Annexxo

Package leaflet: Information for the user

ANNEXXO, 1 000 IU, film-coated tablets
ANNEXXO, 7 000 IU, film-coated tablets
Cholecalciferolum
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm them 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. Important information 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 in ANNEXXO is cholecalciferol (vitamin D).
Vitamin D helps the body absorb calcium and supports bone formation, as well as lowering the level of parathyroid hormone (PTH).
This medicine is recommended in the following cases:

• Prevention or treatment of vitamin D deficiency. Vitamin D deficiency may occur when diet or lifestyle does not provide enough vitamin D, or when the body requires more vitamin D.

ANNEXXO is intended for use in adults.

2. Important information before taking ANNEXXO

When not to 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 have kidney stones or calcifications in the kidneys,
• if you have severe kidney disease,
• if you are already taking additional doses of vitamin D (such as multivitamin preparations or dietary supplements containing vitamin D),
• if you have high levels of vitamin D in your blood or urine (hypervitaminosis D).

Warnings and precautions
Before starting ANNEXXO, discuss with your doctor or pharmacist if:

• you have a high tendency to develop 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
the levels of calcium or phosphate in your blood or calcium in your urine:

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

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

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

• diuretics ("water pills") – 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;
• heart medicines (cardiac glycosides) – you should be monitored by your doctor, and your ECG and blood calcium levels may be monitored;
• antiepileptic drugs (used to treat epilepsy), sedatives (such as hydantoin, barbiturates) or primidone – these reduce the effect of vitamin D;
• calcium-containing products in high doses – these increase the risk of high calcium levels in the blood;
• phosphate-containing products in high doses – these increase the risk of high phosphate levels in the blood;
• magnesium-containing products (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 types of cancer) and antifungal imidazoles 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
For safety reasons, single weekly or monthly doses should not be used during pregnancy: therefore, ANNEXXO 7000 IU should not be used during pregnancy.
If you are breastfeeding, your doctor will monitor the levels of calcium or phosphate in your blood or calcium in your urine.

Driving and using machines
The effect 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 film-coated tablet, i.e. it is considered "sodium-free".

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

Dosage
The dose of ANNEXXO will depend on the level of vitamin D in your body and your response to treatment.

Prevention of vitamin D deficiency:

• ANNEXXO 1000 IU:
  1 tablet daily. If there are multiple risk factors, the dose may be increased to 2 tablets daily, as advised by your doctor.
• ANNEXXO 7000 IU:
  1 tablet once weekly. If there are multiple risk factors, the dose may be increased to 2 tablets weekly, as advised by your doctor.

Treatment of vitamin D deficiency:

• ANNEXXO 1000 IU:
  1–4 tablets/day
• ANNEXXO 7000 IU:
  1–4 tablets/week

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

Taking more ANNEXXO than recommended
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 or go to the nearest hospital emergency department immediately. Take the packaging and any remaining tablets with you.

If you miss a dose of 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 everyone will experience them.
You must stop taking ANNEXXO and seek immediate medical help if any 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 up to 1 in 100 people):

• elevated calcium levels in the 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 the urine (hypercalciuria).

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• itching (skin rash), rash and hives.

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

• loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, polydipsia (excessive thirst), polyuria (excessive urine production), bone pain, kidney calcification, 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
Phone: +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 authorization 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 the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What ANNEXXO contains
The active substance in ANNEXXO is cholecalciferol (vitamin D).
ANNEXXO 1000 IU, coated tablets: each coated tablet contains 10 mg of cholecalciferol concentrate (in powder form) (equivalent to 25 micrograms of cholecalciferol = 1000 IU of vitamin D).
ANNEXXO 7000 IU, coated tablets: each coated tablet contains 70 mg of cholecalciferol concentrate (in powder form) (equivalent to 175 micrograms of cholecalciferol = 7000 IU of vitamin D).

Other ingredients:

• Tablet core: Lactose monohydrate and microcrystalline cellulose (E460 (ii)), sodium octenylsuccinate starch (E1450), corn starch, sodium croscarmellose (E468), sucrose, anhydrous colloidal silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium-chain 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 1000 IU, coated tablets:
Oval, yellow tablets, approximately 3.7 x 8.5 x 5.0 mm in size, with a scored line on one side.
Pack sizes: 30 or 60 coated tablets in white, opaque PVC/Aluminum blisters, packed in a cardboard box.
ANNEXXO 7000 IU, coated tablets:
Round, yellow tablets, approximately 4.2 x 7.3 mm in size, with a scored line on one side.
Pack sizes: 4, 8 or 12 coated tablets in white, opaque PVC-Alu blisters, packed in a 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 for marketing in the European Economic Area under the following names:
Poland: ANNEXXO
Italy: ANNEXXO