Diclofenac Doc Generici

Package leaflet: Information for the patient

DICLOFENAC DOC Generics 30 mg/g gel

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DICLOFENAC DOC Generics is and what it is used for

DICLOFENAC DOC Generics contains the active substance sodium diclofenac and is a non-steroidal anti-inflammatory medicine.
When applied to the skin, DICLOFENAC DOC Generics is used to treat dry, scaly patches on the skin in adults that have been damaged by the sun (known as "actinic or solar keratosis").

2. What you should know before using DICLOFENAC DOC Generics

Do not use DICLOFENAC DOC Generics

• if you are allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• If you have had allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Signs of an allergic reaction include skin rash (urticaria), breathing difficulties (wheezing), or runny nose (allergic rhinitis).
• If you are in the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using DICLOFENAC DOC Generics if

• you currently have or have previously had stomach ulcers or gastrointestinal bleeding,
• you have heart, liver, or kidney problems,
• you suffer from any bleeding disorder or bruise very easily.
• avoid exposure to sunlight and sunlamps during treatment with DICLOFENAC DOC Generics. If skin reactions occur, discontinue use,
• do not apply on wounds, infected skin, or areas with dermatitis,
• avoid contact of DICLOFENAC DOC Generics with eyes, inside the nose or mouth, and do not swallow it. If DICLOFENAC DOC Generics is accidentally ingested, consult your doctor immediately,
• if you develop widespread skin rash, stop using DICLOFENAC DOC Generics and
  consult your doctor,
• after applying medicines containing diclofenac to the skin, you may use a breathable (non-occlusive) dressing. Do not use an occlusive dressing that does not allow air passage.

Children and adolescents
Do not give this medicine to children and adolescents, as actinic keratosis is generally not observed in the pediatric population and has not been studied. Therefore, dosage recommendations and indications for use of this medicine in children and adolescents have not been established.

Other medicines and DICLOFENAC DOC Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Interactions with other medicines are highly unlikely with DICLOFENAC DOC Generics.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor.
DICLOFENAC DOC Generics should be used with caution during the first six months of pregnancy, but must not be used during the last trimester of pregnancy.

Breast-feeding
Consult your doctor if you are breast-feeding. DICLOFENAC DOC Generics may be used with caution during breast-feeding, but it must not be applied to the breast area.

If you are pregnant, trying to become pregnant, or breast-feeding, and your doctor considers this treatment appropriate, you must not apply this medicine to a skin surface larger than one-third of your body, and you must not use it for longer than three weeks.

DICLOFENAC DOC Generics contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram. Benzyl alcohol may cause mild local irritation.

3. How to use DICLOFENAC DOC Generics

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
DICLOFENAC DOC Generics is for topical use only. How to use this medicine

• Pierce the tube opening using the cap.
• Gently apply a small amount of gel to the skin in the area to be treated.
• Generally, 0.5 grams of gel (about the size of a pea) is sufficient to treat an area of 5x5 cm.
• The gel may be applied twice daily, unless otherwise directed by your doctor. When applying the gel to the skin, you may feel a mild cooling sensation.
• After applying the gel, wash your hands unless the treated area includes your hands.
• Do not apply more than 8 grams of gel per day.
• The usual treatment duration is 60–90 days. Maximum efficacy is observed with a treatment duration close to 90 days. Complete healing may occur up to one month after stopping treatment.

If you use more DICLOFENAC DOC Generics than you should
Remove excess gel by washing with water.
If you forget to use DICLOFENAC DOC Generics
Do not apply a double dose to make up for the missed dose. Continue applying the gel twice daily, unless otherwise instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
If you experience any of the following side effects, stop using the gel and inform your doctor as soon as possible:

• skin rash (urticaria), breathing difficulties (wheezing), swelling of the face, runny nose (allergic rhinitis). These symptoms may indicate a possible allergy to DICLOFENAC DOC Generics.

If any of the following common side effects become severe or last for more than a few days, stop using the gel and consult your doctor:

• itching, skin rash, redness or inflammation of the skin, contact dermatitis, pain and blistering.

Other side effects
Common (may affect up to 1 in 10 people)
irritation or tingling at the application site, conjunctivitis, allergic reactions, tenderness when touching the skin, tingling sensation, muscle stiffness, dermatitis, eczema, dry skin, swelling, skin rash (including peeling and blistering), skin breakdown and skin ulcers.
Uncommon (may affect up to 1 in 100 people)
eye pain, eye watering/dry eyes, abdominal pain, diarrhoea, feeling unwell, hair loss, facial swelling, excessive bleeding or oily skin, measles-like rash.
Rare (may affect up to 1 in 1,000 patients)
dermatitis with large blisters.
Very rare (may affect up to 1 in 10,000 people)
stomach bleeding, kidney problems, breathing difficulties (asthma), infected skin rash, skin sensitivity to sunlight.
A temporary change in hair colour at the application site has been reported, which usually resolves when treatment is stopped.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via 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 DICLOFENAC DOC Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Use within 6 months after first opening.
Do not dispose of any medicine via wastewater. 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 DICLOFENAC DOC Generics Contains

• The active substance is sodium diclofenac. Each gram of gel contains 30 mg of sodium diclofenac (3% w/w).
• The other components are sodium hyaluronate, benzyl alcohol, polyethylene glycol monomethyl ether 350, purified water.

Description of the Appearance of DICLOFENAC DOC Generics and Contents of the Pack
DICLOFENAC DOC Generics is a clear, transparent gel, colourless to slightly yellow,
packed in aluminium tubes with a white HDPE screw cap with piercing point,
containing 25 g, 50 g, 60 g, 90 g or 100 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.
Manufacturer
Glenmark Pharmaceuticals s.r.o.
Hvézdova 1716/2b
14078 - Prague 4
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Diclofenac Glenmark 30 mg/g Gel
Spain: Soliker 30 mg/g Gel
Italy: DICLOFENAC DOC Generics