Adrigyl 10 000 IU/ml - Oral Solution Drops - Cholecalciferol or vitamin D3 - 10ml

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Please read this leaflet carefully before taking this medicine as it contains important information for you. You must always take this medicine exactly as instructed in this leaflet or by your doctor, pharmacist or nurse. - Keep this leaflet. You may need to read it again. - Ask your pharmacist for any advice or information. - If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. What is ADRIGYL 10 000 IU/ml, Oral Solution Drops and what is it used for? What should you know before taking ADRIGYL 10 000 IU/ml, Oral Solution Drops? How should you take ADRIGYL 10 000 IU/ml, Oral Solution Drops? What are the possible side-effects? How should ADRIGYL 10 000 IU/ml, Oral Solution Drops be stored?

1. WHAT IS ADRIGYL 10 000 IU/ml, Oral Solution in drops AND WHAT IS IT USED FOR?

Pharmacotherapeutic class VITAMIN D (A: Digestive system and metabolism)

Therapeutic indications

This medicine is indicated for the treatment and/or prevention of vitamin D deficiency.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ADRIGYL 10 000 IU/ml, Oral Solution in drops

List of information needed before taking the medicine Not applicable.

Contraindications

Never take ADRIGYL 10 000 IU/ml, Oral Solution in drops in the following cases: - if you are allergic to the active substance or to any of the other components of this medicinal product mentioned in section 6; - in case of hypercalcaemia (increase in the level of calcium in the blood), hypercalciuria (increase in the level of calcium in the urine) or calcium lithiasis (kidney stones); - in case of illness that may lead to hypercalcaemia or hypercalciuria; - in case of hypervitaminosis D.

Precautions for use; special warnings

Warnings and precautions for use In order to avoid an overdose of vitamin D, respect the dosage and inform your doctor and take into account the total doses of vitamin D in case of association with a treatment already containing this vitamin or in case of use of milk supplemented with vitamin D. If repeated high doses of vitamin D are given, or if combined with high doses of calcium, it is necessary to monitor the calcium level in the blood and urine. Interactions with other medicines Taking or using other medicines: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Interactions with food and drink Not applicable. Interactions with herbal products or alternative therapies Not applicable. Use during pregnancy and lactation Pregnancy and lactation If necessary, this medicine may be prescribed during pregnancy or lactation. However, this supplementation does not replace the administration of vitamin D to the newborn. Ask your doctor or pharmacist for advice before taking any medicine. Sportsmen Not applicable. Effects on ability to drive and use machines The effects on the ability to drive and use machines have not been studied. List of excipients with a known effect Not applicable.

3. HOW TO TAKE ADRIGYL 10 000 IU/ml, Oral Solution in drops

Instructions for proper use Not applicable. Posology, Method and/or route(s) of administration, Frequency of administration and Duration of treatment Posology - Vitamin deficiency in children o Prevention Its implementation is recommended in all infants and young children, in the current conditions of life in case of insufficient exposure to sunlight (ministerial circulars of 21 February 1963 and 6 January 1971) due to the low content of vitamin D in food. § premature babies: 3 to 4 drops per day § 0 to 24 months: with vitamin D-enriched milk: 2 to 3 drops per day without vitamin D-enriched milk: 3 to 5 drops per day with pigmented skin: 7 drops per day § children - adolescents: without digestive pathology: 2 to 3 drops per day with digestive pathology: 2 to 6 drops per day receiving anti-seizure medication: 4 to 6 drops per day o Treatment 6 to 12 drops per day for 4-6 months or 12 to 24 drops per day for 1-2 months. - Vitamin deficiency in pregnant women o Prevention 3 drops per day from the 6th or 7th month. - Vitamin deficiency in adults and the elderly o Prevention 2 to 3 drops per day o Treatment 6 to 60 drops per day. Method of administration Oral use. Pour the drops into a small spoon. The drops can be taken pure or mixed in a liquid or semi-liquid food. Do not heat or boil, or put in food that is too hot. It is preferable not to put the drops in a bottle of water or milk, as the product may settle on the wall. Symptoms and instructions in case of overdose If you have taken more ADRIGYL 10 000 IU/ml, Oral Solution Drops than you should have: Clinical signs of overdose are: - headache, fatigue, loss of appetite, weight loss, failure to thrive; - nausea, vomiting; - profuse urination, intense thirst, dehydration; - kidney stones, calcifications of tissues, especially of the kidney and vessels; - renal failure (failure of kidney function) The biological signs of overdose are: - increased calcium levels in the blood and urine and increased phosphorus levels in the blood and urine. In the event of an overdose, treatment should be stopped, plenty of fluids should be taken, calcium intake should be limited (milk) and a doctor should be consulted. Instructions in case of missed dose(s) Do not take a double dose to make up for the one you have missed. Risk of withdrawal syndrome Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects Like all medicines, this medicine can cause side effects, but they do not occur systematically in everyone. The following side effects have been reported very rarely and particularly in cases of overdose: - hypersensitivity reaction, hypercalcaemia, hypercalciuria, calcium lithiasis. Reporting side effects If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr. By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.

5. Composition

Cholecalciferol (Vitamin D3) (1) 1000000 IU/100 ml.

Excipients : Butylated hydroxytoluene, Saccharin, Sorbic acid, Lemon essential oil, Unsaturated polyglycolysed glycerides.