PATIENT INFORMATION LEAFLET Fenpaed Ibuprofen 100 mg/5 ml Oral Suspension

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

This medicine is available without prescription. However, you still need to give Fenpaed Oral Suspension to your child 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.

You must contact a doctor if your child’s symptoms worsen or do not improve after a few days.

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.

The name of this product is Fenpaed Ibuprofen 100 mg/5 ml Oral Suspension, but it will be referred to as Fenpaed Oral Suspension throughout the leaflet.

In this leaflet:

1.    What Fenpaed Oral Suspension is and what it is used for

2.    What you need to know before you give Fenpaed Oral Suspension

3.    How to give Fenpaed Oral Suspension

4.    Possible side effects

5.    How to store Fenpaed Oral Suspension

6.    Contents of the pack and other information

1.    WHAT FENPAED ORAL SUSPENSION IS AND WHAT IT IS USED FOR

Fenpaed Oral Suspension contains ibuprofen as the active ingredient. This belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Fenpaed Oral Suspension is given to children as a painkiller for relief of mild to moderate muscular pain, headache, sore throat, teething pain and toothache. This medicine can also be used in minor injuries such as sprains and strains. It also reduces temperature in fever (e.g. colds, influenza and post-immunisation fever).

2.    WHAT YOU NEED TO KNOW BEFORE YOU GIVE FENPAED ORAL SUSPENSION Do NOT give this medicine if your child:

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

•    has had an allergic reaction or wheezing after taking aspirin or other non-steroidal anti-inflammatory painkillers. (Symptoms of a rare allergic reaction are given under Section 4: Possible side effects).

•    has ever had a stomach ulcer or a history of bleeding into, or perforation of, the intestine especially after previous NSAID treatment (symptoms may include severe stomach pain or vomiting blood that contains dark particles)

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

•    has ever had severe kidney, heart or liver problems

•    has an inherited intolerance to some sugars

•    is less than 3 months old

•    is taking aspirin above 75 mg daily

Warnings and Precautions

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

You should discuss your child’s treatment with your child’s doctor or pharmacist before giving Fenpaed Oral Suspension, if your child:

•    has high blood pressure, kidney or liver problems

•    has asthma or diabetes

•    has lupus or a mixed connective tissue disease

•    has a chronic inflammatory intestinal disease such as ulcerative colitis, Crohn’s disease or gastrointestinal bleeding

•    has chicken pox

Other medicines and Fenpaed Oral Suspension

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription. Fenpaed 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-ll receptor antagonists such as losartan)

•    Lithium 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 Hydrocortisone)

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

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

•    Mifepristone (used to terminate a pregnancy)

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

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

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

This product is intended for children aged between 3 months and 12 years. If you are an adult taking this product, all the above statements apply and so do the following additional warnings:

•    Do NOT take this product if you are taking aspirin at doses above 75 mg daily. If you are on low dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take this product.

•    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.

•    Do not take if you are in the last three months of pregnancy.

Speak to your doctor or pharmacist before taking if;

•    you are in the first six months of pregnancy

•    you are elderly

•    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 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 attack ‘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.

Pregnancy and breast-feeding

Ibuprofen should NOT be taken in 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.

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.

•    Sodium methyl hydroxybenzoate (E219) and Sodium propyl hydroxybenzoate (E217), may cause allergic reactions (possibly delayed).

3. HOW TO GIVE FENPAED ORAL SUSPENSION

Shake the bottle well before measuring the dose. A measuring spoon is provided to ensure accuracy. The small spoon measures a 2.5 ml dose and the larger spoon measures 5 ml.

Children

This medicine should NOT be given if your child weighs less than 5 kg. The usual daily dose in children is 20 mg per kg of bodyweight in divided doses, every 6 to 8 hours if required. Leave at least 4 hours between doses. For short term use only. Consult a doctor promptly if symptoms persist or worsen.

WARNING: DO NOT EXCEED THE STATED DOSE

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 small spoonful (2.5 ml), followed by another small spoonful (2.5 ml) 6 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 this medicine

If you forget to give a dose, give 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 more medicine than you should

If your child or someone else accidentally 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 your child suffers from the following, stop giving the medicine and seek immediate medical help:

•    Passing blood in their faeces (stools/motions)

•    Passing black tarry stools

•    Vomiting blood or dark particles that look like ground coffee

•    Unexplained wheezing, shortness of breath, skin rash (which may be severe and include blistering or peeling of the skin), itching or bruising, lightheadedness, racing of the heart or fluid retention e.g. swollen ankles, not passing enough urine

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

If your child experiences any of the following, stop giving the medicine and tell your doctor immediately:

•    If 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

Rare:

•    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

•    Flatulence, diarrhoea or constipation

Very Rare:

•    Occasionally hypersensitivity reactions may occur which can cause skin rashes

•    Liver and kidney problems may occur with    Ibuprofen

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

Keep out of sight and reach of children. Do not use after the expiry date shown on the bottle.

Do not store above 25°C.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Fenpaed Oral Suspension contains

The active ingredient is ibuprofen 100 mg per 5 ml

The other ingredients are: Glycerol (E422), Xanthan Gum, Maltitol (E965), Polysorbate 80, Saccharin Sodium (E954), Citric Acid Monohydrate, Sodium Methyl Hydroxybenzoate (E219), Sodium Propyl Hydroxybenzoate (E217), Purified Water and Strawberry Flavour.

What Fenpaed Oral Suspension looks like and contents of the pack

Fenpaed Oral Suspension is a colour-free, white oral suspension.

This medicine comes in amber glass bottles of: 100 ml, with a child-resitant closure.

Marketing Authorisation Holder and Manufacturer

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

PL Number: 04917/0082 Leaflet prepared: December 2015