Voltaren Forte

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Voltaren Forte (Voltaren 140 mg medicated plaster), 140 mg, medicated plaster

Diclofenac sodium
Voltaren Forte and Voltaren 140 mg medicated plaster are different trade names for the same medicine.

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 information leaflet or as directed by a doctor or pharmacist.

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

Table of Contents of the 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 pack 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 trauma, 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 allergicto diclofenacor any of the other ingredientsof this medicine (listed in section 6);
• if you are allergicto any other non-steroidal anti-inflammatory drug(NSAID, e.g. acetylsalicylic acid or ibuprofen);
• if you have ever had asthma attacks, hives, or irritation of the nasal mucosaafter 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 inflammatory conditions (exudative eczema) or eczema;
• in women in the last 3 months of pregnancy;
• in children and adolescents under 16 years of age.

Warnings and precautions

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

• if you have or have had asthma or allergies; you may experience bronchial spasm (bronchospasm), which can make breathing difficult;
• if you notice a skin rashappearing after applying the medicated plaster - in such a case, remove the medicated plaster immediately and stop using the medicine;
• if you have kidney, heart, or liver problems, or if you have had stomach or intestinal ulcers, inflammatory bowel disease, or a tendency to bleedingin the past.

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

Important precautions

• Do not apply the medicated plaster to the eyes or mucous membranes, or allow them to come into contact with the medicated 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 medicated 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 a lack of sufficient 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 for oral diclofenac products 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 excluded 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, as well as 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
Small amounts of diclofenac pass into the breast milk of nursing women.
Before starting treatment with Voltaren Forte during breastfeeding, discuss it with your doctor. Regardless of the situation, Voltaren Forte should never be applied directly to the breast area in nursing women.

Driving and using machines

Voltaren Forte has no effect on the ability to drive or operate 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 patient information leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose is one medicated plaster once a day.
Apply one medicated plaster to the painful area. The maximum total daily dose is 1 medicated 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 topical use.
Instructions for use:

• 1. Cut the sachet along the dotted line and remove the medicated 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. Moisten 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 medicated plaster can be secured with a flexible dressing net.
The medicated plaster can only be used on undamaged, healthy skin.
Do not use the medicated plaster under airtight dressings (occlusive dressings).
Do not use the medicated plaster while bathing or showering.

The medicated plaster should not be divided.

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 more than the recommended dose of Voltaren Forte

Inform your doctor about 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.
If you have 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 medicated 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 affect 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 affect up to 1 in 10,000 people):
allergic reactions or local allergic reactions (contact dermatitis).
In patients using external medicines from the same group of active substances as diclofenac, isolated 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 systemic side effects (such as gastrointestinal or kidney problems or breathing difficulties) is very low.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, you can help provide 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 packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage temperature. Store in the original packaging to protect from light and moisture.
Do not use Voltaren Forte if you notice it is damaged.
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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Voltaren Forte contains

• The active substance of the medicine is diclofenac sodium. Each medicated 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 (to be removed):
Siliconized paper

What Voltaren Forte looks like and contents of the pack

Voltaren Forte is a white self-adhesive medicated 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, 7, and 10 medicated plasters; each plaster is packed in a separate sachet, sachets are packed in a cardboard box.
For more detailed information, contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Haleon România S.R.L.
Str. Costache Negri, Nr. 1-5, Opera Center One
Etaj 6 (Zona 2), Sector 5, Bucharest, Romania

Manufacturer:

Fidia Farmaceutici S.p.A.
Via Andrea Maria Ampere 29
20037 Paderno Dugnano (MI), Italy
HALEON GERMANY GmbH
Barthstraße 4, 80339 Munich, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Romania, the country of export:15308/2024/01
15308/2024/02
15308/2024/03
15308/2024/04

Parallel import authorization number: 215/25

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 /
Wirkstoffhaltige Pflaster.
Bulgaria
Волтарен 140 mg лечебен пластир.
Czech Republic
Voltaren 1x denně.
Estonia
Voltanum.
France
Voltarenactigo 140 mg, emplâtre médicamenteux.
Germany
Voltaren 24 Stunden Schmerzpflaster 140 mg wirkstoffhaltiges Pflaster.
Italy
Voltadol Unidie 140 mg cerotto medicato
Latvia
Voltanum 140 mg ārstnieciskais plāksteris
Lithuania
Voltinex 140 mg vaistinis pleistras
Luxembourg
Voltaren Patch Once Daily, 140 mg emplâtre médicamenteux /
Wirkstoffhaltige 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 approval of the leaflet: 23.06.2025

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