Annexxo

Package Leaflet: Information for the User

ANNEXXO, 30,000 IU, Film-Coated Tablets

Cholecalciferol

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

• You should 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the 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 reduces the level of
parathyroid hormone (PTH).
This medicine is recommended in the following cases:

• Prevention of vitamin D deficiency in adults with identified risk, when adherence to therapeutic recommendations is not achieved through daily administration of small doses of cholecalciferol or treatment of vitamin D deficiency. Vitamin D deficiency may occur when the diet or lifestyle does not provide sufficient 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 your blood or urine,
• if you have kidney stones or calcification 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 treatment with ANNEXXO, you should 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 your blood or calcium levels in your 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 recently taken, 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 your blood will be regularly monitored;
• corticosteroids ("steroids", such as prednisolone, dexamethasone) - it may be necessary to increase the dose of vitamin D;
• cholestyramine (a cholesterol-lowering medicine) or laxatives (such as paraffin oil) - they reduce the absorption of vitamin D;
• heart medicines (digitalis glycosides) - you should be monitored by your doctor and your ECG and calcium levels in your blood may be monitored;
• antiepileptic medicines (used to treat epilepsy), sedatives (such as hydantoin, barbiturates), or primidone - they reduce the effect of vitamin D;
• products containing high doses of calcium: they increase the risk of high calcium levels in your blood;
• products containing high doses of phosphorus - they increase the risk of high phosphate levels in your 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 diseases): these medicines may affect how your 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, ask your doctor for advice 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 30,000 IU during pregnancy.
If you are breastfeeding, your doctor will monitor your calcium or phosphate levels in your blood or calcium levels in your urine.

Driving and using machines

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

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 (23 mg) of sodium per film-coated tablet, which is essentially 'sodium-free'.

3. How to take ANNEXXO

Always take this medicine exactly as your doctor has told you.
If you are not sure, ask 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:

• 1 tablet per month.

Treatment of large vitamin D deficiency:

• 1 tablet per week for a period of up to 4-10 weeks.

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.
If you have taken too many tablets, contact your doctor or go to the emergency department of your 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 forgotten dose.
If you have any further questions on 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 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 pruritus), 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, polydipsia (excessive thirst), polyuria (excessive urine production), bone pain, kidney calcification, kidney stones, dizziness, and arrhythmia (irregular heartbeat).

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Side effects can be reported directly to the Department of Medicines Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C,
02-222 Warsaw,
phone: +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. These measures will help protect the environment.

6. Contents of the pack and other information

What ANNEXXO contains

The active substance is cholecalciferol (vitamin D)
ANNEXXO 30,000 IU film-coated tablets: each film-coated tablet contains 300 mg of cholecalciferol concentrate (in powder form) (which corresponds to 750 micrograms of cholecalciferol = 30,000 IU of vitamin D).
Other ingredients:

• Core: cellulose microcrystalline (E460), sodium starch glycolate type A (E1450), maize starch, croscarmellose sodium (E468), sucrose, silica colloidal anhydrous (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, 30,000 IU, film-coated tablets:
Yellow, round tablets, approximately 5.5 x 13.4 mm in size.
Pack sizes: 2, 3, 4, 5, or 10 film-coated tablets in white, non-transparent blisters of PVC/Aluminum and a 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
Phone: +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:

Country

Poland:
ANNEXXO
Italy:
ANNEXXO

Date of last revision of the leaflet: