Active ingredients: Cholecalciferol
XARENEL 10,000 I.U./ml oral drops, solution
XARENEL 25.000 I.U./2.5 ml oral solution
XARENEL 50.000 I.U./2.5 ml oral solution
XARENEL 100.000 I.U./ml solution for injection
XARENEL 300.000 I.U./ml solution for injection
Why is Xarenel used? What is it for?
XARENEL contains cholecalciferol, better known as vitamin D3. XARENEL is indicated for the prevention and treatment of vitamin D deficiency.
Contraindications When Xarenel should not be used
Do not take XARENEL
- if you are allergic to cholecalciferol (vitamin D3) or any of the other ingredients of this medicine (listed in section 6).
- If you have high levels of calcium in the blood (hypercalcaemia) or in the urine (hypercalciuria).
- If you suffer from kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
- If you suffer from kidney disease (kidney failure) (see section "Warnings and precautions").
Precautions for use What you need to know before taking Xarenel
Talk to your doctor or pharmacist before taking XARENEL.
Your doctor may recommend taking XARENEL as a prevention of vitamin D deficiency:
- in newborns (especially if premature) and infants,
- during the last trimester of pregnancy,
- in women who breastfeed in late winter and spring,
- in the elderly,
- in case of insufficient sun exposure, especially in children and adolescents,
- in case of an unbalanced diet (e.g. low in calcium, vegetarian diet),
- in case of intense skin coloring,
- in case of extensive skin diseases, infectious diseases (such as tuberculosis, leprosy), digestive disorders or liver diseases (liver failure),
- in patients on antiepileptic drugs or on long-term therapy with some anti-inflammatory drugs.
Your doctor may order periodic tests to check the levels of vitamin D in your blood or calcium in your blood and urine in the following cases:
- if you have to follow treatment with XARENEL for a long time and with high doses
- if you are elderly and are already being treated with medicines to treat some heart diseases (cardiac glycosides) or medicines that lower blood pressure by increasing urine production (diuretics)
- if you suffer from sarcoidosis, an inflammatory disease which can affect the whole body and leads to the formation of lumps. If your vitamin D or calcium levels are high, your doctor will reduce the dose or stop treatment with XARENEL .
In general, you should not take XARENEL if you have poor kidney function (see section "Do not take XARENEL"); but if your doctor thinks that treatment with XARENEL is absolutely necessary, you will need to have periodic tests to check your blood calcium and phosphate levels. If your calcium and phosphate levels are elevated, your doctor will reduce the dose or stop treatment with XARENEL.
Tell your doctor in the following cases, as it may be necessary to increase the dosages from those mentioned in section 3. "How to take XARENEL":
- if you are taking medicines used to treat epilepsy (anticonvulsants or barbiturates) (see section "Other medicines and XARENEL");
- if you are taking cortisone medicines to treat inflammation (see section "Other medicines and XARENEL");
- if you are taking medicines to lower blood fat such as colestipol, cholestyramine and orlistat (see section "Other medicines and XARENEL");
- if you are taking aluminum-containing antacids, medicines to treat too much acid in the stomach which may also flow up into the 'esophagus (see section "Other medicines and XARENEL");
- if you are obese;
- if you suffer from digestive diseases (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
- if you suffer from liver disease (liver failure).
Interactions Which drugs or foods may change the effect of Xarenel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking the following medicines, as they may reduce the effect of XARENEL: - medicines used to treat epilepsy (anticonvulsants or barbiturates);
- medicines to reduce blood fats such as colestipol, cholestyramine and orlistat;
- aluminum-containing antacids, medicines to treat too much acid in the stomach which can also go up the esophagus;
- steroids, medicines to treat inflammation.
Also, if you are taking the following medicines, tell your doctor, who will monitor you closely and will carefully consider whether further tests are appropriate:
- thiazide diuretics, medicines to treat high blood pressure by increasing urine production;
- digitalis medicine to treat certain heart disorders;
- preparations containing magnesium;
- warfarin, medicine to thin the blood.
