Voltaren Forte

Package Leaflet: Information for the User

Voltaren Forte

140 mg, medicinal plaster

Diclofenac sodium

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

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

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

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

Voltaren Forte is a medicine that relieves pain. It belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs).
Voltaren Forte is intended for short-term (up to 7 days) local, symptomatic treatment of pain associated with acute strains, sprains, or bruises of the upper and lower limbs, resulting from blunt injuries, in adolescents from 16 years of age and adults.

2. Important information before using Voltaren Forte

When not to use Voltaren Forte

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to any other non-steroidal anti-inflammatory drug (NSAID, e.g., acetylsalicylic acid or ibuprofen);
• if you have ever had an asthma attack, hives, or swelling of the nasal mucosa after taking acetylsalicylic acid or any other NSAID;
• if you have active stomach or duodenal ulcer disease;
• on damaged skin (e.g., abrasions, cuts, burns), infected skin, or skin with inflammation (exudative eczema) or eczema;
• in women in the last 3 months of pregnancy;
• in children and adolescents under 16 years of age.
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Warnings and precautions

Before starting to use Voltaren Forte, discuss it with your doctor or pharmacist:

• if you have or have had asthma or allergies; you may experience bronchospasm (bronchospasm), which makes breathing difficult;
• if you notice a skin rash after applying the medicinal plaster - in such a situation, remove the medicinal plaster immediately and stop using the medicine;
• if you have kidney, heart, or liver function disorders, or if you have had stomach or intestinal ulcers, inflammatory bowel disease, or a tendency to bleeding.

Side effects can be limited by using the lowest effective dose for the shortest possible time.

Important precautions

• Do not apply the medicinal plaster to the eyes or mucous membranes, or allow them to come into contact with the medicinal plaster.
• Elderly patients should use Voltaren Forte with caution, as they are more likely to experience side effects.

To reduce the risk of photosensitivity, after removing the medicinal plaster, avoid exposing the treated area to direct sunlight or sunlamp radiation.
Voltaren Forte should not be used at the same time as other products containing diclofenac or other non-steroidal anti-inflammatory and analgesic drugs, regardless of whether they are used externally or orally.

Children and adolescents

Diclofenac is contraindicated in children and adolescents under 16 years of age. There is insufficient data on the efficacy and safety of diclofenac in children and adolescents under 16 years of age (see section: When not to use Voltaren Forte).

Voltaren Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
As Voltaren Forte is used correctly, only a small amount of diclofenac is absorbed into the body. Therefore, it is unlikely that interactions described in the case of oral medicinal products containing diclofenac will occur.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Voltaren Forte should not be used in the last trimester of pregnancy, as it cannot be ruled out that there is an increased risk of complications for the mother and child (see section: When not to use Voltaren Forte).
In the first and second trimester of pregnancy and in women planning to become pregnant, Voltaren Forte should be used only after consulting a doctor. If treatment is necessary during this period, the dose should be as low as possible and the duration of treatment as short as possible.
After oral administration (e.g., tablets), side effects may occur in the unborn child. It is not known whether the same risk applies to Voltaren Forte when used on the skin.
Breastfeeding

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Small amounts of diclofenac pass into breast milk.
Before starting to use Voltaren Forte during breastfeeding, discuss it with your doctor. In any case, Voltaren Forte should never be applied directly to the breast area in breastfeeding women.

Driving and using machines

Voltaren Forte has no effect on the ability to drive and use machines.

Voltaren Forte contains butylhydroxyanisole (E 320)

Butylhydroxyanisole may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Voltaren Forte

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose is one medicinal plaster once a day.
Apply one medicinal plaster to the painful area. The maximum total daily dose is 1 medicinal plaster per day, even if more than one area is being treated. Only one painful area can be treated at a time.

Method of administration

For cutaneous use.
Instructions for use:

• 1. Cut the sachet along the broken line and remove the medicinal plaster.

To apply the plaster:

• 2. Remove one of the two protective layers.
• 3. Apply the plaster to the painful area and remove the remaining protective layer.
• 4. Gently press with your hand until the plaster is completely stuck to the skin.

To remove the plaster:

• 5. Wet the plaster with water, peel off the edge of the plaster, and gently detach it from the skin.
• 6. To remove any remaining product, rinse the skin with water, gently rubbing it with your fingers in a circular motion.

If necessary, the medicinal plaster can be fixed with an elastic mesh dressing.
The medicinal plaster can only be used on undamaged, healthy skin.

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Do not use the medicinal plaster under airtight dressings (occlusive dressings).
Do not use the plaster while bathing or showering.
Do not divide the medicinal plaster.

Duration of use

Do not use Voltaren Forte for more than 7 days.
If it is necessary to use this medicine for more than 7 days to relieve pain or if symptoms worsen, consult a doctor.

Using a higher dose of Voltaren Forte than recommended

Inform your doctor about the occurrence of serious side effects in case of incorrect use or accidental overdose of the medicine (e.g., in children). The doctor will be able to advise on further action.

Missing a dose of Voltaren Forte

Do not use a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop using the medicinal plaster immediately and tell your doctor if you experience:

sudden itchy rash (hives); swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; sudden drop in blood pressure or weakness.
The following side effects may occur:
Common side effects (may occur in up to 1 in 10 people):
local skin reactions, such as redness of the skin, burning sensation, itching, redness, and inflammation of the skin, skin rash, sometimes with pimples or blisters.
Very rare side effects (may occur in up to 1 in 10,000 patients):
allergic reactions or local allergic reactions (contact dermatitis).
In patients using external medicines from the same group of active substances as diclofenac, single reports of generalized skin rash, allergic reactions, such as skin and mucous membrane swelling, and anaphylactic reactions with acute circulatory disorders and photosensitivity reactions have been noted.
The absorption of diclofenac into the body through the skin is very low compared to the concentration of the active substance in the blood after oral administration of diclofenac. Therefore, the likelihood of side effects affecting the whole body (such as gastrointestinal or kidney disorders or breathing difficulties) is very low.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 to gather more information on the safety of this medicine.

5. How to store Voltaren Forte

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after: EXP.
The expiry date refers to the last day of the month stated.
This medicine does not require any special storage conditions.
Store in the original package to protect from light and moisture.
Do not use Voltaren Forte if you notice any damage to it.
Used plasters should be folded in half, with the adhesive side inward.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Voltaren Forte contains

• The active substance of the medicine is diclofenac sodium. Each medicinal plaster contains 140 mg of diclofenac in the form of diclofenac sodium.
• The other ingredients are:

Outer protective layer:
Polyester fabric
Adhesive layer:
Polyacrylate dispersion
Tributyl citrate
Butylhydroxyanisole (E 320)
Protective layer (removable):
Silicon-coated paper

What Voltaren Forte looks like and contents of the package

Voltaren Forte is a white adhesive medicinal plaster with dimensions of 10 x 14 cm, one side made of fabric and the other of paper. After removing the protective layer, the adhesive foil becomes transparent and light.
Voltaren Forte is available in packs of 2, 5, and 7 medicinal plasters; each plaster is packed in a separate sachet, and the sachets are packed in a cardboard box.

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Not all pack sizes may be marketed.

Marketing authorization holder

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Manufacturer

Fidia Farmaceutici S.p.A.
Via Andrea Maria Ampere 29
20037 Paderno Dugnano
Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria:
Voltadol 24 Stunden Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster
Belgium:
Voltaren Patch Once Daily, 140 mg pleister / emplâtre médicamenteux /
Wirkstoffhaltiges Pflaster.
Bulgaria:
Волтарен 140 mg лечебен пластир.
Czech Republic:
Voltaren 1x denně.
Estonia:
Voltinex.
France:
Voltarenactigo 140 mg, emplâtre médicamenteux.
Germany:
Voltaren 24 Stunden Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster.
Greece:
VOLTADOL 24-HOURS.
Hungary:
Voltaren 140 mg gyógyszeres tapasz
Italy:
Voltadol Unidie 140 mg cerotto medicato.
Latvia:
Voltinex 140 mg ārstnieciskais plāksteris
Lithuania:
Voltinex 140 mg vaistinis pleistras
Luxembourg:
Voltaren Patch Once Daily, 140 mg emplâtre médicamenteux /
Wirkstoffhaltiges Pflaster.
Netherlands:
Voltaren Pleister 140 mg.
Poland:
Voltaren Forte.
Portugal:
Voltaren 24h, 140 mg, emplastro medicamentoso.
Romania:
Voltaren 140 mg emplastru medicamentos.
Spain:
Voltadol 140 mg apósito adhesivo medicamentoso.
Slovakia:
Voltaren 1x denne 140 mg liečivá náplasť
Date of last revision of the package leaflet:March 2025

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