Patient Information Leaflet

ANNOVA 800 IU film-coated tablets, 1,000 IU film-coated tablets, 7,000 IU film-coated tablets, 30,000 IU film-coated tablets

colecalciferol (vitamin D)
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What ANNOVA film-coated tablets are and what they are used for
What you need to know before taking ANNOVA film-coated tablets
How to take ANNOVA film-coated tablets
Possible side effects
How to store ANNOVA film-coated tablets
Contents of the pack and other information

1. What ANNOVA film-coated tablets are and what they are used for

The active substance of ANNOVA film-coated tablets is vitamin D.
Vitamin D helps the body absorb calcium, stimulates bone formation, and reduces levels of parathyroid hormone (PTH).
This medicinal product is recommended in the following cases:

For the prevention or treatment of vitamin D deficiency. Vitamin D deficiency may occur when your diet or lifestyle does not provide sufficient vitamin D, or when your body requires increased amounts of vitamin D (for example, during pregnancy).

ANNOVA is used in adults, elderly people, and adolescents.

2. What you need to know before taking ANNOVA film-coated tablets

Do not take ANNOVA film-coated tablets:

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 the 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).

Warnings and precautions
Talk to your doctor or pharmacist before taking ANNOVA film-coated tablets if:

you have a high tendency to form kidney stones,
you have cancer or any other condition affecting the bones,
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 taking this medicine for a long time,
if you have kidney problems,
if you have sarcoidosis; an immune disorder that can affect the liver, lungs, skin, or lymph nodes.

Other medicines and ANNOVA film-coated tablets
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Inform your doctor especially if you are taking any of the following medicines:

diuretics (or “water tablets”) – your blood calcium levels will be regularly monitored;
corticosteroids (‘steroids’ e.g. prednisolone, dexamethasone) – your vitamin D dose may need to be increased;
cholestyramine (a cholesterol-lowering drug) or laxatives (e.g. liquid paraffin) – may reduce vitamin D absorption;
heart medications (cardiac glycosides) – you should be medically supervised and, if possible, your ECG and blood calcium levels should be monitored;
anticonvulsants (for treatment of epilepsy), hypnotics (e.g. phenytoin, barbiturates) or primidone – these drugs 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) should not be used during vitamin D treatment due to the risk of high magnesium levels;
certain antibiotics for 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 (weight-loss aid) – reduces the absorption of vitamin D.

Pregnancy, breastfeeding and fertility
If you are pregnant or think you might be pregnant, if you are planning a pregnancy, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are breastfeeding, your doctor will monitor your calcium or phosphate levels in the blood, or your calcium levels in the urine.

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

ANNOVA film-coated tablets contain 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.

3. How to take ANNOVA film-coated tablets

Take this medicine exactly as directed 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 ANNOVA will depend on your vitamin D levels and your response to treatment.
Prevention of vitamin D deficiency (maintenance):

for adults, elderly patients, and patients with osteoporosis: 800–1000 IU daily, or an equivalent weekly or monthly dose, with a maximum of 1600 IU daily in patients at high risk of vitamin D deficiency.

Treatment of severe vitamin D deficiency in adults and elderly (loading dose):

800–4000 IU daily or an equivalent weekly or monthly dose.

Patients with renal problems
Your doctor may require you to have regular blood and/or urine tests.
Use in children
ANNOVA is not suitable for use in children under 12 years of age.
In adolescents (12–18 years):

400–800 IU daily depending on the severity of the condition and response to therapy (equivalent to 1 ANNOVA film-coated tablet 800 IU daily or on alternate days). It should only be administered under medical supervision.

If you take more ANNOVA film-coated tablets than you should
You may develop the following symptoms: loss of appetite, thirst, nausea, vomiting,
constipation, abdominal pain, muscle weakness, fatigue, confusion, increased frequency
of urination, 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 packaging and any remaining tablets with you.
If you forget to take ANNOVA film-coated tablets
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking ANNOVA film-coated tablets and contact your doctor immediately 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 (cannot be estimated from available data):

Anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, polydipsia, polyuria, bone pain, kidney calcifications, kidney stones, dizziness and cardiac arrhythmias.

Reporting of side effects
If you experience any side effect, inform your doctor or pharmacist. This includes any possible side effect 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 safety information about this medicine.

5. How to store ANNOVA film-coated tablets

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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ANNOVA film-coated tablets contain
The active substance is colecalciferol (vitamin D)
ANNOVA 800 IU film-coated tablets: each film-coated tablet contains 8 mg of concentrated colecalciferol (in powder form) (equivalent to 20 µg of colecalciferol = 800 IU of vitamin D).
ANNOVA 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).
ANNOVA 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).
ANNOVA 30000 IU film-coated tablets: each film-coated tablet contains 300 mg of concentrated colecalciferol (in powder form) (equivalent to 750 µg of colecalciferol = 30000 IU of vitamin D).
The other components are:

Tablet core: Cellactose 80 (monohydrate lactose and powdered cellulose (E460 (ii))), modified starch, maize starch, croscarmellose sodium (E468), sucrose, anhydrous colloidal silica (E551), magnesium stearate (E572), sodium ascorbate (E301), medium-chain triglycerides, DL-alpha-tocopherol (E307).
Coating: Opadry II Yellow 85F 32659 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 ANNOVA film-coated tablets and contents of the
pack
ANNOVA 800 IU film-coated tablets:
yellow, round, film-coated tablets, 6.1 mm in diameter, with smooth convex surfaces on both sides.
Pack: 30 film-coated tablets in opaque PVC/PVdC-Alu blisters with carton.
ANNOVA 1000 IU film-coated tablets:
yellow, round, film-coated tablets, 7.2 mm in diameter, with smooth convex surfaces on both sides and the letter 'D' imprinted on one side.
Pack: 30 film-coated tablets in opaque PVC/PVdC-Alu blisters with carton.
ANNOVA 7000 IU film-coated tablets:
yellow, round, film-coated tablets, 7.2 mm in diameter, with smooth convex surfaces on both sides and the letter 'W' imprinted on one side.
Packs: 4, 8 or 12 film-coated tablets in opaque PVC/PVdC-Alu blisters with carton.
ANNOVA 30000 IU film-coated tablets:
yellow, round, film-coated tablets, 13.2 mm in diameter, with smooth convex surfaces on both sides.
Packs: 2, 3 or 4 film-coated tablets in opaque PVC/PVdC-Alu blisters with carton.
Not all pack sizes may be marketed.
Marketing Authorization Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00071 Pomezia (RM)
Manufacturer responsible for batch release
Pharma Patent Kft.
Népfürdő utca 22. Duna torony B épület, 10. emelet
1138 Budapest
Hungary
This patient information leaflet was last updated on