Reflex Spray cutaneous spray solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Reflex Spray solution for cutaneous spray

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for using this medicine as described in

this leaflet or as indicated by your doctor or pharmacist.

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

Contents of the leaflet:

1. What Reflex Spray is and what it is used for
2. What you need to know before using Reflex Spray
3. How to use Reflex Spray
4. Possible side effects
5. How to store Reflex Spray
6. Contents of the pack and other information

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

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

This medicine belongs to the group of topical anti-inflammatory agents.

• It is indicated for adolescents aged 12 years and older, and adults, for the relief of muscle and joint pain due to: bruises, sprains, strains, closed trauma (contusions) without open wound, muscle cramps, torticollis, back pain, and lumbago (lower back pain).

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

2. What you need to know before using Reflex Spray

Do not use Reflex Spray:

• If you are allergic to turpentine oil, camphor, menthol, methyl salicylate, or any of the other components of this medicine (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 in the area to be treated is injured or damaged.
• In children under 12 years of age.
• If you suffer from allergic asthma: patients with asthma and any type of allergy that may worsen with the use of an aerosol.
• During the third trimester of pregnancy and while 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 medicine is for external use only; do not ingest.
• Apply Reflex Spray only to intact, undamaged skin.
• Avoid contact of the medicine with the face, mucous membranes (nose, mouth), eyes, and other sensitive areas of the body.
• Do not apply Reflex Spray over large areas of skin, nor under tight bandages, nor if you are about to exercise or apply heat to the treated area. If covering the area where Reflex Spray has been applied, ensure the clothing covering the treated area is loosely fitted.
• Discontinue use of Reflex Spray if you experience irritation, excessive discomfort, or develop sensitivity.
• You must consult your doctor before using this medicine during the first or second trimester of pregnancy.
• Consult a doctor if your condition worsens or does not improve after 7 days of treatment.

Children

Reflex Spray is contraindicated in children under 12 years of age. Children, especially infants, are particularly sensitive to some components of Reflex Spray: application on the skin may cause hypotension, respiratory distress, cyanosis (bluish skin discoloration), and seizures.

Elderly patients

Dose adjustment is not necessary in elderly patients. However, caution is recommended due to the possibility of increased absorption, as the skin may be thinner.

Use of Reflex Spray with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Do not use this medicine excessively or chronically, especially if you are being treated with warfarin (a medicine used to prevent blood clots), as this product contains methyl salicylate and menthol, which could increase the bleeding risk associated with warfarin.

Simultaneous application with other topical medicines containing analgesics and rubefacients is not recommended, as this may lead to an increased risk of adverse effects from both medicines.

This medicine contains methyl salicylate, which may interact with other keratolytic agents, enhancing their effect.

Pregnancy and breastfeeding

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

If used, keep the dose and duration of treatment to a minimum.

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

Driving and operating machinery

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

Reflex Spray contains dimethyl sulfoxide and benzyl alcohol.

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

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

Reflex Spray contains camphor, methyl salicylate, menthol, and turpentine oil (containing alpha-terpinene, beta-caryophyllene, camphor, carvone, limonene, linalool, menthol, pinene, terpineol, terpinolene, and turpentine), which may cause allergic reactions.

3. How to use Reflex Spray

Follow exactly the administration instructions for this medicine provided in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose for adolescents aged 12 years and older and adults is one spray per application, as needed, every 6–8 hours, 3 to 4 times daily. This may be repeated up to a maximum of 4 applications per day.

How to use

Cutaneous use only, exclusively on intact skin.

Apply directly to the affected area without rubbing.

Wash your hands after each application.

Hold the spray about 20 centimeters from the skin and press the valve, keeping the container in an upright position for a few seconds. Allow 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 recommended, skin problems may occur.

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

If the product has been ingested (swallowed), seek immediate medical attention even if no symptoms are present, as symptoms may appear up to 2 hours after ingestion. Accidental ingestion may cause a series of symptoms due to its camphor content, such as characteristic camphor breath odor, burning sensation in the mouth, thirst, sweating, nausea, vomiting, colic, headache, dizziness, delirium, nervousness, epileptic-type seizures, central nervous system excitation or depression, and coma. Treatment for accidental camphor poisoning is symptomatic. Do not induce vomiting.

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

If camphor or menthol is applied inside 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 at telephone number 915 620 420, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the period of use of the combination of active substances in this medicine, 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 rash (which usually disappear upon discontinuation of treatment)

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Reflex Spray

Keep this medicine 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 onto a flame or glowing body.

Do not pierce or burn, even after use. Keep away from all flames and sources of sparks. Do not smoke. Extremely flammable.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Reflex Spray

• The active substances per millilitre are: 65 mg of turpentine oil, 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.

Appearance of the product and contents of the container

Reflex Spray is presented in an aluminium pressurised container with a valve. It is a solution for cutaneous spray (colourless liquid in aerosol form for application to the skin).

Containers with 50 millilitres and 130 millilitres.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Reckitt Benckiser Healthcare, S.A.

Paseo de Gracia, 9, 08007, Barcelona, Spain

Manufacturer:

Chemineau

93, Route de Monnaie (Vouvray) F-37210

France

Date of the most recent revision of the leaflet: April 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)