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RIMCURE FILM-COATED TABLET

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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Triplac film-coated tablets
Rifampicin / Isoniazid / Pyrazinamide
• 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,
nortriptyline)
• 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,
What is in this leaflet:
• Medicines for AIDS like saquinavir, indinavir, efavirenz,
1. What Triplac is and what it is used for
amprenavir, nilfinavir, azatanavir, lopinavir, zidovudine,
2. What you need to know before you take Triplac
nevirapine, stavudine
3. How to take Triplac
• Medicines for epilepsy like tiagabine, carbamazepine,
4. Possible side effects
phenytoine, ethosuximide
5. How to store Triplac
• Medicines for sleeping disorders like diazepam,
6. Contents of the pack and other information
benzodiazepines, buspirone, zopiclone, zolpidem,
zaleplon, hexobarbital
1. What Triplac is andand what it isfor
1. What Triplac is what it is used used for
• Medicines for asthma like theophylline
• Medicines for diabetes like repaglinide and nateglinide
Triplac belongs to a group of medicines called
or oral antidiabetics of sulfonylurea type
antituberculosis agents. It is a fixed combination of three
• p-aminosalicylic acid (a medicine for tuberculosis and
very effective antituberculosis agents which stop the growth
inflammatory bowel diseases)
of mycobacteria. These mycobacteria cause tuberculosis.
• Methadone (a medicine for heroin addicts)
• Medicines for stomach problems like cimetidine
Triplac is used for the initial treatment of tuberculosis.
• Medicines for the treatment of high blood lipids like
cloifibrate, fluvastatin, simvastatin
2. What you need to to know beforetake Triplac Triplac
2. What you need know before you you take
• Medicines for sickness like tropisetron, ondansetron
• Medicines for narcosis like halogenated volatile
Do not take Triplac:
anesthetics
• if you are allergic (hypersensitive) to rifamycins, isoniazid, • Medicines to treat cancer like imatinib, gefitinib,
pyrazinamide or to any of the ingredients of this medicine
irinotecan
(listed in section 6)
• Fexofenadine (a medicine to treat hayfever)
• if you have acute liver problems or previously have had a • Praziquantel (a medicine against tapeworms)
liver problem which was caused by drugs
• Oral typhoid vaccine
• if you are known to have a condition called porphyria
If you are currently taking any of these medicines, ask your
• if you have acute gouty arthritis
doctor about switching to a different medicine while you are
• if you have severe kidney problems
taking Triplac. Often, there are other medicines you can take
• if you are currently taking any of the following
instead.
medications:
If you need to take a medicine for indigestion, such as an
- voriconazole
- protease inhibitors except ritonavir when prescribed to antacid, take your tablets at least one hour before the
antacid.
you at full dose or 600 mg twice daily.
The following examination methods cannot be performed or
Do not take Triplac if any of the above apply to you.
results have to be interpreted with care as long as you take
If you are not sure about anything, ask your doctor or
Triplac:
pharmacist.
• radiographic examination of the gallbladder with contrast
Warnings and precautions
media
Talk to your doctor or pharmacist before taking Triplac.
• microbiological determination of folic acid plasma
Tell your doctor if you have one of the following illnesses
concentrations
before taking this medicine:
• microbiological determination of cyanocobalamin (vitamin
• Liver problems and chronic liver disease
B12) plasma concentrations.
• Kidney problems
Triplac with food and drink:
• Gout
Do not drink any alcohol as long as you receive Triplac.
• Diabetes mellitus
You should avoid food with a high content of tyramine (like
• Epilepsy
cheese, red wine) or histamine (like tuna fish). This food
• Inflammation of peripheral nerves
taken together with Triplac may lead to headache,
• Eye defects
palpitations or flushing.
• Chronic alcoholism
Take this medicine at least one hour before a meal.
• Underfeeding
You should not take Triplac if your body weight is below 30 kg. Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be
You should not interrupt treatment with Triplac without
pregnant or are planning to have a baby, ask your doctor or
consulting your doctor.
pharmacist for advice before taking this medicine.
You should employ additional means of contraception apart Your doctor will assess whether it is possible for you to
from taking the pill as long as you take Triplac.
continue with the treatment of Triplac. If you take Triplac
during pregnancy, your doctor should give you vitamin B6
Other medicines and Triplac:
supplements during pregnancy and vitamin K supplements
Tell your doctor if you are taking, have recently taken or
during the last month of pregnancy.
might take any other medicines, including any medicines
obtained without a prescription.
This medicine goes into human milk, therefore you should
not take Triplac when you are breast-feeding. It is important
Tell your doctor if you take one of the following medicines:
that you tell your doctor if you are breast-feeding or if you
You must not take Triplac with any of the following
intend to breast-feed before receiving Triplac.
medications:
Driving and using machines:
• voriconazole
• protease inhibitors except ritonavir if you are prescribed a This medicine can cause side effects such as dizziness,
confusion and blurred vision. This may make you less able
full dose or 600 mg twice daily.
to do certain things, such as driving or using machines.
You should not take Triplac with any of the following
medications:
3. How to take Triplac
3. How to take Triplac
• nevirapine
• simvastatin
• ritonavir
Always take this medicine exactly as your doctor has told
• oral contraceptives.You should use additional means of
you. Check with your doctor or pharmacist if you are not
contraception as long as you take Triplac.
sure. These doses are for adults and children weighing more
than 30 kg. Children weighing less than this should not take
Tell your doctor also if you take one of the following
these tablets.
medicines:
• Medicines for irregular heart beats like class Ia
The recommended dose is:
antiarrhythmics (quinidine, disopyramide), propafenone,
Adults:
mexiletine, tocainide, lorcainide
The amount of Triplac people take can be different, and this
• Medicines for the heart or blood pressure: calcium
depends on your body weight. Usually, you will be given the
antagonists (such as diltiazem, nifedipine, verapamil,
following number of tablets:
nimodipine, isradipine, nicardipine, nisoldipine), digitoxin, • If you weigh 30 kilograms (kg) to 39 kg – take 2 tablets
digoxin, carvedilol, digoxin, beta-blockers (such as
each day
bisoprolol, metoprolol, propranolol, carvedilol), losartan,
• If you weigh 40 kg to 54 kg – take 3 tablets each day
imidapril, enalapril
• If you weigh 55 kg to 70 kg – take 4 tablets each day
• Diuretics like eplerenone
• If you weigh more than 70 kg – take 5 tablets each day.
• Medicines to suppress the immune system like
Your doctor will prescribe the best dose for you.
ciclosporin, tacrolimus, sirolimus, leflunomide,
Use in children
azathioprine
Triplac is not recommended for children under 6 years of
• Corticosteroids
age or with a body weight of less than 30 kg.
• Medicines to treat fungal infections (antifungals like
fluconazole, itraconazole, ketoconazole, voriconazole,
Older people
terbinafine)
Triplac is well tolerated by most older patients, but you
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).

