REFLEX FORTE GEL

Introduction

Package Leaflet: Information for the User

Reflex Forte Gel

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. See section 4.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

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

Contents of the Package Leaflet:

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

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

Reflex Forte is presented in the form of a gel for cutaneous use. Each container contains 50 grams or 100 grams of gel.

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 your symptoms worsen or do not improve after 7 days of treatment.

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

Do not use Reflex Forte

• If you are allergic to methyl salicylate, turpentine, camphor, or 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 non-steroidal anti-inflammatory drugs (such as ibuprofen).
• If the skin in the area to be treated is wounded or damaged.
• In children under 12 years of age.
  • 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 Forte.

• This medication is for external use only; do not ingest.
• Apply Reflex Forte only 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 Forte to 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 Forte, do so in a way that the garment covering the treated area is slightly loose.
  • Suspend the use of Reflex Forte gel 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 your symptoms worsen or do not improve after 7 days of treatment.

Children

Reflex Forte is contraindicated in children under 12 years of age. Children are especially sensitive (mainly infants) to some components of Reflex Forte: 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 Forte 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), as this medication contains methyl salicylate and menthol, and may increase the risk of bleeding from warfarin.

Simultaneous application with other topical medications that also contain analgesics and rubefacients is not recommended, as it may cause an increase in the adverse effects of both medications.

This medication contains methyl salicylate, which may interact with other keratolytic agents, enhancing 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 Forte gel 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 ingredients of Reflex Forte gel, salicylate, passes into breast milk in low concentrations, and in rare cases, adverse effects have been observed in newborns and breastfed infants. Therefore, the use of Reflex Forte gel 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 Forte 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 alcohol (ethanol) per gram. It may cause a burning sensation on damaged skin.

This medication contains 10 mg of benzyl alcohol per gram. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.

3. How to Use Reflex Forte

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

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

How to use

Cutaneous use, exclusively on intact skin.

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

Rub until the gel has disappeared completely.

Wash your hands after each application.

Use in Children

Reflex Forte 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 Forte than you should

If you have applied more Reflex Forte 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, as they may appear after 2 hours of ingesting the medication. Accidental ingestion may cause a series of symptoms due to its content of camphor, such as characteristic camphor breath odor, heat in the mouth, 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 content of turpentine, 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 (ringing in the ears), deafness, 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 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 when treatment is interrupted)

Frequency not known (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 interrupted 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 Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Reflex Forte

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.

Validity period after opening: 6 months.

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

Composition of Reflex Forte

• The active ingredients per gram of gel are: 100 mg of methyl salicylate, 60 mg of turpentine, 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 Package Contents

Reflex Forte is presented in a tube, it is a transparent gel, slightly yellow, and has a characteristic odor.

Each container contains 50 or 100 grams of gel.

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 this 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/)