Diclofenac Reuloran contains diclofenac as an active substance, which belongs to a group of medicines called nonsteroidal anti-inflammatories (NSAIDs). It is specially aimed to massage on the skin.

Diclofenac Reuloran is used to relieve the pain and reduce the inflammation and swelling on numerous painful conditions which affect the joints and muscles. It can be used to treat:

Adults and adolescents with or over 14 years old
Symptomatic treatment (pain, inflammation and swelling relief) of:
• Light to moderate muscle pain;
• Post-traumatic inflammation on the tendons, ligaments, muscles and joints (sprains, luxation and contusions).

Adults (over 18 years old)
• Located forms of degenerative rheumatism: osteoarthrosis of the peripherical joints and the spine.

DO NOT TAKE DICLOFENAC REULORAN
• If you’re allergic (hyper sensibility) to diclofenac or to any of the other ingredients of this medicine (listed on section 6).
• If you have suffered a allergic reaction to diclofenac or to other medicines used on 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 medicine 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 on the last three months of your pregnancy.
• If you are less than 14 years old.

If any of these conditions applies to you, do not use Diclofenac Reuloran.

WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Diclofenac Reuloran.

Don’t 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. Don’t use it on your mouth. Don’t swallow it. Wash your hands after applying it. Be aware, avoid the contact of Diclofenac Reuloran with the eyes. If that happens, rinse the eyes. If the discomfort prevails, talk to your doctor or pharmacist.

It is possible to use bandages or strips usually used on lesions such as sprains. However, don’t use the gel on air occlusive band aids.

CHILDREN AND ADOLESCENTS
The efficiency and safety data is insufficient for children and adolescents under 14 years old (Consult “Do not take Diclofenac Reuloran”).
On adolescents with or over 14 years old, 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 taking, have recently taken or might take any other medicines.

PREGNANCY AND BREASTFEEDING
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 taking this medicine.
Diclofenac Reuloran should not be used during the last three months of your pregnancy as it may be prejudicial to the unborn child or cause problems at childbirth. Diclofenac Reuloran should only be used under medical supervision during the first 6 months of your pregnancy and the doses should remain low and the duration of the treatment as short as possible.
Diclofenac Reuloran should only be used with medical permission while breastfeeding as diclofenac is absorbed on small quantities by breast milk. Nevertheless, Diclofenac Reuloran should not be applied on the breasts of women who are breastfeeding, nor on extensive skin areas or for a prolonged period of time.

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, on topical use, may cause skin irritation.

Always take this medicine exactly as described in this leaflet or accordingly to your doctor or pharmacist’s indications. Talk to your doctor or pharmacist if you have any doubts.

FOR HOW LONG SHOULD YOU USE DICLOFENAC REULORAN :
Don’t use Diclofenac Reuloran for more than:
Adults and adolescents with or over 14 years old: 2 weeks on the muscle or joint lesions (for example, sprains, luxation and contusions) or tendonitis, except if recommended by your doctor.
Adults (over 18 years old): 3 weeks on the arthrosis pain, except if recommended by your doctor.
If the pain and swollen do not improve within 7 days, or if they worsen, talk to your doctor.

IF YOU TAKE MORE DICLOFENAC REULORAN THAN YOU SHOULD
In the case you accidentally ingest, or if your child accidentally ingests, Diclofenac Reuloran, or if you accidentally use much more than the recommended dose, immediately contact your doctor.

IF YOU FORGET TO TAKE DICLOFENAC REULORAN
If you forgot to apply Diclofenac Reuloran on the due time, apply it as soon as possible and then continue normally. Never take a double dose to compensate a dose you missed.

If you have any doubts on the use of this medicine, talk to your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Some rare or very rare side effects may be severe:
If you notice the following allergy signals, STOP the treatment with Diclofenac Reuloran and immediately tell your doctor or pharmacist:
• Skin rash, with blisters, hives (it may affect 1 to 10 people in 10.000 people).
• Wheezing, shortness of air or sensation of chest tightness (asthma) (it may affect less than 1 person in each 10.000 people).
• Face, lips, mouth, tongue or throat edema (it may affect less than 1 person in 10.000 people).

Other side effects that may occur are normally light, transitory or harmless (if you are concerned, talk to a doctor or pharmacist).

Frequent side effects (it may affect 1 to 10 people in 100 people)
• Skin rash, itchiness, redness or skin peeling.

Very rare side effects (it may affect less than 1 person in 10.000 people)
• The skin may be more sensitive to the sun. Possible signs are a sunburn with itchiness, swelling and blisters.

REPORTING OF SIDE EFFECTS
If you get any side effects, including possible side effects not included on this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly to the INFARMED, I.P., via the contacts below. By reporting side effects, you are helping to provide more data on the safety of this medicine.
INFARMED, I.P.
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisboa
Tel: +351 21 798 73 73
Medicine Hotline: 800 222 444 (free of charge)
Fax: +351 21 798 73 97
Website: http://www.infarmed.pt/web/infarmed/submissaoram
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 components 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
toLife - Produtos Farmacêuticos, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

MANUFACTURER
Farmalabor - Produtos Farmacêuticos, Lda.
Zona Industrial de Condeixa-a-Nova
3150-194 Condeixa-a-Nova
Portugal

Detailed and updated information on this medicine is available through the scan of the 2D code included on the package with a smartphone. The same information is also available on the following URL: https://www.tolifeotc.com/reuloran.

This leaflet was last revised on July 2019.