Ibuprofen-lysine fairmed healthcare

Package leaflet: Information for the patient

Ibuprofen-Lysin Fairmed Healthcare 400 mg film-coated tablets
Ibuprofen
For adults and adolescents weighing 40 kg or more (aged 12 years and above).
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment in adolescents, or in the treatment of migraine headaches or fever in adults, or after 4 days of treatment for pain in adults, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Ibuprofen-Lysin Fairmed Healthcare is and what it is used for
2. Important information before taking Ibuprofen-Lysin Fairmed Healthcare
3. How to take Ibuprofen-Lysin Fairmed Healthcare
4. Possible side effects
5. How to store Ibuprofen-Lysin Fairmed Healthcare
6. Contents of the pack and other information

1. What Ibuprofen-Lysin Fairmed Healthcare is and what it is used for

Ibuprofen-Lysin Fairmed Healthcare belongs to a group of medicines called NSAIDs and contains ibuprofen.
Ibuprofen relieves pain and fever.
Ibuprofen-Lysin Fairmed Healthcare belongs to a group of medicines called NSAIDs and contains ibuprofen.
Ibuprofen relieves pain and fever.
Ibuprofen-Lysin Fairmed Healthcare is used for short-term symptomatic treatment of:

• mild to moderate pain, such as headache, menstrual pain, toothache;
• acute migraine attacks, with or without aura;
• fever.

Ibuprofen-Lysin Fairmed Healthcare is indicated for use in adults and adolescents
weighing 40 kg or more (aged 12 years and above).

2. Important information before using Ibuprofen-Lysin Fairmed Healthcare

When not to use Ibuprofen-Lysin Fairmed Healthcare

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has experienced an allergic reaction such as shortness of breath, asthma, angioedema, urticaria, or rhinitis after taking acetylsalicylic acid or similar pain-relieving medicines (NSAIDs);
• if the patient has severe liver failure, severe kidney failure, or severe heart failure;
• during the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility");
• if the patient currently has or has a history of active peptic ulcer or gastrointestinal bleeding (at least two distinct confirmed episodes of ulcers or bleeding);
• if the patient has previously experienced gastrointestinal bleeding or perforation related to prior treatment with NSAIDs;
• if the patient has cerebral hemorrhage (brain bleeding) or any other active bleeding;
• if the patient is severely dehydrated (e.g. due to vomiting, diarrhea, or insufficient fluid intake);
• if the patient has unexplained disorders of blood formation;

Warnings and precautions
Before starting treatment with Ibuprofen-Lysin Fairmed Healthcare, consult a doctor or pharmacist if:

• the patient has heart diseases, including heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass grafting, peripheral arterial disease (reduced circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack, "TIA");
• the patient has high blood pressure, diabetes, high cholesterol, history of heart disease or stroke in the family, or is a smoker;
• the patient has impaired liver or kidney function. Long-term use requires monitoring of kidney function, liver parameters, and blood counts.
  Generally, habitual use (of several types) of painkillers may lead to permanent kidney damage. This risk may increase with physical exertion associated with loss of salts and dehydration (e.g. caused by vomiting, diarrhea, or insufficient fluid intake);
• the patient has gastrointestinal disorders or chronic inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, currently or in the past;
• caution is required when taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet drugs (e.g. acetylsalicylic acid);
• the patient is taking another medicine from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib), because concomitant use should be avoided (see section "Ibuprofen-Lysin Fairmed Healthcare with other medicines");
• the patient has mixed connective tissue disease (autoimmune disease) or systemic lupus erythematosus (autoimmune disease);
• the patient has certain inherited blood formation disorders (e.g. acute intermittent porphyria);
• the patient has blood clotting disorders;
• the patient has recently undergone major surgery;
• the patient is dehydrated;
• the patient currently has or has a history of asthma or any allergic disease, because shortness of breath may occur;
• the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, as this increases the risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or urticaria;
• the patient has an infection – see the section "Infections" below.

Prolonged use of any painkillers for headache may worsen the headaches. If this occurs or is suspected, medical advice should be sought and treatment discontinued.

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported. If the patient experiences any of these symptoms, Ibuprofen-Lysin Fairmed Healthcare should be stopped immediately and the patient should contact a doctor or emergency services.

Skin reactions
Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If any of the symptoms associated with severe skin reactions described in section 4 occur, Ibuprofen-Lysin Fairmed Healthcare should be discontinued immediately and medical help should be sought without delay.

The risk of adverse effects is minimized by using the lowest effective dose for the shortest possible time. Elderly patients are at increased risk of adverse effects from NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Unless otherwise directed by a doctor, different painkillers should not be used simultaneously.

For all NSAIDs, potentially fatal gastrointestinal bleeding, ulceration, and perforation have been reported at any time during treatment, with or without warning symptoms, and in patients with serious gastrointestinal events in their history. If gastrointestinal bleeding or ulceration occurs, treatment should be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of peptic ulcer, especially complicated by bleeding or perforation (see section 2 "When not to use Ibuprofen-Lysin Fairmed Healthcare"), and in elderly patients. Such patients should start treatment with the lowest available dose. In these patients, combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered. This also applies to patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk.

Patients who have previously experienced gastrointestinal toxicity, especially elderly individuals, should report any unusual gastrointestinal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment.

Infections
Ibuprofen-Lysin Fairmed Healthcare may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen-Lysin Fairmed Healthcare may delay appropriate treatment of infection, potentially increasing the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections associated with chickenpox. If this medicine is used during an infection and symptoms persist or worsen, medical advice should be sought immediately. Use of this medicine during chickenpox is not recommended.

If any of the above conditions apply to the patient, consult a doctor.

Children and adolescents
There is a risk of kidney function disorders in dehydrated adolescents.
This medicine is not intended for use in adolescents weighing less than 40 kg or in children under 12 years of age.

Ibuprofen-Lysin Fairmed Healthcare with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Ibuprofen-Lysin Fairmed Healthcare may affect certain other medicines and vice versa. For example:

• anticoagulants (i.e. blood-thinning medicines/preventing blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine);
• medicines for lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Other medicines may also affect treatment with Ibuprofen-Lysin Fairmed Healthcare. Therefore, always consult a doctor or pharmacist before using Ibuprofen-Lysin Fairmed Healthcare with other medicines, especially if taking any of the following medicines:

Ibuprofen-Lysin Fairmed Healthcare and alcohol
Alcohol should not be consumed while taking Ibuprofen-Lysin Fairmed Healthcare.
Some adverse effects, such as those related to the gastrointestinal system or central nervous system, may occur more frequently when alcohol is used concomitantly with Ibuprofen-Lysin Fairmed Healthcare.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Ibuprofen-Lysin Fairmed Healthcare should not be used during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The medicine may cause kidney and heart dysfunction in the unborn child. It may also increase the risk of bleeding in both mother and child and may result in delayed or prolonged labour. Ibuprofen-Lysin Fairmed Healthcare should not be used during the first six months of pregnancy unless absolutely necessary and prescribed by a doctor.
If treatment during this period is required, or if a patient is trying to conceive, the lowest effective dose should be used for the shortest possible duration. If Ibuprofen-Lysin Fairmed Healthcare is taken for longer than a few days starting from week 20 of pregnancy, it may cause impaired kidney function in the unborn child, potentially leading to reduced amniotic fluid levels (oligohydramnios) or constriction of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk, but is unlikely to affect the breastfed infant.
Short-term use of this medicine at the recommended dose is permitted during breastfeeding.
Consult a doctor if prolonged use of the medicine is required during breastfeeding.

Fertility
This medicine belongs to a group of medicines called NSAIDs, which may impair female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
Ibuprofen has no effect or has a negligible effect on the ability to drive and operate machinery.
However, at higher doses, adverse effects on the central nervous system (such as fatigue and dizziness) may occur, which in individual cases could impair reaction ability, participation in road traffic, and operation of machinery. This is particularly relevant when ibuprofen is taken concomitantly with alcohol.

Ibuprofen-Lysin Fairmed Healthcare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

3. How to take Ibuprofen-Lysin Fairmed Healthcare

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents with body weight of 40 kg (aged 12 years and above):
The recommended single dose is 400 mg of ibuprofen (1 tablet). If needed, an additional dose of 400 mg ibuprofen (1 tablet) may be taken. The appropriate interval between doses should be determined based on observed symptoms and the maximum recommended daily dose. It should not be shorter than 6 hours. Do not take more than 1200 mg of ibuprofen (3 tablets) within 24 hours.
Use in children and adolescents
This medicine is not intended for use in children under 12 years of age or in adolescents with body weight below 40 kg.
This medicine is intended for short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, consult your doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
Method of administration
Ibuprofen-Lysin Fairmed Healthcare is intended for oral use. Tablets should be swallowed whole with a glass of water. In patients with sensitive stomach, it is recommended to take Ibuprofen-Lysin Fairmed Healthcare with food.
Consult your doctor:

• If in adults, treatment of migraine headaches or fever is required for more than 3 days, or if pain treatment is needed for longer than 4 days, or if symptoms worsen.
• If in adolescents aged 12 to 17 years, treatment is required for longer than 3 days, or if symptoms worsen.

Taking more than the recommended dose of Ibuprofen-Lysin Fairmed Healthcare
If more tablets than recommended are taken, or if this medicine is accidentally ingested by children, contact your doctor or nearest hospital immediately for advice on potential risks and further management.
Symptoms of overdose may include: nausea, abdominal pain, vomiting (possibly with blood), or, less commonly, diarrhea. Additionally: headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and nystagmus, as well as worsening of asthma in patients with asthma. Following large doses, symptoms such as drowsiness, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood pressure, decreased blood potassium levels, increased blood potassium levels, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, feeling of coldness, and breathing difficulties have been reported.
Missing a dose of Ibuprofen-Lysin Fairmed Healthcare
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Ibuprofen-Lysin Fairmed Healthcare can cause adverse reactions, although
they do not occur in everyone.
The most commonly observed adverse reactions are gastrointestinal. Gastric or duodenal ulcers (peptic ulcers), perforation or bleeding may occur, sometimes leading to death, particularly in elderly patients (see section 2 "Warnings and precautions"). Nausea, vomiting, diarrhoea, flatulence, constipation, gastrointestinal discomfort, abdominal pain, melaena, haematemesis, lesions (ulceration) in the oral cavity and throat (ulcerative stomatitis), exacerbation of colitis and Crohn's disease have been reported after taking the medicine (see section 2 "Warnings and precautions"). Less frequently, gastritis has been observed. The risk of gastrointestinal bleeding especially depends on the dose and duration of treatment.
The use of Ibuprofen-Lysin Fairmed Healthcare should be discontinued and immediate
medical advice sought if any of the following symptoms occur in the patient:
Uncommon : may affect up to 1 in 100 people

• Severe abdominal pain, especially when the patient starts taking Ibuprofen-Lysin Fairmed Healthcare.
• Black stools, bloody diarrhoea or haematemesis.
• Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with a drop in blood pressure).
• Visual disturbances.

Very rare : may affect up to 1 in 10,000 people

• Worsening of infection-related inflammation (e.g. development of necrotizing fasciitis). If symptoms of infection occur or worsen during treatment with Ibuprofen-Lysin Fairmed Healthcare, immediate medical attention is required. It must be determined whether antimicrobial/antibiotic therapy is indicated.
• Fever, sore throat and oral symptoms, influenza-like symptoms, fatigue, nosebleeds and skin bleeding. These effects may be due to a reduction in the number of white blood cells in the body (agranulocytosis).
• Severe or persistent headache.
• Red, non-elevated, target-shaped or round skin lesions on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin reactions may be preceded by fever and influenza-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

Frequency not known : frequency cannot be estimated from the available data

• Widespread skin rash, high fever, swollen lymph nodes and increased number of eosinophils (a type of white blood cells) (DRESS syndrome).
• Red, scaly widespread rash with nodules under the skin and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever. These symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome.

