Doxazosin 1mg Tablets

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Document: leaflet MAH GENERIC_PL 00289-0357 change

TEVA UK Ref: 231-30-85104-Y LEA DOXAZOSIN A/S TAB TUK Version: 2 20 July 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

Pharma code 538

DOXAZOSIN 1 mg, 2 mg and 4 mg TABLETS

Doxazosin mesylate

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking/using 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. 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 Doxazosin is and what it is used for

2. What you need to know before you take Doxazosin

3. How to take Doxazosin

4. Possible side effects

5. How to store Doxazosin

6. Contents of the pack and other information

OWhat Doxazosin is and what it is used for

Doxazosin belongs to the group of medicines called vasodilatants (alpha-blockers).

Doxazosin is used to treat:

• high blood pressure

• the symptoms caused by an enlarged prostate gland in men.

Doxazosin works by widening the blood vessels, making it easier for the heart to pump blood around the body. This helps to lower blood pressure.

In patients with enlargement of the prostate gland, Doxazosin works by relaxing the muscles around the bladder and prostate gland so that urine may be passed more easily.

What you need to know before you take Doxazosin

Do not take Doxazosin

• if you are allergic to doxazosin, or to other medication from the same medicine category (the so-called quinazolines, such as prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6)

• if you suffer from dizziness when standing up from a lying or sitting position due to decrease in blood pressure (orthostatic hypotension)

• if you have experienced problems with urinating and are using Doxazosin as monotherapy:

• have a loss of urinary control (overflow bladder)

• decreased or absent production of urine (anuria)

• progressive kidney insufficiency

• if you are breastfeeding

Additionally, if you were prescribed doxazosin for an enlarged prostate you should not take this medication if you:

• have low blood pressure

• have congestion of the upper urinary tract

• suffer from chronic infections of the urinary tract

• have bladder stones.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Doxazosin

• at start of the treatment. The blood pressure reducing influence may be stronger, which is noticeable by dizziness and weakness or sometimes fainting. Your doctor may check your blood pressure to minimize the risk. Avoid situations in which you could be hurt when you experience dizziness or weakness

• if you are suffering from acute heart disease

• if you have liver problems. In patients with severe liver function impairment, use of Doxazosin is not recommended.

• if you are using certain medication for erectile dysfunction (PDE-5-inhibitors) such as sildenafil, tadalafil and vardenafil (see section "Taking other medicines").

• 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 Doxazosin.

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

Children and adolescents

Doxazosin is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established.

If any of these apply to you, talk to your doctor before you start to take this medicine.

Other medicines and Doxazosin

Some medicines may influence each other's activity and/or side effects if taken simultaneously (known as interaction). An interaction can occur when this medication is taken at the same time with:

• other blood pressure lowering agents (antihypertensives) or other alpha-blockers (e.g. prazosin, terazosin); the blood pressure lowering effect can be increased

• medicines which may influence the metabolism of the liver such as cimetidine, a H2- receptor antagonist (which acts to decrease the natural production of acid in the stomach)

• medication for erectile dysfunction (PDE-5-inhibitors) such as 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.

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

These remarks can also be applicable to medicines you have taken in the recent past or you will take in the near future as well as medicines you are already taking. Medicines mentioned in this section may be known to you under another name, usually a branded name. In this section only the name of the active ingredient is mentioned and not the branded name. Look at the package or in the patient information leaflet of your other medicines to see what the active ingredient is of the medication you take.

Pregnancy, breast feeding and fertility

• Do not take doxazosin if you are breast feeding. See also section 'Do not take Doxazosin'.

• Alternatively, mothers should stop breast feeding when treatment with doxazosin is necessary.

• If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Doxazosin is not recommended for use during pregnancy unless your doctor decides that the potential benefit of treatment outweighs the risks.

Driving and using machines

Sometimes this medication can make you feel sleepy, dizzy and/or weak, especially when you first start taking the tablets, or can affect your vision. If you are affected do not engage in activities which require concentration, such as driving, operating machines and working at heights.

Doxazosin contains lactose

Patients who are intolerant to lactose should note that Doxazosin tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

How to take Doxazosin

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

The tablets should be taken in a once-daily dosage with a glass of water (one glass).

The recommended dose is:

Adults

• High Blood Pressure

The usual starting dose is 1 mg a day before going to bed.

