XAREXEN 1000 IU Kapsułka twarda
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Treść ulotki
XAREXEN hard capsules
cholecalciferol (vitamin D)
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 pass it on to others, even if they have the same symptoms as you, as it may 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 XAREXEN is and what it is used for
- 2. What you need to know before you take XAREXEN
- 3. How to take XAREXEN
- 4. Possible side effects
- 5. How to store XAREXEN
- 6. Contents of the pack and other information
1. What is XAREXEN and what is it used for
XAREXEN contains cholecalciferol, better known as vitamin D.
XAREXEN is indicated in adolescents over 12 years of age and in adults to prevent
low levels of vitamin D due to conditions involving insufficient production at the skin level and/or increased vitamin D requirement.
2. What you need to know before you take XAREXEN
Do not takeXAREXEN
- If you are allergic to cholecalciferol (vitamin D) or to any of the other ingredients of this medicine (listed in section 6).
- If you have high levels of calcium in the blood (hypercalcemia) and/or in the urine (hypercalcinuria).
- If you have kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis).
- If you have a severe kidney disease (severe renal insufficiency). See section “ Warnings and precautions”.
- If you have high levels of vitamin D
Warnings and precautions
Talk to your doctor or pharmacist before taking XAREXEN.
In the following cases, inform your doctor:
- if you need to follow treatment with XAREXEN for a long period;
- if you are elderly and are already being treated with medicines to treat certain heart diseases (cardiac glycosides) or with medicines that lower blood pressure by increasing urine production (diuretics);
- if you have mild to moderate kidney disease (mild to moderate renal insufficiency);
- if you suffer from a severe kidney disease (severe renal insufficiency), medical monitoring is necessary. See section “ Do not take XAREXEN”; If you have or have had kidney stones (nephrolithiasis) or calcium deposits in the kidneys (nephrocalcinosis), medical monitoring is necessary. See section “ Do not takeXAREXEN”.
Inform your doctor in the following cases, as dosage adjustments may be necessary compared to those indicated in section 3. “How to take XAREXEN”:
- if you are taking medicines to treat infections, such as rifampicin, isoniazid (see section “Other medicines and XAREXEN”);
- if you are taking medicines used for the treatment of epilepsy (antiepileptics) or barbiturates (see section “Other medicines and XAREXEN”);
- if you are taking corticosteroids, medicines to treat inflammation (see section “Other medicines and XAREXEN”);
- if you are taking medicines to reduce blood fats such as colestipol, colestyramine (see section “Other medicines and XAREXEN”);
- if you are taking a medicine to treat obesity called orlistat (see section “Other medicines and XAREXEN”);
- if you are taking antacids containing aluminum, medicines to treat excessive stomach acid that can also reflux into the esophagus (see section “Other medicines and XAREXEN”);
- if you are obese;
- if you suffer from digestive diseases (intestinal malabsorption, cystic fibrosis);
- if you suffer from a liver disease (hepatic insufficiency); if you suffer from sarcoidosis (an inflammatory disease that can affect the whole body and leads to the formation of nodules) and primary hyperparathyroidism (a disease that leads to an increase in calcium levels in the blood and urine).
Children
XAREXEN is not suitable for children between 0 and 12 years of age.
Other medicines andXAREXEN
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 drugs:
* digitoxin, medicine for treating some heart disorders; your doctor will keep you under
close control and will carefully assess whether or not to perform tests;
* warfarin, medicine to make the blood more fluid;
* thiazide diuretics, medicines to treat high blood pressure, increasing the
production of urine;
* rifampicin, isoniazid, medicines to treat infections
* carbamazepine, phenobarbital, phenytoin, primidone, medicines used for the
treatment of epilepsy ( antiepileptics);
* barbiturates,medicines used for the treatment of epilepsy
* corticosteroids, medicines to treat inflammation;
* aluminum-containing antacids, medicines to treat excessive acid in the
stomach that can also reflux into the esophagus;
* colestipol, colestyramine, medicines to reduce blood fats as
* orlistat, a medicine to treat obesity;
* preparations containing magnesium.
* actinomycinis an agent that belongs to the group of actinomycins, antibiotics
produced by various types of bacteria of the Streptomyces species. Actinomycins, exert
a harmful action on living cells.
*imidazole antifungals (e.g., ketoconazole),agents capable of preventing the
growth of fungal organisms ;
*preparations containing magnesium;
XAREXEN with food, beverages and alcohol
To avoid taking an excessive dose of vitamin D, you must consider if you are taking other
products that already contain vitamin D such as fortified foods, vitamin D-enriched milk
(see section “ Warnings and precautions”).
Consumption of large amounts of alcohol for a long time (chronic alcoholism) decreases
vitamin D stores in the liver.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Pregnancy
When necessary, you can take vitamin D during pregnancy,
During the first 6 months of pregnancy, you can take this medicine only if strictly
necessary, due to the risk of harmful effects to the fetus (see section 3. “If you take more
XAREXEN than you should”).
Breastfeeding
When necessary, you can take vitamin D during breastfeeding. This does not
replace the administration of vitamin D in the newborn. Vitamin D and its metabolites
are excreted in breast milk. This aspect must be taken into consideration when
administering further vitamin D to the child.
