Package leaflet: Information for the user

KALED 0.266 mg/0.5 ml oral drops, solution

Calcifediol
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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet :
1. What KALED is and what it is used for
2. What you need to know before taking KALED
3. How to take KALED
4. Possible side effects
5. How to store KALED
6. Contents of the pack and other information

1. What KALED is and what it is used for

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2. What you need to know before taking KALED

Do not take KALED:

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine)
if you have kidney stones
if you have been diagnosed with hypervitaminosis D (excess vitamin D in the body)
if you are pregnant
if you are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking KALED.

Do not exceed the recommended daily intake of vitamin D supplements, such as this medicine; taking excessive doses of vitamin D may lead to poisoning (see section 3, “If you take more KALED than you should”).
While taking this medicine or before starting treatment, your doctor may recommend blood and urine tests to monitor calcium, phosphorus, and other parameters.
Patients with kidney disease require special attention and must be closely monitored by a physician and undergo regular testing.
If you have heart disease, you require special caution and frequent monitoring of serum calcium levels (at least twice weekly at the beginning of treatment), especially if you are taking cardiac glycosides (see within this section, “Other medicines and KALED”).
If you have hypoparathyroidism (insufficient production and secretion of parathyroid hormone), this medicine may be less effective.
If you are prone to developing calcium-containing kidney stones, your doctor should monitor your serum calcium levels.
If you are subject to prolonged immobilization, a reduction in the dosage of this medicine may be necessary.
If you suffer from certain intestinal disorders (e.g., conditions characterized by frequent diarrhea), you may have reduced ability to absorb vitamin D.
If you have sarcoidosis (a disease causing nodules, particularly in the skin), tuberculosis, or other granulomatous diseases, you should take this medicine with particular caution, as there is an increased risk of adverse effects at doses lower than recommended. Your doctor will perform periodic tests to monitor serum calcium and urinary calcium levels.
To avoid potential overdose, your doctor should inform you and your family and/or caregivers about the importance of adhering strictly to the recommended dosages and dietary recommendations, as well as concomitant calcium supplementation.
Interference with laboratory tests: if you are scheduled for diagnostic tests (including blood and urine tests, skin tests involving allergens, etc.), inform your doctor that you are taking this medicine; it may affect test results, for example, cholesterol levels.

Children and adolescents
KALED is not recommended for children and adolescents.
The safety and efficacy of high doses of calcifediol in children have not been adequately evaluated; therefore, for use in children and adolescents, administration of other formulations with lower dosages is recommended.

Other medicines and KALED
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Some medicines may interact with this medicine. Conversely, KALED or calcifediol, the active ingredient of this medicine, may affect the efficacy of other medicines taken concomitantly.

Medicines used to treat epilepsy (such as phenytoin, phenobarbital, and primidone)
certain enzyme inhibitors such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
Heart medications and/or antihypertensives (cardiac glycosides, thiazide diuretics such as hydrochlorothiazide, verapamil)
Cholestyramine, colestipol (for cholesterol), orlistat (for obesity). The administration of these medicines and calcifediol should be spaced by at least 2 hours.
Mineral oil or paraffin (laxatives): the use of an alternative laxative is recommended, or the two products should be taken at a suitable interval.
Certain antibiotics (such as penicillin, neomycin, and chloramphenicol)
Magnesium salts
Other products containing vitamin D
Calcium supplements
Corticosteroids (anti-inflammatory agents)
Rifampicin and isoniazid (used to treat bacterial infections)

KALED with food and drinks
Some foods and beverages are fortified with vitamin D. This should be taken into account, as their effects may add up to those of this medicine and thus become excessive.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, do not take this medicine.

Driving and using machines
KALED does not affect or has a negligible effect on the ability to drive or operate machinery.

KALED contains propylene glycol
This medicine contains approximately 519 mg of propylene glycol in 15 drops (about 35 mg of propylene glycol per drop), equivalent to approximately 1038 mg of propylene glycol per ml.

3. How to take KALED

DO NOT TAKE KALED DAILY.
Dosage
Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Do not take this medicine in higher doses or more frequently than prescribed by your doctor.
Dosages vary depending on the indication, plasma levels of 25-OH-cholecalciferol, patient type,
clinical condition, and the presence of other diseases. Your doctor will also consider your dietary
intake of vitamin D and sun exposure. Your doctor must periodically monitor your calcium and vitamin D
levels, usually before starting treatment and 3 months after beginning treatment.

Adults
The recommended doses are as follows:

As an adjunct to the treatment of osteoporosis in patients with vitamin D deficiency: administration of 15 drops (containing 0.266 mg of calcifediol) once a month for 3–4 months is recommended;
As an adjunct in corticosteroid-induced bone disorders: administration of 15 drops (0.266 mg of calcifediol) once a month is recommended;
Renal osteodystrophy: administration of 15 drops (containing 0.266 mg of calcifediol) once a week or every two weeks is recommended. During treatment, vitamin D, calcium,
phosphorus, and PTH levels must be frequently monitored. If deemed necessary by your doctor,
alternative pharmaceutical formulations with different release profiles may be prescribed.
In patients with malabsorption syndrome: 15 drops (containing 0.266 mg of calcifediol) once a month. Repeat the initial dose one week after starting treatment, then continue with 15 drops once a month for four months. Your doctor will regularly monitor your vitamin D levels. In some cases, your doctor may consider it necessary to administer higher doses or extend treatment duration based on the degree of deficiency confirmed by blood tests and subsequent regular monitoring of corresponding levels.

Children and adolescents
KALED is not recommended for use in children and adolescents.

For oral use. The product can be taken undiluted or diluted in a small amount of water, milk, or fruit juice.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more KALED than you should
If you take a dose higher than prescribed by your doctor (overdose) and/or take it for prolonged periods,
you may develop hypercalcemia (elevated calcium levels in the blood), presence of phosphates in urine and blood, and calcium in urine, potentially leading to renal failure.
Early symptoms of overdose include weakness, fatigue, drowsiness, headache, reduced appetite, dry mouth, metallic taste, nausea, vomiting, abdominal cramps, increased frequency of urination, increased thirst, repeated need to urinate during the night, constipation or diarrhea, dizziness, tinnitus, loss of motor coordination, skin rash, reduced muscle tone (especially in children), bone and muscle pain, and irritability.
Late symptoms of hypercalcemia include: runny nose, itching, decreased libido, calcium deposits in the kidneys, renal failure, osteoporosis in adults, growth retardation in children, weight loss, anemia, conjunctivitis with calcium deposits, light sensitivity, pancreatitis, increased blood urea nitrogen, presence of albumin in urine, increased blood cholesterol, elevated transaminases (SGOT and SGPT), fever, calcification of blood vessels, seizures, and soft tissue calcification.
Rarely, patients may develop high blood pressure and cognitive disturbances; a decrease in an enzyme in the blood called alkaline phosphatase may occur. Imbalances in certain blood components known as electrolytes, together with increased blood acidity, may cause cardiac arrhythmias.
In severe cases (very high calcium levels in the blood), unconsciousness, decreased blood pH, and coma may occur.
Although overdose symptoms are generally reversible, overdose may lead to renal or cardiac failure.
In case of overdose or accidental ingestion, contact your doctor, pharmacist, go to a hospital, or contact a poison control center immediately.

If you forget to take KALED
Do not take a double dose to make up for the missed dose. Take the missed dose as soon as possible, then resume your regular dosing schedule.

If you stop taking KALED
Follow your doctor’s instructions.
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious adverse reactions may occur if the medicine is taken at excessive doses or for longer periods than prescribed by the doctor.

Uncommon (may affect up to 1 in 100 people):

Increased blood urea nitrogen
Albuminuria (presence of albumin in urine)
Hypercalcemia (increased calcium in the blood)
Hypercholesterolemia (increased cholesterol in the blood)
Hypercalciuria (increased calcium in urine)
Weakness
Fatigue
Drowsiness
Headache
Irritability
Cardiac arrhythmias (disturbances in heart rhythm)
Nausea
Vomiting
Dry mouth
Constipation
Taste disturbances with a metallic taste
Abdominal cramps
Anorexia (loss of appetite)
Pancreatitis (inflammation of the pancreas)
Increased transaminases (SGOT and SGPT)
Bone and muscle pain
Calcifications (calcium deposits) in soft tissues
Worsening of kidney function
Nephrocalcinosis (formation of calcium deposits in the kidneys)
Polyuria (increased frequency of urination)
Polydipsia (increased thirst)
Nocturia (frequent need to urinate during the night)
Proteinuria (presence of protein in urine)
Rhinorrhea (runny nose)
Itching
Hyperthermia (fever)
Chills
Asthenia (malaise or weakness)
Decreased libido (sexual desire)

Not known (frequency cannot be determined from available data):

Hypersensitivity reactions such as angioedema (sudden swelling of the skin and mucous membranes) or laryngeal edema (swelling of the throat causing breathing difficulties)

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

Itching
Erythema
Exfoliative dermatitis (skin peeling)
Hyperphosphatemia (increased phosphorus in the blood)
Thirst
Reduced appetite
Hypermagnesemia (increased magnesium in the blood)
Dehydration (loss of body fluids)
Syncope (loss of consciousness)
Metabolic alkalosis (increased blood pH)
Hypervitaminosis D (increased vitamin D in the blood)
Photophobia (intolerance of the eyes to light)
Conjunctivitis with corneal calcification (calcium deposits in the cornea)
Vascular calcification
Dizziness
Sensory disturbance
Hypotonia (decreased muscle tone)

Reporting of side effects
If you experience any side effects, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You may 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 help provide more information on the safety of this medicine.

5. How to store KALED

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.
After first opening the KALED bottle, the medicine remains valid for 17 months (record the date of first opening in the designated space on the carton). After this period, dispose of any remaining medicine.
Store this medicine below 25°C and in the original packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What KALED contains

The active substance is calcifediol. 0.5 ml of KALED contains: 0.266 mg of calcifediol. 0.5 ml of solution corresponds to 15 drops.
The other component is propylene glycol (E1520)

Description of the appearance of KALED and contents of the pack
This medicine is a solution contained in an amber glass bottle with a dropper.
KALED is available in a 5 ml bottle.
Marketing Authorization Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00071 Pomezia (RM), Italy
Responsible manufacturer for batch release
Savio Industrial S.r.l., Via Emilia, 21 – Pavia, Italy
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