Nurofen rapid 400 mg - Film-coated tablets

Ibuprofen, the active ingredient in Nurofen rapid, has a pronounced analgesic, antipyretic and anti-inflammatory effect.

Application

What is Nurofen rapid and what is it used for?

Ibuprofen, the active substance in Nurofen rapid, has a pronounced analgesic, antipyretic and anti-inflammatory effect. Ibuprofen is released quickly from the tablet. Nurofen rapid takes effect after about 30 minutes.

When used correctly, Nurofen rapid is usually very well tolerated.

Application:
- Painful conditions (e.g. back pain, toothache, muscle pain, menstrual pain, nerve pain). Back pain, toothache, muscle pain, joint pain, menstrual cramps, nerve pain)
- For the treatment of the acute headache phase in migraine with and without aura and for the treatment of tension headaches
- Pain in colds and flu-like infections.

If you do not feel better or even worse after the following number of days, consult your doctor:
in adolescents after 3 days
in adults after 3 days of fever or after 4 days with pain.

How is it applied?

What is Nurofen rapid and what is it used for?

Ibuprofen, the active substance in Nurofen rapid, has a pronounced analgesic, antipyretic and anti-inflammatory effect. Ibuprofen is released quickly from the tablet. Nurofen rapid takes effect after about 30 minutes.

Application:
- Painful conditions (e.g. back pain, toothache, muscle pain, menstrual pain, nerve pain). back pain, toothache, muscle pain, joint pain, menstrual cramps, nerve pain)
- For the treatment of the acute headache phase in migraine with and without aura and for the treatment of tension headaches< brbr>- Pain in colds and flu-like infections

If you do not feel better or even worse after the following number of days, consult your doctor:

• for adolescents after 3 days
• In adults after 3 days of fever or after 4 days with pain.

What should you pay attention to before taking it?

What you should be aware of before taking Nurofen rapid?

Nurofen rapid must not be taken,
- if you are allergic to ibuprofen or any of the other ingredients of this medicine listed in section 6. if you have ever had shortness of breath, asthma, runny nose, swelling of your face and/or hands or hives after taking ibuprofen, acetylsalicylic acid or similar painkillers (NSAIDs) before.
- if you have severe liver or kidney dysfunction or heart failure,
- if you have or have had stomach ulcers or bleeding (at least 2 episodes),
- if you have a history of allergic reactions to these medicines.- if you have a history of gastrointestinal bleeding or perforation related to non-steroidal anti-inflammatory drug (NSAID) therapy,
- if you have cerebral haemorrhage (cerebrovascular haemorrhage) or other active bleeding,
- if you have unexplained blood formation disorders,
- if you have a history of gastrointestinal haemorrhage or perforation related to NSAID therapy.
- if you are seriously dehydrated (caused by vomiting, diarrhoea or inadequate fluid intake),
- during the last 3 months of pregnancy,
- by children under 12 years of age (and under 40 kg): due to the high active ingredient content, this dosage form of ibuprofen is not suitable for this age group.

Warnings and precautions
Please talk to your doctor or pharmacist before taking Nurofen rapid,

.- if you have certain skin conditions (systemic lupus erythematosus (SLE), or certain connective tissue disorders (mixed connective tissue disease)),
- if you have severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. At the first sign of skin rashes, mucous membrane lesions or other signs of a hypersensitivity reaction, Nurofen rapid must be stopped immediately,
- if you have certain hereditary disorders in blood formation (e.g. acute intermittent porphyria),
- if you have blood clotting disorders,
- if you have or have had gastrointestinal diseases (ulcerative colitis, Crohn's disease),
- if you have ever had high blood pressure and/or heart disease,
- if you have reduced kidney function,
- if you have liver dysfunction,
- if you are trying to become pregnant,
- 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. Allergic reactions may occur as asthma attacks (called painkiller asthma), Quincke's oedema or hives,
- if you 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 heart), or if you have a heart condition.heart disease, including 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-strokes or strokes).stroke (including mini-stroke or transient ischaemic attack (TIA)),
- if you have high blood pressure, diabetes or high cholesterol, or a family history of heart disease or stroke.If you have a family history of heart disease or stroke, or if you are a smoker,
- medicines such as Nurofen rapid may be associated with a slightly increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and longer treatment. Do not exceed the recommended dose or duration of treatment, which is 3 days for adolescents and 3 days for adults for fever and 4 days for pain.If you are taking 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 smallest effective dose for the shortest possible time,
- side effects may be more frequent in older people,
- side effects may be more frequent in older people,
- side effects may be more frequent in older people,
- side effects may be more frequent in older people.In general, habitual use of (different types of) painkillers can lead to permanent serious kidney damage. Physical stress combined with salt loss and dehydration can 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 you suspect it, you should seek medical advice and
stop treatment. In patients who have frequent or daily headaches despite (or because of) regular use of headache medication, the diagnosis of analgesic headache should be considered,< br>.br>- concomitant use of Nurofen rapid with other NSAIDs, including COX-2-
inhibitors (cyclooxigenase-2 inhibitors), increases the risk of side effects (see
.section "Taking with other medicines") and should therefore be avoided
- there is a risk of renal dysfunction in dehydrated adolescents,
.br>- special medical supervision
is needed immediately after major surgery,
- NSAIDs may mask symptoms of infection or fever.

Taking Nurofen rapid with other medicines
Inform your doctor or pharmacist if you are taking/using,
have recently taken/used or intend to take/use any other
medicines.

Nurofen rapid may interfere with or be affected by other medicines.
For example:

• Drugs that have an anticoagulant effect (i.e. thin the blood/prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
.
• Drugs that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol-containing drugs, angiotensin II receptor antagonists such as losartan)
.
• Some medicines for pain and inflammation (e.g. acetylsalicylic acid, unless your doctor has recommended a low dose).
• Other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxigenase-2 inhibitors)
.

Some other medicines may also interfere with treatment with Nurofen rapid, or
be affected by one itself. Therefore, before using Nurofen
rapid together with other medicines always seek the advice of your doctor or pharmacist.
This applies in particular to taking the following medicines:

Combination of ibuprofen (the
Possible reactions:
Active ingredient in Nurofen rapid) with:
Acetylsalicylic acid or other NSAIDs
as this increases the risk of stomach and intestinal ulcers (anti-inflammatory and pain-relieving
or may increase bleeding
Medium)
Digoxin (for heart failure), as the effect of digoxin can be increased,glucocorticoids (medicines which
Increase the risk of gastrointestinal ulcers or cortisone or cortisone-like substances.
Bleeding (see point 2 "Warnings and precautions").
contained),
Cautions") . . . . . . . . . . . as a result. . . . . . . . are used at the same time. . . .

Thrombocyte aggregation inhibitors	as this may increase the risk of bleeding
Acetylsalicylic acid (low dose)	because the blood-thinning effect may be reduced
Medicines for thinning the blood (such as
Since ibuprofen reduces the blood-thinning effect of these
z. B. Warfarin)
May strengthen medicines
Phenytoin (against epilepsy)	because the effect of phenytoin may be increased
selective serotonin re-
as these increase the risk of gastrointestinal bleeding
Absorption inhibitors (medicines against
can
Depression)
Lithium (a medicine against
Manic-depressive illness and
because the effect of lithium may be increased
Depression)
Probenecid and sulfinpyrazone
because this delays the excretion of ibuprofen
(Medicinal product against gout)
can
because ibuprofen weakens the effect of these medicines
Medicines for high blood pressure and
can and thereby possibly an increased risk for the
Dewatering tablets
Kidney arises
because this causes hyperkalaemia (too much potassium in the blood)
Potassium-sparing diuretics
can occur
Methotrexate (a medicinal product for
Cancer treatment or
because the effect of methotrexate may be increased
Rheumatism treatment)
Tacrolimus and cyclosporine
(Medicinal product for immunosuppression)	because kidney damage can occur
In HIV-positive haemophilia patients ("haemophiliacs"), the
Zidovudine (a medicine for
Risk of joint haemorrhage (haemarthrosis) or bleeding,
Treatment of HIV/AIDS)
which cause swelling to be increased
Sulfonylureas (medicinal products for
because interactions are possible
Lowering the blood sugar)
Chinolone antibiotics	because there is an increased risk of seizures
The concomitant use of ibuprofen and CYP2C9-
Inhibitors may reduce exposure to ibuprofen
(CYP2C9 substrate) increase. In a study with voriconazole
and fluconazole (CYP2C9 inhibitors) was found to be about 80
- 100% increased exposure to S(+)-Ibuprofen
CYP2C9 inhibitors:
found. A reduction in the dose of ibuprofen should be considered in
Consideration should be given if potent CYP2C9-
Inhibitors should be used, especially when high doses
of ibuprofen together with either voriconazole or
Fluconazole should be administered.
Increased risk of occurrence and amplification of
Gastrointestinal bleeding and possible increase in
Alcohol:
Effects on the central nervous system (combination should
should be avoided)
	(active substance
NSARs should not be given 8-12 days after mifepristone administration

