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VORACTIV FILM-COATED TABLETS

Active substance(s): ETHAMBUTOL HYDROCHLORIDE / ISONIAZID / PYRAZINAMIDE / RIFAMPICIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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®

Voractiv film-coated tablets
Rifampicin (150 mg) + Isoniazid (75 mg) + Pyrazinamide (400 mg) +
Ethambutol hydrochloride (275 mg)
(antifungals like fluconazole, itraconazole,
ketoconazole, voriconazole, terbinafine)
• 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
What is in this leaflet:
(levothyroxine)
1. What Voractiv is and what it is used for
• Medicines for pain like morphine etoricoxib,
2. What you need to know before you take
rofecoxib
Voractiv
• Medicines for AIDS like saquinavir, indinavir,
3. How to take Voractiv
efavirenz, amprenavir, nilfinavir, azatanavir,
4. Possible side effects
lopinavir, zidovudine, nevirapine, stavudine
5. How to store Voractiv
• Medicines for epilepsy like tiagabine,
6. Contents of the pack and other information
carbamazepine, phenytoine, ethosuximide
• Medicines for sleeping disorders like
1.
What Voractiv is and
diazepam, benzodiazepines, buspirone,
1. What Voractiv is and what it is used for
what it is used for
zopiclone, zolpidem, zaleplon, hexobarbital
• Medicines for asthma like theophylline
Voractiv belongs to a group of medicines called • Medicines for diabetes like repaglinide and
antituberculosis agents. It is a fixed
nateglinide or oral antidiabetics of
combination of four very effective
sulfonylurea type
antituberculosis agents. It is used to treat
• p-aminosalicylic acid (a medicine for
infections caused by mycobacteria. These
tuberculosis and inflammatory bowel diseases)
mycobacteria cause tuberculosis.
• Methadone (a medicine for heroin addicts)
Voractiv is used for the initial treatment of
• Medicines for stomach problems like
tuberculosis.
cimetidine
• Medicines for the treatment of high blood
lipids like cloifibrate, fluvastatin, simvastatin
2. What you need to know before you
2.What
youVoractiv
need to know before you take Voractiv
• Medicines for sickness like tropisetron,
take
ondansetron
• Medicines for narcosis like halogenated
Do not take Voractiv:
volatile anesthetics
• if you are allergic (hypersensitive) to
• Medicines to treat cancer like imatinib,
rifamycins, isoniazid, pyrazinamide,
gefitinib, irinotecan
ethambutol hydrochloride or to any of the
• Fexofenadine (a medicine to treat hayfever)
ingredients of this medicine (listed in
• Praziquantel (a medicine against
section 6)
tapeworms)
• if you have acute liver problems or previously
• Oral typhoid vaccine
have had a liver problem which was caused
If you are currently taking any of these
by drugs
medicines, ask your doctor about switching to
• if you are known to have a condition called
a different medicine while you are taking
porphyria
Voractiv. Often, there are other medicines you
• if you have acute gouty arthritis
can take instead.
• if you have severe kidney problems
• if you are currently taking any of the following If you need to take a medicine for indigestion,
medications:
such as an antacid, take your tablets at least
- voriconazole
one hour before the antacid.
- protease inhibitors except ritonavir when
The following examination methods cannot be
prescribed to you at full dose or 600 mg
performed or results have to be interpreted with
twice daily.
care as long as you take Voractiv:
Do not take Voractiv if any of the above apply to • radiographic examination of the gallbladder
you.
with contrast media
• microbiological determination of folic acid
If you are not sure about anything, ask your
plasma concentrations
doctor or pharmacist.
• microbiological determination of
Warnings and precautions
cyanocobalamin (vitamin B12) plasma
Talk to your doctor or pharmacist before taking
concentrations.
Voractiv.
Tell your doctor if you have one of the following Voractiv with food and drink:
Do not drink any alcohol as long as you receive
illnesses before taking this medicine:
Voractiv.
• Liver problems and chronic liver disease
You should avoid food with a high content of
• Kidney problems
tyramine (like cheese, red wine) or histamine
• Gout
(like tuna fish). This food taken together with
• Diabetes mellitus
Voractiv may lead to headache, palpitations or
• Epilepsy
• Inflammation of peripheral nerves or the optic flushing.
Take this medicine at least one hour before a
nerve
meal.
• Eye defects
• 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
You should not take Voractiv if your body
baby, ask your doctor or pharmacist for advice
weight is below 30 kg.
You should not interrupt treatment with Voractiv before taking this medicine.
Your doctor will assess whether it is possible for
without consulting your doctor.
you to continue with the treatment of Voractiv. If
You should employ additional means of
you take Voractiv during pregnancy, your doctor
contraception apart from taking the pill as long
should give you vitamin B6 supplements during
as you take Voractiv.
pregnancy and vitamin K supplements during
Other medicines and Voractiv:
the last month of pregnancy.
Tell your doctor or pharmacist if you are taking,
This medicine goes into human milk, therefore
have recently taken or might take any other
you should not take Voractiv when you are
medicines, including any medicines obtained
breast-feeding. It is important that you tell your
without a prescription.
doctor if you are breast-feeding or if you intend
Tell your doctor if you take one of the following
to breast-feed before receiving Voractiv.
medicines:
Driving and using machines:
You must not take Voractiv with any of the
This medicine can cause side effects such as
following medications:
dizziness, confusion and blurred vision. This
• voriconazole
may make you less able to do certain things,
• protease inhibitors except ritonavir if you are such as driving or using machines.
prescribed a full dose or 600 mg twice daily.
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).

