IBU-LYSIN DoppelherzPharma 400 mg film-coated tablets, 20 pcs

Instructions for use for IBU-LYSIN DoppelherzPharma 400 mg film-coated tablets, 20 pcs

Application Notes

Children from 6-9 years (with 20-29 kg body weight)	1/2 Tablet	1-3 times a day	6 hours apart, regardless of the meal
Children from 10-11 years (with 30-39 kg body weight)	1/2 Tablet	1-4 times a day	6 hours apart, regardless of the meal
Adolescents from 12 years and adults (over 40 kg body weight)	1/2-1 Tablet	1-4 times a day&<;BR&> (max. 3 tablets per day)	6 hours apart, regardless of the meal

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient belongs to a group of substances that act both against pain and inflammation and can reduce fever. All three effects are primarily based on the inhibition of an endogenous substance called prostaglandin. This substance must be present as a messenger substance so that pain can be felt, inflammatory reactions can be started or the body temperature can be raised.

Composition

Contraindications

What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Ulcers in the digestive tract, even in history
- Active bleeding, such as:
- Bleeding in the gastrointestinal tract, including in the past
- Cerebral hemorrhage
- Severe dehydration

Under certain circumstances - talk to your doctor or pharmacist about this:
- Gastrointestinal complaints
- Inflammatory bowel diseases, including in history, such as:
- Crohn's disease
- Ulcerative colitis
- Hematopoietic disorders
- High blood pressure
- Severe heart failure
- Severely impaired renal function
- Severely impaired liver function
- Collagenosis (changes in the connective tissue area), such as:
- Lupus erythematosus
- Mixed collagenosis (inflammatory rheumatic collagenosis)
- Porphyria (metabolic disease)
- Major surgery that took place shortly before
- Chickenpox

What age group do you need to consider?
- Children under 6 years of age: The medicine should not normally be used in this group. There are preparations that are more suitable in terms of the strength of the active ingredient and/or dosage form.
- Elderly patients from 65 years of age: The treatment should be well coordinated with your doctor and carefully monitored, e.g. by close controls. The desired effects and undesired side effects of the drug can be stronger or weaker in this group.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Side effects

What adverse effects may occur?

- Gastrointestinal problems such as:
- Nausea
- Vomiting
- Heartburn
- Bloating
- Diarrhea
- Constipation
- Stomach pain
- Bleeding in the gastrointestinal tract
- Tarry stools, please consult a doctor immediately if this occurs
- Inflammation of the gastric mucosa
- Ulcers in the digestive tract, which very rarely can rupture
- Headache
- Dizziness
- Insomnia
- Fatigue
- Irritability
- Excitement
- Skin hypersensitivity reactions such as:
- Skin rash
- Itching
- Attacks of shortness of breath
- Visual disturbances, please consult a doctor immediately if they occur

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Hints

What should you consider?
- The ability to react can also be impaired when used as intended, especially in higher doses or in combination with alcohol. Be particularly careful when driving or using machines (including household ones) that could injure you.
- In case of pain or fever, do not use longer than specified in the leaflet without medical advice!
- With long-term use of painkillers, headaches caused by the painkiller can occur. Talk to your doctor to prevent your headache from becoming chronic.
- The habitual use of painkillers can lead to permanent kidney damage. If several painkillers are combined, or if one painkiller contains several active ingredients, the risk increases.
- Caution: Patients with nasal polyps, chronic respiratory infections, asthma or who are prone to allergic reactions such as hay fever: the medicine can trigger an asthma attack or a severe allergic skin reaction. Therefor consult your doctor before usage.
- Be careful if you are allergic to painkillers!
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.
- Consumption of alcohol should be avoided as far as possible during long-term treatment . Occasional alcohol consumption in small amounts is allowed, but not with the drug.

Detailed instructions for IBU-LYSIN DoppelherzPharma 400 mg film-coated tablets, 20 pcs

Field of use

Ibu-lysin Doppelherzpharma 400 mg film tablets (pack size: 20 pieces) is a pharmacy-only drug

Ibu-lysin Doppelherzpharma 400 mg film tablets (pack size: 20 pcs) helps with mild to moderate pain and can relieve headaches, toothache and menstrual pain on the other hand, it works with fever. The preparation is used for the short-term symptomatic treatment of children weighing 20 kg or more (6 years and older), adolescents and adults. The tablets contain the proven active ingredient ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (so-called NSAR). The medicine works by affecting pain and increased temperature. The advantage of Ibu-lysin Doppelherzpharma 400 Mg film tablets (pack size: 20 pieces) is combined with the amino acid lysine: lysine promotes the absorption of ibuprofen in the body, so that the active ingredient can combat pain and fever promptly. The preparation also has a long-lasting pain-relieving and fever-reducing effect: the effect lasts about 6 hours.

Active substances / ingredients / ingredients

What Ibu-lysin Doppelherzpharma 400 mg film-coated tablets (pack size: 20 pieces) contains:

The active substance is: ibuprofen.
Each film-coated tablet contains 400 mg ibuprofen (as 684 mg ibuprofenDLlysine (1:1)).

The other ingredients are:
Tablet core: Microcrystalline cellulose, coated with silica, copovidone, sodium starch glycolate (TYPE A) (Ph.Eur.), Magnesium Stearate (Ph.Eur.)[pflanzlich]
Film Coating: Poly(vinyl alcohol) partially hydrolyzed, titanium dioxide (E171), talc, macrogol 4000, methacrylic acid-ethyl acrylate copolymer (1:1) (Ph.Eur.), sodium bicarbonate

Contraindications

The product should not be used if there is a known hypersensitivity to any of the above ingredients.

dosage

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

Recommended use of Ibu-lysin Doppelherzpharma 400 mg film tablets (pack size: 20 pcs):

Please swallow the film-coated tablets whole with plenty of liquid (e.g. a glass of water).

For patients who have a sensitive stomach, it is recommended to take the tablet during meals.

The recommended dose is:
Body weight (age) | single dose maximum | total daily dose 20 - 29 kg (children: 6 - 9 years) | 200 mg Ibuprofen (½ film-coated tablet) | 600 mg ibuprofen (1 ½ film-coated tablets)
30 - 39 kg (children: 10 - 11 years) | 200 mg Ibuprofen (½ film-coated tablet) | 800 mg ibuprofen (2 film-coated tablets)
≥ 40 kg (adolescents from 12 years and adults) | 200 - 400 mg ibuprofen (½ - 1 film-coated tablet) | 1200 mg ibuprofen (3 film-coated tablets)

Revenue

• Please swallow the film-coated tablets whole with plenty of liquid (e.g. a glass of water) during or after a meal.
• For patients who have a sensitive stomach, it is recommended to take this medicine with meals.

Patient notes

• Warnings and Precautions
  • Please talk to your pharmacist before taking this medicine.
  • Side effects can be minimized by using the lowest effective dose needed to control symptoms for the shortest period of time.
  • Safety in the gastrointestinal tract
    • Concomitant use of this medicine with other non-steroidal anti-inflammatory drugs, including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors) should be avoided.
    • Elderly patients:
      • Side effects occur more frequently in older patients after the use of NSAR , in particular bleeding and perforations in the stomach and intestines, which can be life-threatening under certain circumstances. Therefore, particularly careful medical supervision is required in elderly patients.
    • Gastrointestinal bleeding, ulcers and perforations:
      • Gastrointestinal bleeding, ulceration and perforation, including fatal outcomes, have been reported during treatment with all NSAR . They occurred with or without prior warning symptoms or a history of serious gastrointestinal events at any time during therapy.
      • The risk of occurrence of gastrointestinal bleeding, ulcers and perforation is higher with increasing NSARdose, in patients with a history of ulcers, especially those complicated with bleeding or perforation, and in elderly patients. These patients should start treatment on the lowest dose available.
      • 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 adverse reactions, particularly if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages 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, anticoagulants 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 develop gastrointestinal bleeding or ulcers during treatment with the medicine, the treatment should be discontinued.
      • NSAR should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as their condition may worsen.
    • Effects on the cardiovascular system
      • Anti-inflammatories/painkillers such as ibuprofen 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 this medicine if you
        • have heart disease, including heart failure (heart failure) and angina pectoris (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 - had a 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 with reddening and blistering, some with fatal outcome, have been reported very rarely (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell's syndrome) with NSARtherapy. The risk of such reactions appears to be highest at the start of therapy, since the majority of these reactions occurred within the first month of treatment. At the first sign of skin rashes, mucosal defects or other signs of a hypersensitivity reaction, Aktren Forte should be discontinued and the doctor consulted immediately.
      • Avoid using this medicine if you have chickenpox (varicella) infection.
    • Other Notes
      • This medicinal product should only be used after careful consideration of the risk/benefit ratio:
        • in certain congenital blood disorders (e.g. acute intermittent porphyria);
        • in certain autoimmune diseases (systemic lupus erythematosus and mixed collagenosis), as these patients are at increased risk of aseptic meningitis.
      • Particularly careful medical supervision is required:
        • if you have impaired kidney function, as this can continue to deteriorate;
        • in liver dysfunction; Hepatic dysfunction increases the risk of developing kidney toxicity and damage, as well as severe, potentially fatal liver reactions;
        • immediately after major surgical interventions;
        • in the case of allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic swelling of the nasal mucosa or chronic respiratory diseases that narrow the airways.
      • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) are observed very rarely. Therapy must be discontinued at the first sign of a severe hypersensitivity reaction after taking Aktren Forte. Medically necessary measures corresponding to the symptoms must be initiated by competent persons.
      • Ibuprofen, the active ingredient in this medicine, can temporarily inhibit the function of platelets (platelet aggregation). Patients with bleeding 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 ibuprofen-containing medicines without your doctor's express instructions.
      • If you are taking medicines to inhibit blood clotting or to lower blood sugar at the same time, you should have your blood clotting or blood sugar levels checked as a precaution.
      • If this drug is administered for a longer period of time, regular monitoring of the liver values, kidney function and blood count is required.
      • The doctor or dentist should be consulted or informed if this medicine is taken before surgery.
      • Prolonged use of any type of pain reliever for a headache can make it worse. If this occurs or is suspected, medical advice should be sought and treatment discontinued. A diagnosis of medication overuse headache (MOH) should be suspected in patients who experience frequent or daily headaches despite (or because of) their regular use of headache drugs.
      • 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).
      • When using NSAR , drug-related side effects, especially those affecting the gastrointestinal tract or the central nervous system, can be increased through simultaneous consumption of alcohol.
• Children and young people
  • There is a risk of renal dysfunction in dehydrated children and adolescents.
  • Please note the information under the "Contraindications" category".

• Ability to drive and use machines
  • Since central nervous side effects such as tiredness and dizziness can occur when using the drug in higher doses, the ability to react can be altered in individual cases and the ability to actively participate in road traffic and operate machines can be impaired. This applies even more in combination 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 safe grip!

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
  • If pregnancy is discovered while using this medicine, the doctor should be informed. You may only use ibuprofen in the first and second trimester of pregnancy after consulting your doctor. This medicine must not be used in the last trimester of pregnancy because of an increased risk of complications for mother and child.
• Lactation
  • Only small amounts of the active ingredient ibuprofen and its breakdown products pass into breast milk. Since adverse consequences for the infant have not yet become known, it is not usually necessary to interrupt breastfeeding if the product is used for a short period of time. However, if longer use or higher doses are prescribed, early weaning should be considered.
• Fertility
  • This medicine belongs to a group of medicines (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible (reversible) after stopping the drug.

Hints

Store cool (6-25 °C), dry and protected from light. Ibu-lysin Doppelherzpharma 400 mg film tablets (pack size: 20 pieces) should be kept out of the reach of children.

In case of pain or fever, do not use longer than specified in the leaflet without medical advice!

Manufacturer: Queisser Pharma GmbH & Co. KG, Schleswiger Strasse 74, 24941 Flensburg