ROCALTROL 0.50 mcg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Rocaltrol0,50microgramssoft capsules

Calcitriol

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Rocaltrol and what is it used for

Rocaltrol contains the active substance calcitriol, (a derivative of vitamin D3) which promotes intestinal absorption of calcium and regulates bone mineralization.

Your doctor will prescribe Rocaltrol if your kidneys are unable to synthesize calcitriol correctly, which can occur if you suffer from:

‑ Renal osteodystrophy (decalcification of bones due to chronic renal failure)

‑ Post-surgical or idiopathic hypoparathyroidism (deficiency of parathyroid hormone that causes abnormal levels of calcium and phosphorus in the blood).

• Pseudo-hypoparathyroidism (a genetic disorder that resembles hypoparathyroidism but is caused by the body's lack of response to parathyroid hormone and not because the levels of this hormone are low).

• Osteomalacia (softening and weakening of bones).
• Rickets (osteomalacia in children) dependent on vitamin D (due to alterations in vitamin D metabolism or its receptors) or hypophosphatemic resistant to vitamin D (due to renal loss of phosphate).

‑ Pre-surgical treatment in primary hyperparathyroidism (elevated levels of parathyroid hormone due to parathyroid gland enlargement), to minimize postoperative hypocalcemia (decrease in blood calcium levels).

2. What you need to know before you start taking Rocaltrol

Do not take Rocaltrol:

• If you are allergic to calcitriol or any of the other components of this medicine (listed in section 6).
• If you have high levels of calcium in the blood.
• If you have vitamin D poisoning.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rocaltrol.

Be particularly careful with Rocaltrol:

• If you have to be immobilized, for example after an operation, as you may have a higher risk of hypercalcemia (high levels of calcium in the blood).
• If you have renal failure, as you have a higher risk of calcification.
• If you have vitamin D-resistant rickets (familial hypophosphatemia), as it may be necessary to modify the need for phosphate supplements.
• Follow the dietary measures recommended by your doctor. If your doctor has not recommended it, do not take other calcium preparations not subject to medical prescription on your own.
• Your doctor will perform periodic checks to control calcium levels in case the dose needs to be adjusted.
• Avoid taking vitamin D or its derivatives (such as dihydrotachysterol) at the same time, as hypercalcemia may occur.

Children

The safety and efficacy of Rocaltrol in children have not been established to make a dosage recommendation.

Other medicines and Rocaltrol

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Note that:

• If you are being treated with digoxin or similar medicines (for heart failure and abnormal heart rate), arrhythmias due to hypercalcemia may appear.
• If you have vitamin D-resistant rickets and are being treated with oral phosphate, your doctor may need to adjust your phosphate supplement intake.
• If you are being treated with thiazide diuretics (for hypertension), as they increase the risk of hypercalcemia (high levels of calcium in the blood).
• If you are taking cholestyramine (a medicine to lower cholesterol and fat levels in the blood) or sevelamer (a medicine to lower phosphate levels in the blood), as they alter the intestinal absorption of calcitriol.
• If you are undergoing chronic renal dialysis, you should avoid taking medicines that contain magnesium (such as antacids), as they may cause hypermagnesemia (elevated magnesium levels in the blood).
• If you are taking corticosteroids, as they may counteract the effects of vitamin D analogs.

Taking Rocaltrol with food and drinks

If your renal function is normal, you should drink liquids adequately to avoid dehydration. Follow the dietary measures recommended by your doctor. If your doctor has not recommended it, do not take other calcium preparations not subject to medical prescription on your own.

Pregnancy and breastfeeding

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

Your doctor will decide whether it is convenient for you to take Rocaltrol. Taking Rocaltrol during breastfeeding requires monitoring of serum calcium levels in the mother and child.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Rocaltrol contains sorbitol

This medicine contains 2.87 - 4.36 mg of sorbitol in each 0.50 mcg capsule.

3. How to take Rocaltrol

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor again.

Normal dose:

Your doctor will determine the optimal dose of Rocaltrol based on the level of calcium you have in your blood. To do this, they will perform analyses at least twice a week.

Once your dose is determined, they will check your blood calcium levels monthly. If the normal levels of calcium are exceeded, your doctor will reduce the dose of Rocaltrol or interrupt treatment until you recover normal blood calcium levels.

For the treatment with Rocaltrol to be optimal, it is necessary that the intake of calcium in the diet is adequate. If necessary, your doctor will prescribe a calcium supplement. It is essential that you strictly follow the diet prescribed by your doctor, as a sudden increase in calcium intake can trigger hypercalcemia (high levels of calcium in the blood).

Dose in other diseases:

Renal osteodystrophy (dialyzed patients)

The initial daily dose is 0.25 micrograms. If your blood calcium levels are normal or moderately low, this dose will be sufficient every two days. If your doctor does not register the expected improvement, they may increase the dose, with intervals of two to four weeks, by 0.25 micrograms daily each time. During this period, your doctor will determine your blood calcium levels at least twice a week.

Most patients respond to doses between 0.5 and 1.0 micrograms per day. It may be necessary to take higher doses when barbiturates or anticonvulsants are administered at the same time.

Hypoparathyroidism and rickets

The recommended initial dose is 0.25 micrograms per day, administered in the morning.

Similarly, if your doctor considers it appropriate, they will increase your dose at intervals of two to four weeks. During the dose adjustment period, your doctor will determine your blood calcium levels at least twice a week.

In patients with hypoparathyroidism, poor absorption is occasionally observed; it may then be necessary to administer higher doses of Rocaltrol.

If you take more Rocaltrol than you should

As calcitriol is a derivative of vitamin D, the symptoms of a calcitriol overdose are the same as those of a vitamin D overdose. These same symptoms can occur if you take high doses of calcium and phosphate while being treated with Rocaltrol.

The acute symptoms of calcitriol poisoning are: anorexia (loss of appetite), headache, vomiting, and constipation. The chronic symptoms are dystrophy (progressive muscle weakness), sensory disorders, fever with thirst, polyuria (increased urine excretion), dehydration, apathy (lack of energy), growth interruption, and urinary infections. Hypercalcemia (high levels of calcium in the blood) can be followed by metastatic calcification of the renal cortex, myocardium, lungs, and pancreas (calcium accumulates in these tissues, causing them to harden).

Treatment will be with emesis (induction of vomiting) or gastric lavage to prevent intestinal absorption of calcium. Liquid paraffin may also be administered to induce fecal excretion. Repeated analysis of blood calcium levels is recommended. If elevated calcium levels persist, force urinary excretion with phosphates or corticosteroids.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or contact the Toxicology Information Service, Telephone (91) 562.04.20, indicating the medicine and the amount ingested.

If you forget to take Rocaltrol

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

If you stop taking Rocaltrol

Your doctor will indicate the duration of your treatment with Rocaltrol. Do not stop treatment before.

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

4. Possible side effects

Like all medicines, Rocaltrol can cause side effects, although not everybody gets them.

The side effects are similar to those observed when taking excessive doses of vitamin D, i.e., hypercalcemia syndrome (high levels of calcium in the blood) or calcium poisoning.

The side effects observed with calcitriol are the following:

Very common side effects(may affect more than 1 in 10 people)

• Hypercalcemia (high levels of calcium in the blood)

Common side effects(may affect up to 1 in 10 people)

• Headache
• Nausea
• Abdominal pain or stomach pain
• Urinary infections
• Rash

Uncommon side effects(may affect up to 1 in 100 people):

• Anorexia (loss of appetite)
• Vomiting
• Increased creatinine in the blood

Side effects with unknown frequency(cannot be estimated from the available data):

• Hypersensitivity (allergy)
• Urticaria (hives, usually with itching on the skin)
• Polydipsia (increased thirst)
• Dehydration
• Apathy (lack of energy)
• Psychiatric disorders
• Muscle weakness
• Sensory disorders
• Insomnia (difficulty sleeping)
• Cardiac arrhythmias (irregular heartbeats)
• Constipation
• Pain in the upper abdomen
• Paralytic ileus (intestinal obstruction)
• Erythema (inflamed and reddened skin)
• Pruritus (itching)
• Growth retardation
• Polyuria (increased urine excretion)
• Nocturia (need to urinate at night)
• Calcinosis (calcium deposits in tissues)
• Fever with thirst
• Thirst
• Weight loss

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rocaltrol

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

Do not store above 25°C. Keep the blister in the outer packaging to protect it from light and moisture.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rocaltrol 0.50 micrograms:

• The active substance is calcitriol. Each soft capsule of Rocaltrol contains 0.50 micrograms of calcitriol.

• The other components are:

Contents of the capsule: butylhydroxyanisole (E-320), butylhydroxytoluene (E-321), coconut oil triglycerides.

Capsule shell: gelatin, glycerol 85%, karion 83 (contains: sorbitol (E-420), mannitol, and hydrogenated corn starch hydrolyzate), titanium dioxide (E-171), red and yellow iron oxide (E-172).

Appearance of the product and pack contents

Rocaltrol 0.50 micrograms soft capsules are oval, brown-orange to orange-red, and opaque.

This medicine is presented in PVC blisters containing 20 soft capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

ATNAHS PHARMA NETHERLANDS B.V.

Copenhagen Towers, Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer

IL CSM Clinical Supplies Management GmbH

Marie-Curie-Strasse 8

Lörrach

Baden-Württemberg, 79539

Germany

or

allphamed PHARBIL Arzneimittel GmbH

Hildebrandstr. 10-12,

Goettingen, Lower Saxony, 37081, Germany

or

Delpharm Poznan S.A.

Ul. Grunwaldzka 189,

Poznan, 60-322,

Poland

Local representative

Laboratorios Rubió, S.A.

Industria, 29 - Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Date of the last revision of this leaflet:January 2021.

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