abortion pill):
as NSAIDs can reduce the effect of mifepristone.

Taking Nurofen rapid with food and drink.
You should avoid drinking alcohol while using Nurofen rapid.
(see table above).

Patients with a sensitive stomach are recommended to take Nurofen rapid together with the
Meal to be taken.

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
During the first 6 months of pregnancy, Nurofen rapid may only be taken on the doctor's orders. Nurofen rapid must not be taken in the last 3 months of pregnancy because of an increased risk of complications for mother and child.

Breastfeeding time
The active substance ibuprofen and its degradation products pass into breast milk only in small amounts. Since adverse effects on the infant have not been reported so far, interruption of breast-feeding will not usually be necessary in the case of short-term use. However, if prolonged use or higher doses are prescribed, early weaning should be considered.

Procreative capacity
Do not take this medicine if you want to become pregnant.

Driving ability and ability to operate machinery.
Nurofen rapid does not require any special precautions for single or short-term use.

How should the medicine be taken?

How to take Nurofen rapid?

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 recommended dose is:
Start treatment with 1 film-coated tablet. Take 1 film-coated tablet every 4 hours thereafter, if necessary.

Do not use more than 3 film-coated tablets (1,200 mg) per day!

Stop treatment when you are symptom-free.

Type of use
For oral use and for short-term use only.

Take the film-coated tablets with plenty of liquid.

Use in children and adolescents
Nurofen rapid must not be taken by children under 12 years of age (and under 40 kg). Due to the high active ingredient content, this dosage form of ibuprofen is not suitable for this age group.

Adolescents
If adolescents need to take this medicine for more than 3 days or if symptoms worsen, medical advice should be sought.

Adults
If your symptoms get worse or do not improve after 3 days (for fever) or after 4 days (for pain), you should see a doctor.

If you have taken more Nurofen rapid than you should
.If you have taken more Nurofen rapid tablets 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 with blood), headache, ringing in the ears (tinnitus), confusion, eye tremor, or rarely diarrhoea
.
In addition, gastrointestinal bleeding, dizziness, blurred vision, hypotension, agitation, confusion, coma, hyperkalaemia, increased prothrombin time/INR, acute renal and hepatic failure, respiratory depression, cyanosis, worsening of asthma in asthmatics.In addition, gastrointestinal bleeding, freezing and respiratory problems have been reported at high doses.
In addition, gastrointestinal bleeding, blurred vision, blood pressure drop, confusion, coma, hyperkalemia, increased prothrombin time/INR, acute renal and liver failure, respiratory depression, cyanosis, worsening of asthma in asthmatics, drowsiness, chest pain, palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, freezing and respiratory problems.

There is no specific antidote.

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 stored?

Do not store above 25°C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton. 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 should Nurofen rapid be stored?

Do not store above 25°C.

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton. 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 notes on the content

Contents of the pack and other information

What Nurofen rapid contains

- The active substance is: Ibuprofen lysine salt. 1 film-coated tablet contains 684.0 mg ibuprofen lysine salt (equivalent to 400 mg ibuprofen).

- The other ingredients are:

Tablet core:
Povidone (K 30)
Carboxymethyl starch sodium (type A)
Magnesium stearate

Tablet coating:
Hypromellose
Talcum
Opaspray White (M-1-7111B) contains: Hypromellose and titanium dioxide (E 171).

Ink: Opacode (S-1-277001 Black) contains: Black iron oxide (E 172), shellac, propylene glycol

What Nurofen rapid looks like and contents of the pack

White to creamy white, oblong film-coated tablet with a black logo imprint on one side in packs of 12, 24 or 48 film-coated tablets.

Not all pack sizes may be placed on the market.