Voltaren Max

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. 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.

Before using the medicine, carefully read the contents of the leaflet, 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 a doctor or pharmacist.

• The leaflet should be kept so that it can be re-read if necessary.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their 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. Package contents 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:

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

In adults (over 18 years of age)

• mild forms of degenerative joint disease.

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2. Important information before using Voltaren MAX

When not to use Voltaren MAX

• if the patient is allergic to the active substance, other nonsteroidal anti-inflammatory drugs used to treat pain, fever, or inflammation, such as ibuprofen or aspirin, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: wheezing or shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, inflammation of the nasal mucosa (rhinitis).
• during the third trimester of pregnancy.
• in children under 14 years of age.

If any of the above information applies to the patient, they should not use Voltaren MAX. In case of doubt, they should consult a doctor or pharmacist.

Warnings and precautions

• Particular caution should be exercised if the patient has damaged skin, open wounds, or eczema. The use of the medicine should be stopped if a rash appears after its use.
• The medicine should not be used in larger quantities or for longer than recommended, unless advised by a doctor.
• Voltaren MAX is for external use only. It should not be used in the mouth or swallowed.
• Contact with the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed with clean water, and a doctor or pharmacist should be consulted.
• The medicine can be used with bandages or dressings normally used for sprains, but it should not be used under dressings that prevent air from reaching the skin.

In case of any questions, the patient should consult a 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 to treat pain or if symptoms worsen, a doctor should be consulted.

Voltaren MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a 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 advised by a doctor, and the dose used should be as small as possible, and the duration of treatment as short as possible.
During breastfeeding, Voltaren MAX can only be used if advised by a doctor, as diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breasts of a nursing woman or to large areas of skin or for extended periods.
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Driving and using machines

Using the medicine does not affect driving or operating machines.

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

Propylene glycol

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 a doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist.
The medicine is for topical use.

Adults and children over 14 years of age

The medicine has a pain-relieving effect 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, the cap should be unscrewed, placed upside down on the protective cover, and turned, which will allow the removal of the protective cover from the tube. This does not apply to tubes with a flip-top closure.
• 2. Then, a small amount of gel should be gently squeezed out of 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 the application of the gel, a gentle cooling effect is felt.

After using the medicine, the patient should:

• Wipe their hands with a tissue and then wash them, unless the hands are the area being treated. The used tissue should be thrown away.
• Wait for the medicine to dry completely before taking a bath. Contact with the eyes and mouth should be avoided.

The medicine should not be used 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.

If the pain and swelling do not improve within 7 days or worsen, the patient should consult a doctor.
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Using more than the recommended dose of Voltaren MAX

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

Missing a dose of Voltaren MAX

If a dose is missed, the patient should use the medicine as soon as they remember, and then continue with the recommended dosing schedule. A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Voltaren MAX can cause side effects, although not everybody gets them.

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

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

• Common (affecting less than 1 in 10,000 people using the medicine): skin rash with blisters, hives.
• Very rare (affecting less than 1 in 10,000 people using the medicine): wheezing, shortness of breath, or feeling of tightness in the chest (asthma).
• Very rare (affecting 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

(affecting less than 1 in 100 people using the medicine): skin rash, itching, redness, or burning of the skin, skin inflammation (including contact dermatitis).

Very rare

(affecting 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.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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
Reporting side effects will help gather more information on the safety of the medicine.
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5. How to store Voltaren MAX

• The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents 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.
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, cetylstearyl alcohol, liquid paraffin, cetomacrogol, carbomers, diethylamine, eucalyptus fragrance composition (with benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool), purified water.

What Voltaren MAX looks like and what the package contains

Voltaren MAX is a white, cooling, non-greasy, non-staining gel.
The medicine is available in tubes containing 50 g or 100 g of gel.
For more detailed information, the patient 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., Costache Negri Street, No. 1-5, Opera Center One, 6th floor (Zone 2), Sector 5, Bucharest, Romania

Manufacturer:

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

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number: 13380/2020/03
13380/2020/05
13380/2020/06
13380/2020/10
13380/2020/15
13380/2020/17
13380/2020/18
13380/2020/22

Parallel import authorization number: 403/22

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Date of leaflet approval: 10.11.2022
[Information about the trademark]
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