IBU-LYSIN 1A Pharma 400 mg film-coated tablets, 10 pcs

Instructions for use for IBU-LYSIN 1A Pharma 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
- Hematopoietic disorders
- Ulcers in the digestive tract, even in history
- Bleeding in the gastrointestinal tract, including in the past
- Active bleeding, such as:
- Cerebral hemorrhage
- Severe heart failure
- Severely impaired renal function
- Severely impaired liver function
- 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 IBU-LYSIN 1A Pharma 400 mg film-coated tablets, 10 pcs

Field of use

Ibu-lysin 1a Pharma 400 mg film-coated tablets (pack size: 10 pcs) - Quick relief for headaches. For the short-term symptomatic treatment of headaches and migraines.

Fast help is needed for tension headaches and migraines! It's a good thing that Ibu-Lysine - 1 A Pharma® 400 mg is available. Because the film-coated tablets contain the active ingredient ibuprofen as ibuprofenDLlysine salt. The proven active ingredient ibuprofen can thus develop its pain-relieving effects even more quickly. But not only that: Ibu-Lysin - 1 A Pharma® 400 mg also has a long-lasting pain-relieving effect. Pain can be relieved for up to 8 hours.

Good to know: Ibu-Lysin - 1 A Pharma® 400 mg is well tolerated and is suitable for use in adults and adolescents over the age of 12 with a body weight of 40 kg or more.

BEEINTRÄCHTIGUNG DER LEBENSQUALITÄT
So-called tension headaches and migraines can severely limit our everyday lives. So that you can counteract a pain attack quickly, it is recommended to take Ibu-Lysin - 1 A Pharma® 400 mg to relieve the annoying headache.

STRESS
Headaches and migraines are often triggered by stress. If this lasts longer, it becomes all the more unpleasant. Finding peace and being able to switch off is therefore essential. Do relaxation exercises, do yoga, or try meditation. Sport is also a very helpful way to reduce stress.

FLÜSSIGKEITSMANGEL
Often underestimated, but important: the majority of our body consists of water. So that our brain can function well and headaches do not occur in the first place, it is important to drink enough. At least 1.5 liters of water or unsweetened tea per day are recommended to keep the body sufficiently hydrated.

HÄUFIGE FRAGEN & ANSWER:

How to take Ibu-Lysin - 1 A Pharma® 400 mg?
Adults and adolescents with a body weight of 40 kg (12 years and older) can take 1 film-coated tablet with water up to 3 times a day if required.
The interval between intakes should be at least 6 hours. Do not take more than 3 film-coated tablets (1,200 mg ibuprofen) in a 24-hour period.

Can I take Ibu-Lysin - 1 A Pharma® 400 mg while pregnant or breastfeeding?
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. Do not take ibuprofen if you are in the last 3 months of pregnancy.

What can I do to prevent tension headaches or migraines?
1. Drink enough water: Water is essential for our body and its function - a deficiency can lead to headaches.
2. Balanced diet: Irregular meals encourage headache attacks – make sure you eat regularly and eat enough fruit and vegetables.
3. Relaxation: Cramped muscles can encourage attacks - sport, yoga or relaxation exercises can help.
4. Sleep: Sufficient sleep, a good mattress and ventilation in the bedroom are important factors in preventing headaches.

Mode of action

Active ingredient Ibuprofen-DL-lysine: Fast acting - well tolerated.

Ibuprofen is an active ingredient that has proven itself for a long time and is one of the most commonly used drugs in Germany. And for a good reason. Because ibuprofen works:

• analgesic and
• anti-inflammatory

At the same time, ibuprofen is well tolerated.
In Ibu-Lysin - 1 A Pharma® 400 mg, ibuprofen is present as a salt with the amino acid lysine - as ibuprofen-DL-lysine. The special plus: the effect of ibuprofen sets in even faster. Because in combination with lysine, ibuprofen dissolves quickly in the stomach and is thus absorbed into the body even more quickly.

Exactly what you need when you need quick help with a headache.

Good to know: 1 film-coated tablet contains 400 mg ibuprofen (as ibuprofenDLlysine).

Active substances / ingredients / ingredients

Ibu-lysin 1a Pharma 400 mg film-coated tablets (pack size: 10 pieces) contains:

Ibuprofen DL-lysine 683.47 mg per 1 tablet = Ibuprofen (400 mg per 1 tablet)

Other ingredients: cellulose, microcrystalline, siliconized; copovidone; Carboxymethyl Starch, Sodium Type A; magnesium stearate (vegetable); Polyvinyl alcohol, partially hydrolyzed

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 Ibu-lysin 1a Pharma 400 Mg film-coated tablets (pack size: 10 pieces):

Ibu-lysin 1a Pharma 400 mg film tablets (pack size: 10 pieces) are suitable for use in adults and adolescents from the age of 12 with a body weight of 40 kg or more.

The film-coated tablets should be swallowed whole with water.

For patients who have a sensitive stomach, it is recommended to take Ibu-Lysin - 1 A Pharma® 400 mg during meals. The film-coated tablets are scored on one side. This is only for splitting the tablet if you have trouble swallowing it whole - not for splitting the tablet into equal doses.

The recommended dose is:
Adults and adolescents weighing 40 kg or more (12 years and older):
Single dose: 1 film-coated tablet (equivalent to 400 mg ibuprofen)
Maximum daily dose: max. 3 film-coated tablets (equivalent to 1,200 mg ibuprofen)

The interval between intakes should be at least 6 hours.

Important: The lowest effective dose should be used for the shortest time necessary to relieve symptoms.
If the intake is required for more than 3 days or if the symptoms worsen, you should seek medical advice.
Please also read the package leaflet and ask your doctor or pharmacist.

Revenue

• This medicine is for oral use.
• For patients who have a sensitive stomach, it is recommended to take the preparation during meals.

Patient notes

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before taking this medicine.
  • Side effects can be minimized by using the lowest effective dose needed to control symptoms for the shortest possible time.
  • Safety in the gastrointestinal tract
    • Concomitant use of this with other non-steroidal anti-inflammatory drugs (NSAR), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors), should be avoided.
  • Elderly patients
    • Side effects occur more frequently in elderly patients after the use of NSAR , in particular bleeding and perforations in the gastrointestinal tract, which can be fatal. Therefore, particularly careful medical supervision is required in elderly patients.
  • Bleeding, ulcers and perforations (perforations) in the gastrointestinal tract
    • Gastrointestinal bleeding, ulceration or perforation, including fatal outcome, have been reported during treatment with all NSAR . They occurred with or without prior warning signs or a history of serious gastrointestinal events at any time during therapy.
    • The risk of occurrence of bleeding, ulceration or perforation in the gastrointestinal tract is higher with increasing NSARdose, in patients with a history of ulcers, particularly with complications of bleeding or perforation (see category "Contraindications"), as well as in elderly patients. These patients should start treatment on the lowest dose available. Please speak to your doctor, as in these cases a combination treatment with protective medicines (e.g. misoprostol or proton pump inhibitors) could be considered. This also applies if you are also taking low-dose acetylsalicylic acid or other active substances that are likely to increase the risk of gastrointestinal disorders.
    • If you have had gastrointestinal side effects in the past, particularly if you are elderly, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of therapy, to your doctor.
    • Caution is advised if you are also taking medicines that may increase the risk of ulcers or bleeding, e.g. B. oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, which are used, among other things, to treat depression, or platelet aggregation inhibitors such as ASS (see category "Interactions").
    • If bleeding or ulcers in the gastrointestinal tract occur during treatment with the drug, the treatment must be stopped.
    • NSAR should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as their condition may worsen (see category "Side effects").
  • Effects on the blood vessels of the heart and brain (cardiovascular and cerebrovascular effects)
    • 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 with treatment with this medicine.
    • 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. See the "Side Effects" category".
    • Avoid using this medicine if you have chickenpox (varicella) infection.
  • Infections
    • This 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.
  • Other Notes
    • The 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).
    • Particularly careful medical supervision is required
      • 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
      • if you have impaired kidney or liver function
      • in case of dehydration
      • if you have an infection - see under "Infections".
    • Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed in very rare cases. At the first sign of a hypersensitivity reaction after taking the drug, treatment must be discontinued. Medically necessary measures corresponding to the symptoms must be initiated by competent persons.
    • Ibuprofen can temporarily inhibit blood platelet function (platelet aggregation). Patients with bleeding disorders should therefore be carefully monitored.
    • If you use this medicine for a long time, you need to have your liver values, kidney function and blood count checked regularly.
    • The doctor or dentist should be consulted or informed if the preparation is taken prior to an operation.
    • 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). This risk may be increased by exercise associated with salt loss and dehydration. The habitual use of painkillers should therefore be avoided.
  • Children and young people
    • The medicine must not be used in children under 12 years of age or adolescents weighing less than 40 kg.
    • There is a risk of renal dysfunction in dehydrated adolescents.

• 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 detected while using the drug, the doctor must be informed. Do not take this medicine in the last 3 months of pregnancy. Avoid using this medicine during the first 6 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 (non-steroidal anti-inflammatory drugs) that can affect fertility in women. This effect is reversible (reversible) after stopping the drug.

Hints

Ibu-Lysine – 1 A Pharma® 400 mg film-coated tablets
Active Ingredient: Ibuprofen (as Ibuprofen-DL-Lysine (1:1)). Areas of application: For the short-term symptomatic treatment of headaches and migraine pain.
For use in adults and adolescents from 12 years of age with a body weight of 40 kg or more.
Warning: In case of pain or fever, do not use longer than specified in the leaflet without medical advice!
For risks and side effects, read the leaflet and ask your doctor or pharmacist! Mat. no.: 2/51012833 Status: December 2020
1 A Pharma GmbH, Keltenring 1+3, 82041 Oberhaching

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

Manufacturer: 1 A Pharma GmbH, Keltenring 1+3, 82041 Oberhaching