Brand name Hidroferol 0.266 mg oral solution

Form solution, oral

Active substance / Dosage

CALCIFEDIOL · 0,266 mg

Prescription type Prescription Only Medicine

ATC code

A11C A11CC A11CC06

Registration number 53683

Manufacturer Faes Farma S.A.

Hidroferol 0.266 mg oral solution solution, oral

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Hidroferol 0.266 mg oral solution is and what it is used for
2. What you need to know before taking Hidroferol 0.266 mg oral solution
3. How to take Hidroferol 0.266 mg oral solution
4. Possible adverse effects
5. Storage of Hidroferol 0.266 mg oral solution
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hidroferol 0.266 mg oral solution

calcifediol monohydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, talk to your doctor, pharmacist or nurse, including any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

What Hidroferol 0.266 mg oral solution is and what it is used for
What you need to know before taking Hidroferol 0.266 mg oral solution
How to take Hidroferol 0.266 mg oral solution
Possible side effects
How to store Hidroferol 0.266 mg oral solution
Contents of the pack and other information

1. What Hidroferol 0.266 mg oral solution is and what it is used for

It contains a form of vitamin D, calcifediol, which is used to treat vitamin D deficiency and related conditions. Vitamin D plays a role in the human body, among other actions, by increasing calcium absorption.

Hidroferol 0.266 mg oral solution is indicated for the treatment of vitamin D deficiency in adults and for the prevention of vitamin D deficiency in adults at identified risk, such as patients with malabsorption syndrome, chronic kidney disease–mineral and bone disorder (CKD-MBD), or any other identified risk.

It is also used to treat bone loss (osteoporosis), in combination with other medications, in patients with vitamin D deficiency or at risk of vitamin D deficiency.

2. What you need to know before taking Hidroferol 0.266 mg oral solution

Do not take Hidroferol 0.266 mg oral solution:

if you are allergic to calcifediol or to any of the other ingredients of this medicine (listed in section 6).
if you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine).
if you suffer from calcium stone (calculi) formation.
if you have hypervitaminosis D (excess vitamin D in the body).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Hidroferol 0.266 mg oral solution.

Do not exceed the recommended daily doses of vitamin D supplements, such as this medicine, as this could lead to intoxication. (See section 3, If you take more Hidroferol 0.266 mg oral solution than you should).
While taking this medicine or before starting treatment, your doctor may recommend blood or urine tests to monitor your calcium, phosphorus, and other parameters.
Patients with kidney disease require special caution and must be closely monitored by their doctor, including periodic laboratory tests.
Patients with heart disease require special caution and should be frequently monitored by their doctor for blood calcium levels, especially those receiving cardiac glycosides (see section Other medicines and Hidroferol 0.266 mg oral solution below).
If you have hypoparathyroidism (insufficient parathyroid hormone function), the effectiveness of this medicine may be reduced.
If you suffer from kidney stone (calculi) formation, your doctor should monitor your blood calcium levels.
Patients with prolonged immobilization may require lower doses of this medicine.
Patients with sarcoidosis (a disease characterized by nodules, usually in the skin), tuberculosis, or other granulomatous diseases must use this medicine with special caution, as they are at higher risk of adverse effects even at doses lower than recommended. Periodic blood and urine calcium level monitoring is required.
Interference with laboratory tests: if you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results. For example, certain cholesterol tests.

Children and adolescents

The safety and efficacy of calcifediol in children and adolescents under 18 years of age have not been established. No data are available.

For pediatric use, the product Hidroferol 0.1 mg/ml oral drops in solution is available on the market, which has a lower dose concentration.

Other medicines and Hidroferol 0.266 mg oral solution

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how this medicine works. Conversely, the active ingredient, calcifediol monohydrate, may affect the efficacy of other medicines taken simultaneously.

Therefore, interactions may occur with the following medicines:

Medicines used to treat epilepsy (such as phenytoin, phenobarbital, and primidone) and other enzyme-inducing drugs (which may reduce the effect of Hidroferol).
Medicines for heart conditions and/or high blood pressure, such as cardiac glycosides, thiazide diuretics, or verapamil.
Cholestyramine, colestipol (for cholesterol), orlistat (for obesity): administration of these medicines should be separated from calcifediol by at least 2 hours.
Mineral oil or paraffin (laxatives): it is recommended to use another type of laxative or separate the administration times of both medicines.
Certain antibiotics (such as penicillin, neomycin, and chloramphenicol).
Magnesium salts.
Other vitamin D-containing products.
Calcium supplements.
Corticosteroids (anti-inflammatory medicines).

Taking Hidroferol 0.266 mg oral solution with food and drinks

Some foods and beverages are fortified with vitamin D. This should be taken into account, as the effects of these foods may add up to those of this medicine and become excessive.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine during pregnancy.

Do not take this medicine while breastfeeding.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

3. How to take Hidroferol 0.266 mg oral solution

The Hidroferol 0.266 mg oral solution ampoule is for ORAL USE ONLY.

Hidroferol 0.266 mg oral solution must NOT be administered by intramuscular and/or intravenous route.

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

DO NOT take Hidroferol 0.266 mg oral solution DAILY. Do not take more medicine or take it more frequently than prescribed by your doctor (weekly, biweekly, or monthly). If you do, you may increase the risk of overdose.

The recommended doses are:

Treatment of vitamin D deficiency and prevention of vitamin D deficiency in patients with identified risk factors: one drinkable ampoule (0.266 mg monohydrate calcifediol), once a month.
As a supplement to specific medication for bone mass loss: one drinkable ampoule (0.266 mg monohydrate calcifediol), once a month.

There are high-risk populations for vitamin D deficiency in which higher doses may be necessary. After appropriate assessment of the degree of deficiency, your doctor may consider a dose of one ampoule every two weeks or weekly.

Your doctor should monitor your calcium and vitamin D levels periodically, usually before starting treatment and every 3–4 months after starting treatment. Depending on the indication, doses will be reduced or spaced further apart over time once symptoms improve or vitamin D deficiency has been corrected.

Oral use.

The contents of the ampoule can be taken alone or diluted in a small amount of water, milk, or juice.

Instructions for opening and using the ampoules are as follows:

Shake the ampoule before use.

Sequence of four illustrations showing hands opening, folding, and separating a medical container with precise movements toward the

Insert the glass ampoule tip into the cylinder provided to assist opening. Hold the body of the ampoule between your thumb and index finger, with the white mark facing upwards.

Place the index finger of your other hand beneath the cylinder covering the ampoule tip, and your thumb above it, as shown in the figure, so that the index fingers of both hands touch each other below the ampoule.

Keep the hand holding the ampoule steady and press the ampoule tip downward with your thumb in a quick, sharp motion to open it.

Once the ampoule is open, remove the tip from the cylinder for future reuse.

If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Hidroferol 0.266 mg oral solution than you should

If you take more of this medicine than the dose prescribed by your doctor (overdose) and/or for prolonged periods, hypercalcemia (elevated blood calcium levels) may occur, along with increased phosphate levels in blood and urine, potentially leading to renal failure. Some symptoms of toxicity may appear quickly, while others may develop over time.

Early symptoms include: weakness, fatigue, headache, loss of appetite, dry mouth, gastrointestinal disturbances such as vomiting, abdominal cramps, constipation or diarrhea, increased thirst; increased urination, muscle pain.

Symptoms that may appear after a delay include: itching, weight loss, growth retardation in children, kidney disorders, light sensitivity, conjunctivitis, increased cholesterol, elevated transaminases, pancreatic inflammation, calcification (calcium salt deposits) in blood vessels and other tissues such as tendons and muscles, increased blood pressure, mental disturbances, irregular heartbeats.

Symptoms of overdose usually improve or disappear when treatment is discontinued, but if poisoning is severe, it could lead to kidney or heart failure.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested (or bring the medicine with you).

If you forget to take Hidroferol 0.266 mg oral solution

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

Take the missed dose as soon as possible, then return to your regular dosing schedule.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Adverse effects may occur if excessive doses are taken or if the medicine is taken more frequently than indicated by the physician, which may lead to hypercalcemia (elevated calcium levels in blood) and hypercalciuria (elevated calcium levels in urine); see section 3 for a description of symptoms.

Other adverse effects include allergic reactions such as itching, local swelling, difficulty breathing, and skin redness.

Reporting of adverse effects

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

5. Storage of Hidroferol 0.266 mg oral solution

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

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

No special storage conditions are required.

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

6. Contents of the pack and other information

Composition of Hidroferol 0.266 mg oral solution

The active substance is calcifediol monohydrate. Each ampoule contains 0.266 mg of calcifediol monohydrate.
The other components (excipients) are: medium-chain triglycerides and alpha-tocopheryl acetate.

Appearance of the product and contents of the pack

Hidroferol 0.266 mg is an oral solution; it is a transparent, colourless or slightly yellowish, viscous liquid free from visible impurities, supplied in glass ampoules.

Each pack contains 10 drinkable ampoules.