PARACALCITOLO 1 MICROGRAMMO Soft capsule

Зміст інструкції

1. Paracalcitolo Teva Italia 1 microgram capsule, 2 microgram capsule
   1. What is Paracalcitolo Teva Italia and what is it 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

Paracalcitolo Teva Italia 1 microgram capsule, 2 microgram capsule

Generic medicine
Read this leaflet carefully before taking this medicine as 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 others, even if they have the same symptoms as you, as it may be harmful
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Paracalcitolo Teva Italia and what is it used for

Paracalcitolo Teva Italia contains the active ingredient paracalcitol, a synthetic form of
active Vitamin D.
Active Vitamin D is necessary for the normal functioning of many tissues
in the body, including the parathyroid gland and bones. In subjects with normal
kidney function, this active form of Vitamin D is produced naturally by
the kidneys, but 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, in cases where
the body is unable to produce enough of it and helps to prevent the
consequences of reduced levels of active vitamin D, namely elevated levels of parathyroid hormone, which
can cause bone problems. Paracalcitolo Teva Italia is indicated in adult patients with
kidney disease in Stages 3, 4 and 5 and in children aged between 10 and 16 years with
kidney disease in 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 any of the other ingredients of this medicine (listed in section 6)
• if you have a very high level of calcium or vitamin D in your blood.

The doctor will be able to tell you if these conditions are relevant 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.
• To control phosphorus levels, it may be necessary to take phosphate binders. If you are taking medicines that bind to phosphate containing calcium, your doctor may need to adjust the dose.
• The doctor will need to perform some blood tests to monitor your treatment.
• In some patients with chronic kidney failure stage 3 and 4, an increase in blood levels of a substance called creatinine has been observed. However, this increase is not reflected in a decrease 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 occurring. It is particularly important that you
tell your doctor if you are taking any of the following medicines:

• to treat fungal infections such as candidiasis or thrush (e.g. ketoconazole)
• to treat heart problems or high blood pressure (e.g. digoxin, and diuretics)
• that contain a source of phosphates (e.g. medicines to reduce calcium levels in the blood)
• that contain calcium or Vitamin D, including supplements and multivitamins that can be purchased without a prescription
• that contain magnesium or aluminum (e.g. some medicines for digestion (antacids) and phosphate binders)
• to reduce cholesterol levels (e.g. cholestyramine).

Paracalcitolo Teva Italia with food and drink
Paracalcitolo Teva Italia can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
There are no adequate data on the use of paracalcitol in pregnant women. The potential
risk associated with human use is unknown, therefore paracalcitol should not be used unless
clearly necessary.
It is not known whether paracalcitol is excreted in breast milk. Before breastfeeding during
the period of taking Paracalcitolo Teva Italia, talk to your doctor.

Driving and using machines
Paracalcitolo Teva Italia should not affect your ability to drive or operate
machinery.

Paracalcitolo Teva Italia contains ethanol
This medicine contains 1.42 mg of alcohol (ethanol) in each capsule. The amount in one
capsule of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small
amount of alcohol in this medicine will not produce significant effects.

3. How to take Paracalcitolo Teva Italia

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.

Chronic Kidney Insufficiency Stage 3 and 4
In adult patients, the recommended initial dose is one capsule a day every day, or
one capsule on alternate days up to three times a week. The doctor will decide the correct
dose for you based on the results of laboratory tests. Once you have started treatment
with Paracalcitolo Teva Italia, it is likely that the dose will need to be adjusted, based on
your response to treatment. Your doctor will help you establish what is the correct dose of Paracalcitolo
Teva Italia for you.

Chronic Kidney Insufficiency, Stage 5
In adult patients, the recommended initial dose is one capsule on alternate days, up to three times
a week. The doctor will decide the correct dose for you based on the results of laboratory tests.
Once you have started treatment with Paracalcitolo Teva Italia, it is likely that
the dose will need to be adjusted, based on your response to treatment. Your doctor will
help you establish what is the correct dose of Paracalcitolo Teva Italia for you.

Liver disease
If you suffer from mild to moderate liver disease, your dose should not
be adjusted. There is no experience in patients with severe liver disease.

Kidney transplant
The recommended dose is one capsule a day every day, or one capsule on alternate days
up to three times a week. The doctor will decide the correct dose for you based on the
results of laboratory tests. Once you have started treatment with Paracalcitolo
Teva Italia, it is likely that the dose will need to be adjusted, based on your response to
treatment. Your doctor will help you establish what is the correct dose of Paracalcitolo Teva Italia
for you.

Use in children and adolescents
In children aged between 10 and 16 years with chronic kidney disease (CKD)
in Stages 3 and 4, the recommended initial dose is one capsule on alternate days, up to three times
a week. Your doctor will decide the appropriate dose for you based on the results of
laboratory tests. Once therapy with Paracalcitolo Teva Italia has started, it is likely that
the dose will be adjusted, depending on how you respond to treatment.
The doctor will help you determine the appropriate dose of Paracalcitolo Teva Italia.
The efficacy of Paracalcitolo Teva Italia in children with CKD at Stage 5 has not been established.
There is no information on the use of Paracalcitolo Teva Italia capsules in children under the age of
10 years.

Use in the elderly
Experience relating to the use of paracalcitol in patients aged 65 years or older is
limited. In general, no overall differences have been observed in terms of efficacy
or safety of the drug between patients aged 65 years or older and younger patients.

If you take more Paracalcitolo Teva Italia than you should
Taking an excessive dose of Paracalcitolo Teva Italia can cause an abnormal increase
in calcium levels in the blood, which can be harmful. Symptoms that may
occur shortly after taking an excessive dose of Paracalcitolo Teva Italia may
include feeling of weakness and/or drowsiness, headache, nausea or vomiting, dryness of the
mouth, constipation, muscle or bone pain, and a metallic taste in the mouth.
Symptoms that can develop over a longer period of taking an
excessive dose of Paracalcitolo Teva Italia include loss of appetite, drowsiness, weight loss, eye pain, runny nose, itchy skin, feeling of heat and fever,
loss of sexual drive and 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 high levels of cholesterol, urea, nitrogen and increased levels of
liver enzymes. In rare cases, Paracalcitolo Teva Italia can cause mental changes that
include confusion, drowsiness, insomnia or nervousness.
If you take an excessive dose of Paracalcitolo Teva Italia or experience any of the
above-mentioned effects, 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 to take the next dose, do not take the forgotten one; simply
continue to take Paracalcitolo Teva Italia as previously indicated (dose and time) by
the doctor.
Do not take a double dose to make up for a missed dose.

If you stop taking Paracalcitolo Teva Italia
Unless your doctor tells you to stop treatment, it is important that you
continue to take Paracalcitolo Teva Italia following your doctor's instructions.
If you have any doubts about the use of 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: Tell your doctor immediately 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).

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the package and
on the 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 at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paracalcitolo Teva Italia contains:

• The active ingredient 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 contents of the pack
Paracalcitolo Teva Italia 1 microgram soft capsules are size 3, oblong, in a
whitish to light grey colour, opaque, filled with a clear solution.
Paracalcitolo Teva Italia 2 micrograms soft capsules are size 3, oval, in a
light orange colour, opaque, filled with a clear solution.
Paracalcitolo Teva Italia is available in capsules in an HDPE bottle with a
screw cap made of polypropylene with a desiccant inserted containing 28 or 30 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan
Italy
Manufacturer:
TEVA Pharmaceutical Works Private Limited Company
Debrecen Pallagi út 13,
H-4042
Hungary
Pharmachemie B.V.
Swensweg 5, Haarlem
2031 GA
Netherlands
Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305, Opava-Komarov
74770
Czech Republic
Merckle GmbH
Ludwig-Merckle-Straße 3, Blaubeuren
89143
Germany
Teva Operations Poland Sp. z.o.o.
ul. Mogilska 80., Krakow
31-546
Poland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Bulgaria TevaPariVit
Germany Paricalcitol-ratiopharm
Spain Paricalcitol Teva
Italy Paracalcitolo Teva Italia