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

Ibuprofen

Read this leaflet carefully because it contains important information for you.

• This medicine is available without prescription for you to treat a mild condition without a doctor’s help. However, you still need to use it carefully to get the best results from it. Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.

What this medicine is for

This medicine contains Ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory medicines, which act to relieve pain and reduce swelling. It can be used to relieve headaches, rheumatic and muscular pain, pain from non-serious arthritic conditions, backache, migraine, period pain, dental pain and neuralgia. It can also be used to reduce fever and relieve the symptoms of colds and flu.

Before you take this medicine

These tablets can be taken by adults and children from the age of 12 years. However, some people should not take this medicine or should talk to their pharmacist or doctor first. Skin reactions

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

Do not take if

• You have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past
• You have had a perforation or a bleeding stomach after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black, tarry stools)
• You are allergic to ibuprofen or any other ingredients in the product, aspirin or other non-steroidal antiinflammatory medicines (you have ever had asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)
• You are taking aspirin with a daily dose above 75mg, or other non-steroidal anti-inflammatory medicines
• You have severe heart, kidney or liver failure
• You are pregnant and in the last three months of pregnancy
• You have asthma, a history of asthma or other allergic disease, bowel problems, ulcerative colitis, Crohn’s disease
• You have other kidney, heart or liver problems, (see above)
• You have a connective tissue disorder such as SLE, (Systemic Lupus Erythematosus)
• You are elderly – you may get more side effects, (see back of leaflet)
• You are taking any other painkillers or receiving regular treatment from your doctor
• You have had a stroke, or have heart problems, high blood pressure, diabetes, high cholesterol, or you smoke – see ‘Risk of heart attack or stroke’ below
• You are pregnant and in the first 6 months of pregnancy
• You are breastfeeding
• You are an adolescent between the age of 12–18 years and have been taking the medicinal product for more than 3 days or if your symptoms worsen.

Other important information

Risk of heart attack or stroke: Ibuprofen may increase the risk if you take large amounts for a long time. The risk is small. Take the lowest amount for the shortest possible time to reduce the risk.

Women of childbearing age: If you take this medicine, it may reduce your ability to become pregnant. This effect will be reversed when you stop taking the medicine.

There is a risk of renal impairment in dehydrated children and adolescents.

Warnings and precautions

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.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen 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 of feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack “TIA”).
• have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Talk to your pharmacist or doctor if:

• you have an infection – please see heading ‚Infections‘ below.

Infections

Ibuprofen may hide signs of infections such as fever and pain. It is therefore possible that ibuprofen 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.

If you take other medicines

Before you take these tablets, please tell your pharmacist about ANY other medicines that you are taking or might be taking at the same time, in particular the following:

• Other pain killers
• Aspirin 75mg, (to prevent heart attacks and strokes) -the protection may be reduced when you take ibuprofen
• Tablets that thin your blood, (e.g. warfarin)
• Mifepristone, (for termination of pregnancy) – do not take ibuprofen if you have taken mifepristone in the last 12 days
• Water tablets, (diuretics), medicines to treat high blood pressure, (antihyperten­sives), medicines for heart problems
• Corticosteroids, lithium, methotrexate, zidovudine
• Quinolone antibiotics, (for infections)
• Medicines for depression
• Ciclosporin or tacrolimus, (given after transplant surgery, or for psoriasis or rheumatism)
• 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-II receptor antagonists such as losartan)

If you are unsure about interactions with other medicines that you may be taking, talk to your pharmacist. This includes medicines prescribed by your doctor and medicines you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

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.

If the foil is broken, do not take that tablet.

AGE HOW MANY HOW OFTEN

Adults and children over 12 years.	One tablet.	Every 4 hours, if required. Up to 3 times a day.
Do not take more than 3 tablets in 24 hours.
Do not take more often than every		4 hours.
Take the lowest amount for the shortest possible time to relieve your symptoms.

Swallow the tablets with water.

Do not give to children under 12 years.

Do not take more than recommended in the table above.

If your symptoms worsen at any time, talk to your doctor. If your symptoms do not go away within 10 days, talk to your doctor.

If you take too many tablets

If you have taken more ibuprofen tablets than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital straightaway 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.

Possible side effects

Most people can take this medicine without any problems but sometimes you may notice some side effects.

If you have any of the following serious side effects, stop taking the tablets and see a doctor straight away:

• 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)
• 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). Stop using ibuprofen if you develop these symptoms and seek medical attention immediately. If you are elderly, you may be more likely to get some of these side effects
• You are sick (vomiting) and it contains blood or dark particles that look like coffee grounds
• Pass blood in your stools or pass black, tarry stools
• Stomach problems including pain, indigestion or heartburn
• Allergic reactions such as skin rash (which can sometimes be severe and include peeling and blistering of the skin), swelling of the face, neck or throat, worsening of asthma, difficulty in breathing
• Meningitis (e.g. stiff neck, fever, disorientation)

Talk to your pharmacist if these other side effects concern you:

• Kidney problems, which may lead to kidney failure
• Feeling sick or being sick
• Headache, hearing problems
• High blood pressure, heart failure
• Fluid retention, which may cause swelling of the limbs
• Rarely, liver problems, diarrhoea, wind, constipation, worsening of colitis or Crohn’s disease
• Very rarely, tiredness or severe exhaustion, changes in the blood which may cause unusual bruising and an increase in the number of infections that you get (e.g. sore throats, mouth ulcers, flu-like symptoms)
• A small increased risk of heart attack or stroke if you take large amounts for a long time
• Skin becomes sensitive to light – frequency unknown

How to store this medicine

This medicinal product does not require any special storage conditions.

Keep this medicine out of the sight and reach of children. Do not use after the Use By date on the end flap of the carton (marked ‘EXP’).

What is in this medicine

Each tablet contains: ibuprofen 400mg. This is the active ingredient.

These tablets also contain pregelatinised starch, maize starch, anhydrous silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol 400, water and titanium dioxide (E171).

The pack contains 12, 16, 24, 32, 48, 84 or 96 white, film coated tablets marked with the letter ‘I’ on one face.

Who makes this medicine

The medicine is manufactured for the Marketing Authorisation holder Max Remedies Ltd, by Max Healthcare Ltd, both located at William Nadin Way, Swadlincote, Derbyshire, DE11 0BB.

Leaflet prepared October 2020.

If you would like any further information about this product, please contact Max Healthcare Ltd, at the above address.

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