Diclofenac Reuloran contains diclofenac as an active substance. This belongs to a group of medicines called nonsteroidal anti-inflammatories (NSAIDs). It is specially formulated to be massaged into the skin.
Diclofenac Reuloran is used to relieve pain and reduce inflammation and swelling in numerous painful conditions affecting the joints and muscles. It can be used to treat:
Adults and adolescents aged 14 or over
Symptomatic treatment (to relieve pain, inflammation and swelling) of:
• Light to moderate muscle pain;
• Post-traumatic inflammation of tendons, ligaments, muscles and joints
(sprains, dislocation and bruising).
Adults (over 18 years old)
• Localised forms of degenerative rheumatism: osteoarthritis of the peripherical
joints and of the spine.
DO NOT USE DICLOFENAC REULORAN
• If you are allergic (hypersensitivity) to diclofenac or to any of the
other ingredients of this medicine (listed in section 6).
• If you have suffered an allergic reaction to diclofenac or other
medicines used for the treatment of pain, fever or inflammation, such as ibuprofen or acetylsalicylic acid
(also used to prevent blood clots). The symptoms of an allergic reaction to these medicines may include:
wheezing or shortness of breath (asthma); skin rash with blisters or hives; swelling of the face or tongue;
nasal discharge.
• If you are in the last three months of pregnancy.
• If you are less than 14 years old.
If any of these conditions apply to you, do not use Diclofenac Reuloran.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Diclofenac Reuloran.
Do not apply on skin with cuts, open wounds or with rashes or eczema. Stop the treatment if you develop a skin rash after applying the product.
Avoid applying on extensive skin areas and for a long period of time, unless recommended by the doctor.
Diclofenac Reuloran is for external use only. Do not use it on your mouth. Do not swallow it. Wash your hands after applying it. Be careful to avoid allowing Diclofenac Reuloran to make contact with your eyes. If that happens, rinse the eyes. If the discomfort continues, talk to your doctor or pharmacist.
It is possible to use on bandages or strips usually used on injuries such as sprains. However, do not use the gel on air occlusive dressings.
CHILDREN AND ADOLESCENTS
Efficacy and safety data is insufficient for children and adolescents under 14 years old (See “Do not use Diclofenac Reuloran”).
In adolescents aged 14 or over, if this medicine is necessary for more than 7 days for pain
relief or if the symptoms worsen, the patient/parents of the adolescent are advised to talk to a doctor.
OTHER MEDICINES AND DICLOFENAC REULORAN
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
PREGNANCY, BREASTFEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before using this medicine.
Do not use Diclofenac Reuloran if you are in the last 3 months of pregnancy. You should not use Diclofenac Reuloran in the first 6 months of your pregnancy unless this is clearly necessary and advised by your doctor. If you require treatment during this period, the lowest dose should be used for the shortest possible time.
Diclofenac Reuloran should only be used with medical advice while breastfeeding as diclofenac is absorbed in small
quantities by breast milk. Nevertheless, Diclofenac Reuloran should not be applied to the breasts of women who are
breastfeeding, nor on extensive skin areas or for a prolonged period of time.
Oral forms (e.g. tablets) of Diclofenac Reuloran may cause adverse effects in the unborn child. It is not known whether the same risk applies with Diclofenac Reuloran when used on the skin.
IMPORTANT DATA ON SOME OF DICLOFENAC REULORAN ’S COMPONENTS
DICLOFENAC REULORAN CONTAINS PROPYLPARABEN AND METHYLPARABEN
The propylparaben and methylparaben components may cause allergic reactions (possibly delayed).
DICLOFENAC REULORAN CONTAINS PROPYLENE GLYCOL
This medicine contains propylene glycol which, when used on the skin, may cause skin irritation.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
FOR HOW LONG SHOULD YOU USE DICLOFENAC REULORAN :
Do not use Diclofenac Reuloran for longer than:
Adults and adolescents aged 14 or over: 2 weeks on muscle or joint injuries (for example,
sprains, dislocation and bruising) or tendonitis, unless recommended by your doctor.
Adults (over 18 years old): 3 weeks on arthrosis pain, unless recommended by your doctor.
If the pain and swelling do not improve within 7 days, or if they worsen, talk to your doctor.
IF YOU USE MORE DICLOFENAC REULORAN THAN YOU SHOULD
In the event that you accidentally ingest, or if your child accidentally ingests, Diclofenac Reuloran, or if you
accidentally use much more than the recommended dose, contact your doctor immediately.
IF YOU FORGET TO USE DICLOFENAC REULORAN
If you forgot to apply Diclofenac Reuloran at the correct time, apply it as soon as possible and then continue as normal.
Never use a double dose to compensate for a dose you missed.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare or very rare side effects may be severe:
If you notice the following signs of allergy, STOP treatment with Diclofenac Reuloran and tell your
doctor or pharmacist immediately:
• Skin rash, with blisters, hives (may affect 1 to 10 people in every 10.000
people).
• Wheezing, shortness of air or sensation of chest tightness (asthma) (may affect less than 1 person in every 10.000 people).
• Edema of the face, lips, mouth, tongue or throat (may affect less than 1
person in every 10.000 people).
Other side effects that may occur are normally mild, transitory or harmless (if you are concerned, talk to a doctor or pharmacist).
Frequent side effects (may affect 1 to 10 people in 100 people)
• Skin rash, itchiness, redness or skin peeling.
Very rare side effects (may affect less than 1 person in 10.000 people)
• The skin may be more sensitive to the sun. Possible signs are sunburn with itchiness, swelling and
blisters.
Side effects of unknown frequency
• Burning feeling at the site of application
• Dry skin
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to INFARMED, I.P., via the
contacts below. By reporting side effects, you can help provide more information on the safety of this
medicine.
Website: http://www.infarmed.pt/web/infarmed/submissaoram (preferably) or via the following contacts:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 73 73
Medicine Hotline: 800 222 444 (free of charge)
Email:
farmacovigilancia@infarmed.pt
WHAT DICLOFENAC REULORAN CONTAINS
The active substance is sodium diclofenac. Each gram of gel contains 10 mg of sodium diclofenac.
The other ingredients are: Sodium hydroxide, Hydroxyethyl cellulose, Carbo-mer 980 NF, Propylene glycol
(E1520), Average chain triglyceride, Propylparaben hydroxybenzoate, Methylparaben hydroxybenzoate and
purified water.
WHAT DICLOFENAC REULORAN LOOKS LIKE AND THE CONTENTS OF THE PACK
Diclofenac Reuloran is presented as a white gel. The tube contains 100g of gel.
MARKETING AUTHORIZATION HOLDER
Towa Pharmaceutical, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal
MANUFACTURER
Medinfar Manufacturing, S.A.
Parque Industrial Armando Martins Tavares
Rua Outeiro da Armada, 5, Condeixa-a-Nova
3150-194 Sebal
Portugal
Detailed and updated information on this medicine is available by scanning the 2D code included on the package with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/reuloran.
This leaflet was last revised on January 2025.