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Active substance(s): ISONIAZID / RIFAMPICIN

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Rimactazid 150 mg / 75 mg, film-coated tablets
Rifampicin / Isoniazid
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
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness 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 Rimactazid is and what it is used for
2. What you need to know before you take Rimactazid
3. How to take Rimactazid
4. Possible side effects
5. How to store Rimactazid
6. Contents of the pack and other information


is and
it isforused for
is and
what what
it is used

Rimactazid belongs to a group of medicines called
antituberculosis agents. It is a fixed combination of two very
effective antituberculosis agents which stop the growth of
mycobacteria. These mycobacteria cause tuberculosis.
Rimactazid is used for the continuation phase treatment of


before you take
take Rimactazid

Do not take Rimactazid:
• if you are allergic (hypersensitive) to rifamycins, isoniazid,
or to any of the ingredients of this medicine (listed in
section 6)
• if you have acute liver problems or previously have had a
liver problem which was caused by drugs
• if you are known to have a condition called porphyria
• if you have severe kidney problems
• if you are currently taking any of the following
- voriconazole
- protease inhibitors except ritonavir when prescribed to
you at full dose or 600 mg twice daily.
Do not take Rimactazid if any of the above apply to you.
If you are not sure about anything, ask your doctor or
Warnings and precautions
Talk to your doctor or pharmacist before taking Rimactazid.
Tell your doctor if you have one of the following illnesses
before taking this medicine:
• Liver problems and chronic liver disease
• Kidney problems
• Diabetes mellitus
• Epilepsy
• Inflammation of peripheral nerves
• Chronic alcoholism
• Underfeeding.
You should not take Rimactazid if your body weight is
below 30 kg.
You should not interrupt treatment with Rimactazid without
consulting your doctor.
You should employ additional means of contraception apart
from taking the pill as long as you take Rimactazid.
Other medicines and Rimactazid:
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
any medicines obtained without a prescription.
Tell your doctor if you take one of the following medicines:
You must not take Rimactazid with any of the following
• voriconazole
• protease inhibitors except ritonavir
if you are prescribed a full dose or 600 mg twice daily.
You should not take Rimactazid with any of the following
• nevirapine
• simvastatin
• ritonavir
• oral contraceptives. You should use additional means of
contraception as long as you take Rimactazid.
Tell your doctor also if you take one of the following
• Medicines for irregular heart beats like class Ia
antiarrhythmics (quinidine, disopyramide), propafenone,
mexiletine, tocainide, lorcainide
• Medicines for the heart or blood pressure: calcium
antagonists (such as diltiazem, nifedipine, verapamil,
nimodipine, isradipine, nicardipine, nisoldipine), digitoxin,
digoxin, carvedilol, digoxin, beta-blockers (such as
bisoprolol, metoprolol, propranolol, carvedilol), losartan,
imidapril, enalapril
• Diuretics like eplerenone
• Medicines to suppress the immune system like
ciclosporin, tacrolimus, sirolimus, leflunomide,
• Corticosteroids
• Medicines to treat fungal infections (antifungals like

fluconazole, itraconazole, ketoconazole, voriconazole,
• Antibiotics like clarithromycin, telithromycin, dapsone,
doxycycline, fluoroquinolones, chloramphenicol, linezolid
• Medicines to treat malaria: atovaquone, quinine
• Medicines for your mood like haloperidol, clozapine,
aripiprazole, tricyclic antidepressants (like amitriptyline,
• Medicines to prevent blood clots like oral
anticoagulants, warfarin
• Hormone treatments like antioestrogens (such as
gestrinone, tamoxifene, toremifene) oestrogens and
progestagens given as hormonal replacement therapy or
contraceptives, thyroid hormones (levothyroxine)
• Medicines for pain like morphine, etoricoxib, rofecoxib
• Medicines for AIDS like saquinavir, indinavir, efavirenz,
amprenavir, nilfinavir, azatanavir, lopinavir, zidovudine,
nevirapine, stavudine
• Medicines for epilepsy like tiagabine, carbamazepine,
phenytoine, ethosuximide
• Medicines for sleeping disorders like diazepam,
benzodiazepines, buspirone, zopiclone, zolpidem,
zaleplon, hexobarbital
• Medicines for asthma like theophylline
• Medicines for diabetes like repaglinide and nateglinide
or oral antidiabetics of sulfonylurea type
• p-aminosalicylic acid (a medicine for tuberculosis and
inflammatory bowel diseases)
• Methadone (a medicine for heroin addicts)
• Medicines for stomach problems like cimetidine
• Medicines for the treatment of high blood lipids like
cloifibrate, fluvastatin, simvastatin
• Medicines for sickness like tropisetron, ondansetron
• Medicines for narcosis like halogenated volatile
• Medicines to treat cancer like imatinib, gefitinib,
• Fexofenadine (a medicine to treat hayfever)
• Praziquantel (a medicine against tapeworms)
• Oral typhoid vaccine
If you are currently taking any of these medicines, ask your
doctor about switching to a different medicine while you are
taking Rimactazid. Often, there are other medicines you can
take instead.
If you need to take a medicine for indigestion, such as an
antacid, take your tablets at least one hour before the
The following examination methods cannot be performed or
results have to be interpreted with care as long as you take
• radiographic examination of the gallbladder with contrast
• microbiological determination of folic acid plasma
• microbiological determination of cyanocobalamin (vitamin
B12) plasma concentrations.
Rimactazid with food and drink:
Do not drink any alcohol as long as you receive Rimactazid.
You should avoid food with a high content of tyramine (like
cheese, red wine) or histamine (like tuna fish). This food
taken together with Rimactazid may lead to headache,
palpitations or flushing.
Take this medicine at least one hour before a meal.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Your doctor will assess whether it is possible for you to
continue with the treatment of Rimactazid.
This medicine goes into human milk, therefore you should
not take Rimactazid when you are breast-feeding. It is
important that you tell your doctor if you are breast-feeding
or if you intend to breast-feed before receiving Rimactazid.
Driving and using machines:
This medicine can cause side effects such as dizziness,
confusion and blurred vision. This may make you less able
to do certain things, such as driving or using machines.

3. How
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. These doses are for adults
and children weighing more than 30 kg. Children weighing
less than this should not take these tablets.
The recommended dose is:
The amount of Rimactazid people take can be different, and
this depends on your body weight. Usually, you will be
given the following number of tablets:
• If you weigh 30 kilograms (kg) to 39 kg – take 2 tablets
each day
• If you weigh 40 kg to 54 kg – take 3 tablets each day
• If you weigh 55 kg to 70 kg – take 4 tablets each day
• If you weigh more than 70 kg – take 5 tablets each day.
Your doctor will prescribe the best dose for you.
Use in children
Rimactazid is not recommended for children under 6 years
of age or with a body weight of less than 30 kg.
Older people
Rimactazid is well tolerated by most older patients, but you

should inform your doctor if you are suffering from liver or
kidney disease. In some cases your doctor may
recommend that you take additional vitamin B6 as long as
you take Rimactazid.
Method of administration
You should take Rimactazid once a day during the
continuation phase of treatment.
Swallow these tablets whole with a drink of water.
Rimactazid should be taken at least 1 hour before a meal.
Duration of treatment:
Rimactazid is usually given in the continuation phase of
treatment for 4 months. Your doctor will decide on the
duration of treatment for you.
If you take more Rimactazid than you should:
If you accidentally take one tablet too many, nothing is likely
to happen. If you accidentally take several tablets too many,
contact your doctor or talk to your nearest hospital casualty
department immediately. If possible, take your tablets or the
box with you to show the doctor what you have taken.
If you forget to take Rimactazid:
If you forget to take a dose, take it as soon as possible.
However, if it is nearly time for your next dose skip the
missed dose and take the next tablet at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Rimactazid:
Always keep taking the tablets until the course is finished,
even if you feel better. If you stop taking the tablets too
soon, the infection may come back. Also, the bacteria may
become resistant to the medicine.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4.4. Possible
side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Serious side effects:
If you have any of the following symptoms of a severe
allergic reaction stop taking this medicine and tell your
doctor immediately or go to the casualty department at
your nearest hospital:
• Sudden difficulty in breathing, speaking and swallowing
• Swelling of lips, tongue, face or neck
• Extreme dizziness or collapse
• Severe or itchy skin rashes, especially if this shows
blistering and there is soreness of the eyes, mouth or
genital organs.
If you experience any of the following side effects
contact your doctor as soon as possible:
• Diarrhoea that is serious, lasts a long time or has blood in
it with stomach pain or fever: This can be a sign of
serious bowel inflammation
• Bleeding into the skin; if you continue taking Rimactazid,
you are at risk of brain haemorrhage (bleeding)
• 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)
• Inflammation of the pancreas, which causes severe pain
in the abdomen and back (pancreatitis)
• Shortage of white blood cells, accompanied by sudden
high fever, severe sore throat and ulcers in the mouth
These are all serious side effects. You may need urgent
medical attention. Serious side effects are rare (may affect
up to1 in 1,000 people) or very rare (may affect up to 1 in
10,000 people).
Other side effects
Common side effects (may affect up to 1 in 10 people):
• Tiredness, drowsiness, headache, light-headedness,
• Damage of peripheral nerves
• Reddening of the eyes, permanent discoloration of soft
contact lenses
• Nausea, vomiting, loss of appetite, abdominal pain,
bloatedness, epigastric distress
• Flushing, itching with or without skin rash, nettle rash
• Allergic or other reactions like skin rash, fever
• Increase of liver enzymes
• Disturbances of liver function which might show as loss
of appetite, nausea, vomiting, fatigue, malaise and
• Reddish discoloration of body fluids and secretions like
urine, tear fluid, sweat, sputum, stools and saliva.
Rare side effects (may affect up to 1 in 1,000 patients):
• Changes of white and red blood cell count, changes of
platelet count, anaemia
• Oedema/swelling because of water retention
• Diarrhoea
• Menstrual disturbances, swelling of breast tissue in men,
early puberty, difficulties in diabetes control, high blood
sugar, Cushing’s syndrome (disease caused by increase
of corticosteroid hormones), induction of crisis in
Addison’s patients (patients with a special form of
hormonal disorder)
• Convulsions, confusion, psychosis, hyperactivity,
euphoria, sleeplessness
• Muscular weakness, myopathy, problems with the
coordination of voluntary muscles (ataxia), increase in
seizure frequency in epileptics
• Disturbances of vision, damage to the optic nerve
• Gastritis, jaundice, inflammation of the liver (in rare cases
• Allergic and other reactions like dry mouth, heartburn,
urination disorders, rheumatic syndromes and symptoms,
pellagra (characterized by gastrointestinal disturbances,

reddening of skin, nervous and mental disorders),
swelling of lymph nodes, acne, skin rash
• Elevation of kidney enzymes, acute kidney failure,
inflammation of the kidney
• Induction of a condition called porphyria (a group of
disorders characterized by light-sensitivity, skin lesions,
anaemia, psychosis and acute abdominal pain).
If you resume therapy after an interruption of treatment with
Rimactazid, a so-called influenza-like syndrome may occur.
It is characterized by fever, shivering and possibly
headache, dizziness, bone and muscle pain. In rare cases
bleeding into the skin, breathing difficulties, asthma-like
attacks, anaemia, shock and kidney failure might develop.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme ( By reporting side
effects you can help provide more information on the safety
of this medicine.


How to
to store

Keep out of the sight and reach of children.
Do not use Rimactazid after the expiry date which is stated
on the carton, label, or blister after EXP. The expiry date
refers to the last day of that month.
Do not store above 30°C.
Blisters: Store in the original package in order to protect
from moisture.
Containers: Keep the container tightly closed in order to
protect from moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.


Contents of
of the
the pack

What Rimactazid contains
The active substances are rifampicin and isoniazid. Each
tablet contains 150 mg rifampicin and 75 mg isoniazid.
- The other ingredients are:
Tablet core:
Pregelatinised maize starch
Maize starch
Sodium laurilsulfate
Magnesium stearate
Titanium dioxide (E171)
Opadry pink 03B54929 [hypromellose, titanium dioxide
(E171), macrogol 400, red iron oxide (E172)]
Opadry clear OY-S-29019 [hypromellose, macrogol 6000]
What Rimactazid looks like and contents of the pack
Rimactazid 150 mg/75 mg, film-coated tablets are darkpink, round and biconvex.
Diameter (9.5 ± 0.4 mm) 9.1-9.9 mm
Rimactazid 150 mg/75 mg, film-coated tablets may be
packed in the following pack sizes:
Carton box with blisters containing:
30, 60, 120, 240, 672 or 1000 film-coated tablets.
White, opaque polypropylene container with polyethylene
cap containing:
500 film-coated tablets.
White, opaque polyethylene container with polypropylene
cap containing:
500 film-coated tablets.
Pack sizes of 500 and 1000 film-coated tablets are
intended for clinical use. Not all pack sizes may be
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd., Frimley Business Park, Frimley, Camberley,
Surrey GU16 7SR.
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Sandoz S.R.L., Str.Livezeni nr. 7a, RO-540472 Targu-Mures,
Genus Pharmaceuticals, Park View House,
65 London Road, Newbury, Berkshire RG14 1JN, UK.
This leaflet was last revised in 11/2013.

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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.