Do not use Feloran Forte gel 5%:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you are hypersensitive to aspirin or other non-steroidal anti-inflammatory drugs with a clinical manifestation of an asthma attack, urticaria or allergic rhinitis;
• if you are under 14 years of age;
• in the last three months of pregnancy.

Warnings and precautions:

Talk to your doctor or pharmacist before using Feloran Forte Gel 5%.

If you have a stomach or duodenal ulcer, heart failure (heart disease that can lead to easy fatigue, shortness of breath, swelling of the ankles, etc.), kidney or liver problems.

The gel is applied only on healthy skin (in the absence of open wounds and injuries).

Do not apply to eyes and mucous membranes.

Do not apply under a bandage, do not take orally.

Do not expose the oiled surface of the skin to sunlight.

In case of skin or other signs of hypersensitivity, the drug should be discontinued.

Other medicines and Feloran Forte gel 5%:

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

Interactions with other drugs are unlikely when Feloran gel is applied to the skin.

Pregnancy and breast-feeding:

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. The use of Feloran Forte gel 5% is not recommended during pregnancy and lactation.

Driving and using machines:

Feloran Forte gel 5% is applied to the skin. Does not affect the ability to drive and use machines.

Side effects:

Feloran Forte gel 5% contains propylene glycol, which may be irritating to the skin.
The product contains sodium benzoate as an excipient, which may have a mild irritant effect on the skin, eyes and mucous membranes.

Like all medicines, Feloran Forte gel 5% can cause side effects, although not everybody gets them.

• When applied to the skin often (in less than 1 in 10 patients) are possible: redness, itching, rash, eczema, flaking and dry skin.
• In rare cases (less than 1 in 1,000 patients), swelling and blistering of the skin at the application site may occur.
• Very rare (less than 1 in 10,000 patients) – skin rash with blisters filled with pus; allergic reactions with swelling of the face, lips, mouth, tongue or throat, often accompanied by a rash and itching, which may cause difficulty swallowing; wheezing or shortness of breath (asthma symptoms); hypersensitivity of the skin to sun exposure.

If you get any side effects, talk to your doctor or pharmacist.

Storage:

Store in the original package at a temperature below 25 ° С. Keep out of reach of children. Shelf life after opening the tube – up to 3 months. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

FELORAN FORTE gel 5% 40 g SOPHARMA

Package leaflet: information for the user

Feloran Forte 5% gel
Feloran® Forte 5% gel

Diclofenac sodium

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 7 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet:

1. What Feloran Forte gel is and what it is used for
2. What you need to know before you use Feloran Forte Gel
3. How to use Feloran Forte gel
4. Possible side effects
5. How to store Feloran Forte gel
6. Contents of the pack and other information

1. What Feloran Forte gel is and what it is used for

Feloran Forte gel contains the active substance diclofenac sodium, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs. Diclofenac relieves the symptoms of inflammation – pain and edema. The gel is specially designed to achieve rapid resorption of diclofenac through the skin and rapid pain relief.
Feloran Forte gel is shown in:

• injuries to tendons, ligaments, muscles and joints due to sprains, sprains, strains, bruises and back pain (sports injuries);
• localized forms of extraarticular rheumatism – tendon inflammations (for example, “tennis elbow”), bursitis (pain and swelling in and around the joints), shoulder-arm syndrome, periarthropathy;
• localized forms of degenerative joint diseases, for example, osteoarthritis of peripheral joints and spine.

2. What you need to know before you use Feloran Forte gel

Do not use Felauran Forte gel

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you are hypersensitive to aspirin or other NSAIDs with clinical signs of an asthma attack, urticaria or allergic rhinitis
• if you are under the age of 14;
• in the last three months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before using Feloran Forte gel.
If you have a stomach or duodenal ulcer, cardiovascular insufficiency (heart disease that can lead to easy tiredness, shortness of breath, swelling of the ankles, etc.), kidney or liver problems.
The gel is applied only to healthy skin (in the absence of open wounds and injuries).
It is not applied to the eyes and mucous membranes.
Not applied under bandage.
Do not take by mouth.
Do not expose the oiled surface of the skin to sunlight.
In case of skin or other signs of hypersensitivity, the use of the drug should be discontinued.

Other medicines and Feloran Forte gel

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with other medicines are unlikely when applying Feloran Forte gel to the skin.

Pregnancy and breast-feeding

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. The use of Feloran Forte gel is not recommended during pregnancy and during lactation.

Driving and using machines

Felauran Forte gel is applied to the skin. Has no influence on the ability to drive and use machines.

Feloran Forte gel contains dimethylsulfoxide: May cause skin irritation.

This medicine contains 2.5 mg sodium benzoate in each gram. Sodium benzoate may cause local irritation.

3. How to use Feloran Forte gel

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.

Felauran Forte gel is applied to the skin.

The recommended dose is:

Adults and adolescents over 14 years of age: the gel is applied to the affected area 2 times a day (preferably morning and evening) and gently rubbed until absorbed by the skin. The required amount of gel depends on the size of the affected area. For example, 1 g of gel (about 6 cm) is enough to spread an area of about 400 cm2. After each application, hands should be washed unless they are the treated area.

The duration of treatment depends on the indications and the effect achieved.

• In case of trauma or rheumatism of soft tissues – it is not recommended to use the gel for more than 14 days, unless this is appointed by a doctor.
• For arthritic pain (adults over 18 years) – it is not recommended to use for more than 2 days, unless the treatment is appointed by a doctor.

When Feloran Forte gel is used without a doctor’s prescription for the indicated indications, a doctor’s consultation is necessary if the patients’ condition does not improve within 7 days or worsens.

Children under 14 years: application of the product in this age group is contraindicated.

Elderly patients (over 65 years): used at the usual dosage.

If you use more Feloran Forte gel than you should

Since the product is applied to the skin, an overdose is unlikely. In case of accidental oral ingestion of large quantities of the product, contact your doctor or contact the nearest medical institution.

If you forget to use Ferran Forte gel

If you forget to dose and the time for your next dose is approaching, administer it as usual. Do not use twice the amount of the medicine at the next administration.

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

4. Possible side effects

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

Serious adverse reactions

If you notice any of the following side effects, stop using Feloran gel and tell your doctor or pharmacist immediately.

Very rare (less than 1 in 10,000 patients):

allergic reactions occurring with swelling of the face, lips, mouth, tongue or throat, often accompanied by rash and itching, which can cause difficulty swallowing; whistling in the chest or shortness of breath (asthma symptoms); skin rash with blisters filled with pus.

Other side effects

Common (less than 1 in 10 patients):

redness, itching, rashes, eczema, flaking and dryness of the skin.

Rare (less than 1 in 1,000 patients):

swelling and formation of bubbles on the skin at the site of application.

Very rare (less than 1 in 10,000 patients):

increased sensitivity of the skin when exposed to the sun.

Not known (cannot be estimated from the available data):

burning sensation at the site of application.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Feloran Forte gel

Store in the original package at a temperature below 25°C.Keep out of the reach of children.

Use within 1 month after opening the tube.

Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.

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 to protect the environment.

6. Contents of the pack and other information

What Feloran Forte gel contains

The active substance is diclofenac sodium 50 mg Big gel.
The other ingredients are: carbomer 980, dimethylsulfoxide, isopropyl alcohol, sodium benzoate, diethanolamine, purified water.

What Feloran Forte gel looks like and contents of the pack

A transparent, colourless jelly mass with a specific smell of isopropyl alcohol. 40 g/120 g of product are dosed in membrane aluminium tubes with polyethylene or polypropylene caps, 1 tube per carton, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria