RAYALDEE 30 micrograms prolonged-release soft capsules

Introduction

Package Leaflet: Information for the Patient

Rayaldee 30micrograms prolonged-release soft capsules

Calcifediol

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 pack

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

1. What is Rayaldee and what is it used for

Rayaldee contains the active substance calcifediol, a form of vitamin D, classified as an antiparatyroide agent. Rayaldee is a "prolonged-release" capsule that slowly releases the active substance.

Rayaldee is used to treat secondary hyperparathyroidism in adultswith chronic kidney disease stage 3 or stage 4. In this disorder, the production of parathyroid hormone (PTH) increases abnormally.

Parathyroid hormone (PTH) plays an important role in controlling the amount of calcium in the bone. When the parathyroid glands produce too much parathyroid hormone, this can cause the loss of calcium from the bones. This can cause bone pain and fractures. Too much calcium in the blood can cause problems with blood vessels and heart, kidney stones, mental confusion, and coma. Rayaldee works by controlling parathyroid hormone levels in the body.

2. What you need to know before you take Rayaldee

Do not take Rayaldee

• if you are allergic to calcifediol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Rayaldee if:

• you have or have had high levels of calcium or phosphate in the blood.

Symptoms of high calcium levels include tiredness, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss.

• you have liver disease or require dialysis.

The safety and efficacy of Rayaldee in patients requiring dialysis or with liver disease have not been established yet.

Very low levels of parathyroid hormone for prolonged periods can lead to a type of abnormal bone structure. This is known as adynamic bone disease, which can only be diagnosed by biopsy. During treatment, your parathyroid hormone levels will be monitored. The dose of Rayaldee may be reduced if parathyroid hormone levels become too low.

Your doctor will need to perform blood tests to monitor your treatment.

Children and adolescents

Rayaldee is not recommended for use in children and adolescents under 18 years because the safety and efficacy have not been established yet.

Other medicines and Rayaldee

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the action of Rayaldee or increase the likelihood of side effects. It is particularly important that you tell your doctor if you are taking medicines such as:

• ketoconazole, itraconazole, voriconazole: used to treat fungal infections such as candida or candidiasis
• clarithromycin, telithromycin: used to treat bacterial infections
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir: used to treat HIV infections
• nefazodone: used to treat depression
• cholestyramine: used to reduce blood cholesterol levels
• heart medicines or medicines to reduce high blood pressure, such as

• digoxin
• diuretics with active substance names that mainly end in "thiazide" or "tizide"

• phenobarbital or other medicines used to prevent seizures

If you are taking medicines that contain calcium, vitamin D, or diuretics, your doctor may need to adjust your dose. If you are taking a medicine that contains digitalis, such as digoxin, your doctor may monitor your calcium levels more closely and adjust your dose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

Do not take Rayaldee without medical supervision. There is no indication that vitamin D is teratogenic in humans at therapeutic doses. If the recommended dose of Rayaldee (more than 2 capsules per day) is exceeded for a prolonged period, it may lead to excessive levels of vitamin D and/or hypercalcemia, which can cause, among other risks to the baby, physical and mental retardation.

Rayaldee has been prescribed to you only. Follow the administration instructions of Rayaldee indicated by your doctor or pharmacist exactly. If you need advice or more information, ask your doctor or pharmacist.

• Breastfeeding

Vitamin D and its metabolites are excreted in human milk. This should be considered when additional vitamin D is given to the breastfed infant. Your doctor will decide whether you should stop breastfeeding or stop treatment with Rayaldee.

Driving and using machines

Rayaldee has no or negligible influence on the ability to drive and use machines.

Rayaldee contains sorbitol

This medicine contains 18 mg of sorbitol in each capsule, which corresponds to 0.064 mg/mg.

Rayaldee contains ethanol

This medicine contains 3.944 mg of alcohol (ethanol) in each capsule, which is equivalent to 0.014 mg/mg (1.4% m/m). The amount of alcohol in one capsule of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will have no noticeable effect.

Rayaldee contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Rayaldee

Follow the administration instructions of this medicine indicated by your doctor exactly. If you are unsure, ask your doctor.

The recommended dose is

• initial dose: 1 capsule once a day
• maximum dose: 2 capsules once a day

Your doctorwill use the results of your laboratory tests to decide the correct dosefor you.

Once treatment with Rayaldee is started, your doctor will decide whether to adjust the dose, depending on how you respond to treatment.

Method of administration

The capsules should be swallowed whole with a glass of water, before bedtime, at least 2 hours after any meal.

If you take more Rayaldee than you should

Too much Rayaldee can lead to abnormally high levels of calcium in the blood, which can be harmful. Symptoms may include: feeling tired, difficulty thinking clearly, muscle weakness, irritability, loss of appetite, vomiting, constipation, and increased thirst.

Tell your doctor immediately if you have taken too much Rayaldee or experience any of these symptoms.

In case of overdose or accidental ingestion, call the Toxicological Information Service at phone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Rayaldee

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

Simply continue taking Rayaldee as previously indicated (dose and time) by your doctor.

If you stop treatment with Rayaldee

Do not stop treatment without your doctor's permission. It is important that you continue taking Rayaldee as indicated.

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

4. Possible side effects

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

Side effects have been reported with the following frequencies:

Common(may affect up to 1 in 10 people)

• constipation, nausea, diarrhea
• increased levels of calcium and phosphate in the blood

Uncommon(may affect up to 1 in 100 people)

• dizziness, headache, weakness
• decreased appetite, stomach upset
• dry mouth, vomiting

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Rayaldee

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

Do not store above 25°C.

Once opened, Rayaldee can be stored for up to 60 days.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rayaldee

• The active substance is calcifediol. Each capsule contains 30 micrograms of calcifediol as calcifediol monohydrate.
• The other ingredients are hard paraffin; liquid paraffin; hypromellose; glycerol monostearate; lauryl macrogolglycerides; anhydrous ethanol; butylhydroxytoluene; modified corn starch (hydroxypropyl starch); carrageenan; anhydrous disodium phosphate; sorbitol (E420) partially dehydrated liquid; brilliant blue FCF (E133); titanium dioxide; purified water.

Medium-chain triglyceride oil is used as a lubricant during manufacturing and may be present in the final formulation in trace amounts.

Appearance and packaging

Rayaldee is supplied in a round plastic bottle with a plastic pressure and twist cap and a heat-sealed inner lining and screw thread.

The Rayaldee capsules are blue and oval, 11.7 mm by 6.4 mm.

Package sizes are 30 capsules or a multipack of 90 capsules (3 packs of 30 capsules).

Not all pack sizes may be marketed.

Marketing authorisation holder

Vifor Fresenius Medical Care Renal Pharma France

100-101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

Manufacturer

Vifor France

100-101 Terrasse Boieldieu

Tour Franklin La Défense 8

92042 Paris La Défense Cedex

France

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Vifor Fresenius Medical Care Renal Pharma España, S.L.

Av. Diagonal 613, Planta 8

08028 Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet: December 2022

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