Alfacalcidol Zentiva

Patient Information Leaflet: Information for the User

Alfacalcidol Zentiva 0.25 micrograms soft capsules, 1 microgram soft capsules

Please read all of this leaflet carefully before 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. Never give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Alfacalcidol Zentiva is and what it is used for
2. What you need to know before taking Alfacalcidol Zentiva
3. How to take Alfacalcidol Zentiva
4. Possible side effects
5. How to store Alfacalcidol Zentiva
6. Contents of the pack and other information

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

Alfacalcidol Zentiva contains the active substance alfacalcidol. Alfacalcidol 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.
Alfacalcidol 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.
Alfacalcidol Zentiva is used to treat diseases in which it is necessary to adjust the amount of calcium in the body in children over 6 years of age, adolescents, and adults. This medicine is used to treat:

• Bone disorders caused by kidney failure (renal osteodystrophy and secondary hyperparathyroidism).
• Disorders of the parathyroid glands. These are small glands located in the neck that produce a substance called parathyroid hormone, which regulates the amount of calcium in your body.
  o The glands may reduce the amount of calcium in the blood (hypoparathyroidism).
• Weakening and softening of the bones due to calcium deficiency (rickets or osteomalacia).

2. What you need to know before taking Alfacalcidol Zentiva

Do not take Alfacalcidol Zentiva:

• If you are allergic to alfacalcidol, peanuts, soybeans, 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 have hyperphosphatemia (increased level of phosphate in the blood) (except in hypoparathyroidism), or hypermagnesemia (increased level of magnesium in the blood).

If you are unsure whether any of the above conditions apply to you, speak with your doctor before taking Alfacalcidol Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Alfacalcidol Zentiva:

• If you are taking any of the medicines listed in the section below “Other medicines and Alfacalcidol 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 while taking this medicine. Read section 4 of this leaflet so that you can recognize any signs that this might be happening to you.
Your doctor may need to adjust your dose.
During treatment with Alfacalcidol Zentiva, your doctor will regularly perform blood and urine tests. This is very important in children, patients with kidney problems, or patients taking a high dose of the medicine. These tests monitor calcium, phosphate, and other parameters in your blood and urine while taking the medicine.
Your doctor may prescribe another medicine called a phosphate binder to take together with Alfacalcidol Zentiva. This will help maintain the correct amount of phosphate in your blood.
Your doctor may also prescribe a calcium supplement to take together with Alfacalcidol Zentiva. This helps maintain the correct amount of calcium in your blood.
Other medicines and Alfacalcidol Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines purchased 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 Alfacalcidol 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 abnormal heartbeat.
• Cholestyramine: to lower cholesterol levels or to help block certain types of diarrhea or itching. Alfacalcidol Zentiva may not be absorbed into the blood as usual.
• Thiazide diuretics, medicines that increase urination: to increase the amount of water (urine) produced by the body. You may have too much calcium in your blood.
• Magnesium-containing antacids and laxatives: you may have too much magnesium in your blood.
• Medicines containing aluminium. These may reduce the intestinal absorption of Alfacalcidol 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 reduce body weight. It may decrease the absorption of vitamin D.

Alfacalcidol Zentiva should be administered at least 1 hour before or 4 to 6 hours after taking cholestyramine, colestipol, sucralfate, aluminium hydroxide, and aluminium-containing antacids (bile acid sequestrants) in order to minimize the potential risk of interaction.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Breastfeeding
Alfacalcidol Zentiva is excreted in breast milk; the decision to stop or avoid breastfeeding must be discussed with your doctor.
Driving and using machines
This medicine usually has a negligible effect on your ability to drive or use machines. However, since 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 impair your ability to drive or use machines.
Alfacalcidol Zentiva contains peanut oil, lecithin (soybean lecithin), ethanol, and sorbitol
Alfacalcidol Zentiva contains peanut oil and lecithin (soybean lecithin). If you are allergic to peanuts or soybeans, 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 exactly as prescribed by your doctor. If you have any doubts, consult 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 test results show that the medicine is working. If you have very low calcium levels in your blood, your doctor may prescribe 3 to 5 micrograms per day. Your doctor may also prescribe another medicine called a calcium supplement. This will help maintain the correct 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 more than 20 kg:
The usual starting dose is 0.25–0.50 micrograms per day.
Other pharmaceutical forms and dosage strengths of alfacalcidol are available for cases where a dose lower than 0.25 micrograms needs to be administered to children under 6 years of age and weighing 20 kg or less, or to children who are unable to swallow capsules.
It is necessary to monitor blood levels of calcium and phosphorus through blood tests. Speak with 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.
You may have too much calcium or phosphate in your blood. Read section 4 of this leaflet so that you can recognize any signs that this might be happening to you.
If you forget to take Alfacalcidolo Zentiva
Do not take a double dose to make up for the forgotten dose.
If you forget to take your medicine, take it as soon as you remember. Then take your next dose at the usual time.
If you stop taking Alfacalcidolo Zentiva
Treatment is usually long-term. Alfacalcidolo Zentiva should be taken regularly. Ask your doctor if you wish to stop taking the capsules.
If you have any further questions 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 side effects to be aware of:
You must seek urgent medical help if you experience any of the following symptoms. You may be
having 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 which could be due to
excess 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 heavily
• You have a headache
• You feel confused
• You feel drowsy
• You have a dry mouth or a metallic taste in your mouth.

