Package leaflet: Information for the patient

Paracalcitolo Teva Italia 1 microgram capsule, 2 microgram capsules

Generic medicine
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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:
1 What Paracalcitolo Teva Italia is and what it is used for
2 What you need to know before taking Paracalcitolo Teva Italia
3 How to take Paracalcitolo Teva Italia
4 Possible side effects
5 How to store Paracalcitolo Teva Italia
6 Contents of the pack and other information

1. What Paracalcitolo Teva Italia is and what it is used for

Paracalcitolo Teva Italia contains the active substance paracalcitol, a synthetic form of active vitamin D.
Active vitamin D is necessary for the normal functioning of many body tissues, including the parathyroid gland and bones. In individuals with normal kidney function, this active form of vitamin D is naturally produced by the kidneys. However, in cases of kidney failure, the production of active vitamin D is significantly reduced. Paracalcitolo Teva Italia therefore provides a source of active vitamin D when the body is unable to produce sufficient amounts on its own, helping to prevent the consequences of low levels of active vitamin D—such as elevated levels of parathyroid hormone—which can lead to bone problems. Paracalcitolo Teva Italia is indicated in adult patients with kidney disease at Stages 3, 4, and 5, and in children aged 10 to 16 years with kidney disease at Stages 3 and 4.

2. What you need to know before taking Paracalcitolo Teva Italia

Do not take Paracalcitolo Teva Italia

if you are allergic to paracalcitol 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 can advise you whether these conditions apply to your case.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paracalcitolo Teva Italia

Before starting treatment, it is important to limit the amount of phosphorus in your diet.
You may need to take phosphate binders to control phosphorus levels. If you are taking phosphate-binding medicines containing calcium, your doctor may need to adjust the dose.
Your doctor will need to carry out certain 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 decline in kidney function.

Other medicines and Paracalcitolo Teva Italia
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 this medicine or increase the likelihood of side effects. It is particularly important that you inform your doctor if you are taking any of the following medicines:

medicines used to treat fungal infections such as candida or thrush (e.g. ketoconazole)
medicines used to treat heart problems or high blood pressure (e.g. digoxin and diuretics)
medicines containing a source of phosphates (e.g. medicines to reduce calcium levels in the blood)
medicines containing calcium or vitamin D, including supplements and multivitamins that can be purchased without a prescription
medicines containing magnesium or aluminium (e.g. certain digestive medicines (antacids) and phosphate binders)
medicines used to reduce cholesterol levels (e.g. cholestyramine).

Paracalcitolo Teva Italia with food and drinks
Paracalcitolo Teva Italia can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There are inadequate data on the use of paracalcitol in pregnant women. The potential risk for humans is unknown; therefore, paracalcitol should not be used unless clearly necessary.
It is not known whether paracalcitol is excreted in breast milk. Talk to your doctor before breastfeeding during treatment with Paracalcitolo Teva Italia.
Driving and using machines
Paracalcitolo Teva Italia is unlikely to affect your ability to drive or use machinery.
Paracalcitolo Teva Italia contains ethanol
This medicine contains 1.42 mg of alcohol (ethanol) per capsule. The amount in one capsule is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

3. How to take Paracalcitolo Teva Italia

Take this medicine exactly as directed by your doctor. If you have
doubts, consult your doctor or pharmacist.
Chronic Kidney Disease Stage 3 and 4
In adult patients, the recommended starting dose is one capsule daily, or one capsule on alternate days up to three times a week. Your doctor will decide the correct dose for you based on laboratory test results. Once you have started treatment with Paracalcitolo Teva Italia, your dose may need to be adjusted depending on your response to treatment. Your doctor will help you determine the correct dose of Paracalcitolo Teva Italia for you.
Chronic Kidney Disease, Stage 5
In adult patients, the recommended starting dose is one capsule on alternate days, up to three times a week. Your doctor will decide the correct dose for you based on laboratory test results. Once you have started treatment with Paracalcitolo Teva Italia, your dose may need to be adjusted depending on your response to treatment. Your doctor will help you determine the correct dose of Paracalcitolo Teva Italia for you.
Liver disease
If you have mild to moderate liver disease, your dose does not need to be adjusted. There is no experience in patients with severe liver disease.
Kidney transplant
The recommended dose is one capsule daily, or one capsule on alternate days up to three times a week. Your doctor will decide the correct dose for you based on laboratory test results. Once you have started treatment with Paracalcitolo Teva Italia, your dose may need to be adjusted depending on your response to treatment. Your doctor will help you determine the correct dose of Paracalcitolo Teva Italia for you.
Use in children and adolescents
In children aged 10 to 16 years with chronic kidney disease (CKD) at Stages 3 and 4, the recommended starting dose is one capsule on alternate days, up to three times a week. Your doctor will decide the appropriate dose for you based on laboratory test results. Once treatment with Paracalcitolo Teva Italia has started, the dose may need to be adjusted depending on your response to treatment. Your doctor will help you determine the appropriate dose of Paracalcitolo Teva Italia.
The efficacy of Paracalcitolo Teva Italia in children with CKD Stage 5 has not been established. There is no information on the use of Paracalcitolo Teva Italia capsules in children under 10 years of age.
Use in the elderly
Experience with paracalcitol in patients aged 65 years and older is limited. In general, no overall differences in efficacy or safety of the medicine have been observed between patients aged 65 years and older and younger patients.
If you take more Paracalcitolo Teva Italia than you should
Taking an excessive dose of Paracalcitolo Teva Italia may cause abnormally high levels of calcium in the blood, which can be harmful. Symptoms that may occur shortly after taking an excessive dose of Paracalcitolo Teva Italia may include weakness and/or drowsiness, headache, nausea or vomiting, dry mouth, constipation, muscle or bone pain, and a metallic taste in the mouth.
Symptoms that may develop over a longer period of excessive dosing of Paracalcitolo Teva Italia include loss of appetite, drowsiness, weight loss, eye pain, runny nose, skin itching, feeling hot and fever, loss of sexual drive, severe abdominal pain (due to inflammation of the pancreas), and kidney stones. Effects on blood pressure and irregular heartbeat (palpitations) may occur. Blood and urine tests may show elevated levels of cholesterol, urea, nitrogen, and increased liver enzymes. In rare cases, Paracalcitolo Teva Italia may cause mental changes including confusion, drowsiness, insomnia, or nervousness.
If you take an excessive dose of Paracalcitolo Teva Italia or experience any of the symptoms listed above, consult a doctor immediately.
If you forget to take Paracalcitolo Teva Italia
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; simply continue taking Paracalcitolo Teva Italia as previously instructed by your doctor (dose and timing).
Do not take a double dose to make up for the forgotten dose.
If you stop taking Paracalcitolo Teva Italia
Unless your doctor tells you to stop treatment, it is important that you continue taking Paracalcitolo Teva Italia as directed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important: Immediately inform your doctor if you notice any of the following side effects:

allergic reactions (such as shortness of breath, wheezing, skin rash, itching, swelling of the face and lips).

Inform your doctor or nurse if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

increased levels in the blood of a substance called calcium, as well as increased levels of another substance in the blood called phosphate (in patients with significant chronic kidney disease); phosphate levels may also rise.
Uncommon (may affect up to 1 in 100 people)
pneumonia (lung infection)
hypersensitivity reactions
decreased levels of parathyroid hormone in the blood
decreased appetite
decreased calcium levels
dizziness
altered taste in the mouth
headache
irregular heartbeat
stomach discomfort or pain
constipation
diarrhoea
dry mouth
heartburn (reflux or indigestion)
nausea
vomiting
acne
skin itching
skin rash
urticaria
muscle cramps
muscle pain
breast tenderness
weakness
fatigue, feeling unwell
swelling in the legs
pain
increased creatinine levels
changes in liver function tests.

If you experience an allergic reaction, please contact your doctor immediately.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
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 Paracalcitolo Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and
label after EXP. The expiry date refers to the last day of that month.
Use within 10 weeks of first opening the bottle.
Do not store above 25°C.
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 Paracalcitolo Teva Italia contains:

The active substance is paracalcitol. 1 microgram: each capsule contains 1 microgram of paracalcitol. 2 micrograms: each capsule contains 2 micrograms of paracalcitol.
The other ingredients are: medium-chain triglycerides, anhydrous ethanol, butylhydroxytoluene (E321).
The capsule shell contains: 1 microgram: gelatin, glycerol, purified water, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172). 2 micrograms: gelatin, glycerol, purified water, titanium dioxide (E171), black iron oxide (E172), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Paracalcitolo Teva Italia and package contents
Paracalcitolo Teva Italia 1 microgram soft capsules, size 3, oblong, white to light grey in colour, opaque, filled with a clear solution.
Paracalcitolo Teva Italia 2 microgram soft capsules, size 3, oval, light orange in colour, opaque, filled with a clear solution.
Paracalcitolo Teva Italia is available in HDPE bottles with polypropylene screw caps and a desiccant, containing 28 or 30 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy

Manufacturers:
TEVA Pharmaceutical Works Private Limited Company
Debrecen Pallagi út 13,
H-4042
Hungary
Pharmachemie B.V.
Swensweg 5, Haarlem
2031 GA
The Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, Opava-Komarov
Czech Republic
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
Germany
Teva Operations Poland Sp. z.o.o.
ul. Mogilska 80, Krakow
31-546
Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Bulgaria TevaPariVit
Germany Paricalcitol-ratiopharm
Spain Paricalcitol Teva
Italy Paracalcitolo Teva Italia