Zinc oxide Sella
Italy
Table of Contents
Patient Information Leaflet: Information for the User
ZINCO OSSIDO SELLA 10% ointment
Zinc oxide
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more advice or information, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days.
Contents of this leaflet:
- What ZINCO OSSIDO SELLA is and what it is used for
- What you need to know before using ZINCO OSSIDO SELLA
- How to use ZINCO OSSIDO SELLA
- Possible side effects
- How to store ZINCO OSSIDO SELLA
- Contents of the pack and other information
1. What ZINCO OSSIDO SELLA is and what it is used for
ZINCO OSSIDO SELLA contains the active substance zinc oxide, which belongs to a group of medicines known as emollient protectives, used to relieve skin irritations.
ZINCO OSSIDO SELLA relieves skin irritations, such as eczema, dermatoses, and minor abrasions.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a few days of using the medicine.
2. What you need to know before using ZINCO OSSIDO SELLA
Do not use ZINCO OSSIDO SELLA
- if you are allergic to zinc oxide 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 ZINCO OSSIDO SELLA.
Use this medicine only on external body areas, as it may be harmful if swallowed or if it comes into contact with the eyes. In case of accidental contact with the eyes, rinse thoroughly with water.
Do not apply ZINCO OSSIDO SELLA to burns or wounds that may be infected.
Avoid prolonged use of this medicine, as it may cause irritation or allergic reactions. If this occurs, stop treatment and consult your doctor, who will advise appropriate therapy.
Children
If you are using this medicine to soothe your child’s skin irritation (diaper dermatitis), check that the irritation improves within a few days. If the dermatitis persists, consult your doctor, who will recommend appropriate treatment for your child.
Other medicines and ZINCO OSSIDO SELLA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions with other medicines are known.
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.
There are no available data regarding the use of ZINCO OSSIDO SELLA during pregnancy and breastfeeding. When used according to the instructions in the package leaflet, this medicine is not absorbed into the bloodstream or breast milk.
Driving and using machines
ZINCO OSSIDO SELLA does not affect the ability to drive or operate machinery.
ZINCO OSSIDO SELLA contains methylparaben
This medicine contains methylparaben, which may cause allergic reactions (including delayed reactions).
3. How to use ZINCO OSSIDO SELLA
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the ointment once or twice daily to clean, dry skin.
Apply a layer of ointment sufficient to cover the affected area completely.
In cases of burns and non-infected skin lesions, apply a thin layer of ointment and, if necessary, cover the area with a dressing.
Finally, perform a circular massage on the affected area to partially absorb the medicine. After the massage, a white, opaque residue will remain.
Use in children
ZINCO OSSIDO SELLA may also be used for irritations (dermatitis) caused by diapers (see section “Children”).
If you use more ZINCO OSSIDO SELLA than you should
Cases of overdose are not known. Symptoms of overdose may include diarrhea, nausea, vomiting, low blood sugar (hypoglycemia), confusion, fatigue, lethargy, bleeding, yellowing of the skin and mucous membranes due to liver problems (jaundice), dark urine, cough, chills, fever, mouth irritation, kidney problems, and decreased copper levels in the blood.
In case of accidental ingestion/intake of ZINCO OSSIDO SELLA, inform your doctor immediately or go to the nearest hospital.
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 will experience them.
The following adverse reactions may occur:
Frequency not known (frequency cannot be estimated from the available data)
- allergic reaction or hypersensitivity manifesting as skin irritation (rash, urticaria), itching and/or swelling (especially of the face, throat and lips), chest tightness, breathing difficulties, burning, tingling and dark spots on the skin.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects can help provide more information on the safety of this medicine.
5. How to store ZINCO OSSIDO SELLA
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 the container in the original packaging, tightly closed, to protect the medicine from light.
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 pack and other information
What ZINCO OSSIDO SELLA contains
- The active substance is zinc oxide. 100 g of ointment contain 10 g of zinc oxide.
- The other components are: white vaseline, liquid paraffin, methyl parahydroxybenzoate (E218).
Description of the appearance of ZINCO OSSIDO SELLA and contents of the pack
Ointment contained in a 30 g tube.
Marketing Authorization Holder and Manufacturer
Laboratorio Chimico Farmaceutico A. Sella s.r.l., Via Vicenza, 67 - 36015 Schio (VI) – Italy.