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
Triplac.
Method of administration
You should take Triplac once a day during the first two
months of treatment.
Swallow these tablets whole with a drink of water.
Triplac should be taken at least 1 hour before a meal.
Duration of treatment:
Triplac is usually given for 2 months at the beginning of
tuberculosis treatment.Your doctor will decide on the
duration of treatment for you.
If you take more Triplac 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 Triplac:
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 Triplac:
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
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 Triplac, 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 to 1 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, muscle or
joint pain
• 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
• Increase in blood uric acid, acute gouty arthritis (chills,
pain and swelling of joints, especially big toe, ankle or
knee).
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, disorders of blood clotting,
swelling of spleen
• 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, enlargement of the liver, inflammation
of the liver (in rare cases severe),

• Allergic and other reactions like dry mouth, heartburn,
urination disorders, rheumatic syndromes and symptoms,
pellagra (affection characterized by gastrointestinal
disturbances, reddening of skin, nervous and mental
disorders), swelling of lymph nodes, acne, skin rash, light
sensitivity
• Elevation of kidney enzymes, acute kidney failure,
inflammation of the kidney, problems with urination
• 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
Triplac, 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 (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety
of this medicine.

5. How toto store Triplac
5. How store Triplac
Keep out of the sight and reach of children
Do not use Triplac 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.. Content of the the packother other information
6 Contents of pack and and information
What Triplac contains
The active substances are rifampicin, isoniazid and
pyrazinamide. Each tablet contains 150 mg rifampicin,
75 mg isoniazid and 400 mg pyrazinamide.
- 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 Triplac looks like and contents of the pack
Triplac, film-coated tablets are ovaloid, pink, biconvex filmcoated tablets.
Dimensions:
- Length (18.0 ± 0.9 mm) 17.1-18.9 mm
- Width (8.0 ± 0.4 mm) 7.6-8.4 mm
Triplac, 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.
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.
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
or
Sandoz S.R.L., Str.Livezeni nr. 7a, RO-540472 Targu-Mures,
Romania.
Distributor:
Genus Pharmaceuticals, Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, UK.
This leaflet was last revised in 11/2013.

*Trademark
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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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