BENGAY 150 mg/100 mg Ointment

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Bengay Pain Relieving Cream, (150 mg + 100 mg)/g, cream
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Bengay Pain Relieving Cream and what is it used for
4. Important information before using Bengay Pain Relieving Cream
   1. When not to use Bengay Pain Relieving Cream:
   2. Warnings and precautions
   3. Bengay Pain Relieving Cream and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. The medicine contains lanolin
5. How to use Bengay Pain Relieving Cream
   1. Children and adolescents
   2. Using more than the recommended dose of Bengay Pain Relieving Cream
   3. Missing a dose of Bengay Pain Relieving Cream
6. Possible side effects
   1. Reporting side effects
7. How to store Bengay Pain Relieving Cream
8. Package contents and other information
   1. What Bengay Pain Relieving Cream contains
   2. What Bengay Pain Relieving Cream looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:

Leaflet attached to the packaging: patient information

Bengay Pain Relieving Cream, (150 mg + 100 mg)/g, cream

Methyl salicylate + Menthol

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

• This medicine should always be used as described in the patient leaflet or as directed by a doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or more information.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, consult a doctor.

Table of contents of the leaflet:

• 1. What is Bengay Pain Relieving Cream and what is it used for
• 2. Important information before using Bengay Pain Relieving Cream
• 3. How to use Bengay Pain Relieving Cream
• 4. Possible side effects
• 5. How to store Bengay Pain Relieving Cream
• 6. Package contents and other information

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

Bengay Pain Relieving Cream is intended for adults and children over 12 years old
and is indicated for the relief of:

• muscle and joint pain and stiffness caused by overuse, injury, or inflammation,
• lower back pain.

2. Important information before using Bengay Pain Relieving Cream

When not to use Bengay Pain Relieving Cream:

• 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 and wounds,
• in children under 12 years of age.

Warnings and precautions

Do not use under an occlusive dressing or under a warming pad.
Stop using if excessive skin irritation occurs (see section 4).
Avoid contact with eyes and mucous membranes.

Bengay Pain Relieving Cream and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken,
and about any medicines you plan to take.
Concomitant use of Bengay Pain Relieving Cream with acetylsalicylic acid may lead to salicylate toxicity.
Do not use Bengay Pain Relieving Cream in patients taking anticoagulant medicines (warfarin), as there is a risk of bleeding.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Bengay Pain Relieving Cream has no effect on the ability to drive and use machines.

The medicine contains lanolin

The medicine may cause local skin reactions (e.g., contact dermatitis).

3. How to use Bengay Pain Relieving Cream

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Apply an appropriate amount of cream to the affected area and rub in gently until fully absorbed.
Use only on the affected area. Repeat every few hours (3 to 4 times a day).
Do not use Bengay Pain Relieving Cream for more than 7 days without consulting a doctor.

Children and adolescents

The cream is intended for use in children over 12 years old.

Using more than the recommended dose of Bengay Pain Relieving Cream

Overdose is unlikely.
Misuse of Bengay Pain Relieving Cream may lead to salicylate toxicity.
If you have ingested the medicine, consult a doctor.

Missing a dose of Bengay Pain Relieving Cream

Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is presented according to the following scheme:
Very common
occurs in more than 1 in 10 patients
Common
occurs in less than 1 in 10 patients
Uncommon
occurs in less than 1 in 100 patients
Rare
occurs in less than 1 in 1,000 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, angioedema, dyspnea (as an allergic reaction), blisters, burning, redness, irritation, pain, paresthesia (tingling, numbness, or changes in skin temperature), itching, and rash have been reported. Burns at the application site have also been reported (frequency not known).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bengay Pain Relieving Cream

Store in a temperature below 25°C.
Keep the medicine out of the 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 month.
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 Bengay Pain Relieving Cream contains

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

What Bengay Pain Relieving Cream looks like and what the pack contains

1 aluminum tube containing 50 g of cream in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

McNeil Healthcare (Ireland) Limited
Office 5, 6 & 7, Block 5
High Street, Tallaght
Dublin 24, D24 YK8N
Ireland

Manufacturer:

JNTL Consumer Health (France) SAS
Domaine de Maigremont
27100 Val de Reuil
Franceemail: [email protected]
Date of last revision of the leaflet: