Ibuprofen apteo med

Package leaflet: Information for the patient

Ibuprofen APTEO MED, 50 mg/g, gel
Ibuprofenum
Please read the following 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 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 after 3 days, or if you feel worse, you should consult a doctor.

Contents of the leaflet

1. What Ibuprofen APTEO MED is and what it is 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 pack and other information

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

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

2. Information before using Ibuprofen APTEO MED

When not to use Ibuprofen APTEO MED

• if the patient is allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced an allergic reaction such as bronchospasm (constriction of the muscles in the lungs, which may cause difficulty in breathing), asthma, rhinitis, nasal itching, rhinitis with sneezing, urticaria (itchy rash), or angioedema (swelling under the skin) while taking acetylsalicylic acid or other medicines in the NSAID group;
• on damaged or diseased skin;
• during the last three months of pregnancy.

Warnings and precautions
Before starting treatment with Ibuprofen APTEO MED, consult your doctor or pharmacist.

• Avoid contact of the medicine with eyes or mucous membranes. Never swallow the medicine.
• Do not apply this medicine to injured skin or open wounds. Ibuprofen APTEO MED should be applied only to intact, healthy skin.
• Do not use under occlusive dressings (waterproof or air-tight bandages or plasters).
• Avoid exposing the treated area to sunlight to reduce the risk of photosensitivity reactions (skin changes such as eczema, blisters, etc.). If skin reactions occur, discontinue use of this medicine immediately.
• Do not use simultaneously with other topical medicines applied to the same area of skin.

Do not use this medicine over a large area of skin or for prolonged periods, as this increases the likelihood of systemic adverse effects. Follow dosing instructions carefully and do not exceed the maximum recommended duration of treatment.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
In patients with active or past history of bronchial asthma, or allergic diseases, ibuprofen may trigger bronchospasm.
Patients with bronchial asthma, hay fever, nasal mucosal swelling (e.g. nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory disorders (especially those with symptoms resembling hay fever) are at higher risk of asthma attacks (so-called analgesic intolerance or drug-induced asthma), local skin or mucosal swelling (so-called Quincke's edema), or urticaria compared to other patients treated with Ibuprofen APTEO MED.
In such patients, Ibuprofen APTEO MED should be used only with appropriate precautions and under direct medical supervision. The same recommendations apply to patients allergic to other substances who experience skin reactions, itching, or urticaria.
Preventive measures should be taken to ensure that children do not come into contact with areas of skin treated with the medicine.
Although systemic availability of ibuprofen after topical application is considerably lower than with oral formulations, rare complications may still occur. Therefore, patients with impaired kidney, heart, or liver function, patients with active or past history of gastric ulcer, patients with inflammatory bowel disease, or patients with bleeding disorders should consult a doctor before using this medicine.
Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients, as they may be more susceptible to adverse effects.
Serious 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 any of the symptoms associated with these serious skin reactions described in section 4 occur, discontinue Ibuprofen APTEO MED immediately and seek medical help.

Ibuprofen APTEO MED and other medicines
Inform 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.
Do not use Ibuprofen APTEO MED simultaneously with other topical medicinal products.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
During the first 6 months of pregnancy, Ibuprofen APTEO MED should not be used unless strictly necessary and recommended by a doctor. This medicine must not be used during the last three months of pregnancy. If treatment is required during this period, the lowest dose for the shortest possible duration should be used.
Do not apply this medicine directly to the breast area in breastfeeding women.
Oral formulations (e.g. tablets) of Ibuprofen APTEO MED may cause adverse effects in the unborn child. It is unknown whether the same risk applies when Ibuprofen APTEO MED is applied to the skin.

Driving and operating machinery
Ibuprofen APTEO MED has no influence on the ability to drive or operate machinery.

3. How to use Ibuprofen APTEO MED

This medicine should always be used exactly as described in this patient information leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a pharmacist.

Adults and adolescents (aged above 12 years):
Apply 4 to 10 cm of gel (corresponding to 50–125 mg of ibuprofen) to the affected area and gently rub in until completely absorbed. If necessary, the medicine may be used more frequently, up to a maximum of 4 times daily.

This medicine is for external use on the skin only.

Apply a thin layer of gel to the affected area and gently rub it into the skin. After applying the gel, hands should be dried with a paper towel and then washed, unless the hands themselves are the treated area. The paper towel should be disposed of in a waste container. Wait several minutes after application to allow the gel to dry before applying a bandage. Also, wait until the gel has dried on the skin before taking a shower or bath.

Ibuprofen APTEO MED should be used at the lowest effective dose for the shortest duration necessary to relieve symptoms. The gel is intended for short-term use only. Do not use this medicine for longer than 7 days (5 days in adolescents). If symptoms persist or worsen after 3 days, consult a doctor.

Children (under 12 years of age):
The safety and efficacy of Ibuprofen APTEO MED have not been established in children under 12 years of age.

Overdose of Ibuprofen APTEO MED
Overdose with Ibuprofen APTEO MED applied topically to the skin is unlikely.

In case of significant overdose, remove the gel from the skin using a paper towel. Dispose of the paper towel in a waste container.

Accidental ingestion of the gel
Symptoms will depend on the amount ingested and the time elapsed since ingestion. Symptoms may include nausea, vomiting, abdominal pain, drowsiness, and low blood pressure.

Seek immediate medical attention by contacting a doctor or going to a hospital.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone experiences them.
The most commonly occurring adverse reactions are skin-related changes. Systemic
availability of ibuprofen when applied topically is low compared to NSAIDs administered orally.
Adverse reactions, especially those affecting the gastrointestinal system, occur significantly less frequently
with topical application of ibuprofen. Nevertheless, during prolonged use and/or application of ibuprofen
over large areas of skin, there is a possibility of systemic adverse reactions occurring. Such reactions may include
abdominal pain, indigestion, stomach and kidney disturbances.

STOP using this medicine and contact your doctor immediately if any of the following occur:

• Symptoms of allergic reaction such as asthma, unexplained wheezing or shortness of breath, itching, runny nose or skin rash.
• Symptoms of hypersensitivity and skin reactions such as redness, swelling, peeling of skin in sheets, formation of blisters or skin desquamation.
• Non-elevated, red, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in mouth, throat, nose, genital organs 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 subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Adverse reactions occurring frequently (may affect up to 1 in 10 patients):

• Skin irritation at the site of application,
• Skin rash,
• Itching,
• Urticaria,
• Redness,
• Burning sensation,
• Contact dermatitis.

Adverse reactions occurring not very frequently (may affect up to 1 in 100 patients):

• Desquamation of the epidermis,
• Dry skin,
• Swelling.

Adverse reactions occurring rarely (may affect up to 1 in 1,000 patients):

• Bullous dermatitis.

Adverse reactions occurring very rarely (may affect up to 1 in 10,000 patients):

• Hypersensitivity reactions,
• Angioedema (rapid swelling of skin, mucous membranes or subcutaneous tissues),
• Bronchospasm (symptoms of hypersensitivity reaction),
• Abdominal discomfort.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Photosensitivity (skin becomes sensitive to light),
• Pustular rash.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 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 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 tube
after: EXP. The expiry date refers to the last day of the stated month.
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 must not be disposed of via wastewater 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 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% (for pH adjustment), isopropyl alcohol, glycerol (E 422), purified water.

What Ibuprofen APTEO MED looks like and contents of the pack
Colourless or slightly yellow, transparent, homogeneous gel with a minty odour (pH 6.7–7.4).
Aluminium tube protected with a membrane, internally coated with epoxy-phenolic varnish,
closed with a HDPE cap with a piercing device.
Available in the following pack sizes:
50 g
100 g
150 g
Not all pack sizes may be marketed.

Marketing Authorisation 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