Ibuprofen apteo med

Patient Information Leaflet

Ibuprofen APTEO MED, 200 mg, film-coated tablets
For adults and adolescents weighing 40 kg or more (aged 12 years and above)
Ibuprofenum
Please read 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for fever or 4 days of treatment for pain, or if you feel worse, consult your doctor.

Leaflet Contents

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

1. What Ibuprofen APTEO MED is and what it is used for

Ibuprofen APTEO MED contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that relieve pain and reduce fever.
This medicine is used for the short-term symptomatic treatment of mild to moderate pain, such as headache, menstrual pain, toothache, and also for the treatment of fever.
If there is no improvement after 3 days of treatment for fever or 4 days of treatment for pain, or if you feel worse, consult your doctor.

2. Important information before taking Ibuprofen APTEO MED

When not to take Ibuprofen APTEO MED:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has experienced breathing difficulties, asthma, nasal congestion, swelling or hives after taking acetylsalicylic acid (aspirin) or other similar pain-relieving medicines (NSAIDs),
• if the patient has a peptic ulcer (or has had two or more episodes of peptic ulcer disease) or gastrointestinal bleeding,
• if the patient has previously experienced gastrointestinal bleeding or perforation after taking NSAIDs,
• if the patient has severe kidney, heart or liver failure,
• if the patient is experiencing bleeding, including bleeding within the brain (cerebral haemorrhage),
• if the patient has unexplained disorders of the blood-forming system,
• in patients with significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake),
• in pregnant women during the third trimester of pregnancy.

Warnings and precautions
Special caution is required when using Ibuprofen APTEO MED:
Taking 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 in high
doses. Do not exceed the recommended dose or duration of treatment.
Serious skin reactions have been reported with the use of 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). If the patient develops any
of the symptoms related to these serious skin reactions described in section 4, Ibuprofen APTEO MED
should be discontinued immediately and medical help should be sought.
Before starting to take Ibuprofen APTEO MED, discuss the following with your doctor
or pharmacist:

• if any skin rash, mucosal changes, blisters or other allergic symptoms appear, discontinue taking Ibuprofen APTEO MED immediately and seek medical help without delay, as these may be the first signs of a very serious skin reaction. Serious skin reactions associated with the use of Ibuprofen APTEO MED have been reported. See section 4.
• Ibuprofen APTEO MED may mask objective signs of infection such as fever and pain. Therefore, Ibuprofen APTEO MED may delay appropriate treatment of infection, potentially leading to an increased 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 ongoing infection and symptoms persist or worsen, medical advice should be sought immediately.
• if the patient has been diagnosed with inherited disorders of blood system function (e.g. acute intermittent porphyria);
• if the patient is elderly, as they may be at greater risk of serious adverse effects associated with NSAID use, particularly gastrointestinal bleeding and perforation, which can be fatal;
• if the patient has had or currently has asthma or allergic disease, as breathing difficulties may occur;
• if the patient has fever, nasal polyps or chronic obstructive respiratory disorders, as there is an increased risk of allergic reactions. These may present as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema or urticaria;
• if the patient has chickenpox (varicella), use of Ibuprofen APTEO MED should be avoided;
• if the patient has impaired liver or kidney function;
• if the patient has recently undergone major surgery;
• if the patient has Crohn's disease or ulcerative colitis, as symptoms may worsen;
• if the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease – diseases affecting the immune system;
• 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 if the patient has had any stroke (including mini-stroke or transient ischaemic attack - TIA);
• if the patient has high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes;
• during prolonged treatment with Ibuprofen APTEO MED, regular monitoring of liver and kidney function and blood counts is required;
• avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to increased risk of adverse effects (see section "Ibuprofen APTEO MED and other medicines").

The risk of adverse effects can be minimized by using the lowest effective dose for the
shortest duration necessary to relieve symptoms.
Gastrointestinal bleeding, ulcers or perforations, which may be fatal,
have been reported during treatment with all NSAIDs, at any time during therapy,
regardless of whether previous warning symptoms were present or whether there was
a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers or perforations increases
with higher NSAID doses and in patients with a history of ulcers, especially if
previously complicated by bleeding or perforation (see "When not to take Ibuprofen APTEO
MED" in section 2), and in elderly patients. In such patients, treatment should
be initiated with the lowest effective doses. In these patients and in patients
requiring concomitant administration of low-dose acetylsalicylic acid or other
medicines that may increase the risk of gastrointestinal disorders, concomitant
treatment with gastroprotective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal adverse effects, particularly elderly individuals,
should report any concerning abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment.
Caution is advised in patients taking concomitant medicines that increase the risk of
ulceration or bleeding, such as corticosteroids, anticoagulants such as warfarin,
selective serotonin reuptake inhibitors (used in the treatment of psychiatric disorders,
including depression) or antiplatelet agents, e.g. acetylsalicylic acid (see "Ibuprofen
APTEO MED and other medicines" in section 2).
The medicine should be discontinued and medical advice sought if gastrointestinal
bleeding or ulceration occurs during treatment with Ibuprofen APTEO MED.
Severe and acute hypersensitivity reactions (e.g. anaphylactic shock) are very rarely observed. After the first signs of severe hypersensitivity following administration of Ibuprofen APTEO MED, the medicine should be discontinued and medical advice sought immediately.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be carefully monitored during treatment.
Ibuprofen may mask symptoms of infection and fever.
Chronic use of pain-relieving medicines (of various types) may generally lead to
permanent kidney damage. This risk may increase during physical exertion associated with salt loss and dehydration. Therefore, such practice should be avoided.
In dehydrated adolescents, there is a risk of impaired kidney function.
Prolonged use of various types of pain-relieving medicines for headache may
worsen symptoms. If such a situation occurs or is suspected, medical advice should be sought and treatment discontinued. In patients with frequent or daily headaches, despite (or because of) regular use of headache medicines, medication-overuse headache should be suspected.
If any of the above situations apply to the patient, contact a doctor
before taking Ibuprofen APTEO MED.
Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported during treatment.
If any of these symptoms occur, Ibuprofen APTEO MED should be discontinued immediately and medical help or emergency medical services should be contacted without delay.

Ibuprofen APTEO MED and other medicines
Ibuprofen APTEO MED may affect the action of other medicines or other medicines may affect
the action of Ibuprofen APTEO MED, for example:

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

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

Some other medicines may affect the action of Ibuprofen APTEO MED or Ibuprofen APTEO MED may affect the action of other medicines. Therefore, always consult your doctor or pharmacist before using Ibuprofen APTEO MED with other medicines.

Ibuprofen APTEO MED and alcohol
The occurrence of certain adverse effects, such as those affecting the gastrointestinal system or central nervous system, may be more likely when taking Ibuprofen APTEO MED and consuming alcohol simultaneously.

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 her doctor or pharmacist before using this medicine.

Pregnancy
Ibuprofen APTEO MED should not be used during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause disturbances in kidney and heart function in the unborn child. It may affect bleeding tendencies in both the mother and child and may result in delivery occurring later or lasting longer than expected. Ibuprofen APTEO MED should not be taken during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to become pregnant, the lowest possible dose should be used for the shortest possible duration. Ibuprofen APTEO MED taken for longer than a few days beyond the 20th week of pregnancy may cause disturbances in kidney function in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, your doctor may recommend additional monitoring.

Ibuprofen should be avoided in women planning pregnancy or who are pregnant. Use of the medicine at any stage of pregnancy should only occur on medical advice.

Breastfeeding
This medicine may be used during breastfeeding for up to 3 days (when treating fever) or 4 days (when treating pain), as only very small amounts of the medicine pass into breast milk.

Effect on fertility
Ibuprofen APTEO MED belongs to a group of medicines called NSAIDs, which may adversely affect fertility in women. This effect is reversible and resolves after stopping treatment.

Driving and operating machinery
When taking high doses of Ibuprofen APTEO MED, adverse effects on the central nervous system such as fatigue and dizziness may occur. In individual cases, reaction time may be prolonged and the ability to actively participate in traffic or operate machinery may be impaired. Concurrent alcohol consumption may intensify adverse effects.

Ibuprofen APTEO MED contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact their doctor before taking this medicine.

Ibuprofen APTEO MED contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ibuprofen APTEO MED

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest necessary duration to relieve symptoms.
Use the lowest effective dose for the shortest period necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Oral administration. For individuals with a sensitive gastrointestinal tract, it is recommended to take the medicine
Ibuprofen APTEO MED with food.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Taking a higher than recommended dose of Ibuprofen APTEO MED
If you take more than the recommended dose of the medicine, or if a child accidentally ingests it, you should always contact a doctor immediately or go to a hospital emergency department to obtain advice on the risks and actions to be taken.
Symptoms of an overdose may include: nausea, vomiting (possibly with blood), abdominal pain, diarrhoea, tinnitus, headache, confusion, nystagmus, gastrointestinal bleeding, restlessness, confusion, coma, prolonged prothrombin time/INR, acute renal failure, liver damage, hypotension, respiratory depression, cyanosis, and worsening of asthma in patients with asthma. With large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
Missing a dose of Ibuprofen APTEO MED
Do not take a double dose to make up for a missed dose.
If you have any further questions concerning 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 occurrence of adverse reactions can be minimized by using the lowest effective dose for the
shortest duration necessary to relieve symptoms. One of the known adverse reactions associated with NSAIDs (see below) may occur.
In such a case or if in doubt, treatment should be discontinued and medical advice should be sought promptly. Elderly patients taking this medicine are at higher risk of experiencing adverse reactions.
If any of the following symptoms occur in a patient, ibuprofen must be discontinued immediately and medical help should be sought :

• symptoms of gastrointestinal bleeding , such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds;
• symptoms of a rare but severe allergic reaction , such as swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, and drop in blood pressure leading to shock. These symptoms may occur even after the first dose;
• red, flat, non-elevated, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, and mucosal 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, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

If any adverse reactions occur or worsen, or if any adverse reactions not listed in this leaflet occur, consult a doctor.
Common (may occur in up to 1 in 10 patients)

• gastrointestinal disorders such as indigestion, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, and minor gastrointestinal bleeding, which may rarely lead to anaemia;
• rash.

