BOOTS IBUPROFEN LONG LASTING 200MG CAPSULES

Active substance: IBUPROFEN

View full screen / Print PDF » Download PDF ⇩

Transcript
THE CO-OPERATIVE IBUPROFEN
200MG LONG LASTING CAPSULES
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
The Co-operative Ibuprofen 200mg Long Lasting
Capsules contain ibuprofen, which belongs to
a group of medicines called Non-Steroidal
Anti-Inflammatory Drugs (NSAIDs). These
medicines 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)
• headache, migraine
• dental pain, period pain
• fever (high temperature)
• the symptoms of colds and flu.
BEFORE YOU TAKE THE MEDICINE
Do not take The Co-operative Ibuprofen
200mg Long Lasting Capsules if you:
• have or have had a stomach ulcer, perforation
or bleeding of the stomach
• 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 other NSAID painkillers, or aspirin
with a daily dose above 75mg
• are in the last 3 months of pregnancy.
Talk to your doctor or pharmacist before
taking The Co-operative Ibuprofen 200mg
Long Lasting Capsules if you:
• 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 liver or kidney problems
• have stomach or bowel disorders including
Crohn’s disease or a condition known as
ulcerative colitis
• 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.

• have, have previously had, or are at risk of
heart problems, high blood pressure or stroke.
Medicines such as The Co-operative Ibuprofen
200mg Long Lasting Capsules may be
associated with a small increased risk of
heart attack (myocardial infarction) or stroke.
Any risk is more likely with high doses and
prolonged treatment. Do not exceed the
recommended dose or duration of treatment
(10 days). If you have heart problems, previous
stroke or think that you might be at risk of
these conditions (for example if you have high
blood pressure, diabetes or high cholesterol or
are a smoker) you should discuss your
treatment with your doctor or pharmacist.
If you are taking other medicines
You must not take these capsules if you are
taking certain other medicines - see section 2
‘Do not take The Co-operative Ibuprofen
200mg Long Lasting Capsules if’.
Talk to your pharmacist or doctor before you
take the capsules if you are taking any regular
medication, especially:
• 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 (anticoagulants (against clotting) and anti-platelet
agents such as warfarin and ticlopidin)
• medicines for high blood pressure (ACEinhibitors such as captopril, beta-blockers
and angiotensin II antagonists) and water
tablets (diuretics)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat
heart failure)
• cyclosporin 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 infections).
Pregnancy and Breastfeeding
Do not take The Co-operative Ibuprofen 200mg
Long Lasting Capsules if you are in the last 3
months of pregnancy. Talk to your doctor before
taking The Co-operative Ibuprofen 200mg Long
Lasting Capsules if you are in the first 6 months
of pregnancy or are breastfeeding.
The Co-operative Ibuprofen 200mg Long Lasting
Capsules belong to a group of medicines, which
may impair fertility in women. This is reversible on
stopping the medicine. It is unlikely that the
capsules, used occasionally, will affect your
chances of becoming pregnant. However, tell
your doctor before taking this medicine if you
have problems becoming pregnant.

Further information overleaf.

HOW TO TAKE THE MEDICINE
Age

Dose and how often to take

Adults, the
elderly and
children
over 12
years

Take 2 capsules (400mg)
each morning and evening, as
required. Swallow capsules
whole (do not chew) with a
glass of water preferably with
or after food. Do not exceed
4 capsules in 24 hours.

The capsules are intended for short-term use
only. Use them for the shortest time needed
to relieve symptoms. Always use the lowest
dose that relieves your symptoms.
Do not take The Co-operative Ibuprofen
200mg Long Lasting Capsules for longer
than 10 days unless your doctor tells you to.
Do not give to children under 12 years.
Talk to a doctor or pharmacist if you do not get
better or get worse, or if new symptoms occur.
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 The Co-operative Ibuprofen
200mg Long Lasting Capsules without any
problems, but it can have side effects, like all
medicines.
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:
Allergic reactions:
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
• 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
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and
exhaustion.

Heart and circulation effects: Medicines
such as The Co-operative Ibuprofen 200mg
Long Lasting 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:
Other stomach and intestine effects including:
• diarrhoea, flatulence, constipation and vomiting.
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).
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.
STORING THE MEDICINE
Do not use after the expiry date shown on
the pack.
Do not store above 25°C.
Store in the original container.
Keep all medicines out of the reach and
sight of children.
FURTHER INFORMATION
What is in this medicine:
The active ingredient is: 200mg of Ibuprofen
in each prolonged release capsule.
The other ingredients are: Microcrystalline
Cellulose, Eudragit NE30D, Hypromellose,
Talc, Collodial Silicon Dioxide. The capsule
shell contains Gelatin, Titanium Dioxide (E171),
Patent Blue V (E131), Erythrosine (E127).
What this medicine looks like and
contents of the pack
The Co-operative Ibuprofen 200mg Long
Lasting Capsules are blue and clear capsules
containing white coated beads, available in
pack sizes of 6, 8, 12 or 16 capsules (not all
pack sizes may be marketed).
Marketing Authorisation Holder:
Galpharm Healthcare Ltd, Upper Cliffe Road,
Dodworth Business Park, Dodworth,
South Yorkshire S75 3SP
Manufacturer:
Galpharm International Ltd, Upper Cliffe Road,
Dodworth Business Park, Dodworth,
South Yorkshire S75 3SP
Date of approval:10/2010

4000368
12345-A

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
(web1)