Ibuprofen Lisine Innfarm

Leaflet accompanying the packaging: patient information

Ibuprofen Lysine InnFarm, 200 mg, coated tablets

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact a doctor (applies to adolescents).
• If there is no improvement or the patient feels worse after 3 days in the case of fever and 4 days in the case of pain treatment, they should contact a doctor (applies to adults).

Table of contents of the leaflet

• 1. What is Ibuprofen Lysine InnFarm and what is it 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 packaging and other information

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

This medicine contains ibuprofen lysine, which is the lysine salt of ibuprofen. Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which relieve pain and reduce fever.

Ibuprofen Lysine InnFarm is used for symptomatic treatment of:

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

If there is no improvement or the patient feels worse after 3 days, they should contact a doctor (applies to adolescents).

If there is no improvement or the patient feels worse after 3 days in the case of fever and 4 days in the case of pain treatment, they should contact a doctor (applies to adults).

2. Important information before taking 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 had bronchospasm, asthma, rhinitis, angioedema, or urticaria after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
• If the patient currently has or has had more than two episodes of stomach or duodenal ulcers or bleeding.
• If the patient has ever had gastrointestinal bleeding or perforation when taking NSAIDs.
• If the patient has severe liver, kidney, or heart failure.
• If the patient has bleeding disorders.
• If the patient has any active bleeding (including bleeding in the brain).
• If the patient has undiagnosed blood formation disorders.
• If the patient is severely dehydrated (due to vomiting, diarrhea, or inadequate fluid intake).
• If the patient is in the last three months of pregnancy.
• If the patient is an adolescent with a body weight below 40 kg or is under 12 years old.

Ibuprofen Lysine InnFarm contains soya lecithin

If the patient is allergic to peanuts or soya, they should not take this medicine.

In case of doubt whether any of the above contraindications apply to the patient, they should consult a doctor or pharmacist.

Warnings and precautions

Before taking Ibuprofen Lysine InnFarm, the patient should discuss it with their doctor or pharmacist:

• If the patient has ever had asthma or other allergic diseases, as they may experience bronchospasm.
• If the patient has hay fever, nasal polyps, or chronic respiratory diseases such as obstructive lung disease, as they are at increased risk of allergic reactions. These reactions can manifest as asthma attacks (so-called analgesic asthma), angioedema, or urticaria.
• If the patient has kidney or liver problems.
• If the patient has or has had high blood pressure or heart failure.
• If the patient has or has had stomach or intestinal diseases (including ulcerative colitis or Crohn's disease).
• If the patient has a certain congenital blood formation disorder (e.g., acute intermittent porphyria).
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (these are autoimmune diseases that can cause joint pain, skin changes, and disorders of other organs).
• If the patient has chickenpox - it is recommended to avoid taking Ibuprofen Lysine InnFarm.
• If the patient has an infection - see below, section "Infections",
• If the patient has recently undergone major surgery.
• If the patient is taking other NSAIDs. Taking this medicine together with other NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of side effects and should be avoided (see section "Ibuprofen Lysine InnFarm and other medicines" below).

Taking anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The patient should not exceed the recommended dose and duration of treatment (3 days for adolescents and 3 days for adults in the treatment of fever and 4 days for adults in the treatment of pain).

Before taking Ibuprofen Lysine InnFarm, the patient should discuss their treatment with a doctor or pharmacist if:

• they have heart diseases such as heart failure, angina pectoris (chest pain), have had a heart attack, have had a bypass operation, have peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or have had any stroke (including mini-stroke or transient ischemic attack - TIA).
• they have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or smoke.

During ibuprofen treatment, allergic reactions to this medicine have been reported, including breathing difficulties, face and throat swelling (angioedema), and chest pain. If the patient experiences any of these symptoms, they should stop taking Ibuprofen Lysine InnFarm immediately 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 generalized exanthematous pustulosis (AGEP). The patient should stop taking Ibuprofen Lysine InnFarm and seek medical help immediately if they experience any symptoms associated with severe skin reactions described in section 4.

Side effects can be minimized by using the smallest effective dose for the shortest possible time. Elderly patients are more likely to experience side effects.

Chronic use of multiple types of painkillers can lead to permanent kidney damage and increase the risk of kidney failure. This risk can be exacerbated by physical exertion associated with loss of electrolytes and dehydration. Therefore, chronic use of painkillers should be avoided.

Long-term use of painkillers for headache can paradoxically increase its severity. If this is suspected or confirmed, the patient should seek medical advice and stop treatment. Headache caused by overuse of painkillers (medication-overuse headache) should be suspected in patients who frequently or daily experience headaches despite (or due to) regular use of painkillers.

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

NSAIDs can mask symptoms of infection and fever.

Infections

Ibuprofen Lysine InnFarm may mask symptoms of infection, such as fever and pain. As a result, Ibuprofen Lysine InnFarm may delay the use of appropriate infection treatment and lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine while an infection is present and the infection symptoms persist or worsen, they should consult a doctor immediately.

Children and adolescents

Dehydrated adolescents are at risk of kidney function disorders.

This medicine should not be used in adolescents with a body weight below 40 kg or in children under 12 years old.

Ibuprofen Lysine InnFarm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

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 it may increase the effect of digoxin;
• corticosteroids (medicines containing cortisone or similar substances), as they may increase the risk of gastrointestinal ulcers or bleeding;
• antiplatelet agents, as they may increase the risk of gastrointestinal bleeding;
• low-dose acetylsalicylic acid, as it may reduce the antiplatelet effect;
• anticoagulant medicines (i.e., blood thinners/anti-clotting agents, such as aspirin/acetylsalicylic acid, warfarin, ticlopidine), as ibuprofen may increase the effect of these medicines;
• phenytoin (used in epilepsy), as it may increase the effect of phenytoin;
• selective serotonin reuptake inhibitors (antidepressants), as they may increase the risk of gastrointestinal bleeding;
• lithium salts (medicines used in manic-depressive illness and depression), as they may increase the effect of lithium salts;
• 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 atenolol, angiotensin II receptor antagonists, such as losartan) and diuretics, as ibuprofen may reduce the effect of these medicines, which can increase the risk of kidney damage;
• potassium-sparing diuretics, as they may increase blood potassium levels;
• methotrexate (a medicine used to treat cancer and rheumatic diseases), as it may increase the effect of methotrexate;
• tacrolimus and cyclosporin (immunosuppressive medicines), as they may cause kidney damage;
• mifepristone (a medicine used to induce abortion), as it may reduce the effect of mifepristone;
• zydovudine (a medicine used to treat HIV and AIDS), as taking ibuprofen may increase the risk of bleeding into the joint or bleeding leading to swelling in HIV-infected patients with hemophilia;
• sulfonylurea derivatives (a group of antidiabetic medicines), as interactions are possible;
• quinolones (a group of antibiotics), as they may increase the risk of seizures;
• medicines that inhibit the CYP2C9 enzyme, such as the antifungal medicines voriconazole or fluconazole, as they may increase exposure to ibuprofen;
• a herbal medicine called Ginkgo biloba, as there is a risk of increased bleeding tendency when ibuprofen and Ginkgo biloba are taken together.

Other medicines may also be affected or have an effect on Ibuprofen Lysine InnFarm treatment. Therefore, before taking Ibuprofen Lysine InnFarm with other medicines, the patient should always consult a doctor or pharmacist.

Ibuprofen Lysine InnFarm with food, drink, and alcohol

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

Certain side effects, such as gastrointestinal side effects, are more likely to occur when Ibuprofen Lysine InnFarm is taken with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.

This medicine should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and child and prolong labor. This medicine should not be used during the first six months of pregnancy unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Lysine InnFarm may cause kidney function disorders in the unborn baby if taken for more than a few days. This may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Only a small amount of ibuprofen and its breakdown products pass into breast milk. This medicine can be taken during breastfeeding if used in the recommended dose for the shortest possible time.

Ibuprofen Lysine InnFarm belongs to a group of medicines that may impair female fertility. This effect is reversible after stopping the medicine. Although it is unlikely that Ibuprofen Lysine InnFarm taken occasionally will affect the chances of getting pregnant, if the patient has problems getting pregnant, they should consult a doctor before taking this medicine.

Driving and using machines

This medicine, when taken for a short period and in the recommended doses, has no or negligible influence on the ability to drive and use machines. If symptoms such as fatigue, dizziness, drowsiness, or vision disturbances occur, the patient should not drive or operate machinery. Consuming alcohol increases the risk of these side effects.

Ibuprofen Lysine InnFarm contains sunset yellow FCF (E 110) and crimson lake (E 124)

This medicine contains colorants (E 110 and E 124), which may cause allergic reactions.

Ibuprofen Lysine InnFarm contains glucose

If the doctor has told the patient that they have an intolerance to some sugars, they should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Ibuprofen Lysine InnFarm

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.

This medicine is intended for short-term use only.

The patient should use the smallest effective dose for the shortest possible time necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).

Adults and adolescents with a body weight of 40 kg or more (from 12 years of age):

The patient should take 1 or 2 tablets (200 mg or 400 mg of ibuprofen) with water, up to a maximum of three times a day, as needed. The patient should leave at least 6 hours between doses. The patient should not take more than 6 tablets in any 24-hour period.

If an adult needs to take Ibuprofen Lysine InnFarm for more than 3 days in the case of fever or more than 4 days in the case of pain treatment, or if symptoms worsen despite taking this product, the patient should consult a doctor.

Use in children and adolescents

This medicine should not be used in adolescents with a body weight below 40 kg or in children under 12 years old.

If an adolescent needs to take this medicine for more than 3 days, or if symptoms worsen despite taking this medicine, the patient should consult a doctor.

Tablets should be swallowed whole with water.

The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

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

Taking a higher dose of Ibuprofen Lysine InnFarm than recommended

If the patient has taken a higher dose of Ibuprofen Lysine InnFarm than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get advice on the possible risk to their health and the actions to be taken.

Symptoms of overdose may include nausea, stomach pain, headache, diarrhea, tinnitus, vomiting (which may contain blood), blood in the stool, disorientation, and nystagmus. Anxiety, agitation, drowsiness, disorientation, or coma may also occur. After taking a large dose, drowsiness, excitement, chest pain, palpitations, heart failure, kidney failure, liver damage, cyanosis, and loss of consciousness have been reported. Additionally, prothrombin time/INR may be prolonged, probably due to disorders of circulating clotting factors in the blood. Acute kidney failure and liver damage may occur. In patients with asthma, asthma may worsen. Furthermore, hypotension and decreased respiratory rate may occur.

Missing a dose of Ibuprofen Lysine InnFarm

The patient should not take a double dose to make up for a missed dose.

In case of any further doubts about taking this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects can be minimized by using the smallest effective dose for the shortest possible time necessary to relieve symptoms. Elderly patients taking this medicine are at increased risk of side effects.

Taking medicines like Ibuprofen Lysine InnFarm may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

If the patient experiences any of the following symptoms while taking this medicine, they should stop taking it and seek medical help immediately:

• Presence of blood in the stool.
• Passing black or tarry stools.
• Vomiting blood or coffee ground-like material.

The patient should stop taking the medicine and consult a doctor if they experience:

• Indigestion or heartburn.
• Stomach pain or other abnormal stomach symptoms.

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

• Swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, decreased blood pressure leading to shock [symptoms of a severe allergic reaction] (very rare). These symptoms may occur even after the first dose of this medicine.
• Asthma attacks (which may be accompanied by a decrease in blood pressure), worsening of asthma symptoms, wheezing, or shortness of breath for unknown reasons [symptoms of a severe allergic reaction] (not very common).
• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, mouth ulcers, genital ulcers, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (very rare).
• Widespread rash, high body temperature, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell) [DRESS syndrome] (frequency cannot be estimated from the available data).
• A red, scaly, generalized rash with bumps under the skin and blisters, mainly in skin folds, on the torso, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment [acute generalized exanthematous pustulosis] (frequency cannot be estimated from the available data). See also section 2.
• Severe abdominal pain, often with nausea and vomiting [pancreatitis] (very rare).
• Fever, sore throat, mouth ulcers, flu-like symptoms, increased fatigue, nosebleeds, and bruising [blood formation disorders] (very rare).
• Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome (frequency cannot be estimated from the available data).

The patient should tell their doctor if they experienceany of the following side effects:

Common(may affect up to 1 in 10 people):

• Gastrointestinal symptoms such as heartburn, stomach pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding that may cause anemia in rare cases.

Uncommon(may affect up to 1 in 100 people):

• Stomach or intestinal ulcers, which may bleed or perforate.
• Mouth ulcers, stomach inflammation, worsening of ulcerative colitis or Crohn's disease.
• Central nervous system disorders, such as headache, dizziness, insomnia, restlessness, irritability, or fatigue.
• Visual disturbances.
• Allergic reactions, such as skin rash or itching.
• Various skin changes.

Rare(may affect up to 1 in 1,000 people):

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

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

• Esophageal inflammation, intestinal narrowing.
• Severe skin and soft tissue infections in patients with chickenpox.
• Fluid accumulation in the tissues, especially in patients with high blood pressure or kidney problems, edema, and foamy urine (nephrotic syndrome), interstitial kidney inflammation that may lead to acute kidney failure.
• Psychotic reactions, depression.

Frequency not known:

• Skin sensitivity to light.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Ibuprofen Lysine InnFarm

The medicine should be stored out of sight and reach of children.

Store in a temperature 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 month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Lysine InnFarm contains

• The active substance is ibuprofen. One tablet contains 200 mg of ibuprofen (in the form of 342 mg of ibuprofen lysine salt).
• Other ingredients are: Tablet core:microcrystalline cellulose silanized (containing microcrystalline cellulose and silicon dioxide), copovidone, sodium croscarmellose (E468), silicon dioxide, magnesium stearate (E470b), talc (E553b). Tablet coating:hypromellose (E464), titanium dioxide (E171), polydextrose, talc (E553b), maltodextrin, medium-chain triglycerides, crimson lake (E124), aluminum lake (E124), sunset yellow FCF (E110), aluminum lake (E110), indigo carmine (E132), aluminum lake (E132), sodium carmellose, glucose monohydrate, Mica-based pearlescent pigment, soya lecithin.

What Ibuprofen Lysine InnFarm looks like and contents of the pack

Ibuprofen Lysine InnFarm is a pale pink, film-coated, biconvex, oblong tablet with a score line on one side. The tablet dimensions are approximately 20.0 mm × 8.0 mm.

The tablets are packed in hard, transparent PVC/Aluminum blisters or child-resistant, opaque PVC/Aluminum blisters reinforced with a polyester layer. One blister pack contains 10 tablets.

A carton box containing 1 (10 tablets) or 2 (20 tablets) blister packs and a patient leaflet.

Not all pack sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization 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 authorized 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

Date of last revision of the leaflet:12/2024