REFLEX SPRAY CUTANEOUS SOLUTION FOR SPRAYING

Introduction

Package Leaflet: Information for the User

Reflex Spray Cutaneous Spray Solution

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

Follow the administration instructions for the medication contained in

this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• 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.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Package Leaflet Contents:

1. What Reflex Spray is and what it is used for
2. What you need to know before starting to use Reflex Spray
3. How to use Reflex Spray
4. Possible side effects
5. Storage of Reflex Spray
6. Package Contents and Additional Information

1. What Reflex Spray is and what it is used for

Reflex Spray is a cutaneous spray solution for application to the skin.

This medication belongs to the group of topical anti-inflammatory drugs.

• It is indicated in adolescents from 12 years of age and in adults, for the relief of muscle and joint pain in: bruises, sprains, strains, trauma (blows) without open wounds, muscle cramps, torticollis, back pain, and lumbalgia (lower back pain).

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

2. What you need to know before starting to use Reflex Spray

Do not use Reflex Spray:

• If you are allergic to turpentine, camphor, menthol, methyl salicylate, or any of the other components of this medication (listed in section 6).
• If you are allergic to salicylates, acetylsalicylic acid (aspirin), or other non-steroidal anti-inflammatory drugs (such as ibuprofen)
• If the skin of the area to be treated is wounded or damaged.
• In children under 12 years of age.
• If you have allergic asthma: asthmatic patients with any type of allergy that may increase with the use of an aerosol.
• During the third trimester of pregnancy and breastfeeding.
• If you have active peptic ulcer or a history of peptic ulcer.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Reflex Spray.

• This medication is for external use only, do not ingest.
• Apply Reflex Spray to intact skin, without wounds.
• Avoid contact of the medication with the face, mucous membranes (nose, mouth), eyes, and other sensitive parts of the body.
• Do not apply Reflex Spray to very large areas of skin, or with tight bandages, or if you are going to exercise or apply heat to the area where it is used. If you cover the area where you have used Reflex Spray, do so in a way that the garment covering the treated area is slightly loose.
• Suspend the use of Reflex Spray if you experience irritation or excessive discomfort or if you develop sensitivity.
• You should consult your doctor before using it during the first or second trimester of pregnancy.
• You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Children

Reflex Spray is contraindicated in children under 12 years of age. Children are especially sensitive (mainly infants) to some components of Reflex Spray: application to the skin can cause a drop in blood pressure, choking, bluish discoloration of the skin, and convulsions.

Elderly Patients

No dose adjustment is necessary in elderly patients. However, caution is recommended due to the possibility of increased absorption since the skin may be thinner.

Using Reflex Spray with Other Medications

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

Do not use this medication excessively or chronically, especially if you are being treated with warfarin (a medication used to prevent blood clots) since this medication contains methyl salicylate and menthol, and may increase the risk of bleeding from warfarin.

It is not recommended to apply it simultaneously with other topical medications that also contain analgesics and rubefacients, as this may potentiate the adverse effects of both medications.

This medication contains methyl salicylate, which may interact with other keratolytic agents, potentiating its effect.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. Reflex Spray is contraindicated during the third trimester of pregnancy and you should consult your doctor before using it during the first and second trimester of pregnancy.

In case of use, limit the dose and duration of treatment to a minimum.

One of the active principles of Reflex Spray, salicylate, passes into breast milk in low concentrations, and in rare cases, adverse effects have been observed in newborns and breastfed children. Therefore, the use of Reflex Spray is not recommended during breastfeeding.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is nil or insignificant.

Reflex Spray contains dimethyl sulfoxide and benzyl alcohol.

This medication may cause skin irritation because it contains dimethyl sulfoxide.

This medication contains 13 mg of benzyl alcohol per milliliter. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.

3. How to Use Reflex Spray

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.

The recommended dose in adolescents from 12 years of age and in adults is 1 spray per application, as needed, every 6-8 hours, 3-4 times a day. It can be repeated up to a maximum of 4 applications per day.

How to use

Cutaneous use, exclusively on intact skin.

Apply directly to the area to be treated and without rubbing

Wash your hands after each application.

Keep the spray about 20 centimeters from the skin and press the valve, keeping the container in a vertical position for a few seconds, and wait for it to evaporate, without rubbing or massaging. Wash your hands after each application.

Use in Children

Reflex Spray is contraindicated in children and adolescents under 12 years of age.

If symptoms persist, do not improve, or worsen after 7 days of treatment, consult your doctor.

If you use more Reflex Spray than you should

If you have applied more Reflex Spray than you should, skin problems may occur.

Due to its camphor content, excessive use can cause skin irritation.

If you have ingested (swallowed) it, go immediately to a medical center, even if you do not notice symptoms, as they may appear after 2 hours of ingesting the medication. Accidental ingestion may cause a series of symptoms due to its camphor content, such as characteristic camphor breath odor, mouth heat, thirst, sweating, nausea, vomiting, colic, headache, dizziness, delirium, nervousness, epileptic convulsions, excitement or depression of the central nervous system, and coma. The treatment of accidental poisoning with camphor is symptomatic. Do not induce vomiting.

Due to its turpentine, menthol, and methyl salicylate content, if you have ingested it, you may notice the following symptoms: stomach burning, abdominal pain, intestinal discomfort, nausea, vomiting, pulmonary edema, hyperventilation, ketosis, and respiratory alkalosis, metabolic acidosis, excitement, sweating, tinnitus, dizziness, sweating, lethargy (lack of energy), tachypnea (increased respiratory rate), psychiatric disorders, confusion, deafness, somnolence, inability to coordinate movements (ataxia), excitement or depression of the central nervous system that can lead to coma, cardiovascular collapse, and respiratory failure; fever, tachycardia, liver damage, blood in the urine.

In case of application of camphor or menthol to the nasal passages, oropharyngeal burning, central nervous system depression, respiratory arrest, and immediate collapse may occur in children.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone may experience them.

During the period of use of the combination of the active ingredients of this medication, the following side effects have occurred with the following frequencies:

Very rare (may affect up to 1 in 10,000 people):

• Hypersensitivity (including urticaria, anaphylaxis, angioedema, and erythema)
• Dermatitis, urticaria, vesicular eruption (which usually disappear after discontinuing treatment)

Frequency not known (frequency cannot be estimated from available data):

• Asthma, bronchospasm
• Contact dermatitis, reactions at the application site, burning at the application site (in case of severe hypersensitivity or occlusive dressing. Treatment should be discontinued immediately.)

Reporting Side Effects

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

5. Storage of Reflex Spray

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Pressurized container. Protect from sunlight and avoid exposure to temperatures above 50°C. Do not spray towards a flame or incandescent body. Do not pierce or burn, even after use. Keep away from any flame or spark source. Do not smoke. Extremely flammable.

Do not use this medication after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Reflex Spray Composition

• The active ingredients per milliliter are: 65 mg of turpentine, 40 mg of camphor, 40 mg of menthol, 25 mg of methyl salicylate.
• The other components (excipients) are: isopropyl alcohol, dimethyl sulfoxide, benzyl alcohol (E-1519). Propellant gas: carbon dioxide.

Product Appearance and Package Contents

Reflex Spray is presented in a pressurized aluminum container with a valve. It is a cutaneous spray solution (colorless liquid in aerosol for application to the skin).

Containers with 50 milliliters and 130 milliliters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Reckitt Benckiser Healthcare, S.A.

C/Mataró, 28

08403 Granollers

Barcelona

Manufacturer:

Chemineau

93, Route de Monnaie (Vouvray) F-37210

France

Date of the last revision of the package leaflet: June 2022

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