TERAZOSIN TEVA 1MG TABLETS

Active substance: TERAZOSIN HYDROCHLORIDE DIHYDRATE

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Patient Information Leaflet
Terazosin Teva 1, 2, 5 and 10 mg Tablets

Please read this leaflet carefully before you receive this medicine. It briefly outlines the most
important things you need to know. If you want to know more about this medicine, or you are not
sure about anything, ask your doctor or pharmacist.
The name of your medicine is Terazosin Teva 1, 2, 5 and 10 mg Tablets.
WHAT IS TERAZOSIN TEVA?
Each tablet contains either 1 mg (white), 2 mg (yellow), 5 mg (tan) or 10 mg (blue) of terazosin as
terazosin hydrochloride dihydrate. The other ingredients are lactose monohydrate, maize starch,
crospovidone, povidone, talc, magnesium stearate, and either no colour (1 mg tablets), quinoline
yellow E104 (2 mg tablets), iron oxide red and yellow E172 (5 mg tablets) or indigo carmine E132
(10 mg tablets)
The 1 mg strength are available in pack sizes1 of 7, 10, 14, 15, 50 and 100 tablets.
The 2 mg strength are available in pack sizes1 of 14, 15, 20, 28, 30, 50, 84, 98 and 100 tablets.
The 5 mg strength are available in pack sizes1 of 7, 14, 20, 28, 30, 50, 84, 98 and 100 tablets.
The 10 mg strength are available in pack sizes1 of 20, 28, 50, 84, 98 and 100 tablets.
The 1 mg, 2 mg and 5 mg tablets are also available in starter packs1.
See outer packaging or the pharmacy label for contents i.e. the number of tablets.
Terazosin Teva is one of a group of medicines called alpha blockers.
The Marketing Authorisation Holder is Teva Pharma B.V., The Netherlands and the company
responsible for manufacture is Teva UK Limited, Eastbourne BN22 9AG England.
Or
The Marketing Authorisation holder is Teva Pharma B.V., The Netherlands. The company responsible for
batch release is Teva Pharmaceutical Works Company Ltd, Debrecen, Hungary*

WHAT IS TERAZOSIN TEVA USED FOR?
Terazosin Teva is used to treat patients suffering from high blood pressure. They help reduce blood
pressure.
They may also be used for the treatment of a condition called benign prostatic hyperplasia which is
common in older men. This condition is caused by the prostate gland growing too big and obstructing
the flow of urine from the bladder. This leads to some unpleasant symptoms such as weak or
interrupted urine flow, a need to pass water more frequently and/or a sudden need to pass water.
Terazosin can relax the muscle of the prostate gland and bladder exit to help relieve these symptoms.
Ask your doctor or pharmacist if you need additional information.

BEFORE YOU TAKE TERAZOSIN TEVA
Are you pregnant or breast-feeding ?
Are you sensitive to any of the ingredients in the medicine, listed above ?
Are you allergic to terazosin or any of the following drugs: alfuzosin, indoramin, prazosin, tamsulosin
or doxazosin (these are all alpha-blockers, used to treat high blood pressure) ?
1

Only marketed pack sizes will be included in the printed version of the PIL
* Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL

Are you being treated for high blood pressure or are you taking other drugs to lower your blood
pressure such as ACE inhibitors, “water tablets”, alpha blockers, beta-blockers or calcium channel
blockers?
Are you taking any phosphodiesterase inhibitors (e.g. Sildenafil)?
Are you taking any other medicines ?
Do you have any heart problems ?
Do you have any liver problems ?
Do you have any of the following rare hereditary problems: galactose intolerance,
Lapp lactase deficiency or glucose-galactose malabsorption ?
Have you ever fallen over or fainted while passing water ?
If the answer to any of these questions is YES, you should not take Terazosin Teva before
talking to your doctor or pharmacist.

If you are undergoing eye surgery because of cataract (cloudiness of the lens)
please inform your eye specialist before the operation that you are using or have
previously used terazosin. This is because terazosin may cause complications
during the surgery which can be managed if your specialist is prepared in
advance.
TAKING TERAZOSIN TEVA
1. READ THIS SECTION IF YOU ARE TAKING TERAZOSIN FOR THE FIRST TIME OR
IF YOU HAVE NOT TAKEN TERAZOSIN IN THE LAST WEEK. IF YOU ARE
CONTINUING TREATMENT WITHOUT A BREAK, PLEASE READ SECTION 2 BELOW:
It is important that you take the correct tablet at the correct time. The tablets should be swallowed
with a drink of water. The first tablet of a new dose should be taken in the evening at bedtime. The
following tablets of the same strength may be taken in the morning.
Treatment of hypertension
Start taking one 1 mg tablet per day (white tablets) from Day 1.
From Day 8 onwards, start taking one 2 mg tablet per day (yellow tablets).
Continue to take one tablet each day until you reach Day 14.
Now read section 2.
Treatment of benign prostatic hyperplasia
Start taking one 1 mg tablet per day (white tablets) from Day 1.
From Day 8 onwards, start taking one 2 mg tablet per day (yellow tablets) for 14 days.
From Day 22 onwards, start taking one 5 mg tablet per day (tan tablets) for 7 days.
When you have finished this 4 week treatment, your doctor will give you a prescription for more
tablets. Depending on your response to terazosin, your doctor will decide which strength of tablets is
best for you.
After starting taking the tablets or changing the tablet strength, it is important that you DO NOT drive
or undertake any hazardous tasks for 12 hours. This is because dizziness, light-headedness or
drowsiness can occur with the first dose, a change in dose or after missing doses and restarting
treatment.
If you are unsure about when to take your tablets, you should consult your doctor for advice.
2. READ THIS SECTION IF YOU HAVE TAKEN TERAZOSIN BEFORE AND ARE
CONTINUING WITH YOUR NEXT PACK.

