Ibuprofen Apteo Med

Package Leaflet: Information for the Patient

Ibuprofen APTEO MED, 50 mg/g, Gel

Ibuprofen

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Package Leaflet

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

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

Ibuprofen APTEO MED is indicated for local, short-term, symptomatic treatment of occasional muscle pain caused by minor bruises, blows, or strains, neck stiffness or other contractures, mild sprains, and lower back pain.
The active substance of this medicine is ibuprofen. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Medicines in this group are used to reduce pain and inflammation. Ibuprofen APTEO MED is intended for use on the skin.
Ibuprofen APTEO MED is intended for use in adults and adolescents over 12 years of age.

2. Important information before using Ibuprofen APTEO MED

When not to use 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 ever had an allergic reaction, such as bronchospasm (constriction of the muscles in the lungs, which can cause shortness of breath), asthma, hay fever, sneezing, runny or itchy nose, or nasal polyps (swelling of the nasal passages), after taking acetylsalicylic acid or other NSAIDs;
• on damaged or diseased skin;
• during the last three months of pregnancy.

Warnings and precautions

Before starting to use Ibuprofen APTEO MED, discuss it with your doctor or pharmacist.

• Do not let the medicine come into contact with the eyes or mucous membranes. Never swallow the medicine.
• Do not apply this medicine to wounded skin or open wounds. Ibuprofen APTEO MED should only be used on undamaged, non-diseased skin.
• Do not use under occlusive dressings (waterproof or airtight bandages or plasters).
• Do not expose the treated area to sunlight to reduce the risk of photosensitivity reactions (skin changes such as eczema, blisters, etc.). If skin reactions occur, stop using this medicine.
• Do not use at the same time as other medicines applied locally to the same skin surface.

Do not use this medicine on a large area of skin or for a long time, as this increases the likelihood of systemic side effects. Follow the instructions for dosage and do not exceed the maximum treatment duration.
Side effects can be reduced by using the smallest effective dose for the shortest necessary duration to relieve symptoms.
In patients with active or history of bronchial asthma or allergic diseases, the use of ibuprofen may cause bronchospasm.
Patients with asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory diseases (especially when they have symptoms similar to hay fever) are more likely to experience asthma attacks (so-called intolerance to painkillers or asthma caused by painkillers), local skin swelling or mucous membrane swelling (so-called Quincke's edema) or hives compared to other patients treated with Ibuprofen APTEO MED.
In these patients, Ibuprofen APTEO MED may only be used with certain precautions and under direct medical supervision. The same recommendations apply to patients allergic to other substances, e.g., those who experience skin reactions, itching, or hives.
Precautions should be taken to prevent children from coming into contact with areas of skin where the medicine has been applied.
Although the systemic availability of topically applied ibuprofen is much lower than that of oral pharmaceutical forms, in rare cases, complications may occur. For this reason, patients with kidney, heart, or liver disorders, patients with active stomach ulcers or a history of them, patients with bowel inflammation, or patients with bleeding ulcers should consult their doctor before using this medicine.
Nonsteroidal anti-inflammatory drugs should be used with caution in elderly patients, as they may be more susceptible to side effects.
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 the use of ibuprofen. If a patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately stop using Ibuprofen APTEO MED and seek medical attention.

Ibuprofen APTEO MED and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not use Ibuprofen APTEO MED at the same time as other medicinal products used locally.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
During the first six months of pregnancy, do not use Ibuprofen APTEO MED unless it is absolutely necessary and recommended by your doctor. Do not use this medicine during the last three months of pregnancy. If treatment is necessary during this period, use the smallest dose for the shortest possible time.
Do not apply this medicine directly to the breast area in breastfeeding women.
Oral forms (e.g., tablets) of Ibuprofen APTEO MED may cause side effects in the unborn child. It is not known if the same risk applies to Ibuprofen APTEO MED when used on the skin.

Driving and using machines

Ibuprofen APTEO MED does not affect the ability to drive or use machines.

