Voltadol - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Diclofenac (Diclofenac sodium)

Voltadol 140 mg medicated plaster

Why is Voltadol used? What is it for?

Voltadol contains the active substance 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 a rheumatic or traumatic nature affecting:

  • joints
  • muscles
  • tendons and ligaments

Talk to 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.

Contraindications When Voltadol should not be used

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 you have ever had asthma attacks, hives or acute inflammation of the nose (rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) 1
  • if your skin has any kind of lesions, for example dermatitis, eczema, infected lesions, burns or wounds
  • if you are in the third trimester of pregnancy (see section "Pregnancy and breastfeeding")
  • if you have an ulcer in the stomach or the first part of the duodenum (peptic ulcer)
  • if the patient is a child or adolescent under 16 years of age.

Precautions for use What you need to know before taking Voltadol

Talk to your doctor or pharmacist before using Voltadol.

Talk to your doctor before using Voltadol:

  • if you have or have had asthma
  • if you have or have had chronic diseases with obstruction of the bronchi
  • if you have or have ever had allergic rhinitis (inflammation of the nose due to allergy)
  • if you have or have ever had "inflammation of the lining of the nose (polyp of the nose)

because it can more easily manifest, compared to other patients, attacks of asthma, local inflammation of the skin, mucosa (Quincke's edema) or urticaria.

Pay particular attention:

  • do not ingest Voltadol
  • do not apply Voltadol to broken, diseased or open skin
  • prevent Voltadol from coming into contact with the eyes or mucous membranes
  • do not use Voltadol with other anti-inflammatory medicines taken by mouth, by injection, rectally or applied to the skin
  • the use of medicines for local use, particularly if for long periods of time, can cause allergic reactions such as skin rash (rash). If this occurs, stop treatment with Voltadol immediately and consult your doctor who will give you therapy suitable
  • do not use Voltadol with an occlusive bandage, ie covering the diseased area with a plastic film that does not let the air through. You can instead use Voltadol with a gauze that lets the air pass
  • avoid exposure to direct sunlight, including sunlamp light, for about 1 day after removing the Voltadol patch, this will reduce the risk of skin reactions due to the sun
  • if you use diclofenac on large areas of skin and for long periods of time, you may experience side effects that affect the whole body
  • if you are an elderly patient because you are more at risk of developing side effects
  • if you have kidney, heart or liver problems
  • if you have ever had an ulcer, an inflammatory bowel disease or if you are prone to bleeding
  • if you are a woman and have fertility problems or are undergoing fertility tests.

Stop the treatment if: you experience allergic reactions or other major side effects after applying Voltadol.

Children and adolescents

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

Interactions Which drugs or foods can modify the effect of Voltadol

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

After applying the patch to the skin, the amount of diclofenac reaching the blood is very low so Voltadol is unlikely to interact with other medicines. 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.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

After application to the skin, the amount of diclofenac reaching the blood is very low compared to when 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 clearly needed because it may increase the risk of miscarriage and malformations in the newborn (such as affecting the heart and the viscera of the abdomen). The risk increases as the dose and duration of diclofenac therapy increases. If you want to get 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 the bleeding time in the mother and newborn, which can occur even at very low doses and an "inhibition of contractions of the uterus" in the mother with delay or prolongation of delivery.

Feeding time

Diclofenac passes into breast milk in small amounts, however no effects on the baby are expected when Voltadol is used at recommended doses. However, you should not use Voltadol if you are breastfeeding unless you have consulted your doctor first. If you are breastfeeding, do not apply Voltadol to your breasts, large areas of skin and for long periods of time (see section Warnings and precautions).

Driving and using machines

Voltadol does not affect the ability to drive or use machines.

Dose, Method and Time of Administration How to use Voltadol: Posology

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Pay particular attention:

  • Only use the patch on skin, which must be intact and healthy.
  • Do not apply Voltadol if you need to take a bath or shower.
  • Use the whole patch and do not exceed the recommended doses.

Use in adults

Apply the Voltadol patch 2 times a day, one in the morning and one in the evening on the area of ​​skin to be treated.

Do not use Voltadol for more than 7-10 days.

Use in adolescents over 16 years of age

Apply the Voltadol patch 2 times a day, one in the morning and one in the evening to the area of ​​skin to be treated. Consult your doctor if the disorder does not go away within 7 days of starting treatment with Voltadol or if you notice a worsening of your 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.

Use in the elderly

Elderly patients should use this medicine with caution as they are more prone to the side effects associated with Voltadol.

Use in patients with kidney or liver problems

Use this medicine with caution if you have kidney or liver problems (see Warnings and precautions section). How to apply the Voltadol patch

  1. Cut the envelope along the dotted line and take the medicated plaster which will be dry and usable and active.
  2. To apply the patch: Remove one of the two protective sheets.
  3. Apply the patch to the area to be treated and remove the remaining protective sheet.
  4. Apply light pressure with the palm of your hand until the patch adheres completely to the skin.
  5. To remove the patch: Wet the patch with water and then lift a flap by pulling gently.
  6. To eliminate any residues of the product, wash the affected area with water, making circular movements with your fingers.

Overdose What to do if you have taken too much Voltadol

If you use more Voltadol than you should

In case of accidental ingestion or use of an excessive dose of Voltadol, notify your doctor immediately or go to the nearest hospital.

If you accidentally swallow the contents of the Voltadol pack or apply too many patches at the same time, you may experience side effects similar to those seen after ingesting too much diclofenac tablets.

If you forget to use Voltadol

Do not use a double dose to make up for a forgotten dose.

If you stop taking Voltadol

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Voltadol

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

After applying the patch to the skin, the amount of diclofenac that reaches the blood is very low, so the risk of experiencing side effects involving the body is limited. However, following applications on large areas of skin and for long periods of time, undesirable effects may appear, especially in the stomach and intestines.

Common side effects (may affect up to 1 in 10 people)

  • various reactions on the skin including rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), itching.
  • reactions in the area where the patch is applied.

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

  • inflammation of the skin with blistering (bullous dermatitis)
  • dry skin
  • burning.

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

  • allergic reactions including hives, severe allergic reactions even after first taking the medicine (anaphylactoid reactions)
  • swelling of the skin, tissues and mucous membranes (angioedema)
  • rash on the skin with the appearance of pustules
  • asthma
  • appearance of spots or redness on the skin following exposure to sunlight or sunlamps.

If you use Voltadol together with other medicines containing diclofenac you may experience reactions on the skin, including severe ones (Stevens-Johnson syndrome, Lyell's syndrome).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Do not store above 30 ° C.

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 package after Expiry. The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

It is important to always have the information on the medicine available, so keep both the box and the package leaflet.

Composition and pharmaceutical form

What Voltadol contains

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

What Voltadol looks like and contents of the pack

Voltadol comes in the form of a medicated plaster, self-adhesive, with the dimensions of 10 x 14 cm.

Each pack contains 5 or 10 or 15 medicated plasters, each patch is contained in an envelope.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Voltadol can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER 09 .0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS AND QUALITY CONTROLS

01.0 NAME OF THE MEDICINAL PRODUCT

VOLTADOL 140 MG MEDICATED PATCH

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

A medicated plaster contains:

Active ingredient: sodium diclofenac 140 mg.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

Medicated plaster.

VOLTADOL consists of a self-adhesive medicated plaster, measuring 10 x 14 cm, consisting of an acrylic matrix containing the active ingredient, applied to an inert support of 100% polyester non-woven fabric; the matrix is ​​protected by two single-layer flaps of siliconized paper.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.


04.2 Posology and method of administration

For cutaneous use only.

Dosage

The product should only be applied to intact and healthy skin and should not be applied when bathing or showering.

The diclofenac medicated plaster should be used for the shortest possible time in relation to the "indication for use".

Adults and adolescents aged 16 and over:

Unless otherwise prescribed, apply a patch 2 times a day, in the morning and in the evening, on the skin of the area to be treated, for a period not exceeding 7-10 days.

If no improvement is seen following the recommended treatment period, a physician should be consulted (see section 4.4).

In adolescents aged 16 years and over, if this product is required for a treatment period exceeding 7 days for pain relief or if symptoms worsen, the patient or the adolescent's relatives are advised to consult a physician. .

Pediatric population

Children and adolescents under the age of 16:

The use of this medicated plaster is not recommended in children and adolescents under the age of 16 years because there are insufficient data to evaluate the safety and efficacy of the medicinal product (see section 4.3).

Senior citizens

This medicinal product should be used with caution in elderly patients as they are more prone to side effects (see section 4.4).

Patients with hepatic or renal insufficiency

For the use of diclofenac medicated plasters in patients with hepatic or renal insufficiency see section 4.4.

Method of administration

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

To apply the patch:

2. Remove one of the two protective sheets.

3. Apply on the part to be treated and remove the remaining protective sheet.

4. Apply light pressure with the palm of your hand until it adheres completely to the skin.

The patch must be used whole.

To remove the patch:

5. Wet the patch with water and then lift a flap by pulling gently.

6. To eliminate any product residues, wash the affected area with water using your fingers in circular movements.


04.3 Contraindications

- Hypersensitivity to the active substance, to acetylsalicylic acid or to other non-steroidal anti-inflammatory preparations (NSAIDs) or to any of the excipients listed in section 6.1

- Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).

- Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds.

- Third trimester of pregnancy (see section 4.6).

- Patients with active peptic ulcer.

Children and adolescents:

Use in children and adolescents under the age of 16 is contraindicated.


04.4 Special warnings and appropriate precautions for use

If diclofenac medicated plasters are used on large skin surfaces and for an extended period of time, the possibility of adverse events cannot be ruled out (see summary of product characteristics for systemic forms of diclofenac).

The medicated plaster should only be applied to intact, healthy skin, and should not be applied to broken skin or open wounds. The patches should not come into contact with the eyes or mucous membranes and should not be swallowed.

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.

Treatment should be stopped immediately if a skin rash develops after applying the medicated plaster.

Patients with asthma, chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to treatment with NSAIDs more often than others patients. Voltadol administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and consult the doctor in order to establish a suitable therapy. After a short period of treatment without appreciable results , consult your doctor.

Although systemic absorption is minimal, the use of Voltadol, as well as any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women planning to become pregnant.

Do not administer topically or systemically another diclofenac medicinal product or other NSAIDs at the same time.

Although systemic effects are expected to be low, the medicated plaster should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulcer or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular care in elderly patients who are more prone to side effects.

Keep this medicine out of the reach and sight of children.

Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass.

Patients should be advised not to expose themselves to direct sunlight or sunlamps for approximately one day after removal of the medicated plaster to reduce the risk of photosensitivity.


04.5 Interactions with other medicinal products and other forms of interaction

Since the systemic absorption of diclofenac following the use of medicated plasters is very low, the risk of developing clinically significant interactions with other medicinal products is negligible.

However, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding cannot be excluded. Concomitant topical or systemic use of other medications containing diclofenac or other NSAIDs is not recommended.


04.6 Pregnancy and breastfeeding

Pregnancy

The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Referring to experience with NSAID treatment for systemic administration, the following is recommended:

Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results from epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.

In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:

o cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);

o renal dysfunction, which can progress to renal failure with oligo-hydroamnios;

the mother and the newborn, at the end of pregnancy, to:

o possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;

or inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Feeding time

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Voltadol no effects on the infant are anticipated. Due to the lack of controlled studies in breastfeeding women, the product should only be used during lactation under the advice of a healthcare professional. In this circumstance, Voltadol should not be applied to the breasts of nursing mothers, nor elsewhere on large areas. of skin or for a prolonged period of time (see section 4.4).


04.7 Effects on ability to drive and use machines

The cutaneous application of topical diclofenac does not affect the ability to drive or use machines.


04.8 Undesirable effects

Adverse reactions (Table 1) are listed by frequency, most frequent first, using the following convention: common (≥ 1/100,

Table 1

Infections and infestations Very rare: Rash with pustules Disorders of the immune system Very rare: Hypersensitivity (including urticaria), angioneurotic edema, anaphylactoid reaction Respiratory, thoracic and mediastinal disorders Very rare: Asthma Skin and subcutaneous tissue disorders Common: Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), pruritus Rare: Bullous dermatitis (eg bullous erythema), dry skin, burning Very rare: Photosensitivity reaction General disorders and administration site conditions Common: Administration site reactions

The use of the product in combination with other drugs containing diclofenac can give rise to skin reactions with severe evolution (Stevens-Johnson syndrome, Lyell syndrome).

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.


04.9 Overdose

There have been no reports of overdose with Diclofenac medicated plasters.

However, undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 pack of 10 patches contains 1400 mg diclofenac sodium). If systemic side effects occur due to incorrect use or accidental overdose (eg in children) with the product, general therapeutic supportive measures are recommended to be taken in case of intoxication with non-steroidal anti-inflammatory drugs. Gastric decontamination and the use of activated charcoal must be considered, especially within a short time of ingestion.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: non-steroidal anti-inflammatory drugs for topical use.

ATC code: M02AA15.

Diclofenac belongs to the therapeutic category of non-steroidal anti-inflammatory drugs (NSAIDs): it has a marked anti-inflammatory, analgesic and antipyretic action, and is indicated for the symptomatic treatment of clinical pictures that benefit from a combined analgesic and anti-inflammatory action.

The action of diclofenac is expressed partly through the inhibition of prostaglandin synthesis and partly through the inhibition of lysosomal enzymes.

The form of medicated plaster, created in order to facilitate the absorption of the active principle at the level of the diseased area, induces the rapid appearance of the pharmacological actions characteristic of diclofenac: anti-inflammatory, anti-edema, analgesic action.


05.2 "Pharmacokinetic properties

Percutaneous absorption of diclofenac after a single application of VOLTADOL medicated plaster produces detectable plasma levels with a peak concentration of 4.98 ± 2.51 ng / ml. The Tmax is 11.73 ± 2.57 h with a latency time of about 4 h (4.41 ± 1.71 h).


05.3 Preclinical safety data

Toxicity studies conducted on animals by oral and / or parenteral administration have shown for diclofenac the same side effects found in humans with the most common undesirable effect represented by gastrointestinal disorders.

Topical treatments performed with VOLTADOL on guinea pigs and rabbits, as part of the tolerability assessments, did not show any side effects after single and / or repeated administration (28 days).

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Basic butyl methacrylate copolymer; acrylate-vinyl acetate copolymer; polyethylene glycol 12 stearate; sorbitan oleate; Non-woven fabric; Silicone paper.


06.2 Incompatibility

Not relevant.


06.3 Period of validity

3 years, in intact packaging.


06.4 Special precautions for storage

Do not store above 30 ° C.


06.5 Nature of the immediate packaging and contents of the package

Carton containing heat-sealed paper / aluminum / ethylene-acrylic acid copolymer bag: each patch is packed in a single bag.

Packs of 5, 10 and 15 patches.

Not all pack sizes may be marketed.


06.6 Instructions for use and handling

Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

07.0 MARKETING AUTHORIZATION HOLDER

GlaxoSmithKline Consumer Healthcare S.p.A. Via Zambeletti s.n.c. Baranzate (MI)

08.0 MARKETING AUTHORIZATION NUMBER

Voltadol 140 mg medicated plaster, 5 patches - A.I.C. n. 035520016

Voltadol 140 mg medicated plaster, 10 patches - A.I.C. n. 035520028

Voltadol 140 mg medicated plaster, 15 patches - A.I.C. n. 035520030

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Date of first authorization: June 2004

Latest renewal date: August 2009

10.0 DATE OF REVISION OF THE TEXT

02/2015

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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