NOTICE
ANSM - Updated: 23/05/2017
Name of the drug
EFFIZINC 15 mg hard capsule
Zinc
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. WHAT IS EFFIZINC 15 mg capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE EFFIZINC 15 mg capsule?
3. HOW TO TAKE EFFIZINC 15 mg, capsule?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE EFFIZINC 15 mg, capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS EFFIZINC 15 mg capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
This medicine is indicated in:
· Inflammatory acne of minor and medium severity.
· Acrodermatitis enteropathic.
2. BEFORE YOU TAKE EFFIZINC 15 mg capsule?
List of information needed before taking the medication
Not applicable.
Cons-indications
Not applicable.
Precautions for use; special warnings
Take special care with EFFIZINC 15 mg capsule:
Precautions for use
For better absorption of the product:
· the drug will be taken on an empty stomach or away from meals.
Interactions with other drugs
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Pregnancy
This medicine should be used during pregnancy only on the advice of your doctor.
If you are planning to become pregnant or if you discover that you are pregnant, consult your doctor because only he can judge the need to continue the treatment, while adapting it to your condition.
Ask your doctor or pharmacist for advice before taking any medicine.
feeding
This medicine can be used during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO TAKE EFFIZINC 15 mg, capsule?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
If you have the impression that the effect of EFFIZINC 15 mg capsule is too strong or too weak, talk to your doctor or pharmacist.
ORAL WAY, to take away meals.
Acne:
· The usual daily dose is 2 capsules in a single dose in the morning on an empty stomach or at a distance from meals with a glass of water.
· This dosage of 2 capsules per day is maintained for 3 months, then reduced to 1 capsule per day.
Solar exhibition:
EFFIZINC 15 mg capsule can be used during sun exposure.
Acrodermatitis enteropathic:
· The daily dosage to be respected, at least until puberty, is 1 capsule.
· At the time of puberty, it may be necessary to increase the dosage to 2 capsules daily.
Symptoms and instructions in case of overdose
If you take more EFFIZINC 15 mg capsule than you should:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take EFFIZINC 15 mg, capsule:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, EFFIZINC 15 mg hard capsules can cause side effects, although not everybody gets them.
Like all medicines, EFFIZINC 15 mg hard capsules can cause side effects, although not everybody gets them, such as:
· Stomach and stomach pains are usually mild and transient.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE EFFIZINC 15 mg, capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use EFFIZINC 15 mg capsule after the expiry date which is stated on the carton.
Storage conditions
There are no special precautions for storage.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away at the sewer or with household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does EFFIZINC 15 mg capsule contain?
The active substance is:
Zinc ................................................. .................................................. ........................................... 15.00 mg
In the form of zinc gluconate ............................................ .................................................. .... 104.55 mg
For a capsule.
The other ingredients are: potato starch, mannitol, anhydrous colloidal silica, magnesium stearate.
Composition of the capsule shell : gelatin, titanium dioxide (E171).
Pharmaceutical form and content
What is EFFIZINC 15 mg, capsule and contents of the pack?
This medicine comes in capsule form. Box of 14, 15, 28, 30, 56 or 60 capsules.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
EXPANSCIENCE LABORATORIES
1 SEASON PLACE
92048 PARIS THE DEFENSE CEDEX
exploiting
EXPANSCIENCE LABORATORIES
1 SEASON PLACE
92048 PARIS THE DEFENSE CEDEX
Maker
MACORS LABORATORIES
ZI PLAIN ISLES
RUE DES CAILLOTTES
89000 AUXERRE
or
EXPANSCIENCE Laboratories
RUE DES FOUR GIRLS
28230 EPERNON
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.