Anorsia

Package leaflet: Information for the patient

ANORSIA 10,000 IU, soft capsules

Colecalciferol (vitamin D3)
Please read 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ANORSIA is and what it is used for
2. What you need to know before taking ANORSIA
3. How to take ANORSIA
4. Possible side effects
5. How to store ANORSIA
6. Contents of the pack and other information

1. What ANORSIA is and what it is used for

ANORSIA contains the active substance colecalciferol, better known as Vitamin D3.
ANORSIA is indicated for:
Prevention and treatment of vitamin D deficiency.
ANORSIA is indicated in adults.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ANORSIA

Do not take ANORSIA
If you are allergic to cholecalciferol (vitamin D3) or to any of the other ingredients of this
medicinal product (listed in section 6).

• If you have high levels of calcium in the blood (hypercalcemia) or in the urine (hypercalciuria)
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis)
• if you have high levels of vitamin D in the body (hypervitaminosis D)
• if you suffer from kidney disease (severe renal impairment) (see section “Warnings and precautions”).

ANORSIA must not be given to neonates and children under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking ANORSIA, particularly:
if you need to take ANORSIA for a long period and at high doses.
If you are elderly and are already taking medicines to treat heart conditions (cardiac glycosides or
diuretics). In this case, you must check calcium levels in blood and urine.
If you are already taking medicines containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk.
If you suffer from a chronic inflammatory disease that can affect all organs, called
sarcoidosis.
If you have impaired kidney function, as vitamin D levels in the body may be altered.
If you are prone to calcium-containing kidney stones.
If you have severe renal failure: in this case, other forms of vitamin D should be used.
If you take this medicine for long-term treatment, especially if you are elderly. In
this case, your doctor will monitor urinary calcium excretion and kidney function. If necessary, your
doctor may reduce the dose.
If you have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).
Inform your doctor if you have any of the following conditions, as an increase in dosage may be necessary as indicated in section 3 “How to take ANORSIA.”:
If you are being treated with medicines for epilepsy (anticonvulsants or barbiturates).
If you are being treated with anti-inflammatory medicines (corticosteroids).
If you are being treated with medicines that reduce blood fat levels (cholestyramine,
colestipol, orlistat) or laxatives (such as paraffin oil).
If you are being treated with medicines used to treat excessive stomach acid production (antacids containing aluminium).
If you are obese.
If you suffer from digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis).
If you suffer from liver disease (hepatic insufficiency).
Children
ANORSIA must not be given to neonates or children under 18 years of age.
Other medicines and ANORSIA
Inform 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, as they may reduce or
increase the effect of ANORSIA:
other medicines containing vitamin D.
medicines used to treat epilepsy (anticonvulsants or barbiturates), such as
phenytoin, phenobarbital, primidone, etc.
medicines to reduce blood fats such as colestipol, cholestyramine, orlistat, and laxatives
(e.g. paraffin oil)
antacids containing aluminium, medicines used to treat excess stomach acid that may
reflux into the oesophagus
thiazide diuretics, medicines used to treat high blood pressure that
increase urine production
digitalis, a medicine used to treat certain heart disorders
medicines used to treat tuberculosis, such as rifampicin and isoniazid
antifungal agents such as imidazoles (e.g. ketoconazole), medicines used to inhibit fungal
growth
warfarin, a medicine used to thin the blood
heart medicines (cardiac glycosides), as you will need to be monitored by a doctor, possibly undergo an ECG, and have your calcium levels checked.
ANORSIA with food, drinks and alcohol
Inform your doctor if you are taking other vitamin D-containing products, vitamin D-fortified foods,
or if you consume vitamin D-enriched milk, so that the total vitamin D intake can be taken into account and excessive doses avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
ANORSIA must not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical condition requires treatment with cholecalciferol at lower dosages.
Pregnancy
Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if strictly
necessary, due to the risk of harmful effects on the fetus (see section 3: “If you take more
ANORSIA”).
However, since vitamin D deficiency is harmful to both fetus and mother, if necessary, your
doctor may prescribe low-dose vitamin D during pregnancy.
Breastfeeding
If necessary, your doctor may prescribe low-dose vitamin D during breastfeeding. This does not
replace the administration of vitamin D to the newborn.
Driving and using machines
ANORSIA does not affect or has a negligible effect on the ability to drive vehicles and use machines.

3. How to take ANORSIA

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment should be determined by your doctor according to your health
condition.
Do not exceed the doses indicated by your doctor.
Take the dose orally.
Take ANORSIA with meals.
Adults and elderly
Prevention:
The recommended dose is 1 capsule every 2 weeks (equivalent to 20,000 IU of vitamin D3 per month).
If there is a high risk of vitamin D deficiency, your doctor will assess whether the dose should be
increased up to 1 capsule per week (equivalent to 10,000 IU of vitamin D3).
Treatment:
The recommended dose is 2 capsules per week (equivalent to 20,000 IU of vitamin D3 weekly) for 1–3
months. Your doctor will determine the most appropriate dose for you and may subsequently prescribe
lower doses.
In cases of severe vitamin D deficiency in adults and elderly patients, the required amount will depend
on vitamin D levels and response to treatment. Your doctor will determine the most suitable dose based
on your response to therapy. Higher doses must be adjusted according to desired serum levels of
25-hydroxycholecalciferol (25(OH)D), severity of the disease, and response to treatment.
Long-term treatment:
In case of long-term treatment, especially if you are an elderly patient, your doctor will monitor urinary
calcium excretion and renal function. If necessary, your doctor may reduce the dose.
If you take more ANORSIA than you should
In case of accidental ingestion/overdose of ANORSIA, inform your doctor immediately or go to the
nearest hospital. Overdose may lead to increased levels of calcium in blood and urine, with symptoms
such as: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine production (polyuria),
constipation and dehydration.
Other symptoms of overdose include:
Diarrhoea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, kidney stones,
nephrocalcinosis and renal failure.
Chronic, excessive overdosage may lead to calcium salt deposits in blood vessels and organs.
Excessive vitamin D intake during the first 6 months of pregnancy may cause severe harm to the fetus
and newborn.
If you forget to take ANORSIA
Do not take a double dose to make up for the missed dose.
If you stop taking ANORSIA
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
ANORSIA contains glycerol
It may cause headache, stomach upset and diarrhoea.
ANORSIA contains Allura Red (E129)
It may cause allergic reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with vitamin D use are the following:

Uncommon side effects (may affect up to 1 in 100 people):
Allergic reactions, weakness, loss of appetite (anorexia), increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria).

Rare side effects (may affect up to 1 in 1,000 people):
Drowsiness, confusion, constipation, intestinal gas (flatulence), stomach ache, nausea, vomiting, diarrhoea, metallic taste, dry mouth, skin rash, itching, urticaria.

Frequency not known (frequency cannot be estimated from the available data):
Headache, excessive calcium deposits in the kidneys (nephrocalcinosis), increased urine production (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, talk to your doctor or pharmacist. You may 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 can help provide more information on the safety of this medicine.

5. How to store ANORSIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of 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 no longer required. This will help protect the environment.
Store below 25  C.
Store in the original packaging to protect the medicine from light.
Do not freeze.

6. Package contents and other information

What ANORSIA contains

• The active substance is colecalciferol (vitamin D). Each soft capsule contains: 0.250 mg colecalciferol (vitamin D) equivalent to 10,000 IU.
• The other components are:
• Capsule contents: refined olive oil, butylated hydroxytoluene (E321).
  Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin succinate, Allura Red AC (E129).

Description of the appearance of ANORSIA and contents of the pack
The pack contains 2, 4, 8 or 10 capsules in a thermo-sealed PVC/PVDC-aluminum blister,
housed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy

Manufacturer
DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy

This medicinal product is authorized in the European Economic Area countries with the
following names:
MT: ANORSIA, 10,000 I.U. soft capsules
IT: ANORSIA

Patient information leaflet

ANORSIA 25,000 UI, soft capsules

Colecalciferol (vitamin D3)
Please read this leaflet carefully before taking this medicine, as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ANORSIA is and what it is used for
2. What you need to know before taking ANORSIA
3. How to take ANORSIA
4. Possible side effects
5. How to store ANORSIA
6. Package contents and other information

1. What ANORSIA is and what it is used for

ANORSIA contains the active substance colecalciferol, better known as Vitamin D3.
ANORSIA is indicated for:
Prevention of vitamin D deficiency only in cases where therapeutic adherence cannot be achieved with daily administration of low doses of colecalciferol.
Treatment of vitamin D deficiency.
ANORSIA is indicated in adults.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking ANORSIA

Do not take ANORSIA

• if you are allergic to cholecalciferol (vitamin D3) 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) or in your urine (hypercalciuria)
• if you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis)
• if you have high levels of vitamin D in your body (hypervitaminosis D)
• if you suffer from kidney disease (severe renal impairment) (see section “Warnings and precautions”).

ANORSIA must not be given to neonates and children under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking ANORSIA, particularly:
if you need to take ANORSIA for a long period and at high doses.
If you are elderly and are already taking medicines to treat heart conditions (cardiac glycosides or
diuretics). In this case, you must check your calcium levels in blood and urine.
If you are already taking medicines containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk.
If you suffer from a chronic inflammatory disease affecting multiple organs called
sarcoidosis.
If you have impaired kidney function, as vitamin D levels in the body may be altered.
If you are prone to developing calcium-containing kidney stones.
If you have severe renal insufficiency: in this case, other forms of vitamin D should be used.
If you are taking this medicine for long-term treatment, especially if you are elderly. In
this case, your doctor will monitor urinary calcium excretion and kidney function. If necessary, your
doctor will reduce the dose.
If you have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism).
Inform your doctor if you have any of the following conditions, as a dosage increase may be required as indicated in section 3 “How to take ANORSIA”:
If you are being treated with antiepileptic drugs (anticonvulsants or barbiturates).
If you are being treated with anti-inflammatory medicines (corticosteroids).
If you are being treated with medicines that reduce blood lipid levels (colestipol,
cholestyramine, orlistat, and laxatives (such as paraffin oil).
If you are being treated with medicines used to treat excessive stomach acid production (antacids containing aluminium).
If you are obese.
If you suffer from digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis).
If you suffer from liver disease (hepatic insufficiency).
Children
ANORSIA must not be given to neonates or children under 18 years of age.
Other medicines and ANORSIA
Inform 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, as they may reduce or
increase the effect of ANORSIA:
other medicines containing vitamin D.
medicines used to treat epilepsy (anticonvulsants or barbiturates), such as
phenytoin, phenobarbital, primidone, etc.
medicines to reduce blood lipids such as colestipol, cholestyramine, orlistat, and laxatives
(e.g. paraffin oil)
antacids containing aluminium, medicines used to treat excess stomach acid that may
reflux into the oesophagus
thiazide diuretics, medicines used to treat high blood pressure, which
increase urine production
digitalis, a medicine used to treat certain heart conditions
medicines used to treat tuberculosis, such as rifampicin and isoniazid
antifungal agents such as imidazoles (e.g. ketoconazole), medicines used to inhibit fungal growth
warfarin, a medicine used to thin the blood
heart medicines (cardiac glycosides), because you will need to be monitored by a doctor, possibly including an ECG, and calcium levels must be checked.
ANORSIA with food, drink and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods,
or if you use vitamin D-enriched milk, so that your total vitamin D intake can be taken into account and excessive doses avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
ANORSIA must not be used during pregnancy and breastfeeding. However, your doctor may
decide that your clinical condition requires treatment with cholecalciferol at lower doses.
Pregnancy
Your doctor will prescribe vitamin D during the first 6 months of pregnancy only if strictly
necessary, due to the risk of harmful effects on the fetus (see section 3: “If you take more
ANORSIA”).
However, since vitamin D deficiency is harmful to both the fetus and the mother, if necessary, your doctor may prescribe low-dose vitamin D during pregnancy.
Breastfeeding
If necessary, your doctor may prescribe low-dose vitamin D during breastfeeding. This does not replace the need for vitamin D supplementation in the newborn.
Driving and using machines
ANORSIA does not affect or has a negligible effect on the ability to drive vehicles and use machines.

3. How to take ANORSIA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment should be determined by your doctor according to your
health condition.
Do not exceed the doses indicated by your doctor.
Take the dose orally.
Take ANORSIA with meals.

Adults and elderly
Prevention:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a month.
Your doctor will determine the most suitable dose for you and may subsequently prescribe lower doses.

Treatment:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a week for 4–12
weeks. Your doctor will determine the most suitable dose for you and may subsequently prescribe lower doses.

During long-term treatment with high doses, urinary calcium excretion and renal function should be monitored, especially in elderly patients. It is recommended to reduce the dose or discontinue treatment if urinary calcium exceeds 7.5 mmol/24 hours (300 mg/24 hours).

In cases of severe vitamin D deficiency in adults and elderly patients, the required amount will depend on vitamin D levels and response to treatment. Your doctor will determine the most appropriate dose based on your response to therapy. Higher doses should be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25(OH)D), disease severity, and response to treatment.

If you take more ANORSIA than you should
In case of accidental ingestion/overdose of ANORSIA, inform your doctor immediately or go to the nearest hospital. Overdose may lead to increased levels of calcium in the blood and urine, with symptoms including: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine production (polyuria), constipation, and dehydration.

Other symptoms of overdose include:
Diarrhoea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and renal failure.

Excessive chronic overdosage may lead to calcium salt deposits in blood vessels and organs. The use of excessive vitamin D doses during the first 6 months of pregnancy may cause severe harm to the fetus and newborn.

If you forget to take ANORSIA
Do not take a double dose to make up for the missed dose.

If you stop taking ANORSIA
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

ANORSIA contains glycerol
It may cause headache, stomach upset, and diarrhoea.

ANORSIA contains Allura Red (E129)
It may cause allergic reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with vitamin D use are the following:

Uncommon side effects (may affect up to 1 in 100 people):
Allergic reactions, weakness, loss of appetite (anorexia), increased levels of calcium in blood (hypercalcemia) and in urine (hypercalciuria).

Rare side effects (may affect up to 1 in 1,000 people):
Drowsiness, confusion, constipation, intestinal gas (flatulence), stomach ache, nausea, vomiting, diarrhoea, metallic taste, dry mouth, skin rash, itching, urticaria.

Frequency not known (frequency cannot be estimated from the available data):
Headache, excessive calcium deposits in the kidneys (nephrocalcinosis), increased urine production (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, talk to your doctor or pharmacist. 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 can help provide more information on the safety of this medicine.

5. How to store ANORSIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the pack 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.
Store below 25 C.
Keep in the original packaging to protect the medicine from light.
Do not freeze.

6. Package contents and other information

What ANORSIA contains

• The active substance is colecalciferol (vitamin D). Each soft capsule contains: 0.625 mg of colecalciferol (vitamin D) equivalent to 25,000 IU.
• The other components are:
• Capsule contents: refined olive oil, butyl hydroxytoluene (E321).
  Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin, succinic acid, and Allura Red AC (E129).

Description of the appearance of ANORSIA and contents of the pack
The pack contains 1, 2, 4 soft capsules in a thermoformed PVC/PVDC and aluminum blister, inserted into a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pharmacare Srl
Via Marghera, 29
20149 Milan
Italy

Manufacturer
DOPPEL FARMACEUTICI S.r.l.
Via Martiri delle Foibe, 1
29016 Cortemaggiore (PC)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
MT: ANORSIA, 25,000 IU, soft capsules
IT: ANORSIA