Felogel neo

Package leaflet: information for the patient

FELOGEL NEO, 10 mg/g, gel
Diclofenacum natricum
Please read this 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 a physician.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Table of contents

1. What FELOGEL NEO is and what it is 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. Contents of the pack and other information

1. What FELOGEL NEO is and what it is used for
FELOGEL NEO contains the active substance sodium diclofenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Diclofenac reduces the severity of inflammatory symptoms—pain and swelling. The gel has been specially formulated to allow rapid absorption of diclofenac through the skin and to provide fast pain relief. FELOGEL NEO is indicated for local symptomatic treatment of traumatic inflammatory conditions of tendons, muscles and joints (e.g. resulting from sprains, strains or contusions), localized inflammatory conditions of soft tissues (such as tendinitis or tennis elbow), and localized mild forms of joint inflammation.

2. Important information before using FELOGEL NEO

When not to use FELOGEL NEO

• if you are allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, including asthma attacks, urticaria, or allergic rhinitis;
• during the last three months of pregnancy.

Warnings and precautions
Before using FELOGEL NEO, consult your doctor or pharmacist:

• if you have a gastric or duodenal ulcer, circulatory failure (heart disease that may cause easy fatigue, shortness of breath, ankle swelling, etc.), or kidney problems;
• if you have previously experienced hypersensitivity to foods or medicines;
• if you suffer from asthma or other allergic conditions;
• if you have previously experienced hypersensitivity to acetylsalicylic acid or other anti-rheumatic drugs;
• the gel should only be applied to intact skin (without open wounds or skin lesions);
• do not apply the gel to the eyes or mucous membranes;
• do not use the gel under occlusive dressings and do not take it orally;
• avoid exposing treated skin to direct sunlight;
• if symptoms of skin hypersensitivity or reactions in other organs occur, treatment should be discontinued. Systemic adverse reactions cannot be ruled out when FELOGEL NEO is applied over large skin areas or during prolonged use.

Children and adolescents
Do not use FELOGEL NEO in children and adolescents under 14 years of age.

FELOGEL NEO and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Although interactions are unlikely when FELOGEL NEO is applied topically, inform your doctor if you are taking acetylsalicylic acid or other anti-inflammatory drugs, corticosteroids, or antihypertensive medicines.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Do not use FELOGEL NEO during breastfeeding.
Do not use FELOGEL NEO during the last three months of pregnancy. During the first six months of pregnancy, FELOGEL NEO should not be used unless considered necessary and recommended by a doctor. If use is necessary, the lowest effective dose should be used for the shortest possible duration.
Oral formulations containing diclofenac may cause adverse effects in the unborn child. It is unknown whether the same risk applies to FELOGEL NEO when applied topically.

Driving and operating machinery
FELOGEL NEO is intended for topical application to the skin. It does not affect the ability to drive or operate machinery.

FELOGEL NEO contains propylene glycol and sodium benzoate
This medicine contains 50 mg of propylene glycol. Propylene glycol may cause skin irritation.
This 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 this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
FELOGEL NEO is intended for topical application to the skin. The usual way of using this medicine is as follows:
Use in adults and adolescents above 14 years of age
Apply the gel locally to the skin 2 to 3 times daily and rub in thoroughly until completely absorbed. The amount required depends on the size of the affected area.
For example: 2 g of gel (approximately 6 cm) is sufficient to cover an area of about 400 cm². After each application, hands should be washed unless they are the area being treated. In cases of thrombophlebitis, do not massage the area where the gel is applied.
Before first use, pierce the aluminium foil seal closing the tube.
The duration of treatment depends on the indication and the response to therapy.
In adults and adolescents above 14 years of age, if using the medicine without consulting a doctor, it should not be used for longer than 14 days. Medical advice is recommended after 7 days of treatment if there is no improvement, or if symptoms worsen.
If this medicinal product is required for pain relief in adolescents aged 14 years and above for longer than 7 days, or if symptoms worsen, the patient or caregiver should consult a doctor.
Use in children and adolescents under 14 years of age
There is insufficient data on the efficacy and safety of use in children and adolescents under 14 years of age.
Use in elderly patients
The medicine should be used at the normally recommended dose.
If in doubt, consult your doctor or pharmacist.
Use of a higher than recommended dose of FELOGEL NEO
Since the medicine is intended for topical use, overdose is unlikely. In case of accidental ingestion of large amounts, or contact with eyes, mucous membranes, or open wounds, consult a doctor or go to the nearest healthcare facility.
Missed dose of FELOGEL NEO
If a dose is missed and it is almost time for the next dose, apply the next dose as usual. Do not apply a double dose to make up for a missed dose.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some rare and very rare adverse reactions may be serious.
If any of the following symptoms of allergy occur, discontinue use of the medicine
FELOGEL NEO and immediately contact a doctor or pharmacist:

• bullous dermatitis: local swelling and blisters may occur at the treated area (may affect up to 1 in 1,000 people);
• allergic reactions such as urticaria (may affect 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 1 in 10,000 people).

Other adverse reactions that may occur are usually mild and transient (if in doubt, contact a doctor or pharmacist).
Common adverse reactions (may affect from 1 to 10 in 100 people):

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

Very rare adverse reactions (may affect less than 1 in 10,000 people):

• photosensitivity.
• papular rash.

Frequency unknown (frequency cannot be estimated from available data):

• burning sensation at the application site.

When the medicine is applied to a large skin surface area, gastrointestinal disorders may occur (loss of appetite, nausea, vomiting, diarrhoea, pain, bleeding, and ulceration).
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: (22) 49-21-301, fax: (22) 49-21-309. Website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store FELOGEL NEO

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
No special requirements regarding the storage temperature of the medicinal product.
Store in the original packaging to protect from light.
After first opening of the tube: 6 months.

6. Contents of the packaging and other information

What FELOGEL NEO contains
The active substance is sodium diclofenac. 1 g of gel contains 10 mg of sodium diclofenac.
Other components of the medicinal product are: carbomer 980, macrogol 400, propylene glycol, diethanolamine, sodium benzoate, isopropyl alcohol, purified water.

What FELOGEL NEO looks like and contents of the pack
A transparent, colourless, homogeneous gel with a characteristic smell of isopropyl alcohol.
Aluminium tube with a membrane, closed with a PP cap, placed in a cardboard box. One tube of 40 g, 60 g or 120 g, together with the package leaflet, in a cardboard box.

Marketing Authorisation 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