Voltadol Unidie

Package leaflet: Information for the user

Voltadol Unidie 140 mg medicated patch

diclofenac sodium
equivalent medicine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after 7 days.

Contents of this leaflet

1. What Voltadol Unidie is and what it is used for
2. What you need to know before using Voltadol Unidie
3. How to use Voltadol Unidie
4. Possible side effects
5. How to store Voltadol Unidie
6. Contents of the pack and other information

1. What Voltadol Unidie is and what it is used for

Voltadol Unidie is a medicine that reduces pain. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Voltadol Unidie is used for short-term local treatment (maximum 7 days) of pain associated with muscle strains, sprains or bruises of arms and legs due to blunt injuries in adolescents aged 16 years and older and in adults.

2. What you need to know before using Voltadol Unidie

Do not use Voltadol Unidie

• if you are allergic to diclofenac or to 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, ibuprofen);
• if you have previously experienced asthma attacks, urticaria, or swelling and irritation inside the nose after taking acetylsalicylic acid or other NSAIDs;
• if you have active gastric or duodenal ulcer;
• on injured skin (e.g. skin abrasions, cuts, burns), infected skin, or skin with inflammation (exudative dermatitis) or eczema;
• during the last three months of pregnancy;
• in children and adolescents under 16 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Voltadol Unidie if you have or have previously had
bronchial asthma or allergies, as you may experience bronchial muscle spasm (bronchospasm),
manifesting as difficulty in breathing;

• if you notice a skin rash appearing after applying the medicated patch. If this occurs, remove the medicated patch immediately and discontinue treatment.
• if you have renal, cardiac, or hepatic dysfunction, or have previously suffered from gastrointestinal ulcers, intestinal inflammation, or a tendency to bleeding.

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

• The medicated patch must not come into contact with or be applied to eyes or mucous membranes.
• Elderly patients should use Voltadol Unidie with caution, as they may be more likely to develop adverse effects.

Avoid exposing the treated area to direct sunlight or sunlamps after removing the medicated patch, in order to reduce the risk of photosensitivity.
Do not use Voltadol Unidie simultaneously with any other medicine containing diclofenac or other non-steroidal anti-inflammatory and analgesic drugs, regardless of whether they are used externally or taken orally.
Children and adolescents
The use of diclofenac is contraindicated in children and adolescents under 16 years of age.
There are insufficient data on efficacy and safety in children and adolescents under 16 years of age (see section Do not use Voltadol Unidie).
Other medicines and Voltadol Unidie
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When Voltadol Unidie is used correctly, only a very small amount of diclofenac is absorbed into the body, making it unlikely that interactions described for oral diclofenac-containing medicines will occur.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
During the last three months of pregnancy, you must not use Voltadol Unidie, as it cannot be excluded that there is an increased risk of complications for mother and child (see “Do not use Voltadol Unidie”).
During the first six months of pregnancy or if you are planning a pregnancy, use Voltadol Unidie only after consulting your doctor. If treatment is necessary during this period, the lowest possible dose for the shortest possible time should be used.
Oral forms (e.g. tablets) of diclofenac may cause adverse effects in the newborn. It is not known whether the same risk applies with Voltadol Unidie when used on the skin.
Breastfeeding
Small amounts of diclofenac are excreted in breast milk.
Consult your doctor before using Voltadol Unidie during breastfeeding. In any case, Voltadol Unidie must not be applied directly to the area around the breast during breastfeeding.
Driving and using machines
Voltadol Unidie does not impair the ability to drive or operate machinery.
Voltadol Unidie contains butylated hydroxyanisole (E320)
Butylated hydroxyanisole may cause localized skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Voltadol Unidie

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
The recommended dose is one medicated patch per day.
Apply one medicated patch to the painful area. The maximum total daily dose is one medicated patch, even if more than one area requires treatment. Treat only one painful area at a time.
Method of administration
Apply to the skin (cutaneous use).
Instructions for use:

1. Cut the pouch along the dotted line and remove the medicated patch.

To apply the patch:

2. Remove one of the two protective films.
3. Apply to the area to be treated and remove the remaining protective film.
4. Press gently with the palm of your hand to ensure the patch adheres completely to the skin.

To remove the patch:

5. Moisten the patch with water, lift one edge, and then gently peel it off the skin.
6. To remove any residual product, rinse the affected area with water, gently rubbing with your fingers using a circular motion.

If necessary, the medicated patch may be secured in place using an elastic mesh bandage.
Use the medicated patch only on intact, healthy skin.
Do not use the medicated patch together with an airtight (occlusive) dressing.
Do not wear the patch while bathing or showering.
Do not cut the medicated patch.
Duration of use
Do not use Voltadol Unidie for more than 7 days.
Consult a doctor if it is necessary to administer the medicine for more than 7 days to relieve pain or if symptoms worsen.
If you use more Voltadol Unidie than you should
Inform your doctor if intense adverse effects occur after incorrect use of this medicine or accidental overdose (e.g. in children). The doctor will advise you on the necessary measures to take.
If you forget to use Voltadol Unidie
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following symptoms occur, inform your doctor immediately and stop using the
patch:
sudden itchy rash (urticaria); swelling of hands, feet, ankles, face, lips, mouth or throat; breathing
difficulties; drop in blood pressure or weakness.
The following side effects may also occur:
Common (may affect up to 1 in 10 people):
local skin reactions such as redness of the skin, burning sensation, itching, red and inflamed skin, skin
rash sometimes with pustules or wheals.
Very rare (may affect up to 1 in 10,000 people):
hypersensitivity reactions or local allergic reactions (contact dermatitis).
In patients using topically applied active substances belonging to the same class of medicines as
diclofenac, isolated cases of generalized skin rash, hypersensitivity reactions such as swelling of the
skin and mucous membranes, and anaphylactoid reactions with acute disturbances in circulatory
regulation and light sensitivity have been reported.
Absorption of diclofenac into the body through the skin is very low compared to the concentration of
active substance in the blood measured after oral administration of diclofenac. Therefore, the likelihood
of general side effects (such as gastrointestinal or renal disorders or breathing difficulties) is very low.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help
provide more information on the safety of this medicine.

5. How to store Voltadol Unidie

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the sachet after
"EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light and moisture.
Do not use Voltadol Unidie if you notice that the packaging is damaged.
Used patches should be folded in half with the adhesive side facing inwards.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Voltadol Unidie contains

• The active substance is sodium diclofenac. Each medicated patch contains 140 mg of sodium diclofenac.
• The other components are:
  Support layer: Non-woven polyester fabric

Adhesive layer:
polyacrylate dispersion
tributyl citrate
butylated hydroxyanisole

Protective layer:
siliconized paper (single-sided)

Description of the appearance of Voltadol Unidie and contents of the pack
Voltadol Unidie is a white, self-adhesive medicated patch measuring 10×14 cm, composed of a non-woven fabric layer and a paper layer. After removal of the protective liner, the adhesive film appears transparent and glossy.
Voltadol Unidie is available in packs containing 2, 5, 7, and 10 medicated patches, with each patch individually enclosed in a sachet.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy

Manufacturers
Fidia Farmaceutici S.p.A.
Via Ampère, 29
20037 Paderno Dugnano, Italy

Haleon Germany GmbH
Barthstraße 4
80339 Munich, Germany

This medicinal product is authorized 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
Czech Republic: Voltaren 1x denně