LEVIOGEL 1% Gel

Зміст інструкції

1. LEVIOGEL 10 mg/g gel
   1. What is LEVIOGEL and what is it used for
   2. What you need to know before using LEVIOGEL
   3. How to use LEVIOGEL
   4. Possible side effects
   5. How to store LEVIOGEL
   6. Contents of the pack and other information

LEVIOGEL 10 mg/g gel

Diclofenac sodico

Read this leaflet carefully before using this medicine as 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 need to read it again.
• If you would like more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

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

1. What is LEVIOGEL and what is it used for

LEVIOGEL contains diclofenac sodium which belongs to the group of Non-Steroidal Anti-inflammatory Drugs (NSAIDs) that work by reducing pain and swelling typical of inflammation.
This medicine is used to reduce pain, swelling and inflammation of the joints, muscles, tendons and ligaments in case of rheumatism or trauma.
See a doctor if you do not feel better or if you feel worse.

2. What you need to know before using LEVIOGEL

Do not use LEVIOGEL

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction to diclofenac or other non-steroidal anti-inflammatory drugs such as aspirin, accompanied by difficulty breathing (asthma), skin rash with the appearance of wheals (urticaria) or sudden cold (acute rhinitis);
• if you are in the last three months of pregnancy (see section 2 “Pregnancy and breastfeeding”);
• in children and adolescents under 14 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using LEVIOGEL.
If a skin rash should occur after applying the product to the skin,

stop treatmentand consult your doctor.
Avoid using this medicine on large areas of skin and for long periods of time.
This medicine should only be used on intact and healthy skin, do not apply the product to wounds or open lesions. After application, do not cover the area with a bandage that does not allow the treated part to breathe (occlusive bandage)
(see section 3 “How to use LEVIOGEL”).
This medicine should not come into contact with the eyes or nose and mouth (mucous membranes).
For external use only, do not ingest.

Children and adolescents
This medicine is not suitable for children and adolescents under 14 years of age (see section 2 “Do not use LEVIOGEL”).

Other medicines and LEVIOGEL
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, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use LEVIOGEL if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. Do not use LEVIOGEL during the first 6 months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is necessary during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) based on diclofenac can cause adverse effects in the newborn. It is not known whether the same risk exists with LEVIOGEL when used on the skin.
Breastfeeding
This medicine should only be used under medical advice during breastfeeding as diclofenac passes into breast milk in small amounts.
If you are breastfeeding, use this medicine only if your doctor has deemed it necessary and under their supervision. Absolutely avoid applying the product to the breast or to large areas of skin and for long periods of time.
Consult your doctor or pharmacist for further information in case of pregnancy or breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles or use machines.

3. How to use LEVIOGEL

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
For external use only.

Adults
The recommended dose in adultsis 3 – 4 applications per day.
Use only for short periods of treatment.

Use in children and adolescents
In adolescents aged between 14 and 18 years, the product should be used for no
more than 7 days. If pain does not improve or symptoms worsen after 7 days, consult a
doctor.
The recommended dose is 3 – 4 applications per day.
In children under 14 years of age, the product should not be used (see section 2
“Do not use LEVIOGEL”).
Method of use
Apply with light friction a quantity of gel varying between a cherry and a walnut, depending on
the size of the area to be treated.
It is possible to cover the treated area with a bandage that allows the skin to breathe (NON-occlusive
bandage).
Caution: Wash your hands thoroughly after application to remove any gel residue.

If you use more LEVIOGEL than you should
In case of ingestion/accidental intake of an excessive dose of LEVIOGEL immediately
notify your doctoror go to the nearest hospital.
If you have any doubts about 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.
With the use of this medicine, the following side effects may occur, classified
by frequency:

Common(may affect up to 1 in 10 people):

• skin rash, skin manifestations characterized by the appearance of lesions (eczema) or redness (erythema), skin inflammation (dermatitis) including that due to contact with an irritating substance (contact dermatitis), itching.

Rare(may affect up to 1 in 1000 people):

• skin lesion manifesting with the appearance of blisters (bullous dermatitis).

Very rare(may affect up to 1 in 10,000 people):

• hypersensitivity reactions (allergic reactions), swelling of the skin and mucous membranes (angioedema);
• skin rash characterized by the appearance of pustules (rash);
• excessive sensitivity of the skin to the sun and UV rays (photosensitivity reaction);
• difficulty breathing (asthma).

Not known(frequency cannot be estimated based on available data):

• burning sensation at the application site;
• dry skin.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist.
You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the
safety of this medicine.

5. How to store LEVIOGEL

Do not store at a temperature above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LEVIOGEL contains
In 1 g of gel:

• The active ingredient is diclofenac sodium 10 mg.
• The other ingredients are 96 percent ethanol, isopropyl alcohol, carbomers, concentrated ammonia solution, purified water.

Description of the appearance of LEVIOGEL and contents of the pack
LEVIOGEL is available in tubes containing 50 g or 100 g of gel.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT Srl – Via Cavour, 70 – 27035 Mede (PV)