Didrogyl

Patient Information Leaflet

DIDROGYL

0.15 mg/ml oral drops, solution
Calcifediol
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, 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What DIDROGYL is and what it is used for
2. What you need to know before taking DIDROGYL
3. How to take DIDROGYL
4. Possible side effects
5. How to store DIDROGYL
6. Package contents and other information

1. What DIDROGYL is and what it is used for

DIDROGYL is a medicine containing calcifediol, a metabolite and the circulating form of Vitamin D in serum, used for the treatment of bone diseases and conditions leading to hypocalcemia (low calcium levels in the blood).
DIDROGYL is indicated in adults for:

• soft and weak bones (osteomalacia due to dietary deficiencies, malabsorption, or treatment with anticonvulsant drugs);
• fragile bones (osteoporosis with osteomalacic component or due to menopause);
• bone disorders due to kidney diseases (renal osteodystrophy) and prolonged treatment with artificial kidney (prolonged hemodialysis);
• decreased calcium levels in the blood due to liver disorders (hypocalcemia associated with hepatic diseases);
• underactive parathyroid glands without a known cause or following surgery (idiopathic or post-operative hypoparathyroidism);
• sudden, involuntary muscle contractions (tetany) due to vitamin D deficiency.

DIDROGYL is indicated in children for:

• decreased calcium levels in the blood (hypocalcemia) in newborns, preterm and immature infants;
• decreased calcium levels in the blood (hypocalcemia) due to treatment with corticosteroid medicines or anticonvulsant drugs, or due to underactive parathyroid glands;
• fragile and deformed bones (deficiency rickets with hypocalcemia);
• bone disorders due to kidney diseases (renal osteodystrophy) and prolonged treatment with artificial kidney (prolonged hemodialysis).

2. What you need to know before taking DIDROGYL

Do not take DIDROGYL if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you are breastfeeding;
• you have high levels of calcium in your blood (hypercalcaemia);
• you suffer from hypercalciuria (high levels of calcium in the urine);
• you have been diagnosed with hypervitaminosis D (excess vitamin D in the body).

Warnings and precautions
Talk to your doctor or pharmacist BEFORE taking DIDROGYL if:

• you are taking preparations containing vitamin D or its derivatives;
• you suffer from granulomatous diseases such as sarcoidosis or tuberculosis;
• you have kidney problems;
• you are obese;
• you have previously suffered from kidney stones;
• you are confined to bed or wheelchair (immobilized);
• you have heart disease, which requires special attention and frequent monitoring of blood calcium levels (at least twice weekly at the beginning of treatment), especially if you are taking cardiac glycosides (see within this section, paragraph "Other medicines and DIDROGYL");
• to avoid potential overdose, your doctor will inform you and your family and/or caregivers about the importance of strictly following the prescribed dosage and dietary recommendations, as well as concomitant use of calcium or vitamin D supplements.

Talk to your doctor or pharmacist DURING treatment with DIDROGYL if:
your blood calcium levels (calcemia) and/or urine calcium levels (calciuria) become abnormal.
Other medicines and DIDROGYL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:

• preparations containing vitamin D or its derivatives;
• medicines that lower cholesterol in the blood (colestipol and cholestyramine);
• medicines that lower blood fats (lipase inhibitors such as orlistat);
• medicines that reduce blood pressure by increasing urine production (thiazide diuretics);
• medicines used to treat epilepsy (such as phenytoin, phenobarbital and primidone);
• medicines that may block vitamin D metabolism (enzyme inhibitors such as ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole);
• medicines used to treat certain heart conditions (cardiac glycosides, verapamil);
• mineral oil or paraffin (laxatives): use of an alternative type of laxative is recommended;
• certain antibiotics (such as penicillin, neomycin and chloramphenicol);
• magnesium salts;
• calcium supplements;
• corticosteroids (anti-inflammatory agents).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
DIDROGYL may be used during pregnancy at the lowest doses.
DIDROGYL must not be used during breastfeeding.
Driving and using machines
DIDROGYL does not impair the ability to drive or operate machinery.
Important information about some excipients:
This medicine contains 340 mg of propylene glycol in a dose of 10 drops, equivalent to 4.92 mg/kg for a 70 kg adult and 17.2 mg/kg for a 20 kg child.
If the child is less than 4 weeks old, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take DIDROGYL

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Dosage
Your doctor will determine the correct dose of DIDROGYL based on your blood calcium levels (calcemia) and
urinary calcium levels (calciuria); they may also ask you to monitor other parameters, such as blood phosphate levels (phosphoremia).
Adults
The usual dose of DIDROGYL is as follows:

• osteomalacia due to dietary deficiencies, malabsorption, or treatment with anticonvulsant drugs : 10–25 drops or more daily, according to need;
• osteoporosis with an osteomalacic component or due to menopause : 10–25 drops or more daily, according to need;
• bone disorders due to kidney disease (renal osteodystrophy) and treatment with artificial kidney (prolonged hemodialysis) : 10–25 drops or more daily, according to need;
• hypocalcemia due to liver disorders : 10–25 drops or more daily, according to need;
• hypocalcemia due to underactive parathyroid glands without a known cause or following surgery (idiopathic or post-surgical hypoparathyroidism) : 10–25 drops or more daily, according to need;
• involuntary and sudden muscle contractions ( tetany ) due to vitamin D deficiency: your doctor may prescribe one of the following treatments: 10 drops daily for 2–3 months. The dose may be reduced to 3 drops daily or 10 drops weekly, depending on urinary calcium levels (calciuria). Your doctor may also recommend repeating this treatment when necessary; 30 drops daily for 6 weeks, together with other medications containing phosphate (1 g in the morning) and magnesium (200 mg in the evening). This treatment should be repeated 3–4 times per year.

Children
The usual dose of DIDROGYL is as follows:

• hypocalcemia in newborns, premature infants, and immature infants : 1 or 2 drops daily for 5 days, in combination with calcium therapy;
• hypocalcemia due to treatment with corticosteroid or anticonvulsant drugs, or due to underactive parathyroid glands : 5–20 drops daily;
• nutritional rickets with hypocalcemia : 4–10 drops daily, in combination with calcium therapy;
• bone disorders due to kidney disease (renal osteodystrophy) and treatment with artificial kidney (prolonged hemodialysis) : 4–15 drops or more daily.

Method of administration
DIDROGYL is an oral solution contained in a bottle equipped with a dropper. Hold the bottle upside down (vertically) over a glass containing a small amount of water (or milk or fruit juice), until the prescribed number of drops has been dispensed. Take the contents of the glass orally.
If you need to take more than 20 drops, you may divide the dose into two or three administrations, as directed by your doctor.
Duration of treatment
Your doctor will determine how long you should take this medicine. If necessary, they may decide to repeat the treatment several times within a year. Do not stop treatment without consulting your doctor.
If you take more DIDROGYL than you should, you may experience: weakness, nausea, vomiting, dry mouth, hard stools (constipation), muscle pain.
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital, as appropriate measures may be required.
If you forget to take DIDROGYL
Do not take a double dose to make up for the missed dose. Take the next dose as prescribed.
If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, DIDROGYL may cause side effects, although not everybody experiences them.
Uncommon side effects (may affect up to 1 in 100 people)

• vomiting, diarrhoea.

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

• dizziness, fainting (syncope);
• muscle weakness or sensory disturbances, decreased muscle tone (hypotonia) or reduced response to stimuli (hyporesponsiveness to stimuli);
• calcification within blood vessels (vascular calcification);
• increased levels of calcium, phosphorus or magnesium in the blood (hypercalcaemia, hyperphosphataemia, hypermagnesaemia);
• thirst or reduced appetite (reduced appetite) or reduced water intake (dehydration);
• increased blood pH, presenting as intractable vomiting, dehydration, confusion, weakness (metabolic alkalosis);
• increased vitamin D levels in the blood (hypervitaminosis D);
• itching, red skin rash (erythema), skin peeling (exfoliative dermatitis);
• increased calcium in urine (hypercalciuria);
• weight loss.

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

• allergic reaction (hypersensitivity);
• increased urine output (polyuria), kidney stones (nephrolithiasis) or urethral stones, calcium accumulation in the kidneys (nephrocalcinosis), dilation of the renal pelvis (hydronephrosis);
• increased nitrogen levels in the blood (azotaemia);
• malaise or fatigue (asthenia);
• calcium deposition under the skin (calcinosis);
• fever or chills;
• disturbances in gait.

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

• urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at "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 DIDROGYL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store DIDROGYL in the original packaging to protect the medicine from light.
The 10 ml vial is valid for 120 days (4 months) after first opening; after this period, any remaining medicine must be discarded.
Do not dispose of medicines 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 DIDROGYL contains
The active substance is calcifediol.
1 ml of DIDROGYL contains: 0.15 mg of calcifediol. One drop contains 5 mcg of calcifediol.
The other component is: propylene glycol.
Description of the appearance of DIDROGYL and contents of the pack
This medicine is a solution, contained in a dark glass bottle with a dropper.
DIDROGYL is available in 10 ml or 3.3 ml bottles.
Marketing Authorization Holder
BRUNO FARMACEUTICI S.p.A. - Via delle Ande, 15 - 00144 ROMA
Manufacturer
SPECIAL PRODUCT’S LINE S.p.A. - Via Fratta Rotonda Vado Largo n.1- 03012 Anagni (FR)
VAMFARMA S.R.L. – Via Kennedy, 5 – 26833 Comazzo (LO)
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