Voltalgnan

Patient Information Leaflet

Voltalgan 3% Cutaneous Foam

diclofenac
Please read this leaflet carefully before using 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 to.

• 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.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

1. What Voltalgan is and what it is used for
2. What you need to know before using Voltalgan
3. How to use Voltalgan
4. Possible side effects
5. How to store Voltalgan
6. Package contents and other information

1. What Voltalgan is and what it is used for

Voltalgan contains the active substance diclofenac. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
Voltalgan 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 condition recurs repeatedly, or if you notice any recent change in its characteristics.

2. What you should know before using Voltalgan

Do not use Voltalgan

• if you are allergic to diclofenac, 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, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), you experienced an allergic reaction manifested by asthma (difficulty breathing due to inflammation and narrowing of the bronchi), angioedema (swelling of the face, lips, tongue, and/or throat with difficulty swallowing and/or breathing), urticaria (skin rash with itching), or acute rhinitis (runny nose due to acute inflammation of the nasal mucosa);
• if your skin has any type of lesion, such as exudative dermatitis (skin irritation with exudate, a fluid formed during inflammation), eczema (skin rash), infected lesions, burns, or wounds;
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if the patient is a child or adolescent under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Voltalgan.
Talk to your doctor before using Voltalgan:

• if you suffer or have suffered from asthma;
• if you suffer or have suffered from chronic bronchial obstructive diseases;
• if you suffer or have suffered from allergic rhinitis (nasal inflammation due to allergy);
• if you suffer or have suffered from inflammation of the nasal mucosa (nasal polyps), as you may be more likely than other patients to experience asthma attacks, local skin or mucosal inflammation (Quincke's edema), or urticaria.

Take particular care:

• do not swallow Voltalgan; wash your hands after use;
• do not apply Voltalgan to damaged, diseased, or open-wounded skin;
• avoid contact of Voltalgan with eyes or mucous membranes, such as the mouth. If this occurs, immediately rinse the area with running water and contact your doctor;
• if you are elderly and/or have stomach problems, do not use Voltalgan together with other anti-inflammatory medicines taken orally, by injection, or rectally;
• do not use Voltalgan under an occlusive dressing, i.e., covering the affected area with an airtight plastic film. You may, however, use Voltalgan with a gauze that allows air passage;
• prolonged use, particularly over long periods, of topical medicines may cause allergic reactions. If this occurs, stop treatment with Voltalgan and consult your doctor for appropriate therapy;
• avoid excessive exposure to sunlight during use of Voltalgan, as this will reduce the risk of sun-induced skin reactions;
• if you use diclofenac over large skin areas and for prolonged periods, you may experience undesirable effects affecting the whole body; do not exceed the recommended dose.

Stop treatment if you develop a skin rash after using Voltalgan.
If you use Voltalgan together with other medicines containing diclofenac, you may experience skin reactions, even serious ones (Stevens-Johnson syndrome, Lyell syndrome).
Children and adolescents
Voltalgan must not be used in children and adolescents under 14 years of age.
Other medicines and Voltalgan
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those without prescription.
After application to the skin, the amount of diclofenac that reaches the bloodstream is low.
However, during high-dose and prolonged treatments, interactions with other medicines cannot be ruled out.
Avoid using other medicines containing diclofenac or non-steroidal anti-inflammatory drugs (NSAIDs) taken orally, by injection, rectally, or applied to the skin.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Voltalgan during the last 3 months of pregnancy. Do not use Voltalgan during the first 6 months of pregnancy unless strictly necessary and under medical advice. If treatment is required 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 unborn child. It is not known whether the same risk applies with Voltalgan when used on the skin.
After application to the skin, the amount of diclofenac reaching the bloodstream is very low compared to oral intake. However, the following is recommended.
Conception, first and second trimesters of pregnancy
Do not use diclofenac during the first and second trimesters of pregnancy except when strictly necessary, as it may increase the risk of miscarriage and congenital malformations in the newborn (such as heart and abdominal organ defects). The risk increases if you take a higher dose of diclofenac or use it for a longer duration.
If you wish to become pregnant or are in the first or second trimester of pregnancy and need to use diclofenac, take the lowest possible dose for the shortest possible time.
Third trimester of pregnancy
Do not use diclofenac during the third trimester of pregnancy, as it may cause harm to the fetal heart, lungs, and kidneys. It may also prolong bleeding time in both mother and newborn, even at very low doses, and inhibit uterine contractions in the mother, leading to delayed or prolonged labor.
Breastfeeding
Diclofenac passes into breast milk in small amounts; however, no effects on the infant are expected when Voltalgan is used at recommended doses.
Do not use Voltalgan during breastfeeding unless you have first consulted your doctor.
If you are breastfeeding, do not apply Voltalgan to the breast, over large skin areas, or for prolonged periods.
Driving and using machines
Voltalgan does not impair the ability to drive vehicles or operate machinery.
Voltalgan contains 7.5 mg of benzyl alcohol per dose (equivalent to 1.5 grams by weight).
Benzyl alcohol may cause allergic reactions and mild local irritation.
Voltalgan contains a fragrance that itself contains limonene.
Limonene may cause allergic reactions.

3. How to use Voltalgan

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.

Use in adults and adolescents over 14 years of age
Apply Voltalgan 1 to 3 times daily, or as directed by your doctor.
Use Voltalgan on the skin only and for short periods of time.
Consult your doctor if symptoms do not improve within 7 days of starting treatment with Voltalgan or if you notice worsening of symptoms.

Use in children under 14 years of age
Voltalgan must not be used in children under 14 years of age.

Use in elderly patients
Elderly patients may use the doses recommended for adults.

How to use Voltalgan

• Shake the can well before use.
• Hold the can upside down and press the dispenser to release enough foam to treat the affected area—for example, a circular mass of foam 3–5 cm in diameter.
• Gently massage the area until the medicine is completely absorbed.

After application:

• Wipe your hands with absorbent paper and then wash them thoroughly to avoid the medicine acting on the hands (unless the hands themselves are the area being treated). If you accidentally apply too much foam, remove the excess with absorbent paper. The absorbent paper should be disposed of in household waste to prevent the product from entering wastewater. Allow the foam to dry for a few minutes on the skin before applying a non-occlusive dressing.

If you use more Voltalgan than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
Cases of overdose with Voltalgan have been reported, but no systemic adverse effects typically associated with oral NSAID overdose—such as vomiting, diarrhoea, dizziness, tinnitus (persistent perception of ringing in the ear), gastrointestinal and/or intestinal bleeding, or seizures—have been reported.
If you accidentally ingest the contents of the Voltalgan bottle, you may experience adverse effects similar to those observed after ingestion of an excessive dose of diclofenac tablets.

If you forget to use Voltalgan
Do not use a double dose to make up for the forgotten dose.

If you stop using Voltalgan
If you have any questions about how to use 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)

• various skin reactions such as irritation, redness, itching, peeling, swelling or blisters (dermatitis, eczema, erythema, rash).

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

• bullous dermatitis (skin inflammation with blister formation).

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

• allergic reactions including urticaria
• angioedema (swelling of the skin, tissues and mucous membranes, e.g. swelling of the face or tongue with difficulty in swallowing and/or breathing)
• skin rash with 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.

Side effects with unknown frequency:

• dry skin
• burning sensation at the site of application.

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Voltalgan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Store below 30°C.
Voltalgan contains a flammable propellant:

• pressurized container: may burst if heated. Do not pierce or burn, even after use.
• protect from sunlight. Do not expose to temperatures above 50°C;
• keep away from heat sources, sparks, open flames, and hot surfaces. Do not smoke;
• do not spray onto an open flame or other source of ignition.

Do not dispose of any medicine via 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 keep the medicine information available; therefore, retain both the carton and the package leaflet.

6. Contents of the pack and other information

What Voltalgan contains

• The active substance is diclofenac. 100 g of cutaneous foam contain 3 g of diclofenac.
• The other components are sodium hydroxide, caprylic/capric macrogol glycerides, hydrogenated soybean lecithin, polysorbate 80, benzyl alcohol, potassium sorbate, disodium phosphate dodecahydrate, all-rac-α-tocopheryl acetate, mint/eucalyptus fragrance, purified water.
• Each pressurised container (50 g) contains: 47.5 g of solution and 2.5 g of propellant (isobutane, n-butane, propane).

Description of the appearance of Voltalgan and contents of the pack
Voltalgan 3% cutaneous foam is a foam for application to the skin.
Each pack contains one pressurised 50 g container of 3% cutaneous foam.
Marketing Authorisation Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan
Manufacturer