VOLTAREN MAX

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Voltaren MAX (Voltaren Forte), 23.2 mg/g, gel
Diclofenacum diethylammonium
Voltaren MAX and Voltaren Forte are different trade names for the same medicine.
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 doctor 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 effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 7 days, consult your doctor.

Table of contents of the leaflet:

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

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

in 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.

in adults (over 18 years of age):

• localized and mild forms of osteoarthritis.

2. Important information before using Voltaren MAX

When not to use Voltaren MAX:

• if the patient is allergic to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain, fever or inflammation, such as ibuprofen or aspirin, or to 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), blistering skin rash 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 applies to the patient, do not use Voltaren MAX. If in doubt, consult a doctor or pharmacist.
Warnings and precautions

• Exercise particular caution if the patient has damaged skin, open wounds, or rashes. Discontinue use of the medicine if a rash appears after application.
• Do not use more of the medicine or for a longer period than recommended, unless otherwise advised by a doctor.
• Voltaren MAX is for external use only. Do not apply it inside the mouth or swallow it.
• 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.
• The medicine may be used together with bandages or dressings commonly used for sprains; however, do not use it under occlusive dressings that prevent air access.
• Keep the medicine out of sight and reach of children.

If in any doubt, 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 treatment longer than 7 days is required in adolescents over 14 years of age for pain relief, or if symptoms worsen, consult a doctor.
Voltaren MAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Voltaren MAX must 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 be used only if recommended by a doctor, and the dose should be as low as possible and the duration of treatment as short as possible.
During breastfeeding, Voltaren MAX may be used only if recommended by a doctor, since diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breasts of a nursing woman, nor to large areas of skin or for prolonged periods.
Driving and operating machinery
The use of this medicine does not affect the ability to drive or operate machinery.
Voltaren MAX contains propylene glycol, butylated hydroxytoluene (E 321) and fragrance composition
Propylene glycol
The medicine contains 50 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.
Butylated hydroxytoluene (E 321)
The medicine may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Fragrance composition
The medicine contains a fragrance composition containing 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 information 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
This medicine provides pain relief for up to 12 hours. It should be applied twice daily (morning and evening) to painful areas.

Instructions for use
Aluminum laminate tube closed with a round or triangular cap

1. To open the tube for the first time, unscrew the cap, turn it over, place it back onto the seal, and twist to remove the protective seal from the tube.
2. Then gently squeeze a small amount of gel from the tube onto the painful or swollen area and massage it slowly into the skin. The amount of gel should be adjusted according to the size of the affected area. An amount equivalent in size from a cherry to a walnut is sufficient. A mild cooling sensation may be felt during application.

Aluminum laminate tube with flip-top cap

1. To open the tube for the first time, use your finger, thumb, the side of your hand, or even the edge of a table to easily open the flip-top cap.
2. The safety seals on both sides of the flip-top cap will break when the tube is opened for the first time.
3. Before first use, check that the safety seal is intact.

or

4. Then gently squeeze a small amount of gel from the tube onto the painful or swollen area and massage it slowly into the skin. The amount of gel should be adjusted according to the size of the affected area. An amount equivalent in size from a cherry to a walnut is sufficient. A mild cooling sensation may be felt during application.

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

or
After applying the medicine:

• Wipe your hands with a tissue and then wash them, unless your hands are the treated area. Dispose of the used tissue in the trash.
• After applying Voltaren MAX, the patient should wait until the medicine is completely dry before bathing. Avoid contact of the gel with eyes and mouth.

Do not use the medicine for longer than:

• in adults and adolescents over 14 years of age: 14 days for muscle and joint strains and tendon inflammation.
• in adults (over 18 years of age): 21 days for pain associated with osteoarthritis, unless otherwise directed by a doctor.

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

• If too much Voltaren MAX is applied, remove the excess with a tissue.
• In case of accidental ingestion of Voltaren MAX, contact a doctor immediately.

Missed dose of Voltaren MAX
If a dose is missed, apply the medicine as soon as remembered, then continue using it as directed. Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

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

• Rare (may occur in 1 to 10 out of 10,000 people using the medicine): skin rash with blisters, urticaria (hives, blistering skin inflammation).
• Very rare (may occur in fewer than 1 out of 10,000 people using the medicine): wheezing, shortness of breath, or feeling of tightness in the chest (asthma).
• Very rare (may occur in fewer than 1 out of 10,000 people using the medicine): swelling of the face, lips, tongue, or larynx.

Other adverse reactions
Other adverse reactions that may occur during the use of Voltaren MAX are usually mild, harmless, and transient.
Common
(may occur in 1 to 10 out of 100 people using the medicine): skin rash, itching, redness or burning sensation of the skin, skin inflammation (including contact dermatitis).
Very rare
(may occur in fewer than 1 out of 10,000 people using the medicine): increased skin sensitivity to sunlight. Symptoms of photosensitivity include sunburn with itching, swelling, and blisters. Papular rash.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store the medicine Voltaren MAX

• Keep the medicine out of the sight and reach of children.
• Store 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 stated month.
• Medicines must 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 is diethylamine salicylate. 1 gram of gel contains 23.2 mg of diethylamine salicylate,
equivalent to 20 mg of sodium diclofenac.
1 gram of the medicinal product contains 50 mg of propylene glycol and 0.2 mg of butylhydroxytoluene (E 321).
The other ingredients are: isopropyl alcohol, oleyl alcohol, coco-caprylo-caprate, liquid paraffin,
macrogol cetostearyl ether, carbomer, diethanolamine, eucalyptus flavouring composition, purified water.

What Voltaren MAX looks like and contents of the pack
Voltaren MAX is a white, cooling, non-greasy, non-staining cream gel.
The medicine is available in tubes containing 50 g, 100 g or 150 g of gel.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
GlaxoSmithKline Consumer Healthcare S.R.L.
Str. Costache Negri, Nr. 1-5, Opera Center One
Floor 6 (Zone 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, Poland

Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation numbers in Romania, the country of export:
13380/2020/15
13380/2020/18
13380/2020/22
13380/2020/24

Parallel import authorisation number: 377/19