DIETRA 10.000 I.U. Miękkie kapsułki

Treść ulotki

1. DIETRA 10,000 IU, soft capsules, 25,000 IU, soft capsules
   1. What is DIETRA and what is it used for
   2. What you need to know before taking DIETRA
   3. How to take DIETRA
   4. Possible side effects
   5. How to store DIETRA
   6. Package contents and other information

DIETRA 10,000 IU, soft capsules, 25,000 IU, 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 DIETRA is and what it is used for
• 2. What you need to know before you take DIETRA
• 3. How to take DIETRA
• 4. Possible side effects
• 5. How to store DIETRA
• 6. Contents of the pack and other information

1. What is DIETRA and what is it used for

DIETRA contains the active ingredient colecalciferol, better known as Vitamin D3.
DIETRA is indicated for:
Prevention and treatment of vitamin D deficiency in adults.
For the prevention of vitamin D deficiency, DIETRA 25,000 IU is used in adults only in
cases where therapeutic adherence is not achieved with the daily administration of low doses of
colecalciferol.
DIETRA 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 DIETRA

Do not take DIETRA

• 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”). DIETRA should not be given to infants and children under 18 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking DIETRA, especially:
if you need to follow a treatment with DIETRA 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 the levels of vitamin D
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 a
dose increase may be necessary as indicated in section 3 “How to take DIETRA”:
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,
colestipol, orlistat and laxatives (such as paraffin oil).
If you are being treated with medicines used for the treatment of excessive acid
production in the stomach (antacids containing aluminum).
If you are obese.
If you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis or fibrocystic disease).
If you suffer from a liver disease (hepatic insufficiency).

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

Other medicines and DIETRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking the following medicines, as they may reduce or
increase the effect of DIETRA:
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, colestipol, orlistat and laxatives
(e.g. paraffin oil).
aluminum-containing antacids, medicines to treat excess 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 some heart disorders.
medicines used to treat tuberculosis, such as rifampicin or 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.
medicines for the heart (cardiac glycosides), because you will need to be monitored by a doctor,
possibly undergo an ECG and check your calcium levels.

DIETRA 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 are using milk enriched with vitamin D, so that they can take into account the total dose of
vitamin D taken and avoid excessive doses.
Consuming high amounts of alcohol for a long period (chronic alcoholism) reduces deposits of
vitamin D 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.
DIETRA 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
DIETRA”).
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
DIETRA does not alter or negligibly alters the ability to drive vehicles and operate machinery.

3. How to take DIETRA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask 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 DIETRA with meals.

DIETRA 10,000 IU soft capsules
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 to 1 capsule once a week (equivalent to 10,000 IU of vitamin D3) is necessary.

Treatment:
The recommended dose is 2 capsules once a 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 must 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.

DIETRA 25,000 IU soft capsules
Adults and the elderly

Prevention:
The recommended dose is 1 capsule (equivalent to 25,000 IU of vitamin D3) once a month.
In case of a high risk of vitamin D deficiency, the doctor will assess whether an increase in the dosage to 2 capsules (equivalent to 50,000 IU of vitamin D3) once a month is necessary.
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 per week) 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 kidney 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 must be adjusted based on the desired serum levels of 25-hydroxycholecalciferol (25(OH)D), the severity of the disease, and response to treatment.

If you take more DIETRA than you should
In case of accidental ingestion/intake of DIETRA, 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, the symptoms of which are as follows: 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.
Excessive chronic overdoses can lead to deposits of calcium salts 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 DIETRA
Do not take a double dose to make up for a missed dose.

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

DIETRA contains glycerol.
It may cause headache, stomach upset, and diarrhea.
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 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).
Rareside effects that may 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 (frequency cannot be estimated from 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 provide more information on the safety of
this medicine.

5. How to store DIETRA

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. Package contents and other information

What DIETRA contains

DIETRA 10,000 IU soft capsules

• 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, butylated hydroxytoluene (E321).
• Capsule shell:glycerol (E422), titanium dioxide (E171), gelatin and Allura Red 40 (E129).

DIETRA 25,000 IU soft capsules

• 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, butylated hydroxytoluene (E321).
• Capsule shell: glycerol (E422), titanium dioxide (E171), gelatin and Allura Red 40 (E129).

Description of the appearance of DIETRA and package contents

DIETRA 10,000 IU soft capsules
The package contains 2, 4, 8, 10 capsules in a heat-sealed PVC/PVDC and aluminum blister.

DIETRA 25,000 IU soft capsules
The package contains 1, 2, 4 capsules in a heat-sealed PVC/PVDC and aluminum blister inserted into
a cardboard box.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 designations:
MT: DEGRAN, soft capsules
IT: DIETRA