Eudorlin migraine film-coated tablets, 20 pcs

Description

Migraine patients suffer considerably because a migraine attack can severely limit those affected and, in the worst case, leave them out of action for several days.A migraine is a one-sided headache that occurs again and again at irregular intervals.The pain is described as pulsating or throbbing and is often accompanied by other symptoms such as nausea, vomiting or visual disturbances.

Areas of application

EUDORLIN Migraine is an anti-inflammatory and analgesic drug (non-steroidal anti-inflammatory drug/anti-rheumatic drug, NSAR).It is used for the symptomatic treatment of the acute headache phase of migraines with and without aura as well as tension headaches.No prescription is required for this product.

Active ingredients and ingredients

EUDORLIN Migraines contain the active ingredient ibuprofen.One film-coated tablet contains 400 mg ibuprofen.The other ingredients are corn starch, highly disperse silicon dioxide, carboxymethyl starch sodium (type A) (Ph. Eur.), magnesium stearate (Ph. Eur.) [pflanzlich], hypromellose, macrogol 4000, povidone K 30 and titanium dioxide (E 171).

Contraindications

If you are known to be hypersensitive to any of the ingredients mentioned, the product should not be used. EUDORLIN Migraine should not be used if you have had allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the past, such as shortness of breath due to narrowing of the airways (bronchospasm), asthma attacks, swelling of the nasal mucosa or skin reactions.Also in the case of unexplained blood formation disorders, existing or repeated gastric/duodenal ulcers or bleeding in the past, a history of gastrointestinal bleeding or breakthrough in connection with previous therapy with non-steroidal anti-inflammatory drugs/anti-inflammatory drugs (NSAR), cerebral hemorrhages or other active bleeding, severe liver or kidney dysfunction, severe heart failure (heart failure), in the last months of pregnancy and in children20 kg (under 6 years) EUDORLIN Migraine must not be used.

Dosage

Recommended use of EUDORLIN Migraine: Please take the film-coated tablets whole with sufficient liquid (e.g. a glass of water) during or after a meal.

20 - 29 kg body weight (children: 6 - 9 years): Single dose: 1/2 film-coated tablet (equivalent to 200 mg ibuprofen), Max. daily dose: 1.5 film-coated tablets (equivalent to 600 mg ibuprofen).

30 - 39 kg body weight (children: 10 - 12 years): Single dose: 1/2 film-coated tablet (equivalent to 200 mg ibuprofen), Max. daily dose: 2 film-coated tablets (equivalent to 800 mg ibuprofen).

from 40 kg body weight (children and adolescents aged 12 and over and adults): Single dose: 1/2 - 1 film-coated tablet (corresponding to 200 - 400 mg ibuprofen), Max. daily dose: 3 film-coated tablets (corresponding to 1200 mg ibuprofen).

After taking the maximum single dose, an interval of at least 6 hours must be maintained before the next dose.

Elderly people and patients with a previous stomach or duodenal ulcer should start with the lowest dosage and be monitored by a doctor.No dose reduction is necessary if there is mild to moderate impairment of kidney or liver function.

In children and adolescents, if it is necessary to take this medicine for more than 3 days or if symptoms worsen, medical advice should be sought.

Do not use this medicine for more than 3 days in children and adolescents and for more than 4 days in adults without medical advice.Please talk to your doctor or pharmacist if you think the medicine is too strong or too weak.

Intake

Please take the film-coated tablets whole with sufficient liquid (e.g. a glass of water) during or after a meal.For further information see instructions for use!

Patient information

Side effects can be reduced by using the lowest effective dose for the shortest period of time necessary to control symptoms.Simultaneous use with other non-steroidal anti-inflammatory drugs, including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided.

Older patients are more likely to experience side effects after using NSAR , especially bleeding and perforations in the stomach and intestines, which can be life-threatening under certain circumstances.Therefore, particularly careful medical monitoring is required in older patients.

Gastrointestinal bleeding, ulcers and perforations, including fatal outcomes, have been reported during treatment with all NSAR . The risk of developing gastrointestinal bleeding, ulcers and perforations is higher with increasing NSARdose, in patients with a history of ulcers, especially with the complications of bleeding or perforations, and in elderly patients.These patients should begin treatment at the lowest available dose.For these patients, as well as for patients who require concomitant therapy with low-dose acetylsalicylic acid (ASA) or other drugs that may increase the risk of gastrointestinal diseases, combination therapy with drugs that protect the gastric mucosa (e.g. misoprostol or proton pump inhibitors) should be considered.

If you have a history of gastrointestinal side effects, especially if you are older, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of therapy.Caution is advised if you are also receiving medicines that may increase the risk of ulcers or bleeding, such as:B. oral corticosteroids, anticoagulant medications such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, to treat depressive moods, or platelet aggregation inhibitors, such as ASA.

If you experience gastrointestinal bleeding or ulcers during treatment, stop treatment immediately and contact a doctor. NSAR should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may worsen.

Medicines such as these may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.Any risk is more likely with high doses and prolonged treatment.Do not exceed the recommended dose or treatment duration (see “Dosage” category for maximum duration)!

If you have heart problems or a previous stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or are a smoker), you should talk to your doctor or pharmacist before starting treatment.

Serious skin reactions with redness and blistering, some fatal, have been reported very rarely with NSARtherapy (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell syndrome).The highest risk of such reactions appears to be at the start of therapy, as in the majority of cases these reactions occurred in the first month of treatment.At the first sign of skin rashes, mucous membrane defects or other signs of a hypersensitivity reaction, the medicine should be discontinued and a doctor should be consulted immediately.

Please talk to your doctor or pharmacist before taking this medicine.The drug should only be used after careful consideration of the benefit-risk ratio in certain autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease).

Particularly careful medical supervision is required if you have gastrointestinal disorders or a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), if you have high blood pressure or heart failure, if you have impaired kidney or liver function, immediately after major surgical procedures, if you have allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic swelling of the nasal mucous membranes or chronic respiratory diseases that narrow the airways.

Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are very rarely observed.At the first signs of a serious hypersensitivity reaction after taking it, you must immediately stop taking the drug and consult a doctor.

Ibuprofen, the active ingredient of the medicine, can temporarily inhibit platelet function (platelet aggregation).Patients with blood clotting disorders should therefore be carefully monitored.

If medicines containing ibuprofen are used at the same time, the anticoagulant effect of low-dose acetylsalicylic acid (preventing the formation of blood clots) may be impaired.In this case, you should therefore not use medicines containing ibuprofen without your doctor's express instructions.

If the drug is administered for a long time, regular monitoring of liver values, kidney function and blood counts is necessary.

If taken before surgical procedures, the doctor or dentist should be consulted or informed.

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 perhaps because of) taking regular headache medication.

In general, the habitual use of painkillers, especially when several painkilling agents are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).

Use of this medicine should be avoided during a chickenpox infection (varicella infection).

There is a risk of kidney dysfunction in dehydrated children and adolescents.

Since central nervous side effects such as tiredness and dizziness can occur when using this medicine in higher doses, in individual cases the ability to react can be changed and the ability to actively participate in road traffic and operate machines can be impaired.This applies to an even greater extent when combined with alcohol.You can then no longer react quickly and specifically enough to unexpected and sudden events.In this case, do not drive a car or other vehicles!Do not operate any tools or machines!Do not work without a secure hold!

Pregnancy

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

Pregnancy: You may only use the medicine in the first and second trimesters of pregnancy after consulting your doctor.The medicine must not be used in the last trimester of pregnancy due to an increased risk of complications for mother and child.

Fertility/childbearing capacity: This preparation belongs to a group of medicines (non-steroidal anti-inflammatory drugs/anti-inflammatory drugs, NSAR) that can impair fertility in women.This effect is reversible (reversible) once the drug is discontinued.

Breastfeeding: The active ingredient ibuprofen and its breakdown products only pass into breast milk in small quantities.Since there are no known adverse consequences for the infant, interruption of breastfeeding is generally not necessary for short-term use.However, if longer use or higher doses are prescribed, early discontinuation of breastfeeding should be considered.

Notes

Long-term, high-dose, improper use of painkillers can cause headaches that cannot be treated with higher doses of the drug.

In general, the habitual use of painkillers, especially when several painkillers are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).

If visual disturbances occur, severe pain in the upper abdomen, tarry stools or vomiting of blood, stop ibuprofen and consult a doctor immediately.

In individual cases, a worsening of infection-related inflammation (e.g. death of tissue parts) has been described in connection with the use of ibuprofen.This may be related to the mechanism of action of ibuprofen.

Therefore, if signs of infection appear new or worsen while using the drug, it is recommended to consult the doctor immediately.It must be checked whether there is an indication for anti-infectious/antibiotic treatment.

Since nervous side effects such as tiredness and dizziness can occur when using ibuprofen in higher doses, the ability to drive a motor vehicle or operate machines may be restricted in individual cases.This applies to an even greater extent when combined with alcohol.

No special precautions are necessary when using ibuprofen as a painkiller once or for a short time.

If ibuprofen is given for a long time, regular monitoring of liver values, kidney function and blood counts is necessary.

Severe general hypersensitivity reactions may occur.They can manifest themselves as facial swelling, tongue swelling, inner larynx swelling with narrowing of the airways, shortness of breath, rapid heartbeat, drop in blood pressure and even threatening shock. If any of these symptoms occur, which can occur even during the first use, immediate medical attention is required.

If you have pain or fever, do not use it for longer than stated in the package leaflet without medical advice!