Package Insert: Information for the User

Rocaltrol 0.25 micrograms Soft Capsules

Calcitriol

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What isRocaltroland what it is used for

2. What you need to know before starting to takeRocaltrol

3. How to takeRocaltrol

4. Possible adverse effects

5. Storage ofRocaltrol

6. Contents of the pack and additional information

Rocaltrol contains calcitriol as its active ingredient, 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 tochronic kidney failure).
• 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 in the metabolism ofvitamin Dor its receptors) or hypophosphatemic resistant tovitamin D(due to renal loss of phosphate).
• Pre-surgical treatment in primary hyperparathyroidism (elevated levels of parathyroid hormone due to enlargement of parathyroid glands), to minimize postoperative hypocalcemia.

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 have to be immobile, 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 insufficiency as you have a higher risk of suffering calcifications.
• If you have resistant rickets tovitamin D(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 non-prescription calcium preparations on your own.
• Your doctor will perform regular checks to control calcium levels if necessary to adjust the dose.
• 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 to make a dosage recommendation.

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 (medication to lower cholesterol and blood fat) or sevelamer (medication to lower blood phosphate), as they alter intestinal absorption of calcitriol.
• If you are undergoing chronic renal dialysis, avoid taking medications containing 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 non-prescription calcium preparations on your own.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 serum calcium levels in the mother and child.

Driving and operating machines

This medication does not affect the ability to drive or operate machines.

Rocaltrol contains sorbitol

This medication contains 2.87 - 4.37 mg of sorbitol in each 0.25 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, he 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 discontinue 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, he 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 medications, 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(can affect more than 1 in 10 people)

• hypercalcemia (high levels of calcium in the blood)

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

• headache
• nausea
• abdominal pain or stomach cramps
• urinary tract infections
• pruritus

Rare side effects(can 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 alterations
• muscle weakness
• sensory disorders
• 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 prospectus. You can also report them directly through the Spanish System of 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 medication.

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. Disposeofthe packaging and medicines you no longer need at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Rocaltrol 0.25 micrograms:

• The active ingredient is calcitriol. Each soft capsule of Rocaltrol contains 0.25 micrograms of calcitriol.

• The other components are:

Caplet content: butylhydroxyanisole (E-320), butylhydroxytoluene (E-321), medium-chain triglycerides.

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

Appearance of the product and contents of the packaging

Rocaltrol 0.25 micrograms soft capsules are oval-shaped, soft gelatin capsules, with one half brown-orange to orange-red opaque and the other half white to light yellow-gray or light orange-gray opaque.

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

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

ATNAHS PHARMA NETHERLANDS B.V.

Copenhagen Towers, Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Responsible 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

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/