When you have finished your last pack, your doctor may give you a prescription for more tablets.
Depending on your response to terazosin, your doctor will decide which strength of tablet you need.
You may be given a new pack of tablets containing either 2 mg (yellow tablets), 5 mg (tan tablets) or
10 mg (blue tablets).
The maintenance dose (usually 2 – 10 mg daily) will be adjusted according to your body’s response to
the medicine.
Take one tablet each day as stated in section1.
If you are unsure about when to take your tablets, you should consult your doctor for advice.
You should continue to take your tablets unless your doctor tells you not to. Do not stop just because
you feel better.
Your doctor will monitor you regularly during your treatment.
If you take more tablets than have been prescribed
If you accidentally take an overdose (more than one tablet a day) call your doctor immediately.
If you should miss a dose
If you have not taken a tablet for several days you should NOT continue using the same tablets.
Return to your doctor for advice.
Terazosin may cause dizziness, light-headedness or drowsiness. Caution must be taken when driving
or operating machinery throughout your treatment. If you feel dizzy, light-headed or faint, you should
sit or lie down until the feeling passes.
TAKING OTHER MEDICINES:
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or 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 drugs 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 drugs for erectile dysfunction.
AFTER TAKING TERAZOSIN TEVA
Terazosin Teva is taken by many patients without any problems.
medicines, it may occasionally cause side effects in some people.

However, like many other

A few people may develop a severe allergic reaction. This is a very rare but very serious side effect. If
you experience any of the following symptoms tell your doctor immediately or go to the casualty
department at your nearest hospital:
Swelling of the face, hands, lips, tongue or throat
Difficulty swallowing or breathing.
When taking Terazosin Teva Tablets for the first time or when starting to take higher dose tablets,
some people may experience dizziness, light-headedness or fainting. These effects may also occur
when standing up quickly from a lying or sitting position. If this occurs 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.

The following side effects have been reported at the approximate frequencies shown:
Common (affecting fewer than one person in ten but more than one person in 100):
Nervousness, sleepiness, pins-and-needles
Blurred vision, problems with colour vision
Uneven or fast heart rate, chest pain
Difficulty breathing, blocked nose, sinusitis, nose bleeds
Feeling sick or being sick, constipation, diarrhoea
Itching, rash
Back pain
Impotence
Dizziness, light-headedness, fainting, feeling of weakness, headache
Swelling, pain in the extremities.
Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):
Depression
Hives (nettle rash)
Decreased sex-drive
Weight gain.
Rare (affecting fewer than one person in 1,000 but more than one person in 10,000):
Urinary tract infection, urinary incontinence
Persistent, painful erection.
Very rare (affecting fewer than one person in 10,000):
Blood disorders
Abnormal heart rhythm.
In addition, the following effects have been reported in either clinical trials or during marketing
experience. However, these may not necessarily have been caused by taking terazosin. Facial
swelling, fever, pain in the shoulder, neck or abdomen, redness of the skin, flatulence, indigestion,
dry mouth, gout, painful joints, arthritis, muscle pain, anxiety, difficulty sleeping, bronchitis, flu and
cold symptoms, swollen or sore throat, cough, sweating, conjunctivitis, noises in the ear such as
ringing or whistling (tinnitus), urinary frequency.
If you experience any other unexpected side effects which you think may be due to receiving this
medicine, ask your doctor.
STORING TERAZOSIN TEVA
Do not use this medicine after the expiry date shown on the outside packaging. Do not store them
above 25°C. These tablets should be stored in the package or container supplied. Do not transfer
them to another container. Keep them in a secure place where children cannot get at them. This
medicine is for you ONLY, do not give to anyone else. Unless your doctor tells you to, do not keep
these tablets for longer than you need. Return all unused medicines to your pharmacist for safe
disposal.

FURTHER INFORMATION
This leaflet only gives a brief outline of some of the more important points about Terazosin Teva. If
you want to know more about this medicine or its effects, please ask your doctor or pharmacist.
Revised: June 2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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