Voltaren Max

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Voltaren MAX (Voltaren Forte), 23.2 mg/g, gel

Diclofenac diethylammonium
Voltaren MAX and Voltaren Forte are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your 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 packaging 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 intended for rubbing into the skin.
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 of:

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., resulting from sprains, overexertion, or bruises),
• back pain,
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, or periarthritis.

in adults and adolescents over 14 years of age:

• limited and mild forms of osteoarthritis.

2. Important information before using Voltaren MAX

When not to use Voltaren MAX:

• during the third trimester of pregnancy.
• in children under 14 years of age.

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

Warnings and precautions

• You should be particularly careful if you have damaged skin, open wounds, or skin eruptions. You should stop using the medicine if a rash appears after using it.
• Do not use more medicine than recommended or for longer than recommended, unless your doctor has advised you to do so.
• Voltaren MAX is intended for external use only. Do not use it in the mouth or swallow it.
• Avoid contact of the gel with your eyes. If the medicine gets into your eyes, rinse them with clean water and consult your doctor or pharmacist.
• The medicine may be used together 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 your doctor or pharmacist before using Voltaren MAX.

Children and adolescents

There is insufficient 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 for pain treatment or if symptoms worsen, consult your doctor.

Voltaren MAX and other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Voltaren MAX should not be used during the last three months of pregnancy, as it may harm the unborn child or cause difficulties during delivery.
During the first six months of pregnancy, Voltaren MAX should only be used if your doctor recommends it, and the dose used should be as small as possible, and the duration of treatment as short as possible.
During breastfeeding, Voltaren MAX may only be used if your doctor recommends it, 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.

3. How to use Voltaren MAX

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The medicine is intended for use on the skin.

Adults and adolescents over 14 years of age

The medicine has an analgesic effect for up to 12 hours. It should be used 2 times a day (morning and evening) on painful areas.

Method of use

Aluminum tube with a round or triangular cap

• 1. To open the tube, before the first use, you should unscrew the cap, put it upside down on the protective cover, and twist it, which will allow you to remove the protective cover from the tube.
• 2. Then, you should 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 application, a gentle cooling effect is felt.

Aluminum tube with a flip-top cap

• 1. To open the tube, before the first use, you should use your finger, thumb, side of your hand, or even the edge of a table to easily open the flip-top cap.
• 2. The protective covers on both sides of the flip-top cap will break when the tube is opened for the first time.
• 3. Before the first use, you should check if the protective cover is not damaged.

or

• 4. Then, you should 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 application, a gentle cooling effect is felt.

• 5. To close the flip-top cap, you should press it with your finger, side of your hand, or even the edge of a table until you hear a "click" sound. You should hold the tube vertically while opening or closing it to prevent possible leakage of the gel from the tube.

After using the medicine, you should:

• Wipe your hands with a tissue and then wash them, unless they are the area being treated. Dispose of the used tissue.

The patient should wait until the medicine is completely dry before taking a bath. Avoid contact of the gel with your eyes and mouth.

• You should not use the medicine for longer than:

• in adults and adolescents over 14 years of age: 14 days in case of muscle and joint overexertion and tendonitis.
• in adults (over 18 years of age): 21 days in case of pain associated with osteoarthritis, unless your doctor recommends otherwise.

If pain and swelling do not improve within 7 days or worsen, you should contact your doctor.

Using more Voltaren MAX than recommended

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

Missing a dose of Voltaren MAX

If you miss a dose, you should use the medicine as soon as you remember, and then continue with the recommended dosage. 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 and may be serious.

If you experience any of the following symptoms, which may be signs of an allergic reaction, you should stop using the medicine immediately, consult your doctor or pharmacist, 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 chest tightness (asthma).
• Very rare (may affect less than 1 in 10,000 people using the medicine): 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, dermatitis (including contact dermatitis).

Very rare

(may affect less than 1 in 10,000 people using the medicine):increased skin sensitivity 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, you should 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltaren MAX

• The medicine should be kept out of the sight and reach of children.
• Store in a temperature below 30°C in the original packaging.
• 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 packaging 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, which corresponds to 20 mg of diclofenac sodium.
1 gram of the medicine contains 50 mg of propylene glycol and 0.2 mg of butylhydroxytoluene (E 321).
The other ingredients are: isopropyl alcohol, oleyl alcohol, cetearyl olivate, liquid paraffin, cetostearyl ether of macrogol, carbomer, diethylamine, eucalyptus fragrance composition, purified water.

What Voltaren MAX looks like and what the packaging contains

Voltaren MAX is a white, cooling, non-greasy, non-staining creamy gel.
The medicine is available in tubes containing 50 g, 100 g, or 150 g of gel.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

GlaxoSmithKline Consumer Healthcare S.R.L.
Str. Costache Negri, Nr. 1-5, Opera Center One
Etaj 6 (Zona 2), Sector 5, Bucharest, Romania

Manufacturer:

GLAXOSMITHKLINE CONSUMER HEALTHCARE GmbH & Co. KG
Barthstraße 4, 80339 Munich, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, the country of export: 13380/2020/15
13380/2020/18
13380/2020/22
13380/2020/24
Parallel import authorization number:377/19

Date of leaflet approval: 25.09.2024

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