Ibuprofen tablets 600 mg – patient leaflet, side effects, dosage

1. What is Ibuprofen and what is it used for

• Ibuprofen belongs to the group of drugs termed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
• Ibuprofen tablets can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), arthritis of the spine (ankylosing spondylitis), and other non-rheumatoid arthropathies.
• Ibuprofen Tablets can also be used for swollen joints, frozen shoulder, bursitis, tendonitis, tenosynovitis, lower back pain, sprains and strains, to treat other painful conditions such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache, including migraine headache.

2. What you need to know before you take Ibuprofen ◆ DO NOT TAKE Ibuprofen if you:

• are allergic to Ibuprofen or any other ingredients of the product (these are listed in Section-6) aspirin or other related painkillers
• have or have had stomach ulcer, perforation or gastrointestinal bleeding
• have increased tendency to bleeding
• are taking more than 75mg of aspirin a day
• suffer from severe liver, kidney or heart failure

• are in the last 3 months of pregnancy

◆ Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you are:

• asthmatic or suffer from other kidney, liver or bowel problems
• suffering from systemic lupus erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of other organs
• trying to become pregnant- Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible upon 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 in becoming pregnant
• in the first 6 months of pregnancy

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. If you have heart problems, previous stroke or think that 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.

◆ Other medicines and Ibuprofen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

• anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan)
• diuretics (water tablets)
• cardiac glycosides, such as digoxin, used to treat heart conditions
• zidovudine (an anti-viral drug)
• steroids (used in the treatment of inflammatory conditions)
• methotrexate (used to treat certain cancers)
• 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, lithium
• any other Ibuprofen preparations, such as those you can buy without a prescription
• any other anti-inflammatory pain killer, including aspirin
• cholestyramine (drug to lower cholesterol)
• medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
• voriconazole or fluconazole (types of anti-fungal drugs)
• gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with Ibuprofen)
• have an infection - please see heading “Infections” below.

◆ Driving and Using Machines

Ibuprofen may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert. ◆ Pregnancy and breast-feeding

Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible upon stopping the medicine. The use of Ibuprofen whilst pregnant or breast feeding should be avoided. Ibuprofen should not be used in the last three months of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

◆ 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 of the infection persist or worsen, consult a doctor without delay.

3. How to take Ibuprofen

Always take Ibuprofen Tablets exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist. Take your Ibuprofen Tablets with or after food. Leave at least 4 hours between each dose.

◆ Adults - The usual dosage is 600 to 1800 mg spread throughout the day. Your doctor may choose to increase this depending on what you are being treated for, but no more than 2400 mg should be taken in one day in divided doses.

◆ Children - The usual daily dosage is 20 mg IBUPROFEN 600mg - POM - 20.02.23 .qxp_00270223/04.......148 X 290mm 20/02/2023 13:38 Page 2 per kg of bodyweight, given in divided doses, except in children weighing less than 30 kg, the total dose given in 24 hours should not exceed 500mg. Ibuprofen Tablets should NOT be taken by children weighing less than 7 kg.

In cases of severe juvenile arthritis your doctor may increase the dosage up to 40 mg/kg of body weight daily in divided doses.

◆ Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

◆ If you take more tablets than you should If you take too many tablets, contact your doctor or hospital immediately. Bring any remaining tablets with you to show the doctor.

Symptoms of overdose: Include headache, drowsiness, low blood pressure and sickness.

◆ If you forget to take a dose

If you forget to take a dose, take as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed. 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).

4. Possible side effects

Like all medicines, your medicine can cause side effects, although not everybody gets them. The following side effects are very rare (less than 1 in 10,000 people) but if you experience any of the effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist.

• Severe allergic reactions: symptoms could include faster heart rate, swelling of the face, tongue and throat.
• Serious skin reaction (Steven-Johnson syndrome and toxic epidermal necrolysis): symptoms could include blistering of the skin, mouth, eyes and genitals. Skin rash, itching or bruising, yellowing of the eyes and / or skin, red or purple discolouration of the skin.
• Peptic ulceration or perforation: symptoms could include severe abdominal pain, indigestion, heartburn, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools /motions) or passing black tarry stools.
• Inflammation of the brain lining: symptoms could include stiff neck, severe headache, feeling or being sick, fever or feeling disorientated.
• Worsening of asthma and wheezing or difficulty in breathing.
• Fluid retention (e.g. swollen ankles), hypertension, heart failure.
• Blurred or disturbed vision or seeing/ hearing strange things.
• Liver, kidney problems or difficulty urinating Ibuprofen, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

If you experience any of the above mentioned side effects then STOP TAKING this medicine immediately and contact your doctor or pharmacist.

◆ Rare side effects (less than 1 in 1000):

• blood disorders (reduction in number of blood cells), kidney problems, liver problems may occur ◆ Other side effects:
• nausea, vomiting, diarrhoea
• hallucinations, dizziness, mood swings
• tingling of hands and feet
• depression, confusion, difficulty sleeping
• anxiety, impaired hearing
• constipation, flatulence (wind)

• unexpected sensitivity of the skin to the sun

  • tiredness, malaise
  • swelling and irritation inside the nose

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

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

If any of the side effects mentioned get serious or if you notice any side effects not listed in this leaflet, contact your doctor or pharmacist.

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5. How to store Ibuprofen

• This medicine should not be used after the “expiry date” printed on the pack.
• Store in cool and dry place protected from light.
• Do not store above 30°C. Do not freeze.
• They should be kept in their original packaging. Keep all medicines out of the sight and reach of children.

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 to protect the environment.

6. Contents of the pack and other information ◆ What Ibuprofen 600mg tablets contain

• The active substance (the ingredient that makes the tablet work) is Ibuprofen. Each tablet contains 600mg of the active ingredient Ibuprofen BP.
• The other ingredients are maize starch, povidone, microcrystalline cellulose, alginic acid, sodium lauryl sulphate, colloidal silicon dioxide, sodium starch glycolate, magnesium stearate, and opadry OY1332G (Pink).

◆ What Ibuprofen tablets look like and contents of the pack

• Ibuprofen 600mg are pink film coated tablets.

• The pack sizes are “84, 100, 250 and 500 tablets

  (dispensing pack) in plastic containers and 84 and 100” tablets in blister packs.

The Marketing Authorization Holder and company responsible for manufacture:

Pharmvit Ltd, 177 Bilton Road, Perivale, Greenford, Middlesex, UB6 7HQ.

Telephone: 0208 997 5444

Fax: 0208 997 5433

To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.

PL 04556 / 0027

Reference: 00270223/04 POM

Date leaflet last revised: February 2023