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IBUCALM 400MG TABLETS

Active substance(s): IBUPROFEN

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Patient Information Leaflet for

P

Ibucalm 400mg Tablets
Read this leaflet carefully before taking your medicine. It does not contain all the information
about your medicine that you may need to know, so please ask your doctor or pharmacist if
you have any questions. This leaflet only applies to Ibucalm 400mg tablets.

1. WHAT THESE TABLETS DO
Ibucalm contains Ibuprofen which is a type of painkiller called a ‘non steroidal anti
inflammatory drug’ (NSAID). It is used to relieve rheumatic and muscular pain, pain of
some arthritic conditions, backache, neuralgia, migraine, headache, dental pain, period pains, feverishness
and the symptoms of cold and flu.
2. CHECK BEFORE YOU TAKE
Do not take these tablets if you:
Are allergic to Ibuprofen or any of the other ingredients listed in section 6
Have a history of allergy to aspirin, ibuprofen or NSAID’s which includes attacks of asthma, swelling of
the nose and throat, skin rashes or a runny nose.
Have an active or a history of recurrent peptic ulcers (more than two).
Are over six months pregnant
Are already taking aspirin at doses of above 75mg daily or taking any other NSAID
Have severe liver, kidney or heart problems
Have a history of gastro intestinal bleeding or perforation related to the use of NSAID’s
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 at high doses. Do not exceed the recommended dose or
duration of treatment.
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’) or think that you
may be at risk have high blood pressure, diabetes, high cholesterol, have a family history of heart disease
or stroke, or if you are a smoker.
Take special care and tell your doctor if you:
Suffering from Systemic Lupus Erythematosus (SLE) a condition of the immune system affecting
connective tissue resulting in joint pain, skin change and disorders of other organs
Have inflammatory bowel disease (e.g. Crohns disease, Ulcerative colitis) as it could get worse
Have kidney problems as these can get worse
Have a history of asthma or allergies
Taking other medicines
Ibucalm 400mg Tablets 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)
Medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta blockers such as
atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of Ibucalm 400mg Tablets. You
should therefore always seek the advice of your doctor or pharmacist before you use Ibucalm 400mg
Tablets with other medicines.
Tell your doctor or pharmacist if you are already taking any of the following medicines:
Diuretics (such as furosemide and triamterene) or beta blockers (such as atenolol and propranolol) for
high blood pressure
Blood thinning medicines that prevent blood clotting e.g. Warfarin
Low dose aspirin (up to 75mg daily)
Taking other medicines such as corticosteroids, anti platelet agents, cardiac glycosides, selective
serotonin reuptake inhibitors (SSRIs), methotrexate, ciclosporin, mifepristone, tacrolimus, zidovudine or
quinolone antibiotics
Children and adolescents
There is a risk of renal impairment in dehydrated children and adolescents.
Pregnancy and breast-feeding
Tell your doctor before taking these tablets if you are pregnant or think you may be pregnant.
Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on
stopping the medicine. It is unlikely that Ibuprofen, used occasionally, will affect your chances of becoming
pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
Medicines such as ibuprofen 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.

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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 feet or hands due to narrow or blocked
arteries), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack 'TIA') or think you may
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.
3. HOW TO TAKE THE TABLETS
Ibucalm is only for short term use. Do not take Ibucalm for longer than 10 days.
Take the lowest dose for the shortest time necessary to relieve your symptoms.
If symptoms persist or worsen consult your doctor.
Dosage in adults, the elderly and children over 12 years:
Take 1 tablet every 4 to 8 hours. Do not take more than 3 tablets in 24 hours.
Take the tablet with food and swallow whole with a drink of water.
Do not give these tablets to children under 12 years old except on the advice of a doctor.
If in adolescents this product is required for more than 3 days or if symptoms worsen a doctor should be
consulted.
Seek medical attention IMMEDIATELY if you accidentally take too many tablets.
If you miss a dose, do not take a double dose to ‘make up’ for the missed dose.
4. POSSIBLE SIDE EFFECTS
Ibucalm can cause side effects. These can be minimised by taking the smallest possible dosage.
Serious side effects
If you suffer from any of the below, at any time during your treatment STOP TAKING the medicine and
seek medical help.
Pass blood in your faeces (stools or motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee grounds
Breathing difficulties such as shortness of breath and wheezing that may lead to dizziness
Swelling of the face, tongue or throat
Skin reactions including itchy, patchy, red or raised skin rash and very rarely skin blistering or peeling
Indigestion, heartburn or stomach pains
STOP TAKING the medicine and tell your doctor if you experience:
Indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
Other side effects
Uncommon reactions: Stomach pain or indigestion, feeling sick, headache
Rare: Diarrhoea, flatulence, constipation and vomiting.
Very rare reactions: Severe problems with your gut (bleeding, perforation, ulcer), worsening of ulcerative
colitis and Crohns disease, kidney problems, liver disorders, changes in the blood which may lead to
fever, sore throat, mouth ulcers, flu-like symptoms, tiredness and unexplained bleeding/bruising
Ibuprofen may slightly increase the risk of heart attack or stroke.
If you experience any of these or any other side effects and they get serious, contact your doctor or
pharmacist.

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5. STORING YOUR MEDICINE

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out of the sight and reach of children
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Do not store above 25˚C.
use after the ‘expiry’ date shown on the carton.
·· DoThenottablets
should be stored in the original packaging to protect from moisture.

6. MORE ABOUT YOUR MEDICINE

The active ingredient in Ibucalm tablets is Ibuprofen. They are round and pink in colour.
The inactive ingredients are Colloidal anhydrous silica, starch, povidone, croscarmellose sodium,
microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate, sodium starch glycollate,
talc, hypromellose (E464), glycerol, carmine (E120) and titanium dioxide (E171).
The product licence holder and manufacturer responsible for release is:
Aspar pharmaceuticals Ltd., Capitol way, Colindale, London NW9 0EQ
The tablets are available in blister packs of 12, 24, 48 and 96

P.L. 08977/0017

Date of preparation May 2016

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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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