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

Instructions for use for IBU-LYSIN AL 400 mg film-coated tablets, 20 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
- Severe dehydration

Under certain circumstances - talk to your doctor or pharmacist about this:
- Collagenosis (changes in the connective tissue area), such as:
- Lupus erythematosus
- Mixed collagenosis (inflammatory rheumatic collagenosis)
- Gastrointestinal complaints
- Porphyria (metabolic disease)
- Major surgery that took place shortly before
- High blood pressure
- Coronary heart disease (circulatory disorders of the heart muscle)
- Peripheral circulatory disorders (e.g. Arms legs)
- Circulatory disorders of the cerebral vessels
- Possible risk of vasoconstriction in the heart, as with:
- Increased fat concentration in the blood
- Diabetes mellitus (diabetes)
- Smoking
- Inflammatory bowel diseases, including in history, such as:
- Crohn's disease
- Ulcerative colitis
- Chickenpox

What age group do you need to consider?
- Children under 12 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
- 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 IBU-LYSIN AL 400 mg film-coated tablets, 20 pcs

Field of use

• This medicine contains ibuprofenDLlysine (1:1), the lysine salt of ibuprofen. Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs/anti-inflammatory drugs (also referred to as NSAR for short), which relieve pain and reduce fever through their effect.
• This medicine is used for the symptomatic treatment of:
  • mild to moderate pain such as headache, period pain and toothache
  • Fever and pain associated with cold.
• If you do not feel better or worse after 3 days with treatment for fever, or if you feel worse after 4 days with treatment for pain, contact your doctor.

Active substances / ingredients / ingredients

684 mg ibuprofen, lysine salt
400 mg ibuprofen
Cellulose, microcrystalline excipient (+)
Copovidone excipient (+)
Crospovidone excipient (+)
Macrogol 4000 excipient (+)
Magnesium stearate (Ph. Eur.) [pflanzlich] excipient (+)
Poly(vinyl alcohol) excipient (+)
Talc excipient (+)
Titanium dioxide excipient (+)

Contraindications

• The drug must not be taken,
  • if you are allergic to ibuprofen or any of the other ingredients of this medicine.
  • if you have ever had shortness of breath, asthma, nasal congestion, swelling or hives after using acetylsalicylic acid or other similar painkillers (NSAR).
  • if you have or have had a history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least 2 separate episodes of proven ulcers or bleeding).
  • if you have a history of gastrointestinal bleeding or perforation (perforation) in connection with previous therapy with NSAR.
  • if you have severe kidney or liver function impairment or suffer from severe heart failure (heart failure).
  • if you have bleeding in the brain (cerebrovascular bleeding) or other active bleeding.
  • if you suffer from blood clotting disorders.
  • in unexplained blood disorders.
  • if you are severely dehydrated (caused, for example, by vomiting, diarrhea or not drinking enough fluids).
  • if you are in the last 3 months of pregnancy.
  • If you are taking low-dose acetylsalicylic acid (ASA). Do not take this medicine if you are also taking low-dose acetylsalicylic acid (in doses greater than 75 mg). If you are being treated with low dose acetylsalicylic acid (up to 75 mg), talk to your doctor or pharmacist before taking this medicine.
  • in children and adolescents weighing less than 40 kg (less than 12 years of age and younger).

dosage

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• The recommended dose is:
  • Adults and adolescents from 40 kg body weight (from the age of 12 years)
    • Take 1 tablet (400 mg ibuprofen) with water every 6 hours as needed. Dosing should not be more frequent than every 6 hours. No more than 3 tablets (1200 mg ibuprofen) may be taken within 24 hours.
• The tablets are for short-term use only. Always take the lowest possible dosage for the shortest possible time to treat your symptoms.
• Talk to your doctor if your symptoms get worse or if you take the tablets for more than 3 days to treat fever or for more than 4 days to treat pain.
• If adolescents are required to take this medicine for more than 3 days or if symptoms worsen, medical advice should be sought.

• If you take more than you should
  • Contact your doctor immediately or go to the emergency room at the nearest clinic. Bring the box of tablets and the leaflet with you. Signs of an overdose may include: nausea, vomiting, stomach pain, diarrhea, ringing in the ears, headache, gastrointestinal bleeding, dizziness, drowsiness, confusion, disorientation and, in rare cases, loss of consciousness.
  • If you have taken more Ibu-Lysine than you should, or if children have accidentally taken the medicine, always contact your nearest doctor or hospital for an assessment of the risk and advice on further treatment.
  • Symptoms can include nausea, stomach pain, vomiting (possibly with blood), headache, ringing in the ears, confusion, and eye tremors. At high doses, drowsiness, chest pain, palpitations, fainting, convulsions (especially in children), weakness and dizziness, blood in the urine, feeling cold and breathing problems have been reported.

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

Revenue

• Take 1 tablet (400 mg ibuprofen) with water every 6 hours as needed.

Patient notes

• Warnings and Precautions
  • Talk to your doctor or pharmacist before taking this medicine:
    • if you suffer from severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The use of ibuprofen should be stopped immediately at the first sign of a skin rash or mucosal lesions or other signs of an allergic reaction.
    • if you have a certain hereditary blood formation disorder (e.g. acute intermittent porphyria).
    • if you are elderly, because then the risk of side effects, especially stomach problems, may be increased.
    • if you have asthma or have had asthma attacks in the past or suffer from allergies, as shortness of breath (difficulty breathing) may occur.
    • if you suffer from hay fever, nasal polyps or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. The allergic reactions can manifest themselves in the form of asthma attacks (so-called analgesic asthma), Quincke's edema or hives (urticaria).
    • if you have chickenpox infection (varicella infection) it is recommended to avoid the use of ibuprofen.
    • if you have impaired liver or kidney function.
    • if you have just had a major surgical procedure.
    • if you suffer from stomach and bowel diseases such as Crohn's disease or ulcerative colitis.
    • if you have systemic lupus erythematosus (SLE) or mixed collagen disease, i.e. diseases that affect the immune system. These cause joint pain, skin changes and other physical problems.
    • if you have ever had or are predisposed to heart problems, high blood pressure or stroke. Medicines like this 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 duration of treatment (3 days for treating fever and 4 days for treating pain). If you have heart problems or a previous stroke, or think you might be at risk for these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or are a smoker), you should discuss your treatment with your doctor or pharmacist.
  • 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 (maximum 4 days). You should discuss your treatment with your doctor or pharmacist before taking it 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 narrowed 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.
  • If you take ibuprofen for a longer period of time, you need to have your liver values, kidney function and blood count checked regularly.
  • Use with NSAR, including cyclooxygenase-2 specific inhibitors, increases the risk of side effects and should be avoided.
  • The risk of side effects can be minimized by using the lowest effective dose for the shortest possible time.
  • In general, the habitual use of (various types of) painkillers can lead to permanent kidney damage. This risk may be increased with exercise associated with salt loss and dehydration. Therefore it should 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.
  • Consult a doctor before taking ibuprofen if the above apply to you.
  • Children and young people
    • There is a risk of renal dysfunction in dehydrated adolescents (age range: >/=12 years to < 18 years).

• Ability to drive and use machines
  • With short-term use and at the doses recommended, this medicine has no or negligible influence on the ability to drive and use machines.

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
  • Tell your doctor if you become pregnant while taking this medicine. Do not use this medicine in the last 3 months of pregnancy. Talk to your doctor before you start taking it during the first 6 months of pregnancy.
• Lactation
  • This medicine may be used during breast-feeding for a maximum of 3 days (to treat fever) or a maximum of 4 days (to treat pain) as only small amounts of this medicine pass into breast milk.
• Fertility
  • This medicine belongs to a group of medicines (NSAIDs) that can affect women's ability to have children. This effect is reversible (reversible) after stopping the drug.

Hints

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

Manufacturer: ALIUD Pharma GmbH, Gottlieb-Daimler-Strasse 19, 89150 Laichingen