Voltaren forte

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Voltaren Forte (Voltaren 140 mg emplastru medicamentos), 140 mg, medicated plaster
Diclofenacum natricum
Voltaren Forte and Voltaren 140 mg emplastru medicamentos are different trade names for the
same medicine.
Please 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 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 reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Leaflet contents

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

Voltaren Forte is a medicine that relieves pain. It belongs to a group of medicines called 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 aged 16 years and older and adults.

2. Important information before using Voltaren Forte

When not to use Voltaren Forte

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to any other non-steroidal anti-inflammatory drug (NSAID, e.g. acetylsalicylic acid or ibuprofen);
• if the patient has ever experienced asthma attacks, urticaria, or swelling and irritation of the nasal mucosa after taking acetylsalicylic acid or any other NSAID;
• if the patient has active peptic ulcer disease of the stomach and/or duodenum;
• on damaged skin (e.g. abrasions, cuts, burns), infected skin, or skin affected by inflammatory conditions (exudative dermatitis) or rash;
• in women during the last three months of pregnancy;
• in children and adolescents under 16 years of age.

Warnings and precautions
Before starting to use Voltaren Forte, discuss this with your doctor or
pharmacist:

• if the patient has or has previously had bronchial asthma or allergies; bronchospasm (airway constriction) may occur, making breathing difficult;
• if the patient notices a skin rash after applying the medicated patch – in such a case, the patch should be removed immediately and use of the medicine discontinued;
• if the patient has impaired kidney, heart, or liver function, or if the patient has previously had stomach or intestinal ulcers, intestinal inflammation, or a tendency to bleeding.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
Important precautions

• Do not apply the medicated patch near the eyes or mucous membranes, and avoid contact of these areas with the patch.
• Elderly patients should use Voltaren Forte with caution, as they are more susceptible to adverse effects.

To reduce the risk of photosensitivity reactions, after removing the medicated patch, avoid exposing the treated area to direct sunlight or solarium radiation.
Voltaren Forte should not be used simultaneously with other products containing diclofenac or other non-steroidal anti-inflammatory and analgesic drugs, regardless of whether they are applied topically or taken 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 currently taking, have recently taken, or plan to take.
When Voltaren Forte is used correctly, only a small amount of diclofenac is absorbed into the body. Therefore, interactions described with oral diclofenac-containing medicinal products are unlikely.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Voltaren Forte should not be used during the last trimester of pregnancy, as increased risk of complications for both mother and child cannot be excluded (see section: When not to use Voltaren Forte).
During the first and second trimesters of pregnancy, and in patients planning to become pregnant, Voltaren Forte should be used only after consultation with 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.
Adverse effects on the unborn child have been reported after oral formulations (e.g. tablets). It is unknown whether the same risk applies to Voltaren Forte when applied to the skin.
Breastfeeding
Small amounts of diclofenac pass into breast milk.
Before starting Voltaren Forte during breastfeeding, discuss this with your doctor. Regardless of the situation, Voltaren Forte should never be applied directly to the breast area in breastfeeding women.
Driving and operating machinery
Voltaren Forte has no effect on the ability to drive or operate machinery.
Voltaren Forte contains butylated hydroxyanisole (E 320)
Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

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. If in doubt, consult a doctor or pharmacist.
The recommended dose is one medicated patch once daily.
Apply one medicated patch to the painful area. The maximum total daily dose is one medicated patch per day, even if more than one area is to be treated. Only one painful area should be treated at any given time.
Method of administration
For topical application to the skin.
Instructions for use:

1. Tear the sachet along the dotted line and remove the medicated patch.

To apply the patch:

2. Peel off one of the two protective layers.
3. Apply the patch to the painful area and remove the remaining protective layer.
4. Press gently with the palm of the hand until the patch adheres completely to the skin.

To remove the patch:

5. Moisten the patch with water, lift the edge of the patch and gently peel it off the skin.
6. To remove any residue, wash the skin with water, gently rubbing in circular motions with the fingers.

If necessary, the medicated patch may be secured with an elastic mesh dressing.
The medicated patch should only be applied to intact, healthy skin.
Do not use the patch under occlusive (airtight) dressings.
Do not use the patch while bathing or showering.
Do not cut the medicated patch.
Duration of use
Do not use Voltaren Forte for longer than 7 days.
If treatment with this medicine is required for more than 7 days to relieve pain, or if symptoms worsen, consult a doctor.
Use of a higher than recommended dose of Voltaren Forte
Inform a doctor if serious adverse reactions occur following incorrect use or accidental overdose (e.g. in children). The doctor will be able to advise on further management.
Missed dose of Voltaren Forte
Do not use a double dose to make up for a missed dose.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You must stop using the medicated patch immediately and consult a doctor if the patient experiences:
sudden itchy rash (urticaria); swelling of hands, feet, ankles, face, lips, mouth or throat;
difficulty breathing; sudden drop in blood pressure or weakness.
The following adverse effects may occur:
Common adverse effects (may occur in no more than 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 spots or blisters.
Very rare adverse effects (may occur in no more than 1 in 10,000 patients):
hypersensitivity reactions or local allergic reactions (contact dermatitis).
In patients using topical medicines from the same active substance group as diclofenac, isolated reports have been documented of generalized skin rash, hypersensitivity reactions such as skin and mucous membrane swelling, anaphylactic-type reactions with acute circulatory disturbances, and photosensitivity reactions.
Systemic absorption of diclofenac through the skin is very low compared to blood concentrations of the active substance achieved after oral administration of diclofenac. Therefore, the likelihood of systemic adverse effects (such as gastrointestinal or kidney disorders or breathing difficulties) is very low.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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, 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 effects helps to provide more information on the safety of this medicine.

5. How to store Voltaren Forte

Keep this medicine out of 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.
There are no special requirements regarding storage temperature. Store in the original packaging to protect from light and moisture.
Do not use Voltaren Forte if you notice any damage to the product.
Used patches should be folded in half with the adhesive side inwards.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices help protect the environment.

6. Contents of the pack and other information

What Voltaren Forte contains

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

Protective outer layer:
Polyester fleece

Adhesive layer:
Polyacrylate dispersion
Tributyl citrate
Butylated hydroxyanisole (E 320)

Protective liner (to be removed):
Siliconized paper

What Voltaren Forte looks like and contents of the pack
Voltaren Forte is a white transdermal patch measuring 10 x 14 cm, one side of which is covered with a non-woven polyester layer and the other with paper. After removal of the protective liner, the adhesive surface becomes transparent and clear.

Voltaren Forte is available in packs containing 2, 5, 7, or 10 medicinal patches; each patch is individually packed in a sachet, and the sachets are packed into a cardboard carton.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

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

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Numbers in Romania, the country of export:
15308/2024/01
15308/2024/02
15308/2024/03
15308/2024/04

Parallel Import Licence Number: 215/25

This medicinal product is authorised 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