Vesarco

Poland
Brand name Vesarco
Form cream
Active substance / Dosage
ivermectin · 10 mg/g
Prescription type Prescription only
ATC code
D11AX22
Registration number 100504599
Manufacturer KeVaRo Group EOOD Pharmadox Healthcare Limited STADA Arzneimittel AG

Table of Contents

Package leaflet: Information for the user

Vesarco, 10 mg/g, cream
Ivermectin
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
  • If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Vesarco is and what it is used for

Vesarco contains the active substance ivermectin, which belongs to a group of medicines called avermectins. The cream is applied to the skin to treat papules and pustules associated with rosacea.
Vesarco may only be used in adults (aged 18 years or older).

2. Important information before using Vesarco

When not to use Vesarco:

  • if the patient is allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Vesarco, discuss it with your doctor or pharmacist.
At the beginning of treatment, some patients may experience a worsening of symptoms of rosacea; however, this is not common and usually resolves within the first week of treatment. If worsening of rosacea symptoms occurs, inform your doctor.
Vesarco and other medicines
Other medicines may affect the action of ivermectin cream; therefore, you must tell your doctor about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Pregnancy and breastfeeding
Use of Vesarco is not recommended during pregnancy. If the patient is breastfeeding, she should not use this medicine; alternatively, breastfeeding may be interrupted before starting treatment with this medicine.
Please consult your doctor, who will help decide whether to use the medicine or to breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding.
Driving and operating machinery
This medicine has no effect or has a negligible effect on the ability to drive and operate machinery.
Vesarco contains:

  • cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis),
  • methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (delayed-type reactions possible).

3. How to use Vesarco

This medicine should always be used exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Important information: Vesarco is intended for topical use on the facial skin only in adults. Do not use this medicine on other parts of the body, especially moist surfaces such as eyes, mouth, or any mucous membranes. Do not swallow.
The recommended dose is one application to the face per day. Apply an amount of cream equivalent to a pea-sized portion to each of the five areas of the face: forehead, chin, nose, and each cheek. Then spread the cream evenly in a thin layer over the entire facial area.
Do not apply the cream near the eyelids, lips, or any mucous membranes, such as inside the nose, mouth, or eyes. If the cream accidentally gets into the eyes or around the eyes, eyelids, lips, mouth, or mucous membranes, rinse the area immediately with plenty of water.
Do not use cosmetics (such as other facial creams or makeup products) before the daily application of Vesarco. These products may be used after the applied cream has dried.
Wash your hands immediately after applying the cream.
Use Vesarco every day throughout the treatment period, and the treatment cycle may be repeated. Your doctor will inform you how long you should use this medicine. The duration of treatment may vary between individuals and depends on the severity of the skin condition.
Improvement may be observed after 4 weeks of treatment. If no improvement is seen after 3 months, discontinue use of ivermectin cream and consult your doctor.
Liver function disorders
If you have liver problems, consult your doctor before using Vesarco.
Use in children and adolescents
Do not use Vesarco in children and adolescents.
How to open the tube with child-resistant cap
To avoid spilling the medicine, do not squeeze the tube while opening or closing it.
Press down on the cap and turn it counterclockwise (to the left). Then remove the cap.

Two hands holding a cap at the end of a device, arrows indicate pressing and turning the cap to remove it

How to close the tube with child-resistant cap
Press down on the cap and turn it clockwise (to the right).

Two hands holding and turning a medical device cap counterclockwise as indicated by an arrow

Use of more than the recommended dose of Vesarco
If you use more than the recommended daily dose, contact your doctor for advice on what steps to take.
Missed dose of Vesarco
Do not use a double dose to make up for a missed dose.
Stopping use of Vesarco
Pimples and bumps will only gradually improve after several applications of this medicine. It is important to continue using Vesarco for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
This medicine may cause the following adverse reactions:
Common adverse reactions (may occur in up to 1 in 10 people):

  • burning sensation of the skin

Uncommon adverse reactions (may occur in up to 1 in 100 people):

  • skin irritation
  • skin itching
  • dry skin
  • worsening of rosacea symptoms (consult a doctor)

Adverse reactions with unknown frequency (cannot be estimated from available data):

  • skin redness
  • skin inflammation
  • facial swelling
  • increased liver enzyme activity (AlAT/AspAT)

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Vesarco

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube
after: EXP. The expiry date refers to the last day of the stated month.
Duration of use after first opening of the tube: 6 months.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help
protect the environment.

6. Contents of the pack and other information

What Vesarco contains

  • The active substance is ivermectin. One gram of cream contains 10 mg of ivermectin.
  • The other ingredients are: glycerol 85%, isopropyl palmitate, carbomer copolymer (type B), dimethicone, disodium edetate, citric acid monohydrate, cetyl alcohol, stearyl alcohol, cetostearyl alcohol polyether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide, purified water.

What Vesarco looks like and contents of the pack
Vesarco is a cream, white to pale yellow in colour. The medicine is supplied in tubes containing 45 g of cream.
Pack size: 1 tube
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
tel: +48 22 855 40 93
Manufacturer/Importer
Kevaro GROUP EOOD
Ulitsa Tsaritsa Eleonora 9, Office 23, Floor 5
1618 Sofia
Bulgaria
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
This medicine is authorised for sale in the European Economic Area under the following names:
Poland Vesarco
Sweden Ivermectin Aristo