Hitrin

Leaflet accompanying the packaging: information for the user

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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, you should tell your doctor or pharmacist. See section 4.

Contents of the leaflet

• 1. What Hytrin is and what it is 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 packaging and other information

1. What Hytrin is and what it is 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 prostate enlargement. 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 walls of blood vessels. It acts on the nerves that affect blood vessels.
Hytrin is intended for people aged 18 to 64.

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, you should discuss it with your doctor or pharmacist.

• Fainting and "first dose" effectHytrin may cause a significant drop 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 a few initial doses. Similar effects may occur when treatment is interrupted or a few doses are missed, and then therapy is resumed.

In order to reduce the likelihood of fainting or severe hypotension, treatment should always be started 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 the patient faints, they 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, you should discuss taking 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, you should 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, you should 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 dose increase should be done under close medical supervision.
• Children and adolescentsThe safety and efficacy of Hytrin have not been studied in children. Hytrin should not be used in children.
• Hytrin and other medicinesYou should tell your doctor or pharmacist about all the medicines you are currently taking, or have recently taken, and about the 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 heart rhythm.
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 drop in blood pressure may occur. However, to reduce the likelihood of these symptoms, you should take a fixed daily dose of alpha-adrenergic blockers, and medicines used to treat erectile dysfunction should be taken 4 hours later.
In order to limit the risk of orthostatic hypotension before starting to take phosphodiesterase type 5 inhibitors, you 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, you should ask your doctor for advice before taking this medicine. The medicine can be used in pregnant and breastfeeding women only if, in the doctor's opinion, 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, you should be cautious when taking Hytrin if you are breastfeeding.

• - Driving and using machinesHytrin has a major impact on the ability to drive and use machines. Dizziness, a feeling of emptiness in the head or drowsiness may occur, especially when starting treatment, changing the dose or resuming treatment. You should be cautious when driving or operating mechanical equipment.

You should avoid driving, performing hazardous work and operating machines, unless it has been shown that the medicine does not affect your physical and mental abilities.
Hytrin contains lactose. If you are intolerant to some sugars, you should contact your doctor before taking the medicine.

3. How to take Hytrin

This medicine should always be taken according to your doctor's recommendations. If you are unsure, you should ask your doctor.
The dose is determined individually, based on the patient's response to treatment. The following information provides general recommendations for taking 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, you should strictly follow this dosing regimen 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 usually 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 lasts 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 occurred 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 usually 1 to 5 mg once a day, although some patients may require a dose of 20 mg/day. 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, you should regularly measure your blood pressure 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 reactions 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, you may consider increasing the dose of the medicine or taking it twice a day. If terazosin hydrochloride is discontinued for several days or longer, treatment should be resumed with the initial dose. In clinical trials, the medicine was given in the morning, except for the initial dose.

Use in elderly patients (over 60 years of age)

In elderly patients, lower doses should be used than in other adult patients. Elderly patients are more likely to experience side effects. Your doctor will provide detailed information on the exact dosage and close monitoring.

Use in children and adolescents (under 18 years of age)

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

Patient usually needs to take Hytrin for several weeks before they start to feel relief from symptoms. Do not stop taking the medicine without consulting your doctor. Your 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.

Taking a higher dose of Hytrin than recommended

If you have taken a higher dose of Hytrin than recommended or someone else has taken the medicine, you should lie down with your feet elevated and seek immediate medical attention at the nearest hospital emergency department. You should take the remaining tablets or the empty packaging of the medicine with you to show to the doctor.
Taking too many tablets may cause excessive blood pressure reduction, fainting, sudden loss of consciousness and rapid heart rate, as well as other severe side effects described in section 4. Possible side effects.

Missing a 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, you should 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 consult your doctor before resuming treatment, starting with the initial dose.

Stopping Hytrin treatment

You should not stop taking Hytrin without your doctor's advice.
If you have any further questions about the use of this medicine, you should 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:

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

If you experience any of these symptoms, you should immediately tell your doctor, 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, prickling
• Drowsiness
• Blurred vision
• Rapid heart rate
• Shortness of breath
• Nasal congestion
• Nausea
• Swelling of foot and ankle tissue

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 heart rate
• Rapid heart rate
• 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. You should 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, gelatinized 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 what the packaging contains

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.

Packaging available:

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: