French pharmacy
The non-prescription drug Rubozinc 15 mg is indicated for the treatment of inflammatory acne of minor and moderate severity and enteropathic acrodermatitis.
For warnings, precautions for use and contraindications, please consult the instructions for use.
Acne is manifested by the presence of comedones and pimples. There are different forms of acne. It can first of all result in the appearance of simple comedones (blackheads and whiteheads). We are talking about retentional acne. But acne can also be accompanied by pimples and larger lesions. In an oxygen-deprived environment, a bacteria naturally present in the skin (called P. acnes) can proliferate and create inflammatory substances which spread to the underlying layers of the skin: this is called inflammatory acne .
Enteropathic acrodermatitis is an inherited disease of metabolism. It leads to a severe deficit in zinc following a defect of its absorption at the level of the intestinal mucosa.
Rubozinc 15 mg is indicated for:
Inflammatory acne manifests as very red, very tender, prominent pimples that may be filled with pus or turn into cysts. They are spread all over the face, neckline, shoulders, back, and are very numerous. The skin is inflamed, shiny from the excessive secretion of sebum, and mild acne treatments do not help.
Enteropathic acrodermatitis is a serious and rare disease affecting young people, caused by a lack of absorption of zinc.
This pathology is characterized by the association of the eruption of pustules (crusts of pus) appearing mainly around natural openings (mouth, nostrils, anus, etc.), hands and soles of the feet, hair loss, inguinal involvement (nails), diarrhea, all associated with a deterioration of the general condition and growth retardation.
Oral use, to be taken away from meals.
Inflammatory acne : The usual daily dose is 2 capsules of the non-prescription drug Rubozinc taken in the morning on an empty stomach or between 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 hard capsule can be used during sun exposure.
Acrodermatitis enteropathique : The daily dosage to be observed, at least until puberty, is 1 capsule of Rubozinc.
At the time of puberty it may be necessary to increase the dosage to 2 capsules daily.
In any case, strictly comply with your doctor's prescription
Active substance : zinc gluconate (corresponding amount of zinc: 15 mg for one capsule)
Other ingredients : wheat starch, hydrated colloidal silica, magnesium stearate, lactose
Composition of the capsule shell : gelatin, titanium dioxide
Excipients with known effect : wheat starch, lactose
In case of doubt, it is essential to seek the advice of your doctor or pharmacist.
Read the instructions carefully.
Box of 60 capsules.
Hormonal acne can be treated locally if it is mild or moderate. The treatment usually comes in the form of a cream, gel or lotion . The most common acne treatments may contain benzoyl peroxide, a retinoid, azelaic acid, and sometimes zinc. In particular, you can use Rubozinc capsules as advised by your doctor to treat inflammatory acne.
Tips to treat your acne:
There are different treatments depending on your acne situation. However, you can reduce your acne breakouts and improve the appearance of your skin by adopting certain reflexes:
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 04/04/2009
RUBOZINC 15 mg capsule
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.
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?
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.
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.
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?
Not applicable.
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.
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.
Do not use RUBOZINC 15 mg capsule after the expiry date which is stated on the carton.
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.
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.
LABCATAL
7, rue Roger Salengro
BP 305
92541 MONTROUGE CEDEX
LABCATAL
7, rue Roger Salengro
BP 305
92541 Montrouge Cedex
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.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
Mineral supplement: zinc
zinc
. Presentations . Composition . Indications . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
RUBOZINC: capsule (white); box of 30.
Refunded at 30%. - price: 4,49 euro (s).
RUBOZINC: capsule (white); box of 60.
Refunded at 30%. - price: 7,22 euro (s).
Laboratory Labcatal
| p gel | |
| Zinc gluconate expressed as Zinc | 15 mg |
| Wheat starch (trace gluten) | + |
| Lactose | + |
Usual dosage:
Treatment of acne : 2 capsules per day, in a single dose, for 3 months; then 1 capsule per day as prescribed by the doctor.
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