Ibuprofen dr. max

Package leaflet: Information for the user

Ibuprofen Dr. Max, 50 mg/g, gel
Ibuprofenum
Please read the entire 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, please consult a pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 7 days (5 days in adolescents), or if the patient feels worse, consult a doctor.

Table of contents of the leaflet:

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

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

Ibuprofen Dr. Max is indicated for local symptomatic relief of occasional muscle pain caused by minor bruises, injuries or overexertion, neck stiffness or other muscle spasms, mild sprains, and lower back pain.
The active substance in 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 Dr. Max is intended for topical use.
Ibuprofen Dr. Max is intended for use in adults and adolescents aged above 12 years.

2. Information before using Ibuprofen Dr. Max

When not to use Ibuprofen Dr. Max

• 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, nasal mucosal inflammation, sneezing, urticaria (itchy rash) or angioedema (swelling under the skin) while taking acetylsalicylic acid or other NSAIDs.
• on damaged or diseased skin.
• during the last three months of pregnancy.

Warnings and precautions
Before starting treatment with Ibuprofen Dr. Max, discuss this with your doctor or
pharmacist.

• The gel should be applied only to intact, healthy skin.
• Avoid contact of the medicine with eyes or mucous membranes. The medicine must never be swallowed.
• Do not apply this medicine to injured skin, open wounds, or skin affected by rash or eczema. Ibuprofen Dr. Max should be applied only to intact, 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, discontinue use of this medicine immediately.
• Do not use simultaneously with other topical medicines applied to the same skin area.

Using this medicine over a large skin surface or for prolonged periods increases the likelihood of
systemic adverse effects. Follow the dosing instructions and do not exceed the maximum duration of treatment.
If symptoms persist for longer than 7 days (5 days in adolescents), consult a doctor.
Serious skin reactions, including 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 the patient develops any of the symptoms associated with these serious skin reactions described in section 4, Ibuprofen Dr. Max must be discontinued immediately and medical help should be sought.

Ibuprofen Dr. Max and other medicines
Inform 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 Dr. Max simultaneously with other topical medicines.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use Ibuprofen Dr. Max during pregnancy or breastfeeding unless absolutely necessary and advised by a doctor.
Do not use Ibuprofen Dr. Max during the last three months of pregnancy. Do not use Ibuprofen Dr. Max during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment during this period is required, the lowest effective dose should be used for the shortest possible duration.
Oral formulations (e.g. tablets) of Ibuprofen Dr. Max may cause adverse effects in the unborn child. It is not known whether the same risk applies to Ibuprofen Dr. Max when applied to the skin.

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

3. How to use Ibuprofen Dr. Max

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 massage until completely absorbed. Repeat if necessary, up to a maximum of 4 times daily.
This medicine is intended for external use on the skin only.
After each application, hands should be thoroughly washed unless they are the treated area.
Do not use Ibuprofen Dr. Max for longer than 7 days. If symptoms persist beyond 7 days (5 days in adolescents), consult a doctor.
Children (under 12 years of age):
The safety and efficacy of Ibuprofen Dr. Max have not been established in children under 12 years of age.
Overdose of Ibuprofen Dr. Max
Overdose following topical application of Ibuprofen Dr. Max to the skin is unlikely.
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 advice from a doctor or go to hospital.
If you miss a dose of Ibuprofen Dr. Max
Do not apply a double dose to make up for a missed dose.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following symptoms, ibuprofen use must be stopped immediately and medical help should be sought:

• Red, flat, non-elevated, target-like or round spots on the trunk, often with blisters in the center, peeling skin, mouth, throat, nose, genital or eye ulcers. 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).

The following adverse reactions may occur:
Not very common (may affect up to 1 in 100 people): mild erythema (skin redness),
dermatitis, local irritation which resolves after discontinuation of treatment.
Rare (may affect up to 1 in 1,000 people): photodermatosis (skin rash caused by increased
sensitivity to sunlight).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 .
Reporting adverse reactions helps to provide more information on the safety of the medicine.
Adverse reactions can also be reported to the responsible entity.

5. How to store Ibuprofen Dr. Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer 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 3 months.
Store below 25°C. Do not store in the refrigerator or freeze.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the package 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% (for pH adjustment), isopropyl alcohol, glycerol (E 422), purified water.

What Ibuprofen Dr.Max looks like and contents of the pack
A colourless or slightly yellow, transparent, homogeneous gel with a mint 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.
Pack sizes: 50 g, 100 g and 150 g
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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:
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía 30
La Concha - Villaescusa
39690 Santander, Cantabria
Spain

This medicinal product is authorised in the following names in the Member States of the European Economic Area:
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