Ibumetin forte 400 mg - Film-coated tablets

One Ibumetin forte 400 mg film-coated tablet contains 400 mg ibuprofen as the active substance.

Application

1. What is ibuprofen and what is it used for?

One ibuprofen forte 400 mg film-coated tablet contains 400 mg ibuprofen as the active substance.

Ibuprofen belongs to a group of medicines called non-steroidal
inflammatory medicines (non-steroidal analgesics/anti-inflammatory drugs (NSAIDs))
. These medicines have analgesic, anti-inflammatory and
fever-reducing effects.

Ibumetine is used

-	For the relief of mild to moderately severe pain (such as headaches,
toothache and period pain);
-	For the relief of pain and fever in the case of colds.

If you do not feel better or even worse after 3-4 days, contact
Your doctor.

How is it applied?

What is ibuprofen and what is it used for?

One ibuprofen forte 400 mg film-coated tablet contains 400 mg ibuprofen as the active substance.

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (non-steroidal analgesics/anti-inflammatory drugs (NSAIDs)). These medicines have analgesic, anti-inflammatory and antipyretic effects.

Ibumetine is used

• For the relief of mild to moderately severe pain (such as headaches,

toothache and period pain),

• For the relief of pain and fever during colds.

If you do not feel better or even worse after 3-4 days, consult your doctor.

What should you pay attention to before taking it?

What should you be aware of before taking ibumetin?

Ibumetin must not be taken

- if you are allergic to ibuprofen or any of the medicines listed in section 6 . other ingredients mentioned in this medicine.

- if you have ever had shortness of breath, asthma, runny nose, swelling or hives after using acetylsalicylic acid or other similar painkillers (NSAIDs).

- if you have brain bleeding (cerebrovascular haemorrhage) or other active bleeding.
- if you have a stomach/small intestine ulcer or stomach/intestinal bleeding (or have had two or more episodes of such).

- if you have had gastrointestinal bleeding or rupture (perforation) while taking NSAIDs previously.

- if you have severe liver, kidney or heart failure (severe dysfunction).

- if you have an unexplained disorder of blood formation.

- if you have a tendency to uncontrolled bleeding (haemorrhages) or disorders of blood clotting (coagulation).

- if you suffer from severe dehydration (dehydration of the body caused by vomiting, diarrhoea or inadequate fluid intake)

- if you are in the last three months of pregnancy (see section
Pregnancy, breast-feeding and fertility).

- by children under 6 years of age or 20 kg body weight

Warnings and Precautions

Please talk to your doctor or pharmacist before taking ibumetin

- if you are pregnant.br>
- 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 an inherited disorder of blood formation (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 ever had high blood pressure and/or heart failure.

- if you have reduced kidney function. Children and young people with fluid deficiency (dehydration) are at risk of kidney dysfunction.

- if you have liver problems.
- if you have recently had major surgery.

- if you have or have had asthma or an allergic condition, as breathlessness may occur.

- if you have hay fever, nasal polyps or chronic obstructive
respiratory disease, as there is an increased risk of allergic reactions. The allergic reactions may appear as asthma attacks (called analgesic asthma), swelling of the skin (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 to thin the blood (such as warfarin), or medicines to stop bleeding.

- If you are taking other medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, blood thinning medicines (such as warfarin), selective serotonin reuptake inhibitors (medicines for depression) or anticoagulants such as acetylsalicylic acid

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

Taking ibumetin in combination with other NSAIDs, including cyclooygenase-2-specific inhibitors may increase the risk of side effects and should be avoided (see section "Taking ibumetin with other medicines").

Skin reactions

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

Risk of heart attack or stroke

Anti-inflammatories/painkillers such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke.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 ibumetin 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 legs or feet due to narrowed or blocked arteries) or any type of stroke (including mini-stroke or transient stroke).

- You may 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").

- Have high blood pressure, diabetes or high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

Windpox

You should avoid taking ibumetin if you have chickenpox (varicella).

Lab control
Please talk to your doctor if you are using this medicine for more than 3-4 days at the same time as medicines to lower blood sugar, potassium-saving draining agents (diuretics) or other medicines.Please talk to your doctor if you are using this medicine for longer than 3-4 days and are taking medicines to lower blood sugar, potassium-saving drugs (diuretics) or medicines to inhibit blood clotting at the same time, as your doctor may order laboratory tests.

Certain side effects that require stopping the medicine

Certain side effects require that you stop taking the medicine and seek medical advice immediately - see section 4. "What are the possible side effects?". If symptoms of illness (such as pain, fever or other signs of inflammation) do not improve sufficiently, reappear or even worsen during the use of ibuprofen, a doctor should be consulted immediately. Consideration should be given to whether additional treatment is required

Possible consequences of improper use of analgesics.

Prolonged, improper use of painkillers may result in headaches, which may not be treated by increased doses of the medicine. Ask your doctor for advice if you suffer from frequent headaches despite using painkillers.

Suddenly stopping painkillers after using high doses for a long time can trigger withdrawal symptoms (e.g. headaches, tiredness, nervousness), which typically disappear within a few days. A renewed use of painkillers may therefore only take place after a doctor's order and after the withdrawal symptoms have subsided.
The habitual use of painkillers may lead to permanent kidney damage with the risk of kidney failure, especially when several analgesic agents are combined.

If any of the above-mentioned conditions worry you, consult a doctor before taking ibumetin.

Children and adolescents

Ibuprofen must not be given to children under 12 years of age unless prescribed by a doctor.

Ibumetine must not be used in children under 20 kg (6 years) because the active substance content is too high.

Older patients (over 65 years)

In older persons, side effects are more frequent and may have more severe consequences. These mainly concern gastrointestinal bleeding and rupture, which can also lead to death. The dosage should therefore be as low as possible (see also "What side effects are possible").

Taking ibumetin with other medicines

Inform your doctor or pharmacist if you are taking/using any other medicines recently or if you are going to take/use any other medicines.

What should you avoid while taking this medicine?

Ibumetine 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 atenolol-containing medicines, angiotensin II receptor antagonists such as losartan)

Some other medicines may also affect treatment with Ibumin. (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan)

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

Combination of ibuprofen (the active substance
possible reactions:
in Ibumetin 400) with:

increased side effects, especially risk of gastrointestinal ulcers and bleeding (this combination is added to
other NSAIDs, including salicylates
avoid, see point 2 "Special care is needed when taking ibumetin 400")
Low-dose salicylates for
The blood-thinning effect could be "blood thinning"
impaired (if taken for a long time)

Heart glycosides (a group of active substances,
increase their concentration in the blood - which serve to strengthen the heart)
appropriate controls and, if necessary, a dose adjustment is recommended.

.

Zidovudine (antiviral drug)	There is evidence of an increased risk of
Joint haemorrhages (haemarthroses) and
Bruising in haemophilia patients (haemophiliacs).

Glucocorticoids Increase the risk of gastrointestinal ulcers or bleeding (see point 2 "Special care is needed when taking Ibumetin 400").

Thrombocyte aggregation inhibitors
Increasing the risk of gastrointestinal drug
Hemorrhage (see point 2 "Particular caution is required when taking Ibumetin 400").

Acetylsalicylic acid (low dose) as a
The inhibition of platelet aggregation inhibitor clumping.
Blood platelets may be affected by the simultaneous use of ibumetin 400.

Anticoagulants (medicinal products to inhibit
NSARs can reduce the effect of
of blood clotting)
Anticoagulants (see point 2 "Special care is required when taking Ibumetin 400"), an increased risk of bleeding is possible. (Control of the coagulation status recommended)
Phenytoin (agent for the treatment of
Increase in the concentration of this medicine seizures).
in the blood possible - appropriate control and, if necessary, dose adjustment recommended.

selective serotonin re-
Increase in the risk of gastrointestinal uptake inhibitors/SSRIs (certain
Hemorrhage (see point 2 "Special precautions with antidepressants).
taking ibumetin 400 is required".
Lithium (drug for the treatment of psychiatric
Increase of the lithium concentration in the blood - diseases)
Control and dose adjustment recommended if necessary.

Probenecid, sulfinpyrazone (agents for the
Delay in the excretion of ibumetin treatment of gout).
400 and this may lead to accumulation in the body with enhancement of its adverse effects (dose reduction of Ibumetin 400 and monitoring recommended).
.

Potassium-saving dehydrators	Amplification of the effect and risk of
Increase of the potassium level in the blood
(hyperkalaemia) (blood pressure control and
Control of potassium level recommended)

Dewetting agents Increase the risk of nephrotoxicity (kidney damage). Control of kidney function recommended, ensure sufficient hydration.

Furosemide and other loop diuretics
Attenuation of their blood pressure lowering (certain diuretic medicines).
Effect (blood pressure controls recommended)

Antihypertensives (antihypertensives) Weakening of their blood pressure-lowering effect (blood pressure checks recommended)ACE inhibitors (drugs for the treatment of
Increasing the risk of kidney damage heart failure and high blood pressure).
and increased risk of an increase in the blood potassium level (hyperkalaemia). Angiotensin II antagonists
(Control of kidney function and potassium level recommended, ensure sufficient hydration).

Methotrexate (anti-cancer drug) Administration of ibumetin 400 within 24 hours before or after treatment with methotrexate may lead to an increase in the blood levels of methotrexate and subsequently increase the toxicity of this substance. (combination to be avoided)

Ciclosporin (agent used to prevent
Increasing the risk of damage in transplant rejection, but also in the
stomach and intestine, kidney and rheumatism).
Liver damage due to NSAIDs possible, cannot be ruled out for Ibumetin 400 either.

Tacrolimus (agent to prevent
The risk of kidney damage is increasedTransplant rejections).
Antidiabetic drugs (medicines to lower the
Blood glucose fluctuations are at combination blood glucose, for oral use).
have been described with NSAIDs (increased blood glucose controls recommended).

Taking ibumetin with food, drink and alcohol.

It is recommended that patients with a sensitive stomach take ibumetin with food. Some side effects, such as those affecting the gastrointestinal system, are more likely to occur when alcohol is taken at the same time as ibumetin.

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

Pregnancy

Inform your doctor if you become pregnant while taking ibumetin.
Do NOT take this medicine in the last 3 months of pregnancy.
Avoid taking this medicine in the first 6 months of pregnancy unless your doctor instructs you otherwise.

Breastfeeding time

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.

Ibumetine belongs to a group of medicines (NSAIDs = non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible after discontinuation of the medicinal product.

Avoid taking this medicine if you are trying to become pregnant.

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 or visual disturbances while taking ibumetin should avoid driving or operating machinery. These effects can worsen when taken in combination with alcohol.

Ibumetin 400 contains lactose.

This medicine contains 26.67 mg lactose (milk sugar). Please only take Ibumetin after consulting your doctor if you are known to suffer from a sugar intolerance.

Sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is almost "sodium-free".

How should the medicine be taken?

How should Ibumetin 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 (over 12 years of age): 1. Age):

Body weight (age) Single dose Maximum daily dose

.≥ 40kg (adolescents 12 and over
1 tablet (equivalent to 400
3 tablets (equivalent to 1200 years and adults)
mg ibuprofen)

children (6 years and over):

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

Ibumetine must not be used in children under 6 years of age.

The tablet may be divided into equal doses.

Body weight (age) Single dose .Maximum daily dose

20- 29 kg
½ (equivalent to 200 mg
1½ (equivalent to 600 mg (children: 6 -9 years)
Ibuprofen)
30- 39 kg
½ (equivalent to 200 mg
2 (equivalent to 800 mg (children: 10- 12 years)
Ibuprofen)
Ibuprofen)

Older persons (65 years and over)

No special dose adjustment is necessary. Because of the possible side effects (see point 2 "Warnings and precautions"), elderly people should be monitored particularly carefully.

Impaired liver or kidney function

If you have impaired liver or kidney function, talk to your doctor before taking ibumetin. See also section 2.

How to use

To take.

Please take ibumetin unchewed with plenty of liquid (e.g. a glass of water) during or after a meal.

There should be at least 6 hours between two intakes.
Duration of use

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

Consult your doctor if you need to take ibumetin for more than 3 days to treat fever and more than 4 days to treat pain, or if your symptoms get worse.

If children and young people need to take this medicine for more than 3 days or if their symptoms get worse, seek medical advice.

Please talk to your doctor or pharmacist if you feel the effect of this medicine is stronger or weaker than you expected.
If you have taken more Ibumetin than you should

.If you have taken more Ibumetin 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, or consult a doctor immediately. Consult a doctor immediately.

Symptoms may include nausea, stomach pain, diarrhoea, vomiting, blood in the stools or vomit (stomach/intestinal bleeding), headache, ringing in the ears (tinnitus), confusion, drowsiness, disorientation, eye tremor and rarely unconsciousness. At high doses, drowsiness, chest pain, palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, freezing and breathing problems have been reported.

Note to healthcare professionals: For more information on overdose, see the end of this leaflet.

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

.

What are the possible side effects?

How to store Ibumetin?

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 blister after
"Use by:" or "Used by:". 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

5. How should Ibumetin be stored?

Do not store above 25°C. Keep in the original packaging to protect the contents from
moisture.

Keep this medicine out of the reach of children.

Do not use this medicinal product after the expiry date which is stated on the outer carton and blister after
,,EXP:" and ,,EXP:" respectively. 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. They
thereby contribute to the protection of the environment.
Ibumetin forte 400 mg - film-coated tablets PL F&B 27-Sep-2013 SPC F&B Nycomed 9-Sep-2011

Special notes on the content

Contents of the pack and other information
What Ibumetin forte 400 mg contains
The active substance is: Ibuprofen. One tablet contains 400 mg ibuprofen.

The other ingredients are:

Tablet core: microcrystalline cellulose, lactose, croscarmellose sodium, sodium lauryl sulphate, magnesium stearate, highly dispersed silicon dioxide

Tablet coating: Hypromellose, talc, titanium dioxide E171

What Ibumetin looks like and contents of the pack

Ibumetin forte 400mg - Film-Coated Tablets are white, oblong film-coated tablets with a break notch on both sides.

The tablet can be divided into equal doses.

Pack sizes: PVC/aluminium blister packs of 20, 40 and 50 film-coated tablets

.