Fertility
No effects of vitamin D on fertility are known.
Driving and operating machinery
It is unlikely that XAREXEN will affect your ability to drive, but you should be aware
that drowsiness may occur as an undesirable effect of treatment with XAREXEN,
although rarely.
3. How to take XAREXEN
Take this medicine following exactly what is reported in this leaflet or
the instructions of your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Taking XAREXEN is recommended in cases such as:
- during the last trimester of pregnancy,
- in breastfeeding women,
- in case of insufficient (e.g. conditions that require staying in closed environments) or ineffective sun exposure (e.g. use of sun filters and screens, winter period),
- in case of a particular diet (for example, low in calcium, vegetarian diet, lactose-free diet, etc.),
- in case of intense skin pigmentation,
To avoid taking an excessive dose of vitamin D, you must consider if you are taking other
products that already contain vitamin D, foods supplemented with vitamin D, milk enriched with
vitamin D (see paragraph 2 “ XAREXEN with food, drinks and alcohol”).
It is recommended to take XAREXEN during meals. The capsule must be swallowed whole.
Cycles of intake of 3 months are recommended.
The recommended dose is:
Adults
1 capsule per day.
Pregnancy (last trimester) and breastfeeding
1 capsule every 2 days.
Use in children
XAREXEN is not suitable for children between 0 and 12 years of age.
Adolescents (> 12 years)
1 capsule every 2 days.
If you take more XAREXEN than you should
In case of accidental ingestion/intake of an excessive dose of XAREXEN, immediately inform
your doctor or go to the nearest hospital.
In case of overdose, increased levels of calcium in the blood
(hypercalcemia) and in the urine (hypercalciuria) may occur, whose symptoms are as follows: nausea, vomiting, thirst,
intense thirst (polydipsia), increased amount of urine excreted (polyuria), constipation and
dehydration.
Chronic excessive dosages can lead to deposits of calcium salts in blood vessels and
organs (consequence of hypercalcemia).
The use of an excessive dose of vitamin D during the first 6 months of pregnancy can cause
serious damage to the fetus and newborn (see paragraph 2 “Pregnancy, breastfeeding and fertility”).
If you forget to take XAREXEN
Do not take a double dose to make up for a missed dose.
If you stop taking XAREXEN
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.
The possible side effects are listed below according to frequency:
uncommon (may affect up to 1 in 100 people)
- increased levels of calcium in the blood (hypercalcemia) and in the urine (hypercalciuria). rare (may affect up to 1 in 1,000 people)
- allergic reactions
- weakness, loss of appetite (anorexia), thirst
- drowsiness, confused state
- constipation, emission of gas (flatulence), abdominal pain, nausea, diarrhea,
- skin rash, itching, urticaria not known (frequency cannot be estimated from available data)
- headache
- vomiting, metallic taste, dry mouth
- excessive calcium deposition in the kidneys (nephrocalcinosis), increased amount of urine excreted (polyuria), intense thirst (polydipsia), kidney disease (renal failure).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at
https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store XAREXEN
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 pack after SCAD.
The expiry date refers to the last day of that month.
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.
Do not freeze.
Store in the original package to protect the medicine from light.
6. Contents of the pack and other information
What XAREXEN contains
* The active ingredient is colecalciferol (vitamin D) 0.025 mg equivalent to 1,000 I.U.
* The other ingredients are: gelatin, titanium dioxide (E171), iron oxide (E 172),
refined olive oil.
Description of the appearance of XAREXEN and contents of the pack
XAREXEN presents as hard capsules with a transparent body and white cap, with a
pink sealing band.
It is available in a pack containing 3 blisters of 10 capsules each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Italfarmaco S.p.A. - Viale F. Testi, 330 - 20126 Milan – Italy
Manufacturer:
Abiogen Pharma S.p.A. - Via Meucci, 36 – Ospedaletto – Pisa, Italy
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- Kraj rejestracji
- Postać farmaceutycznaHard capsule, 1000 IU
- Kod ATCA11CC05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki XAREXENPostać farmaceutyczna: Film-coated tablet, 1000 IUSubstancja czynna: colecalciferolProducent: I.B.N. SAVIO S.R.LWymaga receptyPostać farmaceutyczna: Film-coated tablet, 800 IUSubstancja czynna: colecalciferolProducent: I.B.N. SAVIO S.R.LWymaga receptyPostać farmaceutyczna: Soft capsule, 10,000 IUSubstancja czynna: colecalciferolProducent: PHARMACARE S.R.L.Wymaga recepty
Odpowiedniki XAREXEN w innych krajach
Leki z tą samą substancją czynną dostępne w innych krajach.
Odpowiednik XAREXEN w Hiszpania
Odpowiednik XAREXEN w Polska
Odpowiednik XAREXEN w Ukraina
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Często zadawane pytania
XAREXEN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w XAREXEN jest colecalciferol. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
XAREXEN jest produkowany przez ITALFARMACO S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie XAREXEN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić XAREXEN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (colecalciferol) to m.in. ANNEXXO, ANNOVA, ANORSIA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