Tell your doctor as soon as possible if you notice any of the following signs which could be due to
kidney problems. Kidney problems:

• Needing to urinate less often.
• Swelling anywhere in your body.
• Fever with pain in your side.

Kidney stones may form. Kidney stones can cause sudden, severe pain on 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)
• Itching
• 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
• Diarrhoea, vomiting, constipation, nausea
• Muscle pain
• Fatigue (tiredness)
• Calcinosis (calcium deposits in the body; hard bumps or nodules resembling pimples on the skin)
• Confusional state
• Feeling of weakness or malaise
• Kidney problem
• Nephrolithiasis (kidney stones)
• Nephrocalcinosis (formation of calcium deposits in the kidneys)

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

• Dizziness.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Alfacalcidol Zentiva

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines 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 Alfacalcidol Zentiva contains

• The active substance is alfacalcidol. Each soft capsule contains 0.25 micrograms or 1 microgram of alfacalcidol.
• The other components are: anhydrous citric acid (E330), all-rac-α-tocopherol (E307), propyl gallate (E310), anhydrous ethanol, and refined peanut oil (peanut oil) in the capsule filling; 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 colouring agents:
  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 Alfacalcidol Zentiva and contents of the pack
Alfacalcidol Zentiva 0.25 microgram capsule: brownish-red, oval-shaped soft gelatin capsules containing a clear, light yellow oily liquid. The size is approximately 10.4 mm x 5.6 mm.
Alfacalcidol Zentiva 1 microgram capsule: pale yellow, oval-shaped soft gelatin capsules containing a clear, light yellow oily liquid. The size is approximately 10.4 mm x 5.6 mm.
Alfacalcidol Zentiva is available in white opaque HDPE containers with white opaque HDPE screw caps and induction seals, in packs of 30 or 50 capsules.
White opaque HDPE containers with white opaque polypropylene (PP) screw caps and induction seals, in packs of 90 or 100 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano, Italy

Manufacturers
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 European Economic Area member states under the following names:
Alfacalcidol Strides 0.25 micrograms capsule, soft – Sweden
Alfacalcidol Strides 0.5 micrograms capsule, soft – Sweden
Alfacalcidol Strides 1 micrograms capsule, soft – Sweden
Alfacalcidol Strides 0.25 micrograms soft capsule – Finland
Alfacalcidol Strides 0.5 micrograms soft capsule – Finland
Alfacalcidol Strides 1 micrograms soft capsule – Finland
Alfacalcidol Strides – Norway
Alfacalcidol Zentiva 0.25 micrograms soft capsules – Romania
Alfacalcidol Zentiva 0.50 micrograms soft capsules – Romania
Alfacalcidol Zentiva 1 microgram soft capsules – Romania
Alfacalcidol Strides Pharma – Estonia
Alfacalcidol Strides Pharma 0.25 microgram soft capsules – Lithuania
Alfacalcidol Strides Pharma 0.5 microgram soft capsules – Lithuania
Alfacalcidol Strides Pharma 1 microgram soft capsule – Lithuania
Alfacalcidol Strides Pharma 0.25 microgram soft capsules – Latvia
Alfacalcidol Strides Pharma 0.5 microgram soft capsules – Latvia
Alfacalcidol Strides Pharma 1 microgram soft capsules – Latvia
Czech Republic ENZOLA
Slovakia Medirazin 1 microgram soft capsules
Italy Alfacalcidolo Zentiva