Skip to Content

RIMACTANE CAPSULES 150MG

Active substance(s): RIFAMPICIN

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Rimactane® 150 mg Capsules

rifampicin

Read all of this leaflet carefully before you start taking this medicine.
• 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 of the 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 Rimactane is and what it is used for
2. What you need to know before you take
Rimactane
3. How to take Rimactane
4. Possible side effects
5. How to store Rimactane
6. Contents of the pack and other information

1

Mental health, epilepsy and motor neurone
medicines
• for thought disorders known as ‘antipsychotics’
such as haloperidol
• to calm or reduce anxiety (hypnotics, anxiolytics)
• to help you sleep (barbiturates)
• used for epilepsy such as phenytoin
• used for depression such as amitriptyline and
nortriptyline
• riluzole - used for motor neurone disease.

What Rimactane is and what it is
used for

Rimactane Capsules contain a medicine called
rifampicin. It belongs to a group of medicines called
anti-bacterials. It works by killing the bacteria that
cause infections.
Rimactane Capsules are used to treat the following
bacterial infections:
• In combination with other drugs for the treatment
and prevention of tuberculosis (also known as
TB), an infectious disease mainly affecting the
lungs and some other infections
• Prevention of meningococcal meningitis.

2

Medicines for infections and the immune
system
• used for viral infections such as indinavir,
efavirenz, amprenavir, nelfinavir, atazanavir,
lopinavir and neviparine
• used for fungal infections
• used for bacterial infections (antibiotics)
• used for lowering your immune system such as
ciclosporin, sirolimus and tacrolimus
• praziquantel - used for tapeworm infections
• atovaquone - used for pneumonia
• fexofenadine- used for allergies.

What you need to know before
you take Rimactane

Do not take Rimactane if you:
• are allergic to active substance or to any of the
other ingredients of this medicine (listed in
section 6).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue.
• have jaundice – yellowing of the skin or whites of
the eyes caused by liver or blood problems.
• are taking saquinavir or ritonavir for an HIV
infection (see ‘Other medicines and Rimactane’
section below).

Hormone and cancer medicines
• some hormone medicines (estrogen, systemic
hormones, progestogens) used for contraception
or some types of cancer such as
ethinyloestradiol, levonorgestrel or
dydrogesterone
• some hormone medicines (anti-estrogens) used
for breast cancer or endometriosis such as
tamoxifen, toremifene and gestrinone
• used for cancer (cytotoxics) such as imatinib
• levothyroxine (thyroid hormone) used for thyroid
problems
• irinotecan - used for cancer.

Do not take if any of the above applies to you. If you
are not sure, talk to your doctor or pharmacist
before taking Rimactane Capsules.

Pain, inflammation and gout medicines
• non-steroidal anti-inflammatory drugs (NSAIDS)
such as etoricoxib, aspirin and indometacin
• used for pain such as codeine, morphine,
fentanyl or pethidine
• corticosteroids used for inflammation such as
hydrocortisone, betamethasone and
prednisolone
• methadone - used for heroin withdrawal.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Rimactane if you:
• have a rare blood disorder called ‘porphyria’.
• have or previously had any liver problem.
• have any kidney problems and if you are having
more than 600 mg rifampicin per day.
• have a history of alcohol dependence.
• have taken a course of rifampicin in the past.
• have diabetes. Your diabetes may become more
difficult to control while taking this medicine.
• feel numb or weak in your arms and legs
(peripheral neuropathy).
• are under weight or malnourished.
• wear contact lenses. Taking Rimactane Capsules
may permanently stain soft contact lenses. Do
not wear soft contact lenses whilst you are taking
this medicine and for one week after stopping
treatment.
• the person taking this medicine is a child.
• are aged 65 years or older.

Other medicines
• used for diabetes
• used to relax muscles before surgery
(anaesthetics) such as halothane
• used for feeling sick or being sick such as
ondansetron and aprepitant
• quinine - used for malaria
• theophylline - used for wheezing or difficulty in
breathing
• fesoterodine - used for overactive bladder
• tadalafil - used for impotence
• cimetidine - used for ulcer-healing drugs.

Taking Rimactane with food and drink
Take Rimactane on an empty stomach. This means
at least 30 minutes before food or 2 hours after
food. Do not drink any alcohol while you are taking
Rimactane.

If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before taking
Rimactane Capsules.
Blood Tests
Your doctor will need to check your blood before
you take this medicine. This will help your doctor
know if any changes happen to your blood after
taking this medicine. You may also need to have
regular blood tests to check how your liver is
working.

Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you
are pregnant, plan to get pregnant or think you are
pregnant.
Rimactane may make the contraceptive “pill” work
less well. This means you should change to a
different type of contraception. Instead, you must
use a reliable barrier method of contraception such
as condoms or the “coil” while taking Rimactane. If
you have any questions or are unsure about this
talk to your doctor or pharmacist.
You should not breast-feed if you are taking
Rimactane. This is because small amounts may
pass into the mothers’ milk. If you are
breast-feeding or planning to breast-feed, talk to
your doctor or pharmacist before taking any
medicine.

Other medicines and Rimactane
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines. This includes medicines you buy without
a prescription, including herbal medicines. This is
because Rimactane Capsules can affect the way
some other medicines work. Also some medicines
can affect the way Rimactane Capsules work.
In particular, do not take this medicine, and tell
your doctor, if you are taking:
• Saquinavir or ritonavir used for HIV infection.

Driving and using machines
You may feel dizzy or faint, have problems with
vision or have other side effects that could affect
your ability to drive while taking this medicine. If this
happens, do not drive or use any tools or machines.

The following medicines can make Rimactane
Capsules work less well:
• Antacids used for indigestion. Take Rimactane
Capsules at least 1 hour before taking antacids
• Other medicines used for TB such as
P-aminosalicyclic acid (PAS). PAS and
Rimactane Capsules should be taken at least 8
hours apart.

Rimactane contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3

Tell your doctor if you are taking any of the
following medicines:
Heart and blood medicines
• for high blood pressure, heart disorders or to
control your heartbeat such as
- digoxin
- antiarrhythmics (e.g. quinidine, lorcainide,
disopyramide)
- beta blockers (e.g. propanolol, atenolol)
- calcium channel blockers (e.g. nifedipine,
verapamil)
- ACE inhibitors (e.g. enalapril, imidapril)
- vasodilators (e.g. bosentan)
- water tablets (diuretics) such as eplerenone
• used to thin the blood such as warfarin
• used to lower cholesterol
• used to reduce blood lipid level such as
simvastatin, fluvastatin.

How to take Rimactane

Always take this medicine exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.

Take your medicine on an empty stomach. The best
time to take it is half an hour before a meal with
water.

draft: 996726
laetus code: supplier to add
mat.no.: supplier to add

Continued on the next page >>

Artwork Proof Box
Ref: N040 - correct 150 SPC, PIL align & update QRD temp + RFI (PIL split)
Proof no.
008.1

Date prepared:
02/12/2014

Colours:
Black
Dimensions: 138 x 450 mm

Font size:
7pt
Fonts:
Helvetica

For the treatment of tuberculosis:
Adults: 450 mg or 600 mg Rimactane daily,
depending on your weight, for 6-9 months.

• a painful rash of dark red spots under the skin
which do not go away when you press on them
(purpura)
• brain haemorrhage (bleeding)
• disturbances in the menstrual cycle (in extreme
cases absence of a menstrual period)
• worsening of Addison disease (failure of adrenal
glands)
• worsening of porphyria (a type of blood disorder).

Children: 10 mg to 20 mg per kg of body weight
daily for 6-9 months. The maximum dose is 600 mg
each day.

Occasionally the Rimactane dose is given 2-3 times
a week instead of daily.

Very rare side effects – affects less than 1 out of
10,000 people
• blood disorders (low white blood cells).

Rimactane must always be taken with at least one
and preferably two other anti-tuberculosis drugs.
For the prevention of meningococcal
meningitis:
Adults: 600 mg twice a day for 2 days.

You may notice a reddish colour in your urine,
sweat, phlegm (sputum), saliva or tears. This is
quite common and you need not worry. However,
the red colour may permanently stain soft contact
lenses. The red colour in tears may last for some
time after you have stopped taking the capsules. Do
not wear lenses until you are sure your tears are
colourless.

Children over 1 month: 10 mg per kg every 12
hours for 2 days.

Children under 1 month: 5 mg per kg every 12
hours for 2 days.

Blood tests
• A blood test may show changes in the way the
liver is working.

The maximum dose is 600 mg.

If you are not sure how many capsules to take, ask
your doctor or pharmacist.

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 (www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more
information on the safety of this medicine.

Second time (or subsequent) treatment
If you have been treated with Rimactane before,
your doctor will probably start with a smaller dose.

If you take more Rimactane than you should
If you take more Rimactane than you should, tell a
doctor or go to a hospital casualty department
straight away. Take the medicine pack with you.
This is so the doctor knows what you have taken.
You may feel sick (nausea), be sick (vomiting), have
stomach pain, itching or a headache. You may also
feel tired, sleepy, dizzy or light-headed. Other signs
of taking too much includes swelling of the face,
eyes or eyelids, slurring of speech, difficulty
breathing, fast heartbeat, uneven heartbeats, fits
and heart attack.

5

Keep this medicine out of the sight and reach of
children.
Do not take this medicine after the expiry date
which is stated on the pack. The expiry date refers
to the last day of that month.
Rimactane should be kept in the original package,
in a safe, dry place at room temperature (below
30°C).

If you forget to take Rimactane
If you forget to take a tablet you should take it as
soon as you remember. However, if this is within 2
hours of your next dose you should skip the missed
capsule and carry on taking the rest of your
capsules as usual.

Do not throw away medicines via wastewater or
household waste. Ask your pharmacist how to throw
away of medicines no longer use. These measures
will help protect the environment.

Do not take a double dose to make up for a
forgotten tablet.

6

If you stop taking Rimactane
Keep taking Rimactane until your doctor tells you to
stop. Do not stop taking Rimactane just because
you feel better. If you stop, your infection may get
worse. If you have any further questions on the use
of this product, ask your doctor or pharmacist.

Contents of the pack and other
information

What Rimactane contains
The active substance in Rimactane is rifampicin.
Each Rimactane 150 mg capsule contains 150 mg
rifampicin.
The other ingredients are: calcium stearate, lactose,
titanium dioxide (E171), iron oxide red (E172), iron
oxide black (E172), gelatine, shellac glaze,
propylene glycol (E1520) and ammonium hydroxide
(E527).

Tests
Taking Rimactane may affect the results of some
blood tests. In particular, tests for folate, vitamin
B12 and liver function. If you are going to have a

blood test, it is important to tell your doctor that you
are taking Rimactane.

4

How to store Rimactane

What Rimactane looks like and the contents of
the pack
Rimactane 150 mg capsules are opaque, two-piece,
hard gelatine capsules, reddish-brown in colour,
marked with ‘NG 150’.

Possible side effects

Like all medicines, this medicine can cause
side-effects although not everybody gets them.

The capsules come in secure containers of 100 and
blister packs of 60. Not all pack sizes may be
marketed.

Serious side effects:
If you have any of the following symptoms of a
serious side effect stop taking this medicine
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• You get blistering, peeling, bleeding, scaling or
fluid filled patches on any part of your skin. This
includes your lips, eyes, mouth, nose, genitals,
hands or feet. You may have a serious skin
problem.
• Allergic reactions causing rashes, fever, difficulty
breathing, swallowing problem, wheezing,
swelling of the face, lips, tongue, throat, hands or
feet.
• Serious liver problems such as hepatitis or
jaundice (yellowing of the whites of the eyes and
skin).
• Flu-like symptoms including chills, fever,
headache, dizziness and bone pains may be
followed by bleeding into the skin, breathing
difficulties, asthma-like attacks, anaemia, shock
and kidney failure.

Marketing Authorisation Holder and
Manufacturer:
Sandoz GmbH,
Biochemiestr. 10, 6250 Kundl,
Austria

This leaflet was last revised in 12/2014.

Other side effects:

Common side effects – affects less than 1 out of
10 people
• flushing, itching with or without skin rash or eye
irritation and redness
• loss of appetite (anorexia)
• stomach pains, feeling sick (nausea)
• gaseous distension and upset stomach
• headache, dizziness, unusual tiredness,
weakness, drowsiness, light-headedness
• hair loss
• Asymptomatic increase in liver enzymes.
Uncommon side effects – affects less than 1 out
of 100 people
• urticarial (hives) and more serious
hypersensitivity cutaneous reactions.

draft: 996726
laetus code: supplier to add
mat.no.: supplier to add

Rare side effects – affects less than 1 out of
1,000 people
• difficulty controlling movements, confusion
• kidney problems (sometimes with lower back
pain, fever and rash)
• severe skin reactions, such as Stevens-Johnson
syndrome, vasculitis, exudative conjunctivitis and
generalised hypersensitivity reactions, e.g.
exfoliative dermatitis, Lyell's syndrome and
pemphigoid reactions
• blurred or loss of vision
• being sick (vomiting) or diarrhoea
• diarrhoea that is serious, lasts a long time or has
blood in it with stomach pain or fever
(Pseudomembranous colitis)
• inflammation of the colon
• muscular weakness
• myopathy
• problems with the coordination of voluntary
muscles (ataxia)
• psychoses
• mental confusion
• visual disturbances
• blood disorders (reduced platelet count)
• weight loss, night sweats and fever (eosinophilia)

SZ00000LT000

Artwork Proof Box
Ref: N040 - correct 150 SPC, PIL align & update QRD temp + RFI (PIL split)
Proof no.
008.1

Date prepared:
02/12/2014

Colours:
Black
Dimensions: 138 x 450 mm

Font size:
7pt
Fonts:
Helvetica

Expand view ⇕

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.

Hide