Ibuprofen modafen

Patient Information Leaflet

Ibuprofen MODAFEN, 400 mg, soft capsules
Ibuprofen
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• This medicine should always be used 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 or pharmacist. See section 4.
• If there is no improvement or if you feel worse, consult your doctor:
  • after 3 days of treatment in adolescents,
  • after 3 days when treating fever or 4 days when treating pain in adults.

Table of Contents

1. What Ibuprofen MODAFEN is and what it is 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 pack and other information

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

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
These medicines provide relief by altering the way the body responds to pain and fever.
Ibuprofen MODAFEN is intended for use in adults and adolescents weighing at least 40 kg (aged 12 years and above) for short-term symptomatic treatment of mild to moderate pain, such as:

• headache
• menstrual pain
• toothache
• fever and pain associated with colds

If there is no improvement or if you feel worse, consult your doctor:

• after 3 days of treatment in adolescents,
• after 3 days when treating fever or 4 days when treating pain in adults.

2. Important information before taking Ibuprofen MODAFEN

When NOT to use Ibuprofen MODAFEN

• if the patient is allergic to ibuprofen or any of the ingredients of the medicine (listed in section 6),
• if the patient has experienced asthma, bronchospasm, rhinitis, swelling (angioedema), or urticaria during previous treatment with acetylsalicylic acid or other similar pain-relieving drugs (NSAIDs),
• if the patient has (or has had two or more distinct episodes of) peptic ulceration or bleeding in the stomach and/or duodenum (peptic ulcer),
• if the patient has experienced gastrointestinal bleeding or perforation during previous treatment with NSAIDs (non-steroidal anti-inflammatory drugs),
• if the patient has unexplained disorders of the blood-forming system,
• if the patient has severe liver, kidney, or heart failure,
• if the patient is in the last three months of pregnancy (see section "Pregnancy and breastfeeding"),
• if the patient is severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake),
• if the patient has cerebral haemorrhage (bleeding in the brain) or any other active bleeding.

Warnings and precautions
Before starting treatment with Ibuprofen MODAFEN, consult your doctor or
pharmacist if:

• the patient has systemic lupus erythematosus or mixed connective tissue disease (autoimmune disorders causing joint pain, skin rashes, and fever),
• the patient has certain inherited blood disorders (e.g. acute intermittent porphyria) or coagulation disorders,
• the patient has or has had inflammatory bowel disease (ulcerative colitis or Crohn's disease),
• the patient has reduced kidney function,
• the patient has impaired liver function,
• the patient has recently undergone major surgery,
• the patient suffers or has suffered from asthma or allergic disease, as breathing difficulties may occur,
• the patient has hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), acute swelling (Quincke's oedema), or skin rash,
• the patient is taking medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet drugs such as acetylsalicylic acid,
• the patient has an infection – see below "Infections".

Infections
Ibuprofen MODAFEN may mask signs of infection such as fever and pain. Therefore, Ibuprofen MODAFEN may delay appropriate treatment of infection and consequently increase 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 existing infection and symptoms of infection persist or worsen, medical advice must be sought immediately.

Other warnings
Long-term use of painkillers for headache treatment may worsen headaches (medication-overuse headache). If this occurs or is suspected, treatment with Ibuprofen MODAFEN should be discontinued and the patient should contact their doctor.

• Ibuprofen MODAFEN should be avoided during chickenpox.
• During prolonged treatment with Ibuprofen MODAFEN, regular monitoring of liver and kidney function and blood counts should be performed.
• Concomitant use of Ibuprofen MODAFEN with other NSAIDs, including selective cyclooxygenase-2 inhibitors, may increase the risk of adverse effects; therefore, such combination should be avoided (see section below "Ibuprofen MODAFEN and other medicines").
• Habitual use of more than one painkiller at a time may lead to serious kidney problems and should be avoided. This risk is greater in cases of salt loss and dehydration.
• In dehydrated adolescents, there is a risk of impaired kidney function.
• Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred. If any of these symptoms occur, Ibuprofen MODAFEN must be stopped immediately and medical help must be sought urgently.

Severe 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 severe skin reactions described in section 4, Ibuprofen MODAFEN must be stopped immediately and medical help must be sought.

The use of anti-inflammatory and/or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Before taking Ibuprofen MODAFEN, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or history of stroke (including mini-stroke or transient ischaemic attack - TIA).
• the patient has hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible time. The risk of adverse effects is higher in elderly patients.
If the patient has any of the conditions or states listed above, medical advice should be sought before starting treatment with Ibuprofen MODAFEN.

Ibuprofen MODAFEN and other medicines
Ibuprofen MODAFEN may affect the action of other medicines, or other medicines may affect the action of Ibuprofen MODAFEN. For example:

• anticoagulant medicines (i.e. blood thinners and/or those preventing blood clots, such as: acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. In particular, inform the doctor if the patient is taking the following medicines:

Other medicines may also affect or be affected by treatment with Ibuprofen Modafen. Therefore, always consult a doctor or pharmacist before using Ibuprofen Modafen together with other medicines.

Ibuprofen Modafen and alcohol
Alcohol should not be consumed while taking Ibuprofen Modafen. Some adverse effects, such as those related to the gastrointestinal tract or central nervous system, may be more likely when alcohol is consumed simultaneously with Ibuprofen Modafen.

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 or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you suspect you are pregnant while taking Ibuprofen Modafen.

Do not use this medicine during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Use of the medicine may cause kidney and heart problems in the unborn child. It may also affect bleeding tendencies in both the mother and her child and may cause delivery to occur later than expected or to last longer than anticipated. This medicine should not be used during the first six months of pregnancy unless otherwise advised by a doctor. Taking Ibuprofen Modafen for longer than a few days after the start of week 20 of pregnancy may cause kidney problems in the unborn child and lead to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is required, your doctor may recommend additional monitoring tests.

Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. The medicine may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.

Female fertility
Ibuprofen Modafen belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect reverses upon discontinuation of the medicine.

Driving and operating machinery
When used for short periods at recommended doses, the medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
If the patient experiences dizziness, drowsiness, balance disturbances, or visual disturbances while taking Ibuprofen Modafen, driving and operating machinery should be avoided. These effects may be intensified by concomitant alcohol consumption.

Ibuprofen Modafen contains sorbitol (E 420)
Ibuprofen Modafen contains 72 mg of sorbitol per capsule. Sorbitol (E 420) is a source of fructose. If a patient (or their child) has previously been diagnosed with intolerance to certain sugars or with hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should consult a doctor before taking the medicine or giving it to a child.

3. How to take Ibuprofen MODAFEN

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Unless otherwise prescribed by a physician, the usual dose is:

Dosage:
Adults and adolescents with body weight of 40 kg (aged 12 years and above):
Initial dose: 1 capsule (400 mg of ibuprofen), then if needed, take 1 capsule (400 mg of ibuprofen) every 6 hours. Do not take more than 3 capsules (1200 mg of ibuprofen) within 24 hours.

Children under 12 years of age and adolescents weighing less than 40 kg:
Ibuprofen MODAFEN is not indicated for use in adolescents weighing less than 40 kg or in children under 12 years of age.

Method of administration
For oral use. Take Ibuprofen MODAFEN with a glass of water. Do not chew the capsules.

Patients with sensitive stomach should take Ibuprofen MODAFEN during a meal. Taking the medicine immediately after food may delay the onset of action. In such a case, do not take a higher dose or take the medicine more frequently than recommended.

Duration of treatment
This medicine is intended for short-term use only. Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adolescents
In adolescents, consult a doctor if treatment with Ibuprofen MODAFEN is required for more than 3 days or if symptoms worsen.

Adults
If treatment with Ibuprofen MODAFEN is required for more than 3 days for fever or 4 days for pain, or if symptoms worsen, consult a doctor.

If the patient feels the medicine’s effect is stronger or weaker than expected, consult a doctor or pharmacist.

Overdose of Ibuprofen MODAFEN
If the patient has taken more than the recommended dose of Ibuprofen MODAFEN or if a child has accidentally ingested the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions. Symptoms may include nausea, vomiting (possibly with blood), blood in stool (gastrointestinal bleeding), tinnitus, headache, stomach pain, diarrhoea, and nystagmus. After a large overdose, weakness and dizziness, drowsiness, confusion, disorientation, loss of consciousness, feeling cold, chest pain, palpitations, seizures (mainly in children), blood in urine, and breathing difficulties may occur.

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.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
The patient may experience known adverse effects typical of NSAIDs (see below). If in doubt, treatment should be discontinued and medical advice sought as soon as possible.
Elderly patients taking this medicine have an increased risk of experiencing adverse effects.

DISCONTINUE TAKING THE MEDICINE AND CONTACT A DOCTOR IMMEDIATELY IF
any of the following symptoms occur:

• signs of gastrointestinal bleeding such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• signs of a very rare but serious allergic reaction such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or drop in blood pressure leading to shock. Such a reaction may occur even after the first dose of the medicine.
• red, flat, target-like or circular skin rashes on the trunk, often with blisters in the center, peeling skin, and ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome).
• red, peeling, widespread rash with nodules under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever.

Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

• chest pain, which may indicate a potentially serious allergic reaction called Kounis syndrome.

If any adverse effect occurs or worsens, or if any adverse effect not listed in this leaflet occurs,
inform a doctor immediately.

Common (may affect up to 1 in 10 people)

• gastrointestinal disorders such as heartburn, abdominal pain, nausea, indigestion, vomiting, bloating, diarrhoea, constipation, minor bleeding from the stomach and/or intestines, which may exceptionally lead to anaemia.

Uncommon (may affect up to 1 in 100 people)

• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulceration (oral ulcerative stomatitis), inflammation of the stomach lining (gastritis), exacerbation of colitis and Crohn's disease
• central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue
• visual disturbances
• allergic reactions such as skin rash, itching and asthma attacks. In such cases, treatment with Ibuprofen Modafen must be discontinued immediately and medical advice sought without delay
• various skin rashes.

Rare (may affect up to 1 in 1000 people)

• tinnitus (ringing in the ears)
• kidney damage (papillary necrosis) and increased blood uric acid levels
• hearing disturbances
• increased blood urea levels
• decreased haemoglobin levels.

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

• during NSAID use, cases of oedema, high blood pressure and heart failure have been reported
• oesophagitis or pancreatitis, formation of membrane-like strictures in the small and large intestine (diaphragm-like strictures)
• during chickenpox, severe skin and soft tissue infections have been observed
• reduced urine output and oedema (especially in patients with high blood pressure or impaired kidney function); oedema and cloudy urine (nephrotic syndrome); kidney inflammation (interstitial nephritis) potentially leading to acute renal failure. If any of these symptoms or general malaise occur, treatment with Ibuprofen Modafen should be discontinued and medical advice sought immediately, as these may be early signs of kidney damage or failure.
• blood cell production disorders – initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe weakness, nosebleeds and skin bleeding. In such cases, treatment must be stopped immediately and a doctor consulted. These symptoms must not be treated with painkillers or antipyretics.
• psychotic reactions and depression
• exacerbation of inflammatory conditions associated with infection (e.g. necrotizing fasciitis) has been reported with some painkillers (NSAIDs). If signs of infection occur or worsen during treatment with Ibuprofen Modafen, immediate medical advice should be sought to determine whether antimicrobial or antibiotic treatment is necessary.
• high blood pressure, palpitations, heart failure, myocardial infarction
• liver function disorders, liver damage (especially during long-term treatment), liver failure, acute hepatitis
• during ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever and disturbances of consciousness have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at higher risk of such disorders. If such symptoms occur, medical advice should be sought immediately.
• severe forms of skin reactions such as erythematous blistering rash (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis and/or Lyell's syndrome), hair loss (alopecia)
• severe, generalized hypersensitivity reactions
• worsening of asthma or bronchospasm
• vasculitis.

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

• photosensitivity (photosensitivity reactions).

Taking medicines such as Ibuprofen Modafen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse.
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
Phone: +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 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 cardboard box and
blister pack following "EXP". The expiry date refers to the last day of the specified month.
There are no special storage temperature requirements for this medicine. Store
in the original packaging to protect from moisture.
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 soft capsule contains 400 mg of ibuprofen.
The other ingredients are: macrogol 600 (E 1521), potassium hydroxide (E 525), purified water,
gelatine (E 441), partially dehydrated liquid sorbitol (E 420).

What Ibuprofen Modafen looks like and contents of the pack
Transparent, oval, soft gelatin capsule (approximately 15.8 mm x 9.8 mm) containing a clear, colourless liquid.
Ibuprofen Modafen is available in packs of 10, 20 or 30 soft capsules in blister packs within a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer/Importer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Centrafarm Services B.V.
Van de Reijtstraat 31 E
4814NE Breda
The Netherlands
Clonmel Healthcare Ltd.
Waterford Road
E91 D768 Clonmel
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
STADA Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Poland
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Ibuprofen EG Rapidcaps 400 mg zachte Capsules, Ibuprofen EG Rapidcaps 400 mg capsules Molles, Ibuprofen EG Rapidcaps 400 mg Weichkapseln
Bulgaria: Parabol Max
Czech Republic: IBOVAL RAPID
Estonia: Ibuprofen STADA
Spain: Ibuprofeno Rapid Stadacare 400 mg cápsulas blandas
The Netherlands: Ibuprofen Healthypharm liquid caps 400 mg, zachte capsules
France: IBUPROFENE EG CONSEIL 400 mg, capsule molle
Ireland: Easofen Rapid Relief Max Strength 400 mg soft capsules
Lithuania: Ibuprofen STADA 400 mg minkštosios kapsulės
Luxembourg: Ibuprofen EG RapidCaps 400 mg capsules molles
Latvia: Ibuprofen STADA 400 mg mīkstās kapsulas
Germany: Ibudolor 400 mg Weichkapseln
Poland: Ibuprofen MODAFEN
Romania: BUPROFESS 400mg capsule moi
Slovenia: Ibuprofen STADA 400 mg mehke kapsule