Nurofen rapid 400 mg soft capsules

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (non-steroidal analgesics/anti-inflammatory drugs (NSAIDs)).

How is it used?

What is Nurofen rapid 400 mg and what is it used for?

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (non-steroidal analgesics/anti-inflammatory drugs (NSAIDs)). These medicines provide relief by changing how the body responds to pain and fever.

Nurofen rapid 400 mg soft capsules are used in adults and adolescents weighing 40 kg or more (an age of 12 years and over) for the short-term symptomatic treatment of:

- mild to moderate pain, such as headache, period pain, toothache
- fever and pain associated with colds.

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What should you be aware of before taking this medicine?

What should you be aware of before taking Nurofen rapid 400 mg?

Nurofen rapid 400 mg must not be taken

- if you are allergic to ibuprofen, ponceau 4R (cochineal red A, E 124) or any of the other ingredients of this medicine listed in section 6,
- if you have had a reaction to acetylsalicylic acid (including that contained in aspirin.
- if you have ever had breathlessness, asthma, runny nose, swelling or hives after using acetylsalicylic acid (contained in aspirin) or other similar painkillers (NSAIDs),
- if you have (or have had two or more separate episodes of) a stomach ulcer or stomach bleeding,
- if you have had stomach bleeding or stomach perforation while taking NSAIDs (non-steroidal anti-inflammatory drugs) before,
- if you have an unexplained disorder of blood formation,
- if you have severe liver, kidney or heart failure (severe functional disorders),
- if you are in the last three months of pregnancy (see section
"Pregnancy and breast-feeding"),
- if you have severe dehydration (dehydration of the body caused by vomiting, diarrhoea or inadequate fluid intake),
- if you have brain bleeding (cerebrovascular haemorrhage) or other active bleeding.
Do NOT give the medicine to young people weighing less than 40 kg or children under 12 years of age.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Nurofen rapid:

- if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease (diseases of the immune system that cause joint pain, rashes and fever),
- if you have a certain inherited disorder of blood formation (eg. : acute intermittent
porphyria) or problems with your blood clotting,
- if you have or have ever had bowel disease (ulcerative colitis or Crohn's disease),
- if you have reduced kidney function,
- if you have liver problems,
- if you have recently undergone major surgery,
- if you have or have had asthma or allergic disease, as breathlessness may occur,
- if you have hay fever, nasal polyps or chronic obstructive airway disease, as there is an increased risk of allergic reactions. The allergic reactions may occur as asthma attacks (called analgesic asthma), acute swelling (Quincke's oedema) or skin rash,
- if you are taking other medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, medicines used to thin the blood (such as warfarin), selective serotonin reuptake inhibitors (medicines for depression) or anticoagulants such as acetylsalicylic acid (e.g. in aspirin. e.g. in aspirin).

Other warnings

- Anti-inflammatories/painkillers such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Nurofen rapid if you

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• Have heart disease, including heart failure and angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (blood flow problems in the legs or feet due to narrowed or blocked arteries) or any type of stroke (including mini-stroke or transient ischaemic attack, "TIA"),
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• Have high blood pressure, diabetes or high cholesterol, or a family history of heart disease or stroke, or if you are a smoker,
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- Continued use of painkillers for headaches may make them
worsen them. If this situation occurs or is suspected, you should stop taking Nurofen rapid and contact your doctor,
- You should avoid taking Nurofen rapid if you have chickenpox (varicella), - If Nurofen rapid is taken for a long time, regular checks should be made on your liver, kidneys and blood,
- Taking Nurofen rapid in combination with other NSAIDs, including cyclooxygenase-2 specific inhibitors may increase the risk of side effects and should be avoided (see section "When taking Nurofen rapid with other medicines" below),
- In general, habitual use of (several types of) painkillers can lead to severe kidney disease and should be avoided. The risk is further increased by salt loss and dehydration (lack of fluids).
- NSAIDs can mask the symptoms of infections and of fever.
- Dehydrated adolescents are at risk of renal dysfunction.

By using the minimum effective dose for the shortest time, the incidence . of side effects is minimised. In elderly patients, there is an increased risk of side effects. side effects.

Skin reactions
Serious skin reactions have been reported in association with treatment with Nurofen Immedia. If you develop a rash, lesions of the mucous membranes, blisters or other signs of allergy, you should stop treatment with Nurofen Immedia and seek medical attention immediately as these may be the first signs of a very serious skin reaction. See section 4.

If any of the above conditions worry you, consult a doctor before taking Nurofen rapid.

Taking Nurofen rapid 400 mg with other medicines .

Some other medicines may also interfere with treatment with Nurofen rapid or may themselves be affected by such treatment. You should therefore always seek the advice of your doctor or pharmacist before using Nurofen rapid with other medicines.

Nurofen rapid may interfere with or be interfered with by other medicines.

For example:

- Medicines that have an anticoagulant effect (i.e. thin the blood/prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
- Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as medicines containing atenolol, angiotensin II receptor antagonists such as losartan).

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicinal products.




Other anti-inflammatories and painkillers.
may increase the risk of gastrointestinal
(NSAIDs), including selective cyclooxygenase-2.
Inhibitors that increase ulcers or bleeding.
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Digoxin (for heart failure)

The effect of digoxin may be increased

Glucocorticoids (medicines containing cortisone or.
may increase the risk of gastrointestinal cortisone-like substances).
Increase ulcers or bleeding. .

Anticoagulants	May increase the risk of gastrointestinal
Encroachment or bleeding

Phenytoin (against epilepsy) the effect of phenytoin may be increased

selective serotonin reuptake inhibitors
may increase the risk of bleeding (medicines used for depression
are used for depression)

Lithium (a medicine used for manic depression.
the effect of lithium may be increased and depression).

Probenecid and sulfinpyrazone (medicines for.
it may take longer before ibuprofen in the gout).
body is broken down

Potassium sparing diuretics can lead to high levels of potassium in the blood (hyperkalaemia).

Methotrexate (a drug used to treat cancer and
the effect of methotrexate may increase rheumatism).
being

Tacrolimus and cyclosporine (immunosuppressive
Renal damage may occur Medicinal product)

Zidovudine (a drug used to treat.
In HIV-positive haemophilia patients ("haemophiliacs"), the risk for
HIV/AIDS)
Joint bleeding (haemarthrosis) or bleeding leading to swelling may be increased,

Sulfonylureas (antidiabetic drugs)

Interactions are possible

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Chinolone antibiotics	The risk of seizures may be increased
be

Mifepristone (used to terminate pregnancies.
the effect of mifepristone may be reduced).
being

Acetylsalicylic acid (low dosage)	the blood-thinning effect can
be impaired

Medicines used to thin the blood (such as warfarin) Ibuprofen may increase the effect of these medicines.

Voriconazole and fluconazole (CYP2C9 inhibitors).
The effect of ibuprofen may increase. against fungal infections.
A reduction in the dose of ibuprofen should be considered, especially if high-dose ibuprofen is used with either voriconazole and fluconazole.


Taking Nurofen rapid 400 mg together with alcohol .

Do not drink alcohol while taking Nurofen. Some side effects, such as those affecting the gastrointestinal system or central nervous system, are more likely to occur if alcohol is taken at the same time as Nurofen rapid.

Pregnancy, lactation and reproductive capacity.

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
for advice.

Pregnancy

Inform your doctor if you become pregnant while taking Nurofen rapid.

Do NOT take this medicine during the last 3 months of pregnancy.
Avoid using this medicine in the first 6 months of pregnancy unless your doctor instructs you otherwise.

Lactation

Only small amounts of ibuprofen and its metabolites pass into breast milk. This medicine can be taken during breast-feeding if it is taken at the recommended dose and for the shortest possible time.

Procreative ability

Ibuprofen belongs to a group of medicines (NSAIDs) that can affect fertility in women. This effect is reversible (reversible) when the medicine is stopped.

Driving and ability to operate machinery.

For short-term use and at normal dosage, this medicinal product has no or negligible effect on the ability to drive and use machines.

Patients who experience dizziness, lightheadedness, vertigo or visual disturbances while taking Nurofen rapid should avoid driving or operating machinery. These effects may be worsened if taken in combination with alcohol.

Nurofen rapid 400 mg soft capsules contain 36.66 mg sorbitol per soft capsule.

Please take Nurofen rapid 400 mg soft capsules only after consulting your doctor,
if you are known to suffer from a sugar intolerance.

Nurofen rapid 400 mg soft capsules contain the colouring agent Ponceau 4R (cochineal red A,
E 124). It may cause allergic reactions.

How to take the medicine?

How should Nurofen rapid 400 mg be taken?

Always take this medicine exactly as described in this leaflet or as agreed with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the standard dose is as follows:
Dosing

Adults, children and adolescents weighing 40 kg or more (an age of 12 years and over):

Take 1 capsule (400 mg ibuprofen) with water as a starting dose, then 1 capsule (400 mg ibuprofen) every six hours as needed. Do not take more than 3 capsules (1200 mg ibuprofen) in 24 hours.

Do NOT give Nurofen rapid to young people weighing less than 40 kg or children under 12 years of age.

Mode of administration

To take. Do not chew capsules.

It is recommended that patients with a sensitive stomach take Nurofen rapid with food. If taken shortly after a meal, the onset of action of Nurofen rapid may be delayed. If this is the case, do not take more Nurofen rapid than recommended in section 3 or until the correct time to re-dose has elapsed.

Duration of use

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

Use in children and adolescents

A doctor should be consulted if Nurofen is needed in adolescents for more than 3 days or if the symptoms worsen.

In adults

Consult your doctor if Nurofen rapid is needed to treat fever for more than 3 days and to treat pain for more than 4 days, or if the symptoms get worse.

Please talk to your doctor or pharmacist if you feel that the effect of this medicine is stronger or weaker than you expected.

If you have taken more Nurofen rapid 400 mg than you should

If you have taken more Nurofen rapid than you should, or if children have accidentally taken the medicine, always contact a doctor or hospital near you for an assessment of the risk and advice on further treatment.

Symptoms may include nausea, vomiting (possibly also with blood), blood in the stools (stomach/intestinal bleeding), ringing in the ears (tinnitus), headache, stomach pain, diarrhoea and eye tremor.

At high doses, weakness, spinning dizziness, lightheadedness, confusion, disorientation, fainting, freezing, chest pain, palpitations, convulsions (especially in children), blood in the urine and breathing problems have been reported.

If you have any further questions about taking this medicinal product, ask your doctor or pharmacist.

What are the possible side effects?

How should Nurofen rapid 400 mg be kept?

Do not store above 25° C.

Store in the original packaging to protect the contents from moisture.

Keep this medicine out of the reach of children.

You must not use this medicine after the expiry date which is stated on the outer carton and on the blister pack. The expiry date refers to the last day of the month stated.

Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. By doing so, you are helping to protect the environment.

Special notes on the contents

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Contents of the pack and other information

What Nurofen rapid 400 mg contains

The active substance is ibuprofen.
Each capsule contains 400 mg of ibuprofen.

The other ingredients are:

Filling:
Macrogol 600
Potassium hydroxide
Purified water

Capsule coating:
Sorbitol liquid (E420)
Gelatin
Ponceau 4R (cochineal red A, E 124)

Ink:
Titanium dioxide (E171)
Propylene glycol,
Hypromellose (E464)

Processing aids:
Triglycerides (medium chain)
Lecithin (E322)
What Nurofen rapid 400 mg looks like and contents of the pack

The soft capsules are red, oval and transparent with a Nurofen logo printed in white. The capsules are available in packs of 2, 4, 6, 8, 10, 12, 16, 20, 24, 30, 40 or 50 soft capsules.
Not all pack sizes may be marketed.

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