT INFORMATION LEAFLET
Important things you need to know about Rifinah 300 Tablets
- It is very important that you take Rifinah 300 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 300 Tablets makes all your body fluids an orange or red colour.
Do not worry - this is normal and not harmful
- Take Rifinah 300 Tablets on an empty stomach. This means at least 30
minutes before food or 2 hours after food
- While you are taking Rifinah 300 Tablets, you should not eat cheese,
skipjack tuna or drink red wine (see ‘Taking Rifinah 300 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 300 Tablets are and what they are used for
2. What you need to know before you take Rifinah 300 Tablets
3. How to take Rifinah 300 Tablets
4. Possible side effects
5. How to store Rifinah 300 Tablets
6. Contents of the pack and other information
1. WHAT RIFINAH 300 TABLETS ARE AND WHAT THEY ARE USED
FOR
Rifinah 300 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 300 Tablets are used to treat tuberculosis (also known as TB).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RIFINAH 300
TABLETS
Do not take Rifinah 300 Tablets if:
- You are allergic (hypersensitive) to
- rifampicin
- isoniazid
- any of the other ingredients of the Rifinah 300 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
- You have yellowing of the skin and eyes (jaundice)
- 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 300 Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rifinah 300 Tablets
- 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 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 underweight 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’
- Your 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 Rifinah 300 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 Rifinah 300 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.
Other medicines and Rifinah 300 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 300
Tablets can affect the way some other medicines work. Also some
medicines can affect the way Rifinah 300 Tablets work.
In particular, do not take this medicine, and tell your doctor, if you are
taking:
- Saquinavir or ritonavir used for HIV infection
The following medicines can make Rifinah 300 Tablets work less well:
- Antacids used for indigestion. Take Rifinah 300 Tablets at least 1 hour
before taking antacids
- Other medicines used for TB such as P-aminosalicyclic acid (PAS) and
cycloserine. PAS and Rifinah 300 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 300 Tablets with food and drink
If Rifinah 300 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 300 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 300 Tablets may make the contraceptive “pill” work less well. This
means you should change to a different type of contraception. Instead, you
must use reliable barrier method of contraception such as condoms or the
“coil” while taking Rifinah 300 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 300 Tablets. This is
because small amounts may pass into the mothers’ milk. If you are breastfeeding 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 Rifinah 300
Tablets
Rifinah 300 Tablets contain:
- Sunset yellow: This is a colouring agent that may cause allergic
reactions
- Sucrose: If you have been told by your doctor that you cannot tolerate
some sugars, talk to your doctor before taking Rifinah 300 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 300 TABLETS
Always take Rifinah 300 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 30minutes 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
300 Tablets, especially if you are malnourished, elderly or a diabetic.
How much to take
The usual dose is:
Adults and the Elderly weighing more than 50kg
- Two tablets each day
- If you are elderly, your doctor may monitor your treatment more closely
Adults and the Elderly weighing less than 50kg
- Rifinah 150 Tablets are usually prescribed
Children
This medicine is not recommended for use in children.
If you take more Rifinah 300 Tablets than you should

If you take more Rifinah 300 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.

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 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.

United Kingdom
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

If you forget to take Rifinah 300 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 300 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 300 Tablets.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Rifinah 300 Tablets 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

Malta
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203
Level 3, Rue D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE RIFINAH 300 TABLETS
Do not use your tablets after the expiry date shown on the box.
Keep your medicine in a safe place where children cannot see or reach it.
Your medicine could harm them.
Protect your tablets from moisture and store them below 25°C.
If your doctor decides to stop your treatment return any left over medicine to
the pharmacist. Only keep them if the doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Rifinah 300 Tablets contain:
They contain two active ingredients. Each tablet contains 150mg of
isoniazid and 300mg of rifampicin.
The tablets also contain sodium lauryl sulphate, calcium stearate, sodium
carboxymethylcellulose, magnesium stearate, Avicel PH 101
(microcrystalline cellulose), acacia, gelatin, kaolin, magnesium carbonate,
talc, polyvinylpyrollidone K-30, sucrose, titanium dioxide, aerosil 200,
aluminium lacquer 17% (E-110) and FDC yellow dye.
What Rifinah 300 Tablets look like and contents of the pack
Rifinah 300 Tablets are orange, smooth, shiny, capsule shaped and sugar
coated tablets.
Rifinah 300 Tablets are available in blister packs of 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Rifinah 300 Tablets are manufactured by Sanofi-aventis SpA,
(Località) Valcanello, Casella Postale N46, 03012 Anagni (Frosinone), Italy.
Procured from within the EU and Repackaged by Product Licence holder
P.I.E. Pharma Ltd, 207 Kenton Road, Harrow, Middlesex HA3 0HD.
POM

PL 15361/0460

Leaflet revision and issue date (Ref.) 06.06.16[13]
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)
- 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 300 Tablets.
Blood tests
- A blood test may show changes in the way the liver is working

Rifinah® is a trademark of Gruppo Lepetit SpA.

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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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