NOTICE
ANSM - Updated: 07/10/2009
Name of the drug
HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops
Framed
Please read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions, if you have any doubts, 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, ask your pharmacist.
· If symptoms worsen or persist, see your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the side effects listed as serious, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. WHAT IS HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops AND WHAT CASES IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops?
3. HOW TO TAKE HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral drops solution?
6. ADDITIONAL INFORMATION
1. WHAT IS HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
VITAMINS
(A: digestive system and metabolism)
Therapeutic indications
This medication is indicated to prevent or treat disorders related to a deficient or unbalanced diet.
2. WHAT YOU NEED TO KNOW BEFORE TAKING HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops?
List of information needed before taking the drug
Not applicable.
Contraindications
Never take HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops in the following cases:
· history of allergy to one of the constituents,
· fat absorption disorders,
· chronic malabsorption,
· associated therapy interfering with the absorption of vitamin A.
· hypercalcaemia (abnormally high level of calcium in the blood),
· hypercalciuria (abnormally high level of calcium in the urine),
· Calcium lithiasis (kidney stone).
· in combination with levodopa.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral drops:
Special warnings
Vitamins A and D are present in many medicines. Vitamin D is also present in many baby milks. Avoid combining them with this medication because an overdose of vitamin A or D is likely to cause serious side effects, especially in infants. Follow the dosage and duration of treatment recommended by the doctor. |
Precautions for use
In the event of additional calcium intake, consult your doctor.
All the needs in mineral salts and vitamins are covered by a balanced and diversified diet with traditional staple foods (fruits, vegetables, meat, eggs, fish, cereals, dairy products). Your doctor can help you establish a balanced diet that is right for you. |
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with other drugs
Taking or using other medicines
This drug is contraindicated in combination with levodopa.
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 drink
Not applicable.
Interactions with phytotherapy products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
In the event of a deficiency confirmed by your doctor , this medication may be prescribed during pregnancy.
Avoid the administration of this drug during breast-feeding because of the risk of side effect in the infant.
Ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect: butylhydroxyanisole, butylhydroxytoluene, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), polyoxyethylene 40 hydrogenated castor oil, propylene glycol.
3. HOW TO TAKE HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops?
Instructions for proper use
Not applicable.
Dosage, Method and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Adult, adolescent:
25 drops per day.
Child from 4 to 12 years old:
20 drops per day.
Child from 1 to 3 years old:
15 drops per day.
This specialty is not suitable for infants under 1 year old.
Administration mode
Oral route.
The drops can be diluted in water, milk or fruit juice, ensuring that all of the liquid is absorbed.
Duration of the treatment
Follow the dosage and duration of treatment recommended by the doctor.
Symptoms and instructions for overdose
Not applicable.
Instructions for missing one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral drops, solution can cause side effects, although not everybody gets them.
If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
5. HOW TO STORE HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral drops solution?
Keep out of the reach and sight of children.
Expiration date
Do not use HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral solution in drops after the expiry date stated on the bottle.
Storage conditions
Store at a temperature below 25 ° C.
If necessary, warnings against certain visible signs of deterioration
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with any unused medicine. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT contain, oral solution in drops?
The active substances are:
Synthetic vitamin A (concentrate of) oily form * ........................................ .......................... 250,000 IU
Ergocalciferol (vitamin D 2 ) ............................................ .................................................. ............... 50,000 IU
α Tocopherol (acetate) (vitamin E) ....................................... .................................................. ........ 100 mg
Thiamine hydrochloride (vitamin B 1 ) ........................................ .................................................. .. 100 mg
Pyridoxine (hydrochloride) (vitamin B 6 ) ........................................ .................................................. . 100 mg
Riboflavin (sodium phosphate) (vitamin B 2 ) ....................................... ............................................. 75 mg
Nicotinamide (vitamin PP) ............................................. .................................................. ................ 500 mg
Ascorbic acid (vitamin C) ............................................ .................................................. ............ 2500 mg
Dexpanthenol (vitamin B 5 ) ............................................ .................................................. .................. 200 mg
For 100 ml of oral solution.
* In the form of vitamin A palmitate stabilized with butylhydroxyanisole (9 mg / 1 g) and butylhydroxytoluene (9 mg / 1 g).
15 drops (0.6 ml) = 1500 IU of vitamin A and 300 IU of vitamin D.
20 drops (0.8 ml) = 2000 IU of vitamin A and 400 IU of vitamin D.
25 drops (1 ml) = 2500 IU of vitamin A and 500 IU of vitamin D.
The other ingredients are:
Peanut oil, glycerol, propylene glycol, polyoxyethylenated hydrogenated castor oil 40, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 21.6), sodium saccharin, strawberry flavor, TETRAROME orange 987431, sodium hydroxide or hydrochloric acid, water purified.
Pharmaceutical form and content
What is HYDROSOL POLYVITAMINE PHARMADEVELOPPEMENT, oral drops solution and contents of the outer packaging?
This medication is in the form of an oral drops solution. 20 ml bottle.
Name and address of the marketing authorization holder and the manufacturing authorization holder responsible for batch release, if different
Holder
PHARMA DEVELOPPEMENT SA
MARCY'S WAY
58800 CORBIGNY
Operator
PHARMA DEVELOPMENT
MARCY'S WAY
INDUSTRIAL ZONE
58800 CORBIGNY
Maker
CENEXI
52, RUE MARCEL ET JACQUES GAUCHER
94122 FONTENAY-SOUS-BOIS
or
PHARMA DEVELOPMENT
INDUSTRIAL ZONE, CHEMIN DE MARCY
58800 CORBIGNY
or
BAYER FAMILY HEALTH
33, RUE L'INDUSTRIE
74240 GAILLARD
or
BAYER FAMILY HEALTH
ZI NORD
RUE DU CHAMPS DU GARE
69400 HARNAS
Names of the drug in the Member States of the European Economic Area
Not applicable.
Record approval date
The last date this leaflet was approved is {date}.
Marketing Authorization under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medication is available on the Afssaps (France) website.
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.