Colecalciferol Zentiva Srl

Patient Information Leaflet

Colecalciferolo Zentiva Srl 20,000 IU soft capsules

colecalciferol (vitamin D)
Please read 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Colecalciferolo Zentiva Srl is and what it is used for

Colecalciferolo Zentiva Srl contains the active substance colecalciferol (vitamin D3), which regulates calcium absorption and metabolism, as well as calcium incorporation into bone tissue.
Colecalciferolo Zentiva Srl is used for the initial treatment of clinically significant vitamin D deficiency in adults.

2. What you need to know before taking Colecalciferolo Zentiva Srl

Do not take Colecalciferolo Zentiva Srl:

• if you are allergic to colecalciferol (vitamin D), peanuts, or soy, or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of vitamin D in the blood (hypervitaminosis D);
• if you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria);
• if you have calcium deposits in the kidneys (nephrocalcinosis);
• if you suffer from kidney stones or severe kidney problems.

If any of the conditions listed above apply to you, do not take Colecalciferolo Zentiva Srl.
Warnings and precautions
Talk to your doctor or pharmacist before taking Colecalciferolo Zentiva Srl:

• if you have kidney problems or have had kidney stones. Your doctor will need to measure calcium levels in your blood or urine;

• if you are being treated for a heart condition;

• if your ability to move is severely limited, as in such cases there is a risk of high calcium levels in the blood (hypercalcemia) or high calcium levels in the urine (hypercalciuria);

• if you have sarcoidosis (a disorder of the immune system that may affect the liver, lungs, skin, or lymph nodes);

• if you are taking medicines and/or dietary supplements containing vitamin D and calcium, or eating foods fortified with vitamin D; while taking Colecalciferolo Zentiva Srl, your doctor will monitor vitamin D and calcium levels in your blood to ensure they do not become too high;

• if you suffer from pseudohypoparathyroidism (a rare genetic disorder in which the body's metabolism does not respond to parathyroid hormone (PTH)).

Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
Other medicines and Colecalciferolo Zentiva Srl
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, the following medicines may interact with Colecalciferolo Zentiva Srl:

• Medicines for the heart (cardiac glycosides such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure calcium levels in your blood.
• Thiazide diuretics (used to treat high blood pressure) reduce urinary excretion of calcium and may increase the risk of hypercalcemia.
• Medicines used to treat epilepsy (such as phenytoin) or medicines to induce sleep (barbiturates such as phenobarbital) may reduce the effects of vitamin D.
• Glucocorticoids (steroid hormones such as hydrocortisone or prednisolone) may reduce the effects of vitamin D.
• Laxatives (such as liquid paraffin) or cholesterol-lowering drugs (cholestyramine, colestipol), orlistat, may reduce the absorption of vitamin D.
• Actinomycin (a medicine used to treat certain forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases) may interfere with vitamin D metabolism.
• Medicines used to treat tuberculosis (e.g. rifampicin, isoniazid) may reduce the effects of vitamin D.
• Products containing calcium or phosphate may increase the risk of high calcium or phosphate levels in the blood.
• Products containing magnesium (such as antacids) may increase the risk of high magnesium levels in the blood (hypermagnesemia).

Colecalciferolo Zentiva Srl with food and drink
You should take Colecalciferolo Zentiva Srl preferably with a main meal to help your body absorb vitamin D.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Due to the high dose of vitamin D, Colecalciferolo Zentiva Srl is not recommended during pregnancy and breastfeeding.
There are no data on the effect of vitamin D on fertility. However, normal endogenous levels of vitamin D are not expected to have adverse effects on fertility.
Driving and using machines
Colecalciferolo Zentiva Srl is unlikely to affect the ability to drive or use machinery.
Colecalciferolo Zentiva Srl contains soya oil
Colecalciferolo Zentiva Srl contains soya oil. If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Colecalciferolo Zentiva Srl

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. Please consult your doctor before taking
additional calcium.
Use in adults
The recommended dose is: 1 capsule per week for a maximum of 4-5 weeks.
The capsules should be swallowed whole with water, preferably with the main meal of the
day.
Use in children and adolescents
Colecalciferolo Zentiva Srl is not recommended for use in children and adolescents under
18 years of age. Other formulations of this medicine may be more suitable for children; please ask
your doctor or pharmacist.
If you take more Colecalciferolo Zentiva Srl than you should
If you have taken more of this medicine than prescribed, or if a child has accidentally taken this
medicine, contact your doctor or emergency services for risk assessment and advice. If you take too many capsules,
you may feel unwell; symptoms may include nausea, vomiting, excessive thirst, production of large amounts of urine within 24 hours, constipation,
dehydration, stomach pain, muscle weakness, fatigue, loss of appetite, and elevated levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria) detected by laboratory tests.
If you forget to take Colecalciferolo Zentiva Srl
If you forget to take the capsules, take them as soon as possible. Then, take the next capsule
according to the instructions given by your doctor.
Do not take a double dose to make up for a missed dose.
If you have any 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.
Some side effects can be serious and require immediate medical treatment:
Contact your doctor immediately if you experience symptoms of severe allergic reactions such as:

• swelling of the face, lips, tongue or throat
• difficulty swallowing
• hives and breathing difficulties

Other possible side effects reported with the use of Colecalciferol Zentiva Srl may include:
Uncommon (may affect up to 1 in 100 people)

• excess calcium in the blood (hypercalcemia)
• excess calcium in the urine (hypercalciuria)

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

• skin rash
• itching
• hives

Not known (cannot be estimated from the available data)

• constipation
• gas (flatulence)
• nausea
• abdominal pain
• diarrhoea

Reporting of side effects
If you get any side effects, including ones 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 Colecalciferolo Zentiva Srl

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no 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 Colecalciferolo Zentiva Srl contains

• The active substance is colecalciferol. Each soft capsule contains 0.5 mg of colecalciferol (vitamin D), equivalent to 20,000 IU. The other components are:
• capsule contents: medium-chain triglycerides, D-alpha tocopherol and refined soybean seed oil.
• capsule shell: gelatin, glycerol and purified water.

Description of the appearance of Colecalciferolo Zentiva Srl and package contents
Colecalciferolo Zentiva Srl 20,000 IU soft capsules are transparent, soft gelatin capsules, oval-shaped, light yellow in colour, containing a clear, colourless liquid. Each capsule is marked with the number "58". The capsule dimensions are approximately 11 x 6 mm.
Packaged in PVDC/PVC aluminium blisters.
Pack sizes: 4, 5, 14 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa 7, 20121 Milan, Italy

Manufacturer
FLAVINE PHARMA FRANCE
3 voie d’Allemagne, 13127, VITROLLES
France

This medicinal product is authorised in the European Economic Area countries under the following names