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Nurofen Express 200mg Liquid Capsules

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Document: leaflet MAH GENERIC_PL 00063-0648 change

Ibuprofen 200mg Liquicaps Contains Ibuprofen

INFORMATION FOR THE USER

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription.

However, you still need to use Ibuprofen 200mg Liquicaps carefully to get the best results from them.

Keep this leaflet. You may want to read it again.

If you have any further questions after you have read it, ask your doctor or pharmacist.

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.

If any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

This product is called Ibuprofen 200mg Liquicaps and contains ibuprofen. It will be referred to as 'this medicine' in the rest of this leaflet.

In this leaflet:

1.    What this medicine is and what it is used for

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further Information

1.    What this medicine is and what it is used for

The active ingredient (which makes this medicine work) is Ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling, and high temperature.

This medicine is used for the relief of fever and mild to moderate pain, such as:

•    Headaches and migraine pain

•    Dental pain and neuralgia

•    Period pain

•    Rheumatic, muscular and back pain

•    Feverishness and symptoms of cold and flu

2.    Before taking this medicine

Do not take this medicine if you:

•    are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or other painkillers

•    have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding

•    have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines

•    have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Nonsteroidal anti-inflammatory drugs)

•    are taking other NSAID painkillers or more than 75mg aspirin a day

•    have severe liver or kidney problems

•    have heart problems, high blood pressure or blood coagulation disorder.

•    have breathing difficulties

•    are in the last 3 months of pregnancy

•    are under 12 years old

•    are allergic to peanut or soya as this product contains Lecithin Warnings and precautions

Talk to your doctor or pharmacist before taking this product if you:

•    have or have had asthma

•    have kidney, heart, liver or bowel problems

•    have high cholesterol or previously have had a heart attack or stroke

•    have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease)

•    have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders)

•    are a smoker

•    are in the first 6 months of pregnancy Other warnings

•    This medicine belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that this medicine, used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.

•    Anti-inflammatory/pain-killer medicines such as 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.

•    You should discuss your treatment with your doctor or pharmacist before taking this medicine if you:

- 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.

•    There is a risk of renal impairment in dehydrated children and adolescents

Taking Other Medicines

To reduce the risk of side effects do not take this product with other NSAID containing products (e.g. aspirin, ibuprofen)

This medicine may affect or be affected by some other medicines. For example:

Avoid taking this product with corticosteroid tablets, quinolone antibiotics or medicines that are:

•    anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)

•    To stimulate your heart (e.g., glycosides)

•    to reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

•    To help you passing water (diuretics),

•    For the temporary suppression of your immune system (e.g. methotrexate, ciclosporine, tacrolimus)

•    For mania or depression (e.g., Lithium or SSRls)

•    For pregnancy termination (e.g., mifepristone)

•    For HIV treatment (e.g., zidovudine)

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

Pregnancy and breast feeding

Do not take in the last 3 months of pregnancy or if you are breastfeeding.

Speak to your doctor if you are in the first 6 months of pregnancy.

Important information about some of the ingredients of this medicine

This medicine contains

•    50.5mg of sorbitol per dose, a source of 12.6mg of fructose per dose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

•    Ponceau 4R which may cause allergic reactions.

3.    How to take this medicine

This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.

Adults, the elderly and children & adolescents between 12 and 18 years:

Take 1 or 2 capsules with water, up to three times a day as required.

Leave at least four hours between doses. Do not take more than 6 capsules in 24 hours.

Do not give to children under 12 years.

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 for longer than 10 days unless your doctor tells you to. If symptoms persist or the pain worsens, or if any new symptoms occur, consult your doctor or pharmacist.

If you take more of this medicine than you should, you may feel drowsy or nauseous. You should seek immediate medical advice in the event of an overdose, even if you feel well.

If you forgot to take this medicine, simply refer to the directions above on how to take the medicine and do not take more than is advised.

4.    Possible side effects

STOP TAKING the medicine and seek immediate medical help if you develop:

   signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds.

   signs of serious allergic reaction such as:

-    difficulties in breathing or unexplained wheezing

-    dizziness or faster heartbeat

-    severe skin reaction (rashes, itchiness, peeling, flaking or blistering)

-    swelling of your face or throat

   signs of blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion • signs of liver problems such as stomach pain, jaundice (yellowing of skin and whites of the eyes) or passing dark brown urine

Tell your doctor if you experience:

•    fever, flu-like symptoms, sore throat, mouth ulcers, headache, a stiff neck, vomiting, unexplained bleeding and bruising, severe exhaustion.

•    indigestion, stomach or abdominal pain, constipation, diarrhoea, flatulence or if you feel sick, chest pain or fast, irregular heart beat

•    liver and kidney problems associated with swelling in your arms and legs.

Medicines such as this one may be associated with a small increased risk of heart attack ('myocardial infarction') or stroke. (See Section 2 Other warnings.)

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 this medicine

Keep all medicines out of the sight and reach of children.

Do not use after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not store above 25oC. Store in the original pack.

6. Further information

Each capsule contains the active ingredient Ibuprofen 200mg.

They also contain: Macrogol 600, Potassium hydroxide 50% solution (E525), Gelatin, Sorbitol Liquid, Partially dehydrated (E420), Purified Water, Ponceau 4R (E124), Lecithin (E322) or Phosphatidylcholine in Medium Chain Triglycerides, Triglycerides (medium chain), Ethanol, White Ink (Titanium Dioxide (E171), Polyvinyl Acetate Phthalate, Macrogol 400, Ammonium Hydroxide (E527), Propylene Glycol).

This medicine is available in packs of 10, 12, 16 in blister strips.

Not all packs will be marketed.

Manufacturer: Reckitt Benckiser Healthcare International Ltd,

NG90 2DB, UK.

Licence holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough,

SL1 4AQ

PL 00063/0648

Date of revision: May 2016.