Annexo

Package leaflet: Information for the user

ANNEXXO, 30,000 IU coated tablets
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What ANNEXXO is and what it is used for
2. 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 substance in ANNEXXO is cholecalciferol (vitamin D).
Vitamin D helps the body absorb calcium and supports bone formation and reduces parathyroid hormone (PTH) levels.
This medicine is recommended in the following cases:

• Prevention of vitamin D deficiency in adults at identified risk, when therapeutic recommendations cannot be achieved through daily administration of small doses of cholecalciferol or treatment of vitamin D deficiency. Vitamin D deficiency may occur when diet or lifestyle does not provide sufficient vitamin D, or when the body requires more vitamin D.

ANNEXXO is intended for use in adults.

2. 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),
• you have high levels of calcium in your blood or urine,
• you have kidney stones or calcifications in the kidneys,
• you have severe kidney disease,
• you are already taking additional vitamin D supplements (such as multivitamin preparations or dietary supplements containing vitamin D),
• you have high levels of vitamin D in your blood or urine (hypervitaminosis D).

Warnings and precautions
Before starting ANNEXXO, talk to your doctor or pharmacist if:

• you are prone to developing kidney stones,
• you have cancer or any other condition that may affect the bones,
• you have a disorder of parathyroid hormone balance (pseudohypoparathyroidism).

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

• if you are being treated with this medicine long-term,
• if you have impaired kidney function,
• if you have sarcoidosis or immune system disorders that may affect the liver, lungs, skin, or lymph nodes.

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

Other medicines and ANNEXXO
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• diuretics (water tablets) – blood calcium levels will be monitored regularly;
• corticosteroids ("steroids", such as prednisolone, dexamethasone) – a higher dose of vitamin D may be needed;
• cholestyramine (a cholesterol-lowering medicine) or laxatives (e.g. liquid paraffin) – these reduce the absorption of vitamin D;
• cardiac glycosides (heart medicines) – you should be monitored by your doctor, and your ECG and blood calcium levels may be checked;
• anticonvulsants (used to treat epilepsy), sedatives (such as hydantoin, barbiturates) or primidone – these reduce the effect of vitamin D;
• products containing high doses of calcium – increase the risk of high blood calcium levels;
• products containing high doses of phosphorus – increase the risk of high blood phosphate levels;
• products containing magnesium (such as antacids) – should not be used during vitamin D treatment due to the risk of high magnesium levels;
• certain antibiotics used to treat tuberculosis (rifampicin, isoniazid) may reduce the effectiveness of cholecalciferol;
• actinomycin (a medicine used in the treatment of certain cancers) and imidazole antifungal medicines and ketoconazole (medicines used to treat fungal infections) – these may affect how the body processes vitamin D;
• orlistat (a weight-loss aid) – reduces the absorption of vitamin D.

Pregnancy or breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before taking this medicine.
For safety reasons, single weekly or monthly doses are not recommended during pregnancy: therefore, ANNEXXO 30,000 IU should not be used during pregnancy.
If you are breastfeeding, your doctor will monitor your blood calcium or phosphate levels, or urinary calcium levels.

Driving and using machines
The effect of this medicine on the ability to drive and use machines is unknown.

ANNEXXO contains lactose and sucrose
If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

ANNEXXO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning it is considered "sodium-free".

3. How to take ANNEXXO
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Tablets may be taken with or without food.

Dosage
The dose of ANNEXXO will depend on the patient's vitamin D levels and response to treatment.

Prevention of vitamin D deficiency:

• 1 tablet per month.

Treatment of severe vitamin D deficiency:

• 1 tablet per week for a period of 4–10 weeks.

Patients with kidney disease
Your doctor may recommend regular blood and/or urine tests.

If you take more ANNEXXO than you should
The following symptoms may occur: loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, increased urination, bone pain, kidney dysfunction, and in severe cases, irregular heartbeat, 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 packaging and any remaining tablets with you.

If you forget to take ANNEXXO
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You must stop taking ANNEXXO and seek immediate medical help if symptoms of severe allergic reactions occur, such as:

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

Uncommon adverse reactions (may occur in not more than 1 in 100 people):

• elevated calcium levels in blood (hypercalcaemia) – symptoms include nausea, vomiting, loss of appetite, constipation, stomach pain, bone pain, excessive thirst, frequent urination, muscle weakness, drowsiness and confusion.
• elevated calcium levels in urine (hypercalciuria).

Rare adverse reactions (may occur in not more than 1 in 1000 people):

• itching (skin irritation), rash and urticaria.

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

• loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, polydipsia (excessive thirst), polyuria (excessive urine production), bone pain, nephrocalcinosis (calcification of the kidneys), kidney stones, dizziness and cardiac arrhythmia (irregular heartbeat).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warszawa,
tel.: + 48 22 49 21 301,
fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine ANNEXXO

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine ANNEXXO contains
The active substance in the medicine is cholecalciferol (vitamin D).
ANNEXXO 30,000 IU coated tablets: each coated tablet contains 300 mg of cholecalciferol concentrate (in powder form) (equivalent to 750 micrograms of cholecalciferol = 30,000 IU vitamin D).

Other ingredients:

• Tablet core: celactose 80 (monohydrate lactose and powdered cellulose (E460) (ii)), sodium octenylsuccinate starch (E1450), corn starch, sodium croscarmellose (E468), sucrose, colloidal anhydrous silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium-chain saturated triglycerides, All-rac-alpha-tocopherol (E307).
• Coating: Opadry II Yellow 85F 32659 consisting of polyvinyl alcohol (E1203), titanium dioxide (E171), polyethylene glycol 3350, talc (E553b), quinoline yellow, aluminium lake (E104), yellow iron oxide (E172).

What ANNEXXO looks like and contents of the pack
ANNEXXO 30,000 IU coated tablets:
Yellow, round tablets measuring approximately 5.5 x 13.4 mm.
Pack sizes: 2, 3, 4, 5 or 10 coated tablets in white, opaque blisters made of PVC/aluminum foil, packed in a cardboard box.
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
Tel. +39 06 911801

Manufacturer
ITC Production Srl
via Pontina, km 29
00071 Pomezia (RM)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: ANNEXXO
Italy: ANNEXXO