ITRIN 2 mg Tabletka Powlekana
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Treść ulotki
Itrin 2 mg tablets, 5 mg tablets
terazosine
Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could 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 Itrin is and what it is used for
- 2. What you need to know before you take Itrin
- 3. How to take Itrin
- 4. Possible side effects
- 5. How to store Itrin
- 6. Contents of the pack and other information
1. What is Itrin and what is it used for?
Itrin contains the active ingredient terazosin, which belongs to a group of medicines called alpha
blockers that work by reducing blood pressure (antihypertensives).
Itrin is indicated for the treatment of mild or moderate high blood pressure (hypertension), it can be
used alone (monotherapy) or in combination with other antihypertensive medicines.
2. What you need to know before you take Itrin
Do not take Itrin
- if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to medicines similar to Itrin (quinazoline derivatives)
- if you are pregnant or breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Itrin.
After the first administrations of the medicine, you may experience dizziness, lightheadedness, weakness (asthenia). In these cases, you should lie down for a few minutes.
In some cases, the above effects have occurred in association with rapid increases in dosage
or following the association with high doses of Itrin and another medicine that lowers blood
pressure.
The doctor can minimize this risk by prescribing an initial dose of 1 mg in the evening
before bedtime, then gradually increasing the dosage and using caution if it is deemed
appropriate to combine another medicine with direct or indirect action on blood pressure.
Any association with other antihypertensive medicines may require a reduction in the
dosage of Itrin.
The 2 and 5 mg Itrin tablets are not indicated for the initial phase of therapy.
Symptoms associated with decreased blood pressure values, namely dizziness and lightheadedness, are more likely to occur.
The doctor will warn you about the possibility of
these effects and advise you on the measures to take to cope with them.
It is advisable to inform your ophthalmologist about ongoing or previous treatment with terazosin before
undergoing surgery to remove the opacity of the lens (cataract).
Terazosin may cause complications during surgery that can be treated if the specialist
has been warned in time.
Take Itrin with caution and consult your doctor if:
- you suffer from heart problems (e.g. aortic or mitral stenosis) that cause fluid buildup in the lungs (pulmonary edema);
- you suffer from severe heart problems (severe heart failure);
- you have had a heart attack (right ventricular infarction) caused by problems with the blood vessels that carry blood to the lungs (pulmonary embolism) or by fluid buildup in the membrane that surrounds the heart (pericardial effusion).
- you have had a heart attack in a part of the heart called the left ventricle with low blood pressure.
Other medicines and Itrin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No interactions between terazosin and the following medicines have been observed:
- 1) pain relievers/anti-inflammatory drugs (for example: paracetamol, aspirin, indometacin, ibuprofen, phenylbutazone, propoxyphene, tolmetin);
- 2) medicines for heart disease (cardiac glycosides for example digoxin);
- 3) medicines to reduce blood sugar (oral hypoglycemic agents);
- 4) antiarrhythmic medicines (procainamide-quinidine);
- 5) medicines to reduce anxiety (anxiolytics/sedatives such as chlordiazepoxide, diazepam, flurazepam);
- 6) medicines for gout (antiuricemics);
- 7) medicines against infections (antibiotics and chemotherapeutic agents such as penicillin, ampicillin, erythromycin, tetracycline, trimethoprim and sulfamethoxazole);
- 8) female hormones (estrogens).
Some patients taking medicines from the terazosin family (alpha-blockers) for the
treatment of high blood pressure or enlarged prostate may experience dizziness or
a feeling of “lightheadedness”, which may be caused by the lowering of blood pressure following
sitting or standing up quickly. Some patients have reported these symptoms when
taking medicines for the treatment of erectile dysfunction (impotence) together with
medicines from the terazosin family (alpha blockers).
To reduce the likelihood of these symptoms occurring, you should be on a regular dose of the alpha-blocker before starting treatment for erectile dysfunction.
Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Itrin should not be taken during pregnancy and breastfeeding.
Driving and operating machinery
Since drowsiness or dizziness have occurred in some cases, it is advisable to
be careful when driving vehicles and/or using machinery that requires particular attention
for at least 12 hours after the initial dose or on the occasion of dose increases.
Itrin contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.
Itrin contains Sunset Yellow FCF
May cause allergic reactions.
3. How to take Itrin
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose of Itrin must be adjusted according to the behaviour of blood pressure values.
The recommended initial dose is:
- 1/2 tablet of 2 mg at bedtime.
Subsequent doses:
- the single daily dosage may be increased to 2 mg after 1 or 2 weeks of treatment and may subsequently be increased to 5 or 10 mg once a day, until the desired blood pressure values are reached.
Doses higher than 20 mg per day have rarely been shown to be more effective.
If you are taking other medicines that lower blood pressure (a thiazide diuretic or a beta-
blocker) it may be necessary to reduce the dose of Itrin, at the doctor's discretion.
If you take more Itrin than you should
In case of accidental ingestion/intake of an excessive dose of Itrin, immediately inform your
doctor or go to the nearest hospital.
If you forget to take Itrin
Do not take a double dose to make up for a missed tablet.
If you stop taking Itrin
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 following side effects have been reported:
- dizziness
- headache (cephalalgia)
- fever
- abdominal, cervical and chest pain
- blocked nose (the frequency cannot be defined based on available data).
In most cases, these symptoms disappear with continued therapy without
requiring a reduction in dosage.
As with all medicines of the same type as terazosin (quinazoline derivatives), the disturbances described above may occur, especially as an effect of the first dose.
Other symptoms have been reported, but they cannot be reliably distinguished from those that might
be present in hypertensive subjects not undergoing treatment with terazosin, in particular:
- depression
- insomnia
- irritability, altered sensitivity (paresthesia).
The use of the medicine has led to reports of some cases of:
- reduced platelets in the blood (thrombocytopenia)
- irregular heartbeat (atrial fibrillation)
- some cases of loss of bladder control (urinary incontinence) in postmenopausal women.
In post-authorization clinical studies, cases of:
- persistent penile erection (priapism)
have also been reported.
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/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of
this medicine.
5. How to store Itrin
This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Expiry”.
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 Itrin contains
COMPOSITION
Itrin 2 mg tablets
- The active ingredient is terazosin hydrochloride 2.374 mg equivalent to terazosin base 2 mg
- The other ingredients are lactose, corn starch, talc, magnesium stearate, E-110
Itrin 5 mg tablets
- The active ingredient is terazosin hydrochloride 5.935 mg equivalent to terazosin base 5 mg
- The other ingredients are lactose, corn starch, talc, magnesium stearate, E-132, E-110
Description of the appearance of Itrin and contents of the pack
30 tablets of 2 mg
14 tablets of 5 mg
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Eberlife farmaceutici Spa –Via G. Porzio , SNC– 80143 Napoli
Manufacturer:
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1, 03012 Anagni (FR)
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- Kraj rejestracji
- Postać farmaceutycznaCoated tablet, 2 MG
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ITRINPostać farmaceutyczna: Coated tablet, 2 MGSubstancja czynna: doxazosinProducent: VIATRIS PHARMA S.R.L.Wymaga receptyPostać farmaceutyczna: Coated tablet, 2 MGSubstancja czynna: doxazosinProducent: DYMALIFE PHARMACEUTICAL S.R.L.Wymaga receptyPostać farmaceutyczna: Tablet, 2 MGSubstancja czynna: doxazosinProducent: ITALFARMACO S.P.A.Wymaga recepty
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ITRIN jest produkowany przez EBERLIFE FARMACEUTICI 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 ITRIN 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.
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