OROTRE 500 mg /400 Iu Tabletki
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Treść ulotki
OROTRE 500 mg + 400 UI tablets
Calcium carbonate and cholecalciferol
Read this leaflet carefully before you start to take 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 their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What OROTRE is and what it is used for
- 2. What you need to know before you take OROTRE
- 3. How to take OROTRE
- 4. Possible side effects
- 5. How to store OROTRE
- 6. Contents of the pack and other information
1. What is OROTRE and what is it used for
OROTRE contains cholecalciferol, better known as vitamin D, and calcium carbonate,
substances important for bone formation.
OROTRE is indicated:
- in elderly patientsfor the treatment of calcium and vitamin D deficiency.
- in patients of all ageswho have a risk of calcium and vitamin D deficiency, as an additional treatment for bone fragility (osteoporosis).
Consult your doctor if you do not feel better or if you feel worse.
2. What you need to know before taking OROTRE
Do not take OROTRE
- If you are allergic to calcium carbonate, cholecalciferol or any of the other ingredients of this medicine (listed in section 6).
- If you suffer from increased levels of calcium in the blood or urine, especially if you are immobilised for a long period.
- If you suffer from kidney stones (nephrolithiasis).
- If you suffer from a severe kidney disease (severe renal failure).
- If you suffer from a condition in which there is an excess of vitamin D (Hypervitaminosis D) in the body.
Warnings and precautions
Talk to your doctor or pharmacist before taking OROTRE.
In particular, inform your doctor, who will subject you to blood tests and/or monitoring of
renal function, and may reduce the dose or stop treatment:
- if you are elderly and are already being treated with medicines to treat heart disease or high blood pressure (cardiac glycosides or diuretics), especially if you are prone to kidney stone formation (see section “Other medicines and OROTRE”);
- if you have high levels of calcium in the blood;
- if you suffer from a kidney disease;
- if you suffer from sarcoidosis, an inflammatory disease that can affect the whole body and increases levels of vitamin D in the body;
- if you are a patient confined to immobility and suffer from osteoporosis. Also inform your doctor:
- if you are taking medicines to treat heart disorders (digitalis and thiazide diuretics), bones (bisphosphonates), antibiotics (tetracyclines) or a medicine used to prevent tooth decay (sodium fluoride) (see section “Other medicines and OROTRE”);
- if you are taking other products that already contain vitamin D or calcium (see sections “Other medicines and OROTRE” and “OROTRE with food and drinks”).
Other medicines and OROTRE
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, inform your doctor if you are taking:
- digitalis, medicine for treating heart rhythm disorders. Your doctor will monitor you carefully and subject you to appropriate tests;
- antibiotics (tetracyclines and quinolones), medicines for treating infections. Take the antibiotic at least 2 hours before or 4-6 hours after OROTRE;
- bisphosphonates and strontium ranelate, medicines for treating bone diseases, or sodium fluoride, medicine used to prevent tooth decay. Take the medicine at least 2 hours before OROTRE;
- corticosteroids, medicines for treating inflammation, as they may reduce the effect of vitamin D;
- thiazide diuretics, medicines for treating high blood pressure;
- medicines, supplements, foods or drinks containing vitamin D (see section “OROTRE with food and drinks”);
- iron and zinc. Take the medicine at least 2 hours before or after OROTRE;
- anticonvulsants (phenytoin) or barbiturates, medicines for treating uncontrolled body movements or depression;
- levothyroxine, medicine used to treat thyroid disorders. The administration of OROTRE and levothyroxine should be spaced by at least 4 hours.
- orlistat, medicine used to reduce weight. This medicine may reduce the absorption of fat-soluble vitamins, such as vitamin D.
OROTRE with food and drinks
Consider the total dose of calcium and/or vitamin D when taking other products that contain or foods
fortified with calcium and/or vitamin D.
Take with caution foods containing oxalic acid (e.g. rhubarb, spinach, tea leaves, kiwi,
beetroot), phosphates (e.g. milk, fish, meat and eggs) or phytic acid (whole grains) due to
possible interactions with OROTRE.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Take OROTRE during pregnancy only if prescribed by your doctor.
Breastfeeding
Take OROTRE during breastfeeding only if prescribed by your doctor.
Calcium, vitamin D and its metabolites pass into breast milk.
Driving and operating machinery
OROTRE has no effects on the ability to drive and operate machinery.
OROTRE contains isomalt and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
3. How to take OROTRE
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet to be dissolved in the mouth morning and evening. The tablets can also
be dissolved in a glass of water.
If you take more OROTRE than you should
In case of accidental ingestion/intake of an excessive dose of OROTRE, immediately notify your
doctor or go to the nearest hospital.
You may experience an increase in calcium levels in the blood and urine, the symptoms of which are the
following: intense thirst, nausea, vomiting, frequent need to urinate, constipation and dehydration.
Continuous overdose of Vitamin D can cause calcium deposits in the vessels and tissues, as a
consequence of the increase in calcium concentration in the blood.
If you are also taking foods containing milk or antacid medications, you may experience frequent and
urgent need to urinate, chronic headache, chronic loss of appetite, nausea or vomiting, unusual fatigue or
weakness, high levels of calcium in the blood, low levels of acids in the blood and kidney disease.
These are the symptoms of the “milk-alkali syndrome” (see paragraph 4 “Possible side effects”):
Treatment
Stop treatment with OROTRE and drink plenty of fluids. Depending on your clinical condition and the
medications you are taking, your doctor may decide to modify or discontinue the therapies you are
following and subject you to clinical and laboratory tests.
If you forget to take OROTRE
Do not take a double dose to make up for the missed tablet.
If you stop taking OROTRE
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 everybody gets them.
The side effects reported with the use of OROTRE are listed below:
Uncommon (may affect up to 1 in 100 people):
- high levels of calcium in the blood and urine (hypercalcemia and hypercalciuria). Rare (may affect up to 1 in 1,000 people):
- constipation, difficulty digesting (dyspepsia), passing gas from the intestines (flatulence), nausea, abdominal pain and diarrhoea. Very rare (may affect up to 1 in 10,000 people):
- milk-alkali syndrome (urgent and frequent need to urinate, chronic headache, chronic loss of appetite, nausea or vomiting, unusual tiredness or weakness, high levels of calcium in the blood, low levels of acids in the blood and kidney problems) generally observed only in case of overdose (see section “If you take more OROTRE than you should”);
- itching, skin rash and hives. Not known (frequency cannot be estimated from available data):
- allergic reactions such as swelling of the face, lips and hands (angioedema) or swelling of the larynx (laryngeal edema). Special populationsIn patients with kidney problems, there may also be a potential risk of increased phosphate concentration in the blood, kidney stones and calcifications of the kidneys. See section “Warnings and Precautions”.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help to provide more information on the safety of this medicine.
5. How to store OROTRE
Store at a temperature not exceeding 30°C.
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.
6. Contents of the pack and other information
What OROTRE contains
- The active ingredients are calcium carbonate 1250 mg (equivalent to 500 mg of calcium) and cholecalciferol (vitamin D) 4 mg (equivalent to Vitamin D 400 IU).
- The other ingredients are xylitol povidone, isomaltol(see paragraph “OROTRE contains isomaltol and sucrose”), lemon flavour, mono and diglycerides of fatty acids, sucralose, magnesium stearate.
- The components of the concentrated cholecalciferol are: all-rac-alpha-tocopherol, sucrose (see paragraph “OROTRE contains isomaltol and sucrose”), modified corn starch, sodium ascorbate, medium chain triglycerides, anhydrous colloidal silica.
Description of the appearance of OROTRE and contents of the pack
OROTRE is presented as tablets contained in a bottle.
It is available in packs with 1 bottle of 20 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH - Ziegelhof 24 - 17489 Greifswald, Germany
Manufacturer
Takeda AS, Drammensveien 852, NO-1383 Asker, Norway
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- Postać farmaceutycznaTablet, 500 MG + 400 IU
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki OROTREPostać farmaceutyczna: Coated tablet, 1000 MGSubstancja czynna: calcium carbonateProducent: THERAMEX IRELAND LIMITEDWymaga receptyPostać farmaceutyczna: Injectable solution, 10 %Substancja czynna: calcium gluconateProducent: B. BRAUN MELSUNGEN AGWymaga receptyPostać farmaceutyczna: Injectable solution, 500 MG/5 MLSubstancja czynna: calcium gluconateWymaga recepty
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OROTRE jest produkowany przez CHEPLAPHARM ARZNEIMITTEL GMBH. 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 OROTRE jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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