Ibuprofen Forte Apteo Med

Leaflet attached to the packaging: information for the user

Ibuprofen FORTE APTEO MED, 400 mg, coated tablets

For adults and adolescents with a body weight of 40 kg or more (from 12 years of age onwards)
Ibuprofen

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days in the case of fever treatment and 4 days in the case of pain treatment, there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

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

2. Important information before taking Ibuprofen FORTE APTEO MED

When not to take Ibuprofen FORTE APTEO MED:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has had breathing difficulties, asthma, hay fever, swelling, or hives after taking acetylsalicylic acid (aspirin) or other similar painkillers (NSAIDs),
• if the patient has stomach ulcers (or has had two or more instances of stomach ulcers) or gastrointestinal bleeding,
• if the patient has had bleeding or perforation of the gastrointestinal tract after taking NSAIDs,
• if the patient has severe kidney, heart, or liver failure,
• if the patient has bleeding, including bleeding in the brain (cerebral hemorrhage),
• if the patient has unexplained blood disorders,
• in patients with significant dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• in pregnant women in the third trimester.

Warnings and precautions

When taking Ibuprofen APTEO MED, you should be particularly careful:

Taking anti-inflammatory and/or pain-relieving medications, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose and duration of treatment.
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient experiences any symptoms related to these severe skin reactions described in section 4, they should immediately discontinue Ibuprofen APTEO MED and seek medical attention.

Before starting Ibuprofen FORTE APTEO MED, you should discuss the following with your doctor or pharmacist:

• if you experience: any skin rash, mucosal lesions, blisters, or other signs of allergy, you should discontinue Ibuprofen FORTE APTEO MED and seek medical attention immediately, as these may be the first signs of a severe skin reaction. Severe skin reactions have been reported with Ibuprofen FORTE APTEO MED. See section 4.
• Ibuprofen FORTE APTEO MED may mask the signs of infection, such as fever and pain. Therefore, Ibuprofen FORTE APTEO MED may delay the application of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult a doctor immediately.
• if the patient has a history of hereditary blood disorders (e.g., acute intermittent porphyria);
• if the patient is elderly, as they may be at greater risk of experiencing serious side effects caused by NSAIDs, particularly gastrointestinal bleeding and perforation, which can be fatal.
• if the patient has a history of asthma or allergic disease, as they may experience shortness of breath;
• if the patient has fever, nasal polyps, or chronic obstructive pulmonary disease, as they may be at increased risk of allergic reactions. These can occur as asthma attacks (so-called analgesic-induced asthma), Quincke's edema, or urticaria;
• if the patient has chickenpox (varicella), they should avoid taking Ibuprofen FORTE APTEO MED;
• if the patient has liver or kidney disorders;
• 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 that attack the immune system;
• if the patient has heart diseases, such as heart failure, angina pectoris (chest pain), has had a heart attack, has undergone coronary artery bypass grafting, has peripheral artery disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA);
• if the patient has high blood pressure, diabetes, high cholesterol levels, has a family history of heart disease or stroke, or smokes;
• in the case of long-term administration of Ibuprofen FORTE APTEO MED, regular monitoring of liver and kidney function, as well as blood morphology, is necessary;
• you should avoid concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, due to the increased risk of adverse reactions (see "Ibuprofen FORTE APTEO MED and other medicines" in section 2).

Adverse reactions can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
Gastrointestinal bleeding, ulcers, or perforations, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers, or perforations increases with the dose of NSAIDs and in patients with a history of ulcers, especially if complicated by bleeding or perforation (see "When not to take Ibuprofen FORTE APTEO MED" in section 2), and in elderly patients. In such patients, treatment should be initiated with the lowest effective dose. In these patients and in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, the concomitant use of drugs with a protective effect on the gastric mucosa (e.g., misoprostol or proton pump inhibitors) should be considered.
Patients who have experienced gastrointestinal adverse reactions in the past, especially the elderly, should report any alarming abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Caution should be exercised in patients taking concomitant medications that increase the risk of gastrointestinal ulcers or bleeding, such as corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (used to treat mental disorders, including depression), or antiplatelet agents (e.g., acetylsalicylic acid) (see "Ibuprofen FORTE APTEO MED and other medicines" in section 2).
Treatment should be discontinued and a doctor consulted if gastrointestinal bleeding or ulcers occur during Ibuprofen FORTE APTEO MED treatment.
Severe and acute hypersensitivity reactions (e.g., anaphylactic shock) are very rare. If the first symptoms of severe hypersensitivity occur after administration of Ibuprofen FORTE APTEO MED, treatment should be discontinued and medical attention sought immediately.
Ibuprofen may temporarily inhibit platelet aggregation. Therefore, during treatment, patients with coagulation disorders should be closely monitored.
Ibuprofen may mask signs of infection and fever.
Chronic use of painkillers (of various types) can lead to permanent kidney damage. This risk may increase during physical exertion accompanied by loss of salts and dehydration. Therefore, such behavior should be avoided.
Dehydrated adolescents are at risk of kidney dysfunction.
Long-term use of various painkillers for headache may worsen symptoms. If the patient experiences such a situation or suspects that it may occur, they should consult a doctor and discontinue the medicine. In patients with frequent or daily headaches, despite (or due to) regular use of headache medications, it can be suspected that it is a headache caused by medication overuse.
If any of the above cases apply to the patient, they should consult a doctor before taking Ibuprofen FORTE APTEO MED.
During ibuprofen treatment, allergic reactions to this medicine have been reported, including difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms are observed, Ibuprofen APTEO MED should be discontinued and medical attention or emergency services should be sought immediately.

Ibuprofen FORTE APTEO MED and other medicines

Ibuprofen FORTE APTEO MED may affect the action of other medicines or other medicines may affect the action of Ibuprofen FORTE APTEO MED, e.g.,

• anticoagulant medicines (i.e., blood thinners or medicines that prevent blood clots, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, if the patient is taking:

Other medicines may affect the action of Ibuprofen FORTE APTEO MED or Ibuprofen FORTE APTEO MED may affect the action of other medicines. Therefore, before taking Ibuprofen FORTE APTEO MED with other medicines, the patient should always consult a doctor or pharmacist.

Ibuprofen FORTE APTEO MED with alcohol

The occurrence of certain adverse reactions, such as those related to the gastrointestinal or central nervous system, may be more likely when Ibuprofen FORTE APTEO MED and alcohol are taken concomitantly.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Ibuprofen FORTE APTEO MED should not be used during the last 3 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 affect the patient's and child's tendency to bleed and may cause the delivery to be later or longer than expected. Ibuprofen FORTE APTEO MED should not be taken during the first 6 months of pregnancy, unless absolutely necessary and recommended by a doctor. If treatment is needed during this period or when trying to conceive, the lowest dose should be used for the shortest possible time. Ibuprofen FORTE APTEO MED taken for more than a few days from the 20th week of pregnancy may cause kidney problems in the unborn child, which can lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is needed for more than a few days, the doctor may recommend additional monitoring.
It is recommended to avoid ibuprofen use in women planning pregnancy or who are pregnant. The use of the medicine during pregnancy may only be done on the advice of a doctor.
Breastfeeding
This medicine can be used during breastfeeding for up to 3 days (for fever treatment) or 4 days (for pain treatment), as only small amounts of the medicine pass into breast milk.
Fertility
Ibuprofen FORTE APTEO MED belongs to a group of NSAIDs that may adversely affect female fertility. This effect is reversible and disappears after the end of treatment.

Driving and using machines

When taking high doses of Ibuprofen FORTE APTEO MED, adverse reactions from 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 and operate machinery may be impaired. Concomitant alcohol consumption may enhance adverse reactions.

Ibuprofen FORTE APTEO MED contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking this medicine.

Ibuprofen FORTE APTEO MED contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is essentially 'sodium-free'.

3. How to take Ibuprofen FORTE APTEO MED

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Adverse reactions can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
The smallest effective dose should be used for the shortest duration necessary to relieve symptoms.
If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should consult a doctor immediately (see section 2).
Oral administration. In patients with sensitive gastrointestinal tracts, it is recommended to take Ibuprofen FORTE APTEO MED with food.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor or pharmacist.

Taking a higher dose of Ibuprofen FORTE APTEO MED than recommended

In the event of an overdose, the patient should immediately consult a doctor or go to the hospital emergency department for advice on the risks and actions to be taken.
Symptoms of overdose may include: nausea, vomiting (which may be bloody), abdominal pain, diarrhea, ringing in the ears, headache, disorientation, tremors, and convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and difficulty breathing.

gastric hemorrhage, excitement, disorientation, coma, prolonged prothrombin time/INR, acute renal failure, liver damage, hypotension, respiratory depression, cyanosis, exacerbation of asthma in patients with asthma. These symptoms may occur even after the first administration of the medicine. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and difficulty breathing have been reported.

Missing a dose of Ibuprofen FORTE APTEO MED

A double dose should not be taken to make up for a missed dose.
In case of further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen FORTE APTEO MED can cause side effects, although not everybody gets them.
Adverse reactions can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
It is possible that one of the known side effects of NSAIDs may occur (see below). In such a case or in case of doubt, the patient should discontinue the medicine and consult a doctor as soon as possible. Elderly patients taking this medicine are more likely to experience side effects.

If the patient experiences any of the following symptoms, they should immediately stop taking ibuprofen and seek medical attention:

• symptoms of gastrointestinal bleeding, such as: severe abdominal pain, black tarry stools, vomiting blood or dark particles that look like coffee grounds;
• symptoms of a very rare but serious allergic reaction, such as: swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, low blood pressure leading to shock. These symptoms may occur even after the first administration of the medicine;
• red, scaly, flat, or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, 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 body temperature, and swollen lymph nodes (DRESS syndrome);
• red, scaly, blistering skin rash with bumps under the skin and blisters, usually appearing at the start of treatment, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

If side effects occur or worsen, or if side effects not listed in the leaflet occur, the patient should consult a doctor.

Common(may affect up to 1 in 10 people)

• gastrointestinal disorders, such as indigestion, heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding, which may lead to anemia in exceptional cases;
• rash.

Uncommon(may affect up to 1 in 100 people)

• hay fever;
• allergic reactions with skin rash and itching, as well as asthma attacks (with possible low blood pressure) exacerbating asthma, difficulty breathing (bronchospasm). If any of the above symptoms occur, the patient should discontinue Ibuprofen FORTE APTEO MED and consult a doctor immediately;
• ulcers and perforations of the stomach and intestines, sometimes with bleeding, mouth ulcers, stomach inflammation, worsening of ulcerative colitis and Crohn's disease;
• central nervous system disorders, such as headache, dizziness, insomnia, excitement, irritability, or fatigue, paresthesia;
• vision disorders;
• hives, itching, purpura.

Rare(may affect up to 1 in 1,000 people)

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

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

• esophageal or pancreatic inflammation, formation of membrane-like constrictions in the small and large intestines (development of diaphragm-like intestinal constrictions);
• vasculitis;
• severe skin and soft tissue infections occurring during chickenpox (varicella) infection;
• reduced urine output and swelling (especially in patients with hypertension or kidney disorders);
• nephrotic syndrome (characterized by low albumin levels in the blood, high blood lipid levels, and swelling), interstitial nephritis (inflammation of the kidney tissue), which may be accompanied by acute renal failure;
• psychotic reactions, anxiety, confusion, depression;
• hypertension, palpitations, heart failure, myocardial infarction;
• exacerbation of inflammatory conditions associated with infection (e.g., necrotizing fasciitis) during concomitant use of NSAIDs. If these symptoms occur or worsen, the patient should immediately consult a doctor. Tests should be performed to determine if there are indications for the use of anti-infective agents and/or antibiotics;
• anaphylactic shock, angioedema;
• severe skin reactions, such as skin rash with redness and blisters (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), hair loss (alopecia);
• severe generalized hypersensitivity reactions;
• blood disorders (leukopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, anemia, including aplastic and hemolytic anemia), the first signs of which are: fever, sore throat, mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, treatment should be discontinued and a doctor consulted immediately. Do not take painkillers or antipyretics on your own;
• liver function disorders, liver damage, especially during long-term treatment, liver failure, acute hepatitis, jaundice (yellowing of the skin or whites of the eyes).

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

• red, scaly, blistering skin rash with bumps under the skin and blisters, usually appearing at the start of treatment, accompanied by fever. If such symptoms occur, the patient should discontinue Ibuprofen FORTE APTEO MED and seek medical attention immediately. See also section 2;
• skin sensitivity to light,
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Taking medicines like Ibuprofen FORTE APTEO MED may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
NSAID treatment has been associated with fluid retention, hypertension, and heart failure.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ibuprofen FORTE APTEO MED

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after 'EXP'. The expiry date refers to the last day of that month.
Store the blisters in the outer carton to protect from light. There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen FORTE APTEO MED contains

• The active substance of the medicine is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: Tablet core: lactose monohydrate, corn starch, hypromellose, colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, magnesium stearate

Tablet coating Opadry White 03G28692: hypromellose, titanium dioxide (E 171), macrogol 6000, macrogol 400

What Ibuprofen FORTE APTEO MED looks like and contents of the pack

Coated tablets
White coated tablets, oval in shape, with the number "236" embossed 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 authorization 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
Date of last revision of the leaflet:August 2024