IBUPROFEN 600 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

5. how to store ibuprofen 600 mg tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the blister strip. The expiry date refers to the last day of that month. Discard content 6 months after opening.

This medicinal product does not require any special storage conditions.

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.

If your doctor decides to stop your treatment, return any left over tablets to your pharmacist. Only keep the tablets if your doctor tells you to.

6. contents of the pack and other information

What Ibuprofen tablets contain

The active substance is Ibuprofen available as 600 mg tablets.

The other ingredients are Sodium lauryl sulphate, Croscarmellose sodium, Lactose monohydrate, Microcrystalline cellulose, Povidone, Colloidal Anhydrous silica, Stearic acid, Hypromellose, Macrogols 6000, Purified Talc, Titanium dioxide (E171).

What Ibuprofen tablet looks like and content of the pack

Ibuprofen 600 mg Tablets are white to off-white, pillow-shaped, film coated tablet, plain on both sides.

Ibuprofen 600 mg Tablets are supplied in blister packs of 84 tablets and HDPE container of 500 tablets.

Not all pack sizes may be marketed.

This leaflet was last revised in 05/2020 |POM|

Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

E-mail :

To listen to or request a copy of this leaflet in Braille, large print or audio please call, 020 88311580 (UK only)

Please be ready to give the following information:

Product name

Ibuprofen 600 mg Film-coated tablets

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ibuprofen 600 mg Film-coated tablets

IMPORTANT INFORMATION

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Ibuprofen 600 mg Tablets are and what are they used for

• 2. What you need to know before taking Ibuprofen 600 mg Tablets

• 3. How to take Ibuprofen 600 mg Tablets

• 4. Possible side effects

• 5. How to store Ibuprofen 600 mg Tablets

• 6. Contents of the pack and other information

• 1. What Ibuprofen 600 mg Tablets are and what are they used for Ibuprofen 600 mg Tablets belong to a group of medicines called anti-inflammatory pain killers. They 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), swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains. Ibuprofen 600 mg Tablets can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.

The active ingredient in Ibuprofen 600 mg Tablets is ibuprofen and each tablet contains 600 mg.

2. what you need to know before taking ibuprofen 600 mg tablets

Do not take Ibuprofen 600 mg Tablets:

• If you are pregnant or planning to become pregnant, or are you breast-feeding Ibuprofen 600 mg 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
• If you are sensitive (allergic) to any of the ingredients in the tablets. These are listed in Section 6
• If you have, or have you previously had, a stomach ulcer or other gastric complaint
• 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 If you have a condition which increases your tendency to bleeding If you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers
• If you suffer from liver or kidney disease
• If you suffer from heart disease

Warnings and precautions

Medicines such as any Ibuprofen 600 mg 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 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 an infection – please see heading “infections” below.

• Do you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)?
• Have you been told by your doctor that you have an intolerance to some sugars?
• There is a risk of kidney damage in dehydrated children and adolescents.

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Skin reactions

Serious skin reactions have been reported in association with Ibuprofen 600 mg Tablets treatment. You should stop taking Ibuprofen 600 mg 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 600 mg Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen 600 mg 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 600 mg Tablets

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl salicylic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE inhibitors such as captopril, B-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 (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 (SSRls), used for the treatment of depression antibiotics called quinolones such as ciprofloxacin
• aminoglycosides (a type of antibiotic)
• mifepristone
• any other ibuprofen preparations, 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 (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)

Pregnancy and breast-feeding

The use of Ibuprofen 600 mg Tablets whilst pregnant or breast feeding should be avoided. Ibuprofen 600 mg Tablets should not be used in late (the last three months of) pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and using machines

Ibuprofen 600 mg Tablets 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.

3. how to take ibuprofen 600 mg tablets

ALWAYS take Ibuprofen 600 mg 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 600 mg Tablets with or after food, with a glass of water. Ibuprofen 600 mg Tablets should be swallowed whole and not chewed, broken, crushed or sucked to help prevent discomfort in the mouth or irritation in the throat.

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:

Adults and children over 12 years - 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.

Children - The usual daily dosage is 20 mg per kg of bodyweight, given in divided doses. Ibuprofen 600 mg Tablets should NOT be taken by children weighing less than 7 kg. The 600 mg tablets should not be given to children under the age of 12 years.

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

You should avoid excessive use of painkillers. If you usually take painkillers, especially combinations of different painkillers, you may damage your kidneys, tell your doctor if you are already taking another painkiller before taking this medicine and your doctor will decide whether you should take this medicine. This risk may be increased if you are dehydrated.

If you take more Ibuprofen 600 mg tablets than you should

If you have taken more Ibuprofen 600 mg tablets than you should or if children have taken this medicine by accident always contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you 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 YOUR IBUPROFEN 600 mg TABLETS Take them 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.

4. possible side effects

As with all medicines, Ibuprofen 600 mg Tablets may cause side effects, although they are usually mild and not everyone will suffer from 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.

If you suffer from any of the following at any time during your treatment STOP TAKING Ibuprofen 600 mg Tablets and seek immediate medical help:

• Signs of aseptic meningitis such as severe headache, high temperature, stiffness of the neck, disorientation, and/or intolerance to light.
• Signs of intestinal bleeding such as

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

• – Pass black tarry stools

• – Vomit any blood or dark particles that look like coffee grounds

TELL YOUR DOCTOR AND STOP TAKING THE 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
• Severe sore throat with high fever
• Loss of vision, blurred/disturbed vision (visual impairment) or seeing/hearing strange things(halluci­nations)
• 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)
• 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 cells)
• Fluid retention (e.g. swollen ankles)