NUROFEN EXPRESS 400 MG LIQUID CAPSULES, NUROFEN EXTRA STRENGTH 400 MG LIQUID CAPSULES - patient leaflet, side effects, dosage

Nurofen Extra Strength 400mg Liquid

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 Nurofen Extra Strength 400mg Liquid Capsules carefully to get the best results from them. Nurofen Extra Strength 400mg Liquid Capsules will be referred to as this medicine throughout this leaflet.

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 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.

2. What you need to know before you take this medicine

• 3. How to take this medicine

• 4. Possible side effects

• 5. How to store this medicine

• 6. Contents of the pack and other information

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

The active ingredient (which makes the 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 isused for the relief of:

• – Headaches and migraine pain

• – Dental pain and neuralgia

• – Period pain

• – Rheumatic, muscular and back pain

• – Feverishness and symptoms of cold and flu

• – The pain of non-serious arthritis

2.

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 of aspiring 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
• 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
• have an infection. This medicine may hide signs of infections such as fever and pain. It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

• Serious skin reactions have been reported in association with this medicine. You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesion of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

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 drugs that are prescribed:

• 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)
• medicines that 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, ciclosporin, tacrolimus)
• for mania or depression (e.g. Lithium or SSRIs)
• 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 Nurofen with other medicines.

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 Nurofen Extra Strength 400mg Liquid Capsules, 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 medicineif 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.

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

• 41.93mg sorbitol in each capsule, a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
• Ponceau 4R (E124) which may cause allergic reactions
• This medicine contains 27.9mg potassium per capsule. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

3.

• This product is for short-term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

and 18 years : Take 1 capsule with water, up to three times a day as required.

Leave at least four hours between doses. Do not take more than 3 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 or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

If you have taken more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

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

a severe skin reaction known as DRESS syndrome. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells)A red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis) (frequency not known) See also section 2.

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 heartbeat

Liver and kidney problems associated with swelling in your arms and legs.

• skin becomes sensitive to light (frequency not known)

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 25°C. Store in the original pack.

6. contents of the pack and other information

Each capsule contains the active ingredient Ibuprofen 400mg.

They also contain: Macrogol 600, Potassium Hydroxide 50% solution (E525), Gelatin, Sorbitol Liquid, Partially dehydrated (E420), Purified water, Ponceau 4R (E124), Lecithin (E322), 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, 18, 20, 24, 28,

30, 32, 36, 48, 96 in blister strips. Not all pack sizes will be marketed.

Licence Holder:

Reckitt Benckiser Healthcare (UK) Ltd,

Slough SL1 4AQ

Manufacturer

Reckitt Benckiser Healthcare

International Ltd NG2 3 AA _____________­________________________­_________________________

Product licence number: Nurofen Extra Strength 400mg Liquid Capsules: PL 00063/0653

Date of revision: October 2020

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