ANORSIA 10,000 IU Kapsułka miękka

Treść ulotki

1. ANORSIA 10.000 UI, soft capsules
   1. What is ANORSIA and what is it used for
   2. What you need to know before you take ANORSIA
   3. How to take ANORSIA
   4. Possible side effects
   5. How to store ANORSIA
   6. Contents of the pack and other information
2. ANORSIA 25.000 UI, soft capsules
   1. What is ANORSIA and what is it used for
   2. What you need to know before you take ANORSIA
   3. How to take ANORSIA
   4. Possible side effects
   5. How to store ANORSIA
   6. Contents of the pack and other information

ANORSIA 10.000 UI, soft capsules

Cholecalciferol (vitamin D3)

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is ANORSIA and what is it used for

ANORSIA contains the active ingredient cholecalciferol, 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 you take 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 a kidney disease (severe renal impairment) (see section “Warnings and precautions”).

ANORSIA should not be given to newborns and children under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ANORSIA, especially:
if you need to follow a treatment with ANORSIA for a long period and at high doses.
If you are elderly and are already taking medicines to treat heart disease (cardiac glycosides or
diuretics). In this case, you should check the levels of calcium in the blood and urine.
If you are already taking medicines containing vitamin D, foods supplemented with vitamin D or
milk enriched with vitamin D.
If you suffer from a chronic inflammatory disease that can involve all organs called
sarcoidosis.
If you have impaired kidney function, as vitamin D levels in the body
may be altered.
If you tend to have kidney stones containing calcium.
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 the doctor will monitor urinary calcium and kidney function. If necessary, the
doctor will reduce the dose.
If you have an imbalance in the levels of parathyroid hormone (pseudo-hypoparathyroidism).
Tell your doctor if you have any of the following conditions, as you may need an
increase in dosage 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 medicines for inflammation (corticosteroids).
If you are being treated with medicines that reduce the level of fats in the blood (cholestyramine,
cholestyramine, orlistat and laxatives (such as paraffin oil).
If you are being treated with medicines used for the treatment of excessive acid
in the stomach (antacids containing aluminum).
If you are obese.
If you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis or cystic fibrosis).
If you suffer from a liver disease (hepatic insufficiency).

Children
ANORSIA should not be given to newborns or children under 18 years of age.

Other medicines and ANORSIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 for the treatment of epilepsy (anticonvulsants or barbiturates), such as
phenytoin, phenobarbital, primidone, etc.
medicines to reduce fats in the blood such as cholestyramine, colestyramine, orlistat and laxatives
(e.g. paraffin oil)
aluminum-containing antacids, medicines to treat excessive stomach acid that
can reflux into the esophagus
thiazide diuretics, medicines for the treatment of high blood pressure, which
increase urine production
digitalis, a medicine for the treatment of certain heart disorders
medicines used to treat tuberculosis, such as rifampicin and isoniazid
antifungal agents such as imidazole (e.g. ketoconazole), medicines used to block the
growth of fungal organisms
warfarin, a medicine used to thin the blood
heart medicines (cardiac glycosides), because you will need to be monitored by a doctor,
possibly have an ECG and check calcium levels.

ANORSIA with food, beverages and alcohol
Tell your doctor if you are taking other products containing vitamin D, foods supplemented with vitamin D,
or if you use milk enriched with vitamin D, so that they can take into account the total dose of
vitamin D taken and avoid excessive doses.
Consumption of large amounts of alcohol for a long period (chronic alcoholism) reduces the deposits of
vitamin D in the liver.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
ANORSIA should not be used during pregnancy and breastfeeding. However, your doctor may
decide that your clinical condition necessarily 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, as vitamin D deficiency is harmful to both the fetus and the mother, if necessary, your
doctor will prescribe vitamin D at a low dose during pregnancy.
Breastfeeding
If necessary, your doctor will prescribe vitamin D at a low dose during breastfeeding. This does
not replace the administration of vitamin D to the newborn.

Driving and operating machinery
ANORSIA does not alter or alters negligibly the ability to drive vehicles and operate machinery.

3. How to take ANORSIA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment must be evaluated by the doctor based on your health
conditions.
Do not exceed the doses indicated by the doctor.
Take the dose orally.
Take ANORSIA with meals.

Adults and the elderly

Prevention:
The recommended dose is 1 capsule every 2 weeks (equivalent to 20,000 IU of vitamin D3 per month).
In case of a high risk of vitamin D deficiency, the doctor will assess whether an increase in the
dosage up to 1 capsule per week (equivalent to 10,000 IU of vitamin D3) is necessary.

Treatment:
The recommended dose is 2 capsules per week (equivalent to 20,000 IU of vitamin D3 per week) for 1-3
months. The doctor will establish the most suitable dose for you and may subsequently prescribe lower
doses.
In case of severe vitamin D deficiency in adults and the elderly, the amount will depend on vitamin
D levels and response to treatment. The doctor will establish the most suitable dose for you based on your response to
therapy. Higher doses should be adjusted based on the desired serum levels of 25-hydroxycholecalciferol
(25(OH)D), the severity of the disease, and response to treatment.

Long-term treatment:
In case of long-term treatment, especially if you are an elderly patient, the doctor will monitor
urinary calcium and kidney function. If necessary, the doctor will reduce the dose.

If you take more ANORSIA than you should
In case of accidental ingestion/intake of ANORSIA, immediately inform your doctor or
go to the nearest hospital. In case of overdose, increased levels of calcium
in the blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, intense thirst (polydipsia),
increased amount of urine production (polyuria), constipation, and dehydration.
Other symptoms of overdose are as follows:
Diarrhea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and kidney failure.
Chronic excessive overdoses can lead to calcium salt deposits in blood vessels and
organs. The use of excessive doses of vitamin D in the first 6 months of pregnancy can cause serious damage
to the fetus and newborn.

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

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

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

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 the use of vitamin D are as follows:
Uncommonside effects that can 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).
Rareside effects that can affect up to 1 in 1,000 people:
Drowsiness, confusion, constipation, intestinal gas (flatulence), stomach pain, nausea, vomiting,
diarrhea, metallic taste, dry mouth, skin rash, itching, urticaria.
Not knownfrequency (the frequency cannot be estimated from the available data):
Headache, excessive calcium in the kidneys (nephrocalcinosis), increased amount of urine production (polyuria), intense thirst (polydipsia), kidney disease (renal failure).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the label on the pack after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature below 25  C.
Store in the original package to protect the medicine from light.
Do not freeze.

6. Contents of the pack and other information

What ANORSIA contains

• The active ingredient is cholecalciferol (vitamin D). Each soft capsule contains: 0.250 mg of cholecalciferol (vitamin D) equivalent to 10,000 IU.
• The other ingredients are:
• Capsule content :refined olive oil, butyl hydroxytoluene (E321). Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin succinate and allura red 40 (E129).

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Pharmacare Srl
Via Marghera, 29
20149 Milano
Italy

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
MT: ANORSIA, 10,000 I.U. soft capsules
IT: ANORSIA

ANORSIA 25.000 UI, soft capsules

Cholecalciferol (vitamin D3)

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is ANORSIA and what is it used for

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

2. What you need to know before you take 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 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 a kidney disease (severe renal impairment) (see section “Warnings and precautions”).

ANORSIA should not be given to infants and children under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking ANORSIA, especially:
if you need to follow a treatment with ANORSIA for a long period and at high doses.
If you are elderly and are already taking medicines to treat heart disease (cardiac glycosides or
diuretics). In this case, you should check the levels of calcium in the blood and urine.
If you are already taking medicines containing vitamin D, foods supplemented with vitamin D or
milk enriched with vitamin D.
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 tend to have calcium-containing kidney stones.
If you have severe renal insufficiency: 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 the doctor will monitor urine calcium and kidney function. If necessary, the
doctor will reduce the dose.
If you have an imbalance in parathyroid hormone levels (pseudohypoparathyroidism)
Tell your doctor if you have any of the following conditions, as you may need an
increase in dosage 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 medicines for inflammation (corticosteroids).
If you are being treated with medicines that lower blood fat levels (cholestyramine, colestipol, orlistat and laxatives (such as paraffin oil).
If you are being treated with medicines used to treat excessive acid
production in the stomach (aluminum-containing antacids).
If you are obese.
If you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis or cystic fibrosis).
If you suffer from a liver disease (hepatic insufficiency).

Children
ANORSIA should not be given to infants or children under 18 years of age.

Other medicines and ANORSIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell 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 lower blood fats such as cholestyramine, colestipol, orlistat and laxatives
(e.g. paraffin oil)
aluminum-containing antacids, medicines to treat heartburn that can
rise into the esophagus
thiazide diuretics, medicines for the treatment of high blood pressure, which
increase urine production
digitalis, a medicine for the treatment of some heart disorders
medicines used to treat tuberculosis, such as rifampicin and isoniazid
antifungal agents such as imidazole (e.g. ketoconazole), medicines used to block the
growth of fungi
warfarin, a medicine used to thin the blood
heart medicines (cardiac glycosides), because it will need to be monitored by a doctor,
possibly undergo an ECG and check calcium levels.

ANORSIA with food, drinks and alcohol
Tell your doctor if you are taking other products containing vitamin D, foods supplemented with vitamin D,
or if you use milk enriched with vitamin D, so that they can take into account the total dose of
vitamin D taken and avoid excessive doses.
Consuming large amounts of alcohol for a long period (chronic alcoholism) reduces vitamin D stores in the
liver.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
ANORSIA should not be used during pregnancy and breastfeeding. However, your doctor may
decide that your clinical condition necessarily 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, as vitamin D deficiency is harmful to both the fetus and the mother, if necessary, your
doctor will prescribe vitamin D at a low dose during pregnancy.
Breastfeeding
If necessary, your doctor will prescribe vitamin D at a low dose during breastfeeding. This does
not replace the administration of vitamin D to the newborn.

Driving and operating machinery
ANORSIA does not alter or negligibly alters the ability to drive vehicles and operate machinery.

3. How to take ANORSIA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The dose and duration of treatment must be evaluated by the doctor based on your health
conditions.
Do not exceed the doses indicated by the doctor.
Take the dose orally.
Take ANORSIA with meals.

Adults and the elderly

Prevention:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a month.
The doctor will establish 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. The doctor will establish the most suitable dose for you and may subsequently prescribe lower
doses.
During long-term treatment with high doses, urinary calcium and renal function must be monitored, especially
in elderly patients. It is recommended to reduce the dose or discontinue treatment if
the calcium content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
In case of severe vitamin D deficiency in adults and the elderly, the amount will depend on vitamin D
levels and response to treatment. The doctor will establish the most suitable dose for you based on your
response to therapy. Higher doses should be adjusted based on the desired serum levels of 25-hydroxycholecalciferol
(25(OH)D), the severity of the disease, and the response to treatment.

If you take more ANORSIA than you should
In case of accidental ingestion/intake of ANORSIA, immediately inform your doctor or go to
the nearest hospital. In case of overdose, increased levels of calcium in the
blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, intense thirst (polydipsia), increased
urine production (polyuria), constipation and dehydration.
Other symptoms of overdose are as follows:
Diarrhea, anorexia, fatigue, headache, muscle and joint pain, muscle weakness,
kidney stones, nephrocalcinosis and kidney failure.
Chronic excessive overdoses can lead to calcium salt deposits in blood vessels and
organs. The use of excessive doses of vitamin D during the first 6 months of pregnancy can cause serious damage
to the fetus and newborn.

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

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

ANORSIA contains glycerol
May cause headache, stomach upset and diarrhea.

ANORSIA contains allura red (E129)
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 the use of vitamin D are as follows:
Uncommonside effects that can 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).
Rareside effects that can affect up to 1 in 1,000 people:
Drowsiness, confusion, constipation, intestinal gas (flatulence), stomach pain, nausea, vomiting,
diarrhea, metallic taste, dry mouth, skin rash, itching, hives.
Frequency not known(the frequency cannot be estimated based on available data):
Headache, excessive calcium in the kidneys (nephrocalcinosis), increased urine production (polyuria), intense thirst (polydipsia), kidney disease (renal failure).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help to 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 which is stated on the label on the pack after
Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature below 25  C.
Store in the original package to protect the medicine from light.
Do not freeze.

6. Contents of the pack and other information

What ANORSIA contains

• The active ingredient is cholecalciferol (vitamin D). Each soft capsule contains: 0.625 mg of cholecalciferol (vitamin D) equivalent to 25,000 IU.
• The other ingredients are:
• Capsule content :refined olive oil, butyl hydroxytoluene (E321). Capsule shell: glycerol (E422), titanium dioxide (E171), succinyl gelatin and allura red 40 (E129).

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

Marketing Authorisation Holder and Manufacturer

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

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
MT:ANORSIA, 25,000 IU, soft capsules
IT: ANORSIA