Fenac-Gel belongs to the pharmaceutical group 9.1.10 non-steroidal anti-inflammatory drugs (NSAIDs) for topical use.

Fenac-Gel is an anti-inflammatory and analgesic gel for cutaneous use, indicated in the following situations:

• Inflammation of tendons, ligaments and joints due to sprains, luxations and bruises
• Localized forms of soft tissue rheumatism such as tendonitis, tenosynovitis and bursitis
• Localized forms of degenerative rheumatism: osteoarthritis of peripheral joints and vertebral column.

Do not use Fenac-Gel:

– in case of allergy (hypersensitivity) to diclofenac or any of the other ingredients of Fenac-Gel.

– if you have or ever had ulcers or gastrointestinal bleeding.

– if you have asthma attacks, urticaria or rhinitis precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).

– if you are in your third trimester of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before using Fenac-Gel.

Fenac-Gel must only be used in intact and healthy skin and not in injured skin or open wounds. Avoid any contact with the eyes or mucosae. It must never be used orally.

As there is the possibility of absorption through skin it is not possible to exclude the occurrence of systemic effects (generalized throughout the entire body). The risk of occurrence of these effects depends, among others, on the area exposed, on the amount applied and on exposure time.

The use of Fenac-Gel must be stopped immediately if there are signs of rash (change in the texture and appearance of the skin), injuries in the mucosae or other manifestations of hypersensitivity.

Fenac-Gel contains propylene glycol that may cause some moderate skin irritation in some people.

Do not use Fenac-Gel with airtight occlusive dressing. It can be used with non-occlusive bandages.

Children and adolescents

Indications and posology are not established for children and adolescents aged 14 years old or less.

Other medicines and Fenac-Gel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Provided that systemic absorption from topical use of diclofenac is very low, interactions are unlikely to happen.

Fenac-Gel with food and drink

Not relevant.

Pregnancy and breast-feeding

Since no studies with Fenac-Gel have been carried out in pregnant women, out of precaution, the medicine must not be used in this stage.

There are no data on the use of Fenac-Gel during breast-feeding and therefore its use is not recommended during this period of time.

Fenac-Gel must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Fenac-Gel should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible.

Fenac-Gel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Fenac-Gel should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.

Driving and using machines

Not relevant.

Fenac-Gel contains propylene glycol

Fenac-Gel formulation contains propylene glycol.

Propylene glycol may cause skin irritation.

Provided that this medicine contains propylene glycol it must not be used in open wounds or in large areas of cracked skin or injured skin (such as burns) without prior advice from your doctor or pharmacist.

Fenac-Gel should be rubbed gently into the skin, 3 to 4 times daily.

After application, the hands should be washed unless they are the site being treated.

Cutaneous use.

Fenac-Gel must never be ingested.

Do not apply the treatment for more than 7 days. If symptoms persist or worsen please contact your doctor.

If you have any further questions on the use of this medicine, ask your pharmacist.

If you use more Fenac-Gel than you should

The low systemic absorption of Fenac-Gel renders overdose very unlikely.

In case any significant systemic undesirable effects occur from incorrect use or accidental overdose please contact your doctor or pharmacist immediately.

If you get any side effects not mentioned in this leaflet, talk to your doctor or pharmacist.

If you forget to use Fenac-Gel

Do not take a double dose to make up for a forgotten dose.

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.

Fenac-Gel is usually well tolerated.

Some rare or very rare side effects might be serious.

If you experience any of the following signs of allergy STOP using Fenac-Gel and tell your doctor or pharmacist immediately:

– itching, reddening of the skin, skin rash, (may affect between 1 and 10 in every 10.000 people).

– asthma attacks (may affect less than 1 in every 10.000 people)

– swelling of the face, lips, mouth, tongue or throat (may affect less than 1 in every 10.000 people)

– photosensitivity reactions (sensitivity to light) (may affect less than 1 in every 10.000 people)

Not known: burning sensation at the application site. Dry skin.

Other side effects that may occur are generally mild, passing and harmless. In case you are worried please contact your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system contacts listed below. By reporting side effects you can help provide more information 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

Linha do Medicamento: 800222444 (free)

Fax: + 351 21 798 73 97

website: http://www.infarmed.pt/web/infarmed/submissaoram

E-mail: farmacovigilancia@infarmed.pt

In isolated cases the following side effects may occur: generalized skin eruption, hypersensitivity reactions, asthma attacks, photosensitivity reactions (sensitivity to light). Changes in the skin may present blisters.

Other systemic side effects that may occur are nausea, heartburn and changes in palate.

If any of the side effects gets worse or if you get any side effects not listed in this leaflet, please contact your pharmacist.

Keep this medicine out of the sight and reach of children.

Do not store above 25º C.

Do not use this medicine after the expiry date which is stated on the tube and outer carton after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Fenac-Gel contains

The active substance of this medicine is Diclofenac. Each 100 g of gel contain 1.16 g of Diclofenac diethylammonium equivalent to 1 g of Diclofenac sodium.

The other ingredients are: Diethylamine, acrylic acid polymer, polyoxyl 2 cetyl ether, cetiol LC, isopropyl alcohol, liquid paraffin, propylene glycol and water.

What Fenac-Gel looks like and contents of the pack

Fenac-Gel is a gel packed in tubes containing 100 g of gel.

This leaflet provides important information on Fenac-Gel. In case you have any doubts talk to your doctor or pharmacist as they have more detailed information.

Marketing Authorisation Holder and Manufacturer

Sidefarma – Sociedade Industrial de Expansão Farmacêutica, S.A.

Rua da Guiné, n.º 26

2689-514 Prior Velho

Portugal

For any information about this medicine, please contact the Marketing Authorisation Holder.

Medicinal product not subject to medical prescription.

This leaflet was last revised in December 2020