RINDOX

Patient Information Leaflet

Rindox 30 mg/g gel

diclofenac sodium
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as 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 Rindox is and what it is used for
2. What you need to know before using Rindox
3. How to use Rindox
4. Possible side effects
5. How to store Rindox
6. Contents of the pack and other information

1. What Rindox is and what it is used for

Rindox contains the active substance sodium diclofenac and is a non-steroidal anti-inflammatory dermatological gel. When applied to the skin, Rindox is used to treat a skin condition in adults known as actinic or solar keratosis, caused by excessive exposure to the sun.

2. What you need to know before using Rindox

Do not use Rindox

• 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 an allergic reaction, such as skin rash (urticaria), breathing difficulties (wheezing), or runny nose (allergic rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• if you are in the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Rindox.

• Systemic side effects cannot be ruled out when applying Rindox, especially if the product is used over large areas of skin and for prolonged periods. Consult your doctor if:
• you have or have previously had a gastric ulcer or gastrointestinal bleeding.
• you have heart, liver, or kidney problems.
• you suffer from any bleeding disorder or bruise very easily.
• Avoid exposure to sunlight, including sunlamps, while using Rindox. If skin reactions occur, stop using the product.
• Do not apply on wounds, infected skin, or dermatitis.
• Avoid contact of Rindox with eyes, inside the nose or mouth, and do not ingest it. If Rindox is accidentally swallowed, consult a doctor immediately.
• If you develop a widespread skin rash, stop using Rindox and consult your doctor.
• After applying medicines containing diclofenac to the skin, you may use a permeable (non-occlusive) dressing. Do not use an airtight occlusive dressing.

Children and adolescents
There are no dosage recommendations or indications for the use of Rindox in children and adolescents.
Other medicines and Rindox
Inform your doctor or pharmacist if you are currently taking or have recently taken or might take any other medicines.
Interactions of Rindox with other medicines are very unlikely.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Do not use Rindox if you are in the last three months of pregnancy. You should not use Rindox during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is required during this period, the lowest possible dose for the shortest possible time should be used.
Oral forms (e.g. tablets) of Rindox may cause adverse effects in the unborn child. It is not known whether the same risk applies when Rindox is used on the skin.
Consult your doctor if you are breastfeeding. Rindox may be used with caution during breastfeeding, but it must not be applied to the breast area.
If you are pregnant, trying to become pregnant, or breastfeeding, and your doctor considers this treatment appropriate, Rindox should not be applied to a skin surface larger than approximately one-third of the body and should not be used for longer than three weeks.
Rindox contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram of gel. Benzyl alcohol may cause allergic reactions and mild local irritation.

3. How to use Rindox

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The gel is for external cutaneous use only.

• Before use, pierce the aluminium seal on the tube opening with the tip of the cap.
• Gently apply a small amount of gel to the skin of the area to be treated. The amount of gel needed varies depending on the size of the area to be treated. Generally, 0.5 grams of gel (approximately the size of a pea) is sufficient to treat an area (5 cm x 5 cm), but no more than 8 grams should be applied per day.
• Rindox may be applied twice daily, unless otherwise indicated by your doctor. When applying the gel to the skin, a slight cooling sensation may be felt.
• The usual treatment duration is 60–90 days. Maximum effect has been observed with treatment duration closer to 90 days. Complete healing may occur up to one month after the end of treatment.

Apply the gel to the affected areas of the body and gently massage it 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 too much gel is accidentally applied, wipe off the excess gel with a paper towel.
Dispose of the paper towel in household waste to prevent unused product from entering the aquatic environment.
Before applying a dressing, allow the gel to dry on the skin for a few minutes.
If you use more Rindox than you should
Remove the excess gel by wiping with a paper towel.
If you forget to use Rindox
Continue applying it as directed.
Do not use a double dose to make up for a forgotten dose.
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.
If you experience any of the following side effects, stop using Rindox and inform your doctor as soon as possible:
Skin rash (urticaria); breathing difficulties (shortness of breath); swelling of the face; runny nose (allergic rhinitis). These symptoms may indicate a possible allergy to Rindox.
If any of the following common side effects become severe or last for more than a few days, stop using Rindox and consult your doctor: itching, skin rash, redness of the skin, inflammation, contact dermatitis, pain, and blister formation.

Other common side effects (may affect up to 1 in 10 people)

• irritation or tingling in the treated area
• conjunctivitis
• allergy
• skin tenderness to touch
• tingling
• muscle stiffness
• dermatitis
• eczema
• dry skin
• swelling
• skin rash (including peeling and blistering)
• skin breakdown
• skin ulcers

Uncommon side effects (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 side effects (may affect up to 1 in 1,000 people)

• dermatitis with large blisters

Very rare side effects (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 in the area of application has been reported. This phenomenon usually resolves after discontinuation of treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the 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 Rindox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after EXP. The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Usable duration after first opening: 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rindox contains

• The active substance is sodium diclofenac. Each gram of gel contains 30 mg of sodium diclofenac.
• The other components are sodium hyaluronate, benzyl alcohol (E 1519), polyethylene glycol monomethyl ether 350 and purified water.

Description of the appearance of Rindox and package contents
Rindox is a homogeneous, clear, transparent, colourless or slightly yellow gel, packed in tubes
containing 25 grams, 50 grams, 60 grams, 90 grams or 100 grams of gel.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Strasse 8-10
13435 Berlin
Germany
Manufacturer
Pharma Wernigerode GmbH
Dornbergsweg 35
38855 Wernigerode
Germany
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Italy Rindox
Germany Diclofenac Aristo 30 mg/g Gel
Poland Medulan