Other potential adverse reactions

• Common : may affect up to 1 in 10 people
  • Gastrointestinal symptoms such as heartburn, abdominal pain and nausea, diarrhoea, vomiting, flatulence and constipation.
  • Minor gastrointestinal bleeding, which in exceptional cases may lead to anaemia.
• Uncommon : may affect up to 1 in 100 people Peptic ulceration of the gastrointestinal tract, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of existing intestinal disease (colitis or Crohn's disease), gastritis. Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue.
• Rare : may affect up to 1 in 1,000 people Tinnitus, hearing loss. Flank pain and/or abdominal pain, blood in urine and fever may indicate kidney damage (papillary necrosis). Increased blood uric acid levels, increased blood urea levels.
• Very rare : may affect up to 1 in 10,000 people Aseptic meningitis symptoms such as neck stiffness, headache, nausea, vomiting, fever or disturbances of consciousness have been observed during ibuprofen use. Patients with autoimmune diseases [systemic lupus erythematosus (SLE), mixed connective tissue disease] appear to be predisposed. Blood cell formation disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) – initial symptoms include: fever, sore throat, superficial oral ulcers, influenza-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, treatment must be immediately discontinued and medical advice sought. Do not self-medicate with analgesics or antipyretics.

Severe systemic allergic reaction (hypersensitivity reactions) – symptoms may include: facial, tongue and throat swelling, shortness of breath, rapid heartbeat and drop in blood pressure up to life-threatening shock. If any of these symptoms occur, which may happen even after the first dose, immediate medical attention is required.
Psychotic reactions, depression.
With the use of high doses of NSAIDs, palpitations, heart failure, myocardial infarction, oedema, hypertension and circulatory failure have been reported.
Hypertension, vasculitis.
Asthma, dyspnoea, bronchospasm.
Oesophagitis, pancreatitis, formation of membrane-like intestinal strictures.
Liver damage (initial symptoms may include skin discoloration), especially in cases of long-term treatment, liver failure, acute hepatitis, liver function disorders.
Reduced urine output compared to normal and oedema (especially in patients with high blood pressure or kidney function disorders); oedema and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms or general malaise occur, treatment with Ibuprofen-Lysin Fairmed Healthcare should be discontinued and immediate medical advice sought, as these may be the first signs of kidney damage or kidney failure.
Severe skin reactions, including rash with redness and blister formation, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), hair loss (alopecia).
In exceptional cases during chickenpox, severe skin and soft tissue infections may occur.

• Frequency not known : frequency cannot be estimated from the available data Photosensitivity.

The use of medicines such as Ibuprofen-Lysin Fairmed Healthcare may be associated with a small
increased risk of myocardial infarction ("heart attack") or stroke (see section 2 "Warnings and precautions").
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Ibuprofen-Lysin Fairmed Healthcare

Keep this medicine out of sight and reach of children.
Do not use Ibuprofen-Lysin Fairmed Healthcare after the expiry date stated on the carton and blisters after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Ibuprofen-Lysin Fairmed Healthcare contains
The active substance is ibuprofen. Each coated tablet contains 684 mg of ibuprofen lysinate,
corresponding to 400 mg of ibuprofen.

• Other ingredients are:
  Tablet core: Microcrystalline cellulose, Povidone K30, Sodium carboxymethyl starch (type A), Colloidal anhydrous silica, Magnesium stearate

Coating:
Partially hydrolysed polyvinyl alcohol
Titanium dioxide (E 171)
Macrogol 4000
Talc

What Ibuprofen-Lysin Fairmed Healthcare looks like and contents of the pack
Ibuprofen-Lysin Fairmed Healthcare 400 mg coated tablets
White or almost white, capsule-shaped coated tablets with an embossed mark
“S5” on one side and a smooth surface on the other.
Blister packs made of PVDC/PVC/Aluminium.
Packaging containing 10 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fairmed Healthcare GmbH
Dorotheenstrasse 48
22301 Hamburg
Germany
[email protected]

Manufacturer
Fairmed Healthcare GmbH
Maria-Goeppert-Strasse 3
23562 Luebeck
Germany

This medicinal product is authorised in the European Economic Area countries under the following names: