Benph 5mg tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Terazosin hydrochloride
Available from:
Mylan
ATC code:
G04CA03
INN (International Name):
Terazosin hydrochloride
Dosage:
5mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 07040100
Authorization number:
; PL 04569/0531

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v2/Oct 2016

Myriad Pro

15 Sep 2017

17:42

10 pt

10 pt

170 x 480 mm

Terazosin Hydrochloride 5 mg,10 mg,2 mg,1 mg

28,30,84,50,20,7,14,98,100,10

Leaflet

1206831

618304

1206831

LT1858AB

313718

United Kingdom

Black

Package Leaflet: Information For The

Patient

Benph 1 mg, 2 mg, 5 mg

and 10 mg Tablets

terazosin

Read all of this leaflet carefully before

you start taking this medicine because it

contains important information for you.

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 signs of

illness are the same as yours.

If you get any side effects, talk to your

doctor or pharmacist. This includes any

possible side effects not listed in this

leaflet. See section 4.

What is in this leaflet:

1. What Benph is and what it is used for

2. What you need to know before you take

Benph

3. How to take Benph

4. Possible side effects

5. How to store Benph

6. Contents of the pack and other information

1.

What Benph is and what it is used

for

Your medicine contains terazosin, which

belongs to a group of medicines called

alpha-blockers. Benph is given to adult men

suffering from an enlarged prostate gland

(part of the male sexual organs found just

below the bladder, which can place pressure

on the bladder, causing problems, when

passing water (urine)), as it can relax the

muscles allowing urine to be passed more

easily.

2.

What you need to know before

you take Benph

Do not take Benph:

if you are allergic to terazosin or any of the

other ingredients of this medicine (listed in

section 6)

if you have ever taken a similar medicine

to terazosin (e.g. prazosin, alfuzosin,

indoramin, tamsulosin, doxazosin) and you

suffered an allergic reaction

if you have heart failure which may be

caused by heart valve disease, a blood clot

in the lungs or the membrane (protective

lining) around the heart being inflamed

(pericarditis).

if you have fallen over or fainted whilst

passing water.

Warnings and precautions

Talk to your doctor or pharmacist before

taking Benph:

if you have had or are suffering from other

heart conditions e.g. heart disease, heart

valve disease, angina, heart failure or stroke

if you are taking other medication for high

blood pressure. If a medicine for high blood

pressure is started while you taking this

medicine, then your doctor may need to

adjust your dose.

if you are taking medicines to treat erectile

dysfunction (impotence) (e.g. sildenafil,

tadalafil, vardenafil) (See section ‘other

medicines and Benph’).

if you are on a low salt (e.g. sodium) diet or

are very dehydrated (e.g. you may have had

severe diarrhoea or being sick)

if you have liver or kidney problems

if you have had or are currently suffering

from eye problems due to high blood

pressure

if you have diabetes that requires insulin

treatment.

Terazosin must be used only after excluding

other possible reasons in urinary track for

abnormal/interrupted urinary flow. Terazosin

should not be given to patients with bladder

overflow (you do not feel the urge to urinate),

anuria (your body is not producing any urine)

or advanced renal failure.

Tell your doctor if any of the above apply to

you.

During treatment

When taking this medicine you may

experience a sudden drop in blood pressure

when you stand up, shown by dizziness,

weakness or sweating within a few hours of

taking (this may occur especially after taking

the first dose or during the early stages of

treatment or when treatment is stopped and

then restarted). If you experience a drop in

blood pressure you should lie down with your

legs and feet up in the air until the symptoms

have disappeared. Usually, these effects last

for only a short time.

This medicine can cause painful erections,

which may last for hours and continue even

after sex or masturbation (if left untreated

this can cause problems with getting and

maintaining an erection). If you have an

erection which lasts for more than 4 hours,

you should contact a doctor immediately. (See

section 4: possible side effects).

If you are undergoing eye surgery because of

cataract (cloudiness of the lens) please inform

your eye specialist before the operation that

you are taking or have previously taken this

medicine. This is because terazosin may cause

complications during the surgery which can

be managed if your specialist is prepared in

advance.

Other medicines and Benph

Tell your doctor or pharmacist if you are

taking, have recently taken or might take

any other medicines. This includes medicines

obtained without a prescription or the

following:

medicines to lower blood pressure (e.g.

diltiazem), ACE inhibitors (e.g. ramipril)

or other alpha-blockers (e.g. doxazosin,

alfuzosin)

diuretics (water tablets used to help your

kidneys get rid of extra water and salt from

your body and lower blood pressure) e.g.

furosemide

some patients experience dizziness after

taking medicines used to lower the blood

pressure and terazosin due to the increased

drop in blood pressure.

medicine for erectile dysfunction

(impotence) (e.g. sildenafil, tadalafil,

vardenafil).

Some patients who take alpha-blocker

therapy for the treatment of prostate

enlargement may experience dizziness or

light-headedness, which may be caused by

low blood pressure upon sitting or standing

up quickly. Certain patients have experienced

these symptoms when taking medicines for

erectile dysfunction (impotence) with alpha-

blockers. In order to reduce the likelihood

that these symptoms occur, you should be

on a regular daily dose of your alpha-blocker

before you start medicines for erectile

dysfunction.

Benph with alcohol

Alcohol can increase the effects of this

medicine causing dizziness or fainting. Do not

drink alcohol while taking this medicine if you

are affected.

Pregnancy and breast-feeding

Benph is used to treat a condition found only

in men. It should not be prescribed to women.

Driving and using machines

Benph may make you feel dizzy, light headed

and drowsy. These side effects are more

likely at the start of treatment, or in the case

of missed doses and where treatment has

been stopped and then restarted again. You

may also suffer from blurred vision or other

eyesight changes. Do not drive, operate

machinery or perform any hazardous tasks

for 12 hours when you first start taking your

medicine, or when your doctor increases the

dose you are taking. After this time, make sure

you are not suffering any of these side effects

before carrying out these tasks.

Benph contains lactose

If you have been told by your doctor that you

have an intolerance to some sugars, contact

your doctor before taking this medicine.

Benph 5 mg and 10 mg tablets contain

sunset yellow (E110)

Sunset yellow (E110), may cause allergic

reactions.

3.

How to take Benph

Always take this medicine exactly as your

doctor or pharmacist has told you. Check with

your doctor or pharmacist if you are not sure:

Swallow the tablets whole with a full glass

of water

Take with or without food

Do not chew, break or crush the tablets.

Adults and the elderly (over 65 years of

age) only:

The recommended starting dose is 1 mg of

Benph. Take the very first dose at bedtime as

Benph may make you feel dizzy or faint when

taken for the first time.

Your doctor may adjust your dose depending

on how you respond to the tablets. Response

to treatment should be reviewed at four

weeks of the treatment. If your doctor

increases your dose, he or she may double

your dose at intervals of one week or every

two weeks. The usual maintenance dose is

5 to 10 mg once daily. The maximum daily

dose is 10 mg of Benph.

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v2/Oct 2016

Myriad Pro

15 Sep 2017

17:42

10 pt

10 pt

170 x 480 mm

Terazosin Hydrochloride 5 mg,10 mg,2 mg,1 mg

28,30,84,50,20,7,14,98,100,10

Leaflet

1206831

618304

1206831

LT1858AB

313718

United Kingdom

Black

Use in children and adolescents (under

18 years):

Benph tablets are not recommended for use

in children.

If you take more Benph than you should

If you take more Benph than you should

your blood pressure may suddenly drop and

you may feel dizzy or even faint. If you begin

to feel dizzy, lie down until you feel better.

If the symptoms do not disappear, contact

your doctor or nearest hospital casualty

department immediately. Take any remaining

tablets and the container with you.

If you forget to take Benph

If you forget to take Benph, do not take

a double dose to make up for a forgotten dose

as this may cause a sudden drop in blood

pressure, especially if you take blood pressure

lowering medicines, just carry on as before.

If for any reason, you have stopped taking

Benph for several days, do not continue your

treatment using the same dose. Contact your

doctor as you may need to start taking your

medicine at a lower strength than you have

been used to taking.

If you stop taking Benph

Do not suddenly stop taking your medicine as

this may cause serious changes in your blood

pressure. If you have any further questions on

the use of this medicine, ask your doctor or

pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

If you experience any of the following,

stop taking Benph and tell you doctor

immediately or go to the nearest hospital

emergency department:

Very rare (may affect up to 1 in

10,000 people):

itchy skin or a rash, difficulty breathing,

feeling wheezy, or swelling of the face,

mouth or throat,

fast and uneven heartbeat, which may

make you feel tired, dizzy and short of

breath (atrial fibrillation)

Rare (may affect up to 1 in 1,000 people):

if you suffer from a painful, prolonged

erection which continues even after sex

or masturbation which lasts for more

than 4 hours, you should contact a doctor

immediately. This can lead to permanent

impotence (failure to get and maintain an

erection) if not treated.

When taking Benph for the first time or when

starting to take higher dose tablets dizziness,

light-headedness or fainting may occur. These

effects may also occur when standing up

quickly from a lying or sitting position. If you

are affected by this, you should lie down until

you feel better then you should sit for a few

minutes before standing again to prevent

these effects returning. These side effects

usually go away and should not return once

you have become used to taking your tablets.

Other possible side effects:

Common (may affect up to 1 in 10 people):

feeling dizzy, light-headed or weak

sleepiness

feeling nervous

constipation, diarrhoea, feeling or

being sick

swelling of the ankles or hands

itchy skin or skin rash

uneven or rapid heart beat

breathlessness

headache

impotence

chest pain

tingling or numbness in the hands and feet

fainting on standing

blurred vision or decreased vision (lazy eye)

pain in the extremities (hands and feet)

back pain

feeling weak

nose bleeds, sinusitis or blocked nose

Uncommon (may affect up to 1 in 100 people):

depression

loss of sexual desire

weight gain

fainting

Rare (may affect up to 1 in 1,000 people):

bladder (urinary tract) infection or loss of

control of passing water (incontinence),

mostly in women who have been through

the menopause

Very rare (may affect up to 1 in 10,000 people):

unusual bruising or bleeding of the skin

Not known (frequency cannot be estimated

from the available data): anxiety, difficulty

sleeping, abnormal vision, infection causing

redness and swelling of the thin layer

covering the front of the eye (conjunctivitis),

ringing in the ears, spinning sensation,

irregular heart beat, bronchitis, flu symptoms,

sore throat, cold symptoms, cough, dry

mouth, indigestion, wind, swelling of the face,

sweating, stomach, neck and shoulder pain,

gout, painful joints or muscles, changes in

urinary frequency, fever, dilation of the blood

vessels which may cause redness of the skin.

If you are undergoing eye surgery because

of cataract and you are taking or have taken

this medicine in the past, there may be

complications during the surgery (please see

“Warnings and precautions”).

The use of this medicine may affect the results

of some blood tests. Always tell your doctor

that you are taking this medicine.

Reporting of side effects

If you get any side effects talk to your doctor

or pharmacist. This includes any possible side

effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at: www.mhra.gov.uk/yellowcard. By

reporting side effects you can help provide

more information on the safety of this

medicine.

5.

How to store Benph

Keep this medicine out of the sight and reach

of children.

Do not store above 30°C.

Do not use this medicine after the expiry date

which is stated on the blister and carton after

EXP. The expiry date refers to the last day of

that month.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines

you no longer use. These measures will help

protect the environment.

6.

Contents of the pack and other

information

What Benph contains:

The active substance is terazosin

hydrochloride dihydrate (equivalent to

1 mg, 2 mg, 5 mg and 10 mg of terazosin).

The other ingredients are talc, magnesium

stearate, povidone, pregelatinised starch,

lactose monohydrate (see section 2.

“Important information about some of

the ingredients of Benph”). In addition,

the 2 mg tablet contains quinoline yellow

(E104). The 5 mg and 10 mg tablets contain

sunset yellow (E110) (see section 2 “Benph

5 mg and 10 mg tablets contain sunset

yellow [E110]”).

What Benph looks like and contents of the

pack

The 1 mg tablets are white, round, flat

bevel-edged tablets imprinted ‘E’ and ‘451’ on

one side.

The 2 mg tablets are yellow, round, flat

bevel-edged tablets imprinted ‘E’ and ‘452’ on

one side.

The 5 mg tablets are light orange, round, flat

bevel-edged tablets imprinted ‘E’ and ‘453’ on

one side.

The 10 mg tablets are orange, round, flat

bevel-edged tablets imprinted ‘E’ and ‘454’ on

one side.

They are available in PVC/PVDC/ aluminium

blister packs of:

1 mg: 7, 10, 14, 20, 28, 50 and 100 tablets *

2 mg: 7, 10, 14, 20, 28, 50, 84, 98 and 100 tablets *

5 mg: 14, 20, 28, 30, 50, 84, 98 and 100 tablets *

10 mg: 28, 50, 84, 98 and 100 tablets *

* Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom.

Manufacturer

Gerard Laboratories,

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13,

Ireland.

Generics [UK] Limited,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom.

EGIS Pharmaceuticals PLC,

H-1165 Budapest Bökényföldi út. 118-120.,

Hungary.

This medicinal product is authorised in

the Member States of the EEA under the

following names:

Italy:

Terazosina Mylan Generics

2 mg, 5 mg compresse

United Kingdom:

Benph 1 mg, 2 mg, 5 mg,

10 mg Tablets

This leaflet was last revised in: September

2017

1206831

LT1858AB

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Benph 5mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

1mg:

Each tablet contains 1mg of terazosin (in the form of terazosin hydrochloride dihydrate).

Excipient with known effect:

55mg lactose monohydrate

For the full list of excipients, see section 6.1.

2mg:

Each tablet contains 2mg of terazosin (in the form of terazosin hydrochloride dihydrate).

Excipient with known effect:

110mg lactose monohydrate

For the full list of excipients, see section 6.1.

5mg:

Each tablet contains 5mg of terazosin (in the form of terazosin hydrochloride dihydrate).

Excipients with known effect:

110mg lactose monohydrate

0.01mg Sunset Yellow (E110)

For the full list of excipients, see section 6.1.

10mg:

Each tablet contains 10mg of terazosin (in the form of terazosin hydrochloride dihydrate).

Excipients with known effect:

110mg lactose monohydrate

0.1mg Sunset Yellow (E110)

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

5mg:

Tablet

Light orange, round, flat, bevel edged, tablet imprinted “E” and “453” on one side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Benph tablets are indicated in adults for:

symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH).

4.2

Posology and method of administration

Posology

Adults only:

The dose of terazosin should be managed according to each patient’s response. The following is a

guide to administration.

Initial dose

An initial dose of 1.0mg daily should be given before bedtime. Strict compliance with this

recommendation should be observed to minimise acute first-dose hypotensive episodes.

Subsequent dose

The dose may be increased by approximately doubling the dose at weekly or bi-weekly intervals to

achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily.

Improvements in symptoms have been detected as early as two weeks after starting treatment with

terazosin.

At present there are insufficient data to suggest symptomatic relief with doses above 10mg once daily

Transient side effects may occur at each titration step. If any side effects persist, consideration should

be given to reducing the dose.

Use with thiazide diuretics and other antihypertensive agents

The dose of terazosin should be re-titrated if a thiazide diuretic or antihypertensive agent is added to a

patients medication. On initiation of the new medication hypotension may be observed.

Elderly

Pharmacokinetic studies in the elderly indicate that no alteration in dosage recommendation is

required.

Postural hypotension

Postural hypotension has been reported to occur in patients receiving terazosin for the symptomatic

treatment of urinary obstruction caused by BPH. In these cases, the incidence of postural hypotensive

agents was greater in patients aged 65 years and over (5.6%) than those aged less than 65 years

(2.6%)

Renal impairment

Pharmacokinetic studies indicate that patients with impaired renal function need no alteration in the

recommended dosage. There is no evidence that terazosin aggravates renal dysfunction.

Hepatic impairment

The terazosin dose should be titrated with particular caution in patients with impaired liver function

since terazosin undergoes extensive hepatic metabolism and is mainly excreted by the biliary tract. As

no clinical experience is available in patients with severe hepatic impairment, the use of terazosin is

not recommended in these patients.

Paediatric population

Benph is not recommended for use in children. Safety and efficacy in children has not been

established.

Method of administration

For oral use. Response to treatment should be reviewed at four weeks of the treatment.

If administration is discontinued for more than several days, therapy should be re-instituted using the

initial titration regimen.

Benph tablets should be swallowed whole and not chewed and can be taken with or without food.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to

other alpha-adrenoceptor blockers.

Patients that are hypersensitive to quinazolines.

Patients with a history of micturition syncope.

Congestive heart failure due to mechanical obstruction (e.g. aortic valve or mitral valve stenosis,

pulmonary embolism, restrictive pericarditis).

4.4

Special warnings and precautions for use

In clinical trials, the incidence of postural hypotension was greater in BPH patients than those

with hypertension. In these cases, the incidence of postural hypotension events was greater in

patients aged 65 years and over (5.6%) than those aged less than 65 years (2.6%).

Terazosin hydrochloride, like other alpha-adrenoceptor blockers, can cause marked lowering

of blood pressure, especially postural hypotension and syncope in association with the first

dose or first few doses of therapy. ‘First dose’ effect might occur after the first terazosin dose

or during the initial period of treatment. This consists of: marked reduction of blood pressure

mainly as orthostatic hypotension (vertigo, unsteadiness, syncope). Volume depletion,

restricted salt-intake and advanced age (i.e. 65 years or over) increase the risk of postural

hypotension. A similar effect can be anticipated if therapy is interrupted for more than a few

doses and then re-started. If administration is discontinued for more than several days, therapy

should be re-instituted using the initial dosing regimen.

Syncope has also been reported with other alpha-adrenoceptor blockers in association with

rapid dosage increases or the introduction of another antihypertensive drug. Syncope is

believed to be due to an excessive postural hypotensive effect, although occasionally the

syncopal episode has been preceded by a bout of severe supraventricular tachycardia with

heart rates of 120 to 160 beats per minute.

Postural hypotension is most pronounced within a short time of drug intake, while the risk of

syncope is the greatest 30-90 minutes following drug administration. Dizziness, unsteadiness

and syncope are most likely to be provoked by any of the following: standing up from a

sitting or a supine position, long periods of standing, increased physical load, warm weather

and concomitant drinking of alcoholic beverages (please also see section 4.7).

Management of syncope: the patient should be kept in a supine position with elevated lower

extremities. Supportive and/or symptomatic treatment might be necessary.

Special care should be taken when giving terazosin to individuals with known susceptibility

to developing orthostatic hypotension or to those suffering from: ischaemic or any other heart

diseases, cerebrovascular disorders, III and/or IV degree hypertensive retinopathy, insulin

dependent diabetes, hepatic and/or renal failure.

Due to the vasodilatory effect of terazosin, it should be administered with caution if the

following cardiac conditions are present:

Pulmonary oedema due to aortic or mitral valve stenosis

High output cardiac insufficiency

Right-sided cardiac insufficiency due to pulmonary embolism or pericardial effusion

Left-sided cardiac insufficiency with low filling pressure

In patients with severe coronary heart disease, a very rapid or excessive decrease in blood

pressure can lead to an exacerbation of angina pectoris.

In certain patients with left ventricular failure, the decrease in left ventricular filling

consequent to vigorous therapy may result in a significant fall in cardiac output and systemic

blood pressure after administration of terazosin. These effects should be kept in mind when

introducing therapy and continuous titration of dose used.

The usual half-life of terazosin is approximately12 hours. This may be significantly

prolonged in patients with congestive cardiac failure (by up to 7-8 hours), usually with

reduction on clinical improvement.

Before treating the symptoms of benign prostatic hyperplasia (BPH) with alpha-blockers,

other causes of impaired urinary flow or urinary symptoms should be excluded. Also where

the diagnosis of BPH has been established, it should be confirmed that there is no

concomitant obstruction of the upper urinary tract or any signs of infection before treating

with terazosin. Patients with benign prostatic hyperplasia, who simultaneously suffer from

congestion of the upper urinary tract, chronic urinary tract infection or bladder stones, should

not be treated with terazosin.

Terazosin should not be given to patients with bladder overflow, anuria or advanced renal

failure.

Due to the risk of an excessive decrease in blood pressure, caution is advised for the

concomitant administration of terazosin and thiazides or other antihypertensive medications.

If a thiazide diuretic or another antihypertensive medication is added during treatment with

terazosin, the terazosin dose must be reduced or the drug discontinued. A new dose-titration is

essential. When administering terazosin in addition to other antihypertensives, the dose of the

other antihypertensives should be reduced before commencement of therapy and adjusted

after discontinuation of terazosin.

Since the drug is metabolised in the liver it should only be used with care in patients with

existing hepatic dysfunction. Caution is also recommended, when terazosin is administered

concomitantly with drugs, which may influence hepatic metabolism.

Priapism: rarely, terazosin has been associated with priapism (painful penile erection,

sustained for hours and unrelieved by sexual intercourse or masturbation). Because this

condition can lead to permanent impotence if not promptly treated, patients must be advised

about the seriousness of that condition.

Concomitant use of phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) and

terazosin, may lead to symptomatic hypotension in some patients. In order to minimise the

risk for developing postural hypotension the patient should be stable on the alpha-

adrenoreceptor blocker therapy before initiating use of phospodiesterase-5-inhibitors. In

addition, phosphodiesterase-5-inhibitors should be started on the lowest dose and with a time

interval (e.g. 6 hours) following terazosin administration.

‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been

observed during cataract surgery in some patients on or previously treated with tamsulosin.

Isolated reports have also been received with other alpha- adrenoreceptor blockers and the

possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural

complications during the cataract operation, current or past use of alpha-adrenoreceptor

should be made known to the ophthalmic surgeon and the ophthalmologist in advance of

surgery.

Laboratory tests: Laboratory findings suggestive of haemodilution (e.g. decrease in

haematocrit, haemoglobin, white blood cells, total protein and albumin) have been observed

in controlled clinical trials. No significant effect on prostate specific antigen (PSA) levels was

reported after terazosin treatment for up to 24 months.

Benph tablets contain lactose. Patients with rare hereditary problems of galactose intolerance,

the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

For 5mg & 10mg SmPCs only:

Sunset Yellow (E110) may cause allergic-type reactions including asthma. Allergy is more

common to those people who are allergic to aspirin.

4.5

Interaction with other medicinal products and other forms of interaction

Phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil, vardenafil) (see section 4.4).

In patients receiveing terazosin plus ACE inhibitors or diuretics, the proportion reporting

dizziness or related side effects wasgreater than in the total population of terazosin patients

from clinical trials.

Caution should be observed when terazosin is administered concomitantly with other

antihypertensive agents to avoid the possibility of significant hypotension. When adding

terazosin to a diuretic or other antihypertensive agent, dosing reduction and re-titration of

these agents may be necessary.

Terazosin has been given without interaction with analgesics/anti-inflammatories, cardiac

glycosides, hypoglycemics, antiarrhythmics, anxiolytics/sedatives, antibacterials,

hormones/steroids and drugs used for gout.

4.6

Fertility, pregnancy and lactation

Pregnancy

Terazosin was not teratogenic in either rats or rabbits when administered at oral doses up to

1330 and 165 times, respectively, the maximum recommended human dose. Fetal resorptions

occurred in rats dosed with 480mg/kg/day, approximately 1330 times the maximum

recommended human dose. Increased fetal resorptions, decreased fetal weight and an

increased number of supernumerary ribs were observed in offspring of rabbits dosed with 165

times the maximum recommended human dose. These findings (in both species)

were seen in animal testing, the safety of terazosin use during pregnancy or during breast-

feeding has not yet been established. .Furthermore, data from animal studies show that

terazosin may increase the duration of pregnancy or inhibit labour. Therefore, terazosin

should not be used in pregnancy unless the potential benefit is considered to outweigh the

risk.

Breast-feeding

It is not known whether terazosin hydrochloride is excreted in breast milk. Because many

drugs are excreted in breast milk, caution should be exercised when terazosin hydrochloride

is administered to a nursing woman.

4.7

Effects on ability to drive and use machines

Terazosin tablets have a major influence on the ability to drive and use machines.

Drowsiness, dizziness or light-headedness may occur with the initial dose or in association with

missed doses and subsequent re-initiation of Benph therapy. Patients should be cautioned about these

possible adverse effects and the circumstances in which they occur and advised not drive a vehicle,

operate machinery or perform activities with increased risk of accidents for 12 hours after starting

terazosin and 12 hours after any increase in dose. Thereafter, patients should not drive, operate

machinery or perform activities with increased risk of accidents unless terazosin has been shown not

to affect their physical or mental capacity.

4.8

Undesirable effects

As with other alpha-adrenoceptor blockers , terazosin may cause syncope. Syncopal episodes may

occur within 30 to90 minutes of the initial dose of the medicinal product. Syncope has occasionally

occurred in association with rapid dosage increases or the introduction of another antihypertensive

agent.

In clinical trials in hypertension, the incidence of syncopal episodes was approximately one percent.

In most cases this was believed to be due to an excessive postural hypotensive effect although

occasionally the syncopal episode may be preceded by tachycardia with heart rates of 120 to 160

beats per minute.

If syncope occurs the patient should be placed in a recumbent position and supportive treatment

applied as necessary.

Dizziness, light-headedness or fainting may occur when standing up quickly from a lying or sitting

position. Patients should be advised of this possibility and instructed to lie down if these symptoms

appear and then sit for a few minutes before standing to prevent their recurrence.

These adverse effects are self-limiting and in most cases do not recur after the initial period of therapy

or during subsequent re-titration.

Adverse drug effects reported with terazosin from multiple sources including clinical trials and

spontaneous reports:

Additional adverse reactions reported in clinical trials or reported during marketing experience but not

clearly associated with the use of terazosin have been listed under the frequency heading ‘Not

Known’.

Common

1/100 to

<

1/10)

Uncommon

1/1,000 to

1/100)

Rare

1/10,000

1/1,000)

Very Rare

(<1/10,000)

Not known

(cannot be

estimated from

available data)

Infections and

infestations

Bronchitis, flu

symptoms,

pharyngitis,

rhinitis, cold

symptoms

Blood and

lymphatic

system

disorders

Thrombocytopenia

Immune

system

disorders

Anaphylactic

reactions

Metabolism

and nutrition

disorders

gout

Psychiatric

disorders

Depression

Anxiety, insomnia

Nervous

system

disorders

Nervousness,

somnolence,

paraesthesia, dizziness,

light-headedness

headache

syncope

Eye disorders

Blurred

vision/amblyopia

Abnormal vision,

Conjunctivitis,

IFIS

(intraoperative

floppy iris

syndrome) see

section 4.4.

Ear and

labyrinth

disorders

Tinnitus vertigo

Cardiac

disorders

Palpitations,

tachycardia,

Atrial fibrillation

Arrhythmia

Vascular

disorders

Fainting

vasodilation

Respiratory,

thoracic and

mediastinal

disorders

Dyspnoea, nasal

congestion, sinusitis,

epistaxis

increased cough

Gastrointestinal

disorders

Nausea, constipation,

diarrhoea, vomiting

Dry mouth,

dyspepsia,

flatulence,

abdominal pain

Skin and subcutaneous

tissue disorders

Pruritus, rash

Facial oedema, sweating

Musculoskeletal and

connective tissue

disorders

Back pain

Neck and shoulder pain,

arthralgia, arthritis, joint

disorders, myalgia

Renal and urinary

disorders

Urinary tract

infection and

urinary

incontinence,

(primarily

reported in

post-

menopausal

women)

Urinary frequency

(Pollakiuria)

Reproductive system and

breast disorders

Impotence

Decreased

libido

Priapism

General disorders and

administration site

conditions

postural

hypotension,

asthenia,

oedema, , pain

in the

extremities

chest pain

oedema

Fever

Investigations

Weight

gain

Decreases in

haematocrit

haemoglobin, white

blood cells, total protein

and albumin (suggestive

of haemodilution)

treatment with terazosin

for up to 24 months had

no significant effect on

prostate specific antigen

(PSA) levels.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

4.9

Overdose

Symptoms

Acute hypotension

Management

Cardiovascular support should be of primary importance. The patient should be kept in a supine

position in order to restore blood pressure and heart rate to normal. If this measure is unsuccessful

then shock should be treated with volume expansion followed by administration of vasopressors.

Plasma and electrolyte balance should be restored. Renal function should be monitored and general

supportive measures applied as required. Terazosin is highly protein bound, therefore, dialysis may

not be of benefit.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: alpha-adrenoreceptor antagonists ATC code: G04CA03

Mechanism of action

Although the exact mechanism of the hypotensive action is not established, the relaxation of

peripheral blood vessels appears to be produced mainly by competitive antagonism of post-synaptic

alpha-adrenoceptors. Terazosin usually produces an initial gradual decrease in blood pressure

followed by a sustained antihypertensive action.

Pharmacodynamic effects

Clinical experience indicates that a 2-5% decrease in total cholesterol plasma concentration and a 3-

7% decrease in the combined LDLC + VLDLC fraction plasma concentration from pretreatment

values are associated with the administration of therapeutic doses of terazosin.

In clinical trials, plasma concentrates of total cholesterol and combined low density and very low

density lipoproteins were found to be slightly reduced following terazosin administration.

Additionally, the increase in total cholesterol seen with other hypertensive agents did not occur when

these were used in combination with terazosin.

Studies suggest that alpha-1-adrenoreceptor antagonism is useful in improving the urodynamics in

patients with chronic bladder obstruction such as in benign prostatic hyperplasia (BPH).

The symptoms of BPH are caused mainly by the presence of an enlarged prostate and by the increased

smooth muscle tone of the bladder outlet and prostate, which is regulated by alpha-1-adrenergic

receptors.

In in-vitro experiments, terazosin has been shown to antagonise phenylephrine-induced contractions

of human prostatic tissue. In clinical trials terazosin has been shown to improve the urodynamics and

symptomatology in patients with BPH.

A significant antihypertensive effect has been observed 3 hours following oral administration of

terazosin. The drug’s antihypertensive effect has been reported to persist for 24 hours after oral

administration.

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