Nurofen 200 mg - Coated tablets

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

Application

What is Nurofen and what is it used for?

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

When used correctly, Nurofen 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 and what is it used for?

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

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:

• 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?

Nurofen must not be taken,
- if you are allergic to ibuprofen or any of the other ingredients 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 rupture (perforation) associated with 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 are seriously dehydrated (caused by vomiting, diarrhoea or inadequate fluid intake),
- during the last 3 months of pregnancy,
- of children under 20 kg body weight.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Nurofen,
.- if you have certain skin diseases (systemic lupus erythematosus (SLE), or certain connective tissue diseases (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 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 if you have had a heart attack, bypass surgery, peripheral arterial occlusive 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 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 for a long time, your liver enzymes, 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.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,< brbr>- Concomitant use of Nurofen with other NSAIDs, including COX-2 (cyclooxigenase-2) inhibitors, increases the risk of side effects (see section
"Use with other medicinal products") and should therefore be avoided,
- There is a risk of renal dysfunction in dehydrated adolescents,
.- Immediately after major surgery, special medical supervision is
necessary,
- NSAIDs may mask symptoms of infection or fever.

Nurofen should only be given to children under 12 years of age on a doctor's prescription.

Taking Nurofen 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 may affect 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)
.
• 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 or may be affected by
one of these itself will be impaired. Therefore, before using Nurofen
Always seek the advice of your doctor or pharmacist when taking this medicine with other medicines.
This applies in particular to taking the following medicines:

Combination of ibuprofen (the
Possible reactions:
Active ingredient in Nurofen) with:
Acetylsalicylic acid or other NSAIDs
as this increases the risk of stomach and intestinal ulcers (anti-inflammatory and pain-relieving
or bleeding may increase,
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.
Hemorrhage (see point 2 "Special care when containing):
Taking Nurofen is required"), . . . . . . . . . . . . . .

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 potentiate medicinal products,
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
because the effect of lithium can be enhanced,
Manic-depressive illness and
Depression),
Probenecid and sulfinpyrazone
because this delays the excretion of ibuprofen
(Medicinal product against gout),
can,
Medicines for high blood pressure and
because ibuprofen weakens the effect of these medicines
Dewatering tablets,
can and thereby possibly an increased risk for the
Kidneys arise,
Potassium-sparing diuretics,	because this causes hyperkalaemia (too much potassium in the blood)
can occur,
Methotrexate (a medicinal product for
because the effect of methotrexate may be increased,
Cancer treatment or
rheumatism treatment),
Tacrolimus and cyclosporine
because kidney damage can occur as a result,
(Medicinal products for immunosuppression),
Zidovudine (a medicine for
In HIV-positive haemophilia patients ("haemophiliacs"), the
Treatment of HIV/AIDS):
Risk of joint haemorrhage (haemarthrosis) or bleeding,
which lead to swelling, be increased,
Sulfonylureas (medicinal products for
because interactions are possible,
Lowering blood sugar),
Chinolone antibiotics,	because there is an increased risk of seizures,
CYP2C9 inhibitors:	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
found. A reduction in the dose of ibuprofen should be considered in
Consideration should be given if at the same time potent
CYP2C9 inhibitors are used, especially if
High doses of ibuprofen together with either
Voriconazole or Fluconazole are administered,
Alcohol:	Increased risk of occurrence and amplification of
Gastrointestinal bleeding and possible increase in
Effects on the central nervous system (combination should
should be avoided),
Mifepristone (active ingredient of the so-called
NSARs should not be given 8-12 days after mifepristone administration
Abortion pill):
should be used because NSAIDs may reduce the effect of mifepristone
can reduce.

Taking Nurofen with food and drink.
If possible, do not drink alcohol while using Nurofen (see
above table).

Patients with a sensitive stomach are advised to take Nurofen with a meal.

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
You must not take Nurofen in the last 3 months of pregnancy. Do not take this medicine during the first 6 months of pregnancy unless your doctor recommends it.

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 does not require any special precautions for single or short-term use.

Nurofen contains sodium and sucrose.
This medicine contains sucrose (sugar). Please only take Nurofen after consulting your doctor if you are known to have an intolerance to certain sugars.

This medicine contains sodium: 2 coated tablets contain 1.1 mmol (25.1 mg) of sodium. If you have to follow a low-salt diet, you should take this into account.

How should the medicine be taken?

How to take Nurofen?

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:
Consist exactly with the indicated dosage. Start the treatment with 1-2 coated tablets. Take 1-2 coated tablets every 4 hours thereafter if necessary.

But do not take more than 6 coated tablets (1,200 mg) per day!

Stop the treatment when you are symptom-free.

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

Take the coated tablets unchewed with plenty of liquid.

Use in children and adolescents
Nurofen should only be given to children under 12 years of age on a doctor's prescription.

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 than you should
If you have taken more Nurofen 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.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.In addition, 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 breathing problems have been reported at high doses.

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 to store Nurofen?

Keep this medicine out of the reach of children.

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

You must not use this medicine after the expiry date which is stated on the outer 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 to store Nurofen?

Keep this medicine out of the reach of children.

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

You must not use this medicine after the expiry date which is stated on the outer 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 contains

- The active substance is: Ibuprofen. 1 coated tablet contains 200 mg ibuprofen.

- The other ingredients are:

Tablet core: croscarmellose sodium, sodium dodecyl sulphate, sodium citrate, stearic acid, highly dispersed silicon dioxide

Tablet coating: Carmellose sodium, talc, arabic gum, sucrose, titanium dioxide (E 171), macrogol 6000

Ink: Opacode black, consisting of: Shellac, Iron Oxide Black (E 172), Lecithinum Vegetabile (Soya), Antifoam DC 1510
or
Black Printing Ink consisting of: Shellac, Iron oxide black (E 172), Propylene glycol

What Nurofen looks like and contents of the pack
White to creamy-whitee, round coated tablets domed on both sides with a black logo imprint on one side in packs of 12, 24 or 48 coated tablets.

Not all pack sizes may be marketed.