Package leaflet: Information for the patient

DEVISOL-25, 150 µg/ml, oral drops, solution
Calcifediolum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Devisol-25 is and what it is used for
Important information before taking Devisol-25
How to take Devisol-25
Possible side effects
How to store Devisol-25
Contents of the pack and other information

1. What Devisol-25 is and what it is used for

Devisol-25 is an oral drop formulation. One drop contains 5 micrograms of the active substance

calcifediol. Calcifediol belongs to a group of medicines with vitamin D activity. It is formed in the body from cholecalciferol (vitamin D). This substance is essential for the absorption and utilization of calcium in the normal mineralization of bones.

Indications

Prevention and treatment of hypocalcemia (low calcium levels in the blood), rickets, and osteomalacia (bone demineralization) associated with chronic liver diseases;
Prevention and treatment of hypocalcemia, rickets, and osteomalacia occurring as complications of long-term anticonvulsant therapy and corticosteroid therapy (treatment with corticosteroids, i.e. adrenal cortex hormones such as hydrocortisone or prednisone);
Prevention and treatment of uremic osteodystrophy (bone tissue disorders in severe kidney diseases);
Idiopathic (spontaneous) and postoperative hypoparathyroidism;
Selected cases of familial hypophosphatemic rickets (vitamin D-resistant rickets).

Warning! This medicine should not be used in healthy individuals for the sole purpose of dietary vitamin supplementation.
Calcifediol should not be used for the prevention of rickets in healthy children.

2. Important information before using Devisol-25

When not to use Devisol-25:

if the patient is allergic to calcifediol (vitamin D) or any of the other ingredients of this medicine (listed in section 6);
in case of vitamin D overdose;
in hypercalcemia (high calcium levels in blood) and hypercalciuria (high calcium levels in urine);
in hypothyroidism and adrenal cortex insufficiency;
in hyperparathyroidism;
in kidney stones;
in renal osteodystrophy (bone mineralization disorders);
during prolonged immobilization (in bedridden patients);
in certain malignant diseases.

Warnings and precautions
Before starting treatment with Devisol-25, discuss it with your doctor or pharmacist.
During the initial treatment period – to determine optimal dosage – serum and urinary calcium levels should be measured at least once a week, and subsequently monitored periodically.
In young children – hypersensitivity may occur even with small doses of calcifediol. An individual dose must be determined by a physician to avoid overdose.
In patients concurrently treated with thiazide diuretics (e.g. hydrochlorothiazide) – due to increased risk of hypercalcemia – serum calcium levels should be systematically monitored.
The treating physician should exercise particular caution when administering the medicine to patients:

with atherosclerosis or impaired cardiac function;
with hyperphosphatemia (excess phosphates in blood);
with impaired kidney function;
suffering from sarcoidosis or other granulomatous diseases, due to increased sensitivity to vitamin D. For patients undergoing dialysis during calcifediol treatment, the treating physician will recommend administration of phosphate-binding agents.

Please consult your doctor, even if the above warnings refer to conditions that occurred in the past.
Devisol-25 and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to take.
Calcifediol may enhance the toxic effects of cardiac glycosides (medicines used in heart diseases).
Large doses of calcium supplements should not be taken during calcifediol treatment.
Concurrent use of antacids containing aluminium with calcifediol may increase aluminium levels in blood.
Concurrent use of magnesium-containing preparations may cause hypermagnesemia, especially in patients with chronic kidney disease.
Antiepileptic drugs (hydantoin, barbiturates, primidone) may reduce the effects of vitamin D by accelerating its metabolism.
Concurrent administration of calcifediol may weaken or counteract the effects of calcitonin, etidronate, gallium nitrate, pamidronate, or plicamycin, used in the treatment of hypercalcemia.
Large doses of phosphorus-containing preparations taken simultaneously with calcifediol increase the risk of hyperphosphatemia (excess phosphates in blood), because vitamin D enhances absorption of phosphorus compounds.
During treatment with calcifediol, vitamin D or other vitamin D-acting medicines should not be taken, due to additive effects and increased risk of toxicity.
Devisol-25 with food and drink
Administer the prescribed dose with a small amount of water, milk, or fruit juice.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Risk to normal fetal development in women treated with calcifediol may result from maternal hypercalcemia (excess calcium in blood).
Small amounts of the medicine pass into breast milk.
Driving and operating machinery
No studies on the effect of Devisol-25 on the ability to drive vehicles or operate machinery have been conducted.
Devisol-25 contains propylene glycol (E 1520).
The medicine contains 34.7 mg of propylene glycol in one drop, equivalent to 1040 mg/ml.
Due to the high content of propylene glycol, administration to neonates under 4 weeks of age is not recommended unless absolutely necessary and no other effective product with lower propylene glycol content is available.
It is not recommended to exceed a daily dose of 1 mg/kg body weight of propylene glycol in neonates (up to completion of 4 weeks of life) and a daily dose of 50 mg/kg body weight of propylene glycol in children up to 5 years of age.
Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Women who are pregnant or breastfeeding should not take this medicine without medical advice.
The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.

3. How to use Devisol-25

This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Adults: depending on the condition, 50 to 75 micrograms per day, i.e. 10 to 15 drops per day.
Use in children

therapeutically in chronic liver diseases and in hypocalcemia associated with epilepsy treatment: 20 to 40 micrograms/day, i.e. 4 to 8 drops per day (0.4 to 1.8 micrograms/kilogram body weight/day, average 1.0 microgram/kilogram body weight/day);
prophylactically to prevent rickets and osteomalacia in patients treated with anticonvulsant drugs: 10 to 20 micrograms per day, i.e. 2 to 4 drops per day;
in uremic osteodystrophy, hypophosphatemic rickets, and hypoparathyroidism: individual dosing depending on serum calcium levels.

The prescribed dose should be administered with a small amount of water, milk, or fruit juice.
During treatment, the attending physician will recommend laboratory tests to monitor calcium levels in blood and urine.
Use of a higher than recommended dose of Devisol-25
If a higher than recommended dose has been taken, contact a doctor immediately.
Symptoms may include high blood pressure, irregular heartbeat, abdominal pain, constipation (especially in children and elderly individuals), diarrhea, dry mouth, persistent headache, increased thirst, increased urination (especially at night), loss of appetite, metallic taste in the mouth, nausea and vomiting (especially in children and elderly individuals), weakness; in such cases, consult a doctor as quickly as possible.
Late symptoms of overdose (occurring after a relatively long period) also require immediate medical attention: bone pain and muscle pain, cloudy urine, drowsiness, increased sensitivity of eyes to light, skin itching.
Missed dose of Devisol-25
Do not take a double dose to make up for a missed dose.
In case of any doubts concerning the use of this medicine, consult a doctor or pharmacist.
Discontinuation of Devisol-25
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The frequency of the adverse reactions listed below is unknown (frequency cannot be determined from the available data).
Acute or chronic overdose of vitamin D or its metabolites, including calcifediol, may cause symptoms of toxicity. Chronic hypercalcaemia caused by vitamin D may lead to generalized calcification of blood vessels, kidney stones, and calcification of soft tissues, which may result in hypertension and renal failure. In children, growth retardation may occur. Renal or circulatory failure caused by vitamin D toxicity may lead to death.
Early symptoms of vitamin D toxicity associated with hypercalcaemia:
constipation, diarrhoea, dry mouth, headache, increased thirst, frequent urination, loss of appetite, metallic taste in the mouth, nausea and vomiting, fatigue and weakness.
Late symptoms of vitamin D toxicity associated with hypercalcaemia:
bone pain, cloudy urine, high blood pressure, photophobia (eye sensitivity to light), irregular heartbeat, skin itching, lethargy (drowsiness), muscle pain, nausea and vomiting, pancreatitis (severe abdominal pain), psychosis, mood disturbances, weight loss.
If any of these symptoms occur, consult a doctor immediately.
In some individuals, other adverse reactions not listed in this leaflet may occur during treatment with Devisol-25.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Devisol-25

Keep this medicine out of sight and reach of children.
Pay attention to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep the bottle in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What the medicine Devisol-25 contains

The active substance is calcifediol. 1 ml of drops contains 150 micrograms of calcifediol. 1 drop contains 5 micrograms of calcifediol.
Other ingredients: propylene glycol (E 1520).

What Devisol-25 looks like and contents of the pack
Devisol-25 is a clear liquid.
Brown glass bottle with a cap and a dropper made of PE containing 10 ml of drops. The bottle, together with the patient leaflet, is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Labour Cooperative
Przemysłowa 9 Street
35-105 Rzeszów
Phone: +48 17 862 05 90
Email: [email protected]