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NUROFEN PAIN RELIEF 200MG SOFT CAPSULES

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PL 00063/0651

Nurofen Pain Relief 200mg Soft Capsules

PIL

 
PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen Pain Relief 200mg Soft Capsules Important things that you need to know:


This medicine is a treatment for several types of pain.

Do not take this medicine if you have had a stomach ulcer, perforation or bleeding or if you are in the
last 3 months of pregnancy. If you are pregnant, you should read the section below on ‘before taking this
medicine’ carefully.

Taking some other medicines with Ibuprofen capsules can cause problems. Tell your doctor if you
are taking anything else. If you are, you should read Section 2 below on ‘Before you take Ibuprofen
capsules’ carefully.

Do not take more than 6 capsules in 24 hours.
 You must contact a doctor if your symptoms worsen or do not improve after 3 days for children and
adolescents between 12 and 18 years and after 10 days for adults.
 Ibuprofen can cause side effects, although most people do not have serious problems – see the
section below on ‘side effects’. If you pass bloody or black tarry stools, vomit any blood or dark particles,
have difficulty in breathing, have unexplained wheezing, worsening of existing asthma or swelling of the
face or throat, see your doctor immediately.

Now read the rest of this leaflet. It includes other important information on the safe and effective use
of this medicine that might be especially important for you.
This leaflet was last updated in June 2014.
 

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take this medicine
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 symptoms worsen or do not improve after 10 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.
In this leaflet:
1. What Nurofen Pain Relief 200mg Soft Capsules are and what they are used for
2. Before you take Nurofen Pain Relief 200mg Soft Capsules
3. How to take Nurofen Pain Relief 200mg Soft Capsules
4. Possible side effects
5. How to store Nurofen Pain Relief 200mg Soft Capsules
6. Further information
 

1. WHAT NUROFEN PAIN RELIEF 200mg SOFT CAPSULES ARE
AND WHAT ARE THEY USED FOR
This medicine contains ibuprofen, which belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs).
Your capsules are used for the relief from rheumatic or muscular pain, backache, neuralgia
(sharp pain along nerves), migraine, headache, dental pain, period pain, feverishness, cold
and flu symptoms. They are designed to provide effective relief from pain.

PL 00063/0651

Nurofen Pain Relief 200mg Soft Capsules

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2. BEFORE YOU TAKE NUROFEN PAIN RELIEF 200mg SOFT
CAPSULES
Do not take these capsules if you:
• are allergic to ibuprofen or any of the other ingredients of this product, aspirin or other
related painkillers (see end of section 2 and section 6)
• have had a worsening of asthma, allergic rash or itchy, runny nose when taking similar
medicines
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• ever had stomach bleeding or a perforation due to NSAIDs
• are already taking other drugs that belong to the NSAIDs group
• are taking aspirin at doses of above 75 mg daily
• are in the last 3 months of pregnancy
• suffer from severe heart, liver or kidney disease.
Please see your doctor or pharmacist before taking this medicine if you:
• are elderly, as you may be more likely to suffer from side effects
• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke,
heart, liver, kidney or bowel problems
• are allergic to any other painkiller
• suffer from systemic lupus erythematosus or a mixed connective tissue disease (both
chronic rheumatic diseases)
• suffer from an allergy
• suffer from inflammation of the intestines (ulcerative colitis, Crohn’s disease)
• are on low-dose aspirin (up to 75 mg daily)
• are a smoker
• are in the first 6 months of pregnancy
If symptoms persist or worsen, consult your doctor.
Medicines such as Nurofen Pain Relief 200mg Soft Capsules 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).
If you have heart problems, previous stroke or think you might be at risk of these
conditions (for example if you have high blood pressure, diabetes or high cholesterol or
are a smoker) you should discuss your treatment with your doctor or pharmacist.
There is a risk of renal impairment in dehydrated children and adolescents.
If you are taking any of the following medicines, please see your doctor before
taking the capsules:
• any other painkillers (aspirin or other NSAIDs). Do not take this medicine if you are
taking aspirin at doses of above 75mg daily. If you are on low-dose aspirin (up to 75mg
daily) speak to your doctor or pharmacist before you take Nurofen Pain Relief 200mg Soft
Capsules.
• regular medication for high blood pressure (antihypertensives or diuretics); these
include ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensinII receptor antagonists such as losartan
• blood thinning medicines (anti-coagulants) such as aspirin/acetylsalicylic acid, warfarin,
ticlopidine

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Nurofen Pain Relief 200mg Soft Capsules

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• corticosteroids (anti-inflammatory) which can increase the risk of side effects in the
stomach including bleeding
• anti-platelet agents (prevention of thrombotic cerebrovascular and cardiovascular
diseases)
• serotonin reuptake inhibitors and lithium (for treatment of depression - bipolar disease
and mania)
• cardiac glycosides (treatment of heart failure and cardiac arrhythmia)
• methotrexate (anti-cancer and psoriasis)
• zidovudine (HIV/AIDS infection)
• cyclosporine (to prevent rejection after organ transplant)
• mifepristone (emergency contraceptive)
• tacrolimus (to prevent rejection after organ transplant, treatment of skin diseases)
• quinolone antibiotics
Pregnancy and breast-feeding
Ask your doctor or pharmacist before taking this medicine if you are in the first 6 months of
pregnancy. DO NOT TAKE the capsules if you are in the last 3 months of pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine if you are breastfeeding.
Female fertility
Nurofen Pain Relief 200mg Soft Capsules belong to a group of medicines which may impair
fertility in women. This effect is reversible on stopping the medicine. It is unlikely that
Nurofen Pain Relief 200mg Soft Capsules, when used occasionally, will affect your chances
of becoming pregnant. However, tell your doctor before taking this medicine if you have
problems becoming pregnant.
Driving and using machines
Nurofen Pain Relief 200mg Soft Capsules are unlikely to have any effect on your ability to
drive or use machines.
Important information about some of the ingredients of Nurofen Pain Relief 200mg
Soft Capsules
These capsules contain
• sorbitol. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking these capsules.

3. HOW TO TAKE NUROFEN PAIN RELIEF 200mg SOFT CAPSULES
 
Swallow the capsules whole with water. Do not chew.
Adults, the elderly and children and adolescents between 12 and 18 years:
Take one or two capsules (200mg – 400mg), up to three times a day as required.
Leave at least 4 hours between doses and do not take more than 6 capsules in 24 hours.
This medicine is intended for short-term use only. You should take the lowest dose for the
shortest time necessary to relieve your symptoms.
In children and adolescents between 12 and 18 years:
If in children and adolescents this medicinal product is required for more than 3 days, or if
symptoms worsen a doctor should be consulted.
In adults:
Do not take this medicine for longer than 10 days unless your doctor tells you to.
If symptoms persist or worsen consult your doctor.

PL 00063/0651

Nurofen Pain Relief 200mg Soft Capsules

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Not suitable for children under 12 years.
If you take more Nurofen Pain Relief 200mg Soft Capsules than you should
Problems in overdose are rare, but if you accidentally take more than the recommended
dose contact your doctor immediately.
The following symptoms of overdose can occur:
• nausea, vomiting, stomach ache or, more rarely, diarrhoea.
Other less frequently occurring symptoms of overdose are:
• ringing in the ears, headache, bleeding of the stomach and intestines, effects on the
central nervous system, convulsions, increased concentration of acid waste products
in the blood (metabolic acidosis), prolonged clotting time of the blood, kidney failure,
liver damage or worsening of asthma.
If you forget to take Nurofen Pain Relief 200mg Soft Capsules

Take a dose as soon as you remember. Do not take a double dose to make up for a
forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Nurofen Pain Relief 200mg Soft Capsules can cause side effects,
although not everybody gets them.
If you suffer from any of the following, at any time, during your treatment STOP
TAKING the medicine and seek immediate medical help:
• pass blood in your faeces (stools/motions)
• pass black tarry stools
• vomit any blood or dark particles that look like coffee grounds
• difficulty in breathing, unexplained wheezing, worsening of existing asthma
• other allergic type reactions (e.g. swelling of the face or throat, low blood pressure,
fast heart rate)
STOP TAKING the medicine and tell your doctor if you experience any of the following
side effects, or anything unusual happens:
• indigestion or heartburn
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
• a skin rash (which may be severe), itchy skin or blisters
Medicines such as Nurofen Pain Relief 200mg Soft Capsules may be associated with a
small increased risk of heart attack (myocardial infarction) or stroke.
This medicine may also cause:
• oedema (fluid retention), high blood pressure (hypertension) and heart failure
• headache
• nausea, diarrhoea, constipation, vomiting and flatulence (wind)
• skin peeling
• kidney and liver disorders
• blood disorders. The first signs can be fever, sore throat, mouth ulcers, ‘flu-like symptoms,
severe exhaustion, unexplained bleeding and bruising.

PL 00063/0651

Nurofen Pain Relief 200mg Soft Capsules

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• meningitis symptoms such as fever and chills, severe headache, nausea, vomiting and stiff
neck (in patients with existing auto-immune disorders such as systemic lupus
erythematosus).
• worsening of colitis or Crohn’s disease (inflammation of the bowel).
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 NUROFEN PAIN RELIEF 200mg SOFT
CAPSULES
Keep all medicines out of the sight and reach of children.
Do not use these capsules after the expiry date printed on the blister or carton. The expiry
date refers to the last day of that month.
Keep the capsules in the original pack.
Do not store above 25°C.
In case of poor storage conditions, this product may deteriorate. If you notice any signs of
leakage of the capsules or change in colour, you should discard the capsules.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Nurofen Pain Relief 200mg Soft Capsules contains
The active ingredient is: ibuprofen 200mg.
The other ingredients are: macrogol 600, potassium hydroxide, gelatine, sorbitol (E420),
purified water, Opacode WB white NS-78-18011 (titanium dioxide (E171), hypromellose,
propylene glycol).
(see also end of Section 2 “Important information about some of the ingredients of Nurofen
Pain Relief 200mg Soft Capsules”).
What Nurofen Pain Relief 200mg Soft Capsules look like and contents of the pack
Each Nurofen Pain Relief 200mg Soft Capsules is an oval clear capsule printed in white with
a logo.
This product is available in packs of 4, 10 and 16 capsules. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd
103-105 Bath Road

PL 00063/0651

Nurofen Pain Relief 200mg Soft Capsules

 
Slough, SL1 3UH
United Kingdom
Manufacturer
Reckitt Benckiser Healthcare International Ltd
Thane Road
Nottingham
NG90 2DB, UK
Or
Banner Pharmacaps Europe B.V.
De Posthoornstraat 7
Tilburg
5048 AS, The Netherlands
PL 00063/0651
Text revised: June 2014.

PIL

Expand Transcript

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.

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