Devik 50,000 IU/5 ml oral solution in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Devik 50,000 IU/5 ml oral solution in sachet

Colecalciferol

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it could harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Devik is and what it is used for

Devik oral solution in sachet contains colecalciferol (vitamina D3). Vitamin D3 can be found in certain foods and is also produced by the skin upon exposure to sunlight. Vitamin D3 helps the kidneys and intestines absorb calcium and contributes to bone development. Vitamin D deficiency is the main cause of rickets (deficient bone mineralization in children) and osteomalacia (inadequate bone mineralization in adults).

Devik is used for the initial treatment of vitamin D deficiency in adults.

Your doctor may prescribe this medicine as a supplement to specific osteoporosis treatment. If you have any further questions, consult your doctor or pharmacist and always follow their instructions.

2. What you need to know before starting to take Devik

Do not take Devik

• If you are allergic to colecalciferol 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 D3 in your blood (hypervitaminosis D).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Devik.

• If you are taking certain medicines used to treat heart disorders (e.g., cardiac glycosides such as digoxin).
• If you have sarcoidosis (a disorder of the immune system that may cause increased levels of vitamin D in the body).
• If you are taking other medicines containing vitamin D, or if you consume vitamin D–enriched foods or milk.
• If you are likely to have high exposure to sunlight while taking Devik.
• If you are taking additional supplements containing calcium. Your doctor will monitor your blood calcium levels to ensure they do not become too high while you are taking Devik.
• If you have kidney problems or any kidney disease. Your doctor may want to measure your blood or urine calcium levels.
• Your doctor should monitor your blood calcium levels through blood tests if you are taking a daily dose of vitamin D3 exceeding 1,000 IU over a prolonged period.
• If you have a parathyroid hormone imbalance (pseudohypoparathyroidism).

Use of Devik with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This is especially important if you are taking:

• Medicines that act on the heart or kidneys, such as cardiac glycosides (e.g., digoxin) or diuretics (e.g., bendroflumethiazide). When taken together with vitamin D3, these medicines may cause a substantial increase in calcium levels in the blood and urine.

• Medicines containing vitamin D or if you consume foods rich in vitamin D, such as certain types of vitamin D–enriched milk.

• Actinomycin (a medicine used to treat some forms of cancer) and imidazole antifungals (e.g., clotrimazole and ketoconazole, medicines used to treat fungal diseases). These medicines may affect how your body processes vitamin D3.

• Medicines used to treat tuberculosis, for example rifampicin, isoniazid.

• 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). These medicines may reduce the effect of vitamin D3;

• medicines that lower cholesterol levels in the blood (such as cholestyramine or colestipol);

• certain weight-loss medicines that reduce the amount of fat absorbed by the body (e.g., orlistat);

• certain laxatives (such as liquid paraffin).

Use of Devik with food, drinks and alcohol

This medicine should preferably be taken with a substantial meal to help your body absorb vitamin D3. You may also mix the solution with cold or lukewarm food to facilitate administration. For more information, see section 3 "How to take Devik".

Pregnancy, breastfeeding and fertility

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

The use of this highly concentrated formulation is not recommended during pregnancy.

Driving and using machines

There is limited information on the possible effects of this product on the ability to drive. However, it is not expected to affect your ability to drive or use machinery.

3. How to take Devik

Follow exactly the instructions given by your doctor for administering this medicine. If you are unsure, ask your doctor or pharmacist.

This medicine has an olive oil with forest fruit flavour. Devik should preferably be taken with a main meal. Devik can be taken directly from the sachet, or you may mix the contents of a single-dose sachet of the oral solution with a small amount of cold or lukewarm food immediately before taking it. Make sure you take the full dose.

The amount of colecalciferol will depend on your vitamin D levels and your response to treatment.

Use in adults

The recommended dose is 25,000 IU once weekly.

After the first month, a lower dose may be considered.

If your doctor considers it necessary, the regimen of 50,000 IU/week (one single dose) for 6–8 weeks may be considered.

This initial treatment may be followed by a maintenance therapy, as directed by your doctor.

Alternatively, national dosing recommendations for the treatment of vitamin D deficiency may be followed.

Use in children

Devik is not suitable for use in children and adolescents under 18 years of age.

Use in patients with kidney problems

Devik must not be used in patients with severe renal insufficiency, as vitamin D in the form of colecalciferol is not normally metabolized and other forms of vitamin D should be used.

Use in patients with liver problems

No dose adjustment is required.

Use in elderly patients

Special monitoring of serum and urinary calcium levels and renal function should be performed in elderly patients. Please consult your doctor.

If you take more Devik than you should

If you take more medicine than prescribed, stop taking this medicine and consult your doctor or pharmacist. If you cannot contact your doctor, go to the nearest emergency department and take the packaging with you.

The most common symptoms of overdose are: nausea, vomiting, excessive thirst, production of large amounts of urine over 24 hours, constipation and dehydration, as well as elevated levels of calcium in blood and urine (hypercalcemia and hypercalciuria) observed in laboratory tests.

You may also contact the Toxicology Information Service, telephone 915620420, indicating the medicine and the amount taken.

If you forget to take Devik

Do not take a double dose to make up for forgotten doses.

Take the missed dose as soon as possible and take the following doses on the correct day. However, if it is almost time for the next dose, do not take the missed dose; simply take the next dose as normal.

If you stop taking Devik

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You should stop taking colecalciferol and consult your doctor immediately if you experience symptoms of serious allergic reactions, such as:

• Swelling of the face, lips, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

Possible adverse effects may include:

Uncommon (affects less than 1 in 100 people)

• Too much calcium in the blood (hypercalcemia). Symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, increased need to drink water, muscle weakness, drowsiness, and confusion.
• Too much calcium in the urine (hypercalciuria)

Rare (affects less than 1 in 1,000 people)

• Skin rash
• Itching
• Hives

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Devik

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Devik

The active substance is colecalciferol. 5 ml of solution contain 1,250 mg of colecalciferol, equivalent to 50,000 IU of vitamin D3.

The other components are: refined olive oil and berry flavor (containing glyceryl triacetate, triethyl citrate, propylene glycol, and flavorings).

Nature of the product and pack contents

Devik is marketed in single-dose sachets containing 5 ml of oral solution.

This medicine is available in packs of 1 or 4 sachets in a cardboard box.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Zinereo Pharma, S.L.U.

A Relva s/n, O Porriño

36410 Pontevedra

Spain

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/