Mel max actigel

Patient Information Leaflet

Mel Max Actigel, 20 mg/g, gel
Diclofenacum natricum
Please read this 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
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents

1. What Mel Max Actigel is and what it is 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 pack and other information

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

Mel Max Actigel contains the active substance diclofenac, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Mel Max Actigel provides relief from pain and reduces inflammation and swelling in muscles and joints.
The medicine has analgesic, anti-inflammatory and anti-edematous effects. It is used locally for the treatment of:
Adults and adolescents over 14 years of age:

• Traumatic inflammatory conditions of tendons, ligaments, muscles and joints (e.g. resulting from sprains, strains or contusions),
• Back pain,
• Localized inflammatory conditions of soft tissues, such as tendinitis, tennis elbow, bursitis, periarthritis.

Adults (over 18 years of age):

• Localized and mild forms of osteoarthritis.

If there is no improvement after 7 days, or if you feel worse, consult your 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 non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),

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• if symptoms of allergic reaction occur due to non-steroidal anti-inflammatory drugs, such as wheezing or shortness of breath (asthma), blistering skin rash or urticaria, facial or tongue swelling, nasal mucosal inflammation (rhinitis),
• 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, consult your doctor or pharmacist.

• Do not use the medicine if the patient has damaged skin, open wounds, or skin rashes. Discontinue use if a skin rash appears after application.
• Do not use more gel or for a longer period than stated in the leaflet, unless otherwise advised by a doctor.
• Mel Max Actigel is for external use only. It must not be used in the mouth or swallowed. Hands should be washed after application. Avoid contact of the gel with the eyes. If the medicine gets into the eyes, rinse thoroughly with clean water and contact a doctor or pharmacist.
• Mel Max Actigel may be used together with bandages or dressings commonly used for sprains; however, it should not be applied under occlusive dressings that prevent air access.

Children and adolescents
There is insufficient data on the efficacy and safety of Mel Max Actigel 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 treatment longer than 7 days for pain relief is required, or if symptoms worsen, the patient should contact a doctor.

Mel Max Actigel and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use Mel Max Actigel during the last three months of pregnancy. During the first six months of pregnancy, Mel Max Actigel should not be used unless necessary and specifically recommended by a doctor. If use is required, the lowest effective dose for the shortest possible duration should be applied.
When oral formulations containing the active substance diclofenac (e.g. tablets) are administered, adverse effects on the unborn child may occur. It is not known whether the same risk applies to topical use of Mel Max Actigel.
During breastfeeding, Mel Max Actigel should only be used on medical advice, as diclofenac passes into breast milk in small amounts. In such cases, the gel should not be applied to the breasts of nursing women, nor to large skin areas or for prolonged periods.

Driving and operating machinery
The use of this medicine does not affect the ability to drive or operate machinery.

Mel Max Actigel contains propylene glycol
This medicine contains 50 mg of propylene glycol per 1 g of gel. Propylene glycol may cause skin irritation.

Mel Max Actigel contains fragrance composition Dovena KD1710/L
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This medicine contains a fragrance composition including: hexyl cinnamic aldehyde, 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 product 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. If in doubt, consult a doctor or pharmacist.
This medicine is for topical 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 applied twice daily (preferably in the
morning and evening) to the painful area.
Use of this medicine in children and adolescents under 14 years of age is contraindicated.
Method of application:
Gently rub a small amount of gel into the painful or swollen area.
The amount of gel should be adjusted according to the size of the affected area: an amount equivalent
to the size of a cherry up to the size of a walnut is sufficient. A mild cooling sensation may be felt during
application. After applying the medicine, hands should be washed unless they are the treated area.
Do not use the medicine for longer than:
Adults and adolescents over 14 years of age: 14 days in cases of muscle and joint strains and
tendon inflammation.
Adults (over 18 years of age): 21 days in cases of pain associated with osteoarthritis, unless otherwise
directed by a doctor.
If there is no improvement after 7 days, or if symptoms worsen, consult a doctor.
Use of more Mel Max Actigel than recommended
If too much Mel Max Actigel is applied, remove the excess with a tissue.
In case of accidental ingestion of Mel Max Actigel, contact a doctor immediately.
Missed dose of Mel Max Actigel
If a dose is missed, apply the medicine as soon as remembered, then continue with the recommended
dosing schedule. Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some of the adverse effects, which occur rarely or very rarely, may be serious.
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If any of the symptoms listed below occur, which may be signs of
hypersensitivity, stop using the medicine immediately and contact your doctor or
go to the nearest hospital emergency department:

• Uncommon (affects less than 1 to 10 in 10,000 people taking the medicine): skin rash with blisters.
• Very rare (affects less than 1 in 10,000 people taking the medicine): wheezing, shortness of breath or feeling of tightness in the chest (asthma), swelling of the face, lips, tongue or throat, urticaria (hives).

Other adverse effects
Other adverse effects that may occur during treatment with Mel Max Actigel are
usually mild, harmless and transient.
Common (affects less than 1 to 10 in 100 people taking the medicine):
skin rash, itching, redness or burning sensation of the skin, skin inflammation (including contact dermatitis).
Very rare (affects less than 1 in 10,000 people taking the medicine):
nodular rash, increased sensitivity of the skin to sunlight. Symptoms of photosensitivity include sunburn with itching, swelling and blisters.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Mel Max Actigel

Store below 25°C. Do not store in the refrigerator or freeze.
Keep the medicine out of the 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 stated month.
Shelf-life after first opening of the tube: 1 year.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Mel Max Actigel contains
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• The active substance is sodium diclofenac. One gram of gel contains 20 mg of sodium diclofenac.
• The other components (excipients) are: isopropyl alcohol, propylene glycol, liquid paraffin, cocoyl caprylocaprate, copolymer of acryloyldimethyltaurate and N-vinylpyrrolidone, cetostearyl polyglycol ether, sorbitan trioleate, Dovena KD1710/L fragrance composition (containing, among others: hexyl cinnamic aldehyde, benzyl alcohol, benzyl benzoate, citronellol, eugenol, coumarin, linalool, benzyl salicylate, and 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-butene-2-one), purified water.

What Mel Max Actigel looks like and contents of the pack
Mel Max Actigel is a white to cream-coloured, opaque gel with a characteristic odour. Each pack contains 50 g, 100 g or 180 g of gel.
Pack size 50 g or 100 g
Aluminium tube with a membrane, internally coated with epoxy-phenolic lacquer, fitted with a screw cap made of HDPE with a plug, in a cardboard box.
Pack size 180 g
Aluminium tube with a membrane, internally coated with epoxy-phenolic lacquer, fitted with a screw cap made of PP with a plug, in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal Product Information
tel.: 22 742 00 22
e-mail: [email protected]
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