Geniad

Package leaflet: information for the patient

GENIAD 2 micrograms/ml oral drops, solution

alfacalcidol
Please read 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 for you/your child 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What GENIAD is and what it is used for

GENIAD contains alfacalcidol, a precursor of vitamin D3.
GENIAD 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) 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 (Rickets and D-resistant or D-dependent (pseudo-deficient) osteomalacia, rickets and osteomalacia due to other renal effects on vitamin D metabolism).
• bone density loss after menopause (Postmenopausal osteoporosis) (only in adult women who are postmenopausal).

2. What you need to know before taking/giving GENIAD to the child

Do not take/give GENIAD 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 she is 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 GENIAD 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 check-ups.
An increase in calcium levels in the blood (hypercalcemia) may occur during treatment with GENIAD, with symptoms possibly including 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:

• have arteriosclerosis (hardening of the arteries, the large blood vessels in the body), calcification (sclerosis) of heart valves, kidney stones (nephrolithiasis), as in these cases the child may develop temporary or permanent kidney damage;
• have calcium accumulation in the lungs (calcification of lung tissue). This may cause heart disease;
• have 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 levels of phosphate in the blood (hyperphosphatemia) and potential calcium deposition in healthy tissues (metastatic calcification);
• have an inflammatory disease that may affect the entire body and leads to the formation of nodules (sarcoidosis) or a similar disease;
• have a kidney disease (chronic renal failure).

Also inform the doctor if you/the child are taking digitalis glycosides, medicines used to treat heart conditions. You/the child may experience increased calcium levels in the blood while taking these medicines, thereby increasing the risk of heart rhythm disturbances.

Other medicines and GENIAD
Inform the 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 GENIAD 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 vitamin D-containing preparations;
• aluminium-containing preparations (e.g. aluminium hydroxide, sucralfate);
• bile acid sequestrants such as cholestyramine, medicines used to treat high fat levels in the blood. Take/give GENIAD to the child at least 1 hour before, or 4 to 6 hours after, the bile acid sequestrant.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
GENIAD 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 treatment with GENIAD, taking into account the benefit of breastfeeding for the child and the benefit of treatment for you.
The doctor will closely monitor the breastfed infant during your treatment with GENIAD.

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.

GENIAD contains peanut oil
If you are allergic to peanuts or soya, do not use this medicine.

3. How to take/give GENIAD to the 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 that you/the child undergo regular blood tests and check-ups.

Adults (all indications)
The recommended initial dose is 1 microgram per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose ranges from 0.25 to 1 microgram per day, depending on the response to therapy and laboratory test results obtained during treatment, as requested by the doctor.
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 dose to between 1 and 3 micrograms per day.
In patients with severe hypocalcemia, the doctor may increase the dose to between 3 and 5 micrograms per day. In such patients, the doctor may also prescribe additional medicines containing calcium.

Children weighing more than 20 kg
The recommended initial dose is 1 microgram per day (equivalent to 26 drops of oral solution).
The recommended maintenance dose will be determined by the doctor based on the response to therapy and laboratory test results obtained during treatment.

Children weighing less than 20 kg
The dose depends on the child's weight.
The recommended initial dose is 0.05 microgram/kg per day, equivalent to approximately 1 drop/kg (e.g., for a child weighing 10 kg, the dose is 13 drops per day).
To facilitate dose calculation in these children, the following illustrative dose/weight table is provided:

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 GENIAD than you should
In case of accidental ingestion/overdose of GENIAD, contact your doctor immediately or go to the nearest hospital.
If you forget to take/give the child GENIAD
Do not take/give the child a double dose to make up for the missed dose.
If you stop treatment with GENIAD
If you have any doubts about the use of this medicinal product, 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 GENIAD 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, classified 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, including erythematous, maculopapular, and pustular rashes)

• 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 injury)

• 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, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at the 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 GENIAD

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that month.
Store the medicine in its original packaging, at a temperature not exceeding 25°C, and protect it from light.
After opening, the dropper bottle, tightly reclosed, can be stored at a temperature not exceeding 25°C for a maximum of 10 days.
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 package and other information

What GENIAD contains
The active substance is Alfacalcidol 2 micrograms/ml.
The other components are d,l-alpha-tocopherol, peanut oil.

Description of the appearance of GENIAD and contents of the pack
Oral drops, solution 2 micrograms/1 ml in a pack containing 1 bottle of 10 ml with a dropper pipette.

Marketing Authorization Holder
HOLDER
Dymalife Pharmaceutical S.r.l. – Via Bagnulo, 95 – 80063 Piano di Sorrento (NA) Italy

Manufacturer
Special Product’s Line S.p.A - Strada Paduni, 240 03012, Anagni (FR)
Lachifarma S.r.l. - S.S. 16 Adriatica – Zona Industriale - I-73010 ZOLLINO LE
ITALY