Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging 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 it can be read again if needed.
If advice or further information is needed, please consult a pharmacist.
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.
If there is no improvement or if the patient feels worse after 7 days, consult a doctor.

Table of contents of the leaflet:

What Voltaren MAX is and what it is used for
Important information before using Voltaren MAX
How to use Voltaren MAX
Possible side effects
How to store Voltaren MAX
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 rubbing into the skin.
Voltaren MAX provides relief from pain and reduces inflammation and swelling in the muscles and joints.
The medicine has analgesic, anti-inflammatory, and anti-edematous 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, and periarthritis.

In adults (over 18 years of age):

mild and localized forms of osteoarthritis.

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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, to other non-steroidal anti-inflammatory drugs 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 apply to the patient, do not use Voltaren MAX. If in doubt, consult a doctor or pharmacist.
Warnings and precautions

Exercise special 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 medicine or use it for longer than recommended unless advised otherwise 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, it should not be applied under occlusive dressings that prevent air access.

If you have any questions, contact your doctor or pharmacist before using Voltaren MAX.
Children and adolescents
There is insufficient data on the efficacy and safety of the medicine in children and adolescents under 14 years of age (see section: When not to use Voltaren MAX).
If treatment beyond 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 have a baby, 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 only be used if recommended by a doctor, and the dose used should be as low as possible and the duration of treatment as short as possible.
During breastfeeding, Voltaren MAX may only be used 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 breastfeeding woman, nor to large areas of skin or for prolonged periods.
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Driving and operating machinery
Use of this medicine does not affect the ability to drive or operate machinery.
Voltaren MAX contains propylene glycol, butylhydroxytoluene (E 321) and 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 irritation of the eyes and mucous membranes.
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 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 children over 14 years of age
The medicine provides pain relief for up to 12 hours. It should be applied twice daily (morning and evening) to the painful area.
Instructions for use:

To open the tube, for first use only, unscrew the cap, place it upside down onto the seal, and twist to remove the seal from the tube. This does not apply to tubes with flip-top closure.
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.

After applying the medicine:

Wipe hands with a tissue and then wash them, unless the hands themselves are the treated area. Used tissues should be disposed of 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 degenerative joint disease, unless otherwise directed by a doctor.

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

If too much Voltaren MAX is applied, remove the excess with a tissue.
If Voltaren MAX is accidentally swallowed, seek immediate medical advice.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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, discontinue use of the medicine immediately and contact a doctor or go to the nearest hospital emergency department:

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can also be reported directly to the Department of Monitoring of 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.
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5. How to store Voltaren MAX

Keep this 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 specified month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Voltaren MAX contains
The active substance is diclofenac diethylammonium. 1 gram of gel contains 23.2 mg of diclofenac diethylammonium.
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-capronic triglyceride, liquid paraffin, cetostearyl macrogol ether, carbomers, diethanolamine, eucalyptus fragrance composition (containing benzyl alcohol, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool), purified water.

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

Marketing Authorisation Holder in Romania, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

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

Marketing Authorisation numbers in Romania, country of export:
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 Licence Number: 403/22
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