ALFACALCIDOLO 0.25 micrograms Soft capsule

Зміст інструкції

1. Alfacalcidolo Zentiva 0.25 micrograms soft capsules, 1 microgram soft capsules
   1. What is Alfacalcidolo Zentiva and what it is used for
   2. What you need to know before taking Alfacalcidolo Zentiva
   3. How to take Alfacalcidolo Zentiva
   4. Possible side effects
   5. How to store Alfacalcidolo Zentiva
   6. Package contents and other information

Alfacalcidolo Zentiva 0.25 micrograms soft capsules, 1 microgram soft capsules

Read this leaflet carefully before you start 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 their symptoms are the same as yours because 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 Alfacalcidolo Zentiva is and what it is used for
• 2. What you need to know before you take Alfacalcidolo Zentiva
• 3. How to take Alfacalcidolo Zentiva
• 4. Possible side effects
• 5. How to store Alfacalcidolo Zentiva
• 6. Contents of the pack and other information

1. What is Alfacalcidolo Zentiva and what it is used for

Alfacalcidolo Zentiva contains the active ingredient alfacalcidol. Alfacalcidolo Zentiva belongs to a
group of medicines called vitamin D analogues. It is a type of vitamin D.
Vitamin D controls the levels of two substances in your body. These substances are called calcium and
phosphate. Your body needs both of these substances for healthy bones and teeth.
Alfacalcidolo Zentiva works by increasing the amount of vitamin D in your body. This means that
the levels of calcium and phosphate in your body will also increase.
Alfacalcidolo Zentiva is used for the treatment of diseases in which it is necessary to change the amount of
calcium in the body in children over 6 years of age, adolescents and adults. This medicine is
used to treat:

• Bone alterations caused by renal insufficiency (renal osteodystrophy and secondary hyperparathyroidism).
• Alterations of the parathyroid glands. These are small glands that are located in the neck and produce a substance called parathyroid hormone that changes the amount of calcium present in your body. or The glands can lower the amount of calcium in the blood (hypoparathyroidism).
• Weakening and deformities of the bones due to calcium deficiency (rickets or osteomalacia).

2. What you need to know before taking Alfacalcidolo Zentiva

Do not take Alfacalcidolo Zentiva:

• If you are allergic to alfacalcidol, peanuts, soy or any of the other ingredients of this medicine (listed in section 6).
• If you have signs of vitamin D toxicity.
• If you know you have a condition called hypercalcemia. Symptoms may include fatigue, nausea, vomiting, frequent need to urinate and headache. This means you have high levels of calcium in your blood.
• If you know you suffer from hyperphosphatemia (increased phosphate level in the blood) (except that of hypoparathyroidism), hypermagnesemia (increased magnesium level in the blood).

If you are not sure whether any of the above conditions apply to you, talk to your doctor before
taking Alfacalcidolo Zentiva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alfacalcidolo Zentiva:

• if you are taking any of the medicines in the following section “Other medicines and Alfacalcidolo Zentiva”.
• if you have kidney problems. This includes if you have kidney stones.
• if you have granulomas or sarcoidosis. You may be more sensitive to alfacalcidol.
• if you suffer from atherosclerosis (a condition in which the inside of the artery narrows).

You may have too much calcium or phosphate in your blood when taking this medicine. Read the section
The doctor may need to adjust the dose.
During treatment with Alfacalcidolo Zentiva, the doctor will regularly perform blood and
urine tests. This is very important in children, patients with kidney problems or patients who
are taking a high dose of medicine. This is to check the level of calcium, phosphate and
other parameters in the blood during the intake of the medicine and in the urine.
The doctor may prescribe you another medicine called a phosphate binder to take as well as
Alfacalcidolo Zentiva. This will help maintain the right amount of phosphate in your blood.
The doctor may also prescribe you a calcium supplement to take as well as Alfacalcidolo
Zentiva. This is to maintain the right amount of calcium in your blood.

Other medicines and Alfacalcidolo Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines you bought without a prescription.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Anticonvulsants: for epilepsy or seizures. A higher dose of Alfacalcidolo Zentiva may be needed.
• Barbiturates: for sleep disorders. A higher dose of alfacalcidol may be needed.
• Cardiac glycosides, such as digoxin: for heart problems. You may have too much calcium in your blood. This could cause an irregular heartbeat.
• Cholestyramine: to lower cholesterol levels or to help block some types of diarrhea or itching. Alfacalcidolo Zentiva may not be absorbed into the blood as usual.
• Thiazide diuretics, medicines that make you urinate: to increase the amount of water (urine) produced by the body. You may have too much calcium in your blood.
• Magnesium-based antacids and laxatives: you may have too much magnesium in your blood.
• Medicines containing aluminum. They can decrease the intestinal absorption of Alfacalcidolo Zentiva.
• Vitamin D or its analogues, calcium or calcium-containing preparations: for calcium deficiency. You may have too much calcium in your blood.
• Orlistat: to decrease body weight. It can decrease the absorption of vitamin D.

Alfacalcidolo Zentiva must be administered at least 1 hour before or 4 to 6 hours after taking
cholestyramine, colestipol, sucralfate, aluminum hydroxide and aluminum-based antacids
(bile acid sequestrants) in order to minimize the potential risk of interaction.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Breastfeeding
Alfacalcidolo Zentiva is excreted in breast milk; the decision to discontinue or abstain
from breastfeeding should be discussed with your doctor.

Driving and operating machinery
Usually your medicine may have a very limited effect on your ability to drive or operate
machinery. As dizziness is a possible side effect, you should take this into account when driving
or operating machinery. Consult your doctor if you experience any side effect that could
prevent you from driving or operating machinery.

Alfacalcidolo Zentiva contains peanut oil, lecithin (soy lecithin), ethanol and sorbitol
Alfacalcidolo Zentiva contains peanut oil and lecithin (soy lecithin). If you are allergic to peanuts or
soy, do not use this medicine.
It also contains sorbitol as an excipient. This medicine contains 10 mg of sorbitol in each
capsule.
This medicine contains 1 mg of alcohol (ethanol) in each capsule. The amount in the dose of
this medicine is equivalent to 0.5 ml of beer or 0.01 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

3. How to take Alfacalcidolo Zentiva

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is as follows:

Adults:
The usual starting dose is 0.25-0.50 micrograms per day.
Most people take between 0.25 and 1 microgram per day once blood tests show that the medicine is
working. If you have very low levels of calcium in your blood, your doctor may prescribe between 3 and 5
micrograms per day. Your doctor may also prescribe another medicine called a calcium supplement. This will
help maintain the right amount of calcium in your blood.

Elderly:
The usual starting dose is 0.25-0.5 micrograms per day.

Use in children over 6 years of age and weighing over 20 kg:
The usual starting dose is 0.25-0.50 micrograms per day.
Other pharmaceutical forms and dosages of alfacalcidol are available in cases where a dose
less than 0.25 micrograms needs to be administered to children under 6 years of age and weighing
equal to or less than 20 kg or to children who are unable to swallow the capsules.
It is necessary that the amount of calcium and phosphorus in the blood is monitored by blood tests. Talk
to your doctor.

Method of administration
For oral use.
Do not chew or crush the capsule.

If you take more Alfacalcidolo Zentiva than you should
Inform your doctor immediately. It may be necessary to stop taking this
medicine.
so that any signs that this could happen to you can be identified. .
If you forget to take Alfacalcidolo Zentiva
Do not take a double dose to make up for a missed dose.
If you forget to take the medicine, take it as soon as you remember. Then take the next
dose at the usual time.

If you stop taking Alfacalcidolo Zentiva
Normally the treatment should last for a long period. Alfacalcidolo Zentiva must be
taken regularly. Ask your doctor if you want to stop taking the capsule.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Important side effects to watch out for:
You should seek urgent medical attention if you experience any of the following symptoms. You may
have an allergic reaction if:

• You have difficulty breathing
• Your face or throat swells
• Your skin develops a severe rash.

Immediately inform your doctor if you notice any of the following signs that could be
due to an excess of calcium or phosphate in the blood:

• You feel weak or have muscle or bone pain
• You need to urinate more often
• You feel thirsty
• You feel tired (fatigued)
• You feel nauseous, vomit, have constipation or have lost your appetite
• You are sweating a lot
• You have a headache
• You feel confused
• You feel sleepy
• You have a dry mouth or a metallic taste in your mouth. Inform your doctor as soon as possible if you notice any of the following signs that could be due to problems developing in the kidneys. Kidney problems:
• Need to urinate less often.
• Swelling in any part of your body.
• Fever with pain in your side.

