Skip to Content

UK Edition. Click here for US version.

FENPAED IBUPROFEN 100MG/5ML ORAL SUSPENSION

Active substance(s): IBUPROFEN

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
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.
Further 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 the temperature in fever (e.g. colds, influenza and post-immunisation fever).
2. 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 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.
Take special care if your child suffers from:

high blood pressure, kidney or liver problems

lupus or a mixed connective tissue disease

a chronic inflammatory intestinal disease such as ulcerative colitis, Crohn's disease or gastrointestinal bleeding

asthma
If any of these apply, ask for advice from a doctor or pharmacist before using this medicine.
Medicines such as Fenpaed 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.
Taking other medicines
Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines, including medicines obtained without a
prescription. In particular, tell your doctor if your child is taking any of the following:

Low-dose aspirin (up to 75mg a day)

Diuretics (drugs to help you pass water)

Anti-platelet drugs such as Clopidogrel (drugs that thin the blood)

Antihypertensives (drugs used to treat high blood pressure)

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 medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine), some medicines
that reduce high blood pressure (ACE-inhibitors such as captopril, beta-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 take ibuprofen 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 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.
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).
23LF01300PW

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 5kg. The usual daily dose in children is 20mg 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
DOSAGE: Children (A spoon is provided to measure doses of 2.5 ml or 5 ml)
Babies under 3 months

Do not give

from 3 up to 6 months

2.5 ml 3 times a day

Do not give for more than 24 hours.

(weighing over 5kg)
from 6 months up to 1 year

2.5 ml 3 to 4 times a day

from 1 year up to 4 years

5 ml 3 times a day

from 4 years up to 7 years

7.5 ml 3 times a day

from 7 years up to 12 years

10 ml 3 times a day

Do not give to children aged 6 months and older for more
than 3 days.

Post-immunisation fever: One small spoonful (2.5ml), followed by another small spoonful (2.5ml) 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 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. FURTHER 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-resistant closure.
Marketing Authorisation Holder and Manufacturer
Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.
PL Number: 04917/0082
Leaflet prepared: June 2015
23LF01300PW

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide