Eu-Med 200 mg painkillers 30 tablets

Dexibuprofen, the active substance in Eu-Med, belongs to the group of non-steroidal painkillers and anti-inflammatory drugs (NSAIDs). It works by reducing the body's production of prostaglandins, which control inflammation and pain.
Eu-Med is used to treat pain conditions, such as pain in the musculoskeletal system, toothache or acute menstrual pain, as well as pain and fever associated with colds and flu-like infections.

Contraindications

Eu-Med must not be taken

• if you are allergic to dexibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or other painkillers. Difficulty breathing, asthma, runny nose, skin rash and swelling of the face can occur;
• if you have had bleeding or perforation in the gastrointestinal tract caused by therapy with NSAIDs;
• if you have or have had repeated ulcers in your stomach or duodenum (if you vomit blood, have black stools or bloody diarrhoea, these could be signs of bleeding in your stomach or intestines);
• if you have bleeding in the brain (cerebrovascular bleeding) or other active bleeding;
• if you suffer from an acute episode of intestinal inflammation (ulcerative colitis, Crohn's disease);
• if you suffer from severe heart failure or severe liver or kidney disease;
• from the beginning of the sixth month of pregnancy

interactions

Other medical conditions may affect the use of Eu-Med. Talk to your doctor or pharmacist before taking Eu-Med

• if you have ever had a stomach or duodenal ulcer
• if you have or have previously had chronic inflammation of the bowel (ulcerative colitis or Crohn's disease);
• if you suffer from liver or kidney disease or are an alcoholic;
• if you suffer from a blood clotting disorder (see “Other medicines and Eu-Med 200 mg – Painkillers”);
• if you suffer from edema (fluid retention in the body);
• if you have heart disease or high blood pressure;
• if you have asthma, hay fever or other breathing problems;
• if you suffer from systemic lupus erythematosus (an autoimmune disease affecting the joints, muscles and skin) or mixed connective tissue disease (a type of connective tissue disease);
• if you have problems conceiving (NSAIDs such as Eu-Med can in rare cases affect fertility in women. If you stop Eu-Med this effect is reversed)
• if you have an infection - see under 'Infections'.

The risk of side effects may be increased in elderly patients. If you have to take high doses of Eu-Med, especially if you are over 60 years of age or if you have had stomach or duodenal ulcers, there is an increased risk of side effects in the gastrointestinal tract. This risk may be increased with other medicines you are taking. If you vomit blood, have black stools or bloody diarrhea, this could be a sign of bleeding in the stomach or intestines. Stop taking Eu-Med and see a doctor immediately. Your doctor may consider combination therapy with medicines that protect the gastrointestinal tract.

Anti-inflammatories/painkillers such as dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly 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 Eu-Med,

• if you have heart disease, including heart failure (heart failure) and angina (chest pain), or have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries) or any type of stroke (including mini-stroke or transient ischemic 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.

Skin reactions Serious skin
reactions have been reported in connection with treatment with Eu-Med. If you develop a skin rash, lesions on the mucous membranes, blisters or any other sign of allergy, you should stop using Eu-Med and seek medical attention immediately, as these can be the first signs of a very serious skin reaction. See section 4.

Infections
Eu-Med can mask signs of infection such as fever and pain. Therefore, Eu-Med may delay adequate treatment of the infection, which may lead to an increased risk of complications. This has been seen in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and your infection symptoms persist or worsen, consult a doctor immediately.

If you have chickenpox, you should not take painkillers and anti-inflammatory drugs.

Eu-Med may affect or be affected by other medicines. For example:

• Medicines that have an anticoagulant effect (ie thin the blood/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Drugs that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as drugs containing atenolol, angiotensin II receptor antagonists such as losartan)

The following medicines must not be taken together with Eu-Med (unless they are under medical supervision):

• Non-steroidal painkillers and anti-inflammatory drugs (NSAIDs). If you take Eu-Med with other NSAIDs or acetylsalicylic acid as a pain reliever, there is an increased risk of ulcers and bleeding in the digestive tract.
• Lithium used to treat mood swings. Eu-Med can increase the effect.
• methotrexate. Eu-Med can increase the side effects of methotrexate.

You can take Eu-Med independently of meals. In the case of long-term treatment in particular, however, it is advisable to take the medicine with meals in order to prevent stomach problems.

Excessive alcohol consumption can worsen the gastrointestinal tolerance of Eu-Med.

Pregnancy, lactation and fertility

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. You must not take Eu-Med from the sixth month of pregnancy, as it can seriously harm your unborn child, even at low doses. During the first five months of pregnancy, you should only take Eu-Med after consulting your doctor.

You should not take Eu-Med if you are planning to become pregnant as it may make it more difficult for you to become pregnant. Only small amounts of the active ingredient pass into breast milk. If you are breastfeeding, you must not take EuMed for a long time or in high doses.

Ability to drive and use machines

Caution: This medicine can affect your ability to react and drive.

If you experience dizziness, lightheadedness, tiredness or visual disturbances while using Eu-Med, you must not drive or use machines (see section 4. Possible side effects).

application

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.

Take a painkiller up to 3 times a day.

In general, you should not take more than three Eu-Med painkillers per day.

There should be an interval of 4 to 6 hours between doses.

Take Eu-Med Painkillers with liquid. The tablets can be taken with or without a meal.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (e.g. fever and pain) persist or worsen (see section 2).

The score line allows Eu-Med 200 mg painkillers to be divided into two equal halves. Place the tablet on a hard surface to divide. Use both thumbs or forefingers to press left and right of the break line.

Use in children and adolescents

Please only give your child Eu-Med if prescribed by a doctor.

This dosage form is not suitable for children up to 8 years of age.

Children from 8 to 12 years: up to 3 times a day 1/2 Eu-Med 200 mg painkiller.

Adolescents from 12-18: up to 3 times a day 1 Eu-Med 200 mg painkiller.

Elderly patients (65 years and older)

No special dose adjustment is required if you are over 65 years of age. Due to the increased susceptibility of elderly patients, watch out for side effects in the gastrointestinal area. Patients with liver and/or kidney disease If you have mild to moderate liver or kidney problems you must be careful when taking Eu-Med. Patients with severe liver or kidney dysfunction should not take Eu-Med. Please contact your doctor.

side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The incidence of side effects is lower with short-term use and low doses.

Discontinue Eu-Med and please see a doctor

• if you experience severe abdominal pain, especially at the beginning of treatment.
• if you have black stools or bloody diarrhea or if you vomit blood.
• if you experience a skin rash, severe blistering or peeling of the skin, sores in the mucous membranes or signs of an allergy.
• if you have symptoms such as fever, sore throat, flu-like conditions, tiredness, nosebleeds or bleeding from the skin. These could be due to a reduction in your white blood cells (agranulocytosis).
• if you have severe or persistent headaches.
• if your skin and eyes turn yellow (jaundice).
• if your face, tongue and throat swell and if you have difficulty swallowing or breathing (angioedema).

In the following, all possible side effects are listed, which have been observed especially with high-dose and/or long-term use. With short-term or occasional use of Eu-Med, side effects are much less common than listed here.

Very common side effects - affects more than 1 in 10 people

• indigestion, abdominal pain.

Common side effects – affects less than 1 in 10 but more than 1 in 100 people

• diarrhea, vomiting, or nausea;
• fatigue or sleepiness, lightheadedness, dizziness, headache;
• Skin rash.

Uncommon side effects - affects less than 1 in 100 but more than 1 in 1000 people

• Stomach or gut ulcers and bleeding in the stomach or gut, unusual black stools, mouth sores, inflammation of the stomach (gastritis);
• Small bleeding in the skin (purpura), itching, hives;
• swelling of the face or throat (angioedema);
• insomnia, restlessness, anxiety, visual disturbances, ringing in the ears (tinnitus);
• runny nose and difficulty breathing.

Rare side effects - affects less than 1 in 1000 but more than 1 in 10,000 people

• severe allergic reactions;
• psychotic reactions, depression, irritability;
• confusion, disorientation, agitation;
• temporary poor eyesight;
• hearing impairment;
• flatulence, constipation, perforation in the digestive system (the symptoms are severe abdominal pain, fever, nausea), inflammation of the esophagus, acute flare-up of diverticular disease, colitis or Crohn's disease;
• liver dysfunction, hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes);
• Blood disorders, including a reduction in the number of white or red blood cells or platelets.

Very rare side effects - affects less than 1 in 10,000 people

• General hypersensitivity reactions such as fever with skin rash, abdominal pain, headache, nausea and vomiting;
• increased sensitivity to light
• meningitis (complaints include headache, fever, stiff neck, general malaise) or severe hypersensitivity reactions (difficulty breathing, asthma, tachycardia, low blood pressure, even shock);
• reddening of the skin, mucous membranes or throat;
• blisters on hands and feet (Stevens-Johnson syndrome);
• skin detachment (epidermal necrolysis);
• hair loss;
• kidney inflammation, kidney disease, kidney failure;
• systemic lupus erythematosus (an autoimmune disease);
• very rare bacterial infections affecting the tissue around a muscle may get worse.

Not known (cannot be estimated from the available data):

• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include a rash, fever, swollen lymph nodes, and an increase in eosinophils (a type of white blood cell).
• At the start of treatment a red, scaly, widespread rash with bumps under the skin and blisters accompanied by fever, primarily on the skin folds, trunk and upper extremities (acute generalized pustular rash). Stop using Eu-Med if you develop these symptoms and seek medical attention immediately. See also Section 2

composition

The active substance is dexibuprofen. One film-coated tablet contains 200 mg.

The other ingredients are:

• Tablettenkern: Hypromellose, mikrokristalline Cellulose, Carmellose Calcium, hochdisperses Siliciumdioxid, Talk.
• Film Coating: Hypromellose, Titanium Dioxide (E-171), Glycerol Triacetate, Talc, Macrogol 6000.