Ibuprofen Modafen

Leaflet accompanying the packaging: patient information

Ibuprofen MODAFEN, 600 mg, coated tablets

Ibuprofen

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Ibuprofen MODAFEN contains the active substance ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen MODAFEN is used for the symptomatic treatment of pain and inflammation in joint diseases (e.g., rheumatoid arthritis), degenerative joint diseases (e.g., osteoarthritis), and painful swellings and inflammation after soft tissue injuries.
Ibuprofen MODAFEN, 600 mg, coated tablets are indicated for use in adults and adolescents with a body weight of 50 kg or more (from 15 years of age).

2. Important information before taking Ibuprofen MODAFEN

When not to take Ibuprofen MODAFEN:

• 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 after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), such as bronchospasm, asthma, rhinitis, itching rash, or swelling of the lips, face, tongue, or throat (angioedema).
• if the patient has ever had bleeding or perforation of the stomach related to 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 in the stomach or duodenum (peptic ulcers).
• if the patient has unexplained blood 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 MODAFEN, discuss with your pharmacist or doctor:

• if the patient has systemic lupus erythematosus (SLE, an autoimmune disease) or mixed connective tissue disease (an autoimmune disease).
• 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 dysfunction.
• if the patient has undergone major surgery.
• if the patient has hypersensitivity (allergy) to other substances.
• if the patient has hay fever, nasal polyps, or chronic obstructive pulmonary disease, due to an 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 doses 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 MODAFEN may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Ibuprofen MODAFEN may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in the course of pneumonia caused by bacteria and bacterial skin infections associated with chickenpox.
If the patient is taking this medicine during an infection, and the symptoms of the infection persist or worsen, they should consult a doctor immediately.

Effect on the cardiovascular system

The use of anti-inflammatory/pain-relieving medicines, such as ibuprofen, may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke, especially if they are used in high doses. Do not exceed the recommended dose or duration of treatment.
Before taking Ibuprofen MODAFEN, the patient should discuss their treatment with a doctor or pharmacist if:

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

Effect on the gastrointestinal tract

It is recommended to avoid taking Ibuprofen MODAFEN with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors).
Gastrointestinal bleeding, ulcers, and perforations:
With the use of all NSAIDs, gastrointestinal bleeding, ulcers, and perforations have been reported, sometimes fatal. They occurred at any time during treatment, with or without prior warning symptoms or serious gastrointestinal events in the medical history.
The risk of gastrointestinal bleeding, ulcers, and perforations is higher with increasing doses of NSAIDs and is higher in patients with a history of ulcers, especially with complications such as bleeding or perforation (see section 2 "When not to take Ibuprofen MODAFEN") 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 who have had gastrointestinal side effects in the past - especially the elderly - should consult a doctor if they experience unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment.
Care should be taken 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 MODAFEN and other medicines").
Treatment should be discontinued and a doctor consulted if gastrointestinal bleeding or ulcers occur during treatment with Ibuprofen MODAFEN.

Skin reactions

Serious skin reactions have been reported with the use of Ibuprofen MODAFEN. The patient should stop taking Ibuprofen MODAFEN and seek medical help immediately if they experience a skin rash, changes in the mucous membranes, blisters, or other signs of an allergic reaction, as these may be the first signs of a very serious skin reaction. See section 4.
Other warnings
Very rare, 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 MODAFEN, treatment should be discontinued and a doctor consulted. Medical measures required according to the 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 may 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 who experience frequent or daily headaches despite (or due to) 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 loss and dehydration. Therefore, this should be avoided.

Children and adolescents

Dehydrated adolescents are at risk of kidney dysfunction.
Ibuprofen MODAFEN, 600 mg, coated tablets are not intended for adolescents with a body weight below 50 kg or children and adolescents under 15 years of age.

Ibuprofen MODAFEN 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 MODAFEN may affect the action of some other medicines or other medicines may affect its action.
For example:

• anticoagulant and antiplatelet medicines (i.e., blood thinners/anti-coagulants, such as 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 non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors or acetylsalicylic acid - as they increase the risk of stomach ulcers or bleeding
• digoxin (used to treat various heart conditions), as its action may be enhanced. Monitoring of digoxin serum levels is recommended.
• lithium (used to treat depression and mania), as its action may be enhanced. Monitoring of lithium serum levels is necessary.
• phenytoin (used to prevent seizures), as its action may be enhanced. Monitoring of phenytoin serum levels is recommended.
• zydovudine (used to treat HIV/AIDS)
• corticosteroids (used to treat inflammatory conditions), as they may increase the risk of stomach ulcers or bleeding
• methotrexate (used to treat certain cancers and autoimmune diseases)
• medicines known as immunosuppressants, such as cyclosporine and tacrolimus, as kidney damage may occur
• medicines known as 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 the excretion of aminoglycosides
• mifepristone, as NSAIDs may decrease the action of mifepristone
• diuretics (water pills), as the action of diuretics may be weakened
• potassium-sparing diuretics, as this may lead to hyperkalemia
• probenecid or sulfinpyrazone (used to treat gout), as the excretion of ibuprofen may be delayed
• cholestyramine (used to lower cholesterol levels)
• medicines known as sulfonylureas, such as glibenclamide (used to treat diabetes), as they may affect blood sugar levels
• voriconazole or fluconazole (a type of antifungal medicine) (CYP2C9 inhibitors), as the action of ibuprofen may be enhanced. Consideration should be given to reducing the dose of ibuprofen, especially when using 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 the level of NSAIDs in the blood
• alcohol, bisphosphonates (used in osteoporosis), or pentoxifylline (used in peripheral arterial disease) may enhance the side effects on the gastrointestinal tract and the risk of bleeding and ulcers
• baclofen (a muscle relaxant) due to increased toxicity of baclofen

Ibuprofen MODAFEN may affect the action of some other medicines or other medicines may affect its action. Therefore, before taking Ibuprofen MODAFEN with other medicines, the patient should always consult a doctor or pharmacist.

Ibuprofen MODAFEN with alcohol

The patient should avoid consuming alcohol, 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 child, they should consult a 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 problems in the unborn child. It may also increase the risk of bleeding in the patient and child and prolong 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 to have a narrowed blood vessel (ductus arteriosus) in the heart or kidney problems, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for a longer period than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in very small amounts and usually does not require stopping breastfeeding during short-term use of ibuprofen in the recommended dose for fever and pain. However, if long-term treatment or higher doses are recommended, breastfeeding should be discontinued.
Fertility
Ibuprofen MODAFEN 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 have a negative effect on female fertility. This effect is temporary and reverses after stopping the medicine.

Driving and using machines

Ibuprofen usually has no or negligible influence on the ability to drive and use machines. However, as higher doses may cause side effects from the central nervous system, such as fatigue 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 MODAFEN contains sodium

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

3. How to take Ibuprofen MODAFEN

This medicine should always be taken as directed by the doctor. In case of doubt, consult a pharmacist or doctor.
The patient should take the smallest effective dose for the shortest possible period necessary to alleviate symptoms. In case of infection, they should consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
DOSAGE:
The maximum single dose should not exceed 600 mg of ibuprofen for adults and adolescents with a body weight of 50 kg or more (from 15 years of age).

Adults:

The recommended daily dose is 1200 mg-1800 mg in divided doses. There should be at least a 6-hour interval between doses. The doctor may recommend lower doses. Depending on the nature and severity of the patient's condition, the doctor may decide to increase the dose of the medicine to one 600 mg tablet, taken 4 times a day. The maximum daily dose should not exceed 2400 mg within 24 hours.

Adolescents with a body weight of 50 kg or more (from 15 years of age):

The recommended daily dose is 20 mg/kg body weight to a maximum of 40 mg/kg body weight, divided into 3-4 partial doses. There should be at least a 6-hour interval between doses. The maximum total daily dose should not exceed 2400 mg within 24 hours.
Use in children and adolescents
The dose of ibuprofen in adolescents depends on the patient's age and body weight.
Ibuprofen MODAFEN, 600 mg, coated tablets are not intended for adolescents with a body weight below 50 kg or children and adolescents under 15 years of age.
Elderly patients
Elderly patients should always consult a doctor before taking Ibuprofen MODAFEN. Elderly patients will be more prone to side effects, especially bleeding, ulcers, and perforation of the gastrointestinal tract, which can be fatal. The doctor will provide the patient with appropriate advice.
Reduced liver or kidney function
In case of reduced kidney or liver function, the patient should always consult a doctor before taking Ibuprofen MODAFEN. This medicine should not be taken if there is severe liver or kidney failure.
Method of administration
Ibuprofen MODAFEN is taken orally.
Tablets should be swallowed with a glass of water. Tablets should be swallowed whole, without chewing, crushing, breaking, 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.
Duration of treatment:
The duration of treatment is determined by the doctor.
In the case of rheumatic diseases, it may be necessary to take Ibuprofen MODAFEN for a longer period.

Taking a higher dose of Ibuprofen MODAFEN than recommended

In case of taking a higher dose of Ibuprofen MODAFEN than recommended or accidental ingestion by children, the patient should always consult a 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 often, diarrhea. Additionally, there may be headache, gastrointestinal bleeding, blurred vision, ringing in the ears, disorientation, and nystagmus, 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 of labyrinthine origin, weakness, and vertigo have been reported.

Missing a dose of Ibuprofen MODAFEN

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 a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen MODAFEN 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 common side effects are gastrointestinal in nature. Stomach ulcers, perforation, or gastrointestinal bleeding may occur, sometimes leading to death, especially in elderly patients. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, vomiting blood, oral ulceration, exacerbation of ulcerative colitis, and Crohn's disease have been reported. Less often, gastric mucosal inflammation has been observed.

Effect on the cardiovascular system

The use of medicines such as ibuprofen may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. With the use of NSAIDs, fluid retention (edema), high blood pressure, and heart failure have been reported.

Other side effects

The patient should STOP TAKING Ibuprofen MODAFEN and consult a doctor immediately if they experience any of the following symptoms:

• Symptoms of aseptic meningitis, such as headache, nausea, vomiting, high temperature, stiff neck, or changes in 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 with dark particles resembling coffee grounds (uncommon: may affect up to 1 in 100 people).
• Symptoms of severe allergic reactions, such as swelling of the face, tongue, or throat, 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 with blisters on the skin, especially on the legs, arms, hands, and feet, which can also affect 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 tissue destruction (necrotizing fasciitis) (very rare: may affect up to 1 in 10,000 people) may also occur.
• 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 beginning 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 MODAFEN and consult a doctor immediately. See also section 2.
• Vision loss, blurred, or disturbed vision (visual disturbances) (uncommon: may affect up to 1 in 100 people).

Other side effects

Very common (may affect more than 1 in 10 people):

• gastrointestinal symptoms, such as reflux, abdominal pain, nausea, diarrhea, vomiting, gas (bloating), and constipation
• mild gastrointestinal bleeding, which in exceptional cases may cause anemia

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

• headache
• dizziness or feeling tired
• irritability and restlessness
• drowsiness
• sleep disturbances
• vertigo (labyrinthine vertigo)
• stomach or intestinal ulcers, potentially with bleeding and perforation (a hole in the gastrointestinal tract)
• worsening of ulcerative colitis (inflammation of the colon) and Crohn's disease
• gastric mucosal inflammation
• oral mucosal inflammation with ulcers (ulcerative stomatitis)

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

• hypersensitivity reactions with rash and itching, as well as asthma attacks (possibly with a drop in blood pressure)
• various skin rashes
• edema and cloudy urine (nephrotic syndrome); kidney disease (interstitial nephritis), which can lead to acute kidney failure. Decreased urine output, fluid accumulation in the body (edema), and general malaise may be symptoms of kidney disease, and even kidney failure. If these symptoms occur or worsen, the patient should stop taking Ibuprofen MODAFEN and consult a doctor immediately.

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 diaphragmatic strictures in the intestine
• liver dysfunction, liver failure, acute liver inflammation, liver damage, especially with long-term treatment
• unexplained blood 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 discontinued and a doctor consulted immediately. The patient should 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 (difficulty breathing)
• hair loss (alopecia)

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

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

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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, more information can be collected on the safety of this medicine.

5. How to store Ibuprofen MODAFEN

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging and blister after: EXP. The expiry date refers to the last day of the month stated.
• There are no special precautions for storing the medicine.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen MODAFEN contains

The active substance of the medicine is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
The other ingredients are: tablet core - microcrystalline cellulose 102, maize starch paste, 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 MODAFEN looks like and contents of the pack

White or almost white, coated tablets in the shape of a capsule with the imprint "I 7" on one side and smooth on the other. The approximate dimensions of the tablet are 17.19 mm x 9.23 mm, thickness 6.60 mm.
Colorless, transparent blister pack made of PVC/Aluminum in an outer cardboard box containing 10 or 12 tablets in a blister pack.
Pack sizes:
20, 24, 30, 40, 50, 100 tablets.
Not all pack 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 STADA 600 mg coated tablets
Spain:
Ibuprofeno Pharmaclan 600 mg film-coated tablets EFG
Germany:
Ibuprofen AL 600 mg film-coated tablets
France:
IBUPROFENE EG LABO 600 mg, film-coated tablet
Finland:
Ibuprofen Pharmaclan
Poland:
Ibuprofen MODAFEN

Date of last revision of the leaflet: 04/2025