Important Carefully read all the information below before taking this medication. Keep this information, you may need to come back to it. If you have any other questions speak to your doctor or pharmacist. This medication has been individually prescribed. Do not give it to anyone else. It could be dangerous even if their symptoms are identical to yours. If you see any side effects appear, speak to your doctor or pharmacist. This also applied to any side effects not mentioned below. Summary In this information: 1. What is STEROGYL 2,000,000UI/100ml drinkable solution and when should it be taken? 2. What information is there to know before taking STEROGYL 2,000,000UI/100ml drinkable solution? 3. How do you take STEROGYL 2,000,000UI/100ml drinkable solution? 4. What are the possible side effects? 5. How do you store STEROGYL 2,000,000UI/100ml drinkable solution? 6. Extra information 1. What is STEROGYL 2,000,000UI/100ml drinkable solution and when should it be taken? Pharmaco-therapeutic class: VITAMIN D. (A: Digestive and metabolism device) Therapeutic Indications This medication contains vitamin D which makes the calcium fix onto the bones. It is the prevention and treatment of vitamin D deficiency. 2. What information is there to know before taking STEROGYL 2,000,000UI/100ml drinkable solution? Read all the information available before taking this medication. Not applicable. Contraindications Do not take STEROGYL 2,000,000UI/100ml drinkable solution in the following cases: · allergy to one of its components, · hypercalcemia (abnormally high level of calcium in the blood), · hypercalciuria (abnormally high level of calcium in the urine), · kidney stones. Precautions of use and warning Be careful when taking STEROGYL 2,000,000UI/100ml drinkable solution: Warning! This medication contains alcohol; the alcoholic strength of this syrup is 90% (v/v) (14g of alcohol per drop). To avoid a vitamin D overdose, keep the recommended dose and inform your doctor if you are already taking a medication containing this vitamin or milk containing vitamin D. In case of high and repeated doses of vitamin D/calcium it is recommended to monitor the level of calcium in the blood and urine. Interactions with other drugs Taking other medication: Consult your doctor or pharmacist if you take or have taken another drug, even if it was not a prescription drug. Interaction with food and drinks Not applicable. Interactions with phytotherapy or alternative therapy productss Not applicable. Pregnancy and breast feeding This medication can be prescribed during pregnancy and breast-feeding. Always respect the prescribed dosage by your doctor. Consult your doctor or pharmacist before taking any drugs. Sport Players Not applicable. Effects on the ability to drive and operate machinery The alcohol quantity contained in this medication can alter your ability to drive vehicles and use machinery. List of dilutants Important information concerning STEROGYL 2,000,000UI/100ml drinkable solution: Alcohol content. 3. How do you take STEROGYL 2,000,000UI/100ml drinkable solution? Instructions for correct use Not applicable. Dosage, How to use, Frequency & Length of Treatment Dosage: The normal doses are as follows: - Prevention For newborns having milk enriched with vitamin D: 1-2 drops per day. For newborns being breast-fed or not receiving milk enriched with vitamin D, and children under 5 years: 2-5 drops per day. Adolescents: 1-2 drops per day during winter. Pregnant women: 1-2 drops per day during the last trimester of pregnancy, when the last trimester falls in winter or when not exposed to sunlight. Women who breast-feed: 1-2 drops per day during winter or no sun exposure. Elderly patients: 1-5 drops per day. In case of digestive pathology, renal insufficiency, anti-convulsion treatment or other conditions: follow the medical prescription. - Treatment for deficiency: 5-10 drops per day for 3-6 months. How to use Orally. To open the bottle, turn the lid by pressing down on it (child lock). Close bottle well after use. Do not drink the medication in its pure state, dilute it in water/milk/fruit juice. Symptoms and instructions in case of overdose If you have taken more STEROGYL 2 000 000 UI/100 ml drinkable solution in drops than recommended: Appearance of headaches, loss of appetite, weight loss, slow down in growth, nausea, vomiting, excessive quantity of urine, intense thirst, high blood pressure - these are all signs of an excessive dose of vitamin D among children and newborns. IMMEDIATELY ALERT YOUR DOCTOR. Instructions in case of omission or several doses Not applicable. Risk of withdrawal symptoms. Not applicable. 4. What are the possible side effects? Description of side effects Like all drugs STEROGYL 2 000 000 UI/100 ml drinkable solution in drops can cause side effects (this will not affect everyone): - skin or tissue discomfort: pruritis, spots, erythema, oedema. Declaration of secondary effects If you see any of these side effects appear, speak to your doctor or pharmacist. This also applied to any side effects not mentioned below. You can also declare any side effects via the national declaration system: The ANSM and the network of Regional Centres of Pharmacovigilance. Website: www.ansm.sante.fr. By signaling side effects you are providing more information for the safety of the product. 5. How do you store STEROGYL 2,000,000UI/100ml drinkable solution? Keep out of reach and view from children. Expiry date Do not exceed the expiry date indicated on the outer packaging. Storage conditions Keep an eye out for signs of deterioration. Medication should not be thrown out with the normal household waste. Ask your pharmacist what to do. These measures help protect the environment. 6. Extra information Complete list of active ingredients and dilutants What is in STEROGYL 2,000,000UI/100ml drinkable solution? Active Ingredient: Ergocalciferol: 2,000,000 UI. Per 100ml of drinkable solution. Other ingredients: Hydroquinone, 96.2% ethyl alcohol, purified water. Total alcoholic strength: 90% 1 drop contains 400 UI of vitamin D2 and 14mg of ethanol. 1 ml of solution is 50 drops. Pharmaceutical form and packaging What is STEROGYL 2,000,000UI/100ml drinkable solution and its packaging? Drinkable solution in drops, 20 ml bottle (=1000 drops). Name and Address of Market Authorisation Holder Title DESMA PHARMA S.A.R.L. 25 RUE DE LA BOETIE 75008 PARIS Manager LABORATOIRE DB PHARMA 1 BIS RUE DU COMMANDANT RIVIERE 94210 LA VARENNE SAINT-HILAIRE Manufacturer DMS FARMACEUTICI S.p.A. VIA PROVINCIALE PER LECCO, 78 22038 TAVERNERIO (CO) ITALIE
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