Reflex spray soluciÓn para pulverizaciÓn cutÁnea

Leaflet: information for the user

Reflex Spray skin spray solution

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

Follow exactly the administration instructions contained in this leaflet or those 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

1. What is Reflex Spray 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. Storage of Reflex Spray

6. Contents of the pack and additional information

Reflex Spray is a topical skin spray solution for application on the skin.

This medication 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 in: contusions, muscle strains, sprains, blunt trauma (blows) without open wounds, muscle cramps, torticollis, back pain, and lower back pain (lumbalgia).

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

No use Reflex Spray:

• If you are allergic to eucalyptus oil, 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 nonsteroidal anti-inflammatory drugs (such as ibuprofen).
• If the skin in the area to be treated is injured or damaged.
• In children under 12 years old.
• If you have allergic asthma: patients with any type of allergy that may increase with the use of a spray.
• During the third trimester of pregnancy and lactation.
• If you have active peptic ulcer or have 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 on intact skin, without injuries.
• Avoid contact of the medication with the face, mucous membranes (nose, mouth), eyes, and other sensitive areas of the body.
• Do not apply Reflex Spray on large areas of the 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 it so that the garment that covers the treated area is slightly loose.
• Stop using Reflex Spray if you experience irritation or excessive discomfort or if you develop sensitivity.
• You must consult with your doctor before using Reflex Spray during the first or second trimester of pregnancy.
• You must 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 old. Children are especially sensitive (mainly infants) to some components of Reflex Spray: application on the skin may cause hypotension, choking, blue discoloration of the skin, and convulsions.

Older patients

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

Use of Reflex Spray with other medications

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

Do not use this medication in excess or chronically, especially if you are taking warfarin (a medication used to prevent blood clotting) as this medication contains methyl salicylate and menthol, and may increase the risk of bleeding from warfarin.

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

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

Pregnancy and lactation

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

Limit the dose and duration of treatment to a minimum.

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

Driving and operating machines

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

Reflex Spray contains dimethylsulfoxide and benzyl alcohol.

This medication may cause skin irritation because it contains dimethylsulfoxide.

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

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

The recommended dose in adolescents from 12 years and in adults is 1 pulse per application, as needed, every 6 – 8 hours, 3 to 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 affected area and do not rub.

Wash your hands after each application.

Hold the spray 20 centimeters away 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.

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 content in camphor, excessive use may cause skin irritation.

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

Due to its content in eucalyptus oil, menthol, and methyl salicylate, 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, vertigo, thirst, 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 may lead to coma, cardiovascular collapse, and respiratory failure; fever, tachycardia, liver damage, blood in the urine.

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of the active principles association of this medication, the following adverse 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 generally when the treatment is interrupted)

Unknown frequency (the frequency cannot be estimated from the available data):

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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 122°F (50°C). Do not vaporize near an open flame or hot surface.

Do not pierce or burn, even after use. Keep away from all flames or spark sources. 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 drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and unused medications. This will help protect the environment.

Composition of Reflex Spray

• The active principles per milliliter are: 65 mg of eucalyptus 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 packaging

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

Packaging with 50 milliliters and 130 milliliters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Reckitt Benckiser Healthcare, S.A.

C/Mataró, 28

08403 Granollers

Barcelona

Responsible for manufacturing:

Chemineau

93, Route de Monnaie (Vouvray) F-37210

France

Last review date of the leaflet: June 2022

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