ANNEXXO 1000 IU Film-coated tablets

Зміст інструкції

1. ANNEXXO 1000 IU film-coated tablets, 7000 IU film-coated tablets
   1. What is ANNEXXO and what is it used for
   2. What you need to know before you take ANNEXXO
   3. How to take ANNEXXO
   4. Possible side effects
   5. How to store ANNEXXO
   6. Package Contents and Other Information
2. ANNEXXO 30 000 UI film-coated tablets
   1. What ANNEXXO is and what it is used for
   2. What you need to know before you take ANNEXXO
   3. How to take ANNEXXO
   4. Possible side effects
   5. How to store ANNEXXO
   6. Contents of the pack and other information

ANNEXXO 1000 IU film-coated tablets, 7000 IU film-coated tablets

cholecalciferol (vitamin D)

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 they have the same symptoms as you, as 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 ANNEXXO is and what it is used for
• 2. What you need to know before you take ANNEXXO
• 3. How to take ANNEXXO
• 4. Possible side effects
• 5. How to store ANNEXXO
• 6. Contents of the pack and other information

1. What is ANNEXXO and what is it used for

The active ingredient of ANNEXXO is cholecalciferol (vitamin D).
Vitamin D helps the body absorb calcium, improves bone formation and reduces
levels of parathyroid hormone (PTH).
This medicine is recommended in the following cases:

• To prevent or treat vitamin D deficiency in adults. Vitamin D deficiency can occur when your diet or lifestyle does not provide you with enough vitamin D or when your body requires a greater amount of vitamin D.

ANNEXXO is used in adults.

2. What you need to know before you take ANNEXXO

Do not take ANNEXXO:

• if you are allergic to vitamin D or any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of calcium in your blood or urine,
• if you suffer from kidney stones or have calcium deposits in your kidneys,
• if you suffer from severe kidney impairment,
• if you are already taking supplementary doses of vitamin D (e.g. multivitamins or food supplements containing vitamin D)
• if you have high levels of vitamin D in your blood or urine (hypervitaminosis D)

Warnings and precautions
Talk to your doctor or pharmacist before taking ANNEXXO film-coated tablets

• if you have a high tendency to form kidney stones
• if you have cancer or any other condition that affects the bones
• if you have imbalances in parathyroid hormone levels (pseudo-hypoparathyroidism)

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

• If you are being treated with this medicine for a long time.
• If you suffer from kidney problems.
• If you suffer from “sarcoidosis”: a disorder of the immune system that can affect the liver, lungs, skin or lymph nodes.

Children and adolescents
ANNEXXO is not recommended for children and adolescents.

Other medicines and ANNEXXO
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
In particular tell your doctor if you are taking any of the following medicines:

• diuretics (medicines to help you urinate) - your calcium levels in the blood will be monitored regularly;
• corticosteroids (‘steroids’ such as prednisolone, dexamethasone) - it may be necessary to increase your dose of vitamin D;
• cholestyramine (a medicine that lowers cholesterol) or laxatives (e.g. liquid paraffin) - these can reduce the absorption of vitamin D;
• medicines for the heart (cardiac glycosides) - you must be monitored by a doctor and your ECG and calcium levels in the blood may be monitored;
• anticonvulsants (for the treatment of epilepsy), sedatives (e.g. hydantoin, barbiturates) or primidone - these medicines reduce the effect of vitamin D;
• products containing high doses of calcium: increase the risk of high calcium levels in the blood;
• products containing high doses of phosphorus - increase the risk of high phosphorus levels in the blood;
• products containing magnesium (e.g. antacids) - these should not be used during treatment with vitamin D due to the risk of high magnesium levels;
• some antibiotics for the treatment of tuberculosis (rifampicin, isoniazid) may reduce the effectiveness of cholecalciferol;
• actinomycin (a medicine used to treat some forms of cancer) and imidazole and ketoconazole antifungal agents (medicines used to treat fungal diseases): these medicines can interfere with the way your body processes vitamin D;
• orlistat (weight loss aid) - reduces the absorption of vitamin D.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant or are planning
a pregnancy, ask your doctor for advice before taking this medicine.
Single cumulative weekly or monthly doses are not recommended during pregnancy for safety reasons: ANNEXXO 7,000 IU film-coated tablets should therefore not be used in
pregnancy.
If you are breastfeeding, your doctor will monitor your calcium or phosphate levels in the blood, or your
calcium levels in your urine.

Driving and using machines
No known effects on the ability to drive or operate machinery have been reported.

ANNEXXO contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

ANNEXXO contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e.
essentially “sodium-free”.

3. How to take ANNEXXO

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The tablets can be taken with or without food.

Dose
The dose of ANNEXXO will depend on your vitamin D levels and your response to therapy.

Prevention of vitamin D deficiency:
o ANNEXXO 1000 IU:
1 tablet daily. In case of multiple risk factors, according to your doctor's opinion,
the dose may be increased up to 2 tablets daily.
o ANNEXXO 7000 IU:
1 tablet weekly. In case of multiple risk factors, according to your doctor's opinion,
the dose may be increased up to 2 tablets weekly.

Treatment of vitamin D deficiency:
o ANNEXXO 1000 IU:
from 1 to 4 tablets daily.
o ANNEXXO 7000 IU:
from 1 to 4 tablets weekly.

Patients with kidney problems
Your doctor may require regular blood and/or urine tests.

If you take more ANNEXXO than you should
You may develop the following symptoms: loss of appetite, thirst, nausea, vomiting, constipation, pain
abdominal, muscle weakness, fatigue, confusion, more frequent need to urinate, bone pain,
kidney problems, and in severe cases, changes in heart rate, coma or even death.
If you have taken too many tablets, contact your doctor immediately or go to the emergency room
of the nearest hospital. Bring the package and any remaining tablets with you.

If you forget to take ANNEXXO
Do not take a double dose to make up for the missed dose.
If you have any doubts 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 ANNEXXO and seek immediate medical helpif you experience symptoms of
serious allergic reactions, such as:

• swelling of the face, lips, tongue or throat
• difficulty swallowing
• urticaria and difficulty breathing.

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

• excess calcium in the blood (hypercalcemia) - symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, extreme thirst, increased need to urinate, muscle weakness, drowsiness and confusion
• excess calcium in the urine (hypercalciuria).

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

• Itching, rash and urticaria

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

• anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue (tiredness), confusion, polydipsia (excessive thirst), polyuria (excessive urine production), bone pain, calcifications in the kidneys, kidney stones, dizziness and heart arrhythmias (irregular heartbeat).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. 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 to improve the safety of this
medicine.

5. How to store ANNEXXO

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep this medicine in its original packaging to protect it from light.
Do not use this medicine after the expiry date which is reported on the pack. The expiry date refers to the
last day of that month.
Do not dispose of any medicine in 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 ANNEXXO contains
The active ingredient of the product is cholecalciferol (vitamin D)
ANNEXXO 1000 IU film-coated tablets: each film-coated tablet contains 10 mg
of cholecalciferol concentrate (in powder form) (equivalent to 25 µg of cholecalciferol = 1000 IU
of vitamin D).
ANNEXXO 7000 IU film-coated tablets: each film-coated tablet contains 70 mg
of cholecalciferol concentrate (in powder form) (equivalent to 175 µg of cholecalciferol = 7000 IU
of vitamin D).
The other ingredients are:

• Tablet core: lactose 80 (lactose monohydrate and powdered cellulose (E460 (ii)), starch octenylsuccinate sodium from waxy maize (E1450), corn starch, croscarmellose sodium (E468), sucrose, colloidal anhydrous silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium chain triglycerides, DL-alpha-tocopherol (E307).
• Film coating: Opadry II Yellow 85F32659 consisting of polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol, talc (E553b), quinoline yellow aluminium lake (E104), yellow iron oxide (E172).

Description of ANNEXXO and package contents
ANNEXXO 1000 IU film-coated tablets:
oval tablets, yellow in colour, approximately 3.7 x 8.5 x 5.0 mm in size with a
line-shaped imprint on one side.
Packs: 30 or 60 film-coated tablets in opaque white PVC-Alu blisters and carton.
ANNEXXO 7000 IU film-coated tablets:
round tablets, yellow in colour, approximately 4.2 x 7.3 mm in size with a
line-shaped imprint on one side.
Packs: 4, 8 or 12 film-coated tablets in opaque white PVC-Alu blisters and carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
I.B.N Savio S.r.l.
Via del Mare, 36
00071 Pomezia (RM), Italy

Manufacturer responsible for batch release
ITC Production Srl
via Pontina, 5, km 29
00071 Pomezia (RM)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy ANNEXXO
Poland ANNEXXO

ANNEXXO 30 000 UI film-coated tablets

colecalciferol (vitamin D)

Read this 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 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, as 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 ANNEXXO is and what it is used for
• 2. What you need to know before you take ANNEXXO
• 3. How to take ANNEXXO
• 4. Possible side effects
• 5. How to store ANNEXXO
• 6. Contents of the pack and other information

1. What ANNEXXO is and what it is used for

The active ingredient of ANNEXXO is cholecalciferol (vitamin D).
Vitamin D helps the body absorb calcium, improves bone formation and reduces
levels of parathyroid hormone (PTH).
This medicine is recommended in the following cases:

• To prevent vitamin D deficiency in adults with an identified risk when therapeutic adherence (or compliance) is not achieved with the daily administration of low doses of cholecalciferol or to treat vitamin D deficiency. Vitamin D deficiency can occur when its diet or lifestyle do not provide enough vitamin D or when its body requires a greater amount of vitamin D.

ANNEXXO is used in adults.

2. What you need to know before you take ANNEXXO

Do not take ANNEXXO:

• if you are allergic to vitamin D or to any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of calcium in your blood or urine,
• if you suffer from kidney stones or have calcium deposits in your kidneys,
• if you suffer from severe kidney impairment,
• if you are already taking supplementary doses of vitamin D (e.g. multivitamins or food supplements containing vitamin D).
• if you have high levels of vitamin D in your blood or urine (hypervitaminosis D)

Warnings and precautions
Talk to your doctor or pharmacist before taking ANNEXXO film-coated tablets

• if you have a high tendency to form kidney stones
• if you have cancer or any other condition that affects the bones
• if you have imbalances in parathyroid hormone levels (pseudo-hypoparathyroidism)

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

• If you are being treated with this medicine for a long time.
• If you suffer from kidney problems;
• If you suffer from “sarcoidosis”: an immune disorder that can affect the liver, lungs, skin or lymph nodes.

Children and adolescents
ANNEXXO is not recommended for children and adolescents.

Other medicines and ANNEXXO
Tell your doctor if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:

• diuretics (medicines to help you urinate) - your calcium levels in the blood will be regularly monitored;
• corticosteroids (‘steroids’ such as prednisolone, dexamethasone) - it may be necessary to increase your dose of vitamin D;
• cholestyramine (a medicine that lowers cholesterol) or laxatives (e.g. liquid paraffin) - these can reduce the absorption of vitamin D;
• medicines for the heart (cardiac glycosides) - you should be monitored by a doctor and your ECG and calcium levels in the blood may be monitored;
• anticonvulsants (for the treatment of epilepsy), sedatives (e.g. hydantoin, barbiturates) or primidone - these medicines reduce the effect of vitamin D;
• products containing high doses of calcium: increase the risk of high calcium levels in the blood;
• products containing high doses of phosphorus - increase the risk of high phosphorus levels in the blood;
• products containing magnesium (e.g. antacids) - these should not be used during treatment with vitamin D due to the risk of high magnesium levels;
• some antibiotics for the treatment of tuberculosis (rifampicin, isoniazid) may reduce the effectiveness of cholecalciferol;
• actinomycin (a medicine used to treat some forms of cancer) and imidazole and ketoconazole antifungal agents (medicines used to treat fungal diseases): these medicines can interfere with the way your body processes vitamin D;
• orlistat (weight loss aid) - reduces the absorption of vitamin D.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant or are planning
a pregnancy, consult your doctor before taking this medicine.
Single cumulative weekly or monthly doses are not recommended during pregnancy for safety reasons: ANNEXXO 30,000 IU film-coated tablets should therefore not be used in
pregnancy.
If you are breastfeeding, your doctor will monitor your calcium or phosphate levels in the blood, or your
calcium levels in the urine.

Driving and using machines
No known effects on the ability to drive or operate machinery have been reported.

ANNEXXO contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

ANNEXXO contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, that is to say
essentially “sodium-free”.

3. How to take ANNEXXO

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The tablets can be taken with or without food.

Dosage
The dose of ANNEXXO will depend on your vitamin D levels and your response to therapy.

Prevention of vitamin D deficiency:

• 1 tablet per month.

Treatment of severe vitamin D deficiency:

• 1 tablet per week for 4-10 weeks.

Patients with kidney problems
Your doctor may require regular blood and/or urine tests.

If you take more ANNEXXO than you should
You may develop the following symptoms: loss of appetite, thirst, nausea, vomiting, constipation, pain
abdominal, muscle weakness, fatigue, confusion, more frequent need to urinate, bone pain,
kidney problems, and in severe cases, heart rhythm disturbances, coma or even death.
If you have taken too many tablets, contact your doctor immediately or go to the emergency room
of the nearest hospital. Bring the package and any remaining tablets with you.

If you forget to take ANNEXXO
Do not take a double dose to make up for the missed dose.
If you have any doubts 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 ANNEXXO and seek immediate medical helpif you experience symptoms of
serious allergic reactions, such as:

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

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

• excess calcium in the blood (hypercalcemia) - symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, extreme thirst, increased need to urinate, muscle weakness, drowsiness and confusion
• excess calcium in the urine (hypercalciuria).

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

• Itching, rash and hives

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

• anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue (tiredness), confusion, polydipsia (excessive thirst), polyuria (excessive urine production), bone pain, calcifications in the kidneys, kidney stones, dizziness and cardiac arrhythmias (irregular heartbeat).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. 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 to improve the safety of this
medicine.

5. How to store ANNEXXO

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Keep this medicine in its original packaging to protect it from light.
Do not use this medicine after the expiry date which is reported on the pack. The expiry date refers to the
last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What ANNEXXO contains
The active ingredient of the product is cholecalciferol (vitamin D)
ANNEXXO 30000 IU film-coated tablets: each film-coated tablet contains 300
mg of cholecalciferol concentrate (in powder form) (equivalent to 750 µg of cholecalciferol =
30000 IU of vitamin D).
The other components are:

• Tablet core: cellactose 80 (lactose monohydrate and powdered cellulose (E460 (ii)), starch octenylsuccinate sodium from waxy maize (E1450), corn starch, croscarmellose sodium (E468), sucrose, anhydrous colloidal silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium chain triglycerides, DL-alpha-tocopherol (E307).
• Film coating: Opadry II Yellow 85F32659 consisting of polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol, talc (E553b), quinoline yellow aluminium lake (E104), yellow iron oxide (E172).

Description of the appearance of ANNEXXO and contents of the pack
ANNEXXO 30000 IU film-coated tablets:
round tablets, yellow in colour, approximately 5.5 x 13.4 mm in size.
Packs: 2, 3, 4, 5 or 10 film-coated tablets in opaque white PVC-Alu blisters and
carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
I.B.N. Savio S.r.l.
Via del Mare, 36
00071 Pomezia (RM), Italy

Manufacturer responsible for batch release
ITC Production Srl
via Pontina, 5, km 29
00071 Pomezia (RM)
Italy

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy ANNEXXO
Poland ANNEXXO