Package leaflet: information for the patient

Colecalciferol Alter 25,000 IU, capsules, 50,000 IU, capsules

colecalciferol (vitamin D3)
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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Colecalciferol Alter is and what it is used for
What you need to know before taking Colecalciferol Alter
How to take Colecalciferol Alter
Possible side effects
How to store Colecalciferol Alter
Contents of the pack and other information

1. What Colecalciferolo Alter is and what it is used for

Colecalciferolo Alter contains the active substance colecalciferol (vitamin D3).
Colecalciferolo Alter is used for the initial treatment of clinically significant vitamin D deficiency in adults.

2. What you need to know before taking Colecalciferolo Alter

Do not take Colecalciferolo Alter

if you are allergic to vitamin D3 or to any of the other ingredients of this medicine (listed in section 6);
if you have high levels of calcium in your blood (hypercalcemia) or in your urine (hypercalciuria);
if you have kidney stones;
if you have severe renal insufficiency;
if you have high levels of vitamin D3 in your blood (hypervitaminosis D).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Colecalciferolo Alter if:
you are taking medicines to treat heart conditions (e.g. cardiac glycosides such as digoxin).
you suffer from sarcoidosis (an autoimmune disease that may cause increased levels of vitamin D in the body).
you are taking diuretics (e.g. benzothiadiazines).
you are immobilized.
you suffer from pseudohypoparathyroidism.
you are taking medicines containing vitamin D3 or foods fortified with vitamin D3, or vitamin D3-enriched milk.
you are likely to be exposed to significant sunlight while using vitamin D3.
you are taking other supplements containing calcium. Your doctor should monitor your blood calcium levels to ensure they do not become too high during treatment with vitamin D3.
you have kidney disease or kidney damage, or are predisposed to developing kidney stones. Your doctor may wish to check your calcium levels in blood and urine.
Your doctor should monitor your blood calcium levels through laboratory tests during long-term treatment.

Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.

Other medicines and Colecalciferolo Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:
medicines used to treat heart or kidney diseases, such as cardiac glycosides (e.g. digoxin) or diuretics (e.g. bendroflumethiazide). When these medicines are used together with vitamin D3, they may cause a significant increase in calcium levels in blood and urine.
medicines containing vitamin D3 or foods rich in vitamin D3, such as certain types of vitamin D3-fortified milk.
actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungals (e.g. clotrimazole and ketoconazole, medicines used to treat fungal infections). These medicines may interfere with the body's metabolism of vitamin D3.
medicines used to treat tuberculosis, such as rifampicin and isoniazid.
the following medicines, as they may interfere with the effect or absorption of vitamin D3:

antiepileptic drugs (anticonvulsants), barbiturates;
glucocorticoids (steroid hormones such as hydrocortisone or prednisolone), as they may reduce the effect of vitamin D3;
medicines that lower cholesterol levels in the blood (such as cholestyramine or colestipol);
certain weight-loss medicines that work by reducing fat absorption in the body (e.g. orlistat);
certain laxatives (such as liquid paraffin).

Colecalciferolo Alter with food, drink and alcohol
Colecalciferol should preferably be taken with food to enhance absorption of vitamin D3.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
This high concentration is not recommended for use in pregnant and/or breastfeeding women.

Driving and using machines
Information on the possible effects of this medicine on the ability to drive is limited. However, it is not expected to affect your ability to drive or operate machinery.

This medicine contains sunset yellow FD&C No. 6
It may cause allergic reactions.

3. How to take Colecalciferol Alter

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The capsule must be swallowed whole (for example, with water).
Colecalciferol Alter should preferably be taken with food.
For patients with swallowing difficulties, the capsule can be opened and the dispersible granules poured
into half a glass of water to facilitate administration. This suspension must be consumed immediately after preparation.
Use in adults
The recommended dose is:
25,000 IU: one capsule once a week for 8–12 weeks. After the first month, a dose reduction may be considered.
Higher doses may be required:
50,000 IU: 1 capsule once a week for up to 6 weeks.
Your doctor will determine the appropriate dose for you.
Paediatric population
Colecalciferol Alter is not recommended for children and adolescents under 18 years of age.
Pregnancy and breastfeeding
Colecalciferol Alter is not recommended.
If you take more Colecalciferol Alter than you should
If you take more than prescribed, stop taking the medicine and contact your doctor. If you cannot contact your doctor, go to the nearest hospital emergency department and take the medicine packaging with you.
The most common symptoms of overdose are: nausea, vomiting, excessive thirst, excessive urine production for about 24 hours, constipation, dehydration, and elevated calcium levels in blood and urine (hypercalcaemia and hypercalciuria) as determined by clinical tests.
If you forget to take Colecalciferol Alter
If you forget to take a dose of colecalciferol, take the missed dose as soon as possible. Then take the next dose at the usual time. However, if it is almost time for the next dose, skip the missed dose and take the following dose at the regular time.
If you have any questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible adverse effects associated with the use of colecalciferol may include:
Uncommon (affects up to 1 in 100 people):
increased levels of calcium in the blood (hypercalcemia)
increased levels of calcium in the urine (hypercalciuria).
Rare (affects up to 1 in 1,000 people):
rash
itching
urticaria
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system available at the website
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 Colecalciferol Alter

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 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 Colecalciferolo Alter contains
The active substance is colecalciferol (vitamin D3) 100 CWS Ph.
One capsule contains:
250 mg of colecalciferol (vitamin D3) 100 CWS Ph, equivalent to 25,000 IU.
500 mg of colecalciferol (vitamin D3) 100 CWS Ph, equivalent to 50,000 IU.

The other excipients are:
Colecalciferol 25,000 IU hard capsules:
Gelatin,
Titanium dioxide (E-171),
Red iron oxide (E-172),
Quinoline yellow (E 104),
FD&C Yellow No. 6 (Sunset Yellow FCF) (E 110).

Colecalciferol 50,000 IU hard capsules:
Gelatin,
Titanium dioxide (E-171),
Black iron oxide (E-172),
Quinoline yellow (E 104),
FD&C Yellow No. 6 (Sunset Yellow FCF) (E 110).

Description of the appearance of Colecalciferolo Alter and contents of the pack
Colecalciferolo Alter 25,000 IU is a hard capsule with a yellow body and a light orange cap, containing free-flowing granules of white to yellowish colour. The capsule size is 18 mm x 5.8 mm. It is available in cardboard boxes containing blisters made of Polyamide/Aluminium/PVC – Aluminium. Each box may contain 2, 4 or 8 capsules.

Colecalciferolo Alter 50,000 IU is a hard capsule with a yellow body and a black cap, containing free-flowing granules of white to yellowish colour. The capsule size is 24 mm x 7 mm. It is available in cardboard boxes containing blisters made of Polyamide/Aluminium/PVC – Aluminium. Each box may contain 2, 4 or 8 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi 7,
20144 Milano
Italy

Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain