VOLTADOL 140 mg Plaster Transdermalny

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1. VOLTADOL UNIDIE 140 mg medicated patch
   1. What is VOLTADOL UNIDIE and what is it 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

VOLTADOL UNIDIE 140 mg medicated patch

diclofenac sodium
equivalent medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen 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 is VOLTADOL UNIDIE and what is it 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 the short-term local treatment (maximum 7 days) of pain associated with muscle strains, sprains or bruises of arms and legs due to blunt trauma 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 allergicto diclofenacor to 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, ibuprofen);
• if you have experienced asthma attacks, urticariaor swelling and irritation inside the noseafter taking acetylsalicylic acid or other NSAIDs;
• if you suffer from an active gastric or duodenal ulcer;
• on broken skin(e.g. skin abrasions, cuts, burns), infected or with inflammation(exudative dermatitis) or eczema;
• if you are in the last three months of pregnancy;
• in children and adolescents under the age of 16 years.
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Warnings and precautions
Consult your doctor or pharmacist before taking VOLTADOL UNIDIE if you suffer or have suffered in the
past from bronchial asthma or allergies, you may experience bronchial muscle spasm
(bronchospasm), which manifests with difficulty breathing;

• if you notice a skin rash, which appears after applying the medicated patch. If this happens, remove the medicated patch immediately and stop treatment.
• if you suffer from kidney, heartor liverdysfunction or have suffered in the past from gastrointestinal ulcer, intestinal inflammationor a tendency to bleeding.

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

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 light sensitivity.

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 the age of 16 years.
Sufficient data on efficacy and safety are not available for children and adolescents under the age of 16 years (see section Do not use VOLTADOL UNIDIE).

Other medicines and VOLTADOL UNIDIE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If VOLTADOL UNIDIE is used correctly, only a very small amount of diclofenac
is absorbed into the body, so interactions described for
oral use of medicines containing diclofenac are unlikely.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
During the first six months of pregnancy or if you are planning a pregnancy, you should use VOLTADOL
UNIDIE only after consulting your doctor.
During the last three months of pregnancy, you should not use VOLTADOL UNIDIE, as it is
not possible to exclude an increased risk of complications for the mother and the child (see “Do not
use VOLTADOL UNIDIE”).
Breastfeeding
Small amounts of diclofenac are excreted in breast milk.
Consult your doctor before using VOLTADOL UNIDIE during breastfeeding. In any case,
VOLTADOL UNIDIE should not be applied directly to the area around the breast during
breastfeeding.

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Driving and using machines
VOLTADOL UNIDIE does not impair the ability to drive vehicles and 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 following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, 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 1 medicated patch, even if more than one area needs to be treated. Treat only one painful area at a time.

Method of administration
Apply to the skin (cutaneous use).
Instructions for use:

• 1. Cut the sachet 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. Apply by exerting slight pressure with the palm of your hand until the patch adheres completely to the skin.

To remove the patch:

• 5. Moisten the patch with water, lift one edge and then gently peel off from the skin.
• 6. To remove any product residue, rinse the affected area with water, gently rubbing with your fingertips in a circular motion.

If necessary, the medicated patch can be kept in place using an elastic net bandage.
Use the medicated patch only on intact and healthy skin.
Do not use the medicated patch together with an airtight (occlusive) bandage.
Do not wear the patch while bathing or showering.
Do not split the medicated patch.

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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, after incorrect use of this medicine or occasional overdose (e.g. in children), intense side effects appear. The doctor will be able to advise you on the measures to be taken.

If you forget to use VOLTADOL UNIDIE
Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If the following symptoms occur, inform your doctor immediately and stop using the patch:
sudden itchy rash (urticaria); swelling of the hands, feet, ankles, face, lips,
mouth or throat; difficulty breathing; 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 blisters.

Very rare (may affect up to 1 in 10,000 people):
hypersensitivity reactions or local allergic reactions (contact dermatitis).
In patients who used topical active ingredients 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 anaphylactic reactions with acute
disturbances of circulatory regulation and light sensitivity have been reported.
The absorption of diclofenac into the body through the skin is very low compared to the
concentration of active ingredient in the blood measured after oral administration of diclofenac. Therefore,
the probability of occurrence of general side effects (such as, for example, gastrointestinal
or kidney disorders or difficulty breathing) is very low.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system https://www.aifa.gov.it/content/segnalazionireazioni-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.

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Do not use this medicine after the expiry date which is stated on the pack and on the sachet after
“EXP”. The expiry date refers to the last day of that month.
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 must be folded in half with the adhesive side facing inwards.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What VOLTADOL UNIDIE contains

• The active ingredient is diclofenac sodium. Each medicated patch contains 140 mg of diclofenac sodium.
• The other ingredients are: Supporting layer: Polyester non-woven fabric

Adhesive layer:
polyacrylate dispersion
tributyl citrate
butylhydroxyanisole
Protective layer:
mono-siliconized paper

Description of the appearance of VOLTADOL UNIDIE and contents of the pack
VOLTADOL UNIDIE is a self-adhesive medicated patch, white in color, measuring 10x14
cm, consisting of a non-woven fabric layer and a paper layer.
VOLTADOL UNIDIE is available in packs of 2, 5, 7 and 10 medicated patches in sachets
each containing one patch.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
GLAXOSMITHKLINE CONSUMER HEALTHCARE S.R.L.
via Zambelletti snc
20021 Baranzate
Milan
Italy

Manufacturer
Biofarmitalia S.r.l.
Via Ampere 29
20037 Paderno Dugnano
Italy

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This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: ITAMIONE 140 mg wirkstoffhaltiges Pflaster
Spain: Diclofenac Kapplerpharma 140mg medicated adhesive patch
Italy: VOLTADOL UNIDIE
Czech Republic: Diclofenac Kappler
Slovakia: Diclofenac Kapplerpharma 140mg medicinal plaster

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