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Terazosin 2mg Tablets

Document: leaflet MAH GENERIC_PL 43870-0001 change

Terazosin 2mg, 5mg and 10mg Tablets

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 or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Terazosin is and what it is used for

2.    What you need to know before you take Terazosin

3.    How to take Terazosin

4.    Possible side effects

5.    How to store Terazosin

6.    Contents of the pack and other information

1. What Terazosin is and what it is used for

The name of this medicine is Terazosin 2mg Tablets, Terazosin 5mg Tablets or Terazosin 10mg Tablets referred to as Terazosin throughout this leaflet.

Terazosin belongs to a group of medicines called ‘alpha blockers’ which help to relax smooth muscle and has been prescribed for you to treat one of the following:

•    Improve the obstructive symptoms caused by benign prostatic hyperplasia (BPH) and help the flow of urine from the bladder

•    Treat mild to moderate hypertension (high blood pressure).

2. What you need to know before you take Terazosin

Do not take Terazosin if:

•    You are allergic (hypersensitive) to Terazosin or any of the other ingredients in this medicine (listed in Section 6)

•    You are allergic (hypersensitive) to other medicines in the ‘alpha blocker’ group.

Do not take Terazosin if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Terazosin .

•    You have ever fallen over or fainted whilst passing water.

Warnings and precautions

Talk to your doctor or pharmacist before taking Terazosin if you:

•    Are taking other medication for high blood pressure. If a medicine for high blood pressure is started whilst you are taking Terazosin, your doctor may need to adjust your dose of Terazosin

•    Have any problems with your heart

•    Are taking medicines for erectile dysfunction (e.g. sildenafil, vardenafil, tadalafil)

•    Are planning cataract removal surgery

•    Terazosin can cause fainting or low blood pressure, usually after the first few doses. These effects can also occur if you stop taking Terazosin and then re-start.

•    Terazosin may also lead to decreases of certain laboratory values, such as red blood cells or white blood cells.

If the above applies to you (or you are not sure), talk to your doctor or pharmacist before taking Terazosin.

Other medicines and Terazosin

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtainedwithout a prescription or herbal medicines. This is because Terazosin can affect the way some other medicines work. Also some other medicines can affect the way Terazosin works.

Please tell your doctor or pharmacist if you are taking any of the following:

•    Antihypertensive drugs such as ACE inhibitors (lisinopril, captopril) to treat high blood pressure

•    Diuretics (water tablets).

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.

If you are undergoing eye surgery because of cataracts (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.

Pregnancy and breast-feeding

Do not take Terazosin if you are pregnant, might become pregnant or are breast-feeding, unless you have been advised to do so by your doctor.

Driving and using machines

For the first 12 hours after starting therapy, or every time the dose is increased, you may experience dizziness, light-headedness or drowsiness. Therefore it is very important that you do not drive or use any tools or machines if you are affected.

Terazosin contains Lactose, quinoline yellow lake (E104), red iron oxide (E172) and indigotine lake

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. In addition the 2mg tablets contain quinoline yellow lake (E104), the 5mg tablets contain red iron oxide (E172) and the 10mg tablets contain indigotine lake (E132) .

3. How to take Terazosin

Always take Terazosin exactly as your doctor has told you. The doctor, depending on your needs and tine condition being treated, will decide the dose of Terazosin.You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Swallow the tablets whole with a drink of water.

How much to take - adults and the elderly (over 65 years of age)

•    The usual starting dose is 1 mg before bedtime. Therefore if you are just starting therapy, your doctor will also have prescribed you a 1 mg tablet from another company

•    Your doctor may slowly increase the amount you take until the right dose for you is found.

•    To treat BPH

•    Your doctor may have to increase your dose every 1 or 2 weeks until the right dose is reached. The usual dose is 5 to 10mg taken once daily.

SAME SIZE ARTWORK, SIZE : 145 x 310 1nm


To treat high blood pressure

•    Your doctor may have to increase your dose every week until the right dose is reached. The usual dose is 2mgto 10mgtaken once daily

•    If you start taking other medication for high blood pressure, your doctor may reduce your dose of Terazosin and gradually increase it again .

Children (less than 18 years of age)

Do not give to children less than 18 years of age.

If you take more Terazosin than you should

If you take more Terazosin than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Terazosin

•    If you forget a tablet, take it as soon as you remember. However, if it is nearly time for the next dose, skipthe missed dose

•    Do not take a double dose to make upfor a forgotten dose

•    If you have not taken a tablet for several days, do not continue taking the tablets , but see your doctor for advice on restarting therapy.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

Stop taking Terazosin and see a doctor or go to a hospital straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

•    Severe allergic reactions - signs include skin rash, itching, swollen or lumpy skin, difficulty breathing, swelling of the face, lips, tongue or throat.

Side effects particularly at the beginning or re-start of treatment:

•    Feeling dizzy, light-headed orfaint if you standuptoo quickly.

Fainting can occur after starting therapy, and occasionally after increasing the dose or adding other medication. If this happens, lie down again, and then sit for a few minutes before standing. Tell your doctor if this happens to you.

The most common side effects of Terazosin are:

•    Weakness, dizziness, feeling sick, blurred vision;

•    A fast or uneven heartbeat;

•    Swelling of the hands and feet;

•    Sleepiness;

•    Blocked nose.

Other, less frequent side-effects of Terazosin are:

•    Back pain, neck pain, shoulder pain, pains in hands and feet, pins and needles;

•    Headache;

•    Increased heart rate, irregular heart rate, chest pains;

•    Low blood pressure (hypotension) which can cause dizziness or faintness on standing;

•    Swelling, flushing, facial swelling;

•    Weight gain;

•    Nervousness, depression, anxiety;

•    Shortness of breath or difficulty breathing;

•    Decreased sex-drive, erectile dysfunction, persistent and painful erection;

•    Vertigo (problems with balance that can result in feelings of dizziness or sickness - particularly on standing), ringing in the ears;

•    Stomach pain, indigestion, being sick, constipation, diarrhoea, wind;

•    Dry mouth;

•    Inflammation or pains in joints or muscles;

•    Difficulty sleeping;

•    Bronchitis (inflammation of the lungs);

•    Nose bleeds, sore throat, blocked nose, cough, flu-like symptoms;

•    Skin rashes and itching;

•    Sweating;

•    Vision problems and conjunctivitis;

•    Increased frequency of passing water, urinary infection, lack of bladder control.

•    Low blood cell counts, laboratory tests abnormal

Some patients have experienced unexpected bruising and their blood taking longer than usual to clot after a cut to the skin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects you help provide information on the safety of this medicine

5. How to store i erazosin

•    Keep out of the sight and reach of children

•    Do not use Terazosin after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month

•    Medicines should not be disposedof via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required which will help protect the environment.

6. Contents of the pack and other information

What Terazosin contains

•    The drug substance is terazosin. The tablets come in three strengths containing 2mg, 5mgor 10mgof terazosin as terazosin hydrochloride dihydrate 1

1

   The other ingredients are lactose monohydrate, croscarmellose sodium, cellactose 80, magnesium stearate (E572). In addition the 2mg tablets contain quinoline yellow lake (E104), the 5mgtablets contain rediron oxide (E172) andthe 10mgtablets contain indigotine lake (E132) .

What Terazosin Tablets look like and contents of the pack

•    Terazosin 2mg Tablets are yellow, round, bevelled edged uncoated tablets, marked ‘S151 ’

•    Terazosin 5mgTablets are red, round, bevelled edged uncoated tablets, marked ‘S152’

•    Terazosin 10mgTablets are blue, round, bevelled edged uncoated tablets, marked ‘S153’. Terazosin is only available from your pharmacist on prescription in pack sizes of 28, 56 or 84 tablets. However, not all pack sizes may be marketed.

MA Holder: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park,    306/0'

Liverpool L30 1RD, UK

This leaflet was last revised in July 2016