Dediol

Patient Information Leaflet

DEDIOL 2 mcg/ml oral drops, solution, 0.25 mcg soft capsules

alfacalcidol
Please read all of this leaflet carefully before you start taking/giving the child 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 only for you/the child. Do not give it to other people, even if they have the same symptoms as you do, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What DEDIOL is and what it is used for

DEDIOL contains alfacalcidol, a precursor of vitamin D.
DEDIOL is indicated in adults and children for the treatment of:

• bone fragility, reduced bone mass, and increased fracture risk in patients with kidney disease (renal osteodystrophy), whether undergoing dialysis (a blood filtration system) or not.
• reduced function of the parathyroid glands located in the neck (hypoparathyroidism).
• bone diseases caused by impaired vitamin D metabolism, including in patients with kidney disease (vitamin D-resistant or vitamin D-dependent rickets and osteomalacia (pseudo-deficient), rickets and osteomalacia due to other renal effects on vitamin D metabolism).
• loss of bone density after menopause (postmenopausal osteoporosis) (only in adult women in postmenopause).

2. What you should know before taking/giving DEDIOL to the child

Do not take/give DEDIOL to the child

• if he/she is allergic to alfacalcidol or to any of the other ingredients of this medicine (listed in section 6),
• if pregnant,
• if he/she has high levels of calcium in the blood (hypercalcemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving DEDIOL to the child.
Throughout the treatment period, the doctor will request regular blood tests (calcium and phosphate levels, PTH, alkaline phosphatase, and calcium x phosphate product) and regular monitoring.
An increase in calcium levels in the blood (hypercalcemia) may occur during treatment with DEDIOL. Symptoms may include loss of appetite (anorexia), fatigue, nausea and vomiting, constipation or diarrhoea, frequent need to urinate (polyuria), sweating, headache, intense thirst (polydipsia), high blood pressure (hypertension), drowsiness, and dizziness (see section 4 Possible side effects).
In particular, inform the doctor if you/the child suffer(s) from:

• hardening of the arteries, the large blood vessels in the body (arteriosclerosis), hardening (sclerosis) of heart valves, kidney stones (nephrolithiasis), as in these cases the child may develop temporary or permanent kidney damage;
• calcium accumulation in the lungs (pulmonary tissue calcification). This may cause heart disease;
• a bone disease caused by kidney problems (renal bone disease) or severely reduced kidney function. The doctor may prescribe a medicine called a phosphate binder to prevent high phosphate levels in the blood (hyperphosphatemia) and potential calcium deposition in healthy tissues (metastatic calcification);
• an inflammatory disease that may affect the entire body and leads to the formation of nodules (sarcoidosis) or a similar disease;
• a kidney disease (chronic renal failure).

Also inform the doctor if you/the child are taking digitalis glycosides, medicines used to treat heart disorders. You/the child may experience increased calcium levels in the blood while taking these medicines, thereby increasing the risk of heart rhythm disturbances.
For those engaged in sports activities
The use of medicines containing ethyl alcohol (DEDIOL oral drops) may result in a positive anti-doping test, depending on the blood alcohol concentration limits set by certain sports federations.
Other medicines and DEDIOL
Inform your doctor or pharmacist if you/the child are taking, have recently taken, or might take any other medicines.
In particular, inform the doctor if you/the child are taking:

• anticonvulsants (e.g. barbiturates, phenytoin, carbamazepine, or primidone), medicines used to treat uncontrolled body movements, as higher doses of DEDIOL may be required;
• magnesium-containing antacids, medicines used to treat heartburn;
• thiazide diuretics (medicines used to treat high blood pressure) or calcium-containing preparations. The doctor may request blood tests;
• other preparations containing vitamin D;
• aluminium-containing preparations (e.g. aluminium hydroxide, sucralfate);
• bile acid sequestrants, such as cholestyramine, medicines used to treat high blood fat levels. Take/give DEDIOL to the child at least 1 hour before, or 4 to 6 hours after taking the bile acid sequestrant.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
DEDIOL must not be used during pregnancy unless the doctor considers it strictly necessary.
Breastfeeding
Alfacalcidol is excreted in human milk. The doctor will decide whether you should stop breastfeeding or stop DEDIOL therapy, taking into account the benefits of breastfeeding for the child and the benefits of therapy for you.
The doctor will closely monitor the breastfed infant during your treatment with DEDIOL.
Driving and using machines
Alfacalcidol does not affect or affects negligibly the ability to drive and use machines. However, dizziness may occur during treatment; therefore, take this into account when driving or operating machinery.
DEDIOL capsules contain sesame oil
Rarely, this may cause severe allergic reactions.
DEDIOL drops contain ethanol, sorbitol, methyl-p-hydroxybenzoate, glycerol polyethylene glycol oxystearate, sodium
This medicine contains up to 340 mg of ethanol (alcohol) per dose (corresponding to 6 µg of alfacalcidol), equivalent to 14 vol% ethanol. The amount of ethanol in this medicine is equivalent to less than 9 ml of beer or 4.5 ml of wine per dose.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains 226 mg of sorbitol, as excipient, in 1 µg of alfacalcidol (equivalent to 26 drops).
Sorbitol is a source of fructose. If your doctor has told you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or the child) take this medicine.
This medicine contains methyl-p-hydroxybenzoate: it may cause allergic reactions (including delayed-type reactions).
This medicine contains glycerol polyethylene glycol oxystearate: it may cause gastrointestinal disturbances and diarrhoea.
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially “sodium-free”.

3. How to take/give DEDIOL to a child

Take/give this medicine to the child exactly as directed by the doctor or
pharmacist. If you have any doubts, consult the doctor or pharmacist.
Throughout the entire treatment period, the doctor will require regular blood tests and check-ups for you/the child.
Adults (all indications)
The recommended initial dose is 1 mcg daily (equivalent to 26 drops of oral solution).
The recommended maintenance dose ranges between 0.25 and 1 mcg daily, depending on the therapy results and laboratory tests prescribed by the doctor during treatment.
In cases of osteoporosis, the doctor will determine the most appropriate dose for you based on your health status.
In patients with severe bone dysfunction (except those with renal insufficiency), the doctor may increase the dosage to between 1 and 3 mcg daily.
In patients with severe hypocalcemia, the doctor may increase the dosage to between 3 and 5 mcg daily. In such patients, the doctor may also prescribe other medications containing calcium.
Children weighing more than 20 kg
The recommended initial dose is 1 mcg daily (equivalent to 26 drops of oral solution).
The recommended maintenance dose will be determined by the doctor based on therapy results and laboratory tests prescribed during treatment.
Children weighing less than 20 kg
The dose depends on the child's body weight.
The recommended initial dose is 0.05 mcg/kg daily, equivalent to approximately 1 drop/kg (e.g., for a child weighing 10 kg, the dose is 13 drops daily).
To facilitate dose calculation in these children, the following table provides an illustrative weight-based dosing guide:

It is recommended not to administer the product directly, but to use a teaspoon to correctly measure the exact number of drops to be administered.
If you take/give the child more DEDIOL than you should
In case of accidental ingestion of an excessive dose of DEDIOL, contact your doctor immediately or go to the nearest hospital.
If you forget to take/give the child DEDIOL
Do not take/give the child a double dose to make up for a missed dose.
If you stop treatment with DEDIOL
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 everyone will experience them.
If you/your child experience any of the following symptoms, stop using DEDIOL immediately
and contact your doctor or go to the nearest hospital, where you will be given appropriate and specific
treatment:

• High levels of calcium in the blood (hypercalcemia); your doctor will subsequently restart treatment at a halved dose;
• High levels of phosphate in the blood (hyperphosphatemia);
• High levels of calcium in the urine (hypercalciuria exceeding 6 mg/kg/24 h).

The possible side effects are listed below, grouped according to the following frequency:
Common (may affect up to 1 in 10 people)

• high levels of calcium in the blood (hypercalcemia)
• high levels of phosphate in the blood (hyperphosphatemia)
• increased levels of calcium in the urine (hypercalciuria)
• abdominal pain and discomfort
• skin rash (various types of rash have been reported, such as erythematous, maculopapular, and pustular)
• itching

Uncommon (may affect up to 1 in 100 people)

• headache
• diarrhoea
• vomiting
• constipation
• nausea
• muscle pain (myalgia)
• kidney stones (nephrolithiasis/nephrocalcinosis)
• fatigue/weakness/malaise
• formation of calcium deposits in tissues (calcinosis)

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

• dizziness

Frequency not known
(frequency cannot be estimated from the available data)

• kidney damage (including acute kidney failure)
• confusion

Additional side effects in children
The safety profile observed is similar between adults and children.

Reporting of side effects
If you/your child experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the following website:
“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 DEDIOL

Oral drops, solution: store in the refrigerator (2 °C – 8 °C). Shelf life after first opening: 4 months.
Capsules: store at a temperature not exceeding 25°C.
Keep in the original packaging to protect the medicine from light.
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 medicines 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 DEDIOL contains
Oral drops, solution:

• The active substance is alfacalcidol 2 mcg/ml.
• The other components are polyglyceryl polyricinoleate; citric acid; sodium citrate; sorbitol; d,l-α-tocopherol; methyl parahydroxybenzoate; ethanol (see section 2. DEDIOL oral drops contain ethanol, sorbitol, methyl parahydroxybenzoate, polyglyceryl polyricinoleate, sodium); purified water.

Capsules

• The active substance is alfacalcidol 0.25 mcg.
• The other components are: d,l-α-tocopherol, sesame oil (see section 2. DEDIOL capsules contain sesame oil).
  The capsule shell consists of: gelatin; glycerin; potassium sorbate; titanium dioxide (E171).

Description of the appearance of DEDIOL and contents of the pack
Oral solution
DEDIOL is a solution presented in a 10 ml bottle.
Capsules
DEDIOL is presented as capsules.
Available in packs of 30 capsules containing 0.25 mcg of active substance.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24, 17489 Greifswald (Germany)

Manufacturers
DEDIOL 2 mcg/ml oral drops, solution and DEDIOL 0.25 mcg soft capsules:
LEO PHARMACEUTICAL PRODUCTS Ltd. - Ballerup – DENMARK
DEDIOL 2 mcg/ml oral drops, solution:
Delpharm Bladel B.V.
Industrieweg 1,
5531AD, Bladel
Netherlands
DEDIOL 0.25 mcg soft capsules:
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
Germany