Ibuprofen medicinae

Package leaflet: Information for the patient

IBUPROFEN MEDICINAE, 400 mg, soft capsules
Ibuprofenum
Please read the entire leaflet carefully before using 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, 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 3 days in adolescents or adults for migraine headaches or fever, or within 4 days in adults for pain treatment, or if you feel worse, consult a doctor.

Contents of the leaflet

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

1. What IBUPROFEN MEDICINAE is and what it is used for

IBUPROFEN MEDICINAE belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and contains ibuprofen. Ibuprofen reduces pain and fever.
IBUPROFEN MEDICINAE is indicated for short-term symptomatic treatment of:

• mild to moderate pain, e.g. headaches, menstrual pain, toothache.
• acute migraine attacks with or without aura.
• fever.

IBUPROFEN MEDICINAE is indicated for use in adults and adolescents with body weight of at least 40 kg (aged 12 years and above).

2. Important information before using IBUPROFEN MEDICINAE

When not to take IBUPROFEN MEDICINAE:

• if the patient is allergic to ibuprofen or any other ingredient of this medicine listed in section 6.

• if the patient has previously experienced allergic reactions such as breathlessness, asthma, angioedema, urticaria or rhinitis after taking acetylsalicylic acid or similar pain-relieving medicines (NSAIDs).

• if the patient has severe liver failure, severe kidney failure or severe heart failure.

• if the patient is in the last three months of pregnancy (see section "Pregnancy and breastfeeding").

• if the patient has active or recurrent peptic ulcer or (and) duodenal ulcer (peptic ulcer disease) or gastrointestinal bleeding (at least two distinct confirmed episodes of ulceration or bleeding).

• if the patient has previously experienced gastrointestinal bleeding or perforation related to the use of NSAIDs.

• if the patient has cerebral haemorrhage (cerebrovascular bleeding) or any other active bleeding.

• if the patient is severely dehydrated (e.g. due to vomiting, diarrhoea or inadequate fluid intake).

• if the patient has unexplained disorders of blood cell formation (haematopoietic system).

Warnings and precautions
The use of anti-inflammatory and (or) analgesic medicines such as ibuprofen may be
associated with a small increased risk of heart attack or stroke, particularly when high
doses are used. Do not exceed the recommended dose or duration of treatment.
During treatment with ibuprofen, symptoms of allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck swelling (angioedema), chest pain.
If any of these symptoms occur, discontinue IBUPROFEN MEDICINAE immediately and contact a doctor or emergency medical services without delay.
Before starting treatment with IBUPROFEN MEDICINAE, consult a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina (chest pain), or has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor 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.
• the patient has impaired liver or kidney function. In general, habitual use of (several types of) painkillers may lead to permanent kidney damage. This risk may be increased during physical exertion associated with loss of salts and dehydration (e.g. caused by vomiting, diarrhoea or insufficient fluid intake).
• the patient has or has had gastrointestinal disorders or chronic inflammatory bowel disease such as colitis (ulcerative colitis) or Crohn's disease.
• caution should be exercised if the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet agents (e.g. acetylsalicylic acid).
• the patient is taking another medicine from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib), since concomitant use should be avoided (see section "IBUPROFEN MEDICINAE and other medicines").
• the patient has mixed connective tissue disease (autoimmune disease) or systemic lupus erythematosus (autoimmune disease).
• the patient has certain genetic disorders of blood cell formation (such as acute intermittent porphyria).
• the patient has blood clotting disorders.
• the patient has recently undergone major surgery.
• the patient is dehydrated.
• the patient has asthma or any allergic conditions, as breathlessness may occur.
• the patient has hay fever, nasal polyps or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema or urticaria.
• the patient has an infection – see section "Infections" below.
• prolonged use of any type of painkiller for headache may worsen the headaches. If this occurs or is suspected, medical advice should be sought and treatment discontinued.

Skin reactions
Severe skin reactions have occurred during treatment with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). Treatment with IBUPROFEN MEDICINAE should be discontinued and immediate medical help sought if any symptoms of skin rash, mucosal lesions, blisters or other allergic symptoms appear, as these may be early signs of a very serious skin reaction. See section 4.

The risk of adverse effects is minimized by using the lowest effective dose for the shortest possible time. Elderly patients are at increased risk of adverse effects from NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. Do not take different painkillers simultaneously unless specifically advised by a doctor.

Gastrointestinal bleeding, ulceration or perforation, which may be fatal, have been reported during treatment with all NSAIDs at any time during therapy, with or without warning symptoms or previous serious gastrointestinal events in history. If gastrointestinal bleeding or ulceration occurs, treatment must be discontinued immediately. The risk of gastrointestinal bleeding, ulceration or perforation is greater with increasing NSAID doses, in patients with a history of peptic ulcer, especially complicated by bleeding or perforation (see section 2 When not to take IBUPROFEN MEDICINAE), and in elderly patients. These patients should start treatment with the lowest available dose.

In such patients, and in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase gastrointestinal risk, concomitant treatment with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.

Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial phase of treatment.

Infections
IBUPROFEN MEDICINAE may mask symptoms of infection such as fever and pain.
Therefore, the use of IBUPROFEN MEDICINAE may delay initiation of appropriate treatment for infection and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella (chickenpox). If the patient takes this medicine during an infection and symptoms persist or worsen, immediate contact with a doctor is required. During varicella (chickenpox), use of this medicine should be avoided.

Consult a doctor if any of the above conditions apply to the patient.

Children and adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.
This medicine is not intended for use in adolescents with body weight below 40 kg and in children under 12 years of age.

IBUPROFEN MEDICINAE and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.

IBUPROFEN MEDICINAE may affect the action of other medicines, or other medicines may affect the action of this medicine.

For example:

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

Some other medicines may also affect treatment with IBUPROFEN MEDICINAE.
Therefore, always consult a doctor or pharmacist before using IBUPROFEN MEDICINAE with other medicines.

In particular, inform your doctor or pharmacist if the following medicines are being used:

Drug IBUPROFEN MEDICINAE and alcohol
You should not drink alcohol while taking IBUPROFEN MEDICINAE. Some adverse effects, such as those affecting the gastrointestinal tract or central nervous system, may be more likely if alcohol is consumed at the same time as IBUPROFEN MEDICINAE.

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

Do not take IBUPROFEN MEDICINAE if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may also increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first six months of pregnancy, IBUPROFEN MEDICINAE should not be used unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to become pregnant, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, IBUPROFEN MEDICINAE, if taken for longer than a few days, 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 baby (oligohydramnios). If treatment is required for longer than a few days, your doctor may recommend additional monitoring.

If you have taken this medicine while pregnant, you must speak immediately with your doctor and/or midwife so that appropriate monitoring can be arranged.

Breastfeeding

Ibuprofen passes into breast milk, but is unlikely to affect the baby. Short-term use of this medicine at recommended doses is acceptable during breastfeeding. You should speak with your doctor if you need to use the medicine for a longer period while breastfeeding.

Fertility

This medicine belongs to a group of medicines called NSAIDs, which may impair fertility in women. This effect is reversible after stopping the medicine.

You should consult your doctor if any of the above conditions apply to you.

Driving and operating machinery

Ibuprofen usually has no effect or has a negligible effect on the ability to drive and operate machinery.

However, since adverse effects on the central nervous system such as fatigue and dizziness may occur at higher doses, the ability to react and to actively participate in road traffic and operate machinery may be impaired in individual cases. This is more likely when the medicine is taken together with alcohol.

IBUPROFEN MEDICINAE contains soya

The medicine contains soya lecithin. Do not use if you are known to be hypersensitive to peanuts or soya.

IBUPROFEN MEDICINAE contains potassium

The medicine contains 28 mg of potassium per capsule, which should be taken into account in patients with impaired renal function and in patients who are controlling potassium intake in their diet.

IBUPROFEN MEDICINAE contains sorbitol (E 420)

Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should contact a doctor before taking this medicine.

3. How to use IBUPROFEN MEDICINAE

This medicine should always be taken exactly as described in this patient leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms.
If the patient has an infection, seek immediate medical advice if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents with body weight of at least 40 kg (aged 12 years and above):
The recommended single dose is 1 capsule of IBUPROFEN MEDICINAE. If necessary, one additional capsule may be taken. The appropriate interval between doses should be determined according to observed symptoms and the maximum recommended daily dose. The interval should not be less than 6 hours. Do not take more than 3 capsules of IBUPROFEN MEDICINAE within 24 hours.

This medicine is intended for short-term use only.

Instructions for administration
The capsules should be swallowed whole with a large amount of liquid. Patients with sensitive stomachs are advised to take IBUPROFEN MEDICINAE with food.

Consult a doctor:

• In adults, if treatment for migraine headache or fever is required for more than 3 days, or if pain treatment is required for more than 4 days, or if symptoms worsen.
• In adolescents aged 12 to 17 years, if treatment is required for longer than 3 days or if symptoms worsen.

Use in children and adolescents
This medicine is not intended for use in children under 12 years of age or in adolescents weighing less than 40 kg.

Overdose of IBUPROFEN MEDICINAE
If more capsules than recommended are taken, or if the medicine is accidentally ingested by a child, contact a doctor immediately or go to the nearest hospital for assessment of potential health risks and advice on 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 patients with asthma. Following large doses, drowsiness, disorientation, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, dizziness, presence of blood in urine, hypotension, increased blood potassium levels, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, feeling cold, and breathing difficulties have been reported.

Missed dose of IBUPROFEN MEDICINAE
Do not take a double dose to make up for a missed dose.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, IBUPROFEN MEDICINAE may cause adverse effects, although
they do not occur in everyone.

• Fluid retention (oedema), high blood pressure, and heart failure have been reported with the use of NSAIDs.
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

The most commonly observed adverse effects are gastrointestinal. Gastric and (or) duodenal ulcers (peptic ulcer disease), perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2 "Warnings and precautions"). After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, gastrointestinal discomfort, abdominal pain, melaena, haematemesis, oral and pharyngeal ulcers (ulcerative stomatitis), exacerbation of colitis and Crohn's disease (see section 2 "Warnings and precautions"). Less frequently, inflammation of the gastric mucosa (gastritis) has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.
You must stop taking IBUPROFEN MEDICINAE and contact your doctor immediately if any of the following symptoms occur:

• Severe abdominal pain, especially after starting treatment with IBUPROFEN MEDICINAE (uncommon: may affect up to 1 in 100 people).
• Black stools, bloody diarrhoea, or vomiting blood (uncommon: may affect up to 1 in 100 people).
• Skin rash, severe skin peeling or blisters, mucosal lesions (very rare: may affect up to 1 in 10,000 people), or any signs of hypersensitivity (uncommon: may affect up to 1 in 100 people).
• Fever, sore throat and oral cavity pain, influenza-like symptoms, fatigue, nosebleeds and skin bleeding. This may be due to a decrease in the number of white blood cells in the body (agranulocytosis) (very rare: may affect up to 1 in 10,000 people).
• Severe or persistent headache (very rare: may affect up to 1 in 10,000 people).
• Blisters on the palms and soles (Stevens-Johnson syndrome) (very rare: may affect up to 1 in 10,000 people).
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell) (frequency unknown: frequency cannot be estimated from available data).
• Red, peeling, widespread rash with irregularities under the skin and blisters, mainly located in skin folds, on the trunk and upper limbs, accompanied by fever, at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, treatment with IBUPROFEN MEDICINAE must be discontinued and medical help sought immediately. See also section 2 (frequency unknown: frequency cannot be estimated from available data).
• Red, non-elevated, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, and ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and influenza-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• Red, peeling rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis).

Other possible adverse effects

• Common: may affect up to 1 in 10 people gastrointestinal symptoms such as dyspepsia, abdominal pain and nausea, diarrhoea, vomiting, flatulence (wind), and constipation. Minor gastrointestinal bleeding, which in exceptional cases may lead to anaemia.
• Uncommon: may affect up to 1 in 100 people peptic ulceration of the gastrointestinal tract, potentially with bleeding and perforation, ulcerative stomatitis, worsening of existing intestinal disease (colitis or Crohn's disease), gastritis. Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with a drop in blood pressure). Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, and fatigue.

Visual disturbances.

• Rare: may affect up to 1 in 1,000 people tinnitus, hearing loss. Pain in the flanks and (or) epigastric region, blood in urine, and fever may be symptoms of kidney damage (papillary necrosis). Increased blood uric acid levels, increased blood urea levels.
• Very rare: may affect up to 1 in 10,000 people If signs of infection appear or worsen during treatment with IBUPROFEN MEDICINAE, consult a doctor immediately. It is necessary to determine whether there are indications for anti-infective and/or antibiotic therapy. Aseptic meningitis with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disturbances in consciousness has been observed after ibuprofen administration. Patients with autoimmune disorders (systemic lupus erythematosus (SLE), mixed connective tissue disease) appear to be predisposed. Disorders in blood cell production (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) – initial symptoms include: fever, sore throat, superficial oral ulcers, influenza-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In such cases, treatment must be stopped immediately and a doctor consulted. Do not self-administer analgesics or antipyretic medicinal products (fever-reducing medicines). Severe generalised allergic reactions (hypersensitivity reactions) – symptoms may include: facial, tongue and throat swelling, shortness of breath, rapid heartbeat, drop in blood pressure, up to life-threatening shock. Immediate medical help is required if any of these symptoms occur, even after the first dose. Psychotic reactions, depression. With high-dose NSAID treatment, palpitations, heart failure, myocardial infarction, oedema, hypertension, and heart failure have been reported. Hypertension, vasculitis. Asthma, dyspnoea, bronchospasm. Oesophagitis, pancreatitis, formation of diaphragm-like strictures of the small intestine. If relatively severe epigastric pain, vomiting blood or black stools occur, treatment should be discontinued and medical advice sought. Liver damage (initial symptoms may include skin discolouration), especially with long-term therapy, liver failure, acute hepatitis, liver function disorders. Reduced urine output and oedema (particularly in patients with high blood pressure or reduced kidney function); oedema (swelling) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If any of the above symptoms or general malaise occur, treatment with IBUPROFEN MEDICINAE must be stopped and a doctor contacted immediately, as these may be the first signs of kidney damage or kidney failure. Severe forms of skin reactions, including rash with redness and blisters, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), hair loss (alopecia).
• Frequency not known (frequency cannot be estimated from available data): skin becomes sensitive to light.

Use of medicines such as IBUPROFEN MEDICINAE may be associated with a small increase in the
risk of myocardial infarction ("heart attack") or stroke (see section 2 "Other warnings").
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 of the 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 authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store IBUPROFEN MEDICINAE

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and
blister after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
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 package and other information

What IBUPROFEN MEDICINAE contains

• The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen.
• Other ingredients are:

Capsule filling:
Macrogol 600 (E 1521)
Potassium hydroxide (E 525)
Purified water
Capsule shell:
Purified water
Sorbitol, liquid, partially dehydrated (E 420)
Gelatine (E 441)
Hydrolysed gelatine
Erythrosine (E127)
Soybean lecithin
Medium-chain triglycerides
Macrogol 600 (E 1521)

What IBUPROFEN MEDICINAE looks like and contents of the pack

IBUPROFEN MEDICINAE, 400 mg, soft capsules
Transparent, reddish-pink, oval, soft gelatin capsule containing a sticky liquid ranging in colour from clear to pale pink.

Pack sizes: PVDC/PVC/aluminium blisters containing 8, 16, 24, 32, 40, 48, or 50 soft capsules. The blisters are packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
MEDICINAE Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
tel. +48 42 2008118

Importer
Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany

This medicinal product is authorised in the European Economic Area under the following names:
Poland: IBUPROFEN MEDICINAE
Netherlands: IBUPROFEN MEDICINAE