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)).

Application

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 children and adolescents weighing 40 kg or more (an age of 12 years and over) for the treatment of:

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

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How is it applied?

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.

What should you pay attention to before taking it?

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

Nurofen rapid 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 ever suffered from shortness of breath, asthma, a runny nose,
  swelling or hives after using acetylsalicylic acid (contained in aspirin, among other things) or other similar painkillers (NSAIDs),
.
• If you have a stomach/small intestine ulcer or stomach/intestinal bleeding (or have had two or more different episodes of such),
.
• If you have had stomach/intestinal bleeding or perforation while taking NSAIDs (non-steroidal anti-inflammatory drugs) in the past,
.
• If you suffer from 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 suffer from severe dehydration (dehydration of the body caused by vomiting, diarrhoea or insufficient fluid intake),
.
• If you suffer from brain bleeding (cerebrovascular haemorrhage) or other active bleeding.

Do NOT give the medicine to young people weighing less than 40 kg or . Children under the age of 12 years.

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,
  skin rashes and fever),
.
• If you have severe skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome). At the first sign of
  skin rashes, mucous membrane lesions or other signs of
  sensitivity reaction, Nurofen rapid should be discontinued immediately,
.
• If you have a certain inherited disorder of blood formation (e.g.: acute intermittent porphyria) or problems with your blood clotting,
.
• If you have or have ever had an intestinal 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 an allergic condition, as shortness of breath may occur,
.
• If you suffer from hay fever, nasal polyps or chronic obstructive airway disease, as there is an increased risk of allergic reactions. The allergic reactions can occur as asthma attacks (so-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 corticosteroids taken orally, medicines 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
.
have heart disease, including heart failure and angina, 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").(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").
• Have high blood pressure, diabetes or high cholesterol, or a family history of heart disease or stroke, or if you are a smoker,
.
• Continued use of painkillers for headaches can
  make them worse. 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 of the liver, kidneys and blood should be carried out,
.
• Taking Nurofen rapid in combination with other NSAIDs, including
  cyclooygenase-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 fever.

• In dehydrated adolescents, there is a risk of kidney dysfunction.

By applying the minimum effective dose over the shortest time, the incidence Minimised by side effects. In elderly patients, there is an increased risk of Side effects.

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

Taking Nurofen rapid 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 affected 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 atenolol-containing medicines, 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
Increase ulcers or bleeding Inhibitors . . . . . . . . . . . . . .

Digoxin (against heart failure)	The effect of digoxin may be increased
being
Glucocorticoids (medicines containing cortisone or
can increase the risk of stomach/intestinal
containing cortisone-like substances)
Increase ulcers or bleeding
Anticoagulant	can increase the risk of stomach/intestinal
Increase ulcers or bleeding
Phenytoin (against epilepsy)	The effect of phenytoin may be increased
being
selective serotonin reuptake inhibitors
may increase the risk of bleeding
(Medicinal products used for depression
become)
Lithium (a medicine against manic
The effect of lithium may be increased
Depression and depression)
being
Probenecid and sulfinpyrazone (medicines against
it may take longer before ibuprofen is in
Gout)
Body is split
potassium-sparing diuretics	may cause high levels of potassium in the blood
(hyperkalaemia) lead
Methotrexate (a medicine against cancer and
The effect of methotrexate may be increased
rheumatism)
being
Tacrolimus and cyclosporine (immunosuppressive
Kidney damage may occur
Drug)
Zidovudine (a medicine used to treat
For HIV-positive haemophilia patients
HIV/AIDS)
("haemophiliacs") may increase the risk of
Joint bleeding (haemarthrosis) or
Bleeding leading to swelling,
be elevated,
Sulfonylureas (antidiabetics)	Interactions are possible

. be made. .

Chinolone antibiotics	The risk of seizures may be increased
being
Mifepristone (to stop
the effect of mifepristone can
Pregnancies applied)
be reduced
Acetylsalicylic acid (low dosage)	the blood-thinning effect can
be impaired
Medicines for thinning the blood (such as warfarin)	Ibuprofen can reduce the effect of these
Reinforce medicines.
Voriconazole and Fluconazole (CYP2C9 inhibitors)
The effect of ibuprofen can
against fungal infections
take.
A reduction in the dose of ibuprofen should
especially when considered
become effective when high-dose ibuprofen
either together with voriconazole and
Fluconazole is applied.

Taking Nurofen rapid with alcohol.
Do not drink alcohol while taking Nurofen. Some side effects, such as those affecting the gastrointestinal system or the 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 before taking this medicine.
for advice.

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

Do NOT take this medicine in the last 3 months of pregnancy.
Avoid using this medicine in the first 6 months of pregnancy unless your doctor instructs you otherwise.
Breastfeeding
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 capacity
Ibuprofen belongs to a group of medicines (NSAIDs) that can affect fertility in women. This effect is reversible when the medicine is stopped.

Driving ability and ability to operate machinery.

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

Patients who experience dizziness, lightheadedness, vertigo or visual disturbances while taking Nurofen rapid should avoid driving or operating machinery. These effects can worsen when taken in combination with alcohol.

Nurofen rapid 400 mg soft capsules contain sorbitol.
Please take Nurofen rapid 400 mg soft capsules only after consulting your doctor if you are known to have a sugar intolerance.

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

How should the medicine be taken?

How to take Nurofen rapid 400 mg?

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

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

As a starting dose, take 1 capsule (400 mg ibuprofen) with water, then 1 capsule (400 mg ibuprofen) every six hours if 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.
In adolescents
A doctor should be consulted if Nurofen is needed in adolescents for longer than 3 days or if symptoms get worse.

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 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 than you should
If you have taken more Nurofen rapid than you should, <./strong>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.
Faintness, spinning dizziness, drowsiness, confusion, disorientation, fainting, freezing, chest pain, palpitations, convulsions (especially in children), blood in the urine and breathing problems have been reported at high doses.

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

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What are the possible side effects?

How to store Nurofen rapid 400 mg?

Do not store above 25° C.
Store in the original pack 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 carton and blister pack. The expiry date refers to the last day of the month indicated.

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. In doing so, they contribute to the protection of the environment.

Special instructions for storage

How to store Nurofen rapid 400 mg?

Keep this medicine out of the reach of children.

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

Do not store above 25° C.

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

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. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and further information

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• The active ingredient 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.