Patient Information Leaflet

Paricalcitol Teva1 microgram soft capsules EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as 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 give it to others, even if they have the same symptoms of the disease, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Paricalcitol Teva

3.How to take Paricalcitol Teva

4.Possible side effects

5.Storage of Paricalcitol Teva

6.Contents of the pack and additional information

Paricalcitol Tevacontains the active ingredient paricalcitol, which is a synthetic form of the 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 cases of renal failure, vitamin D production is markedly reduced.

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

Do not takeParicalcitol Teva

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

Your doctor will tell you if these conditions affect you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paricalcitol Teva

• Before starting treatment, it is essential to limit the amount of phosphorus in your diet.
• You may need to use phosphate-binding agents to control your phosphorus levels. If you are taking phosphate-binding agents with calcium content, your doctor may adjust your dose.
• Your doctor will perform blood tests to monitor your treatment.
• In some patients with chronic kidney disease in 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 renal function.

Other medications and Paricalcitol Teva

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

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

• to treat fungal infections such as candida or mouth ulcers (e.g., ketoconazole)
• to treat heart problems or high blood pressure (e.g., digoxin, diuretics, or medications that remove fluids)
• that contain a source of phosphate (e.g., medications to lower calcium levels in the blood)
• that contain calcium or vitamin D, including supplements or multivitamins that can be purchased without a prescription

that can be purchased without a prescription

• that contain magnesium or aluminum (e.g., some medications for indigestion (antacids) and medications that bind to phosphorus)
• to treat high cholesterol (e.g., cholestyramine)

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, consult your doctor or pharmacist before using this medication.

There are insufficient data on the use of paricalcitol in pregnant women. The potential risk for human use is unknown, so paricalcitol should not be used unless strictly necessary.

It is not known if paricalcitol passes into human breast milk. If you are taking Paricalcitol Teva, inform your doctor before breastfeeding your child.

Driving and operating machines

Paricalcitol Teva does not affect your ability to drive or operate machines.

Paricalcitol Tevacontains ethanol

This medication 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 medication does not produce any noticeable effect.

Follow exactly the administration instructions of this medication as indicated by your doctor.

Consult with your doctor or pharmacist if you have any doubts.

Chronic kidney disease, stages 3 and 4

In adult patients, the recommended initial dose is one capsule per day, or one capsule every other day up to a maximum of three times a week.Your doctor will use the results of some laboratory tests to calculate the most appropriate dose for you.At the beginning 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 appropriate dose of Paricalcitol Teva for you.

Chronic kidney disease, stage 5

In adult patients, the recommended initial dose is one capsule every other day, up to a maximum of three times a week.Your doctor will use the results of some laboratory tests to calculate the most appropriate dose for you.At the beginning 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 appropriate dose of Paricalcitol Teva for you.

Liver disease

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

Renal transplant

The recommended dose is one capsule per day, or one capsule every other day 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 begun, it is likely that you will need a dose adjustment based 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 every other day, 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 begun, it is likely that the dose will need to be adjusted, depending on your response to treatment.Your doctor will help you determine the correct dose of Paricalcitol Teva.

The efficacy of Paricalcitol Teva in children with CKD stage 5 has not been established.

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 or more.In general, no differences in efficacy or safety were observed between patients over 65 years and younger patients.

If you take more Paricalcitol Teva than you should

If you experience an overdose or accidental ingestion, consult your doctor or pharmacist immediately.or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

The symptoms that may develop over a long period by taking too much Paricalcitol Teva include loss of appetite, drowsiness, weight loss, eye pain, nasal discharge, itching, feeling of heat and fever, loss of sexual desire, and severe abdominal pain (due to pancreatitis inflammation) and kidney stones.Your blood pressure may be affected and irregular heartbeats (palpitations) may occur.The results of 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 symptoms mentioned above, 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 capsule, do not take the forgotten capsule and continue with the treatment (dose and time) as indicated by your doctor.

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

If you interrupt treatment with Paricalcitol Teva

Unless your doctor tells you to stop treatment, it is essential to take Paricalcitol Teva as indicated by your doctor.

If you have any other doubts about the use of thismedication, ask your doctororpharmacist

Like all medications, Paricalcitol Teva may cause side effects, although not everyone will experience them.

Important: Inform 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)

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

Frequent (may affect up to 1 in 10 people)

• Increased levels of a substance called calcium in the blood, as well as increased calcium time, may also occur increased levels of another substance called phosphate (in patients with significant chronic kidney disease).
• Levels of phosphate in the blood may also increase.

Infrequent (may affect up to 1 in 100 people)

• Pneumonia (lung infection)
• Decreased levels of parathyroid hormone
• Decreased appetite
• Decreased calcium levels
• Dizziness
• Unusual taste in the mouth
• Headache
• Irregular heartbeat
• Abdominal discomfort or pain
• Constipation
• Diarrea
• Dry mouth
• Heartburn (reflux or indigestion)
• Nausea
• Vomiting
• Acne
• Itching skin
• Rash
• Hives
• Muscle cramps
• Muscle pain
• Palpable breast pain
• Weakness
• Feeling of fatigue, discomfort
• Swelling in the legs
• Pain
• Increased levels of creatinine
• Abnormalities in liver function tests

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

Reporting side effects

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packagingand labelafter CAD. The expiration date is the last day of the month indicated.

Use within 10 weeks after opening the bottle.

Do not store above 25 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at your local SIGRE collection pointat your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition of Paricalcitol Teva

• The active ingredient is paricalcitol

Each soft capsule contains 1 microgram of paricalcitol

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

TEVA PHARMA, S.L.U.

C/ Anabel Segura, 11

Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid

Spain

Responsible for manufacturing

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 authorized in the member states of the European Economic Area with the following names:

BulgariaTevaPariVitGermanyParicalcito-ratiopharm

SpainParicalcitol Teva

ItalyParacalcitolo Teva Italia

Last review date of thisleaflet:January 2023

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

You can access detailed and updated information about 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

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