You should not take Voractiv with any of the
following medications:
• nevirapine
• simvastatin
• ritonavir
• oral contraceptives. You should use
additional means of contraception as long as
you take Voractiv.
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

3.
3.

Howtototake
take
Voractiv
How
Voractiv

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 Voractiv 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.
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GEN/VCT/PIL/317_01
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Use in children
Voractiv is not recommended for children under
8 years of age or with a body weight of less
than 30 kg.
Older people
Voractiv 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
Voractiv.
Method of administration
You should take Voractiv once a day during the
first two months of treatment.
Swallow these tablets whole with a drink of
water.
Voractiv should be taken at least 1 hour before
a meal.
Duration of treatment:
Voractiv 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 Voractiv 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 Voractiv:
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.
If you stop taking Voractiv:
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
effects
4. Possible
sideside
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
Voractiv, 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)
• Vision disturbances like blurred vision, eye
pain, red-green colour blindness or even loss
of vision
• 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, lightheadedness, 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).
Uncommon side effects (may affect up to 1 in
100 people):
• Hallucinations, disorientation, confusion,
malaise.
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)
• Psychosis, hyperactivity, euphoria,
sleeplessness, convulsions
• 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
• Numbness, tingling, burning pain or
weakness in hands or feet
• 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
(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 lightsensitivity, skin lesions, anaemia, psychosis
and acute abdominal pain).
If you resume therapy after an interruption of
treatment with Voractiv, a so-called influenzalike 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,
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 to
store
Voractiv
5.
How
store
Voractiv
Keep out of the sight and reach of children.
Do not use Voractiv 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
Contents
of pack
the pack
andinformation
other
6.
of the
and other
information

What Voractiv contains
The active substances are rifampicin, isoniazid,
pyrazinamide and ethambutol hydrochloride.
Each tablet contains 150 mg rifampicin, 75 mg
isoniazid, 400 mg pyrazinamide and 275 mg
ethambutol hydrochloride.
- The other excipients are
Tablet core:
Pregelatinised maize starch, Maize starch,
Sodium laurilsulfate, Microcrystalline cellulose,
Povidone K 30, Crospovidone, Magnesium
stearate, Talc.
Film-coating:
Copovidone, Hypromellose, Talc, Titanium
dioxide (E171), Opadry brown 03B56510
[hypromellose, titanium dioxide (E171),
macrogol 400, red iron oxide (E172)], Opadry
clear OY-S-29019 [hypromellose, macrogol
6000].
What Voractiv looks like and contents of the
pack
Voractiv, film-coated tablets are brown, ovaloid,
biconvex film-coated tablets.
Voractiv, 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.
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250
Kundl, Austria
or
Sandoz S.R.L., Str.Livezeni nr. 7a, RO-540472,
Targu-Mures, Romania
Distributed by:
Genus Pharmaceuticals,
Linthwaite, Huddersfield, HD7 5QH, UK.
This leaflet was last revised in
December 2014.
*Trademark
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25290301

GEN/VCT/PIL/317_01
09/12/2014

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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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