Kidney stones may form. Kidney stones can cause a sharp spasm in one side of the
lower back.
Other possible side effects include :
Common (may affect up to 1 in 10 people):

• Abdominal/stomach pain or discomfort
• Rash
• Hypercalciuria (painful sensation when urinating, abdominal pain, need to urinate frequently/urgently)
• Tingling
• Hypercalcemia (high level of calcium in the blood)
• Hyperphosphatemia (high level of phosphate in the blood)
• Itching

Uncommon (may affect up to 1 in 100 people):

• Headache
• Diarrhea, vomiting, constipation, nausea
• Muscle pain
• Fatigue (tiredness)
• Calcinosis (calcium deposits in the body; hard lumps or nodules similar to pimples on the skin)
• Confusional state
• Feeling weak or unwell.
• Kidney problem
• Nephrolithiasis (kidney stones)
• Nephrocalcinosis (formation of calcium deposits in the kidneys)

Rare (may affect up to 1 in 1,000):

• Dizziness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://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 Alfacalcidolo Zentiva

• 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 bottle after SCAD. The expiry date refers to the last day of that month.
• This medicine does not require particular storage conditions.
• Do not dispose of any medicine in waste water 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 Alfacalcidolo Zentiva contains

• The active ingredient is alfacalcidol. Each soft capsule contains 0.25 micrograms, 1 microgram of alfacalcidol.
• The other ingredients are: anhydrous citric acid (E330), tocopherol all-rac-α (E307), propyl gallate (E310), anhydrous ethanol and refined peanut oil (peanut oil) in the capsule; and gelatin (E441), glycerol (E422), partially dehydrated liquid sorbitol (E420), medium chain triglycerides, lecithin (soy lecithin) and titanium dioxide (E171) in the capsule shell. The capsule shell also contains the following colours: Capsules of 0.25 micrograms: red iron oxide (E172) and black iron oxide (E172) Capsules of 1 microgram: yellow iron oxide (E172)

Description of the appearance of Alfacalcidolo Zentiva and package contents
Alfacalcidolo Zentiva 0.25 microgram capsule: soft gelatin capsules of brownish-red colour, oval in shape, containing a transparent oily liquid of light yellow colour. The size is approximately 10.4 mm x 5.6 mm.
Alfacalcidolo Zentiva 1 microgram capsule: soft gelatin capsules of pale yellow colour, oval in shape, containing a transparent oily liquid of light yellow colour. The size is approximately 10.4 mm x 5.6 mm.
Alfacalcidolo Zentiva is available in an opaque white HDPE container, with an opaque white HDPE screw cap and induction seal in a pack of 30, 50 capsules.
Opaque white HDPE container, with an opaque white PP screw cap and induction seal in packs of 90, 100 capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan

Manufacturer
Zentiva k.s.,
U kabelovny 130,
Prague 102 00,
Czech Republic

Pharma Pack Hungary Kft.
Vasút utca 13., Budaörs,
H-2040,
Hungary

Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck, Germany

Santa S.A
Str. Carpatilor nr. 60,
obiectiv nr. 47, 48, 58, 133,
Municipiul Brasov, Judet Brasov,
cod 500269, Romania

This medicinal product is authorised in the member states of the European Economic Area under the following denominations:
Alfacalcidol Strides 0.25 micrograms capsule, soft
Sweden Alfacalcidol Strides 0.5 micrograms capsule, soft
Alfacalcidol Strides 1 micrograms capsule, soft
Alfacalcidol Strides 0.25 micrograms capsules, soft
Finland Alfacalcidol Strides 0.5 micrograms capsules, soft
Alfacalcidol Strides 1 micrograms capsules, soft
Norway Alfacalcidol Strides
Alfacalcidol Zentiva 0.25 microgram soft capsules
Romania Alfacalcidol Zentiva 0.50 microgram soft capsules
Alfacalcidol Zentiva 1 microgram soft capsules
Estonia Alfacalcidol Strides Pharma
Lithuania Alfacalcidol Strides Pharma 0.25 microgram soft capsules
Alfacalcidol Strides Pharma 0.5 microgram soft capsules
Alfacalcidol Strides Pharma 1 microgram soft capsules
Latvia Alfacalcidol Strides Pharma 0.25 microgram soft capsules
Alfacalcidol Strides Pharma 0.5 microgram soft capsules
Alfacalcidol Strides Pharma 1 microgram soft capsules
Czech Rep. ENZOLA
Slovakia Medirazin 1 microgram soft capsules
Italy Alfacalcidolo Zentiva