Ivermectin stada
Poland
Table of Contents
Patient Information Leaflet
Ivermectin STADA, 10 mg/g, cream
Ivermectinum
Please read all of this leaflet carefully before using the medicine, because it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Ivermectin STADA is and what it is used for
- Important information before using Ivermectin STADA
- How to use Ivermectin STADA
- Possible side effects
- How to store Ivermectin STADA
- Contents of the pack and other information
1. What Ivermectin STADA is and what it is used for
Ivermectin STADA contains the active substance ivermectin, which belongs to a group of medicines called avermectins. This medicine is applied to the skin to treat inflammatory lesions (papules and pustules) associated with rosacea.
Ivermectin STADA may only be used in adults (aged 18 years or older).
2. Information before using Ivermectin STADA
When not to use Ivermectin STADA:
- 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 Ivermectin STADA, consult your doctor or pharmacist.
At the beginning of treatment, some patients may experience a worsening of rosacea symptoms; however, this is not common and usually resolves within the first week of treatment. If worsening of rosacea symptoms occurs, inform your doctor.
Ivermectin STADA and other medicines
Other medicines may affect the action of ivermectin cream; therefore, inform your doctor about all medicines currently used or recently used, as well as any medicines planned for future use.
Pregnancy and breastfeeding
Use of Ivermectin STADA is not recommended during pregnancy.
If the patient is breastfeeding, she should not use this medicine; alternatively, breastfeeding may be discontinued before starting treatment with this medicine.
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.
Ivermectin STADA 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 Ivermectin STADA
This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Important information: Ivermectin STADA is intended for topical use on the facial skin of adults only. This medicine should not be used 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 facial skin once daily. 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 apply cosmetics (such as other facial creams or makeup) before the daily application of this medicine. These products may be used after the applied cream has dried.
Wash your hands immediately after applying the cream.
Use Ivermectin STADA every day for the entire duration of treatment; the treatment course 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 skin lesions.
Improvement may be observed after 4 weeks of treatment. If there is no improvement 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 Ivermectin STADA.
Use in children and adolescents
Ivermectin STADA should not be used in children and adolescents.
How to open the tube with child-resistant cap
To avoid spilling the medicine, do not squeeze the tube when opening or closing it.
Press down on the cap and turn it counterclockwise (to the left). Then remove the cap.
How to close the tube with child-resistant cap
Press down on the cap and turn it clockwise (to the right).
Use of more than the recommended dose of Ivermectin STADA
If more than the recommended daily dose is used, contact your doctor for advice on what actions to take.
Missed dose of Ivermectin STADA
Do not use a double dose to make up for a missed dose.
Stopping use of Ivermectin STADA
Pimples and bumps will only begin to improve after several applications of this medicine. It is important to continue using Ivermectin STADA for as long as directed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this product may 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 your doctor)
Frequency unknown ( cannot be estimated from available data ):
- redness of the skin
- 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 to provide more information on the safety of the medicine.
5. How to store Ivermectin STADA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and tube after: EXP.
The expiry date refers to the last day of the stated month.
Shelf life after first opening the tube: 6 months.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the pack and other information
What Ivermectin STADA 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, macrogol cetostearyl ether, sorbitan stearate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), phenoxyethanol, propylene glycol, oleyl alcohol, sodium hydroxide, purified water.
What Ivermectin STADA looks like and contents of the pack
Ivermectin STADA is a cream, white to pale yellow in colour. It comes in a 45 g tube with a child-resistant closure, packed in a cardboard carton.
Pack size: 1 tube containing 45 g
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Kevaro Group EOOD
Tzaritza Elenora Str. 9
1618 Sofia
Bulgaria
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Poland
Tel. +48 22 737 79 20
This medicine is authorised in the European Economic Area countries under the following names:
Netherlands: Ivermectine CF 10 mg/g, cream
Germany: Ivermectin AL 10 mg/g Creme
Poland: Ivermectin STADA
Sweden: Ivermectin STADA