3. How to use Ibuprofen APTEO MED

This medicine should always be used exactly as described in this package leaflet or as directed by a doctor or pharmacist. In case of doubt, consult your pharmacist.
Adults and adolescents (over 12 years of age):
Apply 4 to 10 cm of gel (an amount equivalent to 50 - 125 mg of ibuprofen) to the painful area and gently rub in until completely absorbed. If necessary, the medicine can be used more frequently, up to 4 times a day.
The medicine is for use on the skin only.
Apply a thin layer of gel to the skin surface and gently rub into the skin. After rubbing the gel into the skin, wash your hands with soap and water, unless your hands are the area being treated. Dry your hands with a paper towel and then wash them with soap and water. Wait a few minutes for the gel to dry on the skin before applying a bandage. Also, wait for the gel to dry on the skin before taking a shower or bath. Ibuprofen APTEO MED should be used in the smallest effective dose for the shortest necessary duration to relieve symptoms. The gel is intended for short-term use only. Do not use this medicine for more than 7 days (5 days in adolescents). If symptoms persist or worsen after 3 days, consult your doctor.
Children (under 12 years of age):
The safety and efficacy of Ibuprofen APTEO MED in children under 12 years of age have not been established.

Accidental ingestion of the gel

Symptoms will depend on the dose ingested and the time elapsed since ingestion. Symptoms may include nausea, vomiting, abdominal pain, drowsiness, and low blood pressure.
Seek medical attention immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are skin changes. The systemic availability of topically applied ibuprofen is low compared to oral NSAIDs. Side effects, especially those affecting the gastrointestinal system, occur much less frequently with topical ibuprofen use. However, during prolonged use and/or application to large areas of skin, there is a possibility of systemic side effects. Reactions such as abdominal pain, indigestion, stomach upset, and kidney problems may occur.
STOP USINGthis medicine and seek medical attention immediately if you experience:

• Symptoms of an allergic reaction such as asthma, unexplained wheezing, shortness of breath, itching, hay fever, or skin rashes.
• Symptoms of hypersensitivity and skin reactions such as redness, swelling, skin peeling, blistering, or skin shedding.
• Red, scaly, circular patches on the trunk, often with blisters in the center, skin peeling, 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 fever, and swollen lymph nodes (DRESS syndrome).
• Red, scaly, rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). Common side effects (may affect up to 1 in 10 people)
• skin irritation at the application site,
• skin rash,
• itching,
• hives
• redness,
• burning sensation,
• contact dermatitis.

Uncommon side effects (may affect up to 1 in 100 people)

• skin peeling,
• dry skin,
• swelling.

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

• blisters.

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

• hypersensitivity reactions,
• angioedema (rapid swelling of the skin and mucous membranes or subcutaneous tissue),
• bronchospasm (symptoms of hypersensitivity reaction),
• abdominal discomfort.

Side effects of unknown frequency (frequency cannot be estimated from available data)

• photosensitivity (skin becomes sensitive to light),
• pustular rash.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
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 carton and tube after: EXP. The expiry date refers to the last day of the month stated.
Before first opening the tube:
This medicine does not require any special storage conditions.
Do not store in the refrigerator or freeze.
After first opening the tube:
Do not use after 30 days.
Store below 25°C. Do not store in the refrigerator or freeze.
Medicines should 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 APTEO MED contains

• The active substance is ibuprofen. Each gram of Ibuprofen APTEO MED contains 50 mg of ibuprofen.
• The other ingredients are: levomenthol, carbomer A, diisopropanolamine 90% (to adjust pH), isopropyl alcohol, glycerol (E 422), purified water.

What Ibuprofen APTEO MED looks like and contents of the pack

Colorless or slightly yellowish, transparent, homogeneous gel with a minty smell (pH 6.7-7.4).
Aluminum tube with a membrane, coated internally with an epoxy-phenolic lacquer, closed with an HDPE cap with a piercer.
50 g
100 g
150 g
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. + 48 22 321 62 40

Manufacturer

LABORATORIOS BOHM, S.A.
C/ Molinaseca, 23
Polígono Industrial Cobo Calleja
28947 Fuenlabrada, Madrid
Spain
INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.
Barrio Solía nº 30
La Concha, Villaescusa
39690 Santander, Cantabria
Spain

Date of last revision of the package leaflet: January 2024