Colecalciferol Sandoz GmbH

Patient Information Leaflet

Colecalciferol Sandoz GmbH 1,000 IU Soft Capsules

Read this entire 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.
• This medicine has been prescribed for you only. Do not give it to others, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Colecalciferolo Sandoz GmbH is and what it is used for

Colecalciferolo Sandoz GmbH contains colecalciferol (vitamin D). Vitamin D helps the body absorb calcium and stimulates bone formation.
This medicinal product is recommended in the following cases:

• Treatment of vitamin D deficiency (serum levels < 25 nmol/L (< 10 ng/mL)) in adults and adolescents.
• Prevention of vitamin D deficiency (serum levels < 25 nmol/L (< 10 ng/mL)) in adults at identified risk.

2. What you need to know before taking Colecalciferolo Sandoz GmbH

Do not take Colecalciferolo Sandoz GmbH

• if you are allergic to colecalciferol 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 severe kidney problems (severe renal failure)
• if you have high levels of vitamin D in your blood (hypervitaminosis D)
• if you have kidney stones or calcium deposits in the kidneys

Warnings and precautions
Do not take more Colecalciferolo Sandoz GmbH than prescribed by your doctor, as this may lead to
overdose. Do not take other vitamin D-containing products simultaneously, unless prescribed by your
doctor. This applies to all forms of vitamin D.
During treatment, adequate calcium levels and sufficient calcium intake, preferably through diet, must
be ensured. Additional calcium should not be taken without consulting your doctor.
Talk to your doctor or pharmacist before taking Colecalciferolo Sandoz GmbH if:

• you have a strong tendency to develop kidney stones
• you have a parathyroid hormone imbalance (pseudohypoparathyroidism)
• you are being treated for heart conditions

If any of the following conditions occur, your doctor will monitor your calcium or phosphate levels
in the blood or your calcium levels in the urine:

• if you have kidney problems
• if you suffer from "sarcoidosis"; an immune system disorder that may affect the liver, lungs, skin, or lymph nodes

Children
Colecalciferolo Sandoz GmbH 1,000 IU must not be used in children under 12 years of age.
Other medicines and Colecalciferolo Sandoz GmbH
Inform 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 for epilepsy such as barbiturates or other anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, primidone)
• other medicines containing vitamin D, including multivitamins
• medicines to control heart rate (e.g. digoxin, digitoxin)
• diuretics (water tablets) such as bendroflumethiazide
• calcium supplements
• medicines for the treatment of tuberculosis, e.g. rifampicin, isoniazid
• medicines causing fat malabsorption, e.g. orlistat, cholestyramine, liquid paraffin
• medicines for the treatment of fungal infections, e.g. ketoconazole, itraconazole
• actinomycin (a medicine used to treat certain types of cancer), as it may interfere with vitamin D metabolism
• glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone)
• magnesium-containing medicines (e.g. antacids, which neutralize stomach acidity)
• phosphorus-containing medicines

Colecalciferolo Sandoz GmbH with food and drink
Colecalciferolo Sandoz GmbH can be taken regardless of meals.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult
your doctor or pharmacist before taking this medicine.
Pregnancy
You should not take this medicine during pregnancy unless you have a confirmed vitamin D deficiency
and your doctor considers it absolutely necessary for you.
In case of vitamin D deficiency, the recommended dose depends on national guidelines; however, the
maximum recommended dose during pregnancy is 4,000 IU/day of vitamin D.
Colecalciferolo Sandoz GmbH is not recommended during pregnancy for treatment with higher doses.
Breastfeeding
Colecalciferolo Sandoz GmbH may be used during breastfeeding. Vitamin D passes into breast milk.
This should be taken into account when additional vitamin D is given to a breastfed infant.
Fertility
There are no data on the effect of Colecalciferolo Sandoz GmbH on fertility. However, normal levels of
vitamin D are not expected to have adverse effects on fertility.
Driving and using machines
Colecalciferolo Sandoz GmbH has no known effect on the ability to drive or operate machinery.

