Ibuprofen 200mg/5ml Oral Suspension

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Document: leaflet MAH GENERIC_PL 04917-0099 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Ibuprofen 200 mg/5 ml Oral Suspension

Read all of this leaflet carefully before you start taking/giving this medicine.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- You must contact a doctor if symptoms persist or worsen after 1 day (infants aged 3-6 months) or 3 days (children aged 6 months to 12 years) or 10 days (for those aged over 12 years)

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Ibuprofen 200 mg/5 ml Oral Suspension is and what it is used for

2. What you need to know before you give/take Ibuprofen 200 mg/5 ml Oral Suspension

3. How to give/take Ibuprofen 200 mg/5 ml Oral Suspension

4. Possible side effects

5. How to store Ibuprofen 200 mg/5 ml Oral Suspension

6. Contents of the pack and other information

1. WHAT IBUPROFEN 200 MG/5 ML ORAL SUSPENSION IS AND WHAT IT IS USED FOR

Ibuprofen 200 mg/5 ml Oral Suspension contains Ibuprofen as the active ingredient. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen 200 mg/5 ml Oral Suspension is given to children under 12 as a painkiller for relief of mild to moderate muscular pain, headache, teething pain and toothache. It also reduces the temperature in fever (e.g. colds, influenza and post-immunisation fever). For adults and children over 12 it can also be used for backache, migraines, neuralgia and relief from non-serious arthritic conditions.

2. WHAT YOU NEED TO KNOW BEFORE YOU GIVE/TAKE IBUPROFEN 200 MG/5 ML ORAL SUSPENSION

Do NOT give/take this medicine if you or your child:

• has an allergy or hypersensitivity to ibuprofen or any of the other ingredients in this medicine (see Section 6 and Section 2: Important information about ingredients)

• has had an allergic reaction or wheezing e.g. an asthma attack, runny nose, skin reaction or swelling after taking aspirin or other non-steroidal anti-inflammatory painkillers

• has ever had a stomach ulcer or a history of bleeding into, or perforation of, the intestine especially after previous NSAID treatment

• is taking any other non-steroidal anti-inflammatory painkillers (NSAIDs)

• has ever had severe kidney, heart or liver problems

• is suffering from severe dehydration

• has an inherited intolerance to some sugars

• is less than 3 months old, except on the advice of a doctor

• suffers from a blood disorder

• are in the last three months of pregnancy

• are trying to conceive.

Warnings and Precautions

There is a risk of renal (kidney) impairment in dehydrated children.

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss yours or your child’s treatment with your doctor or pharmacist before taking this medicine if you are elderly or your child has:

• if you have heart problems including heart failure, angina (chest pain), or if you had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini stroke’ or transient ischaemic attach ‘TIA’)

• if you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker

• kidney, liver or bowel problems

• lupus (SLE) or a mixed connective tissue disease

• a chronic inflammatory bowel disease such as ulcerative colitis or Crohn's disease

• asthma or allergic diseases of the lungs

• has chicken-pox

• has a disorder of porphyrin metabolism.

Speak to your doctor or pharmacist before taking if you are trying to get pregnant. Ibuprofen belongs to a group of medicines which may impair fertility in women. This effect is reversible on 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 becoming pregnant.

If any of these apply, ask for advice from a doctor or pharmacist before using this medicine.

Medicines such as Ibuprofen 200 mg/5 ml Oral Suspension 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. If you have heart problems, previous stroke or if you think that you or your child might be at risk of these conditions (for example if you or your child have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss the treatment with your doctor or pharmacist.

Drinking alcohol while taking Ibuprofen may increase your risk of certain side effects.

Other medicines and Ibuprofen 200 mg/5 ml Oral Suspension

Please tell your doctor or pharmacist if you or your child are taking or has recently taken any other medicines, including medicines obtained without a prescription. Ibuprofen 200mg/5ml Oral Suspension may affect or be affected by some medicines. For example:

• Diuretics (drugs to help you pass water)

• Medicines that are anticoagulants (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)

• Anticoagulants eg. Warfarin and Heparin and Anti-platelet drugs such as Clopidogrel and Ticlopidine (drugs that thin the blood)

• Antihypertensives (drugs used to treat high blood pressure e.g. Captopril or Propranolol)

• Lithium, Phenytoin or Selective serotonin reuptake inhibitors (SSRI’s e.g. Fluoxetine - used to treat mood disorders)

• Methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)

• Zidovudine (used to treat HIV)

• Corticosteroids (anti-inflammatory drugs, such as prednisone)

• Cardiac glycosides (drugs used in the treatment of heart problems, such as Digoxin)

• Ciclosporin or Tacrolimus (used to supress the body’s immune system)

• Quinolone antibiotics (used to treat a wide range of infections e.g. Ciprofloxacin)

• Probenecid and sulfinpyrazone (used to treat gout)

• Moclobemide (used to treat depression)

• Aminoglycosides (an antibiotic)

• Cholestyramine (used to reduce cholesterol)

• Baclofen (used to relax muscles)

• Sulphonylureas (used to treat diabetes)

• Ritonavir (used to treat HIV infection and AIDS)

• Bisphosphonates (used to prevent loss of bone mass)

• Oxpentifylline (used to treat poor circulation to arms and legs)

• any other Ibuprofen preparations or NSAID painkillers, including those you can buy without a prescription.

Some other medicines may also affect or be affected by the treatment of Ibuprofen 200mg/5ml Oral Suspension. You should therefore always seek the advice of your or your child’s doctor or pharmacist before you give Ibuprofen 200mg/5ml Oral Suspension with other medicines.

Pregnancy and breast-feeding

Ibuprofen should NOT be taken during the last 3 months of pregnancy, as it may be harmful to the unborn child. Pregnant women intending to use this product should seek medical advice before use as it should only be taken on doctor’s advice during the first 6 months of pregnancy.

Only small amounts of ibuprofen and its break down products pass into breast milk. As no harmful effects to infants are known to date, it is not usually necessary to stop breast-feeding during short-term use of ibuprofen at the recommended doses.

Important information about some of the ingredients of this medicine

• Maltitol (E965), may have a mild laxative effect (calorific value 2.3 kcal/g). If you have been told that you or your child have an intolerance to some sugars, contact your doctor before taking/giving this medicine.

3. HOW TO GIVE/TAKE IBUPROFEN 200 MG/5 ML ORAL SUSPENSION Shake the bottle well before measuring the dose. A measuring device is provided to ensure accuracy. Contact your doctor for advice if symptoms persist or worsen for more than 10 days in those aged over 12 years. For children aged 6 months to 12 years contact a doctor if symptoms persist or worsen after 3 days. For infants aged 3 months to 6 months contact a doctor if symptoms persist or worsen after 24 hours.

This medicine should NOT be given if your child weighs less than 5 kg. The usual daily dose in children is 20 - 30 mg per kg of bodyweight in divided doses.

Leave at least 4 hours between doses. For oral and short term use only._

WARNING: DO NOT EXCEED THE STATED DOSE

Babies under 3 months	Do not give except on the advice of a doctor
3 - 6 months (weighing more than 5 kg)	1.25 ml dose (50 mg) taken up to 3 times in 24 hours
6 - 12 months (weighing 8 - 10 kg)	1.25 ml dose (50 mg) taken up to 3 times in 24 hours
1 - 4 years (weighing 10 - 15 kg)	2.5 ml dose (100mg) taken up to 3 to 4 times in 24 hours
4 - 7 years (weighing 15-20 kg)	3.75 ml dose (150 mg) taken up to 3 times in 24 hours
7 - 12 years (weighing 20 - 40 kg)	5 ml dose (200 mg) taken up to 3 times in 24 hours

Over 12 years	5 ml to 10 ml dose (100mg - 499mg) taken 3 times in 24
	hours.
	Do not give more than 30 mls (1200 mg) in any 24 hours).

For infants aged 3 - 5 months medical advice should be sought if symptoms worsen or not later than 24 hours if symptoms persist.

If in children aged from 6 months and in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Post-immunisation fever: One 1.25 ml, followed by another 1.25 ml six hours later if necessary. Not more than 2 doses should be given in 24 hours. If fever is not reduced, consult a doctor.

If you forget to give/take this medicine

If you forget to give/take a dose, give/take it as soon as you remember, unless it is almost time for the next dose. Never give a double dose to make up for the missed dose.

If you give/take more medicine than you should

If you or your child takes a lot more than the stated dose (an overdose), you should contact a doctor immediately, or go to the nearest hospital casualty department, and take the bottle with you if you can.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ibuprofen can cause side-effects, although not everybody gets them. The most common side-effect is irritation of the stomach which can cause problems in some patients.

If any of the

following occur, stop giving/taking the medicine and seek immediate medical help:

Passing blood in the stools (faeces/motions)

Passing black tarry stools

Vomiting blood or dark particles that look like coffee grounds

Unexplained wheezing, shortness of breath, skin rash (which may be severe and

include blistering or peeling of the skin), itching or bruising, light-headedness, racing

of the heart or fluid retention e.g. swollen ankles, not passing enough water

stiff neck, headache, nausea, vomiting, fever and disorientation

swelling of the face.

If any of the following occur, stop giving/taking the medicine and tell your doctor:

• If you or your child’s skin starts to turn red or they develop a varied skin reaction or their skin starts to blister or peel, this is very rare

• Unexplained stomach pain, indigestion, heartburn, feeling sick and/or vomiting

• Yellowing of the eyes and/or skin

• Severe sore throat with high fever or unexplained bleeding, bruising and tiredness.

Other unusual effects may include the following:

Uncommon:

• Headache, dizziness, sleeplessness, agitation, irritability or tiredness

• Visual disturbances

Rare:

• Flatulence, diarrhoea or constipation

• Ringing in the ears (tinnitus)

• Kidney damage, increased blood uric acid levels.

Very Rare:

• Occasionally hypersensitivity reactions may occur which can cause skin rashes as well as asthma attacks, swelling of the tongue and breathlessness

• Liver problems may occur with Ibuprofen

• Passing less urine than normal, increased proteins in the blood (detected by tests)

• Crohn's disease or ulcerative colitis or other stomach problems may be exacerbated

• 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

• Depression or psychotic reactions

• Hair loss

• High blood pressure.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE IBUPROFEN 200 MG/5 ML ORAL SUSPENSION

Keep out of the sight and reach of children. Do not use after the expiry date shown on the bottle, the expiry date refers to the last day of that month. Do not store above 25°C. Medicines should not be disposed of via wastewater, ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ibuprofen 200 mg/5 ml Oral Suspension contains

The active ingredient is Ibuprofen 200 mg per 5 ml.

The other ingredients are: Glycerol (E422), Xanthan Gum, Maltitol (E965), Polysorbate 80, Saccharin Sodium (E954), Citric Acid Monohydrate, Sodium Benzoate (E211), Magnesium Aluminium Silicate, Purified Water and Strawberry Flavour (contains propylene glycol).

What Ibuprofen 200 mg/5 ml Oral Suspension looks like and contents of the pack

Ibuprofen 200 mg/5 ml Oral Suspension is a colour-free, white oral suspension. This medicine comes in amber glass bottles containing: 60 ml, 80 ml, 100 ml, 150 ml or 200 ml with a child-resistant closure. Not all pack sizes may be marketed. A double ended spoon with measures of 1.25 ml, 2.5 ml and 5 ml is provided.

This medicine should be used within 3 months of first opening.

Marketing Authorisation Holder

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

Manufacturer

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL Number: 04917/0099

This leaflet was last revised in November 2015