Felogel neo

Leaflet attached to the packaging: patient information

FELOGEL NEO ,10 mg/g, gel
Diclofenac sodium

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is FELOGEL NEO and what is it used for
• 2. Important information before using FELOGEL NEO
• 3. How to use FELOGEL NEO
• 4. Possible side effects
• 5. How to store FELOGEL NEO
• 6. Package contents and other information

1. What is FELOGEL NEO and what is it used for

FELOGEL NEO contains the active substance diclofenac sodium and belongs to a group of medicines called anti-rheumatic or non-steroidal anti-inflammatory drugs. Diclofenac reduces the severity of inflammation symptoms - pain and swelling. The gel has been specially developed to achieve rapid absorption of diclofenac through the skin and rapid pain relief. FELOGEL NEO is indicated for local symptomatic treatment of post-traumatic inflammatory conditions of tendons, muscles, joints (e.g. caused by sprains, strains or bruises), limited inflammatory conditions of soft tissues (such as tendonitis or tennis elbow), and limited and mild forms of arthritis.

2. Important information before using FELOGEL NEO

When not to use FELOGEL NEO

• if the patient is allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6);
• if the patient has been diagnosed with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, asthma, urticaria, or allergic rhinitis;
• in the last three months of pregnancy.

Warnings and precautions

Before starting to use FELOGEL NEO, the patient should consult their doctor or pharmacist

• if the patient has a stomach or duodenal ulcer, circulatory failure (heart disease that can lead to easy fatigue, shortness of breath, swelling around the ankles, etc.),

kidney problems;

• if the patient has experienced hypersensitivity to foods and medicines;
• if the patient has asthma or other allergic diseases;
• if the patient has experienced hypersensitivity to acetylsalicylic acid or other anti-rheumatic medicines;
• the gel should only be used on intact skin (without open wounds and damage);
• the gel should not be applied to the eyes and mucous membranes;
• the gel should not be used under bandages and should not be taken orally;
• the treated skin should not be exposed to direct sunlight;
• in case of skin or other organ hypersensitivity reactions, treatment should be discontinued. It cannot be ruled out that systemic side effects may occur when using FELOGEL NEO on large areas of skin or during prolonged use.

Children and adolescents

FELOGEL NEO should not be used in children and adolescents under 14 years of age.

FELOGEL NEO and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Although the use of FELOGEL NEO on the skin is unlikely to interact with other medicines, the patient should inform their doctor if they are taking acetylsalicylic acid or other anti-inflammatory medicines, corticosteroids, and medicines for lowering blood pressure.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. FELOGEL NEO should not be used during breastfeeding.
FELOGEL NEO should not be used in the last three months of pregnancy. In the first six months of pregnancy, FELOGEL NEO should not be used unless it is necessary and recommended by a doctor. If use is necessary, the smallest dose should be administered for the shortest possible time.
After oral administration of diclofenac-containing medicines, side effects may occur in the unborn child. It is not known if the same risk applies to FELOGEL NEO when used on the skin.

Driving and using machines

FELOGEL NEO is intended for local use on the skin. It does not affect the ability to drive vehicles and operate machinery.

FELOGEL NEO contains propylene glycol and sodium benzoate

The medicine contains 50 mg of propylene glycol. Propylene glycol may cause skin irritation.
The medicine contains 2.5 mg of sodium benzoate. Sodium benzoate may cause local irritation.

3. How to use FELOGEL NEO

This medicine should always be used exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
FELOGEL NEO is intended for use on the skin. The medicine is usually used as follows:

Use in adults and adolescents over 14 years

The gel should be applied locally to the skin 2 to 3 times a day and rubbed in thoroughly until absorbed by the skin. The required amount of gel depends on the size of the affected area.
For example: 2 g of gel (about 6 cm) is sufficient to cover an area of about 400 cm². After each application of the gel, the hands should be washed, unless the hands are being treated. In case of thrombophlebitis, the application site should not be compressed.
Before the first use, the patient should puncture the aluminum foil that seals the tube.
The treatment period depends on the indications and the response to treatment.
In adults and adolescents over 14 years, if the medicine is used without consulting a doctor, it should not be used for more than 14 days. Medical supervision is recommended after 7 days of using the gel if the treatment is not effective or if the symptoms worsen.
If the medicinal product needs to be used in adolescents over 14 years to relieve pain for more than 7 days or if symptoms worsen, the patient or their caregivers should consult a doctor.

Use in children and adolescents under 14 years

There is insufficient data on the efficacy and safety of using FELOGEL NEO in children and adolescents under 14 years of age.

Use in elderly patients

The medicine should be used in the usual recommended dose.
In case of doubts, the patient should consult their doctor or pharmacist.

Using more than the recommended dose of FELOGEL NEO

Since the medicine is intended for local use, overdose is unlikely. In case of accidental ingestion of large amounts of the medicine or contact with the eyes, mucous membranes, or open wounds, the patient should consult their doctor or go to the nearest health center.

Missing a dose of FELOGEL NEO

If a dose is missed and the next dose is approaching, it should be applied as usual. A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, FELOGEL NEO can cause side effects, although not everybody gets them.

Some rare and very rare side effects may be serious.

If any of the following allergy symptoms occur, the patient should stop using FELOGEL NEO and immediately inform their doctor or pharmacist:

• blisters: local swelling and blisters may occur on the treated area (may affect up to 1 in 1000 people);
• allergic reactions, such as urticaria (may affect up to 1 in 10,000 people);
• shortness of breath, wheezing (asthma) (may affect up to 1 in 10,000 people);
• swelling of the face or throat (may affect up to 1 in 10,000 people).

Other side effects that may occur are usually mild and transient (in case of doubts, the patient should inform their doctor or pharmacist).
Common side effects (may affect between 1 and 10 in 100 people):

• redness, itching, rash, skin peeling, and dry skin.

Very rare side effects (may affect less than 1 in 10,000 people):

• photosensitivity.
• maculopapular rash.

Frequency not known (frequency cannot be estimated from the available data):

• burning sensation at the application site.

In case of application to a large skin area, gastrointestinal disorders (loss of appetite, nausea, vomiting, diarrhea, abdominal pain, and bleeding) may occur.
If any side effects occur, including any possible side effects not listed in this leaflet, the patient should consult their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49-21-301, fax (22) 49-21-309.
Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store FELOGEL NEO

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
There are no special storage temperature recommendations for the medicinal product.
Store in the original packaging to protect from light.
After opening the tube: 6 months.

6. Package contents and other information

What FELOGEL NEO contains

The active substance is diclofenac sodium. 1 g of gel contains 10 mg of diclofenac sodium.
The other ingredients of the medicine are: carbomer 980, macrogol 400, propylene glycol, diethanolamine, sodium benzoate, isopropyl alcohol, purified water.

What FELOGEL NEO looks like and what the pack contains

Transparent, colorless gel with a uniform consistency and a characteristic isopropyl alcohol smell.
Aluminum tube with a membrane, closed with a PP cap, in a cardboard box. One tube of 40 g, 60 g, or 120 g, along with the leaflet, in a cardboard box.

Marketing authorization holder

Sopharma Warszawa Sp. z o. o.
Al. Jerozolimskie 136, 02-305 Warsaw
tel.: 22 613 39 30

Manufacturer

SOPHARMA AD
16 Iliensko Shosse str.
1220 Sofia
Bulgaria

Date of the last update of the leaflet: