Thorens 10.000 UI/mL oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Thorens 10,000 IU/ml oral drops solution

colecalciferol (vitamin D3)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Thorens is and what it is used for
2. What you need to know before taking Thorens
3. How to take Thorens
4. Possible side effects
5. How to store Thorens
6. Contents of the pack and other information

1. What Thorens is and what it is used for

Thorens oral solution drops contain colecalciferol (vitamin D3). Vitamin D3 can be found in certain foods and is produced by the body when the skin is exposed to sunlight. Vitamin D promotes calcium absorption in the kidneys and intestine, thereby supporting bone formation. Vitamin D deficiency is the main cause of rickets (defective bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Thorens oral solution drops are used to prevent and treat vitamin D3 deficiency in adults, adolescents, and children who are at identified risk of vitamin D3 deficiency.

Thorens oral solution drops can also be used as an adjunct to specific medication for bone mass loss.

2. What you need to know before taking Thorens

Do not take Thorens

• if you are allergic to vitamin D3 or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
• if you have kidney stones (renal calculi) or severe renal failure;
• if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions

Talk to your doctor or pharmacist before taking Thorens if

• you are being treated with certain medicines used for heart conditions (e.g. cardiac glycosides such as digoxin).

• you have sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D in the body).

• you are being treated with medicines containing vitamin D, or you consume vitamin D–enriched foods or milk.

• you are likely to be exposed to sunlight while using Thorens.

• you take other supplements containing calcium. Your doctor should monitor your calcium levels to ensure they do not become too high during treatment with Thorens.

• you have kidney disease or kidney damage. Your doctor should monitor your calcium levels in blood and urine.

your doctor should monitor blood calcium levels through laboratory tests if daily intake of vitamin D3 exceeds 1,000 IU for a prolonged period.

Taking Thorens with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important if you are taking:

• medicines used to treat heart or kidney conditions, such as cardiac glycosides (e.g. digoxin) or diuretics (e.g. bendroflumethiazide). When these medicines are used together with vitamin D3, they may cause a significant increase in calcium levels in blood and urine.

• medicines containing vitamin D3 or foods rich in vitamin D3, such as certain types of vitamin D3–fortified milk.

• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungals (e.g. clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with the body's processing of vitamin D3.

• the following medicines, as they may interfere with the effect or absorption of vitamin D3:

  • antiepileptic medicines (anticonvulsants), barbiturates;
  • glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
  • medicines that lower cholesterol levels in blood (such as cholestyramine or colestipol);
  • certain medicines used for weight loss by reducing fat absorption (e.g. orlistat);
  • certain laxatives (such as liquid paraffin).

Taking Thorens with food, drinks and alcohol

You should preferably take Thorens with one of your main meals to help absorption of vitamin D3. You may take it alone or mix the drops with cold or lukewarm food to facilitate administration. For more information, see section 3, "How to take Thorens".

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Thorens should be taken during pregnancy and breast-feeding only on the advice of your doctor.

Vitamin D overdosage should be avoided during pregnancy, as prolonged hypercalcemia may cause delayed physical and mental development, supravalvular aortic stenosis, and retinopathy in the child.

Driving and using machines

Information on possible effects of this medicine on the ability to drive is limited. However, it is not expected to affect your ability to drive or use machines.

3. How to take Thorens

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Shake before use.

Thorens should preferably be taken with main meals.

This medicine has an olive oil flavour. Thorens may be taken alone or mixed with a small amount of cold or lukewarm food immediately before ingestion. Make sure you take the full prescribed dose.

Use in adults

The recommended dose for vitamin D deficiency and as a supplement to specific treatment for bone loss (osteoporosis) is 3–4 drops (600 IU – 800 IU) per day.

For the treatment of vitamin D deficiency, the usual dose is 4 drops (800 IU) per day. Higher doses should be adjusted depending on the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the patient’s response to treatment.

The daily dose must not exceed 4,000 IU (20 drops per day).

Use in children and adolescents

For prevention of vitamin D deficiency in children (0 to 11 years) at identified risk, the recommended dose is 2 drops (400 IU) per day. For prevention in adolescents (12 to 18 years) at identified risk, the recommended dose is 3–4 drops (600–800 IU) per day.

For treatment of vitamin D deficiency in children (0 to 11 years) and adolescents (12 to 18 years), the dose should be adjusted depending on the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and the patient’s response to treatment. The daily dose must not exceed 1,000 IU per day for children under 1 year of age, 2,000 IU per day for children aged 1 to 10 years, and 4,000 IU per day for adolescents.

In children, Thorens may be mixed with a small amount of children’s food, yoghurt, milk, cheese, or other dairy products. Do not add Thorens to bottles of milk or other food containers that the child may not consume completely at once, to avoid missing part of the dose. Ensure that the child takes the full prescribed dose. In children who have passed the breastfeeding stage, the prescribed dose should be administered with a main meal.

Do not store any product or food containing Thorens for later use or for the next meal.

Use during pregnancy and breastfeeding

The recommended dose is 400 IU/day (2 drops). Higher doses may be needed after confirmation of vitamin D deficiency, but you must not take more than your doctor recommends.

Instructions for use of the bottle with separate dropper dispenser:

The package contains a bottle and a separate dosing dropper cap. The bottle has a child-resistant closure. The dropper is protected by a plastic ring. To use the medicine, shake the bottle before use and follow the instructions below:

• to open the bottle, press the plastic cap down while turning it at the same time (see Figure 1);

• unscrew the plastic container holding the dosing dropper (see Figure 2);

• insert the dropper cap into the bottle to draw up the contents. Dispense the prescribed number of drops into a spoon;

• to close the bottle, remove the dosing dropper from the bottle and replace the original cap on the bottle (see Figure 3);

• carefully return the dosing dropper to its plastic container and screw it back in.

• Store both the bottle and the dosing dropper in their original box.

Instructions for use of the included dosing dropper bottle:

The package contains a dropper bottle.

The bottle is closed with a child-resistant cap.

The following are instructions for opening and use:

• To open the dropper bottle, press down and turn the plastic cap at the same time;

• Hold the bottle in an upright position, turn it upside down, and dispense the prescribed number of drops into a spoon;

• After administering the drops, return the dropper bottle to an upright position;

• To close the dropper bottle, screw the child-resistant cap back on securely;

• Store the bottle in the original cardboard package.

If you take more Thorens than you should

Stop taking the medicine and contact your doctor or pharmacist immediately if you or your child take more of this medicine than prescribed. If you cannot speak to a doctor, go to the nearest hospital and bring the medicine container with you.

You may also contact the Toxicology Information Service at telephone number 91\ 562\ 04\ 20, indicating the medicine and the amount taken.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for about 24 hours, constipation, dehydration, and elevated levels of calcium in blood and urine (hypercalcemia and hypercalciuria) in clinical tests.

If you forget to take Thorens

If you forget to take a dose of Thorens, take it as soon as possible. Then take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose; instead, take the next dose at the regular scheduled time.

Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like any other medicine, this medicine may cause adverse effects, although not everyone experiences them.

Possible adverse effects associated with the use of Thorens may include:

Uncommon (affects up to 1 in 100 people):

• excess calcium in the blood (hypercalcaemia);
• excess calcium in urine (hypercalciuria).

Rare (affects up to 1 in 1000 people):

• skin rash
• pruritus
• urticaria.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Thorens

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Keep in the original container to protect from light.

Do not refrigerate or freeze.

After first opening the container, the product may be stored for a maximum period of 6 months.

Do not use this medicine if you notice any visible signs of deterioration, such as cloudiness in the solution.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Thorens

• The active substance is colecalciferol (vitamin D3). 1 ml of oral solution (50 drops) contains 10,000 IU of colecalciferol (vitamin D3), equivalent to 0.25 mg. 1 drop contains 200 IU of colecalciferol (vitamin D3).
• The other components are: olive oil.

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Appearance of Thorens and Contents of the Package

Thorens 10,000 IU/ml oral drops in solution is an oily, transparent, oral solution ranging from colourless to yellowish-green, free from visible solid particles and/or precipitates. It is presented in:

• Bottle with a separate dosing dropper

A 20 ml amber glass bottle with a child-resistant cap.

Each package contains an amber glass bottle containing 10 ml of solution (equivalent to 500 drops) and a dropper, bearing the CE mark 0068.

• Bottle with an integrated dosing dropper

A 20 ml glass bottle with an integrated dosing dropper, closed with a child-resistant cap.

Each package contains an integrated dosing dropper for dispensing the 10 ml of solution (equivalent to 500 drops).

Not all presentations may be available on the market.

Marketing Authorization Holder and Manufacturing Responsibility

Abiogen Pharma S.p.A.

Via Antonio Meucci 36

Loc Ospedaletto

Pisa (PI), 56121

Italy

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: THORENS 10,000 IU/ml oral drops, solution

UK: THORENS 10,000 IU/ml oral drops, solution

Ireland: THORENS 10,000 IU/ml oral drops, solution

Belgium: THORENS 10,000 IU/ml oral drops, solution

Germany: THORENS 10,000 IU/ml oral drops, solution

Netherlands: THORENS 10,000 IU/ml oral drops, solution

Norway: THORENS 10,000 IU/ml oral drops, solution

Poland: THORENS 10,000 IU/ml oral drops, solution

Portugal: THORENS 10,000 IU/ml oral drops, solution

Sweden: THORENS 10,000 IU/ml oral drops, solution

Date of the most recent review of this leaflet: April 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).