Medivid

Package leaflet: Information for the patient

Medivid 10,000 U.I./ml oral drops, solution

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, consult 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Medivid is and what it is used for

Medivid contains colecalciferol, better known as vitamin D3.
Medivid 10,000 U.I./ml oral drops:
is used for the prevention and treatment of vitamin D deficiency.

2. What you need to know before taking Medivid

Do not take Medivid
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 severe kidney disease (severe renal failure) (see section “Warnings and precautions”).
• if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Medivid. Your doctor may recommend taking Medivid for prevention of vitamin D deficiency in the following cases:
in newborns (especially if premature) and infants, during the last trimester of pregnancy, during breastfeeding, in the elderly, in case of insufficient or ineffective sun exposure, if you follow a special diet (e.g. low in calcium, vegetarian diet), if you have dark skin pigmentation, in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), if you have liver disease (hepatic insufficiency), if you are being treated with antiepileptic drugs or long-term treatment with certain anti-inflammatory medicines, or if you suffer from gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis, celiac disease).

Your doctor may prescribe periodic blood tests to monitor your vitamin D levels or calcium levels in blood and urine in the following cases:

• if you need to take Medivid for a long period and at high doses
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics)
• if you suffer from sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation.
  If your vitamin D or calcium levels are found to be high, your doctor will reduce the dose or stop treatment with Medivid.
  In general, if you have impaired kidney function, you should undergo periodic tests to monitor calcium and phosphate levels in your blood. If your calcium and phosphate levels are high, your doctor will reduce the dose or discontinue treatment with Medivid.

Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Medivid” may be required:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Medivid”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Medivid”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Medivid”);
• if you are taking a medicine for obesity called orlistat (see section “Other medicines and Medivid”);
• if you are taking antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and Medivid”);
• if you are obese;
• if you suffer from gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• if you suffer from extensive skin diseases;
• if you have liver disease (hepatic insufficiency).

Other medicines and Medivid
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 the effect of Medivid:

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• medicines to lower blood lipids such as colestipol, cholestyramine;
• orlistat, a medicine used to treat obesity;
• antacids containing aluminium, medicines used to treat excessive stomach acid that may rise into the oesophagus;
• corticosteroids, medicines used to treat inflammation;
• actinomycin, an agent belonging to the group of actinomycins, antibiotics produced by various types of Streptomyces bacteria;
• antifungal imidazole agents, capable of inhibiting the growth of fungal organisms.

Moreover, if you are taking any of the following medicines, inform your doctor, who will closely monitor you and carefully assess whether additional tests are needed:

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
• digitalis and other cardiac glycosides, medicines used to treat certain heart disorders;
• magnesium-containing preparations;
• warfarin, a medicine used to make the blood less prone to clotting.

Medivid with food and drink and alcohol
Inform your doctor if you are taking other products containing vitamin D, foods fortified with vitamin D, or if you are using vitamin D-enriched milk, so that your doctor can consider your total vitamin D intake and avoid excessive dosing.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe colecalciferol (vitamin D) only if strictly necessary due to the risk of harmful effects on the fetus (see section 3 “If you take more Medivid than you should”).

Breastfeeding
When necessary, your doctor may prescribe vitamin D during breastfeeding. However, this does not replace the need for vitamin D supplementation in the newborn.
Vitamin D and its metabolites are present in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Fertility
There are no data on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported for vitamin D blood levels within the normal range.

Driving and using machines
It is unlikely that Medivid will affect your ability to drive.

3. How to take Medivid

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor according to your health status.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Medivid during meals.

Prevention: 1-2 drops (equivalent to 250-500 IU of vitamin D3) per day.
Treatment: Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 4 drops (equivalent to 1,000 IU of vitamin D3).

Prevention: 1-2 drops (equivalent to 250-500 IU of vitamin D3) per day. From the second year of life, in the presence of multiple risk factors for vitamin D deficiency and according to the doctor's judgment, the dosage may be increased up to 3 drops per day (equivalent to 750 IU of vitamin D3).
Treatment: Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 8 drops (equivalent to 2,000 IU of vitamin D3).

Prevention: 2-4 drops per day (equivalent to 500-1,000 IU of vitamin D3).
Treatment: 4-16 drops per day (equivalent to 1,000-4,000 IU of vitamin D3). Your doctor will determine the appropriate dose and may subsequently prescribe a lower dose. The daily dose must not exceed 16 drops per day (equivalent to 4,000 IU of vitamin D3).

3-4 drops per day (equivalent to 750-1,000 IU of vitamin D3) during the last trimester of pregnancy. However, in women considered deficient in vitamin D, a higher dose may be required (up to 2,000 IU per day – 8 drops).

Prevention: 3-4 drops per day (equivalent to 750-1,000 IU of vitamin D3).
In the presence of multiple risk factors for vitamin D deficiency, according to the doctor's judgment, the dosage may be increased up to 8 drops per day (equivalent to 2,000 IU of vitamin D3).
Treatment: 4 drops (equivalent to 1,000 IU of vitamin D3) per day. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose. The daily dose must not exceed 16 drops per day (equivalent to 4,000 IU of vitamin D3).

Instructions for use

The package contains 1 bottle and 1 dropper. The bottle is equipped with a child-resistant cap. The dropper comes with a protective cap. To use, follow the instructions below:
a. open the bottle by removing the cap as follows: press down and at the same time unscrew (see Figure 1);
b. unscrew the plastic protective cap covering the tip of the dropper (see Figure 2);
c. insert the dropper into the bottle to draw up the contents. Measure the number of drops prescribed by your doctor into a teaspoon and take it;
d. close the bottle (see Figure 3). Screw the protective cap back onto the tip of the dropper;
e. store the bottle and dropper in the original packaging.

If you take more Medivid than you should
In case of accidental ingestion/overdose of Medivid, inform your doctor immediately or go to the nearest hospital.
In case of overdose, increased levels of calcium in blood and urine may occur, with the following symptoms: nausea, vomiting, thirst, excessive thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Excessive use of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.
If you forget to take Medivid
Do not take a double dose to make up for the missed dose.
If you stop treatment with Medivid
If you have any doubts about the use of 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 (may affect up to 1 in 100 people)

• increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
  Rare (may affect up to 1 in 1,000 people)
• allergic reactions
• weakness, loss of appetite (anorexia), thirst
• drowsiness, confusion
• constipation, passing gas (flatulence), stomach pain, nausea, diarrhoea
• skin rash, itching
  Not known (frequency cannot be estimated from the available data)
• headache
• vomiting, metallic taste, dry mouth
• excessive deposition of calcium in the kidneys (nephrocalcinosis), increased urine output (polyuria), intense thirst (polydipsia), kidney disease (renal failure)

Reporting of side effects
If you experience any side effects, 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 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 Medivid

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 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.
Do not freeze.
Store in the original packaging to protect the medicine from light.
The shelf life of the medicine after first opening the bottle is 5 months
(please record the date of first opening in the designated space on the carton). After this period, any remaining medicine must be discarded.

6. Contents of the pack and other information

What Medivid contains

• The active substance is colecalciferol (vitamin D3) 2.5 mg, equivalent to 100,000 IU. 1 drop contains: 250 IU of vitamin D3.
• The other component is refined olive oil. Description of the appearance of Medivid and contents of the pack Medivid is a solution contained in an amber glass bottle, closed with a child-resistant cap made of polypropylene. It is available in a pack containing 1 bottle of 10 ml and 1 glass dropper. Marketing Authorization Holder and Manufacturer Marketing Authorization Holder: S.F. Group S.r.l. - Via Tiburtina, 1143 - 00156 Rome, Italy Manufacturer: Lachifarma S.r.l. - Laboratorio Chimico Salentino Farmaceutico - S.S.16 Adriatica - Zona Industriale - 73010 Zollino (LE), Italy

Patient Information Leaflet

Medivid 25,000 I.U. oral solution in single-dose container

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, consult 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, consult your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Medivid is and what it is used for
  2. What you need to know before taking Medivid
  3. How to take Medivid
  4. Possible side effects
  5. How to store Medivid
  6. Package contents and other information

1. What Medivid is and what it is used for

Medivid contains colecalciferol, better known as vitamin D3.
Medivid 25,000 IU oral solution in single-dose container is used for:

• the prevention of vitamin D deficiency in adults in cases where therapeutic adherence cannot be achieved with daily administration of low doses of colecalciferol;
• the treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking Medivid

Do not take Medivid
if you are allergic to colecalciferol (vitamina 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 severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
• if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Medivid. Your doctor may recommend taking Medivid to prevent vitamin D deficiency in the following cases:
in elderly patients, insufficient or ineffective exposure to sunlight, special diet (e.g. low calcium diet, vegetarian diet), dark skin pigmentation, extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), liver diseases (hepatic insufficiency), treatment with antiepileptic drugs or long-term therapy with certain anti-inflammatory drugs, gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis, celiac disease).

Your doctor may prescribe periodic blood or urine tests to monitor your vitamin D levels or calcium levels in blood and urine in the following cases:

• if you need to take Medivid for a long time and at high doses
• if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics)
• if you suffer from sarcoidosis, an inflammatory disease that may affect the whole body and leads to nodule formation.

If your vitamin D or calcium levels are elevated, your doctor will reduce the dose or discontinue treatment with Medivid.
In general, if you have impaired kidney function, you should undergo periodic blood tests to monitor calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Medivid.

Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Medivid” may be required:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Medivid”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Medivid”);
• if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Medivid”);
• if you are taking a medicine used to treat obesity called orlistat (see section “Other medicines and Medivid”);
• if you are taking aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and Medivid”);
• if you are obese;
• if you suffer from gastrointestinal disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• if you suffer from extensive skin diseases;
• if you suffer from liver disease (hepatic insufficiency).

Children and adolescents
Medivid 25,000 IU oral solution is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Medivid
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 the effect of Medivid:

• medicines used to treat epilepsy (anticonvulsants or barbiturates);
• medicines to lower blood lipids such as colestipol, cholestyramine;
• orlistat, a medicine used to treat obesity;
• aluminium-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus;
• corticosteroids, medicines used to treat inflammation;
• actinomycin, an agent belonging to the actinomycin group, antibiotics produced by various types of bacteria of the species Streptomyces;
• antifungal imidazole agents, capable of inhibiting fungal growth.

Moreover, if you are taking the following medicines, inform your doctor, who will keep you under close monitoring and carefully evaluate whether additional tests are needed:

• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
• digitalis and other cardiac glycosides, medicines used to treat certain heart disorders;
• magnesium-containing preparations;
• warfarin, a medicine used to make blood less prone to clotting.

Medivid with food and drink and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or vitamin D-enriched milk, so that he or she can consider your total vitamin D intake and avoid excessive dosing.

Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe vitamin D (colecalciferol) only if strictly necessary due to the risk of harmful effects on the fetus (see section 3 “If you take more Medivid than you should”).

Medivid 25,000 IU oral solution is not recommended during pregnancy.
However, since vitamin D deficiency may be harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breastfeeding
Medivid 25,000 IU oral solution is not recommended during breastfeeding.
When necessary, your doctor will prescribe vitamin D during breastfeeding at lower doses.
This does not replace the administration of vitamin D to the newborn. Vitamin D and its metabolites are present in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Fertility
There are no data available on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.

Driving and using machines
It is unlikely that Medivid will affect your ability to drive.

3. How to take Medivid

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by your doctor based on your health condition.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Medivid during meals.

Adults and Elderly
Prevention: 1 single-dose container (equivalent to 25,000 IU of vitamin D3) once a month.
Treatment: 1 single-dose container (equivalent to 25,000 IU of vitamin D3) once a week for 8–12 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.

Paediatric population
The use of Medivid 25,000 IU oral solution is not recommended in neonates, children and adolescents under 18 years of age.

Pregnant women
The use of Medivid 25,000 IU oral solution is not recommended during pregnancy.

If you take more Medivid than you should
In case of accidental ingestion/overdose of Medivid, contact your doctor immediately 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 output (polyuria), constipation and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Taking excessive doses of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

If you forget to take Medivid
Do not take a double dose to make up for the forgotten dose.

If you stop taking Medivid
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 will get them.
Uncommon (may affect up to 1 in 100 people)

• Increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
  Rare (may affect up to 1 in 1,000 people)

• Allergic reactions

• Weakness, loss of appetite (anorexia), thirst

• Drowsiness, confusion

• Constipation, passing gas (flatulence), stomach pain, nausea, diarrhoea

• Skin rash, itching
  Not known (frequency cannot be estimated from the available data)

• Headache

• Vomiting, metallic taste, dry mouth

• Excessive deposition of calcium in the kidneys (nephrocalcinosis), increased amount of urine excreted (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 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 Medivid

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 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.
Do not freeze.
Store in the original packaging to protect the medicine from light.

6. Pack contents and other information

What Medivid contains

• The active substance is colecalciferol (vitamin D3) 0.625 mg, equivalent to 25,000 I.U.
• The other component is refined olive oil.

Description of the appearance of Medivid and pack contents
Medivid is presented as a solution contained in an amber glass container, closed with a
polipropylene cap.
It is available in packs containing 1 or 2 single-dose containers of 2.5 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S.F. GROUP S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturer:
Lachifarma S.r.l. – Laboratorio Chimico Salentino Farmaceutico – S.S.16 Adriatica – Industrial Zone - 73010 Zollino (LE), Italy

Package leaflet: Information for the patient

Medivid 50,000 IU oral solution in single-dose container

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

1. What Medivid is and what it is used for

Medivid 50,000 U.I. oral solution:
is used to treat vitamin D deficiency in adults (age over 18 years).

2. What you need to know before taking Medivid

Do not take Medivid
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 severe kidney disease (severe renal insufficiency) (see section “Warnings and precautions”).
if you have high levels of vitamin D in your blood (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Medivid.
Your doctor may prescribe periodic blood tests to monitor your vitamin D levels or calcium levels in blood and urine in the following cases:
if you need to take Medivid for a long period and at high doses
if you are elderly and are already being treated with medicines for certain heart conditions (cardiac glycosides) or with medicines that reduce blood pressure by increasing urine production (diuretics)
if you have sarcoidosis, an inflammatory disease that can affect the entire body and leads to nodule formation.

If your vitamin D or calcium levels are found to be high, your doctor will reduce the dose or stop treatment with Medivid.
In general, if you have impaired kidney function, you should undergo periodic tests to monitor calcium and phosphate levels in your blood. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Medivid.

Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Medivid” may be required:
if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Medivid”);
if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Medivid”);
if you are taking medicines to lower blood lipids such as colestipol, cholestyramine (see section “Other medicines and Medivid”);
if you are taking a medicine for obesity called orlistat (see section “Other medicines and Medivid”);
if you are taking aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus (see section “Other medicines and Medivid”);
if you are obese;
if you suffer from digestive system diseases (intestinal malabsorption, cystic fibrosis or mucoviscidosis);
if you have extensive skin diseases;
if you have liver disease (hepatic insufficiency).

Children and adolescents
Medivid 50,000 IU oral solution in single-dose container is not recommended for children and adolescents aged 0 to 18 years.

Other medicines and Medivid
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 the effect of Medivid:
medicines used to treat epilepsy (anticonvulsants or barbiturates);
medicines to lower blood lipids such as colestipol, cholestyramine;
orlistat, a medicine used to treat obesity;
aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the oesophagus;
corticosteroids, medicines used to treat inflammation;
actinomycin, an agent belonging to the group of actinomycins, antibiotics produced by various types of bacteria of the species Streptomyces;
antifungal imidazole agents, capable of inhibiting the growth of fungal organisms.

Additionally, if you are taking the following medicines, inform your doctor, who will closely monitor you and carefully assess whether further tests are needed:
thiazide diuretics, medicines used to treat high blood pressure by increasing urine production;
digitalis and other cardiac glycosides, medicines used to treat certain heart disorders;
magnesium-containing preparations;
warfarin, a medicine used to make the blood less likely to clot.

Medivid with food and drink and alcohol
Inform your doctor if you are taking other products containing vitamin D, vitamin D-fortified foods, or using vitamin D-enriched milk, so that the total daily intake of vitamin D can be taken into account and excessive dosing avoided.
Long-term consumption of large amounts of alcohol (chronic alcoholism) reduces vitamin D stores in the liver.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe vitamin D (cholecalciferol) only if strictly necessary due to the risk of harmful effects on the fetus (see section 3 “If you take more Medivid than you should”).
Medivid 50,000 IU oral solution is not recommended during pregnancy. However, since vitamin D deficiency is harmful to both mother and fetus, your doctor may prescribe vitamin D during pregnancy at lower doses when necessary.

Breast-feeding
Medivid 50,000 IU oral solution is not recommended during breast-feeding.
When necessary, your doctor may prescribe vitamin D during breast-feeding at lower doses. This does not replace the need for vitamin D supplementation in the newborn. Vitamin D and its metabolites are excreted in breast milk. This should be taken into account when administering additional vitamin D to the infant.

Fertility
There are no data available on the effects of vitamin D on fertility. However, no adverse effects on fertility have been reported with vitamin D blood levels within the normal range.

Driving and using machines
Medivid is unlikely to affect the ability to drive.

3. How to take Medivid

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dosage and duration of treatment will be determined by the doctor according to your health status.
Do not exceed the doses indicated by your doctor.
The doses must be taken orally. It is recommended to take Medivid during meals.

Adults and Elderly
Treatment: 1 single-dose container (equivalent to 50,000 IU of vitamin D3) once a week for a maximum of 6 weeks. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower dose.

Pediatric population
The use of Medivid 50,000 IU oral solution is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of Medivid 50,000 IU oral solution is not recommended during pregnancy.

If you take more Medivid than you should
In case of accidental ingestion/overdose of Medivid, contact your doctor immediately 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, excessive thirst (polydipsia), increased urine output (polyuria), constipation, and dehydration.
Chronic excessive dosing may lead to calcium salt deposits in blood vessels and organs.
Taking excessive doses of vitamin D during the first 6 months of pregnancy may cause serious harm to the fetus and newborn.

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

If you stop taking Medivid
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 (may affect up to 1 in 100 people)
increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
rare (may affect up to 1 in 1,000 people)
allergic reactions
weakness, loss of appetite (anorexia), thirst
drowsiness, confusion
constipation, passing gas (flatulence), stomach pain, nausea, diarrhoea
skin rash, itching
not known (frequency cannot be estimated from the available data)
headache
vomiting, metallic taste, dry mouth
excessive deposition of calcium in the kidneys (nephrocalcinosis), increased urine output
(polyuria), intense thirst (polydipsia), kidney disease (renal failure)
Reporting of side effects
If you experience any side effects, 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 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 Medivid

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 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.
Do not freeze.
Store in the original packaging to protect the medicine from light.

6.
Contents of the packaging and other information
What Medivid contains
The active substance is colecalciferol (vitamin D3) 1.25 mg, equivalent to 50,000 I.U.
The other ingredient is refined olive oil.

Description of the appearance of Medivid and contents of the packaging
Medivid is a solution contained in an amber glass container, closed with a polypropylene cap.
It is available in packs containing 1 or 2 single-dose containers of 2.5 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturer:
Lachifarma S.r.l. – Laboratorio Chimico Salentino Farmaceutico – S.S.16 Adriatica – Zona Industriale

• 73010 Zollino (LE), Italy