DICLOFENAC 30 mg /G Gel

Зміст інструкції

1. DICLOFENAC DOC Generics 30 mg/g gel
   1. What is DICLOFENAC DOC Generics and what is it used for
   2. What you need to know before you use 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

DICLOFENAC DOC Generics 30 mg/g gel

Equivalent medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you use 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 is DICLOFENAC DOC Generics and what is it used for

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

2. What you need to know before you use DICLOFENAC DOC Generics

Do not use DICLOFENAC DOC Generics

• if you are allergic to diclofenac sodium 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 agents. The signs of an allergic reaction include skin rash (urticaria), difficulty breathing (wheezing) or runny nose (allergic rhinitis).
• If you are in the last 3 months of pregnancy.

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

• you suffer from or have suffered in the past from ulcers or bleeding in the stomach,
• you have problems with your heart, liver or kidneys,
• you suffer from any bleeding disorder or bruise very easily.
• avoid exposure to the sun and tanning lamps during use of DICLOFENAC DOC Generics. If skin reactions occur, stop use,
• do not apply to wounds, skin with infections or dermatitis,
• avoid getting DICLOFENAC DOC Generics in contact with your eyes or with the inside of your nose or mouth and do not swallow it. If you accidentally swallow DICLOFENAC DOC Generics, consult a doctor immediately,
• if you experience widespread rash, stop using DICLOFENAC DOC Generics and

consult your doctor,

• after applying medicines containing diclofenac to the skin, a permeable (non-occlusive) bandage may be used. Do not use an occlusive bandage that does not allow air to pass through.

Children and adolescents
Do not give this medicine to children and adolescents as actinic keratosis is generally not
observed within 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
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
For DICLOFENAC DOC Generics, interactions with other medicines are very unlikely.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, talk to your doctor.
DICLOFENAC DOC Generics should be used with caution in the first six months of pregnancy, but should not
be used in the last trimester of pregnancy.
Breastfeeding
Consult your doctor if you are breastfeeding. DICLOFENAC DOC Generics may be used with caution
during breastfeeding, but should not be applied to the breast.
If you are pregnant, trying to become pregnant or are breastfeeding, and your doctor considers this treatment
appropriate, you should not apply this medicine to a skin surface larger than one-third
of your body and should not use it for more 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 following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.
DICLOFENAC DOC Generics is for
cutaneous use. How to use this medicine

• Pierce the opening of the tube using the cap.
• Gently spread a small amount of gel onto the skin in the area to be treated.
• Generally 0.5 grams of gel (the size of a pea) is sufficient to treat an area of 5x5 cm.
• The gel can be applied twice a day, unless otherwise indicated by your doctor. When spreading the gel onto the skin, you may feel a slight cooling sensation.
• After applying the gel, wash your hands, unless one of the areas to be treated is your hands.
• You should not apply more than 8 grams of gel per day.
• The normal treatment period 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 cessation of therapy.

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 of gel to make up for the forgotten dose. Continue to apply the gel twice
a day unless otherwise indicated by your doctor.
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.

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), difficulty breathing (wheezing), swelling of the face, runny nose (allergic rhinitis). These symptoms indicate a possible allergy to DICLOFENAC DOC Generics.

If any of the common side effects listed below becomes severe or if it lasts 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 treated area, conjunctivitis, allergy, sensation of pain when touching the
skin, tingling, muscle stiffness, dermatitis, eczema, dry skin, swelling, skin rash (including
peeling and blistering), skin thinning and skin ulcers.

Uncommon(may affect up to 1 in 100 people)
eye pain, tearing/dry eyes, abdominal pain, diarrhea, 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)
stomach bleeding, kidney problems, difficulty breathing (asthma), infected skin rash,
skin sensitivity to sunlight.
Temporary changes in hair color in the application area have been reported, which
usually resolves when treatment is stopped.

Reporting of side effects
If you get any side effects, talk to 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 DICLOFENAC DOC Generics

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 tube and the carton after Exp. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Use within 6 months after first opening.
Do not dispose of any medicine in wastewater 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 DICLOFENAC DOC Generics contains

• The active ingredient is diclofenac sodium. Each gram of gel contains 30 mg of diclofenac sodium (3% w/w).
• The other ingredients 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, from colorless to slightly yellow
packaged in aluminum tubes with a white HDPE screw cap with a piercing tip,
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 Member States of the European Economic Area with
the following denominations:
Germany: Diclofenac Glenmark 30 mg/g Gel
Spain: Soliker 30 mg/g Gel
Italy: DICLOFENAC DOC Generics