Calmatel 33,28 mg/ml soluciÓn para pulverizaciÓn cutÁnea

Product Information for the User

Calmatel33.28 mg/ml Skin Spray Solution

Piketoprofeno

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this product information or those provided by your doctor, pharmacist, or nurse.

• Keep this product information, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• Ifyou experience any adverse effects, consult your doctor, pharmacist, or nurse,even if they are not listed in this product information. See section 4.
• Youshould consult a doctor if your condition worsens or does not improveafter 7 days.

Calmatelcontains piketoprofenand belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for adolescents aged 12 years and older and adults for the local relief of mild and occasional pain and inflammation caused by:

• small bruises, blows, strains
• stiff neck or other contractures
• lower back pain
• mild sprains resulting from a twist

Do not use Calmatel

• If you are allergic to piketoprofeno or any of the other components of this medication (listed in section 6).Stop treatment if signs of allergy appear.
• If acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (a type of medication used to reduce inflammation and pain) cause you rinitis, asthma, angioedema (an allergic reaction that can cause swelling in the face, eyes, or tongue and difficulty swallowing or breathing) or urticaria.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Calmatel.

This medication should be used exclusively on the affected area. It should not be used on large areas.

Apply the skin spray solution with caution to the skin, avoiding contact with eyes, mucous membranes, open ulcers or wounds, or other skin conditions.

It is recommended to avoid exposure to the sun and/or UVA rays during treatment with piketoprofeno and for two weeks after the last application.

It is recommended to wash your hands after applying the medication.

It is not recommended to use it with products containing octocrylene (an excipient used in various cosmetic and hygiene products, e.g. sunscreens, shampoos, etc.), as it may cause skin reactions.

If skin reactions appear, stop treatment immediately and consult your doctor.

Use with caution. Do not use near incandescent sources or heat sources, or spray over fire. Keep the container protected from excessive heat and away from flames or sparks. Do not smoke during use.

Children

This medication is not recommended for use in children (under 12 years old).

Use of Calmatel with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

The effects of piketoprofeno on breast milk are unknown. Your doctor will advise you on whether it is safe to use this medication during breastfeeding.

Driving and operating machinery

Due to its administration method, this medication does not affect driving or operating machinery.

Calmatel contains benzyl alcohol

This medication contains 19.97 mg of benzyl alcohol in 1.2 ml (1 propellant).

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol may cause moderate local irritation.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Dosage

Adolescents older than 12 years and adults:

As a general rule, apply to the affected area, 1-2 propulsions for a few seconds, 3 times a day.

Administration form

For exclusive cutaneous administration.

Its application does not require massage and may cause a sensation of cold.

If symptoms do not improve in 7 days, discontinue treatment and consult a doctor.

If you use more Calmatel than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or contact the Toxicological Information Service, phone: 915 620 420 (indicating the medication and the amount used/ingested).

No cases of intoxication have been reported to date.

If you forgot to use Calmatel

Do not apply a double dose to compensate for the missed doses. Apply the missed dose when you remember and then continue with the regular schedule. However, if only a few hours are left before the next application, do not apply the missed dose and wait for the next dose at the scheduled time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications,Calmatelmay cause adverse effects, although not everyone will experience them.

In some cases, reactions may occur at the application site,redness,itching,a burning sensation, and warmth at the application site, eczema, contact dermatitis, and photosensitivity reactions(increased sensitivity to sunlight).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight andreach of children.

No special storage conditions are required.

Pressurized container. Protect from sunlight and avoid exposure to temperatures above50ºC. Do not pierce or burn, even after use. Extremely flammable.Keep away from all flames or spark sources.

Do not usethis medicationafter the expiration date appearing on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit empty containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of empty containers and unused medications. By doing so,you will help protect the environment.

Composition of Calmatel

• The active ingredient is piketoprofeno. Each 50 g bottle contains 2 g of piketoprofeno.
• The other components are: Excipients (camphor, benzyl alcohol (E-1519), methyl salicylate, isopropyl myristate, lavender essence, isopropanol); Propellant (carbon dioxide (E-290)).

Appearance of the product and contents of the packaging

Yellow-colored skin spray solution with a characteristic odor.Aluminum-coated, lacquered, and printed spray can with a polyethylene valve and trigger. Packaging with 60 ml, plus propellant.

Other presentations

Calmatel 18 mg/g Cream: 60 g packaging.

Calmatel 18 mg/g Gel: 60 g packaging.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022-Barcelona (Spain)

Responsible manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca, Barcelona (Spain)

or

Laboratoires Chemineau

93, route de Monnaie

37210 Vouvray

France

Last review date of this leaflet: November 2013

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/