Vitamin D3 S.A.L.F.

PACKAGE LEAFLET: Information for the patient

Vitamina D S.A.L.F. 100,000 IU/ml injectable solution

Vitamina D S.A.L.F. 300,000 IU/ml injectable solution
(CHOLECALCIFEROL)
EQUIVALENT MEDICINE
Please read this leaflet carefully before using 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Vitamina D S.A.L.F. is and what it is used for
2. What you need to know before taking Vitamina D S.A.L.F.
3. How to use Vitamina D S.A.L.F.
4. Possible side effects
5. How to store Vitamina D S.A.L.F.
6. Contents of the pack and other information

1. What Vitamina D S.A.L.F. is and what it is used for

Vitamina D S.A.L.F. contains cholecalciferol, better known as vitamin D, and is indicated for the
treatment of vitamin D deficiency in adults (over 18 years of age).

2. What you need to know before taking Vitamin D S.A.L.F.

Do not take Vitamin D S.A.L.F.:

• if you are allergic to cholecalciferol (Vitamin D) 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 (renal insufficiency) (see section “Warnings and precautions”);
• if you have high levels of vitamin D (hypervitaminosis D).

Warnings and precautions
Talk to your doctor or pharmacist before taking Vitamin D S.A.L.F.
Your doctor may prescribe periodic blood and urine tests to monitor your vitamin D, calcium, and phosphate levels in the following cases:

• if you need to take Vitamin D S.A.L.F. 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 medicines that reduce blood pressure by increasing urine production (diuretics);
• if you have sarcoidosis, an inflammatory disease that may affect the entire body and leads to nodule formation;
• if you have primary hyperparathyroidism, a condition caused by excessive secretion of parathyroid hormone from one or more parathyroid glands;
• if you have kidney problems.

If your levels of vitamin D, calcium, or phosphate are elevated, your doctor will reduce the dose or discontinue treatment with Vitamin D S.A.L.F.
Inform your doctor if you are taking vitamin D from other sources, either medicinal or dietary (see section “Vitamin D S.A.L.F. with food, drink, and alcohol”).
Do not take Vitamin D S.A.L.F. if you have a significant reduction in kidney function (see section “Do not take Vitamin D S.A.L.F.”). In case of mild to moderate reduction in kidney function (mild or moderate renal insufficiency), if your doctor considers treatment with Vitamin D S.A.L.F. absolutely necessary, periodic blood tests to monitor calcium and phosphate levels will be required. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or discontinue treatment with Vitamin D S.A.L.F.
Inform your doctor in the following cases, as higher doses than those indicated in section 3 “How to take Vitamin D S.A.L.F.” may be necessary:

• if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section “Other medicines and Vitamin D S.A.L.F.”);
• if you are taking corticosteroids, medicines used to treat inflammation (see section “Other medicines and Vitamin D S.A.L.F.”);
• if you are taking medicines to lower blood fats (such as colestipol, cholestyramine) or orlistat (a medicine used to treat obesity) (see section “Other medicines and Vitamin D S.A.L.F.”);
• if you are taking aluminum-containing antacids, medicines used to treat excessive stomach acid that may rise into the esophagus (see section “Other medicines and Vitamin D S.A.L.F.”);
• if you are taking laxatives (such as paraffin oil) (see section “Other medicines and Vitamin D S.A.L.F.”);
• if you are obese;
• if you suffer from intestinal malabsorption (e.g., Crohn’s disease, chronic inflammatory bowel disease, celiac disease, cystic fibrosis or mucoviscidosis), or if you have undergone bariatric surgery;
• if you have liver disease (hepatic insufficiency).

Children and adolescents
At these dosages, Vitamin D S.A.L.F. is not recommended for children and adolescents aged 0 to 18 years.
Other medicines and Vitamin D S.A.L.F.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor, who will keep you under close monitoring and carefully assess whether additional tests are needed:

• digitalis and other cardiac glycosides, medicines used to treat certain heart conditions;
• warfarin, a medicine used to prolong blood clotting time, thereby reducing the risk of blood clots;
• magnesium-containing preparations;
• thiazide diuretics, medicines used to treat high blood pressure by increasing urine production.

Additionally, inform your doctor if you are taking any of the following medicines, as they may reduce the effect of Vitamin D S.A.L.F.:

• antiepileptic drugs, such as barbiturates, carbamazepine, phenytoin, used to treat epilepsy;
• corticosteroids, medicines used to treat inflammation;
• certain antibiotics such as rifampicin and isoniazid, used to treat infections;
• aluminum-containing antacids, medicines used to treat excessive stomach acid; concomitant use with vitamin D should be avoided as it may increase the risk of aluminum toxicity;
• lipid-lowering agents (hypolipidemics) such as colestipol and cholestyramine;
• medicines used to treat obesity, such as orlistat;
• laxatives such as paraffin oil;
• actinomycin, a cytotoxic agent belonging to the actinomycin group, antibiotics produced by various types of Streptomyces bacteria;
• antifungal imidazole agents that inhibit fungal growth (e.g., ketoconazole).

Vitamin D S.A.L.F. with food, 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 the total daily intake of vitamin D can be taken into account to 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, consult your doctor or pharmacist before taking this medicine.

Pregnancy
At these dosages, Vitamin D S.A.L.F. 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 if needed.

Breastfeeding
At these dosages, Vitamin D S.A.L.F. is not recommended during breastfeeding.
If necessary, your doctor will prescribe vitamin D at lower doses during breastfeeding. This does not replace the need for vitamin D supplementation in the newborn. Vitamin D and its metabolites are present in breast milk; your doctor will take this into account when prescribing vitamin D to a breastfed infant.

Fertility
There are no data on the effects of Vitamin D S.A.L.F. on fertility.

Driving and using machines
There are no data on the effects of Vitamin D S.A.L.F. on the ability to drive. However, it should be noted that drowsiness may occur as a rare side effect of treatment with Vitamin D S.A.L.F.

3. How to use Vitamin D S.A.L.F.

Use 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 based on your health condition. Do not exceed the doses prescribed by your doctor.
This medicine must be administered by intramuscular injection (intramuscular use). Intramuscular administration is indicated in malabsorption syndromes.

Adults and Elderly
Treatment:
Vitamin D S.A.L.F.
100,000 IU
1 vial (equal to 100,000 IU of vitamin D) per month for 3 months. Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.

Vitamin D S.A.L.F.
300,000 IU
1 vial (equal to 300,000 IU of vitamin D). Your doctor will determine the appropriate dose for you and may subsequently prescribe a lower maintenance dose.

Use in children and adolescents
The use of Vitamin D3 S.A.L.F. at these dosages is not recommended in neonates, children, and adolescents under 18 years of age.

Pregnant women
The use of Vitamin D S.A.L.F. at these dosages is not recommended during pregnancy.

Instructions for use
The vials in the package are equipped with OPC (One Point Cut) and must be opened as follows:
Below the colored dot, the vial has a pre-scored line, eliminating the need for a file to open it. Before opening, ensure that any solution present in the upper part of the vial has flowed down into the lower part. Use both hands to open: hold the lower part of the vial with one hand and, with the other, snap off the top part in the direction opposite to the colored dot.

AFTER OPENING: To avoid the risk of cuts, do not touch the sharp edges or any sharp points created by breaking the vial.

If you use more Vitamin D S.A.L.F. than you should
In case of accidental ingestion/overdose of Vitamin D S.A.L.F., contact 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.

If you forget to use Vitamin D S.A.L.F.
Do not take a double dose to make up for the forgotten dose.

If you stop treatment with Vitamin D S.A.L.F.
If you have any questions 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 experiences them.
The possible side effects are listed below, according to frequency:

Uncommon (may affect up to 1 in 100 people)

• Increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria)
• Headache (cephalalgia)
• Abdominal pain, nausea, diarrhoea, vomiting
• Skin rash, itching

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

• Allergic reactions (hypersensitivity)
• Reduced appetite
• Excessive thirst (polydipsia)
• Drowsiness, confusion
• Constipation (stipsis), flatulence, dry mouth, altered taste (dysgeusia)
• Urticaria
• Increased urine production (polyuria)
• Weakness (asthenia)
• Dizziness
• Cardiac arrhythmia

Very rare (may affect up to 1 in 10,000 people)

• Renal failure

Not known (frequency cannot be estimated from the available data)

• Thirst
• Excessive deposition of calcium in the kidneys (nephrocalcinosis)

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 http://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 Vitamin D S.A.L.F

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 packaging after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light. Do not freeze.
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.

6. Package contents and other information

What Vitamina D S.A.L.F contains
Vitamina D S.A.L.F 100,000 IU/ml injectable solution

• The active substance is colecalciferol (vitamin D) (one vial contains 2.5 mg equivalent to 100,000 IU).
• The other component is refined olive oil.

Vitamina D S.A.L.F 300,000 IU/ml injectable solution

• The active substance is colecalciferol (vitamin D) (one vial contains 7.5 mg equivalent to 300,000 IU).
• The other component is refined olive oil.

Description of the appearance of Vitamina D S.A.L.F and package contents
Vitamina D S.A.L.F is a clear solution with the colour and odour of olive oil, contained in amber glass vials with OPC closure:

Vitamina D S.A.L.F 100,000 IU/ml injectable solution
Available in packs of 5 vials of 100,000 IU/ml.

Vitamina D S.A.L.F 300,000 IU/ml injectable solution
Available in packs of 5 vials of 300,000 IU/ml.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 – 26069 Cenate Sotto (Bergamo) – Tel: +39 035 94 00 97