Document: leaflet MAH GENERIC_PL 00289-0365 change

• leaflet MAH GENERIC_PL 00289-0365
• leaflet MAH GENERIC_PL 20075-0093
• leaflet MAH GENERIC_PL 43870-0002

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TEVA UK Ref: 231-30-85164-W LEA TERAZOSIN A/S TAB TUK Version: 2    11 February 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

TERAZOSIN 2 mg, 5 mg AND 10 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start

taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

INTHIS LEAFLET:

1.    What Terazosin is and what it is used for

2.    Before you take Terazosin

3.    How to take Terazosin

4.    Possible side effects

5.    How to store Terazosin

6.    Further information

OWHAT TERAZOSIN IS AND WHAT IT IS USED FOR

Terazosin belongs to a group of medicines called , alpha-blockers.

I Terazosin is used to treat: i • high blood pressure

¹ • blocked urine flow caused by benign prostatic hyperplasia (BPH), which is common in older men ¹ BPH 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 ofthe prostate gland and bladder exit to help relieve these symptoms.

^2 BEFORE YOU TAKE TERAZOSIN

DO NOT take Terazosin if you:

• are allergic (hypersensitive) to terazosin or any ofthe other ingredients of this medicine • are allergic (hypersensitive) to other similar medicines such as prazosin or doxazosin • have ever fainted when urinating • have the rare hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

Take special care with Terazosin

Talk to your doctor before you start to take this

medicine if you:

• have any liver problems • have any heart problems.

Taking other medicines

Talk to your doctor if you are taking any of the following:

• ACE inhibitors, used to treat high blood pressure e.g. captopril or lisinopril • diuretics ("water tablets"), used to treat heart failure or high blood pressure e.g. furosemide or spironolactone

• any other medicine used to treat high blood pressure e.g. atenolol, verapamil or amlodipine.

Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or lightheadedness, 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.

Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Ifyou 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 usedTerazosin.This is because terazosin may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Important information about some of the

ingredients of Terazosin

•    Patients who are intolerant to lactose should note that Terazosin tablets contain a small amount of lactose. Ifyour doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy and breast-feeding

•    If you are pregnant, planning to become pregnant or are breast-feeding, askyour doctor for advice before taking this medicine.

Driving and using machines

•    Terazosin may cause light-headedness, dizziness, or drowsiness, particularly with the first dose, an increase in your dose, or after missing doses and restarting treatment. DO NOT drive or operate machinery for 12 hours after your first dose, when your dose is increased, or when restarting treatment.

•    If you are affected inany way at any other time while you are takingTerazosin tablets, DO NOT drive or operate machinery.

HOW TO TAKE TERAZOSIN

Always takeTerazosin exactly as your doctor has told you.You should checkwith your doctor or pharmacist ifyou are not sure.

Your doctor will monitor you regularly during your treatment.

(A)    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 (B).

It is important that you take the correct tablet at the correct time.

•    The tablets should be swallowed, preferably with a drinkofwater.

•    The first time you take a new strength of TerazosinTablet, you should take it in the evening at bedtime.

•    Following doses of the same strength may be taken in the morning.

•    If you are at all unsure about when to take yourtablets, you should consult your doctor for advice.

Adults (including the elderly)

•    High Blood Pressure

On days 1 to 7, take one 1 mg tablet each day. The first tablet should be taken at bedtime. From day 8 onwards, take one 2 mg tablet (yellow tablet) each day for a week, until you reach day 14. Remember you should take your first 2 mg tablet at bedtime.

When you have finished this two week treatment, your doctor will decide how to continue your treatment, and may give you a prescription for more tablets. Now read section (B).

•    Benign prostatic hyperplasia

On days 1 to 7, take one 1 mg tablet each day. The first tablet should be taken at bedtime. From day 8 onwards, start taking one 2 mg tablet (yellow tablet) each day for 14 days. Remember you should take your first 2 mg tablet at bedtime.

From day 22 onwards, start taking one 5 mg tablet (tan tablets) each day for 7 days. Remember you should take your first 5 mg tablet at bedtime.

When you have finished this fourweek treatment, your doctor will decide how to continue your treatment, and may give you a prescription for more tablets. Now read section (B).

(B)    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 prescribe more tablets to continue yourtreatment. Your maintenance dose will be adjusted according to how you have responded to treatment, and is usually between 2-10 mg daily. Your doctor will decide which strength oftablet 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) ofTerazosin.

Take one tablet each day.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Children

•    Terazosin is not recommended for use in children.

If you take more Terazosin than you should

•    Ifyou accidentally take more than 1 tablet in a day, you should contact your doctor immediately.

•    lfyou(or someone else) swallow a lot of the tablets all together, orifyouthinkachild has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause very low blood pressure resulting in fainting, dizziness, and drowsiness.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Terazosin

•    Ifyou have forgotten to take a tablet of a new strength at bedtime, askyour doctor or pharmacist for advice before continuing.

•    Ifyou forget to take a tablet at the normal time, take one as soon as you remember. DO NOT take a double dose to make up for a forgotten dose.Take the remaining doses at the correct time.

•    Ifyou have forgotten to take a tablet for several days, DO NOT continue using the same tablets. You must contact your doctor for advice before you start taking Terazosin tablets again as your treatment may have to be restarted as if you are taking it for the first time.

If you stop taking Terazosin

•    You should continue to take your tablets unless your doctor tells you not to. DO NOT stop just because you feel better.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines,Terazosin can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling ofthe lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The most common side effects are:

•    dizziness, light-headedness or fainting.

These effects may occur when you first start taking the tablets or when you start to take a higher dose, especially when standing up quickly from a lying or sitting position. Ifthis happens you should lie down until you feel better then you should sit for a few minutes before standing again to preventthese effects from returning.

These effects usually go away and should not return once you have become used to taking your tablets.

Other common side effects are:

•    weakness

•    sleepiness

•    palpitations

•    feeling sick

•    swelling of the legs and feet

•    blocked or itchy nose

•    blurred vision.

Other less frequent side effects are:

•    backpain

•    pain in extremities i.e. fingers and toes

•    headache

•    water retention

•    weight gain

•    decreased sex drive, inability to get or keep an erection

•    depression, nervousness

•    pins-and-needles

•    vertigo

•    sinusitis (inflammation of the sinuses)

•    fast heart beat

•    shortness of breath.

In addition, the following effects have been reported, however these may not necessarily have been caused by takingTerazosin:

•    swelling of the face, swollen or sore throat

•    chest pain, stomach pain, neck and shoulder pain

•    sweating, fever, cold and flu symptoms

•    bronchitis and increased cough

•    nose bleed, runny nose

•    dry mouth

•    indigestion, constipation, diarrhoea, wind, being sick

•    joint pain/disorders, gout, muscle pain, arthritis

•    tinnitus (ringing in the ears)

•    conjunctivitis (eye infection), changes in vision

•    change in heart rate/beat

•    itchy skin, red skin, rashes

•    anxiety, unable to sleep (insomnia)

•    change in the frequency of passing water

•    urinary tract infection and incontinence have been reported mainly by women who have gone through the menopause

•    unexplained bruising, skin cuts taking longer to heal

•    painful, prolonged erection

•    changes in the chemistry ofthe blood i.e. blood cell numbers may reduce.

Reporting of side effects

Ifyou get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety ofthis medicine.

HOW TO STORE TERAZOSIN

Keep out of the reach and sight of children.

Do not store above 25⁰C. Store in the original package. Do not use Terazosin after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month. Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

^ FURTHER INFORMATION

What Terazosin tablets contain:

•    The active ingredient is 2 mg, 5 mg or 10 mg terazosin (as hydrochloride dihydrate).

•    The other ingredients are lactose monohydrate, maize starch, povidone, crospovidone, talc and magnesium stearate (E572).

•    The 2 mg tablets also contain quinoline yellow (E104).

•    The 5 mg tablets also contain yellow iron oxide (E172) and red iron oxide (E172).

•    The 10 mg tablets also contain indigo carmine (E132).

What Terazosin tablets look like and contents of the pack:

•    The 2 mg tablets are mottled yellow, round, flat tablet with bevelled edges. Embossed with "93" on one-side and "761" on the other side.

•    The 5 mg tablets are mottled tan, round, flat tablet with bevelled edges. Embossedwith "93" on one-side and "762" on the other side.

•    The 10 mg tablets are mottled blue, round, flat tablet with bevelled edges. Embossedwith "93" on one-side and "763" on the other side.

•    The 2 mg are available in packs of 20, 28, 30,

50, 84, and 100 tablets.

•    The 5 mg are available in packs of 14, 20, 28,

30, 50, 84, and 100 tablets.

•    The 10 mg are available in packs of 20, 28, 50, 84, and 100 tablets.

•    The 2 mg and 5 mg tablets also come in starter packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: January 2015 PL 00289/0364-0366

TEUZD

TEVA UK LIMITED    160X 323

Teva Pharmaceuticals Europe B.V 1.3.2

mockup-pil-uk-pl-00289-0364-0365-0366-terazosin-2mg-5mg-10mg-tablets

Approvals

Signed by	Meaning of Signature	Server Date
Darryl Hill	Regulatory Affairs Approval	16-Apr-2015 09:58:53 AM

REG0068768 Version 1.3 Approved Page 3 of 3