Patient Information Leaflet: Information For The User
Patient Information Leaflet
Read all of this leaflet carefully before you starts giving this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, healthcare provider or pharmacist.
This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If your child gets side effects and they become serious, or if you notice any side effects not in this leaflet, please tell your doctor, healthcare provider or pharmacist.
What is in this leaflet
What Zincace Syrup is and what it is used for
Before you give Zincace syrup
How to take Zincace Syrup
Possible side effects
How to store Zincace syrup
Contents of pack and other information
1. What is Zincace syrup and what it is used for
Zincace syrup contains zinc. This is an essential mineral (a so-called trace element) important for many different processes in the body, e.g. for the patient's ability to fight infection. Zinc is an essential trace element involved in many enzyme systems. Severe deficiency causes skin lesion, alopecia, increased susceptibility to infections and failure to thrive in children. Also, it has been shown to block the growth of diarrhoea causing bacteria.
Zincace syrup is used for the treatment of acute and persistent diarrhoea (loose stools) in infants and children as an adjunct to oral rehydration.
2. Before giving Zincace Syrup
Do not take Zincace Syrup if you
if you are allergic (hypersensitive) to zinc or to any of the components of the formulation.
if you have copper deficiency
Talk to your doctor if this applies to you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Zincace Syrup if you suffer from kidney disease.
If this applies to you it is important that you tell your doctor or pharmacist before taking Zincace syrup and they will decide what to do. It may still be safe for you to take syrup.
Take special care with Zincace syrup
Check with your doctor, healthcare provider or pharmacist before giving Zincace syrup if the child is taking:
Penicillamine (used to treat rheumatism and Wilson's disease, Cystinuria)
Sodium valproate (used to treat seizures) or
Ethambutol (used to treat tuberculosis)
Taking other medicines
Please tell your doctor, healthcare provider or pharmacist if the child is taking or has recently taken any other medicines, including medicines obtained without a prescription, vitamins and herbal medicines.
Tell your doctor, healthcare provider or pharmacist if the child is taking:
Certain antibiotics (medicines to treat bacterial infections): tetracyclines, quinolones, cephalexin or ceftibuten.
Zinc may interfere with the uptake of these medicines. Therefore, an interval of at least three hours should be allowed between intake of zinc and any of these medicines.
Keep a list of all the medicines the child takes. Show this list to your doctor, healthcare provider or pharmacist before you start to give a new medicine like Zincace syrup.
Giving Zincace syrup with food and drink Zincace syrup should be given between meals.
Pregnancy and breast-feeding Zinc has been shown to cross the placenta and is present in breast milk in females taking zinc supplements. Only take this product during pregnancy or while breast-feeding if your doctor has advised you to do so.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines Zincace syrup is not expected to have any effect on the ability to drive and use machines.
3. How to take Zincace Syrup?
Always give Zincace syrup exactly as your doctor has told you.
How much to give:
Children less than 6 months old: 2.5ml (10mg) daily for 10 to 14 days
Children 6 months to 5 years old: 5ml (20mg) daily for 10 to 14 days
Giving Zincace syrup
It is recommended you give the doses between meals.
If the child vomits within 30 minutes of taking the dose, give another dose. If in doubt, talk to your doctor or healthcare provider.
If you give more Zincace than you should If you accidentally give too many tablets, talk to your doctor or healthcare provider at once, or go to your nearest emergency unit. The child may require medical attention.
Remember to take the medicine with you and show it to the doctor or the staff of the emergency unit. If you have run out of tablets, take the empty packaging along with you.
If you forget to give Zincace syrup Try not to miss any doses. If you do miss one, give it as soon as you remember, unless the next dose is due in less than 6 hours.
Do not give the missed dose, if the scheduled next dose is due in less than 6 hours.
If you stop giving Zincace syrup Do not stop giving the medicine unless your doctor or healthcare provider tells you to. Always follow the instructions carefully, and complete the course of medication.
If you have any further questions on the use of this product, ask your doctor, healthcare provider or pharmacist.
4. Possible Side Effects
Like all medicines, Zincace can cause side effects, although not everybody gets them.
The most commonly reported side effects (greater than 1 in 10 patients treated)
Vomiting, Regurgitation
In most cases vomiting or regurgitation occurred shortly after administration of the first dose (within 10 min) and was not recurrent.
Frequency not known (estimates are not available):
Stomach pain, Dyspepsia
Reporting of side effects If you get any side effects, talk to your doctor, healthcare provider or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How Zincace is stored ?
Keep out of the reach and sight of children
Do not store above 30°C. Store in the original bottle to protect from moisture.
Do not use Zincace syrup after the expiry date which is stated on the bottle and carton unit. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Zincace syrup contains:
The active substance is zinc (as acetate salt) 20mg per 5 ml of syrup
What Zincace Syrup looks like and contents of pack Amber-coloured bottle of 100 mL with measuring cap
Marketing Authorization Holder
Zorvia Healthcare Limited Suite 4, 10th Floor, Centaurus, Central Avenue, Hiranandani Estate, Ghodbunder Road, Thane West, Maharashtra, India—400607.
