Ointment for pressure sores gemi
Poland
Table of Contents
Package leaflet: Information for the patient
CALLOSOFT CREAM
500 mg/g, cream
Salicylic acid
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed
by the doctor or pharmacist.
- Keep this leaflet, so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement or if you feel worse, consult your doctor.
Leaflet contents
- What Callosoft Cream is and what it is used for
- Important information before use of Callosoft Cream
- How to use Callosoft Cream
- Possible side effects
- How to store Callosoft Cream
- Contents of the pack and other information
1. What Callosoft Cream is and what it is used for
Callosoft Cream is a topical medicine. When applied to the thickened skin, it acts keratolytically (removes dead skin cells), softens and swells the thickened epidermis, facilitating its desquamation.
- This medicine is indicated for the removal of corns and calluses.
2. Information before using medicine M
When not to use medicine M:
- if the patient is allergic to the active substance, salicylates, or any of the other ingredients of this medicine (listed in section 6);
- in patients with diabetes or circulatory disorders;
- if the skin in the area of the corn (callus) is injured or inflamed;
- on deep or extensive lesions;
- in children.
Warnings and precautions
Before starting treatment with this medicine, discuss it with a doctor or pharmacist.
The medicine should be applied exclusively to the corn. Do not apply the medicine to unchanged, healthy skin,
or to damaged skin, as systemic adverse effects of salicylic acid may occur.
Treatment should be discontinued if symptoms of skin irritation or allergic reaction occur.
Avoid contact of the medicine with eyes and mucous membranes.
Children and adolescents
Do not use this medicine in children.
M with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use.
No data available.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
No data available on the safety of use during pregnancy and breastfeeding.
Driving and operating machinery
This medicine does not affect the ability to drive motor vehicles or operate mechanical equipment in motion.
3. How to use M
This medicine should always be used exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
For topical use only (on corns only).
Soak feet in soapy water and dry thoroughly. Hands must be washed thoroughly before and after applying this medicine.
Before use, gently warm the tube of ointment in the hands to soften it and facilitate application. Apply a thin layer of ointment to the corn and cover with a plaster. Repeat the procedure morning and night for several days, without washing the treated areas with water. Soak the feet in hot water, then remove or file down the corn. Do not cut or tear off corns.
If necessary, repeat the treatment after 3 days.
Incompletely removed corns may recur.
Children and adolescents
Do not use this medicine in children.
If you feel the effect of the medicine is too strong or too weak, consult a physician.
Use of more than the recommended dose of medicine M
No data available.
If more medicine is used than recommended, remove the excess ointment.
Missed dose of medicine M
Do not use a double dose to make up for a missed dose.
Discontinuation of medicine M
If you have any further questions about the use of this medicine, consult your physician or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Allergic reactions and skin inflammation may occur.
Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps increase information on the safety of this medicine.
5. How to store M
Keep the medicine out of sight and reach of children.
Store below 25°C in the original closed packaging.
Use within 1 year after first opening of the container.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
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 M contains
- The active substance in the ointment is salicylic acid. Each 1 g of ointment contains 500 mg of salicylic acid.
- The other ingredient (excipient) is a tincture of comfrey, containing: comfrey herb, rapeseed oil, yellow wax, and rosin.
What M looks like and contents of the pack
M is an ointment of greenish-yellow colour with a characteristic odour.
The medicinal product is packed in a polyethylene container containing 10 g of ointment, placed in a cardboard box.
Marketing authorization holder and manufacturer:
Gemipharma Sp. z o.o.
ul. Mickiewicza 36
05-480 Karczew
tel. 22 780 83 05 ext. 70
e-mail: [email protected]