Leaflet: information for the user

Reflex gel

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

• Follow exactly the administration instructions for the medicine 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. See section 4.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

1. What is Reflex and what it is used for

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

3. How to use Reflex

4. Possible side effects

5. Storage of Reflex

6. Contents of the pack and additional information

Reflex is presented in gel form for topical use. Each container contains 50 grams or 100 grams of gel.

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

It is indicated for adolescents from 12 years old and adults for the relief of muscle and joint pain in contusions, sprains, strains, blunt trauma (blows) without open wound, muscle cramps, torticollis, back pain, and lumbago (lower back pain).

Consult a doctor if it worsens or does not improve after 7 days of treatment.

No use Reflex

- If you are allergic to methyl salicylate, eucalyptus oil, camphor, and menthol or to 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 treatment area is injured or damaged.

- In children under 12 years old.

• During the third trimester of pregnancy and lactation.

- If you have an active peptic ulcer or have a history of peptic ulcer.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Reflex

- This medication is for external use only, do not ingest.

- Apply Reflex only 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 to large areas of the skin, or with tight bandages, or if you are going to exercise or apply heat to the area where you use it. If you cover the area where you have used Reflex, do it in a way that the garment covering the treated area is slightly loose.

• Stop using Reflex gel if you experience irritation or excessive discomfort or if you develop sensitivity.
• You should consult with your doctor before using this product 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 is contraindicated in children under 12 years old. Children are especially sensitive (mainly infants) to some components of Reflex: application on the skin may cause hypotension, choking, blue discoloration of the skin, and convulsions.

Older 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.

Use of Reflex with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may have 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 with warfarin.

Do not apply this medication simultaneously with other topical medications that also contain analgesics and rubefacients, as it may cause 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 gel is contraindicated during the third trimester of pregnancy and should consult your doctor before using it during the first and second trimesters of pregnancy. In case of use, limit the dose and duration of treatment to a minimum.

One of the active principles of Reflex gel, 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 gel is not recommended during lactation.

Driving and operating machinery

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

Reflex contains propylene glycol, ethanol, and benzyl alcohol.

This medication contains 140 mg of propylene glycol (E-1520) per gram. Propylene glycol may cause skin irritation.

This medication contains 240 mg of ethanol per gram. It may cause a burning sensation on injured skin.

This medication contains 10 mg of benzyl alcohol per gram. 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 or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose in adolescents 12 years and older and adults is 3 to 4 applications per day every 6-8 hours depending on the intensity of pain and inflammation.

How to use

Topical use, exclusively on intact skin.

Apply a sufficient amount of gel to treat the affected area and spread it evenly.

Massage until the gel has completely disappeared.

Wash your hands after each application.

Use in children

Reflex 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 than you should

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

Due to its content of 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 symptoms, they may appear after 2 hours of ingestion of the medication. Accidental ingestion may cause a series of symptoms due to its content of camphor, such as a characteristic camphor odor of the breath, heat in the mouth, 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 of 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, hearing loss, vertigo, thirst, dizziness, sweating, lethargy (lack of energy), tachypnea (increased respiratory rate), psychiatric disorders, confusion, 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, burning oropharyngeal, depression of the central nervous system, respiratory arrest, and immediate collapse in children may appear.

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 will experience them.

During the period of use of the active ingredients 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 upon interrupting treatment)

Unknown 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 application with occlusive dressings, treatment should be immediately interrupted).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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.

This medication does not require special storage conditions.

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

Shelf life after opening: 6 months.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Reflex

- The active principles per gram of gel are: 100 mg of methyl salicylate, 60 mg of eucalyptus oil, 30 mg of camphor and 30 mg of menthol.

- The other components (excipients) are: isopropyl alcohol, 96% ethanol, propylene glycol (E-1520), hydroxypropyl cellulose (E-463) and benzyl alcohol (E-1519).

Appearance of the product and content of the packaging

Reflex is presented in a tube, it is a transparent, slightly yellow gel with a characteristic odor.

Each package contains 50 or 100 grams of gel.

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 this leaflet: June 2022

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