Ibuprofen modafen: detailed information

Package leaflet: Information for the patient

Ibuprofen MODAFEN, 400 mg, coated tablets
Ibuprofenum
Please read the entire 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, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Adults: If there is no improvement after 3 days in case of fever or after 4 days in case of pain, or if you feel worse, consult a doctor. Adolescents: If there is no improvement after 3 days or if you feel worse, consult a doctor.

Table of contents

What Ibuprofen MODAFEN is and what it is used for
What you need to know 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), which work by reducing pain and fever.
Ibuprofen MODAFEN is used for short-term symptomatic treatment of mild to moderate pain, such as toothache, menstrual pain, and headache, and (or) for short-term symptomatic treatment of fever.
Ibuprofen MODAFEN, 400 mg, coated tablets are indicated for use in adults and adolescents with a body weight of at least 40 kg (aged 12 years and older).
Adults: Consult a doctor if symptoms worsen or if fever persists for more than 3 days, or if pain persists for more than 4 days.
Adolescents: Consult a doctor if symptoms worsen or if fever or pain persists for more than 3 days.

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 such as bronchospasm, asthma, rhinitis, itchy skin rash, or swelling of the lips, face, tongue, or throat (angioedema) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. NSAIDs).
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 peptic ulcers or gastrointestinal bleeding in the past.
if the patient has unexplained blood 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, consult a 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).
chickenpox – use of this medicine should be avoided during chickenpox.
if the patient has or has ever had gastrointestinal disorders (e.g. ulcerative colitis, Crohn's disease), as the patient's condition may worsen.
if the patient has certain inherited blood 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 with 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,
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 is taking this medicine during an infection and symptoms persist or worsen, medical advice should be sought immediately.

Cardiovascular effects
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 at 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), previous heart attack, coronary artery 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.

Gastrointestinal effects
Concomitant use of Ibuprofen MODAFEN with other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, should be avoided.
Gastrointestinal bleeding, ulcers, and perforations:
Gastrointestinal bleeding, ulcers, and perforations have been reported with all NSAIDs, sometimes fatal. These may occur at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration, and perforation is higher with increasing NSAID doses and in patients with a history of peptic ulcers, especially those complicated by bleeding or perforation (see section 2 "When not to use Ibuprofen MODAFEN"), and in elderly patients. These patients should start treatment with the lowest available dose. In such patients, and in patients requiring concomitant treatment with low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, consideration should be given to co-therapy with gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
Patients with a history of gastrointestinal adverse events – especially elderly patients – should contact a 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, e.g. 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 and other medicines").
Treatment should be discontinued and medical advice sought if gastrointestinal bleeding or ulceration occurs during treatment with Ibuprofen MODAFEN.

Serious skin reactions
Serious skin reactions have been reported with ibuprofen use, 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). If the patient develops any symptoms related to these serious skin reactions described in section 4, Ibuprofen MODAFEN should be stopped immediately and medical help sought.

Other warnings
Severe, acute hypersensitivity reactions (e.g. anaphylactic shock) have been very rarely observed. If any symptoms of hypersensitivity occur after taking Ibuprofen MODAFEN, treatment should be discontinued and medical advice sought. Appropriate medical measures must be taken by healthcare professionals according to the symptoms.
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. Ibuprofen MODAFEN should be stopped immediately and the patient should contact a doctor or emergency services if any of these symptoms occur.
Ibuprofen may transiently inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.
Long-term use of any painkillers for headache may worsen it. 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 due to) regular use of analgesics.
Regular monitoring of liver and kidney function and blood morphology is required during long-term ibuprofen use.
Generally, habitual use of analgesics, especially in combination with multiple painkillers, may lead to permanent kidney damage. This risk may be increased during physical exertion associated with salt loss and dehydration. Therefore, such use should be avoided.

Children and adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.
Ibuprofen MODAFEN 400 mg, coated tablets, is not intended for adolescents with body weight below 40 kg and children under 12 years of age.

Ibuprofen MODAFEN and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned to be used. Ibuprofen MODAFEN 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-clotting agents, e.g. acetylsalicylic acid, warfarin, ticlopidine)
medicines for 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 excretion)
other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors or acetylsalicylic acid – because they increase the risk of gastrointestinal ulcers or bleeding
digoxin (used to treat various heart conditions) – because digoxin's effect may be enhanced
lithium (used to treat depression and mania) – because lithium's effect may be enhanced
phenytoin (used to prevent epileptic seizures) – because phenytoin's effect may be enhanced
zidovudine (used to treat HIV/AIDS)
glucocorticosteroids (used to treat inflammatory conditions) – because they may increase the risk of gastrointestinal ulcers or bleeding
methotrexate (used to treat certain cancers and autoimmune diseases)
immunosuppressants such as cyclosporine and tacrolimus – because kidney damage may occur
selective serotonin reuptake inhibitors (SSRIs), used to treat depression
quinolone antibiotics such as ciprofloxacin – because the risk of seizures may be increased
aminoglycosides (a type of antibiotic) – because NSAIDs may reduce aminoglycoside excretion
mifepristone – because NSAIDs may reduce mifepristone's effect
diuretics (water tablets) – because diuretic effect may be weakened
potassium-sparing diuretics – because this may lead to hyperkalaemia
probenecid or sulfinpyrazone (used to treat gout) – because ibuprofen excretion may be delayed
cholestyramine (used to lower cholesterol levels)
sulphonylureas such as glibenclamide (used to treat diabetes) – because they may affect blood sugar levels
voriconazole or fluconazole (types of antifungal agents) (CYP2C9 inhibitors) – because ibuprofen's effect may be enhanced. Dose reduction of ibuprofen should be considered, especially when high doses of ibuprofen are used with voriconazole or fluconazole.
Ginkgo biloba (herbal medicine) – because there is an increased risk of bleeding
ritonavir (antiviral medicine) – may increase NSAID plasma concentrations
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

Other medicines may also affect treatment with Ibuprofen MODAFEN. Therefore, always consult a doctor or pharmacist before using Ibuprofen MODAFEN with other medicines.

Ibuprofen MODAFEN and alcohol
Alcohol consumption should be avoided, as it may worsen adverse effects of this medicine, especially those affecting the stomach, intestines, or brain.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.

Pregnancy

Ibuprofen should not be taken during 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 increase the tendency to bleed in both mother and child and may delay or prolong labour.
During the first 6 months of pregnancy, ibuprofen should not be used unless a 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 the 20th week of pregnancy, ibuprofen may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart or kidney problems, which may lead to low levels of amniotic fluid surrounding the baby (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.

Fertility
Ibuprofen MODAFEN may cause difficulties in becoming pregnant. Inform the doctor if the patient is planning to become pregnant or has 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, at higher doses, adverse effects on the central nervous system such as fatigue and dizziness may occur, which may impair reaction ability and the ability to actively participate in road traffic and operate machinery in individual cases. This is particularly relevant 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 taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of
infection, seek immediate medical advice if symptoms (such as fever and pain) persist or worsen (see section 2).

Dosage:
Adults and adolescents with body weight of 40 kg (aged 12 years and above):
The usual dose is 1 tablet (400 mg of ibuprofen) 1–3 times daily, depending on need. The interval between doses should be at least 6 hours. Do not take more than 3 tablets (1200 mg) within 24 hours.

Duration of treatment:
If this medicine needs to be used for more than 3 days for fever or more than 4 days for pain in adults, or if symptoms worsen, consult a doctor.
If this medicine needs to be used for more than 3 days in adolescents, or if symptoms worsen, consult a doctor.

Method of administration:
Ibuprofen MODAFEN is for oral use.
Swallow the tablets whole with a glass of water. Do not chew, crush, break, split, or suck the tablets, to avoid discomfort in the mouth or throat irritation.
Patients with sensitive stomach are advised to take the tablets with food.
If taken shortly after a meal, the onset of action of ibuprofen may be delayed.

Elderly patients
Elderly patients should always consult a doctor before using Ibuprofen MODAFEN. The patient may be at increased risk of adverse effects, especially gastrointestinal bleeding, ulceration, and perforation, which can be fatal. Your doctor will provide appropriate advice.

Impaired liver or kidney function
If the patient has impaired liver or kidney function, consult a doctor before using Ibuprofen MODAFEN. Do not take this medicine in case of severe hepatic or renal insufficiency.

