IBUPROFEN SAINSBURYS 200 MG COATED TABLETS, IBUPROFEN WELL PHARMACEUTICALS 200 MG COATED TABLETS, IBUPROFEN 200 MG COATED TABLETS - patient leaflet, side effects, dosage

Ibuprofen 200mg Coated Tablets

• PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE.
• Keep this leaflet. You may want to read it again.
• If you have any further questions, ask your pharmacist.
• This medicine has been prescribed for you. Do NOT pass it on to others. It may harm them even if their symptoms are the same as yours.
• If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Ibuprofen tablets are and what they are used for

• 2. Before you take Ibuprofen tablets

• 3. How to take Ibuprofen tablets

• 4. Possible side effects

• 5. How to store Ibuprofen tablets

• 6. Further Information

• 1. What Ibuprofen tablets are and what they are used for

Ibuprofen is one of a group of medicines called non-steroidal anti-inflammatory drugs or NSAIDs, which work by changing the body's response to pain, swelling and high temperature. These tablets are used to provide relief of headache, muscular pain, rheumatic pain, backache, neuralgia (nerve pain), migraine, period pain, dental pain, feverishness and the symptoms of colds and flu.

• 2. Before you take Ibuprofen tablets

Do not take these tablets if:

• You have had gastrointestinal bleeding or perforation when previously taking NSAIDs
• You have had an allergic reaction to aspirin, Ibuprofen, any other NSAIDs orany ofthe ingredients (see section 6 for further information)
• You have had worsening of asthma, developed an allergic rash, facial swelling or an itchy runny nose when taking Ibuprofen, aspirin orsimilar medicines
• You have had liver, kidney or severe heart problems
• You have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• You are in the last 3 months of pregnancy
• You are under 12 years of age

Talk to your pharmacist or doctor if: you have an infection – please see heading “Infections” be­low.

Infections

Ibuprofen tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen 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 ofthe infection persist or worsen, consult a doctor without delay.

Take special care and tell your doctor or pharmacist if:

• You have high blood pressure
• You have asthma or have suffered from asthma
• You have kidney, heart, bowel or liver problems
• You have a condition known as Systemic Lupus

Erythematosus (SLE) – an illness which affects your immune system, It causes joint pain, skin changes and problems with other parts of your body

• You are elderly
• You are pregnant or breastfeeding (see section You are pregnant or breastfeeding)
• 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), in which case, you should discuss yourtreatment with your doctor or pharmacist

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen treatment. You should stop taking Ibuprofen Tablets 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.

Important warning

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack („myocardial infarction“) or stroke. Any riskis more likely with high doses and prolonged treatment. Do not take more medicine than the label-leaflet tells you to. Do not use for a duration of more than (10 days). There is a risk of renal impairment in dehydrated children and adolescents.

Taking other medicines

Do not take this medicine if you are taking aspirin at doses above 75 mg daily. If you are on low dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take Ibuprofen.

Tell your doctor if you are taking other medicines especially the following

• Other pain relievers or products containing aspirin, Ibuprofen or other NSAIDs
• Medicines for high blood pressure e.g. diuretics (frusemide, bendroflumethi­azide, hydrochlorothi­azide), ACE inhibitors (enalapril, Ramipril), Angiotensin II receptor blockers (losartan), beta blockers (atenolol), calcium channel blockers (amlodipine)
• Medicines for treating heart conditions e.g. digoxin for atrial fibrillation (a condition with an irregular heart beat)
• Medicines for thinning the blood (e.g. warfarin and ticlopidine)
• Corticosteroids (e.g. prednisolone)
• Mifepristone (a medicine which is used to start labour)
• Medicines which weaken the immune system (ciclosporin)
• Methotrexate (a medicine for cancer) and rheumatoid arthritis
• Medicines for depression and mood stabilising drugs (lithium, citalopram and fluoxetine)
• Quinolone antibiotics and zidovudine (medicines used to treat bacterial and viral infection)

You should therefore always seek the advice of your doctor or pharmacist before you take Ibuprofen with other medicines, including herbal and homeopathic remedies.

You are pregnant or breast-feeding

Ibuprofen belongs to a group of medicines which may impair fertility in women, This effect is reversible on stopping Ibuprofen. It is unlikely that Ibuprofen, when used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Speak to your doctor or pharmacist before taking Ibuprofen, if you are pregnant, think you are pregnant, are planning to become pregnant or are breast feeding.

Driving and using machinery

Taking Ibuprofen will not affect your ability to drive or use machines.

Important information about the ingredients in Ibuprofen Tablets

Ibuprofen tablets contain lactose monohydrate and sucrose. Ifyou have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Taking with food and drink

Ibuprofen tablets should be taken with water, preferably with or after food.

3. how to take ibuprofen tablets

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).

I Adults, the elderly and adolescents of 12 to 17 £ years: Dose for Ibuprofen:

• .g Take one to two tablets with water to start with, 8 preferably with or after food, followed by one to two tablets every four hours if necessary up to g three times a day
• Do not take more than six tablets in any twenty-four hour period

Adults and the elderly:

If this medicinal product is required for more than 10 days, or if symptoms persist or worsen, contact your doctor.

Adolescents:

If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Children under 12 years:

Do not give Ibuprofen to children under 12 years old.

If you have taken more Ibuprofen than you should, or if children have been taken 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 forget to take Ibuprofen:

If you have missed a dose, do not double up on a dose to make up for the forgotten dose. Take the next dose at the usual time.

If you stop using Ibuprofen:

Please speak to a doctor or pharmacist before stopping this or any medicine.

4. possible side effects

Like all medicines Ibuprofen can have side effects, although not everybody gets them.

If you are elderly you may be more likely to have some of these side effects.

If you get any of these SERIOUS side effects, stop taking the tablets and go to your nearest casualty department at once:

• Yellowing of the skin and eyes or pale stools
• Worsening of existing sever skin infections (you may notice a rash, blistering and discolouration of the skin, fever, drowsiness, diarrhoea and sickness), or worsening of other infections including chicken pox orshingles
• Vomit any blood or dark particles that look like coffee grounds
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Stomach problems including pain, indigestion or heartburn
• Severe skin conditions, causing peeling and blistering of the skin, mouth and eyes
• Unexplained wheezing, shortness of breath, swelling of the lips, face or neck, skin rash or itching, fast heart beat, or low blood pressure, as these may be signs of an allergic reaction
• Meningitis (e.g. stiff neck, fever, disorientation)
• Asevereskin 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 cells).
• Skin becomes sensitive to light – frequency unknown

These other effects are LESS SERIOUS. If they bother you talk to a doctor or pharmacist:

• Kidney or liver problems
• Nausea (feeling sick)
• Headaches
• Abdominal pain (pains in yourstomach) or other abdominal stomach symptoms
• Indigestion or heartburn
• Fever, sore throat, mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising

Uncommon side effects (less than 1 per 100 but more than 1 per 1000) which may occur are as follows:

• Headaches
• Nausea (feeling sick)
• Various skin rashes

Rare side effects (less than 1 per 1000 but more than 1 per 10,000) which may occur are as follows:

• Diarrhoea
• Flatulence (passing wind)
• Constipation
• Vomiting

Very rare side effects (less than 1 per 10,000) which may occur are as follows:

• Kidney or liver problems
• Symptoms of aseptic meningitis (stiff neck, headache, feeling sick, vomiting, fever or disorientation)

The following side effects may also occur but it is not known how frequently they occur:

• Worsening of a previous asthmatic condition
• High blood pressure
• Abnormal fluid accumulation in tissues of the body (oedema)
• Heart failure, a condition in which the heart is unable to pump blood and oxygen to the rest of the body
• Worsening of inflammatory bowel conditions such as ulcerative colitis and Crohn's disease.

Frequency “Not known”

A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen if you develop these symptoms and seek medical attention immediately. See also section 2.

Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If you experience any of these symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking Ibuprofen and see your doctor.

Reporting of side effects: Ifyou getany side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at orsearch for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

Ingredients: See Further information section.

Hazard information/Safety warnings:

All information included in the leaflet.

5. how to store ibuprofen tablets

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

• Do not store above 25°C
• Store in the original package to protect from moisture
• Do not use after the expiry date shown on the package

• 6. Further Information

What does each Ibuprofen tablet contain:

Each tablet contains the active ingredient Ibuprofen BP 200 mg. Other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, sucrose, talc, hypromellose (HPMC 2910), titanium dioxide (E171) calcium carbonate and carnauba wax.

What is in the pack: The product contains white round sugar coated tablets.

Ibuprofen is available in blister packs of 6,12 and 16 tablets*.

• *not all pack sizes may be marketed.