CAMPHORATED ALCOHOL REIG JOFRE CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Camphorated Alcohol Reig Jofre Cutaneous Solution

Read the entire package leaflet carefully because it contains important information for you:

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• You should consult a doctor if symptoms worsen or do not improve after 7 days.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Camphorated Alcohol is and what it is used for
2. What you need to know before you start using Camphorated Alcohol
3. How to use Camphorated Alcohol
4. Possible side effects
5. Storage of Camphorated Alcohol

Contents of the packaging and additional information.

1. What Camphorated Alcohol is and what it is used for

Camphor has analgesic and rubefacient actions.

It is indicated for the relief of localized muscle or joint pain.

2. What you need to know before you start using Camphorated Alcohol

Do not use Camphorated Alcohol:

• if you are allergic to camphor or any of the other components of this medication (listed in section 6).

• Do not ingest.
• Do not apply to the face, wounds, burns, eroded skin, or mucous membranes.

Warnings and Precautions

Do not use in children under 7 years of age. Do not use during pregnancy or breastfeeding.

This medication is for cutaneous use. It should not be used for prolonged periods or on extensive areas of skin.

Consult your doctor if symptoms persist for more than 7 days, worsen, or if irritation or redness occurs.

This medication is highly flammable. Do not use this medication near an open flame, lit cigarettes, or certain devices (e.g., hair dryers).

Use of Other Medications

Do not use with other topical preparations or rubefacients without consulting your doctor.

Camphorated Alcohol contains alcohol (ethanol)

This medication contains 66.7 g of alcohol (ethanol) per 100 ml. It may cause a burning sensation on damaged skin.

3. How to Use Camphorated Alcohol

This medication should be used on intact skin.

Apply a small amount to the area of skin to be treated and rub gently. It can be applied 3 or 4 times a day. Wash your hands after each application.

4. Possible Side Effects

Like all medications, it can have side effects.

In some cases, skin rashes or irritation may occur; interrupt application or consult your doctor.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist. In case of accidental ingestion, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Reporting of Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Camphorated Alcohol

Keep out of the reach and sight of children. No special storage conditions are required. It is highly flammable. Keep the container tightly closed. Do not use Camphorated Alcohol Reig Jofre after the expiration date stated on the packaging.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Camphorated Alcohol:

• The active ingredient is camphor. Each 100 ml of cutaneous solution contains 10 g of camphor.
• The other components (excipients) are: ethanol 96º.

Appearance of the Product and Contents of the Packaging

Camphorated Alcohol is presented in a high-density polyethylene container with a dropper device for administration. Bottles of 250 ml and 500 ml.

Date of the Last Revision of this Package Leaflet:February 2012

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.