VOLTADOL 140 mg Трансдермальный Пластырь

Содержание инструкции

1. Voltadol 140 mg medicated patch
   1. What is Voltadol and what is it used for
   2. What you need to know before using Voltadol
   3. How to use Voltadol
   4. Possible side effects
   5. How to store Voltadol
   6. Contents of the pack and other information

Voltadol 140 mg medicated patch

diclofenac sodium

Read this leaflet carefully before usingthis 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What is Voltadol and what is it used for

Voltadol contains the active ingredient diclofenac sodium. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
Voltadol is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin
affecting:

• joints
• muscles
• tendons and ligaments

Consult your doctor if you do not feel better or if you feel worse after 7 days, if the disorder occurs
repeatedly or if you notice any recent change in its characteristics.

2. What you need to know before using Voltadol

Do not use Voltadol

• if you are allergic to diclofenac sodium, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if in the past you have had an allergic reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) which manifested as asthma (difficulty breathing caused by inflammation and narrowing of the airways), angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing), urticaria (itchy skin rash), or acute rhinitis (runny nose for acute forms of inflammation of the nasal mucosa);
• if your skin has any lesions of any kind, such as exudative dermatitis (skin irritation with exudate, a liquid that forms with inflammation), eczema (skin rash), infected lesion, burns or wounds;
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if you have a lesion of the stomach or upper intestinal mucosa (peptic ulcer);
• if the subject to be treated is a child or adolescent under 16 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Voltadol.
Consult your doctor before using Voltadol:

• if you have or have had asthma;
• if you have or have had chronic diseases with airway obstruction;
• if you have or have had allergic rhinitis (inflammation of the nose due to allergy);
• if you have or have had inflammation of the nasal mucosa (nasal polyps); because you may be more likely to experience asthma attacks, local inflammation of the skin, mucosa (angioedema) or urticaria than other patients.

Take special care:

• do not ingest Voltadol; wash your hands after use;
• do not apply Voltadol to damaged, diseased skin or open wounds;
• avoid contact of Voltadol with the eyes or mucous membranes, such as the mouth. If this occurs, wash the area immediately with running water and contact your doctor;
• do not use Voltadol with other anti-inflammatory medicines taken by mouth, by injection, rectally or applied to the skin;
• the use, especially if for long periods of time, of medicines for local use can cause allergic reactions. If this occurs, immediately stop treatment with Voltadol and consult your doctor who will give you appropriate therapy;
• do not use Voltadol with an occlusive bandage, i.e. covering the affected area with a plastic film that does not allow air to pass through. You can instead use Voltadol with a gauze that allows air to pass through;
• avoid exposure to direct sunlight, including sunlamps, for about 1 day after removing the Voltadol patch, this will reduce the risk of having skin reactions due to the sun;
• if you use diclofenac for long periods of time, you may experience side effects that affect the whole body; do not exceed the recommended dose.

Consult your doctor if:

• if you are elderly;
• if you have kidney, heart or liver problems;
• if you have had a peptic ulcer (lesion of the stomach and upper intestinal mucosa);
• if you are a woman and have fertility problems, if you are undergoing fertility investigations if you intend to become pregnant.

Stop treatment if you develop a skin rash (rash) after applying the medicated patch.
If you use Voltadol with other medicines containing diclofenac, you may experience skin reactions, even serious
(Stevens-Johnson syndrome, Lyell syndrome).

Children and adolescents
Voltadol must not be used in children and adolescents under 16 years of age.

Other medicines and Voltadol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
After applying the patch to the skin, the amount of diclofenac that reaches the blood is low. However
avoid using other medicines containing diclofenac or non-steroidal anti-inflammatory drugs (NSAIDs) taken
by mouth, by injection, rectally or applied to the skin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use Voltadol if you are in the last 3 months of pregnancy. Do not use Voltadol during the first 6 months of
pregnancy unless strictly necessary and as directed by your doctor. If treatment is necessary during this period,
the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of diclofenac can cause adverse effects in the unborn child. It is
not known whether the same risk applies with Voltadol when used on the skin.
After application to the skin, the amount of diclofenac that reaches the blood is very low compared to
when it is taken by mouth. However, the following is recommended:
Conception, first and second trimester of pregnancy
Diclofenac should not be used during the first and second trimester of pregnancy unless in cases of
actual need because it can increase the risk of abortion and malformations in the newborn (such as, for example,
affecting the heart and abdominal organs). The risk increases with increasing dose and duration of
therapy with diclofenac.
If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, take
the lowest dose of diclofenac for the shortest possible time.
Third trimester of pregnancy
Diclofenac should not be used during the third trimester of pregnancy because it can cause damage to the heart, lungs,
kidneys of the fetus. It can also cause a prolongation of bleeding time in the mother and the
newborn, which can occur even at very low doses and inhibition of uterine contractions in the
mother with delayed or prolonged labor.
Breastfeeding
Diclofenac passes into breast milk in small amounts, however, adverse effects on the baby are not expected when
Voltadol is used at the recommended doses.
However, you should not use Voltadol during breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltadol to the breast and for long periods of time (see section Warnings and
precautions).

Driving and operating machinery
Voltadol does not impair the ability to drive vehicles or operate machinery.

3. How to use Voltadol

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.
Pay particular attention:

• Use the patch only on intact and healthy skin.
• Do not apply Voltadol if you are going to take a bath or shower.
• Use the patch whole and do not exceed the recommended doses.

Adults and adolescents 16 years of age and over
The recommended dose is one patch twice a day, in the morning and in the evening, on the skin of the area to be treated,
for a period not exceeding 7 days.
Consult your doctor if the discomfort does not resolve within 7 days of starting treatment with Voltadol or if you notice
a worsening of symptoms.

Use in children and adolescents under 16 years of age
Voltadol should not be used in children and adolescents under 16 years of age.

How to apply the Voltadol patch

• 1. Cut the sachet along the dotted line and remove the medicated patch, which will be dry and ready to use.
• 3. Apply the patch to the area to be treated and remove the remaining protective film.

• 4. Apply gentle pressure with the palm of your hand until the patch adheres completely to the skin.

To remove the patch:

• 5. Wet the patch with water and then lift a corner by gently pulling.
• 6. To remove any product residue, wash the affected area with water, making circular movements with your fingers.

If you use more Voltadol than you should
In case of accidental ingestion or use of an excessive dose of Voltadol, immediately inform your doctor or
go to the nearest hospital.
Cases of overdose with Voltadol have been reported, but no systemic adverse effects have been reported
that can be caused by overdose with oral NSAIDs, e.g., vomiting, diarrhea, dizziness, tinnitus
(persistent perception of noise in the ear), stomach and/or intestinal bleeding, seizures.
If you accidentally ingest the contents of the Voltadol package or apply too many patches
at the same time, you may experience undesirable effects similar to those observed after ingestion of an
excessive dose of diclofenac tablets.

If you forget to use Voltadol
Do not use a double dose to make up for a missed dose.

If you stop using Voltadol
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.

Common side effects (may affect up to 1 in 10 people)
To apply the patch:

• 2. Remove one of the two protective sheets.
• rash (skin rash), eczema (skin inflammation), erythema (skin redness), dermatitis (including allergic dermatitis and contact dermatitis), itching
• reactions at the site where the patch is applied.

Rare side effects (may affect up to 1 in 1,000 people)

• bullous dermatitis (skin inflammation with the appearance of blisters)
• dry skin
• burning sensation at the application site.

Very rare side effects (may affect up to 1 in 10,000 people)

• allergic reactions including urticaria, severe allergic reactions (anaphylactoid reactions and angioedema)
• angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing)
• rash with the appearance of pustules
• asthma (difficulty breathing caused by inflammation and narrowing of the bronchi)
• appearance of spots, swelling or redness on the skin following exposure to sunlight or sunlamps.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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

Do not store at a temperature above 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after Expiry. The expiry date
refers to the last day of that month.
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.
It is important to always have the information about the medicine available, therefore keep both the box

6. Contents of the pack and other information

What Voltadol contains

• The active ingredient is diclofenac sodium. Each medicated patch contains 140 mg of diclofenac sodium.
• The other ingredients are basic butyl methacrylate copolymer, acrylic-vinyl acetate copolymer, polyethylene glycol 12 stearate, sorbitan oleate, non-woven fabric, siliconized paper.

Description of the appearance of Voltadol and contents of the pack
Voltadol is presented in the form of a medicated, self-adhesive patch, measuring 10 x 14 cm.
Each pack contains 5 or 10 or 15 medicated patches, each patch being contained in a sachet.

Marketing Authorisation Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan

Manufacturer
IBSA Farmaceutici Italia S.r.l.
S.S. 11 Padana Superiore km 160
Cassina de’ Pecchi (MI)