Fedivelle

Package leaflet: Information for the patient

Fedivelle 1,000 IU soft capsules

colecalciferol
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 others, 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, speak to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Fedivelle is and what it is used for

Fedivelle contains vitamin D3, which regulates the absorption and metabolism of calcium and
the incorporation of calcium into bone tissue.
Fedivelle is indicated in the following cases:

• Treatment of vitamin D deficiency in adults and adolescents.
• Prevention of vitamin D deficiency in adults at identified risk.
• Certain bone conditions, such as thinning of the bone (osteoporosis), when administered together with other medicines.

2. What you need to know before taking Fedivelle

Do not take Fedivelle:

• if you are allergic to cholecalciferol or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you have kidney stones;
• if you have severe kidney problems.

Warnings and precautions
While taking Fedivelle, your doctor will monitor the level of calcium in your blood and/or urine to ensure it does not become too high.
Talk to your doctor or pharmacist before taking Fedivelle if:

• you have a very high risk of developing kidney stones;
• you have any condition that may affect your bones;
• you have an altered hormonal metabolism of the parathyroid gland (pseudohypoparathyroidism);
• you have "sarcoidosis"; an immune system condition that may affect the liver, lungs, skin, or lymph nodes;
• you have heart problems;
• you are already taking additional doses of calcium or vitamin D.

Children and adolescents
This medicine is not intended for use in children under 12 years of age.
Other medicines and Fedivelle
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• high-dose calcium-containing products: increase the risk of high calcium levels in the blood;
• heart medicines (cardiac glycosides, such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure calcium levels in the blood;
• thiazide diuretics, as they may increase the risk of hypercalcemia;
• medicines for epilepsy (such as phenytoin) or sedatives (barbiturates, such as phenobarbital), as these medicines may reduce the effect of vitamin D;
• antibiotics such as rifampicin and isoniazid used to treat bacterial infections;
• laxatives (such as paraffin oil), orlistat, a medicine used to treat obesity, or a cholesterol-lowering medicine called colestyramine, as they may reduce the absorption of vitamin D;
• magnesium-containing products (e.g. antacids) – these should not be used during treatment with vitamin D due to the risk of high magnesium levels;
• phosphate-containing products in large amounts. These agents increase the risk of high blood phosphate levels;
• actinomycin (a medicine used to treat certain forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases), as they may interfere with vitamin D metabolism;
• glucocorticoids (steroid hormones, such as hydrocortisone or prednisolone). These may reduce the effect of vitamin D.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not take this medicine during pregnancy unless you have a confirmed vitamin D deficiency.
During pregnancy, high doses of vitamin D3 administered weekly or monthly rather than daily are not recommended for safety reasons.
Breastfeeding
Fedivelle may be used during breastfeeding when vitamin D deficiency is confirmed.
Vitamin D passes into breast milk. This should be taken into account when prescribing additional vitamin D supplementation to a breastfed infant. Such supplementation does not replace vitamin D administration in newborns.
Driving and using machines
No effects on the ability to drive or operate machinery are known.
Fedivelle contains tartrazine
It may cause allergic reactions.
Fedivelle contains sorbitol
This medicine contains 4.8 mg of sorbitol per capsule.

3. How to take Fedivelle

The amount of Fedivelle you need will depend on your vitamin D levels and your response to treatment.
Treatment of vitamin D deficiency (loading dose) in:

• Adults: 1,000–4,000 IU/day (1 to 4 capsules per day)
• Adolescents: 1,000 IU/day (1 capsule per day); higher doses may be administered according to the physician's advice, but must not exceed 4,000 IU per day (4 capsules per day). Depending on individual circumstances, the physician may adjust the dose. Any further treatment with Fedivelle must be decided by the physician.

Prevention of vitamin D deficiency (maintenance dose) in adults: 1,000 IU (1 capsule) per day.
In addition to specific therapy in patients with osteoporosis: 1,000 IU (1 capsule) per day.
Swallow the capsule whole (not chewed) with water, preferably together with a substantial meal.

Use in children
This medicinal product is not intended for use in children under 12 years of age.

If you take more Fedivelle than you should
If you have taken too many Fedivelle capsules, contact your doctor or pharmacist immediately. Take the medicine pack with you.
An overdose may lead to increased levels of calcium in the blood and urine, as identified by laboratory tests.
Signs and symptoms of overdose may include loss of appetite, thirst, nausea, vomiting, diarrhoea followed by constipation, abdominal pain, headache, muscle and joint pain, muscle weakness, fatigue, confusion, increased frequency of urination with calcium in the urine, kidney problems, and in severe cases, irregular heartbeat, coma, or even death.

If you forget to take Fedivelle
Do not take a double dose to make up for the missed dose. If you forget to take your capsules, take them as soon as possible. Then take the next dose at the correct time according to your doctor's instructions. However, if it is almost time for your next dose, do not take the missed dose but take the next dose at the usual time.

If you stop taking Fedivelle
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)

• too much calcium in the blood (hypercalcemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness and confusion
• too much calcium in the urine (hypercalciuria)

Rare side effects (may affect up to 1 in 1,000 people)

• rash
• itching
• raised itchy rash (urticaria)

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 Fedivelle

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 use this medicine if you notice any visible signs of deterioration.
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.

6. Package contents and other information

What Fedivelle contains

• The active substance is colecalciferol.
• The other components are medium-chain triglycerides, all-rac-α-tocopheryl acetate, gelatin (E441), glycerol (E422), liquid sorbitol (E420) (partially dehydrated), and tartrazine yellow (E102).

Description of the appearance of Fedivelle and package contents
Fedivelle 1,000 IU capsules are yellow, round, transparent soft gelatin capsules containing a clear, transparent liquid.
Blister pack containing 30 capsules.

Marketing Authorization Holder and Manufacturer
Theramex Ireland Limited
3 Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

Manufacturer
NetPharma Lab Consulting Services
Carretera de Fuencarral, 22
28051 – Alcobendas
Madrid
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:
Netherlands: Fedivelle 1,000 IU
Spain: Lundeos 1,000 UI cápsulas blandas
Italy: Fedivelle 1,000 U.I. capsule molli

Package leaflet: Information for the patient

Fedivelle 20,000 IU soft capsules

colecalciferol
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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Fedivelle is and what it is used for

Fedivelle contains vitamin D3, which regulates calcium absorption and metabolism, and calcium incorporation into bone tissue.
Fedivelle is indicated for the treatment of vitamin D deficiency in adults.

2. What you need to know before taking Fedivelle

Do not take Fedivelle:

• if you are allergic to colecalciferol or to any of the other ingredients of this medicine (listed in section 6);
• if you have high levels of calcium in your blood or urine;
• if you have kidney stones;
• if you have severe kidney problems.

Warnings and precautions
While taking Fedivelle, your doctor will monitor the level of calcium in your blood and/or urine to ensure that it does not become too high.
Talk to your doctor or pharmacist before taking Fedivelle if:

• you have a very high risk of developing kidney stones;
• you have any condition that may affect your bones;
• you have an altered hormonal metabolism of the parathyroid gland (pseudohypoparathyroidism);
• you have "sarcoidosis"; a condition of the immune system that may affect the liver, lungs, skin, or lymph nodes;
• you have heart problems;
• you are already taking additional doses of calcium or vitamin D.

Children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
Other medicines and Fedivelle
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• calcium-containing products at high doses: increase the risk of high calcium levels in the blood;
• heart medications (cardiac glycosides, such as digoxin). Your doctor may monitor your heart with an electrocardiogram (ECG) and measure calcium levels in your blood;
• thiazide diuretics, as they may increase the risk of hypercalcemia;
• medicines for epilepsy (such as phenytoin) or sedatives (barbiturates, such as phenobarbital), as these medicines may reduce the effect of vitamin D;
• antibiotics such as rifampicin and isoniazid used to treat bacterial infections;
• laxatives (such as paraffin oil), orlistat, a medicine used to treat obesity, or a cholesterol-lowering medicine called cholestyramine, as they may reduce the absorption of vitamin D;
• magnesium-containing products (e.g. antacids) – these should not be used during treatment with vitamin D due to the risk of high magnesium levels;
• products containing large amounts of phosphorus. These agents increase the risk of high blood phosphate levels;
• actinomycin (a medicine used to treat certain forms of cancer) and imidazole antifungals (medicines such as clotrimazole and ketoconazole used to treat fungal diseases), as they may interfere with vitamin D metabolism;
• glucocorticoids (steroid hormones, such as hydrocortisone or prednisolone). These may reduce the effect of vitamin D.

Pregnancy and breastfeeding
Pregnancy
This medicine is a high-dose formulation and is not recommended for use during pregnancy.
Breastfeeding
Fedivelle may be used during breastfeeding. Vitamin D passes into breast milk. This should be taken into account when prescribing additional vitamin D to a breastfed infant.
Driving and using machines
No effects on the ability to drive or use machines are known.
Fedivelle contains sorbitol
This medicine contains 4.8 mg of sorbitol per capsule.

3. How to take Fedivelle

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The amount of Fedivelle you need will depend on your vitamin D levels and your response to treatment.
Treatment of vitamin D deficiency (loading dose) in adults: 20,000 IU per week (1
capsule).
After the first month of treatment and depending on your condition, your doctor may consider a lower dose. Any further treatment with Fedivelle must be decided by your doctor.
Swallow the capsule whole (do not chew) with water, preferably with a substantial meal.
Use in children
This medicine is not recommended for use in children and adolescents.
If you take more Fedivelle than you should
If you have taken too many Fedivelle capsules, contact your doctor or pharmacist immediately. Bring the medicine pack with you.
An overdose may lead to increased levels of calcium in the blood and urine, as identified by laboratory tests.
Signs and symptoms of overdose may include loss of appetite, thirst, nausea, vomiting, diarrhoea followed by constipation, abdominal pain, headache, muscle and joint pain, muscle weakness, fatigue, confusion, more frequent urination with calcium in the urine, kidney problems, and in severe cases, irregular heartbeat, coma, or even death.
If you forget to take Fedivelle
Do not take a double dose to make up for a forgotten dose. If you forget to take your capsules, take them as soon as possible. Then take the next dose at the correct time according to your doctor's instructions. However, if it is almost time for your next dose, do not take the missed dose but take the next dose at the usual time.
If you stop treatment with Fedivelle
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Uncommon side effects (may affect up to 1 in 100 people)

• too much calcium in the blood (hypercalcaemia). You may feel or be sick, lose your appetite, have constipation, stomach ache, feel very thirsty, have muscle weakness, drowsiness and confusion
• too much calcium in the urine (hypercalciuria). Rare side effects (may affect up to 1 in 1,000 people)
• rash
• itching
• itchy, raised rash (urticaria)

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 Fedivelle

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fedivelle contains

• The active substance is colecalciferol.
• The other components are medium-chain triglycerides, all-rac-α-tocopheryl acetate, gelatin (E441), glycerol (E442), and liquid sorbitol (E420) (partially dehydrated).

Description of the appearance of Fedivelle and package contents
Fedivelle 20,000 IU capsules are soft, round, transparent yellowish capsules containing a clear, transparent liquid.
Blister packs containing 5, 10 and 14 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Theramex Ireland Limited
3 Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland

Manufacturer

NetPharma Lab Consulting Services
Carretera de Fuencarral, 22
28051 – Alcobendas
Madrid
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Netherlands: Fedivelle 20,000 IU
Spain: Lundeos 20,000 UI cápsulas blandas
Italy: Fedivelle 20.000 U.I. capsule molli