Hitrin

Package Leaflet: Information for the User

Hytrin, 2 mg, 5 mg, 10 mg, tablets
Terazosin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Hytrin and what is it used for
• 2. Important information before taking Hytrin
• 3. How to take Hytrin
• 4. Possible side effects
• 5. How to store Hytrin
• 6. Contents of the pack and other information

1. What is Hytrin and what is it used for

One tablet of 2 mg, 5 mg or 10 mg of Hytrin contains 2 mg, 5 mg or 10 mg of the active substance - terazosin, in the form of terazosin hydrochloride dihydrate.
Hytrin belongs to a group of medicines called alpha-adrenergic blockers (medicines used to treat conditions such as high blood pressure and certain prostate diseases).
Hytrin relieves the symptoms of benign prostatic hyperplasia. In combination with other blood pressure lowering medicines, it can also be used to treat high blood pressure.
Benign prostatic hyperplasia: Hytrin relaxes the muscles of the prostate gland, which surrounds the inner part of the urethra in men. This makes it easier to urinate, and the symptoms are relieved.
High blood pressure: Hytrin lowers blood pressure by widening small blood vessels (located away from the heart). This reduces the resistance to blood pumping by the heart. Hytrin does not act directly on the blood vessel walls. It acts on the nerves that affect the blood vessels.
Hytrin is intended for adults from 18 to 64 years old.

2. Important information before taking Hytrin

When not to take Hytrin

• if you are allergic (hypersensitive) to terazosin hydrochloride, its analogs or any of the other ingredients of Hytrin (listed in section 6);
• if you are allergic to any other alpha-adrenergic receptor antagonist, such as alfuzosin, doxazosin;
• if you have experienced fainting during or immediately after urination.

Warnings and precautions

Before starting to take Hytrin, discuss it with your doctor or pharmacist.

• Fainting and "first dose effect"Hytrin may cause a significant decrease in blood pressure, especially orthostatic hypotension (a sudden drop in blood pressure when changing position from lying to standing) and fainting associated with the first dose or the first few doses. Similar effects may occur when treatment is interrupted or several doses are missed, and then therapy is resumed.

In order to minimize the risk of fainting or severe hypotension, treatment should always start with a dose of 1 mg of terazosin from other companies, given in the evening, after going to bed. Tablets containing 2 mg, 5 mg or 10 mg of terazosin are not recommended during the initial treatment period. The dose should be gradually increased, according to the recommendations given in section 3.
The patient should be warned to avoid situations that may lead to injury in case of fainting during the initial treatment period. If fainting occurs, the patient should be laid down, and if necessary, the doctor will provide supportive treatment.
Hytrin should not be used in patients who have experienced fainting during urination.

• -Cataract surgeryBefore cataract surgery, discuss the use of Hytrin with your doctor, so that the ophthalmologist can prepare for a modification of the surgical technique.
• -Liver function disordersHytrin should be used with caution in patients with liver function disorders.

If laboratory tests are to be performed, inform your doctor that you are taking Hytrin, as the medicine may interfere with the results of some tests.
If you are taking other medicines, also read the section "Hytrin and other medicines".

• Elderly patientsThe dose of Hytrin used in elderly patients should be as low as possible, and the increase in dose should be done under close medical supervision.
• Children and adolescentsThe safety and efficacy of Hytrin in children have not been established. Hytrin should not be used in children.
• Hytrin and other medicinesTell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. It may be necessary to reduce and re-adjust the dose of terazosin.

If you are taking other blood pressure lowering medicines, such as captopril, lisinopril, thiazide diuretics and calcium antagonists (amlodipine, diltiazem).
If you are taking such medicines as labetalol and carvedilol for the treatment of angina pectoris or irregular heartbeat.
If Hytrin is used with phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil and vardenafil [these medicines are used to treat erectile dysfunction (impotence) and chronic heart failure], a significant decrease in blood pressure may occur. However, to minimize the risk of these symptoms, a fixed daily dose of alpha-adrenergic blockers should be taken, and medicines used to treat erectile dysfunction should be taken 4 hours later.
In order to limit the risk of orthostatic hypotension before starting the use of phosphodiesterase type 5 inhibitors, the patient should first have a regular dose of Hytrin established.

• - Pregnancy and breastfeedingIf you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The medicine can be used in pregnant and breastfeeding women only if the expected benefits to the mother outweigh the possible risk to the fetus.

Breastfeeding
It is not known whether terazosin hydrochloride passes into breast milk. Since many medicines pass into breast milk, caution should be exercised when using Hytrin in breastfeeding women.

• - Driving and using machinesHytrin has a major influence on the ability to drive and use machines. Dizziness, feeling of emptiness in the head or drowsiness may occur, especially when starting treatment, changing the dose or resuming treatment. Caution should be exercised when driving vehicles or operating machinery.

Avoid driving vehicles, performing hazardous work and operating machinery, unless it has been shown that the medicine does not affect the patient's physical and mental abilities.
Hytrin contains lactose. If you have an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Hytrin

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor.
The following information provides general recommendations for the use of Hytrin.

Recommended dose

Initial dose

The initial dose is 1 mg of terazosin from other companies, once a day, in the evening, after going to bed. Do not take a higher dose. During the initial treatment period, this dosing regimen should be strictly followed to minimize the risk of severe hypotension.

Subsequent doses

Benign prostatic hyperplasia

The dose should be gradually increased until the desired clinical response is achieved. The recommended dose range is 5 to 10 mg once a day. The flow rate of urine measured about 24 hours after the last dose showed that in benign prostatic hyperplasia, the beneficial effect is maintained throughout the dosing interval. A reduction in the severity of symptoms was observed after 2 weeks of treatment with terazosin hydrochloride. The improvement in urine flow rate occurs slightly later. If terazosin hydrochloride is discontinued for several days or longer, treatment should be resumed with the initial dose.

Hypertension

The dose should be gradually increased until the desired blood pressure reduction is achieved. The recommended dose range is 1 to 5 mg once a day, although in some patients a dose of 20 mg/day may be required. It does not appear that doses higher than 20 mg produce further blood pressure reduction. Doses higher than 40 mg have not been studied. Before taking the next dose of the medicine, blood pressure should be regularly measured to check if blood pressure control is maintained throughout the day. It may also be helpful to measure blood pressure 2 to 3 hours after taking the dose to check if the maximum and minimum responses to the medicine are similar, as well as to record symptoms such as dizziness or palpitations, which may be caused by excessive blood pressure reduction. If after 24 hours there is a significant decrease in the therapeutic effect, it may be necessary to increase the dose of the medicine or take it twice a day. If terazosin hydrochloride is discontinued for several days or longer, treatment should be resumed with the initial dose. In clinical studies, the medicine was given in the morning, except for the initial dose.

Use in elderly patients (over 60 years old)

In elderly patients, lower doses should be used than in other adult patients. In elderly patients, there is a higher risk of side effects. The doctor will provide detailed information on the exact dosing and close monitoring.

Use in children and adolescents (under 18 years old)

Due to the lack of data on the efficacy and safety of Hytrin, it is not recommended to use the medicine in children and adolescents.

Dosage and administration

Oral administration: Hytrin tablets should be swallowed whole, with a sufficient amount of liquid. The tablets should not be chewed. They can be taken with food.

Duration of treatment

Patients usually need to take Hytrin for several weeks before they start to feel relief from symptoms. Do not stop taking the medicine without consulting your doctor. The doctor will probably recommend gradually reducing the dose before completely stopping the medicine. This will prevent the patient's condition from worsening and reduce the risk of withdrawal symptoms, such as headache, nausea, vomiting, diarrhea, insomnia, nervousness and anxiety.

Overdose of Hytrin

If you have taken more than the recommended dose of Hytrin or someone else has taken the medicine, the patient should be laid down with their feet elevated relative to the body. Immediately seek help from the nearest hospital emergency department. Take any remaining tablets or the empty package of the medicine with you to show the doctor.
Taking too many tablets may cause excessive blood pressure reduction, with fainting, sudden loss of consciousness and rapid heartbeat, as well as other severe side effects described in section 4. Possible side effects.

Missed dose of Hytrin

If you miss a dose of Hytrin, you can take it as soon as possible, unless it is time for the next dose. In this case, take the medicine as recommended. Do not take a double dose to make up for the missed dose. Do not take more than one tablet per day.
If you stop treatment for several days or longer, you should start again after consulting your doctor, starting with the initial dose.

Stopping Hytrin treatment

Do not stop taking Hytrin without your doctor's advice.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hytrin can cause side effects, although not everybody gets them.
Some side effects can be serious:

• difficulty breathing;
• severe allergic reaction (itching or skin rash);
• excessive blood pressure reduction;
• swelling of the face, lips.

If you experience any of these symptoms, tell your doctor immediately, as it may be necessary to adjust the dose of the medicine.
The following side effects may occur as a result of taking terazosin hydrochloride. When evaluating side effects, the following frequencies were taken into account:
Common side effects(may occur in less than 10 patients in 100):

• Headache
• Dizziness
• Palpitations (heart pounding)
• Muscle weakness or lack of strength
• Weakness
• Painful erection

Uncommon(may occur in 1 patient in 100):

• Feeling of low blood pressure when standing up from a sitting or lying position
• Fainting
• Feeling of tingling, numbness, or prickling
• Drowsiness
• Blurred vision
• Rapid heartbeat
• Shortness of breath
• Nasal congestion
• Nausea
• Swelling of the feet and ankles

Rare(may occur in less than 10 patients in 10,000):

• Weight gain

Unknown(frequency cannot be estimated from the available data):

• Respiratory tract infection, pneumonia
• Sore throat
• Nasal inflammation
• Urinary tract infection
• Decreased platelet count
• Hypersensitivity
• Gout (a form of arthritis)
• Anxiety (unpleasant state of mind)
• Insomnia
• Feeling of spinning
• Blurred vision
• Eye redness and inflammation
• Ringing in the ears
• Irregular heartbeat
• Rapid heartbeat
• Low blood pressure
• Nosebleeds
• Cough
• Pain when eating and speaking
• Abdominal pain
• Constipation
• Diarrhea
• Dry mouth
• Vomiting
• Abdominal discomfort
• Excessive gas
• Fever
• Rash
• Increased sweating
• Facial swelling
• Allergic reaction
• Joint pain
• Arthritis
• Muscle pain
• Neck pain
• Involuntary urination
• Frequent urination
• Prolonged, painful erection
• Chest pain
• Flu
• Intraoperative floppy iris syndrome (a complication that may occur during cataract surgery)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49-21-301,
fax: +48 22 49-21-309,
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hytrin

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use Hytrin after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Other information

What Hytrin contains

• The active substance of the medicine is terazosin. One tablet contains 2 mg, 5 mg or 10 mg of terazosin (Terazosinum) in the form of terazosin hydrochloride dihydrate.
• The other ingredients are: lactose, corn starch, pregelatinized starch, talc, magnesium stearate, quinoline yellow, lake (E 104) - Hytrin 2 mg tablets, iron oxide red, iron oxide yellow, iron oxide black (E 172) - Hytrin 5 mg tablets, indigo carmine, lake (E 132) - Hytrin 10 mg tablets.

What Hytrin looks like and contents of the pack

The 2 mg tablet of Hytrin is yellow.
The 5 mg tablet of Hytrin is light brown.
The 10 mg tablet of Hytrin is blue.

Pack sizes:

Hytrin 2 mg tablets
(Continuation of treatment)
28 tablets - 2 blisters of 14 tablets each.
Hytrin 5 mg tablets
(Continuation of treatment)
28 tablets - 2 blisters of 14 tablets each.
Hytrin 10 mg tablets
(Continuation of treatment)
28 tablets - 2 blisters of 14 tablets each.
Blisters made of PVC/PVDC/Aluminum in a cardboard box.

Marketing authorization holder and manufacturer Marketing authorization holder:

Amdipharm Limited
Temple Chambers
3 Burlington Road
Dublin 4
Ireland
Manufacturer:
AESICA QUEENBOROUGH LIMITED
Queenborough, Kent
ME11 5EL
United Kingdom
Or
Famar Italia S.p.A.
Via Zambeletti, 25
20021 Baranzate (Milano)
Italy
Or
Aesica Pharmaceuticals S.r.L.
Via Praglia, 15
10044 Pianezza
Italy

Date of last revision of the leaflet: