Ibumetin Weichkapseln Express 400 mg

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

Application

1. What is Ibumetin Express and what is it used for?

Ibumetin Express contains an active substance called ibuprofen. Ibuprofen belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs). These medicines relieve pain and reduce fever.

Ibumetin Express is used in adults and adolescents with a body weight of 40 kg and above (aged 12 years and older) for the short-term symptomatic treatment of: 

- mild to moderate pain such as headache, menstrual pain, toothache, muscle pain, and joint pain. 

- fever associated with colds.

What should you consider before taking it?

2. What should you consider before taking Ibumetin Express?

Do not take Ibumetin Express:
- if you are allergic to ibuprofen 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 an (itchy) rash after using acetylsalicylic acid or other similar pain relievers (NSAIDs). 

- if you have had gastrointestinal bleeding or perforation during previous use of NSAIDs. 

- if you have a stomach ulcer or stomach bleeding (or have had two or more distinct episodes of such). 

- if you have severe impairment of liver or kidney function, or heart failure. 

- if you have cerebral haemorrhage (cerebrovascular bleeding) or other active bleeding.

- if you have a blood clotting disorder or another bleeding disorder. 

- if you are severely dehydrated (caused by vomiting, diarrhoea, or insufficient fluid intake). 

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

Do not give this medicine to adolescents weighing less than 40 kg or to children under 12 years of age.

Warnings and precautions 

Please speak to your doctor, pharmacist, or healthcare professional before taking Ibumetin Express if you: 

- have asthma. - suffer from systemic lupus erythematosus (SLE) 

- a disorder of the immune system affecting connective tissue, leading to joint pain, skin changes, and disorders of other organs 

- or mixed connective tissue disease. 

- have an inherited disorder of blood formation (acute intermittent porphyria). 

- have or have had bowel problems or diseases (ulcerative colitis, Crohn's disease). 

- have high blood pressure (hypertension) or heart disease. 

- suffer from kidney or liver disease. 

- have just had major surgery. 

- suffer from hay fever, nasal polyps, or chronic obstructive respiratory diseases, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic asthma), acute swelling (Quincke's oedema), or hives.

Additional warnings: 

- Prolonged use of any type of pain reliever for headaches can make them worse. This is known as medication overuse headache (MOH). If this is the case or suspected, stop taking this medicine and contact your doctor. 

- In general, the frequent use of (several types of) pain relievers can lead to permanent severe kidney problems. This risk may be increased during physical exertion combined with fluid deficiency. Do not take this medicine if you feel dehydrated. 

- During chickenpox (varicella), it is recommended to avoid using Ibumetin Express. 

- With prolonged use of Ibumetin Express, regular monitoring of your liver function, kidney function, and blood counts is required. 

- The use of Ibumetin Express together with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided, as this may increase the risk of side effects (see "Taking Ibumetin Express with other medicines"). 

- There is a risk of renal impairment in dehydrated adolescents.

Do not use different types of pain-relieving medicines at the same time without a prescription from a doctor. 

Anti-inflammatory medicines/painkillers like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Discuss your treatment with your doctor or pharmacist before taking Ibumetin Express if you: 

- have heart disease, including heart failure and angina pectoris (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulatory disorders 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 levels, or have a family history of heart disease or stroke, or if you smoke.

Infections 

Ibumetin Express may hide signs of infections such as fever and pain. Therefore, it is possible that Ibumetin Express may delay appropriate treatment of the infection, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine during an infection and your infection symptoms persist or worsen, consult a doctor immediately.

Skin reactions 

Serious skin reactions have been reported in connection with treatment with Ibumetin Express. Stop taking Ibumetin Express and seek medical attention immediately if you develop a skin rash, damage to the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very serious skin reaction (see section 4.).

Side effects can be reduced by using the lowest effective dose for the shortest duration necessary. Elderly patients have an increased risk of side effects.

Taking Ibumetin Express with other medicines 

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or might take/use any other medicines. For example: 

- Medicines that have an anticoagulant effect (i.e. thin the blood/prevent blood clots, e.g. acetylsalicylic acid, warfarin, ticlopidine). 

- Medicines that lower high blood pressure (e.g. ACE inhibitors [captopril], beta-blockers [atenolol], angiotensin-II receptor antagonists [losartan]). 

- Other anti-inflammatory painkillers (NSAIDs). 

- Digoxin (used to treat heart failure), phenytoin (used to treat epilepsy), or lithium (used to treat depression/manic depression). 

- Glucocorticoids (anti-inflammatory medicines, e.g. prednisolone). 

- Selective serotonin reuptake inhibitors (SSRIs, used to treat depression, e.g. fluoxetine). - Probenecid and sulfinpyrazone (medicines used to treat gout). 

- Diuretics (medicines that help you pass water). 

- Cholestyramine (used to lower cholesterol levels). 

- Methotrexate (used to treat rheumatoid arthritis, psoriasis, and certain cancers). - Ciclosporin or tacrolimus (used to suppress the body's immune system). 

- Aminoglycosides (used to treat bacterial infections). - Zidovudine (used to treat HIV). - Sulphonylureas (used to treat diabetes). 

- Quinolone antibiotics (used to treat a wide variety of infections, e.g. ciprofloxacin). 

- Mifepristone (used for medical termination of pregnancy). 

- Voriconazole and fluconazole (used to treat fungal infections).

Taking Ibumetin Express with food, drink, and alcohol 

If you suffer from mild indigestion, it is recommended to take this medicine with a meal or milk to avoid gastrointestinal problems.

Some side effects, such as those affecting the gastrointestinal tract or the central nervous system, are more likely to occur if alcohol is consumed at the same time as Ibumetin Express.

Pregnancy, breastfeeding and fertility 

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy 

Inform your doctor if you become pregnant while taking Ibumetin Express. 

Do not take Ibumetin Express if you are in the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn child. It may affect your and your baby's bleeding tendency and cause labour to begin later or last longer than expected. 

Do not take Ibumetin Express during the first 6 months of pregnancy unless your doctor advises you to and it is absolutely necessary. If you need treatment during this period, or while you are trying to get pregnant, the lowest dose should be taken for the shortest possible duration. If Ibumetin Express is taken for more than a few days from the 20th week of pregnancy onwards, it can cause kidney problems in your unborn child, which can lead to a reduced amount of amniotic fluid surrounding your baby (oligohydramnios) or to the narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding 

Only small amounts of ibuprofen and its breakdown products pass into breast milk. This medicine can be taken during breastfeeding if taken at the recommended dose and for the shortest possible time.

Fertility 

Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon stopping the medicine.

Driving and using machines 

This medicine has no or negligible influence on the ability to drive and use machines when used short-term.

However, at higher doses, side effects such as dizziness, drowsiness, or visual disturbances may occur, impairing the ability to react in road traffic and to operate machines. These side effects are more likely in combination with alcohol.

Ibumetin Express contains sorbitol (E 420) 

This medicine contains 83 mg sorbitol in each soft capsule. Sorbitol is a source of fructose. Speak to your doctor before you (or your child) take or receive this medicine if your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI) – a rare genetic disorder in which a person cannot break down fructose.

How to take the medicine?

3. How to take Ibumetin Express? 

Always take this medicine exactly as described in this leaflet or exactly as your doctor, pharmacist, or healthcare professional has told you. Check with your doctor, pharmacist, or healthcare professional if you are not sure. 

The recommended dose is: 

Adults and adolescents from 40 kg body weight (12 years of age and older) 

Take one soft capsule with water. 

If needed, taking one soft capsule can be repeated at intervals of at least 6 hours. Do not take more than three soft capsules within a 24-hour period. 

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. Higher doses than recommended may carry serious risks. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2.). 

Adults: If you do not feel better or feel worse after 3 days with fever or after more than 4 days with pain, contact your doctor. 

Adolescents from 12 years: If you need to take this medicine for more than 3 days, or if symptoms worsen, consult your doctor. 

Ibumetin Express is for oral use. 

The soft capsules must be swallowed whole with a glass of water. If you suffer from mild indigestion, it is recommended to take this medicine with a meal or milk to avoid gastrointestinal problems. 

Use in children and adolescents 

Do not give Ibumetin Express to adolescents weighing less than 40 kg or to children under 12 years of age. There is a risk of reduced kidney function in dehydrated children and adolescents. 

If you take more Ibumetin Express than you should 

If you have taken more Ibumetin Express than you should, or if children have accidentally taken the medicine, always contact a doctor or nearest hospital to obtain an assessment of the risk and advice on further treatment. 

Symptoms may include nausea, vomiting (possibly containing blood), stomach pain, diarrhoea, ringing in the ears (tinnitus), headache, and blood in the stool (gastrointestinal bleeding). At high doses, dizziness, drowsiness, occasional agitation, seizures, and disorientation or coma have been reported. 

If you forget to take Ibumetin Express 

Do not take a double dose to make up for a forgotten dose. 

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

What are possible side effects?

4. What are possible side effects?

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious. Stop taking this medicine and seek medical help immediately if you develop any of the following symptoms:

Very rare (may affect up to 1 in 10,000 people) 

- Signs of gastrointestinal bleeding such as severe abdominal pain, black tarry stools, vomiting of blood or dark particles that look like coffee grounds.

- Signs of rare but severe allergic reactions such as worsening of asthma, unexplained wheezing, swelling of the face, tongue, or throat, shortness of breath, rapid heartbeat, and a drop in blood pressure leading to shock. These can even occur upon first use of this medicine. 

- Severe skin reactions such as rashes covering the whole body, peeling