Prospect: information for the user

Rocaltrol0,50microgramssoft capsules

Calcitriol

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.See section 4

1. What is Rocaltrol and what is it used for

2. What you need to know before taking Rocaltrol

3. How to take Rocaltrol

4. Possible adverse effects

5. Storage of Rocaltrol

6. Contents of the package and additional information

Rocaltrol contains as its active ingredient calcitriol, (a derivative ofvitamin D3) which promotes intestinal absorption of calcium and regulates bone mineralization.

Your doctor will prescribe Rocaltrol if your kidneys cannot synthesize calcitriol correctly, which may occur if you have:

‑Renal osteodystrophy (bone decalcification due to chronic kidney disease)

‑Post-surgical or idiopathic hypoparathyroidism (deficiency of theparathyroid hormonethat causes abnormal levels of calcium and phosphorus in the blood)

• Pseudohypoparathyroidism (genetic disorder that resembleshypoparathyroidismbut is caused by the body's lack of response to theparathyroid hormoneand not because the levels of this hormone are low).

• Osteomalacia (softening and weakening of the bones).
• Rickets (osteomalacia in children) dependent onvitamin D(due to alterations invitamin Dmetabolism or its receptors) or hypophosphatemic resistant tovitamin D(due to renal phosphate loss).

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

Do not take Rocaltrol:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rocaltrol.

Be especially careful with Rocaltrol:

• If you need to be immobilized, for example after surgery, as you may be at a higher risk of hypercalcemia (high levels of calcium in the blood).
• If you have renal insufficiency as you are at a higher risk of suffering from calcifications.
• If you have resistant rickets tovitamin D(familial hypophosphatemia) as your doctor may need to modify your phosphate supplement needs.
• Follow the dietary measures recommended by your doctor. If your doctor has not recommended it, do not take other non-prescription calcium preparations on your own.
• Your doctor will perform regular checks to monitor your calcium levels and adjust the dose if necessary.
• Simultaneous intake of vitamin D or its derivatives (such as dihydrotaquisterol) should be avoided as it may cause hypercalcemia.

Children

The safety and efficacy of Rocaltrol in children have not been established, so a dosage recommendation cannot be made.

Other medications and Rocaltrol

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

Be aware that:

• If you are being treated with digoxin or similar medications (for heart failure and abnormal heart rate), arrhythmias due to hypercalcemia may occur.
• If you have rickets resistant tovitamin Dand are being treated with oral phosphate, your doctor may need to adjust your phosphate supplement intake.
• If you are being treated with thiazide diuretics (medications used for hypertension) as they increase the risk of hypercalcemia (high levels of calcium in the blood).
• If you are taking cholestyramine (a medication to lower cholesterol and blood fat levels) or sevelamer (a medication to lower blood phosphate levels), as they alter the intestinal absorption of calcitriol.
• If you are undergoing chronic renal dialysis, you should avoid taking medications 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 enough liquids to avoid dehydration. Follow the dietary measures recommended by your doctor. If your doctor has not recommended it, do not take other non-prescription calcium preparations on your own.

Pregnancy and breastfeeding

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

Your doctor will decide whether or not you should take Rocaltrol. Taking Rocaltrol during breastfeeding requires monitoring of the mother's and child's serum calcium levels.

Driving and operating machinery

This medication does not affect your ability to drive or operate machinery.

Rocaltrol contains sorbitol

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor again.

Normal dose:

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

Once your dose is determined, your doctor will monitor your calcium levels in the blood monthly. If your calcium levels exceed normal levels, your doctor will reduce your Rocaltrol dose or interrupt treatment until your calcium levels return to normal.

For the treatment with Rocaltrol to be optimal, it will be necessary for you to have an adequate calcium intake in your diet. 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 calcium levels in the blood are normal or moderately low, this dose will suffice every two days. If your doctor does not record the expected improvement, you may increase the dose, with intervals of two to four weeks, by 0.25 micrograms per day. During this period, your doctor will determine your calcium levels in the blood, at least twice a week.

Most patients respond to doses ranging from 0.5 to 1.0 micrograms per day. Higher doses may be necessary 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 period of dose fixation, your doctor will determine your calcium levels in the blood, at least twice a week.

In patients with hypoparathyroidism, occasional poor absorption may be observed; in such cases, higher doses of Rocaltrol may be necessary.

If you take more Rocaltrol than you should

Since calcitriol is a derivative ofvitamin D, the symptoms of calcitriol overdose are the same as those of vitamin D overdose. The same symptoms may appear if high doses of calcium and phosphate are taken while on Rocaltrol treatment.

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

It will be treated with emesis (induction of vomiting) or gastric lavage, to prevent intestinal absorption of calcium. Paraffin liquid may also be administered to provoke fecal excretion. It is recommended to perform repeated blood calcium tests. If high calcium levels persist, forced urine excretion with phosphates or corticosteroids may be necessary.

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

If you forget to take Rocaltrol

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Rocaltrol

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

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

Like all medicines, Rocaltrol can cause side effects, although not everyone will experience them.

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

The side effects observed with calcitriol are as follows:

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 cramps
• urinary tract infections
• pruritus

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

• anorexia (loss of appetite)
• vomiting
• increased creatinine in the blood

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

• hypersensitivity (allergy)
• urticaria (hives usually with itching on the skin)
• polydipsia (increased sensation of thirst)
• dehydration
• apathy (lack of energy)
• psychiatric disturbances
• muscle weakness
• sensory disturbances
• insomnia (difficulty sleeping)
• cardiac arrhythmias (irregular heartbeats)
• constipation
• upper abdominal pain
• paralytic ileus (intestinal obstruction)
• erythema (inflamed and reddened skin)
• pruritus (itching)
• growth retardation
• polyuria (increased urine excretion)
• nocturia (urge to urinate at night)
• calcinoses (calcium deposits in tissues)
• fever with thirst
• thirst
• weight loss

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above25°C. Store the blister pack in the outer packaging to protect it from light and moisture.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose ofthe packaging and medicines that you no longer need at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Rocaltrol 0.50 micrograms:

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

• The other components are:

Caplet content: butylhydroxyanisole (E-320), butylhydroxytoluene (E-321), coconut oil triglycerides.

Caplet coating: gelatin, 85% glycerol, karion 83 (contains: sorbitol (E-420), mannitol, and hydrogenated cornstarch hydrolysate), titanium dioxide (E-171), iron oxide red and yellow (E-172).

Appearance of the product and content of the container

Rocaltrol 0.50 micrograms soft capsules are oval-shaped, soft gelatin capsules with a brown-orange to reddish-orange opaque color.

This medication is presented in a PVC blister containing 20 soft capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ATNAHS PHARMA NETHERLANDS B.V.

Copenhagen Towers, Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Responsible for manufacturing

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

Last review date of this leaflet:January 2021.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/