IBULYSIN ADGC 400 mg film-coated tablets, 10 pcs

Instructions for use for IBULYSIN ADGC 400 mg film-coated tablets, 10 pcs

Application Notes

Adolescents from 12 years and adults (over 40 kg body weight)

1 Tablet

1-3 times a 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
- Bleeding in the gastrointestinal tract, including in the past
- Severely impaired liver function
- Severely impaired renal function
- Severe heart failure
- Active bleeding, such as:
- Cerebral hemorrhage
- Hematopoietic disorders
- 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
- Blood clotting disorder
- High blood pressure
- Coronary heart disease (circulatory disorders of the heart muscle)
- Circulatory disorders of the cerebral vessels
- Peripheral circulatory disorders (e.g. Arms legs)
- Possible risk of vasoconstriction in the heart, as with:
- Increased fat concentration in the blood
- Diabetes mellitus (diabetes)
- Smoking
- 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 12 years of age: The medicine must not be used.
- 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
- Inflammation of the oral mucosa
- Headache
- Dizziness
- Fatigue
- Insomnia
- 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 IBULYSIN ADGC 400 mg film-coated tablets, 10 pcs

Field of use

Ibulysin ADGC 400 mg film-coated tablets (pack size: 10 pieces) is used for the short-term symptomatic treatment of headaches and migraine pain. The active substance contained is ibuprofen, combined with the salt lysine, and belongs to the drug group of non-steroidal anti-inflammatory drugs (NSAR). Ibulysin ADGC® can be used in adults and adolescents over the age of 12 with a body weight of 40 kg or more.

Active substances / ingredients / ingredients

Active ingredients of Ibulysin ADGC 400 mg film-coated tablets (pack size: 10 pieces):

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

The other ingredients are: Tablet core: microcrystalline cellulose, silica-coated, copovidone, sodium starch glycolate (Type A) (Ph.Eur.), magnesium stearate (Ph.Eur.)[pflanzlich] Film-coating: poly(vinyl alcohol) partially hydrolysed, titanium dioxide ( E171), Talc, Macrogol 4000, Methacrylic acid-ethyl acrylate copolymer (1:1) (Ph.Eur.), sodium bicarbonate.

Contraindications

If you are known to be hypersensitive to any of the ingredients listed above, this product should not be used.

dosage

Recommended use of Ibulysin ADGC 400 mg film-coated tablets (pack size: 10 pcs):

Adults and adolescents weighing 40 kg or more (12 years and older):
As needed, take 1 tablet up to three times daily with water.
The interval between intakes should be at least six hours.
Do not take more than three tablets (1200 mg ibuprofen) within 24 hours.

Revenue

• The medicine is for oral use
• The film-coated tablets are scored on one side. The score line is only for breaking the tablet if you have trouble swallowing it whole.

Patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking this medicine:
    • if you have or have had asthma or allergic diseases, as shortness of breath may occur.
    • if you suffer from hay fever, nasal polyps or chronic airway disease that narrows the airways, as there is an increased risk of allergic reactions. These can manifest themselves as asthma attacks (so-called analgesic asthma), Quincke's edema or hives (urticaria).
    • if you have kidney, heart, liver or bowel problems.
    • if you have a history of gastrointestinal disease (such as ulcerative colitis or Crohn’s disease).
    • if you have certain congenital blood disorders (e.g. acute intermittent porphyria).
    • if you have systemic lupus erythematosus (SLE) or what is known as mixed collagen disease - these are diseases of the immune system that cause joint pain, skin changes and other organ disorders.
    • if you have chickenpox (varicella) - in this case it is advisable not to take this preparation as your condition could become worse.
    • if you have an infection - see below under 'Infections".
    • if you have just had major surgery.
    • if you are dehydrated.
    • if you are also taking other NSAR . Concomitant use with other NSAR (including the so-called selective COX-2 inhibitors) should be avoided.
    • if you are in the first six months of pregnancy.
  • Other warnings
    • 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 (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 NSAR . The risk of such reactions is highest for patients in the first month of treatment. If you develop a skin rash, lesions on the mucous membranes, blisters or any other sign of allergy, you should stop using the medicine and seek medical attention immediately, as these can be the first signs of a very serious skin reaction.
    • Side effects can be minimized by using the lowest effective dose for the shortest possible time. The risk of side effects is increased in elderly patients.
    • Ibuprofen can temporarily impair blood platelet function (platelet aggregation). Patients with bleeding disorders should therefore be closely monitored.
    • The doctor or dentist should be asked or informed if the drug is used before an operation.
    • Habitual use of various types of pain relievers can lead to permanent kidney damage with a risk of kidney failure. This risk may be increased by exercise associated with salt loss and dehydration. The habitual intake of painkillers should therefore be avoided.
    • 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.
    • If you use ibuprofen for a longer period of time, your liver values, kidney function and blood count must be checked regularly.
    • NSAR can mask symptoms of infection and fever.
    • Infections
      • The medicine can mask signs of infection such as fever and pain. Therefore, it is possible that the drug delays 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.
  • Children and young people
    • The medicine should not be used on children under 12 years of age or adolescents weighing less than 40 kg.
    • There is a risk of renal dysfunction in dehydrated adolescents.

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
  • Do not take this medicine in the last three months of pregnancy. Avoid using this medicine during the first six months of pregnancy unless your doctor recommends otherwise.
• Lactation
  • Only small amounts of ibuprofen and its breakdown products pass into breast milk. The medicine can therefore be used during breast-feeding if it is used at the recommended dose and for the shortest possible time.
• Fertility
  • This preparation belongs to a group of medicines that can affect fertility in women. This effect is reversible (reversible) after stopping the drug.

Hints

IBULYSIN ADGC 400 mg film-coated tablets Active ingredient: ibuprofen (as ibuprofenDLlysine (1:1)). Areas of application: Short-term symptomatic treatment of headaches and migraines in adults and adolescents aged 12 and over with a body weight of 40 kg or more. If the use of this medicine is required for more than three days or if the symptoms worsen, the patient should seek medical advice. Warning: In case of pain or fever, do not use longer than specified in the package leaflet without medical advice! Pharmacy only.
For risks and side effects, read the leaflet and ask your doctor or pharmacist.
Zentiva Pharma GmbH, 65927 Frankfurt am Main
Status: December 2021

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

Manufacturer: Zentiva Pharma GmbH, Linkstraße 2, 10785 Berlin