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RIMSTAR FILM-COATED TABLET

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

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

• Antibiotics like clarithromycin, telithromycin,
dapsone, doxycycline, fluoroquinolones,

25290302

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19/01/2016

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 (may affect up to 1 in 1,000 people)
• Extreme dizziness or collapse (may affect up
to 1 in 1,000 people)
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,
haematologic 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)
• 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
(may affect up to 1 in 1,000 people)
• Bleeding into the skin; if you continue taking
Voractiv, you are at risk of brain haemorrhage
(bleeding, may affect up to 1 in 1,000 people)
• Vision disturbances like blurred vision, eye
pain, red-green colour blindness or even loss
of vision (may affect up to 1 in 1,000 people)
• Shortage of white blood cells, accompanied
by sudden high fever, severe sore throat and
ulcers in the mouth (agranulocytosis, may
affect up to 1 in 1,000 people).
These are all serious side effects. You may need
urgent medical attention.
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).
Frequency not known:
• Inflammation of the blood vessels
If you resume therapy after an interruption of
treatment with Voractiv, 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,
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.
to store
Voractiv
5.How
How
to store
Voractiv
Keep this medicine out of the sight and reach of
children.
Do not use this medicine 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
ofpack
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), Macrogol 400, Macrogol 6000,
Iron oxide red (E172).
What Voractiv looks like and contents of the
pack
Voractiv, film-coated tablets are brown, ovaloid,
biconvex film-coated tablets, plain on both sides.
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
February 2016.

*Trademark
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25290302

GEN/VCT/PIL/343_07
25/02/2016

MHRA Header Box
Product
Title

Voractiv film-coated tablets

Component

Leaflet

Pack Size

60's

IG code

25290302

Dimensions

138 x 450mm

Proof No.

07

Colours used
Black

Fonts used
Helvetica 55 Roman
Helvetica 75 Bold

Date

25/02/2016

PCP Header Box
Operator

David Heaton

Artwork No

GEN/VCT/PIL/317

CRN

12453

Reason
for Change

PIL update at request of Sandoz.

MHRA/IMB
submission
required

Product Title
Strength/Form
Format
Min type size
No. of Colours

Suffix

Approved by

Date

Issued by

Date

A

Yes

GENUS VORACTIV
film-coated tablets
138 x 450 mm
8/9 pt
1

Date Created
09/12/2014
Type (carton etc) LEAFLET
Country
UK
Job No:
GEN/VCT/PIL/343

Black

Typefaces
Helvetica 55 Roman, Helvetica 75 Bold
Artwork prepared by David Heaton +44 (0)1462 431277 dc.heaton@ntlworld.com

No. of Draft
_01
_02
_03
_04
_05
_06
_07

Date
23/09/2015
24/09/2015
25/09/2015
13/11/2015
18/02/2016
19/02/2016
25/02/2016

Reason for Draft
New file
Corrections
Text correction
Text revision
MHRA text revision
Correction
Text revision

Important.
Please ensure that the texts and layout are to your
satisfaction as David Heaton cannot accept liability for
any errors overlooked.
All Bar Codes and Braille text must be verified by the
client/manufacturer/printer. David Heaton is unable to
do this and cannot accept liability for any errors.
Colours may not reproduce accurately on this proof. You
should refer to Pantone references for accurate colour
match.

Expand Transcript

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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