Diclofenac Zentiva

Package leaflet: Information for the user

DICLOFENAC ZENTIVA 10 mg/g gel

Read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What DICLOFENAC ZENTIVA is and what it is used for

DICLOFENAC ZENTIVA contains the active substance sodium diclofenac and belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) for topical use.
DICLOFENAC ZENTIVA 10 mg/g gel is used for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting the joints, muscles, tendons or ligaments.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using DICLOFENAC ZENTIVA

Do not use DICLOFENAC ZENTIVA

• if you are allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), you experienced an allergic reaction manifested by asthma (difficulty breathing due to inflammation and narrowing of the airways), angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing), urticaria (skin rash with itching), or acute rhinitis (runny nose due to acute inflammation of the nasal mucosa);
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if the patient is a child or adolescent under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using DICLOFENAC ZENTIVA.
Pay particular attention:

• do not swallow the gel; after use, clean your hands with absorbent paper and then wash your hands (see section 3);
• Diclofenac Zentiva should only be applied to intact and healthy skin: do not apply it to skin wounds or open lesions.
• do not apply the gel to eyes or mucous membranes (e.g., mouth or vagina): if this occurs, rinse immediately with running water and contact your doctor.
• discontinue use of the medicine if you develop a skin rash after application.
• DICLOFENAC ZENTIVA may be used with non-occlusive dressings (such as gauze allowing air passage) but must not be used with occlusive dressings (such as plastic film that does not allow air passage).
• If you use diclofenac gel over large areas of skin and for prolonged periods of time, you may experience adverse effects that could affect the entire body. Do not exceed the recommended dose.

Children and adolescents
Use in children and adolescents under 14 years of age is contraindicated.
Other medicines and DICLOFENAC ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
It is unlikely that Diclofenac Zentiva gel will interact with other medicines.
DICLOFENAC ZENTIVA with food and drink
No interaction with food is known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Diclofenac should not be used during the first and second trimesters of pregnancy unless clearly needed.
Do not use DICLOFENAC ZENTIVA if you are planning a pregnancy or during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required during this period, the lowest possible dose for the shortest possible time should be used.
Diclofenac must not be used during the third trimester of pregnancy because it may cause harm to the fetus and mother when taken during this period.
Oral forms (e.g., tablets) of diclofenac may cause adverse effects in the newborn. It is not known whether the same risk applies with DICLOFENAC ZENTIVA when applied to the skin.
Breastfeeding
If you are breastfeeding, this gel should only be used after consulting your doctor and evaluating with him the risk/benefit ratio in your specific case.
During breastfeeding, DICLOFENAC ZENTIVA must not be applied to the breast, nor elsewhere over large areas of skin or for prolonged periods of time.
Driving and using machines
Topical application of DICLOFENAC ZENTIVA does not impair the ability to drive or operate machinery.
DICLOFENAC ZENTIVA contains ethanol
This medicine contains 144 mg of alcohol (ethanol) in 1 g of gel, equivalent to 14%.
It may cause a burning sensation on damaged skin.

3. How to use DICLOFENAC ZENTIVA

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses without medical advice.

Use in adults:
Apply DICLOFENAC ZENTIVA 3 or 4 times daily to the affected area, gently massaging it in. The amount to apply depends on the size of the area to be treated. A quantity varying in size from a cherry to a walnut (approximately 2–4 g of gel) is sufficient to treat an area of 400–800 cm².
Use only for short-term treatment.

Use in adolescents (aged 14 to 18 years):
Apply DICLOFENAC ZENTIVA 3 or 4 times daily to the affected area, massaging gently. The amount to apply depends on the size of the area to be treated. A quantity varying in size from a cherry to a walnut (approximately 2–4 g of gel) is sufficient to treat an area of 400–800 cm².
Consult your doctor if symptoms do not improve within 7 days of starting treatment with Diclofenac Zentiva gel or if symptoms worsen.

Use in children under 14 years of age:
Do not use DICLOFENAC ZENTIVA in children under 14 years of age.

Use in elderly patients (over 65 years of age):
The recommended adult dose may be used.

Instructions for use:
DICLOFENAC ZENTIVA is for external use only. Apply the gel to the affected areas of the body and massage gently into the skin. Afterwards, dry your hands with a paper towel and then wash them, unless the hands themselves are the area being treated. If an excessive amount of gel is accidentally applied, wipe off the excess with a paper towel. The paper towel should be disposed of in household waste to prevent unused product from entering the aquatic environment.
Diclofenac gel may be used under non-occlusive dressings, but must not be used under occlusive dressings (which do not allow air passage). Allow the gel to dry on the skin for a few minutes before applying a dressing.

After application:

• Clean your hands with a paper towel and then wash them, unless they are the area being treated. The paper towel should be disposed of in household waste after use.
• Wait for the gel to dry before taking a shower or bath.

If you use more DICLOFENAC ZENTIVA than you should
Cases of overdose are not known.
The low systemic absorption of topical diclofenac makes overdose highly unlikely.
However, adverse effects similar to those observed after an overdose of diclofenac tablets may be expected if topical diclofenac is accidentally ingested (one 50 g tube contains the equivalent of 500 mg of sodium diclofenac). In case of accidental ingestion leading to significant systemic adverse effects, general therapeutic measures normally used to treat poisoning with non-steroidal anti-inflammatory drugs should be implemented.
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.
The side effects are listed below by frequency:
Common (may affect up to 1 in 10 people)

• Rash
• Eczema
• Erythema
• Dermatitis (including contact dermatitis)
• Itching (pruritus)

Rare (may affect up to 1 in 1,000 people)

• Skin inflammation with blistering (bullous dermatitis)

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

• Allergic reactions (including urticaria)
• Swelling of the face, lips, tongue and/or throat, with difficulty swallowing and/or breathing (angioedema)
• Skin rash with appearance of pustules
• Asthma (difficulty breathing due to inflammation and narrowing of the bronchi)
• Appearance of spots or redness on the skin following exposure to sunlight or sunlamps.

Not known

• Burning sensation at the application site
• Dry skin

In such cases, it is recommended to immediately discontinue treatment and contact your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at the following website: 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 ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Usable duration after first opening of the tube: 4 weeks.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What DICLOFENAC ZENTIVA contains

• The active substance is diclofenac. 100 g of gel contain 1 g of sodium diclofenac.
• The other components are: purified water, 96% ethanol, isopropyl alcohol, carbomer, concentrated ammonia solution.

Description of the appearance of DICLOFENAC ZENTIVA and contents of the pack
Topical gel.
Pack contents: 50 g of gel.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l., Via P. Paleocapa 7, 20121 Milan
Manufacturer
DOPPEL FARMACEUTICI S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC).