Ibuprofen-lysine fairmed healthcare

Package leaflet: Information for the patient

Ibuprofen-Lysin Fairmed Healthcare 200 mg film-coated tablets
Ibuprofen
For adults, adolescents and children with body weight of 20 kg (aged 6 years and above).
Please read carefully all the information in this leaflet 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, so that you can read it again if necessary.
• If you need advice or further information, please contact 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 children and adolescents, or after 3 days of treatment for 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 reduces fever.
Ibuprofen-Lysin Fairmed Healthcare is used for short-term symptomatic treatment of:

• mild to moderate pain, such as headache, menstrual pain, toothache;
• fever.

Ibuprofen-Lysin Fairmed Healthcare is indicated for use in adults, adolescents and children weighing 20 kg or more (aged 6 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 breathlessness, 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 has active or a history of peptic ulcer disease of the stomach/duodenum
  (gastrointestinal ulcers) or bleeding (at least two separate confirmed episodes of ulcers or
  bleeding);

• if the patient has previously experienced gastrointestinal bleeding or perforation related to earlier treatment with NSAIDs;

• if the patient has bleeding in the brain (cerebrovascular haemorrhage) or any other active bleeding;

• if the patient is severely dehydrated (e.g. due to vomiting, diarrhoea 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), or has had a 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 ischaemic attack, "TIA");
the patient has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or is a smoker;
the patient has impaired liver or kidney function. In case of long-term use, monitoring of kidney function, liver parameters and blood counts is necessary.
Generally, habitual use (of several types) of pain-relieving medicines may lead to permanent kidney damage. This risk may increase during physical exertion associated with loss of salts and dehydration (e.g. caused by vomiting, diarrhoea or insufficient fluid intake).
the patient has gastrointestinal disorders or chronic inflammatory bowel disease, such as colitis (ulcerative colitis) or Crohn's disease currently or in the past;
caution should be exercised when taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulant medicines (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants) or antiplatelet medicines (e.g. acetylsalicylic acid);
the patient is taking another medicine from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib), as their 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 or in the past has asthma or any allergic disease, as breathlessness may occur;
the patient has hay fever, nasal polyps or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema or urticaria.
the patient has an infection – see the heading "Infections" below.
Long-term use of any painkillers for headaches may worsen them. If such a situation 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 if used at 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 during treatment. If the patient experiences any of these symptoms, treatment with 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 related to severe skin reactions described in section 4 occur, treatment with Ibuprofen-Lysin Fairmed Healthcare should be stopped 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, particularly 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, or in patients with a history of serious gastrointestinal events. 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 disease, especially if 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, concomitant use of protective medicines (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 medicines that may increase gastrointestinal risk.

Patients who have previously experienced toxic gastrointestinal effects, particularly elderly individuals, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly 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 children and adolescents.
This medicine is not intended for use in children weighing less than 20 kg or under 6 years of age.

Ibuprofen-Lysin Fairmed Healthcare and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
Ibuprofen-Lysin Fairmed Healthcare may affect certain other medicines and vice versa.
For example:
anticoagulant medicines (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 seek medical or pharmaceutical advice 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 affecting the gastrointestinal system or the 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 baby, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Ibuprofen-Lysin Fairmed Healthcare must not be used during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. The drug may cause disturbances in kidney and heart function in the unborn child. It may also affect the tendency to bleed in both mother and child and may result in delivery occurring later or lasting longer than expected.

Ibuprofen-Lysin Fairmed Healthcare should not be used during the first six months of pregnancy unless absolutely necessary and specifically recommended by a doctor. If treatment during this period is necessary, or if the 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 levels of amniotic fluid surrounding the fetus (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If prolonged treatment beyond a few days is required, the doctor may recommend additional monitoring.

Breastfeeding

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

Fertility

This medicine belongs to a group of drugs known as NSAIDs, which may impair female fertility. This effect is reversible upon discontinuation of the drug.

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 related to the central nervous system (such as fatigue and dizziness) may occur, and in individual cases, reaction ability, active participation in road traffic, and operation of machinery may be impaired. This is particularly relevant in cases of concomitant ibuprofen and alcohol use.

Ibuprofen-Lysin Fairmed Healthcare contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to take Ibuprofen-Lysin Fairmed Healthcare

This medicine should always be taken exactly as described in this patient 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 200 mg to 400 mg of ibuprofen (1–2 tablets). If needed, an additional dose of 200 mg to 400 mg of ibuprofen (1–2 tablets) may be taken. The appropriate interval between doses should be determined based on observed symptoms and the maximum recommended daily dose. The interval must not be less than 6 hours. Do not exceed 1200 mg of ibuprofen (6 tablets) within 24 hours.

Use in children
Children: Body weight from 20 kg to 29 kg (aged 6–9 years):
The single dose is 200 mg of ibuprofen (1 tablet). Do not exceed a total daily dose of 600 mg of ibuprofen (3 tablets) within any 24-hour period. The interval between doses must not be less than 6 hours.

Children: Body weight from 30 kg to 39 kg (aged 10–11 years):
The single dose is 200 mg of ibuprofen (1 tablet). Do not exceed a total daily dose of 800 mg of ibuprofen (4 tablets) within any 24-hour period. The interval between doses must not be less than 6 hours.

This medicine is not intended for use in children weighing less than 20 kg or in children under 6 years of age.
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 immediately 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. For individuals with sensitive stomachs, it is recommended to take Ibuprofen-Lysin Fairmed Healthcare with food.

Consult your doctor:

• If in adults, treatment for fever exceeds 3 days or treatment for pain exceeds 4 days, or if symptoms worsen.
• If in children and adolescents, treatment is required for more than 3 days or if symptoms worsen.

Taking more Ibuprofen-Lysin Fairmed Healthcare than recommended
If more tablets than recommended have been taken, or if this medicine has been accidentally ingested by children, contact your doctor or the nearest hospital immediately for advice on potential risks and further management.
Symptoms of overdose may include: nausea, abdominal pain, vomiting (which may contain blood), or, less commonly, diarrhoea. Additionally: headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and nystagmus, as well as worsening of asthma in patients with asthma. With large doses, drowsiness, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, haematuria, hypotension, low blood potassium levels, high blood potassium levels, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold sensation, and breathing difficulties have been reported.

If you forget to take Ibuprofen-Lysin Fairmed Healthcare
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, Ibuprofen-Lysin Fairmed Healthcare can cause adverse effects, although
they do not occur in everyone.
The most commonly observed adverse effects are gastrointestinal. Gastric or duodenal ulcers
(peptic ulcers), perforation or bleeding may occur, sometimes leading to death, especially in elderly
patients (see section 2 "Warnings and precautions"). After taking the medicine, nausea, vomiting,
diarrhoea, flatulence, constipation, gastrointestinal discomfort, abdominal pain, black stools,
haematemesis (vomiting blood), oral and pharyngeal lesions (oral ulceration), exacerbation of
colitis or Crohn's disease may be reported (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.
Treatment with 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 hypotension).
• 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 is necessary to determine whether antimicrobial/antibiotic therapy is indicated.
• Fever, sore throat and oral pain, influenza-like symptoms, fatigue, epistaxis and skin bleeding. These effects may be due to a decrease in the number of white blood cells in the body (agranulocytosis).
• Severe or persistent headache.
• Red, flat, disc-shaped or round skin lesions on the trunk, often with central blisters, skin desquamation, 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 eosinophil count (a type of white blood cell) (DRESS syndrome).
• Red, scaly widespread rash with nodules under the skin and blisters, mainly located in skin folds, on the 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 severe allergic reaction called Kounis syndrome.

Other potential adverse effects

• Common : may affect up to 1 in 10 people

  • Gastrointestinal symptoms such as dyspepsia, 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, oral ulceration, exacerbation of pre-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 1000 people Tinnitus, hearing loss. Flank pain and/or abdominal pain, haematuria and fever may be symptoms of 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 with neck stiffness, headache, nausea, vomiting, fever or disturbances of consciousness has been observed during ibuprofen use. Patients with autoimmune diseases [systemic lupus erythematosus (SLE), mixed connective tissue disease] appear to be predisposed. Blood cell production disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) – initial symptoms include: fever, sore throat,
  superficial oral ulcers, influenza-like symptoms, severe fatigue, epistaxis 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, dyspnoea, tachycardia and hypotension up to life-threatening shock. If any of these symptoms occur, which may happen even after the first dose, immediate medical assistance 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 discolouration), especially with long-term treatment, liver failure, acute hepatitis, liver function abnormalities.
  Reduced urine output compared to usual and oedema (especially in patients with high blood pressure or kidney dysfunction); 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 failure.
  Severe forms of skin reactions, including rash with erythema 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
increase in the risk of myocardial infarction ("heart attack") or stroke (see section 2 "Warnings and
precautions").
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ibuprofen-Lysin Fairmed Healthcare

Keep this medicine out of the 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen-Lysin Fairmed Healthcare contains
The active substance is ibuprofen. Each coated tablet contains 342 mg of ibuprofen lysinate,
corresponding to 200 mg of ibuprofen.

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

Coating:
Polyvinyl alcohol partially hydrolysed
Titanium dioxide (E 171)
Macrogol 4000
Talc

What Ibuprofen-Lysin Fairmed Healthcare looks like and contents of the pack
Ibuprofen-Lysin Fairmed Healthcare 200 mg coated tablets
White or almost white, film-coated, capsule-shaped tablets with an embossed indentation
"S4" on one side and smooth on the other side.
PVDC/PVC/Aluminium foil blisters.
Pack sizes containing 10, 12, 15, 20 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 member states under the following names: