Package leaflet: Information for the user

VoltaFlex cream

Herbal preparation based on comfrey
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 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, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3–4 days.

Contents of this leaflet:

What VoltaFlex is and what it is used for
What you need to know before using VoltaFlex
How to use VoltaFlex
Possible side effects
How to store VoltaFlex
Contents of the pack and other information

1. What VoltaFlex is and what it is used for

Traditional herbal medicinal product of plant origin used for topical treatment of bruises (bruises, sprains,
sports- and accident-related injuries, muscular and joint pain).
Traditional herbal medicinal product of plant origin intended for use in the specified indication based solely
on long-standing use experience.
VoltaFlex is used in adults and adolescents aged 12 years and older.
Consult a doctor if you do not feel better or if you feel worse after 3–4 days.

2. What you need to know before using VoltaFlex

Do not use VoltaFlex

if you are allergic to comfrey herb or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using VoltaFlex.
Do not apply on damaged or irritated skin.
Avoid contact with eyes or mucous membranes. Wash your hands before and also after use, unless the area to be treated is the hands.
Children
The use of this medicine in children under 12 years of age has not been established due to lack of adequate data.
Other medicines and VoltaFlex
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interaction studies have been conducted.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Due to insufficient data, use during pregnancy and breastfeeding is not recommended.
Driving and using machines
No studies have been conducted to evaluate the effects on the ability to drive vehicles or operate machinery.
VoltaFlex contains sorbic acid, propylene glycol, ethanol, and fragrances containing allergens.
Sorbic acid may cause localized skin reactions (e.g., contact dermatitis).
This medicine contains 40 - 60 mg of propylene glycol per dose and fragrances containing citral, citronellol, eugenol, d-limonene, linalool, and geraniol which may cause allergic reactions.
This medicine contains approximately 59 mg of alcohol (ethanol) per gram, equivalent to about 7.4% (V/V). It may cause a burning sensation on damaged skin.

3. How to use VoltaFlex

Use this medicine exactly as stated 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:
Adults and adolescents aged 12 years and older:
Unless otherwise prescribed by a doctor, apply a layer of cream approximately 2–3 cm long (equivalent to 1.0–1.5 g of cream) to the affected area 2–3 times daily.

Use in children
VoltaFlex is not recommended for use in children under 12 years of age.

Method of administration
For topical use only.
VoltaFlex is suitable for ointment dressing.

Duration of use
This medicine should not be used for longer than 2 weeks.
If symptoms worsen or do not improve after 3–4 days of treatment, consult a doctor, pharmacist, or qualified healthcare professional.

If you use more VoltaFlex than you should
No cases of overdose have been reported.

If you forget to use VoltaFlex
Do not apply a double dose to make up for the missed dose.

If you have any doubts 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.
In very rare cases (may affect up to 1 in 10,000 people), erythema (redness of the skin) may occur.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 VoltaFlex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and the carton after "Exp.".
The expiry date refers to the last day of that month.
No special storage conditions are required for the unopened medicine.
Period of validity after first opening: 1 year. Do not store above 25 °C after first opening of the container.
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.

6. Contents of the package and other information

What VoltaFlex contains
The active substance is: herbal preparation based on comfrey.
1 g of cream contains 0.10 g of herbal preparation based on comfrey (Symphytum x uplandicum),
(0.5 – 0.7:1), composed of:
0.04 g of liquid extract of the plant Symphytum x uplandicum (comfrey) (1.2 – 1.5:1), extraction solvent:
water;
0.06 g of liquid extract of the press residue after aqueous extraction of the plant Symphytum x uplandicum,
(comfrey) (0.7 – 1.1:1), extraction solvent: ethanol 30% (V/V).
The other excipients are: hydroxyethyl salicylate, sorbic acid (E200), purified water, macrogol 20 glycerol
monostearate, glycerol monostearate 40-55, isopropyl myristate, ethanol 96% (V/V) (total ethanol content approximately 7.4% (V/V)), octyldodecanol, propylene glycol (E1520), all-rac-α-tocopheryl acetate,
dimethicone (100 cst), rosemary oil, fir needle oil.

Description of the appearance of VoltaFlex and contents of the package
Cream ranging from white to beige.
VoltaFlex is available in tubes containing 20 g, 50 g, 100 g or 150 g of cream.
It is possible that not all pack sizes are marketed.

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Flexivert Schmerzcreme
Bulgaria Флексиверт крем
Croatia Dr. Theiss gavezova krema
Italy VoltaFlex
Lithuania Provami kremas
Romania Flexivert cremă
Czech Republic Kostival Dr. Theiss
Slovakia Flexivert
Slovenia Flexivert
Hungary Flexivert krém

[Note: This printed material includes the modification of the Marketing Authorisation Holder and the name change - AT/H/1336/001/IB/002 - submitted in parallel]