Annexxo

Package Leaflet: Information for the User

ANNEXXO, 1,000 IU, coated tablets

ANNEXXO, 7,000 IU, coated tablets

Cholecalciferol

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is ANNEXXO and what is it 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 is ANNEXXO and what is it used for

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

• Prevention or treatment of vitamin D deficiency. Vitamin D deficiency may occur when the diet or lifestyle does not provide enough vitamin D or when the body needs 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 the blood or urine,
• if you have kidney stones or kidney calcification,
• 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 the blood or urine (hypervitaminosis D)

Warnings and precautions

Before starting treatment with ANNEXXO, discuss it with your doctor or pharmacist

• if you have a high tendency to form kidney stones
• if you have cancer or any other condition that may affect the bones
• if you have a disorder of parathyroid hormone balance (pseudohypoparathyroidism)

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

• if you are being treated with this medicine for a long time.
• if you have kidney function disorders,
• if you have sarcoidosis; and 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.

ANNEXXO and other medicines

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

• diuretics - calcium levels in the blood will be regularly monitored;
• corticosteroids ("steroids", such as prednisolone, dexamethasone) - may require increased vitamin D doses;
• cholestyramine (a cholesterol-lowering medicine) or laxatives (e.g., paraffin oil) - reduce vitamin D absorption;
• cardiac glycosides (e.g., digoxin) - the patient should be monitored by a doctor and possibly monitored for ECG and calcium levels in the blood;
• antiepileptic drugs (used to treat epilepsy), sedatives (such as hydantoin, barbiturates), or primidone - 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 phosphate levels in the blood;
• products containing magnesium (such as antacids), 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 cholecalciferol;
• actinomycin (a medicine used to treat certain types of cancer) and antifungal medicines imidazole and ketoconazole (medicines used to treat fungal infections): these medicines may affect how the body processes vitamin D;
• orlistat (a weight loss aid) - reduces vitamin D absorption.

Pregnancy or breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
For safety reasons, it is not recommended to take single weekly or monthly doses during pregnancy: therefore, do not take ANNEXXO 7000 IU during pregnancy.
If you are breastfeeding, your doctor will monitor your calcium or phosphate levels in the blood or calcium levels in the urine.

Driving and using machines

No known effects on the ability to drive and use machines.

ANNEXXO contains lactose and sucrose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

ANNEXXO contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take ANNEXXO

Always take this medicine exactly as your doctor has told you.
In case of doubt, consult your doctor or pharmacist.
Tablets can 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:

o ANNEXXO 1000 IU:
1 tablet daily. In case of multiple risk factors, according to your doctor's instructions, the dose can be increased to 2 tablets daily
o ANNEXXO 7000 IU:
1 tablet once a week. In case of multiple risk factors, according to your doctor's instructions, the dose can be increased to 2 tablets weekly

Treatment of vitamin D deficiency:

o ANNEXXO 1000 IU:
1-4 tablets/day
o ANNEXXO 7000 IU:
1-4 tablets/week

Patients with kidney disease

Your doctor may prescribe regular blood and/or urine tests.

Overdose of ANNEXXO

The following symptoms may occur: loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, frequent urination, bone pain, kidney function disorders, and in severe cases, irregular heartbeat, coma, or even death.
In case of overdose, contact your doctor or go to the emergency department of the nearest hospital immediately. Bring the package and any remaining tablets with you.

Missed dose of ANNEXXO

Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ANNEXXO can cause side effects, although not everybody gets them.
Stop taking ANNEXXO and seek medical help immediatelyif 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):

• high levels of calcium in the blood (hypercalcemia) - symptoms include nausea, vomiting, loss of appetite, constipation, abdominal pain, bone pain, excessive thirst, frequent urination, muscle weakness, drowsiness, and confusion.
• high levels of calcium in the urine (hypercalciuria).

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

• itching (skin itching), rash, and hives.

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

• loss of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, excessive thirst, frequent urination, bone pain, kidney calcification, kidney stones, dizziness, and irregular heartbeat.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can 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.
Store in the original package 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 month.
Medicines should 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 pack and other information

What ANNEXXO contains

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

• Tablet core: celactose 80 (lactose monohydrate and powdered cellulose (E460) (ii)), sodium octenyl succinate starch (E1450), corn starch, croscarmellose sodium (E468), sucrose, colloidal anhydrous 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), macrogol 3350, talc (E553b), quinoline yellow, aluminum lake (E104), yellow iron oxide (E172).

What ANNEXXO looks like and contents of the pack

ANNEXXO, 1000 IU, coated tablets:
Oval, yellow tablets with dimensions of approximately 3.7 x 8.5 x 5.0 mm with a line printed on one side.
Pack sizes: 30 or 60 coated tablets in white, non-transparent blisters with PVC/Aluminum and cardboard box.
ANNEXXO, 7000 IU, coated tablets:
Round, yellow tablets with dimensions of approximately 4.2 x 7.3 mm with a line printed on one side.
Pack sizes: 4, 8, or 12 coated tablets in white, non-transparent blisters with PVC-Alu and cardboard box.
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
Tel. +39 06 911801

Manufacturer

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

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

Poland:
ANNEXXO
Italy:
ANNEXXO

Date of last revision of the package leaflet: