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RIMACTAZID 150 MG/75 MG FILM-COATED TABLET

Active substance(s): ISONIAZID / RIFAMPICIN / ISONIAZID / RIFAMPICIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

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
pharmacist.
• 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

1.

What Rimactazid is and what it is used for

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
tuberculosis.

2.

What you need to know before you 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 medications:
- voriconazole
- protease inhibitors except ritonavir when prescribed to you
at full dose or 600 mg twice daily.

doxycycline, fluoroquinolones, chloramphenicol, linezolid
• Medicines to treat malaria: atovaquone, quinine
• Medicines for your mood like haloperidol, clozapine,
aripiprazole, , tricyclic antidepressants (like amitriptyline,
nortriptyline) ,
• Medicines to prevent blood clots like oral anticoagulants,
warfarin,
• Hormone treatments like antioestrogens (such as
gestrinone, tamoxifene, toremifene) estrogens 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
anesthetics
• Medicines to treat cancer like imatinib, gefitinib, irinotecan
• 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 antacid.

The following examination methods cannot be performed or
results have to be interpreted with care as long as you take
Rimactazid:
• radiographic examination of the gallbladder with contrast media
Do not take Rimactazid if any of the above apply to you.
• microbiological determination of folic acid plasma
concentrations
If you are not sure about anything, ask your doctor or pharmacist.
• microbiological determination of cyanocobalamin (vitamin
B12) plasma concentrations
Warnings and precautions
Talk to your doctor or pharmacist before taking Rimactazid.
Rimactazid with food and drink:
Tell your doctor if you have one of the following illnesses
Do not drink any alcohol as long as you receive Rimactazid.
before taking this medicine:
You should avoid food with a high content of tyramine (like
• Liver problems and chronic liver disease
cheese, red wine) or histamine (like tuna fish). This food taken
• Kidney problems
together with Rimactazid may lead to headache, palpitations or
• Diabetes mellitus
flushing.
• Epilepsy
Take this medicine at least one hour before a meal.
• Inflammation of peripheral nerves
• Chronic alcoholism
Pregnancy and breast-feeding:
• Underfeeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
You should not take Rimactazid if your body weight is below 30 kg.
pharmacist for advice before taking this medicine.Your doctor
will assess whether it is possible for you to continue with the
You should not interrupt treatment with Rimactazid without
treatment of Rimactazid.
consulting your doctor.
This medicine goes into human milk, therefore you should not
You should employ additional means of contraception apart
take Rimactazid when you are breast-feeding. It is important
from taking the pill as long as you take Rimactazid.
that you tell your doctor if you are breast-feeding or if you
intend to breast-feed before receiving 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
medications:
• 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
medications:
• 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:
• 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, azathioprine
• Corticosteroids
• Medicines to treat fungal infections (antifungals like
fluconazole, itraconazole, ketoconazole, voriconazole,
terbinafine)
• Antibiotics like clarithromycin, telithromycin, dapsone,

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 to take Rimactazid

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:

Adults:
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.

Continued on the next page >>

Use in children
Rimactazid is not recommended for children under 6 years of
age or with a body weight of less than 30 kg.

• Disturbances of vision, damage to the optic nerve
• Gastritis, jaundice, inflammation of the liver (in rare cases
severe)
• Allergic and other reactions like dry mouth, heartburn,
Older people
urination disorders, rheumatic syndromes and symptoms,
Rimactazid is well tolerated by most older patients, but you
pellagra (characterized by gastrointestinal disturbances,
should inform your doctor if you are suffering from liver or
reddening of skin, nervous and mental disorders), swelling of
kidney disease. In some cases your doctor may recommend
lymph nodes, acne, skin rash
that you take additional vitamin B6 as long as you take
• Elevation of kidney enzymes, acute kidney failure,
Rimactazid.
inflammation of the kidney
• Induction of a condition called porphyria (a group of
Method of administration
disorders characterized by light-sensitivity, skin lesions,
You should take Rimactazid once a day during the continuation
anaemia, psychosis and acute abdominal pain)
phase of treatment.
Swallow these tablets whole with a drink of water.
If you resume therapy after an interruption of treatment with
Rimactazid should be taken at least 1 hour before a meal.
Rimactazid, a so-called influenza-like syndrome may occur.
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.

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
(agranulocytosis).
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, dizziness
• 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 weakness
• 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, Cushingʼs syndrome (disease caused by increase of
corticosteroid hormones), induction of crisis in Addisonʼs
patients (patients with a special form of hormonal disorder)
• Convulsions, confusion, psychosis, hyperactivity, euphoria,
sleeplessness
• Muscular weakness, myopathy, problems with the
co-ordination of voluntary muscles (ataxia), increase in
seizure frequency in epileptics

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 (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 Rimactazid

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.

6.

Contents of the pack and other information

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
Crospovidone
Magnesium stearate
Talc

Film-coating:
Copovidone
Hypromellose
Talc
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 dark-pink,
round and biconvex.
Dimensions: 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 marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd., Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10,
6250 Kundl, Austria.
or

Sandoz S.R.L, Str.Livezeni nr. 7a,
RO-540472 Targu-Mures, Romania.

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.

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