Ibuprofen lysine innfarm

Package leaflet: Information for the patient

Ibuprofen Lysine InnFarm, 200 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 3 days, you should contact your doctor (applies to adolescents).
• If there is no improvement or if your condition worsens after 3 days in the case of fever and after 4 days in the case of pain treatment, you should contact your doctor (applies to adults).

Contents of the leaflet

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

1. What Ibuprofen Lysine InnFarm is and what it is used for

This medicine contains ibuprofen lysinate, which is the lysine salt of ibuprofen. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which relieve pain and reduce fever.
Ibuprofen Lysine InnFarm is used for the symptomatic treatment of:

• mild to moderate pain, such as headache, menstrual pain and toothache,
• fever and pain associated with colds.

If there is no improvement or if your condition worsens after 3 days, you should contact your doctor (applies to adolescents).
If there is no improvement or if your condition worsens after 3 days in the case of fever and after 4 days in the case of pain treatment, you should contact your doctor (applies to adults).

2. Important information before using Ibuprofen Lysine InnFarm

When not to take Ibuprofen Lysine InnFarm:

• If the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever previously experienced asthma, rhinitis, angioedema, or urticaria after taking acetylsalicylic acid or other similar pain-relieving medicines (NSAIDs).
• If the patient currently has (or has had more than twice in the past) gastric or duodenal ulcer or gastrointestinal bleeding.
• If the patient has ever previously experienced gastrointestinal bleeding or perforation related to the use of NSAIDs.
• If the patient has severe liver, kidney, or heart failure.
• If the patient has blood clotting disorders.
• If the patient has any active bleeding (including intracranial bleeding).
• If the patient has undiagnosed blood disorders.
• If the patient is severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake).
• If the patient is in the last 3 months of pregnancy.
• If the patient is an adolescent with body weight below 40 kg or is under 12 years of age.

Ibuprofen Lysine InnFarm contains soya lecithin
If the patient is allergic to peanuts or soya, they should not take this medicine.
If in doubt whether any of the above contraindications apply to the patient,
consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Ibuprofen Lysine InnFarm, discuss this with your doctor
or pharmacist:

• If the patient has or has ever had asthma or other allergic conditions, as breathlessness may occur.
• If the patient suffers from hay fever, nasal polyps, or chronic obstructive respiratory diseases, as such patients have an increased risk of allergic reactions. These may include asthma attacks (so-called analgesic-induced asthma), angioedema (Quincke's oedema), or urticaria.
• If the patient has kidney or liver problems.
• If the patient has or has ever had high blood pressure or heart failure.
• If the patient has or has ever had stomach or intestinal disorders (including ulcerative colitis or Crohn's disease).
• If the patient has certain inherited blood disorders (e.g. acute intermittent porphyria).
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (these are immune system disorders that manifest with joint pain, skin changes, and organ dysfunction).
• If the patient has chickenpox – use of Ibuprofen Lysine InnFarm is not recommended.
• If the patient has an infection – see below, section titled “Infections”,
• If the patient has recently undergone major surgery.
• If the patient is taking other NSAIDs. Concomitant use of this medicine with other NSAIDs, including selective COX-2 inhibitors, increases the risk of adverse effects and should be avoided (see section titled “Ibuprofen Lysine InnFarm and other medicines” below).

Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated
with a small increased risk of heart attack or stroke, particularly when used at high
doses. Do not exceed the recommended dose or duration of treatment (3 days in adolescents and
3 days in adults for fever, and 4 days in adults for pain).
Before using Ibuprofen Lysine InnFarm, the patient should discuss treatment with a doctor
or pharmacist if:

• The patient has heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack – TIA).
• The patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. If the patient experiences any of these symptoms, they should immediately stop taking Ibuprofen Lysine InnFarm and contact a doctor or emergency services.

Severe 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 generalised exanthematous pustulosis (AGEP). Discontinue taking Ibuprofen Lysine InnFarm immediately and seek urgent medical help if any symptoms of severe skin reactions described in section 4 occur.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible time. Elderly individuals are more susceptible to adverse effects.

Regular use of multiple types of painkillers may lead to permanent kidney damage and increase the risk of kidney failure. This risk may be increased by physical exertion associated with electrolyte loss and dehydration. Therefore, avoid habitual use of painkillers.

Long-term use of any painkillers for headache may paradoxically increase headache severity. If this is suspected or confirmed, medical advice should be sought and treatment discontinued. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of headache medications.

If Ibuprofen Lysine InnFarm is used long-term, regular monitoring of liver and kidney function and peripheral blood morphology is necessary.

NSAIDs may mask symptoms of infection and fever.

Infections
Ibuprofen Lysine InnFarm may conceal symptoms of infection such as fever and pain. Therefore,
Ibuprofen Lysine InnFarm may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, they should consult a doctor immediately.

Children and adolescents
Dehydrated adolescents are at risk of impaired kidney function.
Do not use in adolescents with body weight below 40 kg or in children under 12 years of age.

Ibuprofen Lysine InnFarm and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use.
Ibuprofen Lysine InnFarm may affect the action of other medicines or other medicines may affect the action of Ibuprofen Lysine InnFarm. For example:

• Acetylsalicylic acid or other NSAIDs, as they may increase the risk of gastrointestinal ulcers or bleeding;
• Digoxin (used in heart failure), as the effect of digoxin may be intensified;
• Glucocorticoids (medicines containing cortisone or cortisone-like substances), as they may increase the risk of gastrointestinal ulcers or bleeding;
• Antiplatelet medicines, as they may increase the risk of gastrointestinal bleeding;
• Acetylsalicylic acid (in low dose), as the antithrombotic effect may be weakened;
• Anticoagulant medicines (i.e. blood thinners/preventing clot formation, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine), as ibuprofen may enhance the effect of these medicines;
• Phenytoin (used in epilepsy), as the effect of phenytoin may be intensified;
• Selective serotonin reuptake inhibitors (medicines for depression), as they may increase the risk of gastrointestinal bleeding;
• Lithium salts (medicines used in bipolar disorder and depression), as the effect of lithium salts may be intensified;
• Probenecid and sulfinpyrazone derivatives (used in gout), as they may slow down the elimination of ibuprofen;
• Blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan) and diuretics, as ibuprofen may reduce the effectiveness of these medicines, potentially increasing the risk of kidney damage;
• Potassium-sparing diuretics, as they may lead to increased potassium levels in blood;
• Methotrexate (used in treatment of malignant tumours and rheumatic diseases), as the effect of methotrexate may be intensified;
• Tacrolimus and cyclosporine (immunosuppressive medicines), as they may cause kidney damage;
• Mifepristone (used for medical abortion), as the effect of mifepristone may be reduced;
• Zidovudine (used in treatment of HIV and AIDS), as ibuprofen use may increase the risk of joint bleeding or bleeding leading to swelling in HIV-infected patients with haemophilia;
• Sulfonylurea derivatives (antidiabetic medicines), as drug interactions are possible;
• Quinolones (antibiotics), as they may increase the risk of seizures;
• Medicines inhibiting the CYP2C9 enzyme, such as antifungal agents voriconazole or fluconazole, as they may increase exposure to ibuprofen;
• The herbal medicine St. John's wort (Hypericum perforatum), as there is a risk of increased bleeding tendency when ibuprofen and St. John's wort are used together.

Other medicines may also interact with or be affected by Ibuprofen Lysine InnFarm. Therefore, always consult a doctor or pharmacist before using Ibuprofen Lysine InnFarm with other medicines.

Ibuprofen Lysine InnFarm with food, drink, and alcohol
Patients with sensitive stomachs are advised to take Ibuprofen Lysine InnFarm with food.
The risk of certain adverse effects, e.g. gastrointestinal adverse effects, is increased when alcohol is consumed together with Ibuprofen Lysine InnFarm.

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.
Do not take Ibuprofen Lysine InnFarm if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. This medicine may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Do not use Ibuprofen Lysine InnFarm during the first 6 months of pregnancy unless a doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofen Lysine InnFarm may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Only a small amount of ibuprofen and its metabolites pass into breast milk. This medicine may be used during breastfeeding if taken at the recommended dose for the shortest possible time.

Ibuprofen Lysine InnFarm belongs to a group of medicines that may impair female fertility. This effect reverses after discontinuation of the medicine. Although it is unlikely that occasional use of Ibuprofen Lysine InnFarm affects the chances of conception, if the patient has difficulty conceiving, she should consult a doctor before taking this medicine.

Driving and operating machinery
This medicine, when used short-term and at recommended doses, has no effect or a negligible effect on the ability to drive or operate machinery. If symptoms such as fatigue, dizziness, drowsiness, or visual disturbances occur, do not drive or operate machinery. Alcohol consumption increases the risk of these adverse effects.

Ibuprofen Lysine InnFarm contains aluminium lake with sunset yellow (E 110) and aluminium lake with carmine red (E 124)
This medicine contains colourants (E 110 and E 124), which may cause allergic reactions.

Ibuprofen Lysine InnFarm contains glucose
If the doctor has diagnosed the patient with an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

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

3. How to take Ibuprofen Lysine InnFarm

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for short-term use only.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).

Adults and adolescents weighing 40 kg or more (aged 12 years and above):
Take 1 or 2 tablets (200 mg or 400 mg of ibuprofen) with water, up to three times daily as needed. At least 6 hours should elapse between doses. Do not take more than 6 tablets within any 24-hour period.

If treatment with Ibuprofen Lysine InnFarm is required for more than 3 days for fever or more than 4 days for pain in adults, or if symptoms worsen despite using this product, the patient should consult a doctor.

Use in children and adolescents
Do not use in adolescents weighing less than 40 kg or in children under 12 years of age.
If treatment with this medicine is required for more than 3 days in adolescents, or if symptoms worsen despite using this medicine, medical advice should be sought.

Tablets should be swallowed whole with water.
The break line on the tablet is intended only to facilitate breaking the tablet for easier swallowing.

Patients with a sensitive stomach are advised to take Ibuprofen Lysine InnFarm with food.

Overdose of Ibuprofen Lysine InnFarm
If a patient has taken more than the recommended dose of Ibuprofen Lysine InnFarm, or if a child has accidentally ingested the medicine, seek immediate medical advice from a doctor or go to the nearest hospital to assess potential health risks and receive guidance on necessary actions.

Symptoms of overdose may include nausea, abdominal pain, headache, diarrhoea, tinnitus, vomiting (possibly with blood), blood in stool, disorientation, and nystagmus. Psychomotor agitation, drowsiness, disorientation, or coma may also occur. After ingestion of a large dose, drowsiness, restlessness, chest pain, palpitations, renal failure, liver damage, cyanosis (bluish discoloration of skin and mucous membranes), loss of consciousness, seizures, and convulsions (particularly in children) may occur. Increased tendency to bleed, weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may also be observed. Additionally, prothrombin time/INR may be prolonged, likely due to disturbances in circulating coagulation factors. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms is possible. Moreover, low blood pressure and reduced respiratory rate may occur.

Missed dose of Ibuprofen Lysine InnFarm
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 all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Elderly patients taking this medicine are at increased risk of adverse effects.
Use of medicines such as Ibuprofen Lysine InnFarm may be associated with a slightly increased risk of myocardial infarction (heart attack) or stroke.

If any of the following symptoms occur during treatment with this medicine, the patient should stop taking the medicine and seek immediate medical help:

• Detection of blood in the stool.
• Passing black or tarry stools.
• Vomiting blood or black material resembling coffee grounds.

The patient should stop taking the medicine and contact a doctor if any of the following occur:

• Indigestion or heartburn.
• Abdominal pain or other abnormal gastrointestinal symptoms.

If any of the following symptoms occur, the patient must stop taking the medicine
and immediately consult a doctor or go to the nearest hospital emergency department:

• Swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock [symptoms of severe allergic reaction] (very rare). These symptoms may occur even after the first dose of this medicine.
• Asthma attacks (possibly accompanied by low blood pressure), worsening of asthma symptoms, wheezing or unexplained shortness of breath [symptoms of severe allergic reaction] (not common).
• Reddish, flat, round or oval skin lesions, often with blisters in the centre, skin peeling, ulceration of the mouth, throat, nose, genital organs or eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome] (very rare).
• Widespread rash, high fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell) [DRESS syndrome] (frequency cannot be determined from available data).
• Red, scaly, generalised rash with subcutaneous nodules and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment [acute generalised exanthematous pustulosis] (frequency cannot be determined from available data). See also section 2.
• Severe upper abdominal pain, often with nausea and vomiting [pancreatitis] (very rare).
• Fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and subcutaneous haemorrhages [blood cell production disorders] (very rare).
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome (frequency cannot be determined from available data).

The patient should inform the doctor if any of the following adverse effects occur:

Common (may occur in less than 1 in 10 people):

• Gastrointestinal symptoms such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhoea, constipation, and minor gastrointestinal bleeding which may lead to anaemia in exceptional cases.

Uncommon (may occur in less than 1 in 100 people):

• Gastric or intestinal ulcers, which may lead to bleeding or perforation.
• Mucosal inflammation of the oral cavity with ulceration, gastric mucosal inflammation, exacerbation of colitis and Crohn’s disease.
• Central nervous system disorders, such as headache, dizziness, insomnia, psychomotor agitation, irritability or fatigue.
• Visual disturbances.
• Allergic reactions, such as skin rash and itching.
• Various skin changes.

Rare (may occur in less than 1 in 1,000 people):

• Tinnitus (ringing in the ears).
• Kidney damage (papillary necrosis) and increased blood uric acid levels.

Very rare (may occur in less than 1 in 10,000 people):

• Oesophagitis, intestinal stricture.
• Severe skin infections and complications involving subcutaneous tissue in patients with chickenpox.
• Fluid retention, especially in patients with hypertension or kidney problems, oedema, foamy urine (nephrotic syndrome), interstitial nephritis which may lead to acute kidney failure.
• Psychotic reactions, depression.
• Cases of worsening inflammatory conditions due to infection (e.g. necrotising fasciitis) have been reported in association with the use of non-steroidal anti-inflammatory drugs (NSAIDs). If signs or symptoms of infection appear or worsen during ibuprofen treatment, the patient should seek immediate medical advice. It should then be determined whether treatment of the infection / antibiotic therapy is indicated.
• Hypertension, vasculitis, palpitations, heart failure, myocardial infarction.
• Liver function disorders, liver damage (especially with long-term use), liver failure, acute hepatitis.
• Aseptic meningitis (inflammation of the membranes surrounding the brain, presenting with neck stiffness, headache, nausea, vomiting, fever or altered consciousness). Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) may be particularly susceptible.
• Hair loss.

Frequency not known

• Skin becomes sensitive to light.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 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 Lysine InnFarm

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Package and Other Information

What Ibuprofen Lysine InnFarm Contains

• The active substance is ibuprofen. One tablet contains 200 mg of ibuprofen (as 342 mg of ibuprofen lysine salt).
• The other components are:
  Tablet core: microcrystalline cellulose silicon dioxide (containing: microcrystalline cellulose and colloidal anhydrous silica), copovidone, sodium croscarmellose (E468), colloidal anhydrous silica, magnesium stearate (E470b), talc (E553b).
  Tablet coating: hypromellose (E464), titanium dioxide (E171), polydextrose, talc (E553b), maltodextrin, medium-chain triglycerides, carmine red, aluminium lake (E124), orange yellow, aluminium lake (E110), indigo carmine, aluminium lake (E132), sodium carboxymethylcellulose, glucose monohydrate, mica-based pearlescent pigment, soy lecithin.

What Ibuprofen Lysine InnFarm Looks Like and Contents of the Pack
Ibuprofen Lysine InnFarm is in the form of elongated, biconvex, pastel pink, coated tablets, shiny with a score line on one side. The tablet dimensions are approximately 20.0 mm × 8.0 mm.
The coated tablets are packed in hard transparent blister packs made of PVC/Aluminum foil or child-resistant, white opaque blister packs made of PVC/Aluminum foil reinforced with a polyester layer. Each blister pack contains 10 tablets.
A lithographed cardboard box containing 1 (10 tablets) or 2 (20 tablets) blister packs and the package leaflet.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder
INN-FARM d.o.o.
Maleševa ulica 014
1000 Ljubljana
Slovenia
Tel.: +386 70 390 711
Fax: +386 5191 116
e-mail: [email protected]

Importer
ALKALOID-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana – Črnuče
Slovenia
Tel.: +386 1 300 42 90
Fax: +386 1 300 42 91
email: [email protected]

Terapia SA
Str. Fabricii, nr. 124,
Cluj-Napoca, 400632,
Romania
Tel.: +40 (264) 501 500
Fax: +40 (264) 415 097
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
United Kingdom (Northern Ireland): IBUPROFEN LYSINE 342 mg film-coated tablets
Germany: Ibuprofen INN-FARM 200 mg Filmtabletten
Hungary: Dolowill Rapid 342 mg filmtabletta
Poland: Ibuprofen Lysine InnFarm
Romania: PADUDEN Rapid 200 mg comprimate filmate
Slovenia: Ibuprofen INN-FARM 200 mg filmsko obložene tablete
Slovak Republic: IBUPROFEN InnFarm 200 mg
Netherlands: IBUPROFEN InnFarm 200 mg filmomhulde tabletten