Package leaflet: Information for the patient

Ibuprofen MODAFEN, 200 mg, coated tablets
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Adults: If there is no improvement after 3 days of treatment for fever or after 4 days for pain, or if you feel worse, consult your doctor. Children and adolescents: If there is no improvement after 3 days, or if you feel worse, consult your doctor.

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), which work by reducing pain and fever.
Ibuprofen MODAFEN is used for the short-term symptomatic relief of mild to moderate pain, such as toothache, menstrual pain and headache, and (or) for the short-term symptomatic treatment of fever.
Ibuprofen MODAFEN 200 mg coated tablets are indicated for use in adults, adolescents and children weighing at least 20 kg (aged 7 years and above).
Adults: Consult your doctor if symptoms worsen or if fever persists for more than 3 days, or if pain persists for more than 4 days.
Children and adolescents: Consult your 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 had 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 of the stomach or intestine related to previous treatment with NSAIDs.
if the patient currently has a stomach or duodenal ulcer or gastrointestinal 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 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. due to vomiting, diarrhoea, or inadequate 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).
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 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,
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
The use of anti-inflammatory/pain-relieving 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, bypass surgery, 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 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. These events may occur at any time during treatment, with or without prior warning symptoms or previous serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers, and perforation increases with higher NSAID doses and is greater in patients with a history of 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 at the lowest available dose. In such patients, and in patients requiring additional treatment with low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, concomitant treatment with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal adverse effects – 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 with other medicines").
Treatment should be discontinued and medical advice sought if gastrointestinal bleeding or ulceration occurs during treatment with Ibuprofen MODAFEN.

Severe skin reactions
Severe 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 generalised exanthematous pustulosis (AGEP). If the patient experiences any of the symptoms associated with these severe skin reactions described in section 4, Ibuprofen Pharmaclan should be discontinued immediately and medical help sought.

Other warnings
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. If the first signs of hypersensitivity occur after taking Ibuprofen MODAFEN, treatment should be stopped and medical advice sought. Appropriate medical measures, according to symptoms, must be taken by healthcare professionals.
Allergic reactions to ibuprofen have been reported, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. Ibuprofen Pharmaclan should be discontinued 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 headaches. 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 painkillers.
During prolonged use of ibuprofen, regular monitoring of liver and kidney function and blood morphology is required.
Generally, habitual use of painkillers, especially in combination with multiple painkillers, may lead to permanent kidney damage. This risk may be increased during physical exertion associated with loss of salt and dehydration. Therefore, such use should be avoided.

Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Ibuprofen MODAFEN 200 mg coated tablets are not intended for children with body weight below 20 kg or under 7 years of age.

Ibuprofen MODAFEN with other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, and about any medicines planned for future use. 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 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), as digoxin's effect may be enhanced
lithium (used to treat depression and mania), as lithium's effect may be enhanced
phenytoin (used to prevent epileptic seizures), as phenytoin's effect may be enhanced
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 (a herbal medicine), as there is an increased risk of bleeding
ritonavir (an antiviral medicine) may increase NSAID plasma concentrations
alcohol, bisphosphonates (used for osteoporosis), or pentoxifylline (used for 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

Some 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 with 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 child, she should consult a doctor before using this medicine.

Pregnancy

Do not take ibuprofen if the patient is in the last three 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 the mother and the 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 the 20th week of pregnancy, ibuprofen may cause narrowing of a blood vessel (ductus arteriosus) in the unborn child's heart or kidney problems, 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 interrupt 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 or 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, contact your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Dosage:
Adults and adolescents with body weight from 40 kg (aged 12 years and above):
The usual dose is 1 or 2 tablets (200–400 mg of ibuprofen) as a single dose or repeated 3 to 4 times daily, depending on need. The interval between doses should be at least 6 hours. The maximum daily dose should not exceed 6 tablets (1200 mg) within 24 hours.

Children with body weight from 20 kg (aged 7 years) to 39 kg (aged 11 years):
Children with body weight 20–29 kg (aged 7–9 years): 1 tablet (200 mg of ibuprofen) 1–3 times daily as needed, with at least 6-hour intervals between doses. The maximum daily dose should not exceed 3 tablets (600 mg) within 24 hours.
Children with body weight 30–39 kg (aged 10–11 years): 1 tablet (200 mg of ibuprofen) 1–4 times daily as needed, with at least 6-hour intervals between doses. The maximum daily dose should not exceed 4 tablets (800 mg) within 24 hours.

Duration of treatment:
If this medicine needs to be used in adults for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen, consult a doctor.
If this medicine needs to be used in children and adolescents for more than 3 days 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, suck or divide the tablets to avoid oral discomfort or throat irritation.
Patients with a sensitive stomach are advised to take the tablets with food.
If taken shortly after a meal, the onset of ibuprofen’s effect may be delayed.

Elderly patients
Elderly patients should always consult a doctor before using Ibuprofen MODAFEN. Patients may be at increased risk of adverse effects, especially gastrointestinal bleeding, ulcers, and perforation, which may 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 liver or kidney failure.

Overdose of Ibuprofen MODAFEN
If you or someone else (especially a child) has taken more than the recommended dose of Ibuprofen MODAFEN, contact a doctor or the nearest hospital immediately for advice on the risks and necessary actions.
Symptoms may include nausea, abdominal pain, vomiting (possibly bloody), or, less commonly, diarrhea. Additionally, headache, gastrointestinal bleeding, blurred vision, tinnitus, confusion, and nystagmus may occur, as well as worsening of asthma in asthmatic patients. With higher doses, drowsiness, restlessness, confusion, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), vertigo, weakness, and dizziness may occur. Other possible symptoms include hematuria, hypotension, hyperkalemia, metabolic acidosis, prolonged prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, cold sensation, and breathing disturbances.

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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The patient can minimize the risk of adverse effects by taking the lowest effective dose for the shortest duration necessary to relieve symptoms.
The following adverse effects should be considered largely dose-dependent and may vary between patients.
The most commonly observed adverse effects are gastrointestinal in nature. Gastrointestinal ulcers, perforation or 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. Gastritis 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 connection with the use of NSAIDs.
The list of adverse effects below includes all those occurring during long-term treatment with high doses in patients with rheumatic diseases. The frequencies stated, which go beyond very rare reports, refer to short-term use of daily doses up to a maximum of 1200 mg ibuprofen for oral dosage forms and up to 1800 mg for suppositories.
You should STOP USING Ibuprofen MODAFEN and consult a doctor immediately 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) appear to 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).
Red, flat, target-like or circular 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 rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) (very rare: may affect up to 1 in 10,000 people).
Widespread rash, high fever and swollen lymph nodes (DRESS syndrome) (frequency unknown: frequency cannot be estimated based on available data).
Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency unknown: frequency cannot be estimated based on available data).
Loss of vision, blurred or disturbed vision (visual disturbances) (not uncommon: may affect up to 1 in 100 people).

Other adverse effects
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 uncommon (may affect up to 1 in 100 people):

hypersensitivity reactions with rash and itching, as well as asthma attacks (possibly with decreased blood pressure)
headache
dizziness or feeling of fatigue
restlessness and irritability
drowsiness
difficulty sleeping
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 (colitis ulcerosa) and Crohn's disease
gastritis (inflammation of the gastric mucosa)
inflammation of the 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 uric acid levels in blood, elevated blood urea levels

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

pancreatitis
oesophagitis
formation of intestinal strictures
liver function disorders, liver failure, acute hepatitis, liver damage, particularly with 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 stopped immediately and a doctor consulted. 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 arterial blood pressure, vasculitis
asthma, bronchospasm, dyspnoea (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, the use of Ibuprofen MODAFEN should be discontinued and a doctor consulted immediately.

Frequency unknown (frequency cannot be estimated based on 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Ibuprofen MODAFEN

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following: EXP. The expiry date refers to the last day of the stated month.
There are no special storage instructions 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. 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 200 mg of ibuprofen.
The other ingredients are: tablet core – microcrystalline cellulose 102, maize starch paste,
povidone K-90, sodium lauryl sulfate, sodium croscarmellose, 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, round, film-coated tablets with the imprint "G2" on one side and smooth on the other. The approximate diameter of the tablet is 8.52 mm and thickness 4.60 mm.
Colourless, transparent PVC/aluminium blister in an outer cardboard box containing 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 countries under the following names:
Czech Republic: Ibuprofen STADA 200 mg potahované tablety
Spain: Ibuprofeno Pharmaclan 200 mg comprimidos recubiertos con película EFG
Germany: Ibuprofen Pharmaclan 200 mg Filmtabletten
France: IBUPROFENE PHARMACLAN 200 mg comprimé pelliculé
Finland: Ibuprofen Pharmaclan
Poland: Ibuprofen MODAFEN

Ibuprofen modafen