Ibuprofen Modafen

Leaflet accompanying the packaging: patient information

Ibuprofen Pharmaclan, 400 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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• Adults: If after 3 days for fever or after 4 days for pain there is no improvement or the patient feels worse, they should consult a doctor. Adolescents: If after 3 days there is no improvement or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

1. What is Ibuprofen Pharmaclan and what is it used for

Ibuprofen Pharmaclan contains the active substance ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by reducing pain and fever.

Ibuprofen Pharmaclan is used for the short-term symptomatic treatment of mild to moderate pain, such as toothache, menstrual pain, and headache, and/or for the short-term symptomatic treatment of fever.

Ibuprofen Pharmaclan, 400 mg, coated tablets are indicated for use in adults and adolescents with a body weight of 40 kg (from 12 years of age).

Adults: If symptoms worsen or if fever persists for more than 3 days or pain persists for more than 4 days, a doctor should be consulted.

Adolescents: If symptoms worsen or if fever or pain persists for more than 3 days, a doctor should be consulted.

2. Important information before taking Ibuprofen Pharmaclan

When not to take Ibuprofen Pharmaclan

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had an allergic reaction, such as bronchospasm, asthma, rhinitis, itching, skin rash, or swelling of the face, lips, tongue, or throat (angioedema) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g., NSAIDs).
• if the patient has ever had bleeding or perforation of the stomach or intestines in connection with previous NSAID treatment.
• if the patient currently has an ulcer or bleeding in the stomach or small intestine (duodenum), or if the patient has had two or more such episodes of ulcers or bleeding from the stomach or duodenum (peptic ulcers).
• if the patient has unexplained blood formation disorders.
• if the patient has severe heart failure.
• if the patient has severe liver or kidney failure.
• if the patient is in the last three months of pregnancy.
• if the patient has severe dehydration (e.g., due to vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

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

• if the patient has systemic lupus erythematosus (SLE, an autoimmune disease) or mixed connective tissue disease (an autoimmune disease affecting connective tissue).
• during chickenpox, it is recommended to avoid taking this medicine.
• if the patient has or has had gastrointestinal disorders (ulcerative colitis, Crohn's disease), as their condition may worsen.
• if the patient has certain inherited blood disorders (e.g., acute intermittent porphyria).
• if the patient has liver or kidney function disorders.
• if the patient has undergone major surgery.
• if the patient has an allergy to other substances.
• if the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease due to increased risk of allergic reactions. Allergic reactions can manifest as asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's edema), or hives.
• if the patient is dehydrated.
• if the patient has an infection - see "Infections" below. The risk of side effects increases with increasing dose of the medicine and in elderly patients. Therefore, it is necessary to start treatment with the lowest possible dose and continue treatment for the shortest possible period necessary to alleviate symptoms.

Infections

Ibuprofen Pharmaclan may mask the symptoms of an infection, such as fever and pain. Therefore, it is possible that Ibuprofen Pharmaclan may delay the use of appropriate infection treatment, which may lead to increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox.

If the patient takes this medicine during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor.

Effect on the cardiovascular system

The use of anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.

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

• they have heart disease, including heart failure, angina pectoris (chest pain), or have had a heart attack, bypass surgery, or peripheral arterial disease (poor blood circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including "mini-stroke" or transient ischemic attack, TIA);
• they have high blood pressure, diabetes, high cholesterol, or have a family history of heart disease or stroke, or if they smoke.

Effect on the gastrointestinal tract

Avoid taking Ibuprofen Pharmaclan at the same time as other nonsteroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors).

Gastrointestinal bleeding, ulcers, and perforations:

All NSAIDs have been reported to cause gastrointestinal bleeding, ulcers, and perforations, sometimes fatal. These events can occur at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulcers, and perforations is higher with increasing NSAID dose and is higher in patients with a history of ulcers, especially if complicated by bleeding or perforation (see section 2 "When not to take Ibuprofen Pharmaclan") and in elderly patients. These patients should start treatment with the lowest available dose.

For these patients, as well as patients requiring additional treatment with low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal disorders, concomitant treatment with protective medicines (e.g., misoprostol or proton pump inhibitors) should be considered.

Patients with a history of gastrointestinal side effects, especially the elderly, should consult their doctor if they experience unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.

Caution is advised when taking other medicines that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants (blood thinners) such as warfarin, selective serotonin reuptake inhibitors (used to treat mental disorders, including depression), or antiplatelet agents such as acetylsalicylic acid (see section 2 "Ibuprofen Pharmaclan and other medicines").

Stop treatment and consult a doctor if gastrointestinal bleeding or ulcers occur during treatment with Ibuprofen Pharmaclan.

Skin reactions

Serious skin reactions have been reported with Ibuprofen Pharmaclan. Stop taking Ibuprofen Pharmaclan and seek medical help immediately if the patient experiences a skin rash, mucosal lesions, blisters, or other signs of allergy, as these can be the first signs of a very serious skin reaction. See section 4.

Other warnings

Very rarely, severe, acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. If the patient experiences the first symptoms of a hypersensitivity reaction after taking Ibuprofen Pharmaclan, treatment should be discontinued and a doctor consulted. Medical measures required according to symptoms must be taken by a healthcare professional.

Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with bleeding disorders should be closely monitored.

Long-term use of any pain-relieving medicines for headaches can worsen them. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite (or because of) regular use of pain-relieving medicines.

During long-term use of ibuprofen, regular monitoring of liver, kidney, and blood morphology is required.

In general, habitual use of pain-relieving medicines, especially in combination with several pain-relieving medicines, can lead to permanent kidney damage. This risk may be increased during physical exertion associated with salt and dehydration loss. Therefore, this should be avoided.

Children and adolescents

Dehydrated adolescents are at risk of kidney function disorders.

Ibuprofen Pharmaclan, 400 mg, coated tablets are not intended for adolescents with a body weight below 40 kg and children under 12 years of age.

Ibuprofen Pharmaclan 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 Pharmaclan may affect the action of some other medicines or other medicines may affect its action.

For example:

• anticoagulants and antiplatelet agents (i.e., blood thinners/anti-coagulants, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• medicines to lower high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, or angiotensin II receptor antagonists, such as losartan) and diuretics (used to increase urine production)
• other nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors or acetylsalicylic acid - as they increase the risk of stomach or intestinal ulcers or bleeding
• digoxin (used to treat various heart conditions), as its effect may be enhanced
• lithium (used to treat depression and mania), as its effect may be enhanced
• phenytoin (used to prevent seizures), as its effect may be enhanced
• zydovudine (used to treat HIV/AIDS)
• corticosteroids (used to treat inflammatory conditions), as they may increase the risk of stomach or intestinal ulcers or bleeding
• methotrexate (used to treat certain cancers and autoimmune diseases)
• immunosuppressants, such as cyclosporine and tacrolimus, as kidney damage may occur
• selective serotonin reuptake inhibitors (SSRIs, used to treat depression)
• quinolone antibiotics, such as ciprofloxacin, as the risk of seizures may be increased
• aminoglycosides (a type of antibiotic), as NSAIDs may decrease aminoglycoside elimination
• mifepristone, as NSAIDs may decrease mifepristone's effect
• diuretics (water pills), as the effect of diuretics may be weakened
• potassium-sparing diuretics, as this may lead to hyperkalemia
• probenecid or sulfinpyrazone (used to treat gout), as ibuprofen elimination may be delayed
• cholestyramine (used to lower cholesterol)
• sulfonylureas, such as glibenclamide (used to treat diabetes), as they may affect blood sugar levels
• voriconazole or fluconazole (a type of antifungal medicines) (CYP2C9 inhibitors), as ibuprofen's effect may be enhanced. Consider reducing the ibuprofen dose, especially when taking high doses of ibuprofen with voriconazole or fluconazole.
• Ginkgo biloba (a herbal medicine), as there is an increased risk of bleeding
• ritonavir (an antiviral medicine) may increase NSAID plasma levels
• alcohol, bisphosphonates (used for osteoporosis), or pentoxifylline (used for peripheral arterial disease) may enhance the gastrointestinal side effects and the risk of bleeding and ulcers
• baclofen (a muscle relaxant) due to increased baclofen toxicity
• Other medicines may also affect treatment with Ibuprofen Pharmaclan. Therefore, before taking Ibuprofen Pharmaclan with other medicines, the patient should always consult their doctor or pharmacist.

Ibuprofen Pharmaclan with alcohol

Alcohol should be avoided, as it may enhance the side effects of this medicine, especially those affecting the stomach, intestines, or brain.

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 their doctor before taking this medicine.

Pregnancy

• Ibuprofen should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprofen may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the patient and child and prolong or delay labor.
• During the first 6 months of pregnancy, ibuprofen should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
• From the 20th week of pregnancy, ibuprofen may cause the unborn child's arterial duct to narrow or cause kidney disorders, which can lead to low amniotic fluid levels around the baby (oligohydramnios). If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk in very small amounts and usually does not require breastfeeding to be stopped during short-term use of ibuprofen at the recommended dose for fever and pain.

Fertility

Ibuprofen Pharmaclan may cause difficulty in getting pregnant. The patient should inform their doctor if they plan to get pregnant or are having trouble getting pregnant.

This medicine belongs to a group of medicines (NSAIDs) that may adversely affect female fertility.

This effect is reversible after stopping the medicine.

Driving and using machines

Ibuprofen generally has no or negligible influence on the ability to drive and use machines.

However, as higher doses may cause side effects such as drowsiness and dizziness, the ability to react and participate in traffic or operate machinery may be impaired in individual cases. This is more likely when combined with alcohol.

Ibuprofen Pharmaclan contains sodium

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

3. How to take Ibuprofen Pharmaclan

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

In case of doubt, the patient should consult their doctor or pharmacist.

The patient should take the smallest effective dose for the shortest possible period necessary to alleviate symptoms.

In case of infection, the patient should consult their doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

DOSAGE:

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

The usual dose is 1 tablet (400 mg ibuprofen) 1-3 times a day, as needed. The interval between doses should be at least 6 hours. Do not take more than 3 tablets (1200 mg) in 24 hours.

Duration of treatment:

If it is necessary to take this medicine for more than 3 days in case of fever or for more than 4 days in case of pain in adults, or for more than 3 days in adolescents, or if symptoms worsen, the patient should consult their doctor.

Method of administration

Ibuprofen Pharmaclan is taken orally.

Tablets should be swallowed with a glass of water. Tablets should be swallowed whole, without chewing, crushing, or sucking, to prevent discomfort in the mouth or throat irritation.

Patients with sensitive stomachs are advised to take the tablets with food.

If the medicine is taken shortly after eating, the onset of action of ibuprofen may be delayed.

Elderly patients

Elderly patients should always consult their doctor before taking Ibuprofen Pharmaclan. The patient may be more likely to experience side effects, especially bleeding, ulcers, and perforations of the gastrointestinal tract, which can be fatal.

The doctor will provide the patient with appropriate advice.

Liver or kidney function disorders

If the patient has liver or kidney function disorders, they should consult their doctor before taking Ibuprofen Pharmaclan. This medicine should not be taken in case of severe liver or kidney failure.

Taking a higher dose of Ibuprofen Pharmaclan than recommended

In case of taking a higher dose of Ibuprofen Pharmaclan than recommended or accidental ingestion by children, the patient should always consult their doctor or the nearest hospital for advice on the risk and actions to be taken.

Symptoms may include nausea, abdominal pain, vomiting (which may be bloody), or, less commonly, diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, ringing in the ears, disorientation, and nystagmus (eye movement disorder) may occur, as well as worsening of asthma in asthmatics. At high doses, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), vertigo, weakness, and dizziness have been reported.

Missing a dose of Ibuprofen Pharmaclan

A double dose should not be taken to make up for a missed dose.

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

4. Possible side effects

Like all medicines, Ibuprofen Pharmaclan can cause side effects, although not everybody gets them.

The patient can minimize the risk of side effects by taking the smallest effective dose for the shortest possible period necessary to alleviate symptoms.

Regarding the following side effects, it should be considered that they are largely dose-dependent and vary from patient to patient.

The most commonly observed side effects are gastrointestinal in nature. Gastrointestinal ulcers, perforations, or bleeding may occur, sometimes leading to death, especially in the elderly. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, and dyspepsia have been reported. Less commonly, gastrointestinal bleeding, which can rarely lead to anemia, has been observed.

The use of medicines such as ibuprofen may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke, especially when used in high doses. NSAID use has been reported to cause water retention (edema), high blood pressure, and heart failure.

The list of side effects below includes all side effects that have occurred during long-term treatment with high doses in patients with rheumatism. The frequencies, which exceed very rare reports, refer to short-term use of daily doses up to a maximum of 1200 mg ibuprofen in oral formulations and up to a maximum of 1800 mg in suppositories.

STOP TAKING Ibuprofen Pharmaclan and consult a doctor immediately if the patient experiences any of the following symptoms:

• Symptoms of aseptic meningitis, such as headache, nausea, vomiting, high fever, stiff neck, or impaired consciousness (very rare: may affect up to 1 in 10,000 people). Patients with autoimmune diseases (SLE, mixed connective tissue disease) are more likely to be affected.
• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, blood in the stool (feces/intestinal contents), or black, tarry stools, vomiting blood, or coffee-ground-like vomit (less common: may affect up to 1 in 100 people).
• Symptoms of severe allergic reactions, such as facial swelling, tongue or throat swelling, difficulty breathing, rapid heartbeat, low blood pressure, potentially life-threatening shock (very rare: may affect up to 1 in 10,000 people).
• Severe skin reactions involving the whole body, with blisters on the skin, especially on the legs, arms, hands, and feet, which may also involve the face and mouth (erythema multiforme, Stevens-Johnson syndrome). This can be even more severe, with blisters becoming larger and spreading, and parts of the skin may peel off (Lyell's syndrome) (very rare: may affect up to 1 in 10,000 people). Severe infections with skin destruction (necrotizing fasciitis) may also occur (very rare: may affect up to 1 in 10,000 people).
• A red, scaly, widespread rash with bumps under the skin and blisters, mainly on the skin folds, torso, and upper limbs, with fever at the start of treatment (acute generalized exanthematous pustulosis) (frequency not known: frequency cannot be estimated from the available data). If these symptoms occur, the patient should stop taking Ibuprofen Pharmaclan and consult a doctor immediately. See also section 2.
• Vision loss, blurred, or disturbed vision (visual disturbances) (less common: may affect up to 1 in 100 people).

Other side effects

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

• gastrointestinal symptoms, such as acid reflux, abdominal pain, nausea, diarrhea, vomiting, bloating, and constipation
• mild gastrointestinal bleeding, which can rarely lead to anemia

Less common (may affect up to 1 in 100 people):

• allergic reactions with rash and itching, as well as asthma attacks (likely due to a drop in blood pressure)
• headache
• dizziness or feeling tired
• restlessness and irritability
• feeling drowsy
• sleep disturbances
• feeling dizzy (vertigo)
• various skin rashes
• stomach or intestinal ulcers, potentially with bleeding and perforation (hole in the gastrointestinal tract)
• worsening of ulcerative colitis (inflammation of the colon) and Crohn's disease
• gastritis (inflammation of the stomach lining)
• mouth ulcers (stomatitis)

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

• toxic optic neuropathy
• hearing loss
• ringing in the ears (tinnitus)
• kidney tissue damage (renal papillary necrosis), elevated uric acid levels in the blood, elevated urea levels in the blood

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

• pancreatitis
• esophagitis
• formation of diaphragm-like intestinal strictures
• liver function disorders, liver failure, acute liver inflammation, liver damage, especially with long-term treatment
• unexplained blood formation disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, treatment should be stopped immediately and a doctor consulted. Do not take pain-relieving or antipyretic medicines.
• depression, psychotic reactions
• palpitations (feeling of rapid or forceful heartbeat), heart failure, heart attack
• high blood pressure, blood vessel inflammation
• asthma, bronchospasm, shortness of breath (breathing difficulties)
• hair loss (alopecia)
• edema and cloudy urine (nephrotic syndrome); kidney inflammation (interstitial nephritis), which can lead to acute kidney failure. Decreased urine production, fluid accumulation in the body (edema), and general malaise may be symptoms of kidney disease, even kidney failure. If these symptoms occur or worsen, the patient should stop taking Ibuprofen Pharmaclan and consult a doctor immediately.

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

• a severe skin reaction known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms). Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell).
• feelings of numbness, tingling, or prickling
• optic neuritis
• stuffy nose and runny nose
• skin becomes sensitive to light (photosensitivity reactions).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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, it is possible to gather more information on the safety of this medicine.

5. How to store Ibuprofen Pharmaclan

• The medicine should be kept out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month.
• There are no special storage precautions for this medicine.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Pharmaclan contains

The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.

The other ingredients are: tablet core - microcrystalline cellulose 102, maize starch, povidone K-90, sodium lauryl sulfate, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, tablet coating - hypromellose 2910, hydroxypropylcellulose, macrogol 400, titanium dioxide (E 171).

What Ibuprofen Pharmaclan looks like and contents of the pack

White or almost white, oval, coated tablets with the imprint "I 6" on one side and smooth on the other. The approximate dimensions of the tablet are 13.55 mm x 8.24 mm, and the thickness is 6.00 mm.

Colorless, transparent PVC/Aluminum blister pack in an outer cardboard box containing 10 or 12 tablets in a blister pack.

Package sizes:

10, 12, 20, 24, 30, 40, 48 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and importer

Marketing authorization holder:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Importer:

Pharmazet Group s.r.o.

Třtinová 260/1

196 00 Prague 9

Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic: Ibuprofen Pharmaclan

Estonia:

Ibuprofeno Pharmaclan 400 mg film-coated tablets EFG

Germany:

Ibuprofen Pharmaclan 400 mg film-coated tablets

France:

IBUPROFENE PHARMACLAN 400 mg film-coated tablets

Finland:

Ibuprofen Pharmaclan

Poland:

Ibuprofen Pharmaclan

Date of last revision of the leaflet: