Ibuprofen modafen: detailed information

Package leaflet: Information for the patient

Ibuprofen MODAFEN, 600 mg, coated tablets
Ibuprofenum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Ibuprofen MODAFEN is and what it is used for
Important information before taking Ibuprofen MODAFEN
How to take Ibuprofen MODAFEN
Possible side effects
How to store Ibuprofen MODAFEN
Contents of the pack and other information

1. What Ibuprofen MODAFEN is and what it is 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 symptomatic treatment of pain and inflammation in joint diseases (e.g. rheumatoid arthritis), degenerative joint conditions (e.g. osteoarthritis), and painful swelling and inflammation following soft tissue injuries.
Ibuprofen MODAFEN, 600 mg, coated tablets are indicated for use in adults and adolescents with body weight of 50 kg (aged 15 years and above).

2. Important information before using Ibuprofen MODAFEN

When not to use Ibuprofen MODAFEN:

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 experienced an allergic reaction after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), such as bronchospasm, asthma, rhinitis, itchy skin rash, or swelling of the lips, face, tongue or throat (angioedema).
if the patient has ever experienced gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
if the patient currently has a stomach or small intestine (duodenal) ulcer or bleeding, or if the patient has had two or more episodes of stomach or duodenal ulcers or bleeding in the past (peptic ulcers).
if the patient has unexplained blood formation disorders.
if the patient has severe heart failure.
if the patient has severe liver or severe kidney failure.
if the patient is in the last three months of pregnancy.
if the patient has severe dehydration (e.g. caused by vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions
Before using Ibuprofen MODAFEN, discuss this 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, use of this medicine should be avoided.
if the patient has or has ever had gastrointestinal disorders (ulcerative colitis, Crohn's disease), as the patient's condition may worsen.
if the patient has certain inherited blood formation disorders (e.g. acute intermittent porphyria).
if the patient has impaired liver or kidney function.
if the patient has recently undergone major surgery.
if the patient has hypersensitivity (allergy) to other substances.
if the patient has hay fever, nasal polyps or chronic obstructive respiratory disease due to increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), sudden swelling (Quincke's oedema) or urticaria.
if the patient is dehydrated.
if the patient has an infection – see section “Infections” below.

The risk of adverse effects increases with higher doses of the medicine and in elderly patients. Therefore, treatment should be initiated at the lowest possible dose and continued for the shortest duration necessary to relieve symptoms.
Infections
Ibuprofen MODAFEN may mask symptoms of infection such as fever and pain. Therefore, treatment with Ibuprofen MODAFEN may delay appropriate treatment of infection, potentially increasing 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 infection and symptoms persist or worsen, medical advice should be sought immediately.
Effect on the cardiovascular system
Use of anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction (heart attack) or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before starting Ibuprofen MODAFEN, the patient should discuss treatment with a doctor or pharmacist if:

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

Effect on the gastrointestinal tract
Avoid concomitant use of Ibuprofen MODAFEN with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (cyclooxygenase-2 inhibitors).
Gastrointestinal bleeding, ulcers and perforations:
Gastrointestinal bleeding, ulcers and perforations have been reported with all NSAIDs, sometimes resulting in death. These events may occur at any time during treatment, with or without warning symptoms or previous serious gastrointestinal events in history.
The risk of gastrointestinal bleeding, ulceration and perforation is greater with increasing NSAID doses and in patients with a history of ulcers, particularly those complicated by bleeding or perforation (see section 2 “When not to use Ibuprofen MODAFEN”) and in elderly patients. These patients should start treatment at the lowest available dose. In such patients, and in patients requiring additional treatment with low-dose 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 adverse effects – especially elderly patients – should contact their doctor if they experience unusual abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning 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 psychiatric disorders, including depression) or antiplatelet agents such as acetylsalicylic acid (see section 2 “Ibuprofen MODAFEN with other medicines”).
Treatment should be discontinued and medical advice sought if gastrointestinal bleeding or ulceration occurs during treatment with Ibuprofen MODAFEN.
Skin reactions
Serious skin reactions have been reported with the use of Ibuprofen MODAFEN. Treatment should be stopped and immediate medical help sought if the patient develops a skin rash, mucosal lesions, blisters or other allergic symptoms, as these may be early 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 first signs of a hypersensitivity reaction occur after taking Ibuprofen MODAFEN, treatment must be stopped and medical advice sought. Medical personnel must take appropriate measures according to symptoms.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with bleeding disorders should be closely monitored.
Long-term use of any analgesic for headache may worsen headaches. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication-overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) regular use of analgesics.
During long-term ibuprofen use, regular monitoring of liver and kidney function and blood morphology is required.
Generally, habitual use of analgesics, especially in combination with multiple analgesics, may lead to permanent kidney damage. This risk may be increased during physical exertion associated with loss of salts and dehydration. Therefore, this should be avoided.
Children and adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.
Ibuprofen MODAFEN 600 mg, coated tablets is not intended for adolescents weighing less than 50 kg or for children and adolescents under 15 years of age.
Ibuprofen MODAFEN with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, and any medicines the patient plans to take. Ibuprofen MODAFEN may affect the action of certain other medicines or other medicines may affect its action. For example:

anticoagulants and antiplatelet agents (i.e. blood thinners/anti-clotting agents, 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 output)
other non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 inhibitors or acetylsalicylic acid – because they increase the risk of gastrointestinal ulcers or bleeding
digoxin (used to treat various heart conditions), as digoxin's effect may be enhanced. Monitoring of digoxin serum concentration is recommended.
lithium (used to treat depression and mania), as lithium's effect may be enhanced. Monitoring of lithium serum concentration is necessary.
phenytoin (used to prevent epileptic seizures), as phenytoin's effect may be enhanced. Monitoring of phenytoin serum concentration is recommended.
zidovudine (used to treat HIV/AIDS)
glucocorticosteroids (used to treat inflammatory conditions), as they may increase the risk of gastrointestinal 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 reduce aminoglycoside excretion
mifepristone, as NSAIDs may reduce mifepristone's effect
diuretics (water tablets), as diuretic effect may be weakened
potassium-sparing diuretics, as this may lead to hyperkalaemia
probenecid or sulfinpyrazone (used to treat gout), as ibuprofen excretion 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 ibuprofen's effect may be enhanced. Consideration should be given to reducing the ibuprofen dose, especially when high doses of ibuprofen are used with voriconazole or fluconazole.
ginkgo biloba (herbal medicine), as there is an increased risk of bleeding
ritonavir (an antiviral medicine) may increase NSAID plasma concentration
alcohol, bisphosphonates (used in osteoporosis) or pentoxifylline (used in peripheral arterial circulation disorders) may exacerbate gastrointestinal adverse effects and increase the risk of bleeding and ulcers
baclofen (a muscle relaxant) due to increased baclofen toxicity

Ibuprofen MODAFEN may affect the action of certain other medicines or other medicines may affect its action. Therefore, always consult a doctor or pharmacist before using Ibuprofen MODAFEN with other medicines.
Ibuprofen MODAFEN with alcohol
Avoid drinking alcohol, as it may worsen the adverse effects of this medicine, especially those affecting the stomach, intestines or brain.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Pregnancy

Do not take ibuprofen 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 dysfunction in the unborn child. It may increase the tendency to bleed in both the mother and child and may delay or prolong labour.
During the first 6 months of pregnancy, ibuprofen should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause narrowing of a blood vessel (ductus arteriosus) in the child's heart or kidney disorders, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in very small amounts and usually there is no need to discontinue breastfeeding during short-term use of ibuprofen at the recommended dose for fever and pain. However, if longer-term treatment or higher doses are recommended, earlier discontinuation of breastfeeding should be considered.
Fertility
Ibuprofen MODAFEN may cause difficulties in becoming pregnant. Inform your doctor if you are planning to become pregnant or have problems conceiving.
This medicine belongs to a group of medicines (NSAIDs) that may adversely affect fertility in women. This effect is reversible after discontinuation of the medicine.
Driving and operating machinery
Ibuprofen generally has no effect or a negligible effect on the ability to drive and operate machinery. However, since higher doses may cause adverse effects on the central nervous system such as fatigue and dizziness, the ability to react and actively participate in road traffic and operate machinery may be impaired in individual cases. This is particularly true when combined with alcohol.
Ibuprofen MODAFEN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Ibuprofen MODAFEN

This medicine should always be used according to the doctor's recommendations. If in doubt, consult a pharmacist or doctor.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, contact 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 body weight of 50 kg or more (aged 15 years and above).

Adults:
The recommended daily dose is 1200 mg–1800 mg, divided into several doses. At least a 6-hour interval should be maintained between doses. The doctor may recommend lower doses. Depending on the nature and severity of the condition, the doctor may decide to increase the dose up to one 600 mg tablet taken four times daily. The maximum daily dose of 2400 mg within 24 hours must not be exceeded.

Adolescents with body weight of 50 kg or more (aged 15 years and above):
The recommended daily dose is 20 mg/kg body weight up to a maximum of 40 mg/kg body weight, divided into 3–4 partial doses. At least a 6-hour interval should be maintained between doses. The total maximum daily dose must not exceed 2400 mg within 24 hours.

Use in children and adolescents
The dose of ibuprofen in adolescents depends on age and body weight.
Ibuprofen MODAFEN 600 mg, coated tablets, is not intended for adolescents with body weight below 50 kg, nor for children and adolescents under 15 years of age.

Elderly patients
Elderly patients should always consult a doctor before using Ibuprofen MODAFEN. Elderly individuals are more susceptible to adverse effects, especially gastrointestinal bleeding, ulceration, and perforation, which may be fatal. The doctor will provide appropriate advice.

Impaired liver or kidney function
In case of impaired kidney or liver function, always consult a doctor before using Ibuprofen MODAFEN. Do not use this medicine if severe liver or kidney failure is present.

Method of administration
Ibuprofen MODAFEN is for oral use.
Tablets should be swallowed whole with a glass of water. Tablets must be swallowed whole, without chewing, crushing, breaking, or sucking, to avoid oral discomfort or throat irritation.
Patients with sensitive stomachs are advised to take the tablets with food.
If taken shortly after a meal, the onset of action of ibuprofen may be delayed.

Duration of treatment:
The duration of treatment is determined by the doctor.
In rheumatic diseases, prolonged treatment with Ibuprofen MODAFEN may be necessary.

Overdose of Ibuprofen MODAFEN
If more than the recommended dose of Ibuprofen MODAFEN has been taken, or if the medicine has been accidentally ingested by children, always contact a doctor or the nearest hospital for advice on potential risks and necessary actions.
Symptoms may include nausea, abdominal pain, vomiting (which may be bloody), or, less commonly, diarrhoea. Additionally, headache, gastrointestinal bleeding, blurred vision, tinnitus, disorientation, and nystagmus may occur, as well as worsening of asthma in asthmatic patients. With large doses, drowsiness, restlessness, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), vestibular vertigo, weakness, dizziness, haematuria, hypotension, hyperkalaemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold sensation, and breathing disturbances have been reported.

Missed dose of Ibuprofen MODAFEN
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
The patient can minimize the risk of adverse reactions by taking the lowest effective dose for the shortest duration necessary to relieve symptoms.
The following adverse reactions should be considered as being largely dose-dependent and varying between patients.
The most commonly observed adverse reactions are gastrointestinal in nature. Gastrointestinal ulcers, perforation or bleeding may occur, sometimes leading to death, particularly in elderly individuals. After administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Gastritis has been observed less frequently.
The use of drugs such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Fluid retention (oedema), high blood pressure and heart failure have been reported in connection with the use of NSAIDs.
You should DISCONTINUE TREATMENT with Ibuprofen MODAFEN and immediately consult a doctor if any of the following symptoms occur:

Symptoms of aseptic meningitis, such as headache, nausea, vomiting, high fever, neck stiffness or disturbances in consciousness (very rare: may affect up to 1 in 10,000 people). Patients with autoimmune diseases (SLE, mixed connective tissue disease) may be predisposed.
Symptoms of gastrointestinal bleeding, such as relatively severe upper abdominal pain, presence of blood in stool (faeces/intestinal contents) or black, tarry stools, vomiting blood or dark particles resembling coffee grounds (not 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 up to life-threatening shock (very rare: may affect up to 1 in 10,000 people).
Severe rash affecting the whole body, with blisters on the skin, particularly on the legs, arms, hands and feet, which may also involve the face and mouth (erythema multiforme, Stevens-Johnson syndrome). This may become more serious, with blisters enlarging and spreading, and parts of the skin peeling off (Lyell's syndrome) (very rare: may affect up to 1 in 10,000 people). Severe infection may also occur, manifesting as destruction (necrosis) of the skin, subcutaneous tissue and muscles (necrotizing fasciitis) (very rare: may affect up to 1 in 10,000 people).
Red, scaly, widespread rash with nodules under the skin and blisters located mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency unknown: frequency cannot be estimated from available data). If these symptoms occur, discontinue use of Ibuprofen MODAFEN and contact a doctor immediately. See also section 2.
Loss of vision, blurred or disturbed vision (visual disturbances) (not uncommon: may affect up to 1 in 100 people).

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

Gastrointestinal symptoms such as acid regurgitation, abdominal pain, nausea, diarrhoea, vomiting, gas (flatulence) and constipation
Minor gastrointestinal bleeding, which in exceptional cases may lead to anaemia

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

Headache
Dizziness or feeling of fatigue
Restlessness and irritability
Drowsiness
Difficulty falling asleep
Sensation of spinning (vestibular vertigo)
Gastric or intestinal ulcer, potentially with bleeding and perforation (a hole in the wall of the gastrointestinal tract)
Exacerbation of colitis (inflammation of the colon) and Crohn's disease
Gastritis
Mucosal inflammation of the mouth with ulcers (ulcerative stomatitis)

Not common (may affect up to 1 in 100 people):

Hypersensitivity reactions with rash and itching, as well as asthma attacks (possibly with decreased blood pressure)
Various skin rashes
Oedema and cloudy urine (nephrotic syndrome); kidney inflammatory disease (interstitial nephritis), which may lead to acute kidney failure. Reduced urine output, fluid accumulation in the body (oedema) and general malaise may be symptoms of kidney disease, or even kidney failure. If the mentioned symptoms occur or worsen, discontinue 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 (papillary necrosis), increased uric acid levels in blood, increased urea levels in blood

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

Pancreatitis
Oesophagitis
Development of intestinal strictures
Liver function disorders, liver failure, acute hepatitis, liver damage, particularly in cases of long-term treatment
Unexplained blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) – initial symptoms include: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In such cases, treatment must be immediately discontinued and medical advice sought. Self-medication with painkillers or antipyretics should not be used.
Depression, psychotic reactions
Palpitations (sensation of rapid heartbeat, fluttering or pounding), heart failure, myocardial infarction
High blood pressure, vasculitis
Asthma, bronchospasm, dyspnoea (difficulty breathing)
Alopecia (hair loss)

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

A severe skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling and increased eosinophil count (a type of white blood cell).
Sensations such as numbness, tingling, pricking
Skin becomes sensitive to light (photosensitivity reactions)
Nasal congestion and runny nose

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ibuprofen MODAFEN

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater 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 pack and other information

What Ibuprofen MODAFEN contains
The active substance is ibuprofen. Each coated tablet contains 600 mg of ibuprofen.
The other ingredients are: tablet core – microcrystalline cellulose 102, maize starch, povidone K-90, sodium lauryl sulfate, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate; tablet coating – hypromellose 2910, hydroxypropylcellulose, polyethylene glycol 400, titanium dioxide (E 171).

What Ibuprofen MODAFEN looks like and contents of the pack
White or almost white, capsule-shaped coated tablets with an embossed mark "I 7" on one side and smooth on the other side. The approximate dimensions of the tablet are 17.19 mm x 9.23 mm, thickness 6.60 mm.
The tablets are packed in colourless, transparent PVC/aluminium blisters, placed in an outer cardboard box containing 10 or 12 tablets per blister.
Pack sizes:
20, 24, 30, 40, 50, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Importer:
Marketing Authorisation 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Czech Republic: Ibuprofen STADA 600 mg potahované tablety
Spain: Ibuprofeno Pharmaclan 600 mg comprimidos recubiertos con película EFG
Germany: Ibuprofen AL 600 mg Filmtabletten
France: IBUPROFENE EG LABO 600 mg, comprimé pelliculé
Finland: Ibuprofen Pharmaclan
Poland: Ibuprofen MODAFEN