Uncommon (may occur in up to 1 in 100 patients)

• runny nose;
• allergic reactions with skin rash and itching, as well as bronchial asthma attacks (possibly with decreased blood pressure), worsening of asthma, breathing difficulties (bronchospasm), shortness of breath. If any of these symptoms occur, stop taking Ibuprofen APTEO MED and consult a doctor immediately;
• gastric and intestinal ulcers, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulceration (oral ulcerative stomatitis), gastric mucosal inflammation, exacerbation of colitis and Crohn's disease;
• central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability or fatigue, paresthesia;
• visual disturbances;
• urticaria, itching, purpura.

Rare (may occur in up to 1 in 1,000 patients)

• optic neuritis;
• toxic optic neuropathy;
• hearing disturbances;
• tinnitus (ringing in the ears);
• dizziness;
• kidney damage (papillary necrosis) and increased blood uric acid levels.

Very rare (may occur in up to 1 in 10,000 patients)

• oesophagitis or pancreatitis, formation of membrane-like strictures in the small and large intestine (intestinal diaphragm formation);
• vasculitis;
• severe skin infections and soft tissue complications during varicella virus infection (varicella);
• reduced urine output and oedema (particularly in patients with hypertension or impaired kidney function);
• cloudy urine (nephrotic syndrome), kidney inflammation (interstitial nephritis), which may be associated with acute renal failure;
• psychotic reactions, anxiety, confusion, depression;
• worsening of inflammatory conditions related to infection (e.g. necrotizing fasciitis) during concomitant use of non-steroidal anti-inflammatory drugs. If these symptoms occur or worsen, immediate medical consultation is required. Investigations should be performed to determine whether antimicrobial or antibiotic therapy is indicated;
• hypertension, palpitations, heart failure, myocardial infarction;
• symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever or altered consciousness during ibuprofen use. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) may be at higher risk of this complication. Immediate medical attention is required if these symptoms occur;
• severe skin reactions such as erythematous blistering rash (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell's syndrome), hair loss (alopecia);
• severe generalized hypersensitivity reactions;
• blood cell production disorders (leukopenia, thrombocytopenia, neutropia, pancytopenia, agranulocytosis, anaemia, including aplastic and haemolytic anaemia), the first signs of which may include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding. In such cases, treatment must be stopped immediately and a doctor should be consulted. Do not self-medicate with analgesics or antipyretics;
• liver function disorders, liver damage, particularly during prolonged treatment, liver failure, acute hepatitis, jaundice (yellowing of the skin or whites of the eyes).

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

• red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, stop taking Ibuprofen APTEO MED and seek medical help immediately. See also section 2;
• skin becomes sensitive to light;
• chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Taking medicines such as Ibuprofen APTEO MED may be associated with a small
increased risk of heart attack (myocardial infarction) or stroke.
Cases of oedema, hypertension and heart failure have been reported during NSAID therapy.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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.: 22 49 21 301,
fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen APTEO MED

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP. The expiry date refers to the last day of the stated month.
Store blisters in the outer packaging to protect from light. No special
requirements for storage.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen APTEO MED contains

• The active substance is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
• Other ingredients are:
  Tablet core: Lactose monohydrate, corn starch, hypromellose, anhydrous colloidal silicon dioxide, microcrystalline cellulose, sodium croscarmellose, magnesium stearate
  Tablet coating Opadry White 03G28692: Hypromellose, titanium dioxide (E 171), macrogol 6000, macrogol 400

What Ibuprofen APTEO MED looks like and contents of the pack
Coated tablets
White, film-coated, capsule-shaped tablets imprinted with the number "235" on one side and smooth on the other side.
Pack sizes: 10, 12, 20, 24, 30, 48, 50, 60, 84, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231

Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Wave Pharma Limited
Ground floor, Cavendish House
369 Burnt Oak Broadway
Edgware, HA8 5AW,
United Kingdom
Interpharma Services Ltd.
43A Cherni Vrach Blvd.
1407 Sofia
Bulgaria
Ascend Laboratories (UK) Ltd.
4 Floor, Cavendish House
369 Burnt Oak Broadway
Edgware HA8 5AW
United Kingdom
Ascend GmbH
Sebastian-Kneipp-Straße 41
60439 Frankfurt am Main,
Germany