Annexxo

Package leaflet: Information for the user

ANNEXXO 1 000 IU film-coated tablets, 7 000 IU film-coated tablets

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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 substance of ANNEXXO is colecalciferol (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:

• For the prevention or treatment of vitamin D deficiency in adults. Vitamin D deficiency may occur when your diet or lifestyle does not provide sufficient vitamin D, or when your body requires higher amounts of vitamin D.

ANNEXXO is used in adults.

2. What you need to know before taking 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 have severe renal impairment,
• if you are already taking additional doses of vitamin D (e.g. multivitamins or dietary 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 affecting the bones,
• if you have imbalances in parathyroid hormone levels (pseudohypoparathyroidism).

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

• If you are on long-term treatment with this medicine.
• If you have kidney problems.
• If you have 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
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• diuretics (medicines to increase urine production) – your blood calcium levels will be monitored regularly;
• corticosteroids (‘steroids’ such as prednisolone, dexamethasone) – your dose of vitamin D may need to be increased;
• cholestyramine (a cholesterol-lowering medicine) or laxatives (e.g. mineral oil) – may reduce the absorption of vitamin D;
• heart medicines (cardiac glycosides) – you must be monitored by a doctor and your ECG and blood calcium levels may be checked;
• anticonvulsants (for the treatment of epilepsy), sedatives (e.g. phenytoin, 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;
• certain antibiotics used to treat tuberculosis (rifampicin, isoniazid) may reduce the effectiveness of colecalciferol;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal agents and ketoconazole (medicines used to treat fungal diseases): these medicines may interfere with how your body processes vitamin D;
• orlistat (used for weight loss) – reduces the absorption of vitamin D.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Cumulative weekly or monthly single doses are not recommended during pregnancy for safety reasons: therefore, ANNEXXO 7,000 IU film-coated tablets should not be used during pregnancy.
If you are breastfeeding, your doctor will monitor your blood levels of calcium or phosphate, or your urinary calcium levels.
Driving and using machines
No known effects on the ability to drive or use machinery have been reported.
ANNEXXO contains lactose and sucrose
If your doctor has informed you that you have an intolerance to certain sugars, consult 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 exactly as instructed by 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 treatment.

Prevention of vitamin D deficiency:

• ANNEXXO 1000 IU:
  1 tablet daily. In case of multiple risk factors, and according to the doctor’s advice, the dose may be increased up to 2 tablets daily.
• ANNEXXO 7000 IU:
  1 tablet weekly. In case of multiple risk factors, and according to the doctor’s advice, the dose may be increased up to 2 tablets weekly.

Treatment of vitamin D deficiency:

• ANNEXXO 1000 IU:
  1 to 4 tablets daily.
• ANNEXXO 7000 IU:
  1 to 4 tablets weekly.

Patients with kidney problems
Your doctor may require you to have 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, abdominal pain, muscle weakness, fatigue, confusion, increased need to urinate, bone pain, kidney problems, and in severe cases, changes in heart rhythm, coma, or even death.
If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking ANNEXXO and seek immediate medical help 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 side effects (may affect up to 1 in 100 people):

• excess calcium in the blood (hypercalcaemia) – 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, kidney calcifications, kidney stones, dizziness and cardiac arrhythmias (irregular heartbeat).

Reporting of side effects
If you experience any side effects, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 help provide more information on 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 the original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 ANNEXXO contains
The active substance is colecalciferol (vitamin D)
ANNEXXO 1000 IU film-coated tablets: each film-coated tablet contains 10 mg of concentrated colecalciferol (in powder form) (equivalent to 25 µg of colecalciferol = 1000 IU of vitamin D).
ANNEXXO 7000 IU film-coated tablets: each film-coated tablet contains 70 mg of concentrated colecalciferol (in powder form) (equivalent to 175 µg of colecalciferol = 7000 IU of vitamin D).

The other components are:

• Tablet core: cellactose 80 (monohydrate lactose and powdered cellulose (E460 (ii)), sodium starch octenyl succinate from waxy maize (E1450), maize starch, sodium croscarmellose (E468), sucrose, anhydrous colloidal silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium-chain triglycerides, DL-alpha-tocopherol (E307).
• 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 package contents
ANNEXXO 1000 IU film-coated tablets:
oval, yellow tablets, approximately 3.7 x 8.5 x 5.0 mm in size, with a line imprint on one side.
Pack sizes: 30 or 60 film-coated tablets in white opaque PVC-Alu blisters, with carton outer.
ANNEXXO 7000 IU film-coated tablets:
round, yellow tablets, approximately 4.2 x 7.3 mm in size, with a line imprint on one side.
Pack sizes: 4, 8 or 12 film-coated tablets in white opaque PVC-Alu blisters, with carton outer.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Italy: ANNEXXO
Poland: ANNEXXO

Package leaflet: information for the user

ANNEXXO 30,000 UI film-coated tablets

colecalciferol (vitamin D )
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking 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 substance of ANNEXXO is colecalciferol (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 at identified risk when therapeutic adherence (compliance) is not achieved with daily administration of low doses of colecalciferol, or to treat vitamin D deficiency. Vitamin D deficiency may occur when diet or lifestyle do not provide sufficient vitamin D, or when the body requires higher amounts of vitamin D.

ANNEXXO is used in adults.

2. What you need to know before taking 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 have severe renal impairment,
• if you are already taking additional doses of vitamin D (e.g. multivitamins or dietary 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 affecting the bones,
• if you have imbalances in parathyroid hormone levels (pseudohypoparathyroidism).

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

• If you are on long-term treatment with this medicine.
• If you have kidney problems;
• If you have sarcoidosis: an immune disorder that may 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 without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• diuretics (medicines to increase urine production) – your blood calcium levels will be monitored regularly;
• corticosteroids (‘steroids’ such as prednisolone, dexamethasone) – your dose of vitamin D may need to be increased;
• cholestyramine (a cholesterol-lowering medicine) or laxatives (e.g. mineral oil) – these may reduce the absorption of vitamin D;
• heart medications (cardiac glycosides) – you must be monitored by a doctor and your ECG and blood calcium levels may be checked;
• anticonvulsants (for the treatment of epilepsy), sedatives (e.g. phenytoin, 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;
• certain antibiotics for the treatment of tuberculosis (rifampicin, isoniazid) may reduce the effectiveness of colecalciferol;
• actinomycin (a medicine used to treat certain types of cancer) and imidazole antifungal agents and ketoconazole (medicines used to treat fungal infections): these medicines may interfere with how your body processes vitamin D;
• orlistat (weight-loss aid) – reduces the absorption of vitamin D.

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

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

ANNEXXO contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to certain 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 exactly as your doctor has told you. 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 treatment.
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 you to have 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, abdominal pain, muscle weakness, fatigue, confusion, increased need to urinate, bone pain, kidney problems, and in severe cases, changes in heart rhythm, coma, or even death.
If you have taken too many tablets, contact your doctor immediately or go to the nearest hospital emergency department. Take the pack and any remaining tablets with you.
If you forget to take ANNEXXO
Do not take a double dose to make up for the forgotten 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 everyone gets them.
Stop taking ANNEXXO and seek immediate medical help 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 side effects (may affect up to 1 in 100 people):

• excess calcium in the blood (hypercalcaemia) – 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, kidney calcifications, kidney stones, dizziness and cardiac arrhythmias (irregular heartbeat).

Reporting of side effects
If you experience any side effects, inform your doctor or pharmacist. This includes any
possible side effects not listed in this patient information leaflet. 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 help provide more information on 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 the original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
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 ANNEXXO contains
The active substance in this product is colecalciferol (vitamin D).
ANNEXXO 30000 IU film-coated tablets: each film-coated tablet contains 300 mg of concentrated colecalciferol (in powder form) (equivalent to 750 µg colecalciferol = 30000 IU vitamin D).
The other components are:

• Tablet core: Cellactose 80 (monohydrate lactose and powdered cellulose (E460(ii))), sodium octenyl succinate of maize starch (E1450), maize 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 the appearance of ANNEXXO and the contents of the pack
ANNEXXO 30000 IU film-coated tablets:
round, yellow tablets, approximately 5.5 x 13.4 mm in size.
Pack sizes: 2, 3, 4, 5 or 10 film-coated tablets in white opaque PVC-Alu blisters, with carton outer.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
Italy: ANNEXXO
Poland: ANNEXXO