Paricalcitol Teva 1 microgram soft capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Paricalcitol Teva 1 microgram capsules soft EFG
Read all of this leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
What this leaflet contains:
- What Paricalcitol Teva is and what it is used for
- What you need to know before taking Paricalcitol Teva
- How to take Paricalcitol Teva
- Possible side effects
- How to store Paricalcitol Teva
- Contents of the pack and other information
1. What Paricalcitol Teva is and what it is 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 normally functioning kidneys, the active form of vitamin D is naturally synthesized in the kidney; however, in cases of kidney failure, the production of vitamin D is markedly reduced.
Paricalcitol provides a source of active vitamin D when the body cannot produce sufficient amounts, and helps prevent the consequences of low levels of active vitamin D, specifically elevated levels of parathyroid hormone, which may 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 starting Paricalcitol Teva
Do not take Paricalcitol Teva
- if you are allergic to paricalcitol or to any of the other ingredients of this medicine (listed in section 6)
- if you have very high levels of calcium or vitamin D in your blood
Your doctor will advise you if any of these conditions apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Paricalcitol Teva
- Before starting treatment, it is important that you limit the amount of phosphorus in your diet.
- You may need to use phosphate-binding agents to control phosphorus levels. If you are taking calcium-containing phosphate binders, your doctor may adjust your dose.
- Your doctor will carry out blood tests to monitor your treatment.
- In some patients with stage 3 and 4 chronic kidney disease, 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 need to take any other medicines.
Some medicines may affect the action of this medicine or may increase the likelihood of side effects. It is particularly important to inform your doctor if you are taking any of the following medicines:
- for treating fungal infections such as candida or oral thrush (e.g. ketoconazole)
- for treating heart problems or high blood pressure (e.g. digoxin, diuretics or medicines that remove fluid)
- containing a source of phosphate (e.g. medicines to reduce calcium levels in the blood)
- containing calcium or vitamin D, including supplements or multivitamins that can be
purchased without a prescription
- containing magnesium or aluminium (e.g. some medicines for indigestion (antacids) and medicines that bind phosphate)
- for treating high cholesterol levels (e.g. cholestyramine)
Paricalcitol Teva with food, drink and alcohol
Paricalcitol Teva may be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
There are insufficient data on the use of paricalcitol in pregnant women. The potential risk for human use 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 Teva contains 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 contained in this medicine does not produce any noticeable effect.
3. How to take Paricalcitol Teva
Follow exactly the administration instructions for this medicine as indicated by your doctor.
Consult 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 daily, or one capsule on alternate days up to a maximum of three times a week. Your doctor will use the results of certain laboratory tests to calculate the most appropriate dose for you. At the beginning of treatment with Paricalcitol Teva, a dose adjustment may be necessary depending on your response to treatment. Your doctor will determine the appropriate 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 certain laboratory tests to calculate the most appropriate dose for you. At the beginning of treatment with Paricalcitol Teva, a dose adjustment may be necessary depending on your response to treatment. Your doctor will determine the appropriate 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 is no data available in patients with severe liver disease.
Renal 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 certain laboratory tests to decide the correct dose for you. Once treatment with Paricalcitol Teva has started, a dose adjustment may be necessary 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 per week. Your doctor will use the results of laboratory tests to decide the correct dose. Once Paricalcitol Teva treatment is initiated, the dose may 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 has not been established in children with stage 5 chronic kidney disease.
There is no information on the use of Paricalcitol Teva capsules in children under 10 years of age.
Use in elderly patients
Experience with paricalcitol in patients over 65 years of age is limited. In general, no differences in efficacy or safety have been observed between patients over 65 years and younger patients.
If you take more Paricalcitol Teva than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
Excess Paricalcitol Teva may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may appear shortly after taking too much Paricalcitol Teva include a feeling of weakness and/or drowsiness, headache, nausea (stomach upset), or vomiting (feeling dizzy), dry mouth, constipation, muscle or bone pain, and a metallic taste in the mouth.
Symptoms that may develop over a longer period due to taking too much Paricalcitol Teva include loss of appetite, drowsiness, weight loss, eye pain, nasal discharge, itching, sensation of heat and fever, loss of sexual desire, and severe abdominal pain (due to inflammation of the pancreas) and kidney stones. Your blood pressure may be affected and you may experience 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 symptoms listed 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 dose, do not take the missed capsule and continue your treatment as normally scheduled (dose and time) as directed by your doctor.
Do not take a double dose to make up for missed doses.
If you stop taking Paricalcitol Teva
Unless your doctor tells you to stop treatment, it is important to take Paricalcitol Teva as directed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Paricalcitol Teva can cause adverse effects, although not everyone experiences them.
Important: Immediately tell your doctor if you notice any of the following adverse 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 adverse effects:
Frequent (may affect up to 1 in 10 people)
- Increased blood levels of a substance called calcium; in addition to prolonged calcium elevation, increased levels of another substance called phosphate may also occur (in patients with significant chronic kidney disease).
- Blood phosphate levels may also increase.
Uncommon (may affect up to 1 in 100 people)
- Pneumonia (lung infection)
- Decreased levels of parathyroid hormone
- Decreased appetite
- Decreased calcium levels
- Dizziness
- Altered taste
- 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 on palpation
- Weakness
- Feeling of fatigue, malaise
- Swelling in the legs
- Pain
- Increased creatinine levels
- Abnormal liver function tests
If you experience an allergic reaction, please contact your doctor immediately.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the container and label after EXP. The expiry date refers to the last day of the month indicated.
Use within 10 weeks after opening the vial.
Do not store above 25 °C.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your usual pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Paricalcitol Teva
- The active substance is paricalcitol.
Each soft capsule contains 1 microgram of paricalcitol.
-
The other components 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 of the product and contents of the container
Paricalcitol Teva 1 microgram soft capsules are oval, white to grey in colour, size 3, opaque, filled with a clear solution.
Paricalcitol Teva is available in HDPE bottles closed with a polypropylene screw cap and containing a desiccant, with 28 or 30 soft capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
TEVA PHARMA, S.L.U.
C/ Anabel Segura, 11
Edificio Albatros B, 1st floor,
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
The 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 medicinal product is authorized 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 latest review of this package leaflet: January 2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76707/P_76707.html