3. How to take Colecalciferolo Sandoz GmbH

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose should be individually determined based on the required amount of vitamin D supplementation.
The patient's dietary habits should be carefully evaluated, and consideration should be given to the vitamin D content artificially added to certain types of food.
Adults
Medical supervision is necessary, as the required dose may vary depending on the patient's response.
Treatment of vitamin D deficiency:
800 IU - 4,000 IU daily, depending on the severity of the condition and the patient's response to treatment.
Prevention of vitamin D deficiency:
800 IU - 1,000 IU daily
The dose should be adjusted according to the desired serum levels of 25-hydroxycolecalciferol (25(OH)D), the severity of the disease, and the patient's response to treatment.
After the first month, your doctor may decide to reduce the dose, depending on the severity of your condition and your response to treatment.
Use in children and adolescents
Colecalciferolo Sandoz GmbH 1,000 IU must not be used in children under 12 years of age.
Treatment of vitamin D deficiency in adolescents (12–18 years):
800 IU–4,000 IU daily, depending on the severity of the condition and the patient's response to treatment. It must be administered only under medical supervision. The daily dose must not exceed 4,000 IU.
Method of administration
Swallow the capsules whole with water, without chewing them.
If you take more Colecalciferolo Sandoz GmbH than you should
If you have taken an excessive amount of Colecalciferolo Sandoz GmbH, contact your doctor or pharmacist immediately. Excess vitamin D can cause disturbances in calcium metabolism. The following symptoms may occur: weakness, fatigue, headache, nausea, vomiting, diarrhoea, excessive urination, calcium in the urine, dry mouth, nocturia, protein in the urine, intense thirst, loss of appetite, dizziness.
If you forget to take Colecalciferolo Sandoz GmbH
If you forget to take a dose of Colecalciferolo Sandoz GmbH, 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, do not take the missed dose; take the next dose at the regular time. Do not take a double dose to make up for the missed dose.
If you have any questions about 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 everybody gets them.
Stop taking Colecalciferol Sandoz GmbH and 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 difficulty breathing

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

• excess calcium in the blood (hypercalcaemia). You may feel weak or unwell, lose your appetite, become constipated, have stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion
• excess calcium in the urine (hypercalciuria)

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

• itching
• rash
• hives

Not known (cannot be estimated from the available data):

• constipation
• flatulence
• nausea
• abdominal pain
• diarrhoea
• hypersensitivity reactions such as angioedema or laryngeal oedema

Reporting of side effects
If you experience any side effect, including those 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 Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Colecalciferolo Sandoz GmbH contains
Colecalciferolo Sandoz GmbH 1,000 IU soft capsules: the active substance is colecalciferol. Each
soft capsule contains 25 micrograms of colecalciferol (vitamin D3), equivalent to 1,000 IU.
The other components are: butylhydroxytoluene (BHT) (E-321), medium-chain triglyceride oil,
gelatin (E-441), glycerol 99.5% (E-422), titanium dioxide (E-171), yellow iron oxide (E-172),
red iron oxide (E-172), and purified water.

Description of the appearance of Colecalciferolo Sandoz GmbH and package contents
Colecalciferolo Sandoz GmbH 1,000 IU soft capsules are soft, opaque orange oval capsules, size 2. The capsule length is approximately 9.5 mm and the width is approximately 6.2 mm.
Opaque PVC/PVDC//Aluminum blister
Colecalciferolo Sandoz GmbH 1,000 IU soft capsules are available in packages containing 30 or 60
soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH,
Biochemiestraße 10,
6250 Kundl,
Austria

Manufacturer
GAP S.A.
Agissilaou 46
173 41 Agios Dimitrios
Greece
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben,
Germany

This medicinal product is authorized in the European Economic Area Member States under the
following names

Patient information leaflet

Colecalciferolo Sandoz GmbH 20,000 IU soft capsules, 25,000 IU soft capsules, 50,000 IU soft capsules

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.
• 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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Colecalciferolo Sandoz GmbH is and what it is used for

Colecalciferolo Sandoz GmbH contains colecalciferol (vitamin D). Vitamin D helps
the body absorb calcium and promotes bone formation.
This medicine is recommended to initiate treatment of clinically significant
vitamin D deficiency in adults (serum levels < 25 nmol/L (< 10 ng/mL)).
Colecalciferolo Sandoz GmbH is indicated in adults.

2. What you need to know before taking Colecalciferolo Sandoz GmbH

Do not take Colecalciferolo Sandoz GmbH

• if you are allergic to colecalciferol 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 severe kidney problems (severe renal failure)
• if you have high levels of vitamin D in your blood (hypervitaminosis D)
• if you have kidney stones or calcium deposits in the kidneys

Warnings and precautions
Do not take more Colecalciferolo Sandoz GmbH than prescribed by your doctor, as overdose may occur. Do not take other vitamin D-containing products simultaneously, except those prescribed by your doctor. This applies to all forms of vitamin D.
During treatment, adequate calcium levels and sufficient calcium intake should be ensured, preferably through diet. Additional calcium should not be taken without medical advice.
Consult your doctor or pharmacist before taking Colecalciferolo Sandoz GmbH if:

• you have a high tendency to develop kidney stones
• you have a parathyroid hormone imbalance (pseudohypoparathyroidism)
• you are being treated for heart disease

If any of the following conditions apply, your doctor will monitor your calcium or phosphate levels in
the blood, or your calcium level in the urine:

• if you have kidney problems
• if you suffer from "sarcoidosis"; a disorder of the immune system that may affect the liver, lungs, skin, or lymph nodes
• if you are immobilized

Other medicines and Colecalciferolo Sandoz GmbH
Inform 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 for epilepsy such as barbiturates or other anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, primidone)
• medicines to control heart rate (e.g. digoxin, digitoxin)
• diuretics ("water tablets") such as bendroflumethiazide
• medicines for the treatment of tuberculosis, e.g. rifampicin, isoniazid
• medicines causing fat malabsorption, e.g. orlistat, cholestyramine, liquid paraffin
• medicines for the treatment of fungal infections, e.g. ketoconazole, itraconazole
• actinomycin (a medicine used to treat certain types of cancer), as it may interfere with vitamin D metabolism
• glucocorticosteroids (steroid hormones such as hydrocortisone or prednisolone)
• medicines containing magnesium (e.g. antacids, which neutralize stomach acidity)
• medicines containing phosphorus.

Colecalciferolo Sandoz GmbH with food and drinks
Colecalciferolo Sandoz GmbH can be taken independently of meals.
Children and adolescents
Colecalciferolo Sandoz GmbH 20,000 IU, 25,000 IU, 50,000 IU must not be used in children and adolescents (< 18 years).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Colecalciferolo Sandoz GmbH is not recommended during pregnancy.
Vitamin D passes into breast milk; therefore, mothers should avoid high doses during breastfeeding. Colecalciferolo Sandoz GmbH is not recommended during breastfeeding.
Driving and using machines
Colecalciferolo Sandoz GmbH does not affect or affects negligibly the ability to drive and use machines.
No studies have been conducted.

3. How to take Colecalciferol Sandoz GmbH

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dose should be individually determined according to the extent of vitamin D supplementation required.
The patient's dietary habits should be carefully assessed, and the content of artificially added vitamin D in certain food types should be taken into account.

Adults
Medical supervision is necessary, as dose requirements may vary depending on the patient's response.
The initial loading dose of 100,000 IU can be achieved by:
1 capsule of 20,000 IU/week for 4-5 weeks
or
1 capsule of 25,000 IU/week for 4 weeks
or
1 to 2 capsules of 50,000 IU taken within one week.

After completion of the initial loading dose, a lower maintenance dose should be considered, depending on desired serum levels of 25-hydroxycholecalciferol (25(OH)D), disease severity, and the patient's response to treatment.
Alternatively, national dosage recommendations for the treatment of vitamin D deficiency may be followed. The duration of treatment is usually limited to the first month of therapy, depending on the physician's decision.

Method of administration
You must swallow the capsules whole with water, without chewing them.

If you take more Colecalciferol Sandoz GmbH than you should
If you have taken an excessive amount of Colecalciferol Sandoz GmbH, contact your doctor or pharmacist immediately. Excess vitamin D causes disturbances in calcium metabolism. The following symptoms may occur: weakness, fatigue, headache, nausea, vomiting, diarrhoea, excessive urination, calcium in urine, dry mouth, nocturia, protein in urine, intense thirst, loss of appetite, dizziness.

If you forget to take Colecalciferol Sandoz GmbH
If you forget to take a dose of Colecalciferol Sandoz GmbH, take the missed dose as soon as possible. Then take the next dose at the usual time. However, if it is almost time for your next dose, do not take the missed dose; take the next dose as normal.
Do not take a double dose to make up for a forgotten dose.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Colecalciferol Sandoz GmbH and 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.

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

• excess calcium in the blood (hypercalcaemia) – you may feel weak or unwell, lose your appetite, become constipated, have stomach ache, feel very thirsty, have muscle weakness, drowsiness or confusion
• excess calcium in the urine (hypercalciuria)

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

• itching
• rash
• hives

Not known (cannot be estimated from the available data):

• constipation
• flatulence
• nausea
• abdominal pain
• diarrhoea
• hypersensitivity reactions such as angioedema or laryngeal oedema

Reporting of side effects
If you experience any side effect, including those 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 Sandoz GmbH

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Colecalciferolo Sandoz GmbH contains
Colecalciferolo Sandoz GmbH 20,000 IU soft capsules
The active substance is colecalciferol. Each soft capsule contains 0.5 mg of colecalciferol (vitamin D3), equivalent to 20,000 IU.
The other components are: butylated hydroxytoluene (BHT) (E-321), medium-chain triglyceride oil, gelatin (E-441), glycerol 99.5% (E-422), titanium dioxide (E-171), iron oxide red (E-172), and purified water.

Colecalciferolo Sandoz GmbH 25,000 IU soft capsules
The active substance is colecalciferol. Each soft capsule contains 0.625 mg of colecalciferol (vitamin D3), equivalent to 25,000 IU.
The other components are: butylated hydroxytoluene (BHT) (E-321), medium-chain triglyceride oil, gelatin (E-441), glycerol 99.5% (E-422), titanium dioxide (E-171), and purified water.

Colecalciferolo Sandoz GmbH 50,000 IU soft capsules
The active substance is colecalciferol. Each soft capsule contains 1.25 mg of colecalciferol (vitamin D3), equivalent to 50,000 IU.
The other components are: butylated hydroxytoluene (BHT) (E-321), medium-chain triglyceride oil, gelatin (E-441), glycerol 99.5% (E-422), titanium dioxide (E-171), iron oxide red (E-172), and purified water.

Description of the appearance of Colecalciferolo Sandoz GmbH and package contents
Colecalciferolo Sandoz GmbH 20,000 IU soft capsules are opaque pink oval soft capsules, size 3. The capsule length is approximately 11.2 mm and the width is approximately 6.4 mm.
Colecalciferolo Sandoz GmbH 25,000 IU soft capsules are opaque white oval soft capsules, size 3. The capsule length is approximately 11.3 mm and the width is approximately 6.9 mm.
Colecalciferolo Sandoz GmbH 50,000 IU soft capsules are opaque red oval soft capsules, size 6. The capsule length is approximately 13.5 mm and the width is approximately 8.4 mm.
Opaque PVC/PVDC//Aluminium blister
Colecalciferolo Sandoz GmbH 20,000 IU soft capsules are available in packages containing 4, 5, 6, 12 or 56 x1 (hospital pack) soft capsules.
Colecalciferolo Sandoz GmbH 25,000 IU soft capsules are available in packages containing 2 or 4 soft capsules.
Colecalciferolo Sandoz GmbH 50,000 IU soft capsules are available in packages containing 2, 3 or 4 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH,
Biochemiestraße 10,
6250 Kundl,
Austria

Manufacturer
GAP S.A.
Agissilaou 46
173 41 Agios Dimitrios
Greece
Salutas Pharma GmbH
Otto-Von-Guericke-Allee 1
39179 Barleben,
Germany

This medicinal product is authorized in the European Economic Area Member States under the following names