IBUPROFEN 400 MG TABLETS, IBUPROFEN 400 MG COATED TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take ibuprofen 400 mg coated tablets

Do not take Ibuprofen 400 mg Coated Tablets if you:

• are allergic to Ibuprofen or any of the other ingredients (see section 6)
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• have had asthma, skin rash, itchy runny nose or facial swelling when previously taking Ibuprofen, aspirin or , similar medicines
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs)
• suffer from severe liver, kidney or heart failure
• are in the last 3 months of pregnancy
• have a condition which increases your tendency to bleeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ibuprofen 400 mg Coated Tablets if you:

• are pregnant or planning to become pregnant, or breast-feeding. Ibuprofen 400 mg Coated Tablets may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant
• are sensitive (allergic) to any of the ingredients in the tablets. These are listed in Section 6.
• have, or have previously had a stomach ulcer or other gastric complaint. Do not take Ibuprofen 400 mg Coated Tablets if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.
• suffer from asthma or have ever had an allergic reaction or suffered from wheezing after taking Ibuprofen, aspirin or other anti-inflammatory pain killers
• suffer from swelling and irritation inside the nose
• suffer from liver or kidney disease
• suffer from heart disease. Medicines such as Ibuprofen 400 mg Coated Tablets 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. You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen 400 mg Coated Tablets if you:

– have heart problems including heart failure, angina (chest pain) or you have had a heart attack, bypass surgery or peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries).

– have any kind of stroke or think that you might be at risk of these conditions (e.g. if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol or are a smoker).

• have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)
• have chickenpox or shingles
• have been told by your doctor that you have an intolerance to some sugars
• your child is dehydrated. As there is a risk of kidney

damage in dehydrated children and adolescents.

• have been diagnosed with medication overuse headache (MOH) despite regular use of analgesics
• have been consuming excessive alcohol with NSAIDs, including Ibuprofen may increase the risk of adverse effects on the gastrointestinal tract such as GI bleeding or the central nervous system
• have an infection – please see heading “Infections” below.

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen 400 mg Coated Tablets treatment. You should stop taking Ibuprofen 400 mg Coated 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.

Infections

Ibuprofen 400 mg Coated Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen 400 mg Coated 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.

Other medicines and Ibuprofen 400 mg Coated Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl­salicyclic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines. In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

• diuretics (water tablets)
• cardiac glycosides, such as digoxin, used to treat heart conditions
• lithium
• zidovudine (an anti-viral drug)
• steroids (used in the treatment of inflammatory conditions)
• methotrexate (used to treat certain cancers and rheumatoid arthritis)
• medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response)
• medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression
• antibiotics called quinolones such as ciprofloxacin
• aminoglycosides (a type of antibiotic)
• mifepristone
• any other Ibuprofen, such as those you can buy without a prescription
• any other anti-inflammatory pain killer, including aspirin cholestyramine (a drug used to lower cholesterol)
• medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (type of anti-fungal drugs) gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with Ibuprofen).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of Ibuprofen 400 mg Coated Tablets whilst pregnant or breast-feeding should be avoided. Ibuprofen 400 mg Coated Tablets should not be used in late (last three months of) pregnancy and should only be taken in the first 6 months of the pregnancy on the advice of your doctor. The use of Ibuprofen 400 mg Coated Tablets may impair female fertility and is not recommended in women attempting to conceive.

Driving and using machines

Ibuprofen 400 mg Coated Tablets may make you feel dizzy or drowsy or feel tired or affect your vision. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

3. how to take ibuprofen 400 mg coated tablets

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Ibuprofen 400 mg Coated Tablets are for short-term use only. 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).

Do not take Ibuprofen for longer than 10 days.

Swallow the tablets with water during or after meals.

The usual dose is:

Adults, the elderly and children over 12 years:

The starting dose is 1 tablet 3 times a day as required. Leave at least 4 hours between doses and do not take more than three tablets in any 24 hour period. The risk of side effects is greater in the elderly, so your doctor will give you the lowest dose possible.

Children below 12 years: Not recommended.

• ■S In cases of severe juvenile arthritis your doctor may 8 increase the dosage up to 40 mg/kg in divided doses.

I If you take more Ibuprofen 400 mg Coated Tablets a. than you should

If you have taken more Ibuprofen 400 mg Coated Tablets than you should, or if children have 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.

Take your medicine and this leaflet with you.

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 400 mg Coated Tablets Do not take a double dose to make up for a forgotten tablet. If you forget to take a dose, take it as soon as you remember unless it is almost time for your next dose.

If you stop using Ibuprofen 400 mg Coated Tablets Please speak to your doctor or pharmacist before stopping this or any medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of time necessary to control your symptoms.

