NOTICE
ANSM - Last updated: 04/04/2009
Name of the medicinal product
RUBOZINC 15 mg capsule
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
Review summary
In this notice :
1. WHAT IS RUBOZINC 15 mg, hard capsule AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE RUBOZINC 15 mg capsules?
3. HOW TO TAKE RUBOZINC 15 mg capsule?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE RUBOZINC 15 mg capsule?
6. ADDITIONAL INFORMATION
1. WHAT IS RUBOZINC 15 mg, hard capsule AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Therapeutic indications
This medicine is indicated in:
· Inflammatory acne of minor severity and mean,
· Acrodermatitis enteropathic.
2. BEFORE YOU TAKE RUBOZINC 15 mg capsules?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take RUBOZINC 15 mg capsule if:
· If you are allergic (hypersensitive) to wheat, due to the presence of wheat starch.
· If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with RUBOZINC 15 mg capsule:
Special warnings
This medication may be used for celiac disease. Wheat starch may contain gluten, but only trace, and is therefore considered safe for celiac disease.
The use of RUBOZINC is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Precautions for use
For better absorption of the product:
· the medication will be taken on an empty stomach or at a distance from meals.
NEVER LEAVE TO CHILDREN.
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - Breastfeeding
Pregnancy
This medication should only be used during pregnancy on the advice of your doctor.
If you are planning a pregnancy or are discovering that you are pregnant, consult your doctor as he alone can judge the need for further treatment while adapting it to your condition.
feeding
This medication may be used during breast-feeding.
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
List of excipients with known effect:: wheat starch, lactose.
3. HOW TO TAKE RUBOZINC 15 mg capsule?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
If you feel that the effect of RUBOZINC 15 mg capsule is too strong or too weak, talk to your doctor or pharmacist.
ORAL TRACK
Take away from 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.
RUBOZINC 15 mg may 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 per day.
IN ALL CASES COMPLY WITH THE ORDER OF YOUR DOCTOR STRICTLY
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, RUBOZINC 15 mg capsule is likely to have side effects, although not everyone is subject to it.
· During the treatment, it is possible that pains in the stomach and stomach occur; they are usually moderate and transient.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE RUBOZINC 15 mg capsule?
Keep out of the reach and sight of children.
Expiration date
Do not use RUBOZINC 15 mg capsule after the expiry date which is stated on the carton.
Storage conditions
No special storage conditions.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does RUBOZINC 15 mg capsules contain?
The active substance is:
Zinc Gluconate
Quantity corresponding to zinc metal ............................................. .................................................. ..... 15 mg
For a capsule.
The other components are:
Wheat starch, hydrated colloidal silica (Levilite), magnesium stearate, lactose.
Composition of the capsule shell : gelatin.
Pharmaceutical form and content
What is RUBOZINC 15 mg capsule and contents of the pack?
This medication is in the form of a capsule.
Box of 30 or 60 capsules.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
LABCATAL
7, rue Roger Salengro
BP 305
92541 MONTROUGE CEDEX
exploiting
LABCATAL
7, rue Roger Salengro
BP 305
92541 Montrouge Cedex
Maker
LABCATAL
Industrial area of Mont Blanc
1 rue de l'Industrie
74106 ANNEMASSE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.