IBUPROFEN 200 MG TABLETS BP - patient leaflet, side effects, dosage

Pharmacode position may change as per Suppliers m/c requirement & additional small pharma code may appear on the front / back panel

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibuprofen 200mg tablets BP ibuprofen

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.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. see section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 10 days

What is in this leaflet:

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

• 2. What you need to know before you take Ibuprofen Tablets

• 3. How to take Ibuprofen Tablets

• 4. Possible side effects

• 5. How to store Ibuprofen Tablets

• 6. Contents of the pack and other information

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

Each tablet contains 200mg of Ibuprofen.

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs) that work by relieving pain, reducing inflammation, swelling and fever.

Ibuprofen 200mg Tablets are for effective relief from rheumatic and muscular pain, backache, headache, dental pain, migraine, neuralgia, period pain, feverishness and the symptoms of colds and flu.

2. what you need to know before you take ibuprofen tablets

Please read the following information. Do not give to children under 12 years.

Do not take if you:

• have or have ever had a stomach ulcer, perforation or bleeding including due to NSAIDs.
• are allergic to or have had an allergic reaction (e.g. asthma, rhinitis, angioedema, urti caria) to ibuprofen or any other ingredient of the product, aspirin or other related pain killers
• suffer from severe liver, kidney or heart failure.
• are in the last 3 months of pregnancy

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.

Take special care and talk to a pharmacist or your doctor before taking this medicine if you have or are:

• 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.
• are asthmatic or suffer from kidney, liver or bowel problems, or any allergic reaction e.g. hayfever
• suffering from Systemic Lupus Erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs.
• trying to become pregnant (ibuprofen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This medicine is reversible upon stopping the medicine. It is unlikely that ibuprofen, used occasionally will affect your changes of becoming pregnant, however, tell your doctor before taking this medicine, if you problems becoming pregnant)
• are in the first 6 months of pregnancy, or are breast-feeding
• 12–18 years old as there is a risk of renal impairment. Therefore ask a doctor before

use if you are a 12–18 year old who has not been drinking fluids or has lost fluids due

to continuous vomiting or diarrhoea.

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

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen tablets 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.

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. Do not exceed the recommended dose or duration of treatment (10 days). There is an increased risk of the elderly having side effects.

Use in children

This medicine is NOT recommended for children under 12 years of age (see section 3).

Other medicines and Ibuprofen Tablets

Do not use this medicine if you are:

• taking other NSAID painkillers, or aspirin with a daily dose above 75mg

Ibuprofen 200mg Tablets may affect or be affected by some other medicines. Talk to your doctor or pharmacist if you are taking:

• aspirin/ acetyl salicylic acid, warfarin, ticlopidine (medicines that are anti-coagulants i.e. thin blood/ prevent clotting)
• ACE-inhibitors such as captopril, beta blockers such as atenolol, angiotensin-ll receptor antagonists such as losartan (medicines that reduce high blood pressure)
• corticosteroids (an anti-inflammatory drug)
• Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) (used for treatment of depression)
• cardiac glycoside such as digoxin (a heart medicine)
• lithium (used to treat depression)
• methotrexate (used to treat arthritis and certain forms of cancer)
• tacrolimus and ciclosporin (used to dampen down your immune response)
• zidovudine (an anti-viral drug)
• ciprofloxacin (quinolone antibiotics)
• mifepristone (for termination of pregnancy) – do not take ibuprofen if you have taken mifepristone in the last 12 days.

Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen with other medicines.

Ibuprofen Tablets with food and drink

The tablets should be swallowed with a drink of water. Take with or after food to reduce the possibility of side effects (see section 3).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• DO NOT use Ibuprofen Tablets in the last three months of pregnancy.
• Speak to your doctor or pharmacist before taking Ibuprofen Tablets if you are in the

first six months of pregnancy, are breast-feeding or planning to breast-feed.

Driving and using machines

These tablets do not affect your ability to drive or use machinery.

Ibuprofen Tablets contain lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Ibuprofen Tablets contain sodium

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially 'sodium free’

3. how to take ibuprofen tablets

For oral administration and short term use only.

Adults, the elderly and children over 12 years

Take 1–2 tablets (200 to 400 mg) up to three times a day. The tablet should be taken with water. If you are not sure, how much to take, ask your doctor or your pharmacist.

DO NOT take more than 6 tablets (1200 mg) in any 24 hour period. You should NOT take this medicine for longer than 10 days unless your doctor tells you to. If your symptoms persist or worsen, consult your doctor.

If in adolescents (age range: > 12 years to < 18 years) this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

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).

Use in children

This medicine is NOT recommended for children under 12 years of age.

If you take more Ibuprofen Tablets than you should

If you take more tablets than you should or if children have taken the medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken. Bring any remaining tablets with you to show your doctor. 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 Tablets

If you have missed a dose, take it as soon as you remember. DO NOT take a double dose to make up for the missed dose.

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

4. possible side effects

Like all medicines, Ibuprofen Tablets may sometimes cause side effects although not everyone gets them.

STOP taking these tablets and seek medical help IMMEDIATELY if you experience any

of the following reactions:

• peptic ulceration or perforation: Symptoms could include severe abdominal pain, 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, headache, feeling or being sick, fever or feeling disorientated
• severe allergic reactions: symptoms could include dizziness or fainting, faster heart rate, swelling of the face, tongue and throat.
• worsening of asthma and wheezing or difficulty breathing
• heart failure or chest pain (you may be tired, have difficulty in breathing or swollen legs)
• reduction in blood cells which can make the skin pale or yellow, cause fever, sore throat, mild mouth ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleeding from the skin or nose.
• liver problems: symptoms could include yellowing of the skin or the whites of the eyes
• kidney problems: symptoms could include swelling of the ankles, feel breathless, very tired or weak,have no appetite,, pass more or less urine, have blood in the urine or cloudy urine.
• skin reactions: symptoms could include blistering, skin rash, itching and hives
• 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)

Other possible side effects:

Uncommon side effects (affecting between 1 in 100 and 1 in 1,000 people)

• allergic reactions such as hives, skin rashes and itching (or SLE)
• stomach: abdominal pain, indigestion, heartburn and feeling sick
• nervous system: headache

Rare side effects (affecting between 1 in 1000 and 1 in 10,000 people)

• diarrhoea
• wind
• constipation
• vomiting (being sick)

Very rare side effects (affecting 1 in 100,00 people)

• high blood pressure
• nervousness, visual disturbance, ringing in the ears and vertigo

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

• 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 tablets

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

Do not store above 25°C. Store in the original package.

Do not use the tablets after the expiry date which is stated on the label or carton, after EXP („EXP“ will need to be confirmed by yourselves first). 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 Tablets contain

The active substance is ibuprofen.

The other ingredients are lactose monohydrate, potato starch, methylcellulose, sodium starch glycolate type A, colloidal anhydrous silica, magnesium stearate, sucrose, talc, titanium dioxide (E171), maize starch and pregelatinised starch.

What Ibuprofen Tablets look like and contents of the pack

The tablets are white and sugar coated.

They are available in blister packs of 12 or 16 tablets (not all pack sizes may be marketed).

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip, HA4 6QD

United Kingdom

Manufacturer

Bristol Laboratories Limited

Unit 3, Canal side, Northbridge road

Berkhamsted, Herts, HP4 1EG

United Kingdom

This leaflet was last revised in 01/2021.