Mel Max Actigel

Leaflet attached to the packaging: patient information

Mel Max Actigel, 20 mg/g, gel

Diclofenac sodium

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Mel Max Actigel and what is it used for

Mel Max Actigel contains the active substance diclofenac, which belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs).
Mel Max Actigel 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. It is used for local treatment of:

• 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.

Adults and adolescents over 14 years of age:

• the medicine is used to treat the above conditions.

Adults (over 18 years of age):

• the medicine is also used to treat mild and limited forms of osteoarthritis.

If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Mel Max Actigel

When not to use Mel Max Actigel

• if the patient is allergic to the active substance, other NSAIDs, or any of the other ingredients of this medicine (listed in section 6),

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• in case of symptoms of an allergic reaction caused by NSAIDs, such as: wheezing or shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, rhinitis (hay fever),
• during the last three months of pregnancy,
• in children and adolescents under 14 years of age.

Warnings and precautions

Before starting to use Mel Max Actigel, the patient should discuss it with their doctor or pharmacist.

• The medicine should not be used if the patient has damaged skin, open wounds, or skin eruptions. The use of the medicine should be stopped if a skin rash appears after its use.
• The medicine should not be used in larger quantities or for a longer period than recommended in the leaflet, unless advised by a doctor.
• Mel Max Actigel is intended for external use only. It should not be used in the mouth or swallowed. After use, the hands should be washed. Contact between the gel and the eyes should be avoided. If the medicine gets into the eyes, they should be rinsed with clean water, and the patient should consult their doctor or pharmacist.
• The medicine can be used together with bandages or dressings usually applied in case of sprains, but it should not be used under dressings that prevent air from reaching the skin.

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 Mel Max Actigel").
In adolescents over 14 years of age, if the medicine needs to be used for more than 7 days to treat pain or if the symptoms worsen, the patient should consult their doctor.

Mel Max Actigel and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently using or have recently used, as well as any medicines they plan to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Mel Max Actigel should not be used during the last three months of pregnancy. During the first six months of pregnancy, the medicine should not be used unless it is necessary and recommended by a doctor. If use is necessary, the smallest possible dose should be applied for the shortest possible time.
After oral administration of diclofenac-containing medicines (e.g., tablets), side effects may occur in the unborn child. It is not known if the same risk applies to Mel Max Actigel when used on the skin.
During breastfeeding, Mel Max Actigel can be used only on the advice of a doctor, as diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breasts of nursing women or to large areas of skin or for extended periods.

Driving and using machines

Using the medicine does not affect driving or operating machinery.

Mel Max Actigel contains propylene glycol

The medicine contains 50 mg of propylene glycol per 1 g of gel. Propylene glycol may cause skin irritation.

Mel Max Actigel contains the fragrance composition Dovena KD1710/L

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The medicine contains a fragrance composition that includes, among others: hexyl cinnamaldehyde, benzyl alcohol, benzyl benzoate, citronellol, eugenol, coumarin, linalool, benzyl salicylate, and 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one. These substances may cause allergic reactions. The medicine contains 0.002 micrograms of benzyl alcohol per 1 g of gel.

3. How to use Mel Max Actigel

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for use on the skin.
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 (preferably in the morning and evening) on the painful areas.
Using the medicine in children and adolescents under 14 years of age is contraindicated.
Method of use:
A small amount of gel should be gently rubbed into the painful or swollen areas.
The amount of gel should be adjusted to the size of the affected area: the amount of gel corresponding to the size of a cherry to a walnut is sufficient. During application, a mild cooling effect can be felt. After use, the hands should be washed, unless they are the area being treated.
The medicine should not be used for longer than:
Adults and adolescents over 14 years of age:14 days in case of muscle and joint strains and tendonitis.
Adults (over 18 years of age):21 days in case of pain associated with osteoarthritis, unless the doctor recommends otherwise.
If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

Using a larger than recommended dose of Mel Max Actigel

In case of using an excessive amount of Mel Max Actigel, the excess should be removed with a cloth.
In case of accidental ingestion of Mel Max Actigel, the patient should immediately consult their doctor.

Missing a dose of Mel Max Actigel

In case of missing a dose, the medicine should be used as soon as the patient remembers, and then the usual dosing schedule should be continued. A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Mel Max Actigel can cause side effects, although not everybody gets them.

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

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In case of experiencing any of the following symptoms, which may be signs of an allergic reaction, the patient should immediately stop using the medicine, consult their doctor, or go to the nearest hospital emergency department:

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

Other side effects

Other side effects that may occur when using Mel Max Actigel are usually mild, harmless, and temporary.
Common(occurring in 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(occurring in less than 1 in 10,000 people using the medicine):
papular rash, increased sensitivity of the skin to sunlight. Symptoms of hypersensitivity are sunburn with itching, swelling, and blisters.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Mel Max Actigel

Store at a temperature below 25°C. Do not store in the refrigerator or freeze.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the tube: 1 year.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mel Max Actigel contains

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• The active substance of the medicine is diclofenac sodium. One gram of gel contains 20 mg of diclofenac sodium.
• The other ingredients (excipients) are: isopropyl alcohol, propylene glycol, liquid paraffin, cocoyl caprylocaprate, acryloyldimethyltaurine ammonium copolymer and N-vinylpyrrolidone, cetostearyl ether of macrogol, sorbitan trioleate, fragrance composition Dovena KD1710/L (contains, among others: hexyl cinnamaldehyde, benzyl alcohol, benzyl benzoate, citronellol, eugenol, coumarin, linalool, benzyl salicylate, and 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one), purified water.

What Mel Max Actigel looks like and what the packaging contains

Mel Max Actigel is a white to creamy, non-transparent gel with a characteristic odor. One packaging contains 50 g, 100 g, or 180 g of gel.
Packaging size 50 g or 100 g
Aluminum tube with a membrane, coated internally with an epoxy-phenolic varnish, with an HDPE cap and a piercer, in a cardboard box.
Packaging size 180 g
Aluminum tube with a membrane, coated internally with an epoxy-phenolic varnish, with a PP cap and a piercer, in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

phone: 22 742 00 22
e-mail: [email protected]

Date of the last update of the leaflet:

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