Ibuprofen Apteo Med

Leaflet attached to the packaging: information for the user

Ibuprofen APTEO MED, 200 mg, coated tablets

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

Read the leaflet carefully 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your 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 you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

Ibuprofen 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 short-term symptomatic treatment of mild or moderate pain, such as headache, menstrual pain, 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 you feel worse, you should consult your doctor.

2. Important information before taking Ibuprofen APTEO MED

When not to take Ibuprofen APTEO MED:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if you have had breathing difficulties, asthma, hay fever, swelling, or hives after taking acetylsalicylic acid (aspirin) or other similar painkillers (NSAIDs),
• if you have stomach ulcers (or have had two or more episodes of stomach ulcers) or gastrointestinal bleeding,
• if you have had bleeding or perforation of the gastrointestinal tract after taking NSAIDs,
• if you have severe kidney, heart, or liver failure,
• if you have bleeding, including bleeding in the brain (cerebral hemorrhage),
• if you have 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 like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used 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 occurred with ibuprofen use. If you experience any symptoms related to these severe skin reactions described in section 4, you should stop taking Ibuprofen APTEO MED and seek medical attention immediately.

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

• if you experience: any skin rash, mucosal lesions, blisters, or other symptoms of allergy, you should stop taking Ibuprofen 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 APTEO MED. See section 4.
• Ibuprofen APTEO MED may mask the signs of infection, such as fever and pain. As a result, Ibuprofen APTEO MED may delay the application of appropriate infection treatment and lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medicine while an infection is present and the symptoms of the infection persist or worsen, you should consult your doctor immediately.
• if you have a history of hereditary blood disorders (e.g., acute intermittent porphyria);
• if you are elderly, as you may be at greater risk of experiencing serious side effects caused by NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal;
• if you have asthma or an allergic disease, as you may experience shortness of breath;
• if you have fever, nasal polyps, or chronic obstructive respiratory disease, as you may be at increased risk of allergic reactions. These can occur as asthma attacks (so-called analgesic asthma), Quincke's edema, or hives;
• if you have chickenpox (varicella), you should avoid taking Ibuprofen APTEO MED;
• if you have liver or kidney disorders;
• if you are immediately after major surgery;
• if you have Crohn's disease or ulcerative colitis, as symptoms may worsen;
• if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease - diseases that attack the immune system;
• if you have heart diseases, such as heart failure, angina pectoris (chest pain), you have had a heart attack, coronary artery bypass grafting, you have peripheral artery disease (poor blood circulation in the legs due to narrowed or blocked arteries), or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA);
• if you have high blood pressure, diabetes, high cholesterol levels, if there is a history of heart disease or stroke in your family, or if you smoke;
• with long-term use of Ibuprofen 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 increased risk of adverse reactions (see "Ibuprofen 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 increasing NSAID dose and in patients with a history of ulcers, especially if complicated by bleeding or perforation (see "When not to take Ibuprofen APTEO MED" in section 2), and in the elderly. In such patients, treatment should be initiated with the lowest effective dose. In these patients, as well as in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, consideration should be given to concomitant use with drugs that protect the gastric mucosa (e.g., misoprostol or proton pump inhibitors).
Patients who have experienced gastrointestinal adverse reactions in the past, especially the elderly, should report any disturbing abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Care should be taken 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 APTEO MED and other medicines" in section 2).
Stop treatment and consult a doctor if gastrointestinal bleeding or ulcers occur during Ibuprofen APTEO MED treatment.
Ibuprofen may temporarily inhibit platelet aggregation. Therefore, during treatment, patients with coagulation disorders should be closely monitored.
Ibuprofen may mask signs of infection.
Chronic use of painkillers (of any type) 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 damage.
Long-term use of various painkillers for headache can exacerbate symptoms. If you experience such a situation or suspect it may occur, you should consult your doctor and stop taking 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 applies to you, you should consult your doctor before taking Ibuprofen APTEO MED.
There have been reports of allergic reactions to this medicine, including difficulty breathing, swelling around the face and neck (angioedema), chest pain. If you notice any of these symptoms, you should stop taking Ibuprofen APTEO MED and seek medical attention immediately.

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, e.g.

• anticoagulant medicines (i.e., blood thinners or medicines that prevent blood clots, such as aspirin - 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 you are taking or have recently taken, as well as any medicines you plan to take. Especially if you are taking:

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

Ibuprofen APTEO MED with alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ibuprofen APTEO MED during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney or heart problems in the unborn child. It may affect the tendency to bleed in you and your child and may cause the delivery to be later or longer than expected. Do not take Ibuprofen APTEO MED during the first 6 months of pregnancy, unless absolutely necessary and recommended by your doctor. If you need treatment during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. Ibuprofen 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 baby (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
Do not use ibuprofen 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 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 APTEO MED, side effects from the central nervous system, such as fatigue and dizziness, may occur.
In single cases, the reaction time may be prolonged, and the ability to actively participate in traffic and operate machinery may be impaired. Concomitant alcohol consumption may enhance these side effects.