STOP TAKING Ibuprofen 400 mg Coated Tablets and seek immediate medical help if you experience:

• 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).
• Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck or an intolerance to bright light.
• Serious allergic reaction which causes swelling of the face or throat.
• Signs of intestinal bleeding such as

• – Passing blood in your faeces (stools/motions).

• – Passing black tarry stools.

• – Vomiting any blood or dark particles that look likecoffee grounds.

Tell your doctor and stop taking Ibuprofen 400 mg Coated Tablets if you experience:

• Unexplained stomach pain (abdominal pain) or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.
• Unexplained wheezing, shortness of breath, skin rash, itching or bruising (these may be symptoms of an allergic reaction).
• Yellowing of the eyes and/or skin (jaundice).
• Severe sore throat with high fever (these may be symptoms of a condition known as agranulocytosis).
• Blurred or disturbed vision (visual impairment) or seeing/hearing strange things (hallucinations).
• Fluid retention e.g. swollen ankles (this may be a sign of kidney problems).
• Severe spreading skin rash (Stevens-Johnson Syndrome ‚toxic epidermal necrolysis‘ and erythema multiforme, symptoms include severe skin rash, blistering of skin, including inside mouth, nose, and genitals, as well as skin peeling which may be accompanied with symptoms such as aching, headaches and feverishness).

Medicines such as Ibuprofen 400 mg Coated Tablets have been associated with a small increased risk of high blood pressure, heart attack (myocardial infarction) or stroke. Medicines such as Ibuprofen Tablets have in exceptional cases been associated with severe skin problems for patients with chickenpox or shingles.

Blood disorders, such as reduction in blood cells and platelet counts – the first signs are: high temperature, sore throat, mouth ulcers, flu-like symptoms, bleeding from the mouth, nose, ear and the skin. Kidney problems such as reduced kidney function, fluid retention (oedema), inflammation of the kidney and kidney failure. Liver problems such as inflammation of the liver, reduced liver function and yellowing of the eyes and/or skin (jaundice) or severe skin reactions may occur rarely with Ibuprofen.

Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn's disease or colitis.

Other side effects

Common (affects up to 1 in 10 people):

• rash
• feeling dizzy or tired
• diarrhoea, being sick, wind, constipation
• headache – if this happens while you are taking this medicine it is important not to take any other medicines for pain to help with this.

Uncommon (affects up to 1 in a 100 people):

• feeling drowsy
• feeling anxious
• feeling a tingling sensation or ‚pins and needles‘
• difficulty sleeping
• hives
• itching
• visual disturbances, hearing problems
• hepatitis, yellowing of your skin or eyes, reduced liver function
• reduced kidney function, inflammation of the kidneys, kidney failure
• sneezing, blocked, itchy or runny nose (rhinitis)
• stomach or gut ulcer, hole in the wall of the digestive tract
• inflammation of your stomach lining
• small bruises on your skin or inside your mouth, nose or ears
• difficulty breathing, wheezing or coughing, asthma or worsening of asthma
• ringing in ears (tinnitus)
• sensation of feeling dizzy or spinning (vertigo)
• mouth ulcers.

Rare (affects up to 1 in a 1000 people):

• feeling depressed or confused
• a brain infection called ‚non-bacterial meningitis‘
• loss of vision
• reduction in blood cells (anaemia)
• serious allergic reaction which causes difficulty in breathing or dizziness
• severe sore throat with high fever (agranulocytosis).

Very rare (affects up to 1 in 10,000 people):

• liver failure
• heart failure
• heart attack
• inflammation of the pancreas.

Not known (frequency cannot be estimated from available data):

• Worsening of ulcerative colitis or Crohn's Disease (inflammation of the colon)
• 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).
• 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 Tablets if you develop these symptoms and seek medical attention immediately. See also section 2.
• Skin becomes sensitive to light.

5. how to store ibuprofen 400 mg coated tablets

Keep this medicine out of the sight and reach of children. Do not store the tablets above 25°C.

Keep them in the original pack.

Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Ibuprofen 400 mg Coated Tablets contain:

The active substance is Ibuprofen.

The other ingredients are Pregelatinised starch, maize starch, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 6000, erythrosine lake (E127), titanium dioxide (E171) and docusate sodium.

What Ibuprofen 400 mg Coated Tablets look like and contents of the pack:

Ibuprofen 400 mg Coated Tablets are pink, biconvex, film-coated tablets with “I 400” on one side and packed in blister packs of 24, 48, 84.

Not all pack sizes may be marketed.

Produced for:

Well Pharmaceuticals, Merchants Warehouse, Castle Street, Manchester, M3 4LZ, UK.

Marketing Authorisation Holder and Manufacturer: Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK. Tel: 01515561860, Fax: 01515561855

Email:

Product Licence No.: PL 20395/0080.

0

Date leaflet revised: December 2020.