Voltaren forte

Patient Information Leaflet: Information for the User

Voltaren Forte
140 mg, medicated patch
Diclofenacum natricum
Please read this leaflet carefully before using this medicine because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

Table of 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 to 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 of the stomach and/or duodenum;
• on damaged skin (e.g. abrasions, cuts, skin 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.
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Warnings and precautions
Before starting treatment with Voltaren Forte, consult your doctor or pharmacist:

• if the patient suffers or has previously suffered from bronchial asthma or allergies; bronchospasm (airway constriction) which makes breathing difficult may occur;
• if the patient notices a skin rash after applying the medicated patch – in such a case, the patch must 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, inflammatory bowel disease, or a tendency to bleeding.

The risk of 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 must not be used simultaneously with other products containing diclofenac or other non-steroidal anti-inflammatory and analgesic agents, regardless of whether they are used topically 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
Inform your doctor or pharmacist about any medicines currently taken or recently used, as well as any medicines you plan to take.
When Voltaren Forte is used correctly, only a small amount of diclofenac is absorbed into the body. Therefore, drug interactions described with oral diclofenac-containing medicinal products are unlikely to occur.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning a pregnancy, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Voltaren Forte must 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 pregnancy, Voltaren Forte should be used only after consultation with a doctor. If treatment is necessary during this period, the dose used should be as low as possible and the duration of treatment as short as possible.
After administration of oral formulations (e.g. tablets), adverse effects in the unborn child may occur. It is unknown whether the same risk applies to Voltaren Forte when applied to the skin.
Breastfeeding

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Small amounts of diclofenac pass into breast milk.
Before starting treatment with Voltaren Forte during breastfeeding, consult your doctor. Regardless of the situation, Voltaren Forte must 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 your doctor or pharmacist. If in doubt, consult your 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
Topical application to the skin.
Instructions for use:

1. Cut 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 your hand until the patch is fully adhered 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 residual product, wash the skin with water, gently rubbing it in circular motions with your fingers.

If necessary, the medicated patch may be secured with an elastic dressing net.
The medicated patch must only be applied to intact, healthy skin.

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Do not use the medicated patch under airtight (occlusive) dressings.
Do not use the patch while bathing or showering.
Do not cut the medicated patch into pieces.
Duration of use
Do not use Voltaren Forte for longer than 7 days.
If use of this medicine is required for more than 7 days to relieve pain, or if symptoms worsen, consult your doctor.
Use of more than the recommended dose of Voltaren Forte
Inform your doctor about any serious adverse reactions in case of incorrect use or accidental overdose (e.g. in children). Your doctor will be able to advise on further management.
Missed dose of Voltaren Forte
Do not apply a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this product may cause adverse effects, although not everybody will experience them.
Discontinue use of the medicated patch immediately and contact a doctor if the patient experiences:
sudden itchy rash (urticaria); swelling of the 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 up to 1 in 10 people):
local skin reactions such as redness, burning sensation, itching, erythema and skin inflammation, skin rash, sometimes with small blisters or vesicles.
Very rare adverse effects (may occur in up to 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 of generalized skin rashes, hypersensitivity reactions such as skin and mucosal swelling, anaphylactoid reactions with acute circulatory disturbances, and photosensitivity reactions have been observed.

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 renal disorders or breathing difficulties) is very low.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a 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.
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 carton and sachet following EXP.
The expiry date refers to the last day of the stated month.
This medicine does not require any special storage temperature conditions.
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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This practice will help protect the environment.

6. Contents of the package 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.
• Other components 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 made of fleece and the other of paper. After removal of the protective liner, the adhesive film becomes transparent and clear.
Voltaren Forte is available in packs containing 2, 5 or 7 medicinal patches; each patch is individually packed in a sachet, and the sachets are packed in a cardboard box.

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Not all pack sizes may be marketed.
Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
Rzymowskiego Street 53
02-697 Warsaw
Tel. 800 702 849
Manufacturer
Fidia Farmaceutici S.p.A.
Via Andrea Maria Ampere 29
20037 Paderno Dugnano
Italy
This medicinal product is authorised in the European Economic Area countries 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

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