KALED 0,266 MG/0,5 ML Oral drops, solution

Содержание инструкции

1. KALED 0,266 mg/0,5 ml oral drops, solution
   1. What is KALED and what is it 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

KALED 0,266 mg/0,5 ml oral drops, solution

Calcifediol

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is KALED and what is it used for

KALED is a medicine containing calcifediol, used in adults for the treatment of vitamin D deficiency only in cases where the administration of very high doses of vitamin D is necessary in the following conditions:

• Adjunctive treatment in the care of osteoporosis
• In patients with malabsorption syndrome (difficulty absorbing nutrients)
• Osteodystrophy (bone disease) in patients with renal insufficiency
• As an adjunct in bone problems caused by corticosteroids (anti-inflammatory drugs used in the treatment of various diseases).

2. What you need to know before taking KALED

Do not take KALED:

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from hypercalcemia (high levels of calcium in the blood) or hypercalciuria (high levels of calcium in the urine)
• if you suffer from 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 can, in fact, cause poisoning (see section 3, paragraph “If you take more KALED than you should”).
• During the intake of this medicine or before starting it, your doctor may advise you to undergo blood and urine tests to check the levels of calcium, phosphorus and other parameters.
• Patients with kidney disease require particular attention and must be subjected to careful medical monitoring and regular tests.
• If you suffer from heart disease, you need particular attention and must be subjected to frequent monitoring to check calcium levels (at least twice a week at the beginning of treatment), especially if you are taking cardiac glycosides (see within this section, paragraph “Other medicines and KALED”).
• If you suffer from hypoparathyroidism (insufficient synthesis and secretion of parathyroid hormone), this medicine may be less effective.
• If you are prone to developing calcium-containing kidney stones, your doctor must monitor your calcium levels.
• If you are confined to prolonged immobilization, a reduction in the dosage of this medicine may be necessary.
• If you suffer from certain intestinal diseases (such as, for example, diseases characterized by frequent diarrhea) you may experience a reduction in the ability to absorb vitamin D.
• If you suffer from sarcoidosis (a disease involving the formation of nodules, particularly at the skin level), tuberculosis or other diseases characterized by the formation of nodules, you should take this medicine with particular caution as you have a greater risk of developing side effects at doses lower than those recommended. Your doctor will subject you to periodic tests to check calcium and calcium urine levels.
• In order to avoid a possible overdose, the doctor must inform you and your family and/or those who assist you of the importance of adhering to the recommended dosages and the recommendations provided regarding diet and concomitant intake of calcium supplements.
• Interference with laboratory tests: if you are to undergo diagnostic tests (including blood tests, urine tests, skin tests involving the use of allergens, etc.), inform your doctor that you are taking this medicine; it may, in fact, affect the results, for example, cholesterol levels.

Children and adolescents
KALED is not recommended in 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, the administration of other low-dose forms is recommended.

Other medicines and KALED
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Some medicines can interfere with this medicine. Conversely, KALED or calcifediol, the active
ingredient of this medicine, can affect the effectiveness of other medicines taken at the same time.

• Medicines used for the treatment of epilepsy (such as phenytoin, phenobarbital and primidone)
• some enzyme inhibitors such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole.
• Cardiac and/or antihypertensive medicines (cardiac glycosides, thiazide diuretics such as hydrochlorothiazide, verapamil).
• Cholestyramine, colestipol (for cholesterol), orlistat (for obesity). The intake of these medicines and that of calcifediol should be at least 2 hours apart.
• Mineral oil or paraffin (laxatives): the use of another type of laxative or the intake of the two medicines at a suitable distance is recommended.
• Some antibiotics (such as penicillin, neomycin and chloramphenicol).
• Magnesium salts.
• Other products containing vitamin D.
• Calcium supplements.
• Corticosteroids (anti-inflammatory drugs).
• Rifampicin and isoniazid (used for the treatment of bacterial infections)

KALED with food and drink
Some foods and some drinks are supplemented with vitamin D. This must be taken into account as their effects
may add up to those of this medicine and therefore be excessive.

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

Driving and operating machinery
KALED does not alter or negligibly alters the ability to drive vehicles or operate machinery.

KALED contains propylene glycol
This medicine contains approximately 519 mg of propylene glycol in 15 drops (approximately 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
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Do not take this medicine in doses higher or with a frequency greater than that prescribed by your doctor.
The doses vary depending on the indications based on plasma levels of 25-OH-cholecalciferol, the type
of patient and their conditions and the presence of other diseases. The doctor will also take into account the intake
of vitamin D with food and exposure to the sun. The doctor must periodically monitor your calcium and vitamin D levels, usually before starting treatment and 3 months after the start of the latter.

Adults
The recommended doses are as follows:

• As an adjunct to the treatment of osteoporosis in patients with vitamin D deficiency: it is recommended to administer 15 drops (containing 0.266 mg of calcifediol) per month for 3-4 months;
• As an adjunct in bone diseases induced by corticosteroids: it is recommended to take 15 drops (0.266 mg of calcifediol) once a month.
• Renal osteodystrophy: it is recommended to take 15 drops (containing 0.266 mg of calcifediol) once a week or every two weeks. During treatment, vitamin D, calcium,

phosphorus and PTH levels must be frequently monitored. If the doctor deems it necessary, they will
prescribe pharmaceutical forms with different release characteristics.

• In patients with malabsorption syndrome: 15 drops (containing 0.266 mg of calcifediol) per month. Repeat the initial dose one week after starting treatment and then continue with the administration of 15 drops once a month for four months. The doctor will subject you to regular monitoring of Vitamin D levels. In some cases, the doctor may deem it necessary to administer higher doses or for longer periods of time depending on the degree of ascertained deficiency by performing the relevant blood tests and subsequent regular checks of the corresponding levels. Children and adolescentsKALED is not recommended in children and adolescents. For oral use. The product can be taken alone 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 shouldIf you take a dose of this medicine higher than that prescribed by your doctor (overdose) and/or if you take it for prolonged periods of time, hypercalcemia (high levels of calcium in the blood), the presence of phosphates in the urine and blood and the presence of calcium in the urine with possible consequent risk of kidney failure may occur. Initial symptoms of overdose include weakness, fatigue, drowsiness, headache, reduced appetite, dry mouth, perception of a metallic taste, nausea, vomiting, abdominal cramps, increased frequency of urination, increased thirst, repeated need to urinate during the night, constipation or diarrhea, dizziness, ringing in the ears, loss of motor coordination, rash, reduced muscle tone (especially in children), bone and muscle pain, and irritability. Late symptoms of hypercalcemia include: runny nose, itching, decreased libido, formation of calcium deposits in the kidneys, kidney failure, osteoporosis in adults, growth retardation in children, weight loss, anemia, conjunctivitis with calcium deposition, light sensitivity, pancreatitis, increased blood urea nitrogen levels, albuminuria, increased blood cholesterol, increased transaminases (SGOT and SGPT), fever, formation of calculi within the vessels, convulsions, calcification of soft tissues. Rarely, patients may develop high blood pressure and altered thinking; a decrease in a blood enzyme called alkaline phosphatase may occur; imbalances of some blood components called electrolytes together with an increase in blood acidity can cause heart rhythm disturbances. In the most severe cases (very high levels of calcium in the blood), loss of consciousness, decreased blood pH and coma can occur. Although overdose symptoms are usually reversible, overdose may cause renal or cardiac failure. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a hospital or contact a poison control center. If you forget to take KALEDDo not take a double dose to make up for the missed dose. Take the missed dose as soon as possible; then resume the normal dosage schedule.

In case of interruption of KALED administration
Follow your doctor's instructions.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important adverse reactions may occur in case of treatment with excessive doses or for periods of
time longer than prescribed by the doctor.

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

• increased blood urea nitrogen
• albuminuria (presence of albumin in the urine)
• hypercalcemia (increased calcium in the blood)
• hypercholesterolemia (increased cholesterol in the blood)
• hypercalciuria (increased calcium in the urine)
• weakness
• fatigue
• drowsiness
• headache
• irritability
• cardiac arrhythmias (irregular heartbeat).
• nausea
• vomiting
• dry mouth
• constipation
• taste alterations 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
• deterioration of renal 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 proteins in the urine).
• rhinorrhea (runny nose)
• pruritus (itching)
• hyperthermia (fever)
• chills
• asthenia (malaise or fatigue)
• decreased libido (sexual desire)

Not known(frequency cannot be estimated based on available data):

• Hypersensitivity reactions such as angioedema (sudden swelling of the skin and mucous membranes) or laryngeal edema (swelling of the throat with difficulty breathing). Rare(may affect up to 1 in 1,000):
• pruritus (itching)
• erythema (redness of the skin)
• exfoliative dermatitis (peeling of the skin)
• hyperphosphatemia (increased phosphorus in the blood)
• thirst
• reduced appetite
• hypermagnesemia (increased magnesium in the blood)
• dehydration (loss of fluids)
• syncope (loss of consciousness)
• metabolic alkalosis (increased blood pH)
• hypervitaminosis D (increased vitamin D in the blood)
• photophobia (sensitivity of the eyes to light)
• conjunctivitis with calcifications (calcium deposits) of the cornea
• vascular calcification
• dizziness
• sensory disturbance
• hypotonia (decreased muscle tone)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects, you can help to improve the safety information of this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important adverse reactions may occur in case of treatment with excessive doses or for periods of
time longer than prescribed by the doctor.

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

• increased blood urea nitrogen
• albuminuria (presence of albumin in the urine)
• hypercalcemia (increased calcium in the blood)
• hypercholesterolemia (increased cholesterol in the blood)
• hypercalciuria (increased calcium in the urine)
• weakness
• fatigue
• drowsiness
• headache
• irritability
• cardiac arrhythmias (irregular heartbeat).
• nausea
• vomiting
• dry mouth
• constipation
• taste alterations 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
• deterioration of renal 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 proteins in the urine).
• rhinorrhea (runny nose)
• pruritus (itching)
• hyperthermia (fever)
• chills
• asthenia (malaise or fatigue)
• decreased libido (sexual desire)

Not known(frequency cannot be estimated based on available data):

• Hypersensitivity reactions such as angioedema (sudden swelling of the skin and mucous membranes) or laryngeal edema (swelling of the throat with difficulty breathing). Rare(may affect up to 1 in 1,000):
• pruritus (itching)
• erythema (redness of the skin)
• exfoliative dermatitis (peeling of the skin)
• hyperphosphatemia (increased phosphorus in the blood)
• thirst
• reduced appetite
• hypermagnesemia (increased magnesium in the blood)
• dehydration (loss of fluids)
• syncope (loss of consciousness)
• metabolic alkalosis (increased blood pH)
• hypervitaminosis D (increased vitamin D in the blood)
• photophobia (sensitivity of the eyes to light)
• conjunctivitis with calcifications (calcium deposits) of the cornea
• vascular calcification
• dizziness
• sensory disturbance
• hypotonia (decreased muscle tone)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects, you can help to improve the safety information 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 which is reported on the pack after EXP. The expiry date refers to the last day of that month.
After the first opening of the KALED bottle, the validity of the medicine is 17 months (note the date of first
opening in the appropriate space on the packaging). After this period, dispose of any remaining medicine.
Store this medicine at a temperature below 25°C and in the original packaging to protect it from
light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What KALED contains

• The active ingredient 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, equipped with a dropper.
KALED is available in a 5 ml bottle.

Marketing Authorisation Holder
I.B.N. Savio S.r.l., Via del Mare, 36 – 00071 Pomezia (RM), Italy

Manufacturer responsible for batch release
Savio Industrial S.r.l., Via Emilia, 21 – Pavia, Italy