XARENEL with food and drink and alcohol
Tell your doctor if you take other products that already contain vitamin D, foods supplemented with vitamin D, or if you are using milk fortified with vitamin D, so that he can take into account the total amount of vitamin D you are taking and avoid overdosing.
Taking large amounts of alcohol for a long time (chronic alcoholism) lowers the vitamin D stores in the liver.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
During the first 6 months of pregnancy, your doctor will prescribe this medicine only if considered strictly necessary, due to the risk of harmful effects on the fetus. (see section 3. "If you take more XARENEL than you should").
Feeding time
When needed, your doctor will prescribe this medicine while you are breastfeeding. This does not replace the administration of vitamin D in the newborn.
Driving and using machines
XARENEL is unlikely to affect the ability to drive.
Dosage and method of use How to use Xarenel: Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The doses and duration of treatment will be evaluated by your doctor based on your state of health. Do not exceed the doses indicated by your doctor.
Doses must be taken orally. It is recommended that XARENEL be taken with meals.
XARENEL 10,000 I.U./ml oral drops, solution
The daily doses indicated below can also be taken once a week by multiplying the indicated daily dose by seven.
Infants, Children and Adolescents (<18 years)
Prevention: the recommended dose is 2-4 drops per day (equal to 500-1000 I.U. of vitamin D3).
Treatment: the recommended dose is 8-16 drops per day (equal to 2,000-4,000 IU of vitamin D3) for 4-5 months.
Pregnant women
The recommended dose is 3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3) in the last trimester.
Adults and Elderly
Prevention: the recommended dose is 3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3). In case of high risk of deficiency, the doctor will evaluate whether it is necessary to increase the dosage up to 8 drops per day (equal to 2,000 I.U. of vitamin D3).
Treatment: the recommended dose is 20-40 drops per day (equal to 5,000- 10,000 IU of vitamin D3) for 1-2 months.
Instructions for Use
The pack contains 1 bottle and 1 dropper. The bottle comes with a child resistant capsule. The dropper comes with a case. For use, follow the instructions below:
- open the bottle by removing the cap as follows: press and unscrew at the same time;
- unscrew the plastic case that wraps the dropper tip;
- insert the dropper into the bottle to withdraw the contents. Dose the number of drops prescribed by the doctor in a teaspoon and take them;
- close the bottle. Screw the case back onto the dropper tip;
- put the bottle and the dropper back in the box.
XARENEL 25.000 I.U./2.5 ml oral solution
Infants, Children and Adolescents (<18 years)
Prevention: the recommended dose is 1 single-dose container (equal to 25,000 I.U. of vitamin D3) every 1-2 months.
Treatment: the recommended dose is 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a week for 16-24 weeks.
Pregnant women
The recommended dose is 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month in the last quarter.
Adults and Elderly
Prevention: the recommended dose is 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month. In case of high risk of deficiency, the doctor will evaluate if it is necessary to increase the dosage to 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: the recommended dose is 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
XARENEL 50.000 I.U./2.5 ml oral solution
Infants, Children and Adolescents (<18 years)
Prevention: the recommended dose is 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2-4 months.
Treatment: the recommended dose is 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
Pregnant women
The recommended dose is 2 single-dose containers (equal to 100,000 I.U. of vitamin D3) at the beginning of the last trimester.
Adults and Seniors
Prevention: the recommended dose is 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2 months. In case of high risk of deficiency, the doctor will evaluate if it is necessary to increase the dosage to 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: the recommended dose is 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks
If you forget to take XARENEL
Do not take a double dose to make up for a forgotten dose.
If you stop taking XARENEL
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Xarenel
In case of accidental ingestion / intake of an excessive dose of XARENEL, notify your doctor immediately or go to the nearest hospital. In the event of an overdose, increased levels of calcium in the blood and urine may occur, the symptoms of which are as follows: nausea, vomiting, thirst, intense thirst (polydipsia), increased amount of urine excreted (polyuria), constipation and dehydration.
Chronic overdosing can lead to deposits of calcium salts in blood vessels and organs.
Using an excessive dose of vitamin D in the first 6 months of pregnancy can cause serious harm to the fetus and newborn.
Side Effects What are the side effects of Xarenel
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported with the use of vitamin D are the following:
- allergic reactions - weakness, loss of appetite (anorexia), thirst
- drowsiness, confusion
- headache
- constipation, gas (wind), belly pain, nausea, vomiting, diarrhea, metallic taste, dry mouth
- skin rash, itching
- excessive calcium deposition in the kidneys (nephrocalcinosis), increased amount of urine excreted (polyuria), intense thirst (polydipsia), kidney disease (kidney failure)
- increased levels of calcium in the blood (hypercalcemia) and urine (hypercalciuria).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Store at a temperature not exceeding 30 ° C. Do not freeze. Store in the original package to keep the medicine protected from light.
XARENEL 10,000 I.U./ml oral drops, solution
The validity of the medicine after first opening the bottle is 5 months (write the date of first opening in the space provided on the box). After this period, the residual medicinal product must be discarded.
Deadline "> Other information
What XARENEL contains
XARENEL 10,000 I.U./ml oral drops, solution:
- The active ingredient is cholecalciferol (vitamin D3) 2.5 mg equal to 100,000 I.U. 1 drop contains: 250 I.U. of vitamin D3.
- The other component is refined olive oil.
XARENEL 25.000 I.U./2.5 ml oral solution In a single-dose container:
- The active ingredient is cholecalciferol (vitamin D3) 0.625 mg equal to 25,000 I.U.
- The other component is refined olive oil.
XARENEL 50.000 I.U./2.5 ml oral solution In a single-dose container:
- The active ingredient is cholecalciferol (vitamin D3) 1.25 mg equal to 50,000 I.U.
- The other component is refined olive oil.
Description of what XARENEL looks like and contents of the pack
Oral drops, solution
XARENEL is presented as a solution contained in an amber glass bottle, closed with a polypropylene child resistant cap.
It is available in packs with 1 bottle of 10 ml and 1 dropper.
Oral solution
XARENEL is presented as a solution contained in an amber glass container, closed with a polypropylene capsule.
It is available in packs of 1, 2 or 4 single-dose 2.5ml containers.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
XARENEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
XARENEL 10,000 I.U./ml oral drops, solution
10 ml contain: cholecalciferol (vitamin D3) 2.5 mg equal to 100,000 I.U.
1 drop contains: 250 I.U. of vitamin D3.
XARENEL 25.000 I.U./2.5 ml oral solution
A single-dose container contains: cholecalciferol (vitamin D3) 0.625 mg equal to 25,000 I.U.
XARENEL 50.000 I.U./2.5 ml oral solution
A single-dose container contains: cholecalciferol (vitamin D3) 1.25 mg equal to 50,000 I.U.
XARENEL 100.000 I.U./ml solution for injection
One vial contains: cholecalciferol (vitamin D3) 2.5 mg equal to 100,000 I.U.
XARENEL 300.000 I.U./ml solution for injection
One vial contains: cholecalciferol (vitamin D3) 7.5 mg equal to 300,000 I.U.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
• Injectable solution;
• oral solution;
• oral drops, solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Prevention and treatment of vitamin D deficiency
04.2 Posology and method of administration -
XARENEL can be administered on a daily, weekly, monthly or yearly basis (see section 5.2).
In case of oral therapy, it is recommended that XARENEL be administered with meals (see section 5.2). Intramuscular therapy is indicated only in cases of malabsorption syndromes.
Prevention of vitamin D deficiency: preventive administration of XARENEL is recommended in all conditions characterized by greater risk of deficiency or increased need. It is generally recognized that the prevention of vitamin D deficiency must be carried out:
• systematically in the newborn (in particular in the premature baby), in the infant, in the pregnant woman (last trimester) and in the nursing woman at the end of winter and in spring, in the elderly subject, possibly in the child and adolescent if the sun exposure is insufficient;
• in the following conditions:
§ poor sun exposure or intense skin pigmentation, unbalanced diet (low in calcium, vegetarian, etc.), extensive dermatological pathologies or granulomatous diseases (tuberculosis, leprosy, etc.);
§ subjects being treated with anticonvulsants (barbiturates, phenytoin, primidone);
§ subjects being treated with long-term corticosteroid therapies;
§ digestive pathologies (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
§ liver failure.
Treatment of vitamin D deficiency: Vitamin D deficiency must be ascertained clinically and / or by laboratory investigations. Treatment is aimed at restoring vitamin D deposits and will be followed by maintenance therapy if the risk of deficiency persists, at a dose of vitamin D suitable for prevention (see above "Prevention of vitamin D deficiency"). In most cases it is advisable not to exceed a cumulative dose of 600,000 I.U. per year, unless otherwise advised by the doctor.
As an indication, the following dosage schedule is provided, to be adapted in the judgment of the physician on the basis of the nature and severity of the deficiency status (see also section 4.4).
XARENEL 10,000 I.U./ml oral drops, solution
The daily doses indicated below can also be taken once a week by multiplying the indicated daily dose by seven.
Babies, Children and Adolescents (
Prevention: 2-4 drops per day (equal to 500-1,000 I.U. of vitamin D3).
Treatment: 8-16 drops per day (equal to 2,000-4,000 IU of vitamin D3) for 4-5 months.
Pregnant women
3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3) in the last quarter.
Adults and Seniors
Prevention: 3-4 drops per day (equal to 750-1,000 I.U. of vitamin D3). In subjects at high risk of deficiency it may be necessary to increase the dosage up to 8 drops per day (equal to 2,000 I.U. of vitamin D3).
Treatment: 20-40 drops per day (equal to 5,000-10,000 I.U. of vitamin D3) for 1-2 months.
Instructions for Use
The pack contains 1 bottle and a dropper. The bottle comes with a child resistant capsule. The dropper comes with a case. For use, follow the instructions below:
to. open the bottle by removing the cap as follows: press and unscrew at the same time;
b. unscrew the plastic case that wraps the dropper tip;
c. insert the dropper into the bottle to withdraw the contents. Measure the drops into a spoon and administer (see "Posology and method of administration");
d. close the bottle. Screw the case back onto the dropper tip;
And. put the bottle and the dropper back in the package.
XARENEL 25.000 I.U./2.5 ml oral solution
Babies, Children and Adolescents (
Prevention: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) every 1-2 months.
Treatment: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a week for 16-24 weeks.
Pregnant women
1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month in the last quarter.
Adults and Seniors
Prevention: 1 single-dose container (equal to 25,000 I.U. of vitamin D3) once a month. In subjects at high risk of deficiency it may be necessary to increase the dosage to 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: 2 single-dose containers (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
XARENEL 50.000 I.U./2.5 ml oral solution
Babies, Children and Adolescents (
Prevention: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2-4 months.
Treatment: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
Pregnant women
2 single-dose containers (equal to 100,000 I.U. of vitamin D3) at the beginning of the last quarter.
Adults and Seniors
Prevention: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) every 2 months. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a month.
Treatment: 1 single-dose container (equal to 50,000 I.U. of vitamin D3) once a week for 8-12 weeks.
XARENEL 100.000 I.U./ml solution for injection
Newborns up to 24 months
Prevention: It is recommended to administer the doses with XARENEL 10,000 I.U. / ml oral drops, solution or with XARENEL 25.000 I.U./2.5 ml oral solution or with XARENEL 50.000 I.U. / 2.5 ml oral solution.
Treatment: 1 ampoule (equal to 100,000 I.U. of vitamin D3) once a month for 4-6 months.
Children and Teenagers (2-18 years)
Prevention: 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 4-8 months.
Treatment: 1 ampoule (equal to 100,000 I.U. of vitamin D3) once a month for 4-6 months.
Pregnant women
1 ampoule (equal to 100,000 I.U. of vitamin D3) at the beginning of the last quarter.
Adults and Seniors
Prevention: 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 4 months. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 ampoule (equal to 100,000 I.U. of vitamin D3) every 2 months.
Treatment: 2 ampoules (equal to 200,000 I.U. of vitamin D3) once a month for 3 months.
Instructions for Use
Doses can be administered orally or intramuscularly.
The vials are equipped with a pre-breaking ring and must be opened as follows: hold the lower part of the vial with one hand; place the other hand on top by placing your thumb over the white ring and exert pressure.
XARENEL 300.000 I.U./ml solution for injection
Newborns up to 24 months
It is recommended to administer the doses with XARENEL 10,000 I.U. / ml oral drops, solution or with XARENEL 25.000 I.U./2.5 ml oral solution or with XARENEL 50.000 I.U. / 2.5 ml oral solution.
Children and Teenagers (2-18 years)
Prevention: 1 ampoule (equal to 300,000 I.U. of vitamin D3) once a year.
Treatment: 1 vial (equal to 300,000 I.U. of vitamin D3) to be repeated after 3 months.
Adults and Seniors
Prevention: 1 ampoule (equal to 300,000 I.U. of vitamin D3) once a year. In subjects at high risk of deficiency it may be necessary to increase the dosage to 1 ampoule (equal to 300,000 I.U. of vitamin D3) every 6 months.
Treatment: 1 vial (equal to 300,000 I.U. of vitamin D3) to be repeated after 6 weeks.
Instructions for Use
Doses can be administered orally or intramuscularly.
The vials are equipped with a pre-breaking ring and must be opened as follows: hold the lower part of the vial with one hand; place the other hand on top by placing your thumb over the white ring and exert pressure.
04.3 Contraindications -
Hypersensitivity to cholecalciferol or to any of the excipients listed in section 6.1.
Hypercalcemia, hypercalciuria.
Kidney stones (nephrolithiasis, nephrocalcinosis).
Renal failure (see section 4.4).
04.4 Special warnings and appropriate precautions for use -
In case of prolonged administration with high dosages, it is advisable to monitor the serum level of 25-hydroxy-cholecalciferol. Stop taking XARENEL when the serum level of 25-hydroxy-cholecalciferol exceeds 100 ng / ml (equivalent to 250 nmol / l).
In elderly patients already being treated with cardiac glycosides or diuretics it is important to monitor calcium and calcium. In case of hypercalcaemia or renal insufficiency, reduce the dose or discontinue treatment.
To avoid overdose, take into account the total dose of vitamin D when combining with treatments already containing vitamin D, foods supplemented with vitamin D or when using milk enriched with vitamin D.
In the following cases it may be necessary to increase the dosages compared to those indicated:
• subjects being treated with anticonvulsants or barbiturates (see section 4.5);
• subjects being treated with corticosteroid therapies (see section 4.5);
• subjects being treated with lipid-lowering agents such as colestipol, cholestyramine and orlistat (see section 4.5);
• subjects being treated with aluminum-containing antacids (see section 4.5);
• obese subjects (see section 5.2);
• digestive disorders (intestinal malabsorption, mucoviscidosis or cystic fibrosis);
• liver failure.
The product should be prescribed with caution to patients suffering from sarcoidosis, due to the possible increase in the metabolism of vitamin D in its active form. In these patients, the level of calcium in serum and urine should be monitored.
Patients with renal insufficiency have an impaired metabolism of vitamin D; therefore, if they are to be treated with cholecalciferol, the effects on calcium and phosphate homeostasis should be monitored.
04.5 Interactions with other medicinal products and other forms of interaction -
The concomitant use of anticonvulsants or barbiturates may reduce the effect of vitamin D3 by metabolic inactivation.
In case of treatment with thiazide diuretics, which reduce the urinary elimination of calcium, monitoring of serum calcium concentrations is recommended.
Concomitant use of glucocorticosteroids may reduce the effect of vitamin D3.
When treated with digitalis-containing drugs, oral administration of calcium combined with vitamin D increases the risk of digitalis toxicity (arrhythmia). Close medical supervision and, if necessary, monitoring of electrocardiography and serum calcium concentrations are therefore required.
A concomitant use of aluminum-containing antacids can interfere with the efficacy of the drug by decreasing the absorption of vitamin D, while preparations containing magnesium may expose you to the risk of hypermagnesaemia.
Animal studies have suggested a possible potentiation of the action of warfarin when administered with calciferol. Although there is no similar evidence with the use of cholecalciferol, caution should be exercised when the two drugs are used concurrently.
Cholestyramine, colestipol and orlistat reduce the absorption of vitamin D, while chronic alcoholism decreases the stores of vitamin D in the liver.
04.6 Pregnancy and breastfeeding -
Pregnancy
In the first 6 months of pregnancy, vitamin D should be taken with caution due to the risk of teratogenic effects (see section 4.9).
Feeding time
When needed, vitamin D can be prescribed during breastfeeding. This supplementation does not replace the administration of vitamin D in the newborn.
04.7 Effects on ability to drive and use machines -
No data are available on the effects of the product on the ability to drive. However, an effect on this ability is unlikely.
04.8 Undesirable effects -
If the dose is in accordance with actual individual needs, XARENEL is well tolerated, thanks also to the body's ability to accumulate cholecalciferol in adipose and muscle tissues (see section 5.2).
The side effects reported with the use of vitamin D are the following:
Immune system disorders:
hypersensitivity reactions.
Metabolism and nutrition disorders:
weakness, anorexia, thirst.
Psychiatric disorders:
drowsiness, confusion.
Nervous system disorders:
headache.
Gastrointestinal disorders:
constipation, flatulence, abdominal pain, nausea, vomiting, diarrhea, metallic taste, dry mouth.
Skin and subcutaneous tissue disorders:
rash, itching.
Renal and urinary disorders:
nephrocalcinosis, polyuria, polydipsia, renal failure.
Diagnostic tests:
hypercalciuria, hypercalcemia.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
Discontinue XARENEL when calcium exceeds 10.6 mg / dl (2.65 mmol / l) or if calcium exceeds 300 mg / 24 h in adults or 4-6 mg / kg / day in children. overdose manifests itself as hypercalciuria and hypercalcemia, the symptoms of which are as follows: nausea, vomiting, thirst, polydipsia, polyuria, constipation and dehydration.
Chronic overdoses can lead to vascular and organ calcification as a result of hypercalcemia.
Overdose during the first 6 months of pregnancy can have toxic effects in the fetus: there is a correlation between excess intake or extreme maternal sensitivity to vitamin D during pregnancy and delayed physical and mental development of the child, supravalvular aortic stenosis and retinopathy.
Maternal hypercalcemia can also lead to suppression of parathyroid function in infants resulting in hypocalcemia, tetany and convulsions.
Treatment in case of overdose
Discontinue administration of XARENEL and proceed with rehydration.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: Vitamin D and analogues, cholecalciferol.
ATC code: A11CC05.
Vitamin D corrects a deficiency situation and increases the intestinal absorption of calcium.
05.2 "Pharmacokinetic properties -
As with other fat-soluble vitamins, the absorption of cholecalciferol in the intestine is favored by the concomitant intake of foods containing fat.
Cholecalciferol is present in the bloodstream in association with specific α-globulins that transport it to the liver, where it is hydroxylated to 25-hydroxy-cholecalciferol. A second hydroxylation occurs in the kidneys, where 25-hydroxy-cholecalciferol is transformed into 1,25-dihydroxy-cholecalciferol, which is the active metabolite of vitamin D responsible for the effects on phosphocalcic metabolism.
Non-metabolized cholecalciferol is accumulated in adipose and muscle tissues to be made available according to the needs of the organism: for this reason XARENEL can also be administered on a weekly, monthly or annual basis. In obese subjects the bioavailability of vitamin D is reduced. cause of excess adipose tissue.
Vitamin D is eliminated in the faeces and urine.
05.3 Preclinical safety data -
Preclinical studies conducted in various animal species show that toxic effects occur in animals at doses significantly higher than those expected for therapeutic use in humans.
In repeat dose toxicity studies, the most commonly seen effects were: increased calcium, decreased phosphaturia and proteinuria.
At high doses, hypercalcemia was observed. In a prolonged condition of hypercalcemia, the most frequent histological changes (calcification) were affecting the kidneys, heart, aorta, testes, thymus and intestinal mucosa.
Reproductive toxicity studies have shown that cholecalciferol has no harmful effects on fertility and reproduction.
At doses that are equivalent to therapeutic ones, cholecalciferol has no teratogenic activity.
Cholecalciferol has no potential for mutagenic and carcinogenic activity.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
XARENEL 10,000 I.U./ml oral drops, solution: refined olive oil.
XARENEL 25.000 I.U./2.5 ml oral solution: refined olive oil.
XARENEL 50.000 I.U./2.5 ml oral solution: refined olive oil.
XARENEL 100.000 I.U./ml solution for injection: refined olive oil for injectable use.
XARENEL 300.000 I.U./ml solution for injection: refined olive oil for injectable use.
06.2 Incompatibility "-
There are no known incompatibilities with other drugs.
06.3 Period of validity "-
XARENEL 10,000 I.U./ml oral drops, solution: 3 years in intact packaging. After first opening the bottle: 5 months.
XARENEL 25.000 I.U./2.5 ml oral solution: 3 years.
XARENEL 50.000 I.U./2.5 ml oral solution: 2 years
XARENEL 100.000 I.U./ml solution for injection: 3 years.
XARENEL 300.000 I.U./ml solution for injection: 3 years.
06.4 Special precautions for storage -
Store at a temperature not exceeding 30 ° C, in the original package to keep the medicine protected from light. Do not freeze.
06.5 Nature of the immediate packaging and contents of the package -
XARENEL 10,000 I.U./ml oral drops, solution
Amber glass bottle containing 10 ml, closed with a child resistant polypropylene cap. The pack contains 1 bottle and 1 dropper.
XARENEL 25.000 I.U./2.5 ml oral solution
Amber glass container containing 2.5 ml, closed with a polypropylene cap. Packs of 1, 2 or 4 single-dose containers.
XARENEL 50.000 I.U./2.5 ml oral solution
Amber glass container containing 2.5 ml, closed with a polypropylene cap. Packs of 1, 2 or 4 single-dose containers.
XARENEL 100.000 I.U./ml solution for injection
Amber glass vial. The pack contains 6 ampoules.
XARENEL 300.000 I.U./ml solution for injection
Amber glass vial. The pack contains 2 ampoules.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Italfarmaco S.p.A
Viale F. Testi, 330
20126 Milan - Italy
08.0 MARKETING AUTHORIZATION NUMBER -
XARENEL 10,000 I.U. / ml oral drops, solution - 10 ml bottle
037564010
XARENEL 25,000 I.U. / 2.5 ml oral solution - 1 single-dose container 2.5 ml
037564046
XARENEL 25,000 I.U. / 2.5 ml oral solution - 2 single-dose containers 2.5 ml
037564097
XARENEL 25,000 I.U. / 2.5 ml oral solution - 4 single-dose containers 2.5 ml
037564059
XARENEL 50,000 I.U. / 2.5 ml oral solution - 1 single-dose container 2.5 ml
037564061
XARENEL 50,000 I.U. / 2.5 ml oral solution - 2 single-dose containers 2.5 ml
037564085
XARENEL 50,000 I.U. / 2.5 ml oral solution - 4 single-dose containers 2.5 ml
037564073
XARENEL 100,000 I.U. / ml solution for injection - 6 ampoules 1 ml
037564022
XARENEL 300,000 I.U. / ml solution for injection - 2 ampoules 1 ml
037564034
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 23 February 2008
Date of most recent renewal: 23 February 2012
10.0 DATE OF REVISION OF THE TEXT -
27 October 2016
