PARICALCITOL TEVA 1 MICROGRAM SOFT CAPSULES

Introduction

Package Leaflet: Information for the Patient

Paricalcitol Teva1 microgram soft capsules EFG

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 and other information:

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

1. What is Paricalcitol Teva and what is it used for

Paricalcitol Teva contains the active substance paricalcitol, which is a synthetic form of active vitamin D.

Active vitamin D is necessary for the proper functioning of many tissues in the body, including the parathyroid gland and bones. In people with normal kidney function, the active form of vitamin D is naturally synthesized in the kidney, but in the case of kidney failure, vitamin D production is markedly reduced.

Paricalcitol provides a source of active vitamin D when the body cannot produce enough and helps prevent the consequences of low levels of active vitamin D, specifically high levels of parathyroid hormone, which can cause bone problems. Paricalcitol Teva is used in adult patients with chronic kidney disease stages 3, 4, and 5 and in children aged 10 to 16 years with chronic kidney disease stages 3 and 4.

2. What you need to know before you take Paricalcitol Teva

Do not takeParicalcitol Teva

• if you are allergic to paricalcitol or any of the other ingredients of this medicine (listed in section 6)
• if you have very high levels of calcium or vitamin D in the blood

Your doctor will tell you if you are affected by these conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Paricalcitol Teva

• Before starting treatment, it is essential to limit the amount of phosphorus in your diet.
• You may need to use phosphorus binders to control phosphorus levels. If you are taking calcium-containing phosphorus binders, your doctor may adjust your dose.
• Your doctor will perform blood tests to monitor your treatment.
• In some patients with chronic kidney disease stages 3 and 4, an increase in blood levels of a substance called creatinine has been observed. However, this increase does not reflect a reduction in kidney function.

Other medicines and Paricalcitol Teva

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

Some medicines may affect the action of this medicine or increase the likelihood of side effects. It is particularly important to inform your doctor if you are taking any of the following medicines:

• to treat fungal infections such as thrush (e.g., ketoconazole)
• to treat heart problems or high blood pressure (e.g., digoxin, diuretics, or fluid-removing medicines)
• that contain a phosphate source (e.g., medicines to reduce calcium levels in the blood)
• that contain calcium or vitamin D, including supplements or multivitamins that can be bought without a prescription

which contain magnesium or aluminum (e.g., some antacids and phosphate binders)

• to treat high cholesterol (e.g., colestyramine)

Paricalcitol Tevawith food, drink, and alcohol

Paricalcitol Teva can be taken with or without food.

Pregnancy and breastfeeding

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

There is limited data on the use of paricalcitol in pregnant women. The potential risk for humans is unknown, therefore, paricalcitol should not be used unless strictly necessary. It is not known whether paricalcitol passes into human breast milk. If you are taking Paricalcitol Teva, inform your doctor before breastfeeding your child.

Driving and using machines

Paricalcitol Teva does not affect the ability to drive or use machines.

Paricalcitol Tevacontains ethanol

This medicine contains 1.42 mg of alcohol (ethanol) in each capsule, equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to take Paricalcitol Teva

Follow the instructions for administration of this medicine exactly as your doctor has told you.

Ask your doctor or pharmacist if you are unsure.

Chronic kidney disease, stages 3 and 4

In adult patients, the recommended initial dose is one capsule daily, or one capsule on alternate days, up to a maximum of three times a week. Your doctor will use the results of some laboratory tests to calculate the most suitable dose for you. At the start of treatment with Paricalcitol Teva, it is likely that you will need a dose adjustment, depending on your response to treatment. Your doctor will calculate the suitable dose of Paricalcitol Teva for you.

Chronic kidney disease, stage 5

In adult patients, the recommended initial dose is one capsule on alternate days, up to a maximum of three times a week. Your doctor will use the results of some laboratory tests to calculate the most suitable dose for you. At the start of treatment with Paricalcitol Teva, it is likely that you will need a dose adjustment, depending on your response to treatment. Your doctor will calculate the suitable dose of Paricalcitol Teva for you.

Liver disease

If you have mild or moderate liver disease, your dose will not need to be adjusted. However, there are no data in patients with severe liver disease.

Kidney transplant

The recommended dose is one capsule daily, or one capsule on alternate days, up to a maximum of three times a week. Your doctor will use the results of some laboratory tests to decide on the correct dose for you. Once treatment with Paricalcitol Teva has started, it is likely that you will need a dose adjustment, depending on your response to treatment. Your doctor will help you determine the correct dose of Paricalcitol Teva.

Use in children and adolescents

In children aged 10 to 16 years with chronic kidney disease stages 3 or 4, the recommended initial dose is one capsule on alternate days, up to three times a week. Your doctor will use the results of your laboratory tests to decide on the correct dose. Once Paricalcitol Teva has been started, it is likely that the dose will need to be adjusted, depending on how you respond to treatment. Your doctor will help you determine the correct dose of Paricalcitol Teva.

The efficacy of Paricalcitol Teva has not been established in children with chronic kidney disease stage 5.

There is no information on the use of Paricalcitol Teva capsules in children under 10 years of age.

Use in elderly patients

There is limited experience with the use of paricalcitol in patients over 65 years of age. In general, no differences in efficacy or safety were observed between patients over 65 years of age and those under 65.

If you take more Paricalcitol Teva than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

Taking too much Paricalcitol Teva may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may appear soon after taking too much Paricalcitol Teva may include a feeling of weakness and/or drowsiness, headache, nausea (stomach upset) or vomiting (feeling sick), dry mouth, constipation, muscle or bone pain, and a metallic taste in the mouth.

Symptoms that may develop over a long period of taking too much Paricalcitol Teva include loss of appetite, drowsiness, weight loss, eye pain, nasal discharge, itching, feeling hot, and fever, loss of sexual desire, and severe abdominal pain (due to pancreatitis) and kidney stones. Your blood pressure may be affected, and there may be irregular heartbeats (palpitations). Blood and urine tests may show high levels of cholesterol, urea, nitrogen, and elevated liver enzymes. Paricalcitol Teva may occasionally cause mental changes, including confusion, drowsiness, insomnia, or nervousness.

If you take more paricalcitol than you should, or experience any of the above symptoms, seek advice from your doctor immediately.

If you forget to take Paricalcitol Teva

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Continue with your treatment (dose and time) as your doctor has told you.

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

If you stop taking Paricalcitol Teva

Unless your doctor tells you to stop treatment, it is important to take Paricalcitol Teva as your doctor has told you.

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

4. Possible side effects

Like all medicines, Paricalcitol Teva can cause side effects, although not everybody gets them.

Important: Tell your doctor immediately if you notice any of the following side effects:

• Allergic reactions (such as shortness of breath, wheezing, rash, itching, or swelling of the face and lips)

Tell your doctor or nurse if you experience any of the following side effects:

Common (may affect up to 1 in 10 people)

• increased levels of calcium in the blood, in addition to increased calcium time, an increase in another substance called phosphate may occur (in patients with significant chronic kidney disease).
• phosphate levels in the blood may also increase.

Uncommon (may affect up to 1 in 100 people)

• pneumonia (lung infection)
• decreased levels of parathyroid hormone
• decreased appetite
• decreased levels of calcium
• dizziness
• unusual taste in the mouth
• headache
• irregular heartbeat
• stomach discomfort or pain
• constipation
• diarrhea
• dry mouth
• heartburn (reflux or indigestion)
• nausea
• vomiting
• acne
• itching of the skin
• rash
• hives
• muscle cramps
• muscle pain
• breast tenderness
• weakness
• feeling tired, unwell
• swelling in the legs
• pain
• increased levels of creatinine
• abnormal liver function tests

If you experience an allergic reaction, please contact your doctor immediately.

Reporting of side effects

If you get 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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paricalcitol Teva

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

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

Use within 10 weeks after opening the bottle.

Do not store above 25°C.

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

6. Contents of the pack and further information

Composition of Paricalcitol Teva

• The active substance is paricalcitol

Each soft capsule contains 1 microgram of paricalcitol

• The other ingredients are medium-chain triglycerides, anhydrous ethanol, butylhydroxytoluene (E321).
• The capsule shell contains: gelatin, glycerol, purified water, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172)

Appearance and packaging of the product

Paricalcitol Teva 1 microgram soft capsules are oval, white to gray, size 3, opaque, filled with a clear solution.

Paricalcitol Teva is available in HDPE bottles with a screw cap and desiccant inside, containing 28 or 30 soft capsules.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

TEVA PHARMA, S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid

Spain

Manufacturer

Merckle GmbH,

Ludwig-Merckle-Str. 3, 89143 Blaubeuren

Germany

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Czech Industries s.r.o.

Ostravska 29, c.p. 305, 74770 Opava-Komarov

Czech Republic

or

Teva Operations Poland Sp. z.o.o.

ul. Mogilska 80, Krakow, 31-546

Poland

This medicine is authorised in the Member States of the European Economic Area under the following names:

Bulgaria TevaPariVitGermany Paricalcito-ratiopharm

Spain Paricalcitol Teva

Italy Paracalcitolo Teva Italia

Date of last revision of this leaflet:January 2023

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/

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76707/P_76707.html

)