Voltaren Max

Package Leaflet: Information for the Patient

Voltaren MAX, 23.2 mg/g, Gel

Diclofenac Diethylammonium

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

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

1. What is Voltaren MAX and what is it used for

Voltaren MAX contains the active substance diclofenac, which belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs).
Voltaren MAX is a white gel for topical use.
Voltaren MAX provides relief from pain, reduces inflammation and swelling in the areas of muscles and joints.
The medicine has analgesic, anti-inflammatory, and anti-swelling effects.
The medicine is used for local treatment:

• in adults and adolescents over 14 years of age:
  for post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., caused by sprains, strains, or bruises),
• for back pain,
• for limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.

In adults (over 18 years of age):

• for limited and mild forms of degenerative joint disease.

2. Important information before using Voltaren MAX

When not to use Voltaren MAX

• during the last three months of pregnancy,
• in children under 14 years of age.

If any of the above applies to you, do not use Voltaren MAX. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions

• Be careful if you have damaged skin, open wounds, or eczema. Stop using the medicine if a rash appears after use.
• Do not use more medicine or use it for longer than recommended, unless advised by a doctor.
• Voltaren MAX is for external use only. Do not use it in the mouth or swallow it.
• Avoid contact of the gel with the eyes. If the medicine gets into the eyes, rinse them with clean water and consult a doctor or pharmacist.
• The medicine can be used with bandages or dressings usually used for sprains, but do not use it under airtight dressings.
• Keep the medicine out of the sight and reach of children.

In case of any doubts, consult a doctor or pharmacist before using Voltaren MAX.

Children and adolescents

There is not enough data on the efficacy and safety of using the medicine in children and adolescents under 14 years of age (see section: When not to use Voltaren MAX).
If the medicine needs to be used for more than 7 days in adolescents over 14 years of age to treat pain, or if symptoms worsen, consult a doctor.

Voltaren MAX and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Voltaren MAX during the last three months of pregnancy, as it may harm the unborn baby or cause difficulties during delivery.
During the first six months of pregnancy, do not use Voltaren MAX unless necessary and advised by a doctor. If use is necessary, use the smallest possible dose for the shortest possible time.
After oral administration (e.g., tablets), side effects may occur in the unborn baby. It is not known if the same risk applies to Voltaren MAX when used on the skin.
During breastfeeding, Voltaren MAX can be used only if advised by a doctor, as diclofenac passes into breast milk in small amounts. In such cases, do not apply the medicine to the breasts of a nursing woman or to large areas of skin or for extended periods.

Driving and using machines

Using the medicine does not affect driving or using machines.

Voltaren MAX contains propylene glycol, butylhydroxytoluene (E 321), and a fragrance composition

Propylene glycol

The medicine contains 50 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.

Butylhydroxytoluene (E 321)

The medicine may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

Fragrance composition

The medicine contains a fragrance composition with benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool, which may cause allergic reactions.
The medicine may cause mild local irritation.

3. How to use Voltaren MAX

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.
In case of doubts, consult a doctor or pharmacist.
The medicine is for topical use.

Adults and adolescents over 14 years of age

The medicine provides pain relief for up to 12 hours. It should be used 2 times a day (morning and evening) on painful areas.

Method of use:

• 1. To open the tube, before the first use, unscrew the cap, place it upside down on the protective cover, and twist, which will allow the removal of the protective cover from the tube.
• 2. Then, gently squeeze a small amount of gel from the tube onto the painful or swollen area, slowly rubbing it into the skin. The amount of gel should be adjusted to the size of the affected area. A sufficient amount of gel is equivalent to the size of a cherry, up to the size of a walnut. During rubbing, a gentle cooling effect is felt.

After using the medicine:

• Wipe your hands with a tissue, then wash them, unless they are the area being treated. Dispose of the used tissue in a household waste bin, not in the toilet, to prevent the product from entering the drainage system.
• Before applying a dressing or a breathable bandage, wait a few minutes until the gel dries on the skin. If you need to take a shower or bath, apply the product later.

Do not use the medicine for longer than:

• in adults and adolescents over 14 years of age: 14 days in case of muscle and joint strains and tendonitis.
• in adults (over 18 years of age): 21 days in case of pain associated with degenerative joint disease, unless advised otherwise by a doctor.

Use the smallest possible dose for the shortest possible time.
If pain and swelling do not improve within 7 days or worsen, consult a doctor.

Using more Voltaren MAX than recommended

• In case of using too much Voltaren MAX, remove the excess with a tissue.
• In case of accidental ingestion of Voltaren MAX, consult a doctor immediately.

Missing a dose of Voltaren MAX

If you miss a dose, use the medicine as soon as you remember, then continue with the recommended dosing schedule. Do not use a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects are rare or very rare but can be serious.

If you experience any of the following symptoms, which may be signs of an allergic reaction, stop using the medicine immediately, consult a doctor, or go to the nearest hospital emergency department:

• Rare(may affect up to 1 in 10,000 people using the medicine):skin rash with blisters, hives (vesicular dermatitis).
• Very rare (may affect less than 1 in 10,000 people using the medicine): wheezing, shortness of breath, or feeling of tightness in the chest (asthma), swelling of the face, lips, tongue, or throat.

Other side effects

Other side effects that may occur when using Voltaren MAX are usually mild, harmless, and temporary.

Common

(may affect up to 1 in 100 people using the medicine):skin rash, itching, redness, or burning of the skin, skin inflammation (including contact dermatitis).

Very rare

(may affect less than 1 in 10,000 people using the medicine):increased sensitivity of the skin to sunlight. Symptoms of hypersensitivity are sunburn with itching, swelling, and blisters. Papular rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren MAX

• Keep the medicine out of the sight and reach of children.
• Store in a temperature below 30°C.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of 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 Voltaren MAX contains

The active substance of the medicine is diclofenac diethylammonium. 1 gram of gel contains 23.2 mg of diclofenac diethylammonium, equivalent to 20 mg of diclofenac sodium.
1 gram of the medicine contains 50 mg of propylene glycol, 0.2 mg of butylhydroxytoluene (E 321), and 1 mg of fragrance composition (eucalyptus fragrance composition with benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool).
Other ingredients are: isopropyl alcohol, oleyl alcohol, cetearyl olivate, liquid paraffin, cetostearyl ether of macrogol, carbomer, diethylamine, purified water.

What Voltaren MAX looks like and contents of the pack

Voltaren MAX is a white, cooling, non-greasy, non-staining gel.
The medicine is available in tubes containing 20 g, 30 g, 50 g, 60 g, 100 g, 120 g, 150 g, 200 g (2 tubes of 100 g each), or 180 g of gel.
Not all pack sizes may be marketed.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
Rzymowskiego 53
02-697 Warsaw
phone: 800 702 849

Importer:

Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany
Date of last revision of the leaflet: December 2024