IBUCALM 400 MG TABLETS, IBUPROFEN 400 MG TABLETS BP - patient leaflet, side effects, dosage

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, 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

Skin Reactions: serious skin reactions have been reported in association with Ibucalm tablets 400mg treatment. You should stop taking Ibucalm tablets 400mg and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

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.

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

• ■ Have an infection – please see heading “Infections” below

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-ll 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

Infections

Ibucalm 400mg tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibucalm 400mg tablets may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

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.

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 you may be at risk of these conditions (for example: if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker) you should discuss your treatment with your doctor or pharmacist.

This medicine contains less than 1 mmol Sodium (23mg) per 640mg tablet, that is to say essentially ‚sodium-free‘.

3. how to take the tablets

Ibucalm is only for short term use. Do not take Ibucalm for longer than 10 days.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

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.

If you take more Ibucalm 400mg tablets than you should

Seek medical attention IMMEDIATELY if you accidentally take too many tablets.

If you have taken more Ibucalm 400mg tablets than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

If you miss a dose, do not take a double dose to ‘make up' for the missed dose.

Ibucalm can cause side effects. These can be minimised by taking the smallest possible

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. A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cell)

Frequency not known: a red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibucalm tablets 400mg if you develop these symptoms and seek medical attention immediately. See also Section 2.

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.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

■ Keep out of the sight and reach of children ■ Do not store above 25 C.

• ■ Do not use after the ‘expiry’ date shown on the carton. ■ The tablets should be stored in the original packaging to protect from moisture.