Bengay maść przeciwbólowa

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Bengay Pain Relief Cream
(150 mg + 100 mg)/g, cream
Methyl salicylate + Menthol
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• This medicine should always be used according to the instructions provided in the patient leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet for future reference.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if symptoms worsen, consult your doctor.

Table of Contents:

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

1. What Bengay Pain Relief Cream is and what it is used for

Bengay Pain Relief Cream is intended for adults and children aged 12 years and older and is indicated for the relief of:

• muscle and joint pain and stiffness caused by overexertion, injury, or inflammatory conditions,
• lower back pain.

2. Information before using Bengay Maść Przeciwbólowa

When not to use Bengay Maść Przeciwbólowa:

• if the patient is allergic to methyl salicylate, menthol, or any of the other ingredients of this medicine (listed in section 6),
• on damaged skin or wounds,
• in children under 12 years of age.

Warnings and precautions
Do not use under occlusive dressings or with heating pads.
Discontinue use if excessive skin irritation occurs (see section 4).
Avoid contact of the ointment with eyes and mucous membranes.

Bengay Maść Przeciwbólowa 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.
Concomitant use of Bengay Maść Przeciwbólowa with acetylsalicylic acid may lead to salicylate toxicity.
Bengay Maść Przeciwbólowa should not be used in patients taking anticoagulants (warfarin), due to the risk of bleeding.

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.

Driving and operating machinery
Bengay Maść Przeciwbólowa has no effect on the ability to drive or operate machinery.

The medicine contains lanolin
This medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Bengay Maść Przeciwbólowa

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Apply the appropriate amount of cream to the affected area and rub in gently with massage until completely absorbed.
Use only on the affected area. Repeat application several times a day (3 to 4 times daily).
Use of Bengay Maść Przeciwbólowa without medical advice should not exceed 7 days.
Children and adolescents
The cream is intended for use in children above 12 years of age.
Use of more than the recommended dose of Bengay Maść Przeciwbólowa
Overdose is unlikely.
Misuse of Bengay Maść Przeciwbólowa may lead to toxic effects of salicylate.
In case of ingestion, seek medical advice immediately.
Missed dose of Bengay Maść Przeciwbólowa
Do not apply a double dose to make up for a missed application.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The frequency of adverse effects is presented according to the following classification:
Very common – occurs in more than 1 in 10 patients
Common – occurs in 1 to 10 in 100 patients
Uncommon – occurs in 1 to 10 in 1,000 patients
Rare – occurs in 1 to 10 in 10,000 patients
Very rare – occurs in less than 1 in 10,000 patients
Frequency not known – frequency cannot be estimated from the available data
Very rarely reported: angioedema, dyspnea (as an allergic reaction), blisters,
burning sensation, erythema, irritation, pain, paraesthesia (tingling, numbness or sensation of altered
skin temperature), pruritus and rash. Skin burns at the application site have also been reported (frequency
not known).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or nurse. Adverse effects 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects enables better assessment of the safety of the medicine.

5. How to store Bengay Maść Przeciwbólowa

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Bengay Maść Przeciwbólowa contains

• The active substances are methyl salicylate and menthol.
• The other ingredients are: stearic acid, glycerol monostearate, lanolin, polysorbate 85, sorbitol tristearate, triethanolamine, purified water.

What Bengay Maść Przeciwbólowa looks like and contents of the pack
1 tube containing 50 g of cream in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Bulgaria, the country of export:
McNeil Healthcare (Ireland) Ltd.
Offices 5-7, Block 5
High Street, Tallaght
Dublin 24
D24 YK8N, Ireland
Manufacturer:
JNTL Consumer Health (France) SAS
Domaine de Maigremont
27100 Val de Reuil, France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorization number in Bulgaria, the country of export: 20020117
Parallel import authorization number: 253/25