Package leaflet: Information for the patient

Terazosin Teva 1, 2, 5 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 Terazosin Teva is and what it is used for

2.    What you need to know before you take Terazosin Teva

3.    How to take Terazosin Teva

4.    Possible side effects

5.    How to store Terazosin Teva

6.    Contents of the pack and other information

1. What Terazosin Teva is and what it is used for

Terazosin Teva is one of a group of medicines called alpha blockers.

Terazosin Teva is used to treat patients suffering from high blood pressure. They help reduce blood pressure.

Terazosin Teva 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.

2. What you need to know before you take Terazosin Teva Do not take Terazosin Teva:

-    if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6).

-    If you have ever experienced a brief loss of consciousness when passing water, or just after passing water. This symptom happens more commonly if you get up during the night to pass water Warnings and precautions

Talk to your doctor or pharmacist before taking Terazosin Teva if you have if you experience or suffer from any of the following:

• Fainting, unsteadiness or vertigo (a sensation of spinning around) caused by low blood pressure on standing up. It is more common:

■    when you first start treatment

■    when you restart treatment after a few days break

■    if your body does not have enough fluids

'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

■    if you are on a low-salt diet

■    in elderly (over 65 years of age)

o You may be more likely to experience fainting on standing if:

■    your dose of Terazosin is increased rapidly

■    you are also taking a diuretic (water tablet) or other medicine to help reduce your blood pressure.

o You may notice that you have a rapid heartbeat just before fainting. The risk of fainting is greatest between 30 and 90 minutes after having taken your dose of Terazosin.

•    Hypotension (low blood pressure). Y our doctor will monitor your blood pressure.

•    Heart problems such as water in the lungs or heart failure

•    Impaired liver function

•    Advanced kidney failure that requires intensive treatment or dialysis

•    Absence of urine production or decrease of the flow of urine

•    Upper urinary tract obstruction (when it is difficult for the urine to flow from the kidneys to the bladder)

•    Persistent infection of the urinary tract (an infection that could not been cured by treatment)

•    Bladder stones

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 Teva. This is because Terazosin Teva may cause complications during the surgery, which can be managed if your specialist is prepared in advance.

Other medicines and Terazosin Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

o Other medicines used in the treatment of high blood pressure (other antihypertensive agents including ACE inhibitors and water tablets)

o Medicines used for the treatment of erectile dysfunction (PDE-5 inhibitors e.g. sildenafil, tadalafil, vardenafil). 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.

Terazosin Teva with food and drink and alcohol

Taking food and drink has no influence on your treatment with Terazosin Teva. Please be aware that alcohol may increase the risk of dizziness, light-headedness or drowsiness.

Pregnancy and breast-feeding

Terazosin Teva is NOT recommended during pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

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

Dizziness, light-headedness or drowsiness may occur with the initial dose or in association with missed doses and subsequent restart of terazosin therapy. Patients should be cautioned about these possible adverse events and the circumstances in which they may occur and advised to avoid driving or hazardous tasks for approximately the first 12 hours after the initial dose or when the dose is increased.

Terazosin Teva contains lactose

Terazosin Teva contains milk sugar (lactose). If you know that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Terazosin Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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 ON THE NEXT PAGE:

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 section 3, subsection 1.

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.

Use in children and adolescents

Terazosin is not recommended for children and adolescents under 18 years If you take more Terazosin Teva than you should

If you accidentally take an overdose (more than one tablet a day) call your doctor immediately. Taking too many tablets may cause your blood pressure to fall too low and other serious effects. Symptoms of overdose may include: dizziness, confusion, fainting, shortness of breath, fall in blood pressure, pounding of your heart (palpitations), rapid heartbeat, feeling sick, muscle cramps, low levels of sugar in your blood, low levels of potassium in your blood.

If you forget to take Terazosin Teva

If you forget to take a dose of Terazosin Teva, you can take it as soon as you remember unless it is time for the next dose, in which case you should continue with your medication as prescribed. Do NOT take a double dose to make up for a forgotten tablet.

If you stop taking Terazosin Teva

If you have not taken a tablet for several days you should NOT continue using the same tablets. Return to your doctor for advice.

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.

A few people may develop a severe allergic reaction. This is a very rare (may affect up to 1 in 10,00 people) but very serious side effect. If you experience any of the following symptoms stop taking Terazosin Teva, contact 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.

You should stop taking Terazosin Teva and see your doctor immediately if you get prolonged and painful penile erection. This is a rare side effect may affect up to 1 in 1,000 people)

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

•    nervousness, sleepiness, pins-and-needles, spinning feeling (vertigo)

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

•    depression

•    hives (nettle rash)

•    decreased sex-drive

•    weight gain.

•    transient loss of consciousness.

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

•    urinary tract infection, urinary incontinence

•    persistent, painful erection.

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

•    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, irregular heartbeat 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.

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 Terazosin Teva

These tablets should be stored in the package or container supplied. Do not transfer them to another container. Do not store them above 25°C. This medicine is for you ONLY, do not give to anyone else.. 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. .

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outside packaging 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 Terazosin Teva contains

-    The active substance is 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)

What Terazosin Teva looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem,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., Swensweg 5, 2031 GA Haarlem,The Netherlands. The company responsible for batch release is Teva Pharmaceutical Works Company Ltd, Debrecen, Hungary*

Or

The Marketing Authorisation holder is Teva Pharma B.V., Swensweg 5, 2031 GA Haarlem,The Netherlands. The company responsible for batch release is Merckle GmbH, Ludwig-Merckle-Str.3, Weiler, 89143 Blaubeuren, Germany *

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

This leaflet was last revised in

November 2014

PL 14776/0047-50