Package leaflet: Information for the user

XAREXEN hard capsules

colecalciferol (vitamin D )
Please read all of this leaflet carefully before you start 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 their symptoms are the same 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 XAREXEN is and what it is used for
What you need to know before taking XAREXEN
How to take XAREXEN
Possible side effects
How to store XAREXEN
Contents of the pack and other information

1. What XAREXEN is and what it is used for

XAREXEN contains colecalciferol, better known as vitamin D.
XAREXEN is indicated in adolescents over 12 years of age and in adults to prevent low levels of vitamin D due to conditions causing insufficient production in the skin and/or increased vitamin D requirements.

2. What you need to know before taking XAREXEN

Do not take XAREXEN

If you are allergic to cholecalciferol (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 (hypercalcemia) and/or in your urine (hypercalciuria).
If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
If you have severe kidney disease (severe renal failure). See section “Warnings and precautions”.
If you have high levels of vitamin D.

Warnings and precautions
Talk to your doctor or pharmacist before taking XAREXEN.
Inform your doctor in the following cases:

if you need to take XAREXEN for a long period;
if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics);
if you have mild to moderate kidney disease (mild to moderate renal failure);
if you have severe kidney disease (severe renal failure), medical supervision is required. See section “Do not take XAREXEN”;

If you have or have had kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis), medical supervision is required. See section “Do not take XAREXEN”.
Inform your doctor in the following cases, as a dosage adjustment compared to those indicated in section 3 “How to take XAREXEN” may be necessary:

if you are taking medicines to treat infections, such as rifampicin, isoniazid (see section “Other medicines and XAREXEN”);
if you are taking antiepileptic medicines or barbiturates used to treat epilepsy (see section “Other medicines and XAREXEN”);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and XAREXEN”);
if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and XAREXEN”);
if you are taking a medicine for obesity called orlistat (see section “Other medicines and XAREXEN”);
if you are taking aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and XAREXEN”);
if you are obese;
if you suffer from digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
if you suffer from liver disease (hepatic insufficiency); if you suffer from sarcoidosis (an inflammatory disease that may affect the whole body and leads to nodule formation) and primary hyperparathyroidism (a condition leading to increased calcium levels in blood and urine).

Children
XAREXEN is not suitable for children aged between 0 and 12 years.
Other medicines and XAREXEN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines:

Digitalis, a medicine used to treat certain heart disorders; your doctor will closely monitor you and carefully evaluate whether tests are needed;
Warfarin, a medicine used to make the blood less likely to clot;
Thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
Rifampicin, isoniazid, medicines used to treat infections;
Carbamazepine, phenobarbital, phenytoin, primidone, medicines used to treat epilepsy (antiepileptics);
Barbiturates, medicines used to treat epilepsy;
Corticosteroids, medicines used to treat inflammation;
Aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus;
Colestipol, cholestyramine, medicines used to lower blood lipids;
Orlistat, a medicine used to treat obesity;
Preparations containing magnesium;
Actinomycin, an agent belonging to the group of actinomycins, antibiotics produced by various types of bacteria of the species Streptomyces. Actinomycins exert a harmful effect on living cells;
Antifungal imidazoles (e.g., ketoconazole), agents capable of inhibiting the growth of fungal organisms;
Preparations containing magnesium;

XAREXEN with food, drinks and alcohol
To avoid taking an excessive dose of vitamin D, you should consider whether you are taking other products already containing vitamin D, such as fortified foods or vitamin D-enriched milk (see section “Warnings and precautions”).
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You may take vitamin D during pregnancy when necessary.
During the first 6 months of pregnancy, you should take this medicine only if strictly necessary, due to the risk of harmful effects on the foetus (see section 3 “If you take more XAREXEN than you should”).

Breastfeeding
You may take vitamin D during breastfeeding when necessary. However, this does not replace the need for vitamin D supplementation in the newborn. Vitamin D and its metabolites are excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Fertility
No effects of vitamin D on fertility are known.

Driving and using machines
It is unlikely that XAREXEN affects the ability to drive. However, you should be aware that drowsiness may occur as a side effect of treatment with XAREXEN, although this is rare.

3. How to take XAREXEN

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.
The intake of XAREXEN is recommended in cases such as:

during the last trimester of pregnancy,
in breastfeeding women,
in case of insufficient sun exposure (e.g. conditions forcing prolonged indoor stay) or ineffective exposure (e.g. use of sunscreens and sun-blocking agents, winter months),
in case of special diets (e.g. low-calcium diet, vegetarian diet, lactose-free diet, etc.),
in case of deeply pigmented skin,

To avoid taking an excessive dose of vitamin D, you must consider whether you are taking other products containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk (see section 2 “XAREXEN with food, drink and alcohol”).
It is recommended to take XAREXEN during meals. The capsule must be swallowed whole.
Treatment cycles of 3 months are recommended.
The recommended dose is:
Adults
1 capsule daily.
Pregnancy (last trimester) and breastfeeding
1 capsule every 2 days.
Use in children
XAREXEN is not suitable for children aged between 0 and 12 years.
Adolescents (> 12 years)
1 capsule every 2 days.
If you take more XAREXEN than you should
In case of accidental ingestion/overdose of XAREXEN, contact your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria) may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs (a consequence of hypercalcemia).
Taking an excessive dose of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn (see section 2 “Pregnancy, breastfeeding and fertility”).
If you forget to take XAREXEN
Do not take a double dose to make up for the forgotten dose.
If you stop taking XAREXEN
If you have any doubts 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 will experience them.
The possible side effects are listed below by frequency:
Uncommon (may affect up to 1 in 100 people)

Increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).
Rare (may affect up to 1 in 1,000 people)
Allergic reactions
Weakness, loss of appetite (anorexia), thirst
Drowsiness, confusion
Constipation, gas (flatulence), stomach pain, nausea, diarrhoea
Skin rash, itching, hives
Not known (frequency cannot be estimated from the available data)
Headache
Vomiting, metallic taste, dry mouth
Excessive deposition of calcium in the kidneys (nephrocalcinosis), increased urine output (polyuria), intense thirst (polydipsia), kidney disease (renal failure).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You may also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store XAREXEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
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 you no longer use. This will help protect the environment.
Do not store above 25°C.
Do not freeze.
Store in the original packaging to protect the medicine from light.

6. Package contents and other information

What XAREXEN contains
The active substance is colecalciferol (vitamin D) 0.025 mg, equivalent to 1,000 I.U.
The other components are: gelatin, titanium dioxide (E171), iron oxide (E172), refined olive oil.

Description of the appearance of XAREXEN and package contents
XAREXEN is presented as hard capsules with a transparent body and white cap, with a pink sealing band.
It is available in a pack containing 3 blisters of 10 capsules each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Italfarmaco S.p.A. - Viale F. Testi, 330 - 20126 Milan - Italy
Manufacturer:
Abiogen Pharma S.p.A. - Via Meucci, 36 - Ospedaletto - Pisa, Italy
October 2025