Bg pattern

ROCALTROL 0.50 mcg SOFT GEL CAPSULES

Prescription review online

Prescription review online

A doctor will review your case and decide whether a prescription is medically appropriate.

Talk to a doctor about this medicine

Talk to a doctor about this medicine

Discuss your symptoms and possible next steps in a quick online consultation.

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use ROCALTROL 0.50 mcg SOFT GEL CAPSULES

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

Show original

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).

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/

Online doctors for ROCALTROL 0.50 mcg SOFT GEL CAPSULES

Discuss questions about ROCALTROL 0.50 mcg SOFT GEL CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

0.0 (0)
Doctor

Даниэль Чики

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

Camera Book a video appointment
€55
5.0 (140)
Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

Camera Book a video appointment
€50
5.0 (3)
Doctor

Томаш Гжеловський

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
Camera Book a video appointment
€80
5.0 (25)
Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

Camera Book a video appointment
€70
5.0 (764)
Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

Camera Book a video appointment
€55

Frequently Asked Questions

Is a prescription required for ROCALTROL 0.50 mcg SOFT GEL CAPSULES?
ROCALTROL 0.50 mcg SOFT GEL CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ROCALTROL 0.50 mcg SOFT GEL CAPSULES?
The active ingredient in ROCALTROL 0.50 mcg SOFT GEL CAPSULES is calcitriol. This information helps identify medicines with the same composition but different brand names.
Who manufactures ROCALTROL 0.50 mcg SOFT GEL CAPSULES?
ROCALTROL 0.50 mcg SOFT GEL CAPSULES is manufactured by Atnahs Pharma Netherlands Bv.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ROCALTROL 0.50 mcg SOFT GEL CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ROCALTROL 0.50 mcg SOFT GEL CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ROCALTROL 0.50 mcg SOFT GEL CAPSULES?
Other medicines with the same active substance (calcitriol) include ROCALTROL 0.25 mcg SOFT GEL CAPSULES, ALDEXINA 25,000 IU HARD CAPSULES, ALDEXINA 50,000 IU HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
bg-pattern-dark

Stay informed about Oladoctor

News about new services, product updates and useful information for patients.

Follow us on social media