Ibuprofen APTEO MED contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

Ibuprofen APTEO MED contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that 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 leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Adverse reactions can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
Use the smallest effective dose for the shortest duration necessary to relieve symptoms.
If the symptoms of an infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2).
Oral administration. In patients with sensitive stomachs, it is recommended to take the medicine 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 dose of Ibuprofen APTEO MED than recommended

In case of overdose, always seek immediate medical attention, consulting your doctor or going to the hospital emergency department to assess the risk and advise on actions to be taken.
Symptoms of overdose may include: nausea, vomiting (which may be bloody), abdominal pain, diarrhea, ringing in the ears, headache, disorientation, nystagmus, gastrointestinal bleeding, excitement, disorientation, coma, prolonged prothrombin time/INR, acute renal failure, liver damage, hypotension, depression, respiratory depression, cyanosis, aggravation of asthma in patients with asthma. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties.

Missing a dose of Ibuprofen APTEO MED

Do not take a double dose to make up for a forgotten dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 will occur (see below). In such a case or in case of doubt, you should stop taking the medicine and consult your doctor as soon as possible. Elderly people taking this medicine are more likely to experience side effects.

If you experience any of the following symptoms, stop taking ibuprofen and seek medical attention immediately:

• 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 use of the medicine;
• red, scaly, ring-shaped or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
• red, scaly rash with bumps under the skin and blisters, with fever at the start of treatment (acute generalized exanthematous pustulosis).

If you experience or worsen any side effects, or experience side effects not listed in the leaflet, consult your doctor.

Frequent(may occur in up to 1 in 10 patients)

• gastrointestinal disorders such as indigestion, heartburn, abdominal pain, nausea, vomiting, bloating with gas, diarrhea, constipation, and minor gastrointestinal bleeding, which can lead to anemia in rare cases;
• rash.

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

• runny nose;
• allergic reactions with skin rash and itching, as well as asthma attacks (with possible decreased blood pressure) exacerbating asthma, difficulty breathing, wheezing. If you experience any of these symptoms, stop taking Ibuprofen APTEO MED and consult your doctor immediately;
• stomach and intestinal ulcers, sometimes with bleeding and perforation, inflammation of the oral mucosa with ulcers (ulcerative stomatitis), gastritis, worsening of ulcerative colitis and Crohn's disease;
• central nervous system disorders such as headache, dizziness, insomnia, excitement, irritability, or fatigue;
• vision disorders;
• hives, itching, purpura.

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

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

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

• inflammation of the esophageal or pancreatic mucosa, formation of membranous narrowing in the small and large intestine (formation of pseudo-diverticula of the intestine);
• 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);
• cloudy urine (nephrotic syndrome), kidney inflammation (interstitial nephritis), which may be accompanied by acute renal failure;
• psychotic reactions, anxiety, confusion, depression;
• high blood pressure, palpitations, heart failure, myocardial infarction;
• worsening of inflammatory conditions associated with infection (e.g., necrotizing fasciitis) during concomitant use of NSAIDs. If these symptoms occur or worsen, you should immediately consult your doctor. You should undergo tests to check if there are indications for the use of anti-infective agents and/or antibiotics;
• hypertension, palpitations, heart failure, myocardial infarction;
• severe skin reactions such as skin rash with redness and blisters (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), hair loss (alopecia);
• severe generalized allergic reactions;
• blood disorders (leukopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, anemia, including aplastic and hemolytic anemia), the first symptoms of which are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding. In such cases, treatment should be stopped immediately and a doctor consulted. Do not take painkillers or antipyretics on your own;
• liver 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 available data)

• red, scaly rash with bumps under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever at the start of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking Ibuprofen APTEO MED and seek medical attention immediately. See also section 2;
• skin becomes sensitive to light,
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen 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 packaging and blister after the abbreviation: EXP. The expiry date refers to the last day of the specified month.
Store blisters in the outer packaging to protect from light. There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen APTEO MED contains

• The active substance of the medicine is ibuprofen. Each coated tablet contains 200 mg of ibuprofen.
• Other ingredients are: Tablet core: lactose monohydrate, corn starch, hypromellose, anhydrous colloidal silica, 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, pillow-shaped tablets with "235" 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