Accidental overdose of Ibuprofen MODAFEN
If more than the recommended dose of Ibuprofen MODAFEN is taken, or if the medicine is 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 overdoses, drowsiness, restlessness, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), vertigo, weakness, dizziness, haematuria, hypotension, hyperkalaemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, feeling of coldness, and breathing disorders 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, 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 gastrointestinal bleeding may occur, sometimes leading to death, particularly in elderly individuals. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration. Gastric mucosal inflammation has been observed less frequently.
The use of medicines 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 association with the use of NSAIDs.
The list of adverse reactions below includes all adverse reactions occurring during long-term treatment with high doses in patients with rheumatism. The frequencies given, which go beyond very rare reports, refer to short-term use of daily doses of up to 1200 mg ibuprofen for oral dosage forms and up to 1800 mg for suppositories.
You should DISCONTINUE USE of Ibuprofen MODAFEN and consult a doctor immediately if any of the following symptoms occur:

Symptoms of aseptic meningitis, such as: headache, nausea, vomiting, high temperature, 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) are predisposed.
Symptoms of gastrointestinal bleeding, such as relatively severe epigastric pain, presence of blood in stool (faeces/intestinal contents) or black, tarry stools, blood in vomit or vomit containing 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).
Red, flat, target-like or round skin lesions on the trunk, often with blisters in the centre, skin peeling, ulceration in the mouth, throat, nose, genital organs and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome) (very rare: may affect up to 1 in 10,000 people).
Extensive rash, high body temperature and enlarged lymph nodes (DRESS syndrome) (frequency unknown: frequency cannot be estimated from available data).
Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis) (frequency unknown: frequency cannot be estimated from available data).
Loss of vision, blurred or disturbed vision (visual disturbances) (not uncommon: may affect up to 1 in 100 people).

Other adverse reactions
Common (may affect up to 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

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

hypersensitivity reactions with rash and itching, as well as asthma attacks (possibly with low blood pressure)
headache
dizziness or feeling of fatigue
restlessness and irritability
drowsiness
difficulty falling asleep
sensation of spinning (dizziness)
various skin rashes
gastric or intestinal ulcer, potentially with bleeding and perforation (a hole in the wall of the gastrointestinal tract)
exacerbation of colitis (colonic inflammation) and Crohn's disease
gastric mucosal inflammation
inflammation of oral mucosa with ulcers (ulcerative stomatitis)

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), elevated blood uric acid levels, elevated blood urea levels

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

pancreatitis
oesophagitis
development of intestinal adhesions
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 antipyretic medicines 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, shortness of breath (difficulty breathing)
alopecia (hair loss)
oedema and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis), which may lead to acute renal failure. Reduced urine output, fluid accumulation in the body (oedema) and general malaise may be symptoms of kidney disease or even renal failure. If any of these symptoms occur or worsen, Ibuprofen MODAFEN should be discontinued and medical advice sought immediately.

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

sensations such as numbness, tingling, pricking
optic neuritis
nasal congestion and runny nose
skin becomes sensitive to light (photosensitivity reactions)
chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse reactions
If any adverse reactions 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 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Ibuprofen MODAFEN

Keep the medicine out of 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 stated month.
No special storage instructions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This 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 400 mg of ibuprofen.
The other ingredients are: tablet core – microcrystalline cellulose 102, maize starch gelatinised, 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, oval film-coated tablets, embossed with the mark "I 6" on one side and smooth on the other. The approximate dimensions of the tablet are 13.55 mm x 8.24 mm, with a thickness of 6.00 mm.
The tablets are packed in colourless, transparent PVC/aluminium blisters, contained in an outer cardboard box with 10 or 12 tablets per blister.
Pack sizes:
10, 12, 20, 24, 30, 40, 48 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 European Economic Area under the following names:
Czech Republic: Ibuprofen STADA 400 mg potahované tablety
Spain: Ibuprofeno Pharmaclan 400 mg comprimidos recubiertos con película EFG
Germany: Ibuprofen Pharmaclan 400 mg Filmtabletten
France: IBUPROFENE PHARMACLAN 400 mg comprimé pelliculé
Finland: Ibuprofen Pharmaclan
Poland: Ibuprofen MODAFEN