Dietra

Patient Information Leaflet

DIETRA 10,000 IU, soft capsules, 25,000 IU, soft capsules

Colecalciferol (vitamin D3)
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 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, contact 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 taking 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 DIETRA is and what it is used for

DIETRA contains the active substance colecalciferol, better known as Vitamin D3.
DIETRA is indicated for:
The 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 compliance cannot be achieved with daily administration of low-dose 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 colecalciferol (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 have kidney disease (severe renal impairment) (see section “Warnings and precautions”). DIETRA must not be given to neonates and children under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking DIETRA, particularly:

• if you need to take DIETRA 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, your blood and urine calcium levels should be checked.
• 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 may affect any organ, 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 are taking this medicine long-term, especially if you are elderly. In this case, your doctor will monitor your urinary calcium excretion and kidney function. If necessary, your doctor may reduce your dose.
• if you have a disorder affecting parathyroid hormone levels (pseudohypoparathyroidism).

Inform your doctor if you have any of the following conditions, as you may require an increased dosage as described 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 lower blood fat levels (cholestyramine, colestipol, orlistat, and laxatives such as liquid paraffin).
• if you are being treated with medicines used to treat excessive stomach acid production (aluminum-containing antacids).
• if you are obese.
• if you suffer from digestive disorders (intestinal malabsorption, cystic fibrosis or mucoviscidosis).
• if you suffer from liver disease (hepatic insufficiency).

Children
DIETRA must not be given to neonates 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 medicines.

In particular, inform 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 to treat epilepsy (anticonvulsants or barbiturates), such as phenytoin, phenobarbital, primidone, etc.
• medicines to lower blood fats such as colestipol, cholestyramine, orlistat, and laxatives (e.g. liquid paraffin).
• aluminum-containing antacids, medicines used to treat excess stomach acid that may reflux into the esophagus.
• thiazide diuretics, medicines used to treat high blood pressure that increase urine production.
• digitalis, a medicine used to treat certain heart conditions.
• medicines used to treat tuberculosis, such as rifampicin or isoniazid.
• antifungal agents such as imidazoles (e.g. ketoconazole), medicines used to inhibit 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 including an ECG and monitoring of your calcium levels.

DIETRA with food, drinks and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or if you consume vitamin D-enriched milk, so that your total vitamin D intake can be assessed 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

DIETRA must not be used during pregnancy and breastfeeding. However, your doctor may decide that your clinical condition requires treatment with colecalciferol 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 DIETRA”).

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 to administer vitamin D to the newborn.

Driving and using machines
DIETRA does not alter or impairs negligibly the ability to drive or operate machinery.

3. How to take DIETRA

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 must be determined by your doctor according to your health condition.
Do not exceed the doses indicated by your doctor.
Take the dose orally.
Take DIETRA with meals.

DIETRA 10,000 IU soft capsules
Adults and 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, your doctor will assess whether the dose should be increased up to 1 capsule once a week (equivalent to 10,000 IU of vitamin D3).
Treatment:
The recommended dose is 2 capsules once a week (equivalent to 20,000 IU of vitamin D3 per week) 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), disease severity, and response to treatment.
Long-term treatment:
In case of long-term treatment, especially in elderly patients, your doctor will monitor urinary calcium excretion and renal function. If necessary, your doctor may reduce the dose.

DIETRA 25,000 IU soft capsules
Adults and 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, your doctor will assess whether the dose should be increased up to 2 capsules (equivalent to 50,000 IU of vitamin D3) once a month.
Your doctor will determine the most appropriate 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. Your doctor will determine the most appropriate 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. The dose should be reduced or treatment discontinued 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 suitable dose based on your response to therapy.
Higher doses must be adjusted according to desired serum levels of 25-hydroxycholecalciferol (25(OH)D), disease severity, and response to treatment.

If you take more DIETRA than you should
In case of accidental ingestion/overdose of DIETRA, 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:
Diarrhea, loss of appetite (anoresis), fatigue, headache, muscle and joint pain, muscle weakness, kidney stones, nephrocalcinosis, and renal failure.
Chronic and excessive overdosage may lead to deposition of calcium salts 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 DIETRA
Do not take a double dose to make up for the missed dose.

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

DIETRA contains glycerol.
It may cause headache, gastrointestinal disturbances, and diarrhea.
It may cause allergic reactions.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects reported with vitamin D use are as follows:

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, gas from the intestine (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 accumulation 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 DIETRA

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 you no longer use. 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 DIETRA contains
DIETRA 10,000 IU soft capsules

• The active substance is colecalciferol (vitamin D). Each soft capsule contains: 0.250 mg of 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, and Allura Red AC (E129).

DIETRA 25,000 IU soft capsules

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

Description of the appearance of DIETRA and contents of the pack
DIETRA 10,000 IU soft capsules
The pack contains 2, 4, 8, or 10 capsules in a thermoformed blister made of PVC/PVDC and aluminium.
DIETRA 25,000 IU soft capsules
The pack contains 1, 2, 4 capsules in a thermoformed blister made of PVC/PVDC and aluminium, placed 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 authorised in the European Economic Area Member States under the following names:
MT: DEGRAN, soft capsules
IT: DIETRA