Patient information leaflet

Rayaldee 30 micrograms prolonged-release soft capsule

calcifediol
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rayaldee is and what it is used for
What you need to know before taking Rayaldee
How to take Rayaldee
Possible side effects
How to store Rayaldee
Contents of the pack and other information

1. What Rayaldee is and what it is used for

Rayaldee contains the active substance calcifediol, a form of vitamin D, classified as a parathyroid suppressive agent.
Rayaldee is a “prolonged-release” capsule that gradually releases the active substance.
Rayaldee is used to treat secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease. This is a condition in which the production of parathyroid hormone (PTH) is abnormally increased.
Parathyroid hormone (PTH) plays an important role in regulating the amount of calcium in the bones.
If the parathyroid glands produce too much parathyroid hormone, it can cause loss of calcium from the bones. This may lead to bone pain and fractures. Excess calcium in the blood can cause blood and cardiovascular problems, kidney stones, mental confusion, and coma.
Rayaldee works by controlling parathyroid hormone levels in the body.

2. What you need to know before taking Rayaldee

Do not take Rayaldee

if you are allergic to calcifediol or to 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 your blood. Symptoms of high blood calcium levels include fatigue, 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 yet been established.

Very low levels of parathyroid hormone over long periods may cause an abnormal type of bone structure.
This is known as adynamic bone disease, which can only be diagnosed by biopsy. Your parathyroid hormone levels will be monitored throughout your treatment. Your dose of Rayaldee may be reduced if your parathyroid hormone levels become very low.
To monitor your treatment, your doctor will need to perform blood tests.

Children and adolescents
Rayaldee is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not yet been established.

Other medicines and Rayaldee
Inform 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 make side effects more likely. It is essential to inform your doctor if you are taking medicines such as:

ketoconazole, itraconazole, voriconazole: used to treat fungal infections, such as 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 cholesterol levels in the blood
heart medications or medications to lower high blood pressure, such as
- digoxin
- diuretics with active substance names mostly ending in “thiazide” or “tizide”
phenobarbital or other medicines used to prevent seizures

Your doctor may need to adjust your dose if you are taking medications containing calcium, vitamin D, or diuretics. If you are taking medications containing digitalis, such as digoxin, your doctor may monitor your calcium levels more closely and may adjust your dose.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy Do not take Rayaldee without medical supervision. There is no evidence that vitamin D is teratogenic in humans at therapeutic doses. However, prolonged intake of doses exceeding the recommended dose of Rayaldee (more than 2 capsules per day) may lead to excessive levels of vitamin D and/or hypercalcemia, potentially resulting in delayed physical and mental development and other risks for the unborn child. Rayaldee has been prescribed specifically for you. Always take Rayaldee exactly as instructed by your doctor or pharmacist. For further information or advice, consult your doctor or pharmacist.
Breastfeeding Vitamin D and its metabolites are excreted in breast milk. This should be taken into account when administering additional vitamin D to a breastfed infant. Your doctor will decide whether to discontinue breastfeeding or treatment with Rayaldee.

Driving and using machines
Rayaldee has no effect or a negligible effect on the ability to drive and use machines.

Rayaldee contains sorbitol and ethanol
This medicine contains 18 mg of sorbitol per capsule, equivalent to 0.064 mg/mg.
This medicine contains 3.944 mg of alcohol (ethanol) in each capsule, equivalent to 0.014 mg/mg (1.4% w/w). The amount of this medicine in each capsule 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 observable effects.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially “sodium-free”.

3. How to take Rayaldee

Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor.

The recommended dose is

initial dose: 1 capsule once daily
maximum dose: 2 capsules once daily

Based on the results of your laboratory tests, your doctor will decide the appropriate dose for you. Once treatment with Rayaldee has started, your doctor will decide whether to adjust your dose depending on your response to treatment.

Instructions for use
Swallow the capsules whole with a glass of water, before going to bed, at least 2 hours after meals.

If you take more Rayaldee than you should
Taking too much Rayaldee may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms may include fatigue, difficulty thinking clearly, muscle weakness, irritability, loss of appetite, vomiting, constipation, and increased thirst.
Contact your doctor immediately if you have taken an excessive dose of Rayaldee or if you experience any of these symptoms.

If you forget to take Rayaldee
Do not take a double dose to make up for the missed dose.
Simply continue taking Rayaldee as previously prescribed by your doctor (dose and timing).

If you stop taking Rayaldee
Do not stop treatment without your doctor’s consent. It is important to continue taking Rayaldee as prescribed by your doctor.

If you have any questions about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported with the following frequencies:
Common (may affect up to 1 in 10 people):

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

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

dizziness, headache, weakness
loss of appetite, stomach discomfort
dry mouth, vomiting

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency. Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rayaldee

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
After opening, Rayaldee can be stored for up to 60 days.
Do not use this medicine after the expiry date stated on the label and carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rayaldee contains

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, lauric macrogol glycerides, anhydrous ethanol, butylated hydroxytoluene, modified starch (hydroxypropylated starch), carrageenan, anhydrous disodium hydrogen phosphate, partially dehydrated liquid sorbitol (E420), Brilliant Blue FCF (E133), titanium dioxide, purified water.

Medium-chain triglyceride oil is used as a lubricant during manufacturing,
and traces may be present in the final formulation.
Description of the appearance of Rayaldee and package contents
Rayaldee is supplied in a white round plastic bottle with a push-and-turn plastic closure, featuring screw threads and an inner heat-sealed seal.
Rayaldee capsules are blue, oval soft capsules measuring 11.7 mm by 6.4 mm.
The pack contains 30 capsules, while the multiple pack contains 90 capsules (3 packs of 30 capsules).
Not all pack sizes may be marketed.
Marketing Authorization 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
This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany Rayaldee 30 Mikrogramm Weichkapsel retardiert
Ireland Rayaldee 30 microgram prolonged-release capsule, soft
Italy Rayaldee 30 microgrammi capsula molle a rilascio prolungato
Spain Rayaldee 30 microgramos cápsula blanda de liberación prolongada
United Kingdom Rayaldee 30 microgram prolonged-release capsule, soft
(Northern Ireland)
Denmark Rayaldee 30 mikrogram depotkapsel, blød
Sweden Rayaldee 30 mikrogram depotkapsel, mjuk
Norway Rayaldee 30 mikrogram depotkapsel, myk
Portugal Rayaldee 30 microgramas cápsula mole de libertação prolongada
Netherlands Rayaldee 30 microgram zachte capsule met verlengde afgifte