Reflex Forte gel

Spain
Brand name Reflex Forte gel
Form gel
Active substance / Dosage
Prescription type Over The Counter
Registration number 59479
Reflex Forte gel gel

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Reflex Forte gel

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

  • Follow exactly the instructions for use of 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

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

Contents of the leaflet:

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

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

Reflex Forte is presented as a topical gel. Each container contains 50 grams or 100 grams of gel.

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

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

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 Forte

Do not use Reflex Forte

  • If you are allergic to methyl salicylate, turpentine oil, camphor, menthol, 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.

    • 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 Forte

  • This medicine is for external use only; do not ingest.
  • Apply Reflex Forte 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 Forte over large areas of skin, under tight bandages, during physical exercise, or with application of heat to the treated area. If covering the area where Reflex Forte has been applied, ensure that the covering garment is loosely fitted.
    • Discontinue use of Reflex Forte gel if you experience irritation, excessive discomfort, or develop sensitivity.
    • You should 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 Forte is contraindicated in children under 12 years of age. Children, especially infants, are particularly sensitive to some components of Reflex Forte: application on the skin may cause low blood pressure, respiratory distress, bluish discoloration of the skin, and seizures.

Elderly patients

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

Use of Reflex Forte with other medicines

Inform your doctor or pharmacist if you are 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 medicine contains methyl salicylate and menthol, which could increase the risk of bleeding 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 Forte gel 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, the dose and duration of treatment should be kept to a minimum.

One of the active ingredients in Reflex Forte gel, 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 Forte gel is not recommended during breastfeeding.

Driving and using machines

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

Reflex Forte contains propylene glycol, ethanol, and benzyl alcohol.

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

This medicine contains 240 mg of alcohol (ethanol) per gram. It may cause a burning sensation on damaged skin.

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

Reflex Forte 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 Forte

Follow exactly the instructions for use provided in this leaflet or those given 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 3 to 4 applications per day, every 6–8 hours, depending on the intensity of pain and inflammation.

How to use

For topical use only, applied exclusively to intact skin.

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

Rub in until the gel has completely disappeared.

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 recommended, skin problems may occur.

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

If it has been ingested (swallowed), you must immediately go to a medical center even if you do not have symptoms, 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-like 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 of accidental camphor poisoning is symptomatic. Do not induce vomiting.

Due to its content of turpentine oil, menthol, and methyl salicylate, if ingested, you may experience the following symptoms: stomach burning, abdominal pain, gastrointestinal discomfort, nausea, vomiting, pulmonary edema, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, excitement, sweating, ringing in the ears (tinnitus), deafness, vertigo, thirst, dizziness, sweating, lethargy (lack of energy), tachypnea (increased respiratory rate), psychiatric disorders, confusion, 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, seek immediate medical attention or call the Toxicology Information Service at telephone 915 620 420, indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 resolve upon discontinuation of treatment)

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

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

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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Reflex Forte

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

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

Validity period after first opening: 6 months.

Medicines should 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 properly 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 Forte

  • The active ingredients per gram of gel are: 100 mg of methyl salicylate, 60 mg of turpentine 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 contents of the container

Reflex Forte is presented in a tube as a slightly yellow, transparent gel with a characteristic odour.

Each container holds 50 or 100 grams of gel.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 review of this leaflet: April 2026

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