Ibuprofen Dr. Max

Package Leaflet: Information for the User

Ibuprofen Dr.Max, 50 mg/g, Gel

Ibuprofen

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days (5 days in adolescents) there is no improvement or the patient feels worse, they should contact a doctor.

Package Leaflet Contents:

• 1. What is Ibuprofen Dr.Max and what is it used for
• 2. Important information before taking Ibuprofen Dr.Max
• 3. How to take Ibuprofen Dr.Max
• 4. Possible side effects
• 5. How to store Ibuprofen Dr.Max
• 6. Package contents and other information

1. What is Ibuprofen Dr.Max and what is it used for

Ibuprofen Dr.Max is indicated for the local symptomatic relief of occasional muscle pain caused by minor bruises, injuries or strains, neck stiffness or other contractions, 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 Dr.Max is intended for external use. Ibuprofen Dr.Max is intended for use in adults and adolescents over 12 years of age.

2. Important information before taking Ibuprofen Dr.Max

When not to use Ibuprofen Dr.Max

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had an allergic reaction, such as bronchospasm (constriction of the airway muscles in the lungs, which can cause shortness of breath), asthma, hay fever, itching of the nose and inflammation of the nasal mucosa, sneezing, hives (itchy rash) or angioedema (swelling under the skin) when taking acetylsalicylic acid or other NSAIDs.
• on damaged or diseased skin.
• during the last 3 months of pregnancy.

Warnings and precautions

Before starting to take Ibuprofen Dr.Max, the patient should discuss it with their doctor or pharmacist.

• The gel should only be applied to undamaged, healthy skin.
• Avoid contact of the medicine with the eyes or mucous membranes. Never swallow the medicine.
• Do not apply this medicine to wounded skin, open wounds, or skin affected by rash or eczema. Ibuprofen Dr.Max should only be applied to undamaged, non-diseased skin.
• Do not use under occlusive dressings (waterproof or airtight 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, stop using this medicine.
• Do not use at the same time as other medicines applied locally to the same skin surface.

Using this medicine on a large skin surface or for a long time increases the likelihood of systemic side effects. Follow the instructions for dosing and do not exceed the maximum treatment duration. If symptoms persist for more than 7 days (5 days in adolescents), consult a doctor. Serious skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient experiences any of the symptoms associated with these serious skin reactions described in section 4, they should stop using Ibuprofen Dr.Max and seek medical help.

Ibuprofen Dr.Max and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines they plan to take. Do not use Ibuprofen Dr.Max at the same time as other medicines applied locally.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine. Do not use Ibuprofen Dr.Max during pregnancy or breastfeeding, unless the doctor considers it absolutely necessary. Do not use Ibuprofen Dr.Max during the last 3 months of pregnancy. Do not use Ibuprofen Dr.Max during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period, use the smallest dose for the shortest possible time. Oral forms (e.g., tablets) of Ibuprofen Dr.Max may cause side effects in the unborn child. It is not known if the same risk applies to Ibuprofen Dr.Max when used on the skin.

Driving and using machines

Ibuprofen Dr.Max does not affect the ability to drive or use machines.

3. How to take Ibuprofen Dr.Max

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a 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 massage until completely absorbed. Repeat as needed, up to a maximum of 4 times a day. This medicine is for external use only. After each application of the gel, wash hands thoroughly, unless they are the area being treated. Do not use Ibuprofen Dr.Max for more than 7 days. If symptoms persist for more than 7 days (5 days in adolescents), consult a doctor. Children (under 12 years of age): The safety and efficacy of Ibuprofen Dr.Max in children under 12 years of age have not been established.

Overdose of Ibuprofen Dr.Max

Overdose of Ibuprofen Dr.Max after topical application to the skin is unlikely.

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. Consult a doctor or go to the hospital immediately.

Missing a dose of Ibuprofen Dr.Max

Do not take a double dose to make up for a missed dose. If you have any questions about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen Dr.Max can cause side effects, although not everybody gets them. If the patient experiences any of the following symptoms, they should stop using ibuprofen and seek medical help:

• Red, non-raised, target-like or circular 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 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, peeling rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The following side effects may occur:
Uncommon(may affect up to 1 in 100 people): moderate erythema (redness of the skin), skin inflammation, local irritation, which disappears after stopping treatment.
Rare(may affect up to 1 in 1,000 people): photodermatosis (skin rash caused by increased sensitivity to sunlight).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration 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. By reporting side effects, you can help provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Ibuprofen Dr.Max

Keep this 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 3 months. 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. Package contents and other information

What Ibuprofen Dr.Max contains

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

What Ibuprofen Dr.Max 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. Pack sizes: 50 g, 100 g, and 150 g. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

LABORATORIOS BOHM, S.A.
C/ Molinaseca, 23
Polígono Industrial Cobo Calleja
28947 Fuenlabrada, Madrid
Spain
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía 30
La Concha - Villaescusa
39690 Santander, Cantabria
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Ibuprofen Dr.Max
Slovakia:
Ibuprofen Dr.Max 50 mg/g gel
Poland:
Ibuprofen Dr.Max
Romania:
Ibuprofen Dr.Max 50 mg/g gel

Date of last revision of the package leaflet: 04/2025