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GALPHARM IBUPROFEN 200 MG SOFT CAPSULES
Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor or pharmacist if
your symptoms worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
WHAT THIS MEDICINE IS FOR
This medicine contains ibuprofen. Ibuprofen is
one of a group of non-steroidal antiinflammatory drugs (known as NSAIDs) which
work by changing how the body responds to
pain, swelling and high temperature.
This medicine is used to relieve:
• rheumatic and muscular pain, backache
• neuralgia (nerve pain), dental pain, period pain
• headache, migraine
• fever (high temperature)
• the symptoms of colds and flu.
BEFORE YOU TAKE THE MEDICINE
Do not take this medicine if you:
• have (or have had two or more episodes of)
a stomach ulcer, perforation or bleeding of
• are allergic to ibuprofen, to any of the
ingredients (listed in section 6), or to aspirin
or other painkillers (an allergic reaction may
be recognised as shortness of breath,
runny nose, skin rash or itching)
• have kidney or heart failure or severe liver failure
• are taking aspirin with a daily dose above 75mg
• are in the last 3 months of pregnancy.
Warnings and precautions
Anti-inflammatory/pain-killer medicines like
ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly
when used in high doses. Do not exceed the
recommended dose or duration of treatment.
You should discuss your treatment with your
doctor or pharmacist before taking this
medicine if you:
• have heart problems including heart failure,
angina (chest pain), or if you have had a
heart attack, bypass surgery, peripheral
artery disease (poor circulation in the legs
or feet due to narrow or blocked arteries),
or any kind of stroke (including ‘mini-stroke’
or transient ischaemic attack “TIA”).
• have high blood pressure, diabetes, high
cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
• are elderly because you may be at more
risk of having serious side effects,
particularly stomach problems
• have or have suffered from asthma,
diabetes, high cholesterol or have allergies
• have an intolerance to some sugars (these
capsules contain sorbitol)
• have liver or kidney problems
• have stomach or bowel disorders including
Crohn’s disease or a condition known as
• have Systemic Lupus Erythematosus (SLE) –
an illness which affects your immune
system. It causes joint pains, skin changes
and problems with other parts of your body.
There is a risk of renal impairment in
Other medicines and this medicine
You must not take these capsules if you are
taking certain other medicines - see section 2
‘Do not take this medicine if you’.
This medicine may affect or be affected by
some other medicines. For example:
• medicines that are anti-coagulants (i.e. thin
blood/prevent clotting e.g. aspirin/
acetylsalicylic acid, warfarin, ticlopidine)
• aspirin at low dose as an anti-platelet
medicine (i.e. 75mg or below daily), as taking
ibuprofen may reduce the effectiveness of
the aspirin or cause stomach problems
• other medicines for thinning the blood
• other NSAID painkillers, including
cyclooxygenase-2 selective inhibitors
• medicines that reduce high blood pressure
(ACE-inhibitors such as captopril, beta-blockers
such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan)
• antidepressants called selective-serotonin
reuptake inhibitors (SSRIs) e.g. fluoxetine
• corticosteroids (for skin problems and
allergies e.g. cortisol)
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat
heart failure e.g. digoxin)
• ciclosporin and tacrolimus
(immunosuppressant medicines often used
following organ transplants)
• mifepristone (a medicine used to terminate
pregnancy – NSAIDs should not be used
for 12 days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to
treat bacterial infection e.g. ciprofloxacin).
Some other medicines may also affect or be
affected by the treatment of this medicine. You
should therefore always seek the advice of
your doctor or pharmacist before you use this
medicine with other medicines.
Pregnancy and Breastfeeding
Do not take this medicine if you are in the last 3
months of pregnancy. Talk to your doctor before
taking Ibuprofen Capsules if you are in the first
6 months of pregnancy or are breastfeeding.
These capsules belongs to a group of medicines
which may affect fertility in women. Fertility goes
back to normal when you stop taking the medicine.
It is unlikely that if you only take these capsules
occasionally it will affect your chances of becoming
pregnant. If you have problems becoming pregnant
talk to your doctor before taking this medicine.
HOW TO TAKE THE MEDICINE
Do not give to children under 12 years.
• This medicine is for short-term use only.
• Take the lowest dose for the shortest time
• Do not take these capsules for longer than
• If in adolescents this medicinal product is
required for more than 3 days, or if symptoms
worsen a doctor should be consulted.
If you do not get better, or get worse, talk to
your doctor. They will tell you if it is safe to
carry on taking the medicine.
If you take too many capsules:
Talk to a doctor straight away, or go to your
nearest hospital casualty department. Take the
carton and this leaflet with you.
POSSIBLE SIDE EFFECTS
Most people take these capsules without any
problems, but they can have side effects, like
To reduce the chance of side effects,
especially if you are elderly, use the lowest
effective dose for the shortest possible time.
STOP TAKING the capsules and contact
your doctor immediately if you develop
any of the following symptoms at any
time while taking your medicine:
The following reactions may mean you are
having an allergic reaction to this medicine:
• asthma, worsening of asthma, unexplained
wheezing or shortness of breath
• swelling of the face, lips, tongue and throat
(causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse
• also, there may be skin reaction (including
hives, rash and itching) – very rarely these can
be severe with blistering and peeling skin.
Stomach and bowel problems including:
• stomach discomfort or pain, nausea,
indigestion or heartburn, stomach ulcer or
perforation, mouth ulcers
• stomach bleeding which can result in vomit with
blood or dark particles (like coffee grounds),
black tarry stools or blood passed in your stools
• worsening of bowel problems (ulcerative
colitis or Crohn’s disease).
Blood disorders which can cause:
• unexplained or unusual bruising or bleeding
Further information overleaf ➥
Generic Ibuprofen 200mg Liquid Capsules
Dose and how often to take
Initial dose 1 or 2 capsules to
be swallowed whole with water,
preferably with or after food. Do
not chew. Then if necessary 1
or 2 capsules every 4 hours. Do
not take more often than every 4
hours. Do not take more than 6
capsules in any 24 hour period.
Art 31 & MA Name
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion.
Heart and circulation effects: Medicines such
as ibuprofen capsules may be associated with a
small increased risk of heart attack (myocardial
infarction), high blood pressure, heart failure,
swelling due to fluid build-up (oedema) or stroke.
Other side effects that may occur include
those listed below. If you experience any of
these symptoms, or have any other unusual
symptoms or concerns with your medicine,
stop taking the capsules and see your doctor.
Other stomach and intestine effects
including diarrhoea, flatulence, constipation
Liver problems that might be indicated by
yellowing of the skin and eyes (jaundice)
and/or pale coloured stools and dark urine.
Kidney problems that might be indicated by
passing less or more urine than normal,
cloudy urine, blood in the urine, pain in the
back and/or swelling (particularly of the legs) –
very rarely kidney failure.
Nervous system problems including headache
and aseptic meningitis (which can have symptoms
such as severe headache, stiff neck, disorientation,
fever and eye sensitivity to light in those with
existing auto-immune disorders such as lupus).
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.
STORING THE MEDICINE
Do not use after the expiry date shown on the
pack. Do not store above 25°C. Store in the
Keep out of the sight and reach of children.
What is in this medicine:
The active ingredient is: Ibuprofen 200 mg
per liquid capsule.
The other ingredients are: macrogol 600,
potassium hydroxide, gelatine, sorbitol, purified
water, titanium dioxide, isopropyl alcohol, propylene
glycol, hypromellose. Also contains Ponceau 4R
(E124), which may cause allergic reactions.
What this medicine looks like and
contents of the pack
Each oval, red capsule is printed in white with
‘I200’. This pack contains 16 capsules.
Marketing Authorisation Holder and
Marketing Authorisation Holder:
Banner Pharmacaps Europe P.O. Box 5037,
5004 EA Tilburg, The Netherlands.
Manufacturer: Patheon Softgels B.V. P.O. Box
5037, 5004 EA Tilburg, The Netherlands.
Text revised: October 2015.
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.