Nurofen rapid 200 mg soft capsules

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Ibuprofen belongs to the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs, non-steroidal anti-inflammatory drugs).

How is it used?

What is Nurofen rapid and what is it used for?

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs, non-steroidal anti-inflammatory drugs). These medicines work by changing the way the body reacts to pain and fever. Nurofen rapid breaks down quickly in the body and the active ingredient released from the capsule is thus easily absorbed and gets to the painful area quickly.

Nurofen rapid is used for the short-term, symptomatic treatment of:

- mild to moderately severe pain such as headaches, toothaches and period pains
- fever and pain associated with the common cold.

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What should you be aware of before taking this medicine?

What should you be aware of before taking Nurofen rapid?

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. any of the other ingredients of this medicine mentioned in section 6,
- if you have ever in the past experienced shortness of breath, asthma attacks, rhinitis, swelling of the face and/or hands or hives after taking ibuprofen, acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs),
- if you have any existing stomach/duodenal ulcers (peptic ulcers) or stomach bleeding (at least 2 distinct episodes of proven ulcers or bleeding) or have a history of repeated ulcers or bleeding,
- if you have ever had a gastrointestinal bleeding or rupture (perforation) associated with previous therapy with NSAIDs,
- if you have severe liver or kidney damage or severe heart muscle weakness,
- in children under 20 kg body weight,
- if you have cerebral haemorrhage (cerebrovascular haemorrhage) or other active bleeding.
- if you have unexplained blood formation disorders,
- if you are severely dehydrated (dehydration caused by vomiting, diarrhoea or inadequate fluid intake),
- during the last three months of pregnancy.

Warnings and precautions

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

- if you have certain skin diseases (systemic lupus erythematosus (SLE) or mixed connective tissue disease),
- if you have certain congenital disorders of blood formation (e.g. acute intermittent porphyria),
- if you suffer from blood clotting disorders,
- if you suffer or have suffered from stomach and intestinal diseases (ulcerative colitis, Crohn's disease),
- if you have reduced kidney function,
- if you have liver dysfunction,
- if you suffer or have suffered from asthma or allergic reactions, shortness of breath may occur,
- if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, the risk of an allergic reaction is greater. The allergic reactions may appear as asthma attacks (so-called analgesic asthma), Quincke's oedema or hives,
- If you take Nurofen rapid for a long time, your liver values, kidney function and blood count should be monitored regularly,
- Side effects can be minimised by taking the lowest effective dose for the shortest possible time,
- In elderly patients, side effects may occur more frequently,
- In general, habitual use of (different types of) painkillers can lead to permanent severe kidney damage. Physical stress combined with salt loss and dehydration may increase the risk. This should be avoided,
- Prolonged use of any type of painkiller for headaches can make them worse. If this is the case or suspected, medical advice should be sought and treatment discontinued. The diagnosis of Medication Overuse Headache (MOH) should be suspected in patients who suffer from frequent or daily headaches despite (or because of) regularly taking medicines for headaches,
- if you experience gastrointestinal bleeding, ulceration or perforation associated with the use of this medicine. These conditions may occur without any previous warning symptoms. They are not limited to patients with previous medical conditions and can be life-threatening. If you experience gastrointestinal bleeding or ulcers, treatment should be discontinued,
- Simultaneous use of Nurofen rapid with other NSAIDs, including COX-2 inhibitors (cyclooxigenase-2 inhibitors), increases the risk of side effects (see section ""Use with other medicines"") and should therefore be avoided,
- if you are planning to become pregnant,
- Taking Nurofen rapid during chickenpox disease should be avoided
- There is a risk of kidney dysfunction in dehydrated children and adolescents,
- Special medical supervision is needed immediately after major surgery,
- NSAIDs may mask the symptoms of infection or fever.
Skin reactions

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

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 (heart failure) and angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (problems with blood flow 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.

Talk to your doctor before taking Nurofen rapid if any of the above apply to you.

Taking Nurofen rapid with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any 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-halt). (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

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

This applies in particular to the use of the following medicines:

Other NSAIDs (anti-inflammatory and
since this may increase the risk of stomach and pain), including
intestinal ulcers or bleeding, cyclooxigenase-2 inhibitors,

. . . . . . . . . . . .

Digoxin (for heart failure),	because the effect of digoxin is increased
can,
Glucocorticoids (medicines containing cortisone
because this increases the risk of stomach and
or contain cortisone-like substances),
May increase intestinal ulcers or bleeding,
Antiplatelet agents,	because this increases the risk of bleeding
may increase,
Acetylsalicylic acid (low dose),	because the blood-thinning effect is reduced
can,
Medicines used to thin the blood (such as
Since ibuprofen has the blood-thinning effect
warfarin),
this medicine may intensify,
Phenytoin (against epilepsy),	because the effects of phenytoin are increased
can,
Selective serotonin reuptake inhibitors
Since these increase the risk of gastrointestinal bleeding
(medicines for depression),
can increase,
Lithium (a medicine for manic
because the effects of lithium are enhanced
depressive illness and depression),
can,
Probenecid and sulfinpyrazone (medicinal products
Since this increases the excretion of ibuprofen
against gout),
can be delayed,
Medicines for high blood pressure and
Since ibuprofen reduces the effect of these medicines
Dewatering tablets,
can weaken and thereby possibly
creates an increased risk to the kidneys,
Potassium-sparing diuretics,	because this causes hyperkalaemia (too much potassium
in the blood) may occur,
Methotrexate (a medicinal product for
Since the effect of methotrexate is enhanced
cancer treatment or rheumatism treatment),
can be,

Tacrolimus and cyclosporine (drugs used for.
because it can cause kidney damage, immunosuppression),
Zidovudine (a medicine used to treat.
In HIV-positive haemophilia patients (""haemophiliacs""), the risk of joint bleeding HIV/AIDS):
(haemarthrosis) or bleeding leading to swelling may be increased, sulphonylureas (medicines used to lower
as interactions are possible,
of blood sugar), . . . was observed. . . . .

quinolone antibiotics,	because of an increased risk of seizures
there is,
CYP2C9 inhibitors:	The concomitant use of ibuprofen
and CYP2C9 inhibitors may increase exposure
to ibuprofen (CYP2C9 substrate)
increase. In a study with voriconazole and
Fluconazole (CYP2C9 inhibitors), an increase of
about 80-100% increased exposure to
S(+)-Ibuprofen was found. A reduction in
Ibuprofen dose should be considered
be considered if concomitant potent CYP2C9-
Inhibitors are used, in particular
when high doses of ibuprofen are used together with
either voriconazole or fluconazole
should be administered

Taking Nurofen rapid with food, drink and alcohol

Swallow the capsule with water. If you have a sensitive stomach, it is recommended to take Nurofen rapid during meals. If you take Nurofen rapid shortly after a meal, the onset of action may be delayed. If this occurs, do not take more Nurofen rapid than recommended in section ""How to take Nurofen rapid"" and do not go below the time interval between 2 intakes.

The occurrence of some side effects, especially those affecting the gastrointestinal tract, is more likely when Nurofen rapid is used together with alcohol.
Pregnancy, lactation and fertility .

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

This medicine must not be taken during the last 3 months of pregnancy. Unless otherwise prescribed by your doctor, do not take this medicine during the first
6 months of pregnancy.

Lactation

This medicine passes into breast milk but can be taken during breast-feeding if the recommended dose is followed and it is used for the shortest possible time.

Procreative capacity

This medicine belongs to a group of medicines (NSAIDs) which may affect fertility in women. This effect is reversible (reversible) after stopping the medicine.

Driving and ability to operate machinery

When taken as directed for a short time, this medicine has no or negligible effect on the ability to drive or use machinery. If side effects such as tiredness and dizziness occur, do not drive or operate machinery. Consumption of alcohol increases the risk of these side effects.

Nurofen rapid 200 mg soft capsules contain 22.26 mg sorbitol per soft capsule.

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

Nurofen rapid 200 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 be taken?

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.

The recommended dose is:

Adults and adolescents weighing 40 kg or more:

Initial dose: take 1 to 2 capsules (200 or 400 mg of ibuprofen) with water. If necessary, you can take another dose of 1 or 2 capsules (200 or 400 mg ibuprofen). Do not exceed the maximum daily dose of 6 capsules within
24 hours. The interval between 2 doses should be no shorter than 4 hours for a 200 mg dose and no shorter than 6 hours for a 400 mg dose.

Children from 20 kg (about 6 years old) to 39 kg body weight:
Nurofen rapid must only be used in children with a body weight of at least 20 kg. The maximum daily dose is 20 to 30 mg ibuprofen per kg body weight, divided into 3-4 individual doses. The time interval between 2 doses should not be shorter than 6 hours. Do not exceed the recommended maximum daily dose. A maximum dosage of
30 mg/kg ibuprofen should not be exceeded within 24 hours. For dosing in children, the following dosing information applies:

Body weight
Single dose
Frequency of use




Children weighing 20 kg - 29 kg
1 capsule (corresponding to
as necessary, a
200 mg ibuprofen)
further capsule may be taken after 8 hours

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Do not take more than 3 capsules (up to
600 mg ibuprofen) within
24 hours.

Children weighing 30 kg - 39 kg
1 capsule (equivalent to
as necessary, a
200 mg ibuprofen)
further capsule may be taken after 6 to 8

hours.



Do not take more than 4 capsules (up to
800 mg ibuprofen) within
24 hours.



Type of use

For oral use, for short-term use only. Do not chew.

Use in children and adolescents

If the use of this medicine is necessary in children and adolescents for more than 3 days or if symptoms worsen, medical advice should be sought. Other forms of this medicine may be more suitable for children, talk to your doctor or pharmacist.

Adult use

If adults need to take this medicine for more than 3 days for fever or for more than 4 days for pain, or if symptoms get worse, medical advice should be sought.

If you have taken more Nurofen rapid than you should

If you have taken more Nureflex 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, stomach pain, vomiting (possibly including blood), gastrointestinal bleeding, headache, ringing in the ears (tinnitus), confusion, eye tremor (nystagmus), or rarely diarrhoea.

In addition, at high doses, reports have been made of spinning dizziness, weakness and lightheadedness, drowsiness, blurred vision, low blood pressure, chest pain, palpitations, agitation, disorientation, coma, convulsions (especially in children), loss of consciousness, increased blood potassium (hyperkalaemia), increased prothrombin time/INR, acute renal failure, liver damage, blood in the urine, freezing, respiratory depression, cyanosis, worsening of asthma in asthmatics and breathing problems have been reported.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

How should Nurofen rapid be kept?

Do not store above 25 °C. Keep in the original packaging.

Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the outer carton and 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 contains

The active substance is ibuprofen. Each capsule contains 200 mg of ibuprofen.

The other ingredients are:

Filling: macrogol 600, potassium hydroxide (min. 85 % purity), purified water

Shell: sorbitol liquid (E 420), partially dehydrated, gelatine, ponceau 4R (E 124)

Ink: Opacode WB white NS-78-18011 (consisting of titanium dioxide (E 171), propylene glycol, hypromellose (E 464)).

What Nurofen rapid looks like and contents of the pack

Red, oval and transparent soft capsules with imprint.

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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