What is Reflex and what is it used for?
Reflex is available as a gel for use on the skin. Each pack contains 50 grams of gel.
This medicine belongs to the group of topical anti-inflammatory medicines.
It is indicated for use in adolescents 12 years and older and in adults for the relief of muscle and joint pain in bruises, strains, sprains, trauma (blows) without open wound, muscle cramps, torticollis, back pain and low back pain (pain in the lower back).
You should consult a doctor if it gets worse or does not improve after 7 days of treatment.
2. What you need to know before you start using Reflex
Do not use Reflex
- If you are allergic to methyl salicylate, turpentine, camphor and menthol or any of the other ingredients 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 wounded or injured.
- In children under 12 years of age.
During the third trimester of pregnancy and breast-feeding.
- If you suffer from active peptic ulcer or have a history of peptic ulcer.
Warnings and precautions
Ask your doctor or pharmacist before you start using Reflex
- This medicine is for external use only, do not swallow.
- Apply Reflex only to intact, unbroken skin.
- Avoid contact with the face, mucous membranes (nose, mouth), eyes and other sensitive parts of the body.
- Do not apply Reflex to very 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 Reflex has been used, do so in such a way that the garment covering the treated area is slightly loose.
Discontinue use of Reflex gel if you experience excessive irritation or discomfort or if you develop sensitivity.
You should consult a doctor before use 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 of age. Children are particularly sensitive (especially infants) to some components of Reflex: application to the skin may cause pressure drop, choking, bluish discolouration of the skin and convulsions.
Elderly patients
No dose adjustment is necessary in elderly patients. However, caution is advised due to the possibility of increased absorption as the skin may be thinner.
Use of Reflex with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
Do not use this medicine in excess or chronically, especially if you are taking warfarin (a medicine used to prevent blood clots) as this medicine contains methyl salicylate and menthol, and may increase the risk of bleeding from warfarin.
Concomitant application with other medicinal products for skin use that also contain analgesics and rubefacients is not recommended because potentiation of the adverse effects of both medicinal products may occur.
This medicinal product contains methyl salicylate, which may interact with other keratolytic agents, enhancing their effect.
Pregnancy and lactation
If you are pregnant or breast-feeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine. Reflex gel is contraindicated during the third trimester of pregnancy and you should consult your doctor before use during the first and second trimester of pregnancy. If used, limit the dose and duration of treatment to a minimum.
One of the active ingredients of Reflex gel, salicylate, passes in low concentrations into breast milk and, in rare cases, adverse effects have been observed in newborns and nursing infants. Therefore, the use of Relex gel is not recommended during lactation.
Driving and use of machines
The influence of this medicinal product on the ability to drive and use machines is nil or negligible.
Reflex contains propylene glycol, ethanol and benzyl alcohol.
This medicine contains 140 mg of propylene glycol (E-1520) in each gram. Propylene glycol may cause skin irritation.
This medicine contains 240 mg of alcohol (ethanol) in each gram. It may cause a burning sensation on broken skin.
This medicine contains 10 mg of benzyl alcohol in each gram. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.
3. How to use Reflex
Follow exactly the instructions for use given in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose in adolescents from 12 years of age and adults is 3 to 4 applications per day every 6 to 8 hours depending on the intensity of pain and inflammation.
How to use
Cutaneous use, exclusively on whole skin.
Apply enough gel to treat the affected area and spread evenly.
Rub in until the gel has completely disappeared.
Wash hands after each application.
Use on children
Reflex 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 than you should
If you have applied more Reflex than you should, skin problems may occur.
Due to its camphor content, overuse may cause skin irritation.
If ingested (swallowed), you should seek immediate medical attention even if you do not notice symptoms, these may appear within 2 hours after ingestion of the medicine. Accidental ingestion may produce a series of symptoms due to its camphor content such as characteristic camphor breath odour, heat in the mouth, thirst, sweating, nausea, vomiting, colic, headache, dizziness, delirium, nervousness, epileptic-like convulsions, excitation or depression of the central nervous system and coma. Treatment of accidental camphor poisoning is symptomatic. Do not induce vomiting.
Due to its content of turpentine, menthol and methyl salicylate, if swallowed you may notice the following symptoms: heartburn, abdominal pain, intestinal discomfort, nausea, vomiting, pulmonary oedema, hyperventilation, ketosis and respiratory alkalosis, metabolic acidosis, excitement, sweating, ringing in the ears (tinnitus), deafness, vertigo, thirst, dizziness, sweating, lethargy (lack of energy), tachypnoea (increased respiratory rate), psychiatric disorders, confusion, drowsiness, 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.
In case of application of camphor or menthol to the nostrils, oropharyngeal burning, central nervous system depression, respiratory arrest and immediate collapse may occur in children.
In case of overdose or accidental ingestion, seek medical attention immediately or call the Poisons Information Service, telephone 915 620 420, indicating the medicine and the quantity taken.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody suffers from them.
During the period of use of the combination of the active substances in this medicinal product, 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 rash (which usually disappear after discontinuation of treatment).
Frequency not known (cannot be estimated from available data):
Asthma, bronchospasm
Contact dermatitis, application site reactions, burning at the application site (in case of severe hypersensitivity or application with occlusive dressings. Treatment should be discontinued immediately).
Reporting of side effects
If you experience any side effects, please contact your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects you can help to provide more information on the safety of this medicine.
5. Storage of Reflex
Keep out of the sight and reach of children.
This medicine does not require special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month indicated.
Shelf life after opening: 6 months.
Medicines should not be flushed down the drain or thrown away. Please dispose of unneeded medicines and containers at the SIGRE Point at the pharmacy. Ask your pharmacist how to dispose of packaging and medicines you no longer need. In this way, you will help to protect the environment.
6. Package contents and additional information
Composition of Reflex
- The active ingredients per gram of gel are: 100 mg methyl salicylate, 60 mg turpentine, 30 mg camphor and 30 mg menthol.
- The other ingredients (excipients) are: isopropyl alcohol, ethanol 96%, propylene glycol (E-1520), hydroxypropyl cellulose (E-463) and benzyl alcohol (E-1519).
Appearance of the product and contents of the package
Reflex is a clear, slightly yellow gel with a characteristic odour.
Each pack contains 50 grams of gel.