After 1 to 2 weeks the dose may be increased to 2 mg a day for a further 1 to 2 weeks.

Your doctor may continue to increase your dose up to a maximum of 16 mg a day depending on how your blood pressure responds to treatment.

• Enlarged Prostate

The usual starting dose is 1 mg a day before going to bed. After 1 week the dose will be increased to 2 mg a day for 1 week.

Afterwards, your doctor may increase your dose in steps at 1 to 2 week intervals up to a maximum of 8 mg a day depending on the effects of the medicine.

The score line on 2 and 4 mg tablets is only there to help you break the tablet if you have difficulty swallowing it whole.

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If you take more Doxazosin than you should

If you have taken more than the dosage prescribed or if you think a child or someone else has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause low blood pressure, which may make you feel dizzy or faint. In case of serious dizziness or imminent fainting you should lie down immediately with your head downward. 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 Doxazosin

If you forget to take a tablet, leave that dose out completely. Then go back to your usual schedule.

Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. In case of doubt you should always consult your pharmacist or doctor.

If you stop taking Doxazosin

You should continue to take these tablets for as long as your doctor tells you to. If the use of this medication is suddenly stopped, the symptoms that existed before the start of the treatment may reoccur.

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

Possible side effects

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

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if you experience any of the following effects:

• allergic reactions, this can be recognized by e.g. rash and/or itch

• swelling of the face due to fluid accumulation (facial oedema).

These are very serious but uncommon side effects. You may need urgent medical attention or hospitalisation.

Common (may affect up to 1 in 10 people)

• infection of the respiratory tract

• infection of the urinary tract

• headache

• dizziness

• sleepiness

• low blood pressure (hypotension), faintness or dizziness caused by low blood pressure when getting up from a sitting or lying position (postural hypotension)

• sensation that one's self or the surroundings are moving or spinning (vertigo)

• palpitations, rapid heart rate (tachycardia)

• inflammation of the airway (bronchitis), cough, shortness of breath, runny nose (rhinitis)

• abdominal pain, pain or discomfort in the upper abdomen (dyspepsia), dry mouth, feeling sick

• severe itching (pruritus)

• back pain, muscle pain

• bladder infection (cystitis), urinary incontinence

• weakness and loss of strength

• chest pain

• flu-like symptoms

• swelling of tissue due to fluid accumulation, usually in the lower limbs (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)

• allergic drug reaction

• lack of appetite

• anxiety, nervousness

• gout

• increased appetite

• agitation, depression

• sleeplessness (insomnia)

• stroke

• reduced sense of touch (hypoesthesia)

• fainting

• tremor

• ringing in the ears (tinnitus)

• chest pains (angina pectoris)

• heart attack (myocardial infarction)

• nose bleeds

• diarrhoea

• constipation, flatulence, being sick

• inflammation of the mucous membrane of the stomach and intestines (gastroenteritis)

• skin rash

• joint pain

• painful urination (dysuria)

• more frequent need to urinate, blood in urine (haematuria)

• inability to have or maintain an erection (impotence)

• weight increase

• abnormal liver function tests

• pain

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

• muscle cramps, muscle weakness

• more frequent urination of large volumes of urine (polyuria)

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

• decrease in white blood cells; this may cause a higher susceptibility to infections

• decrease in blood platelets, which may result in bruising or easy bleeding

• blurred vision

• abnormal heart rhythms (cardiac arrhythmia)

• dizziness when getting up from a sitting or lying position (dizziness postural)

• hot flushes

• tingling without apparent cause (paresthesia)

• hair loss (alopecia)

• red or purple discolorations of the skin (purpura)

• slow heart rate (bradycardia)

• increased tightness of the chest caused by cramp of the respiratory tract muscles (aggravated bronchospasm)

• jaundice; this can be recognized by a yellow colour of the skin

• inflammation of the liver that can cause a yellow colour of skin and eyes (hepatitis)

• bile disorder (cholestasis)

• hives (urticaria)

• increased urine volume (increased diuresis), urination disorders, the need to wake and pass urine at night (nocturia)

• discomfort or enlargement of the breast tissue in men (gynaecomastia)

• persistent, usually painful erection of the penis (priapism).

• tiredness

• general feeling of being unwell (malaise).

Not known frequency (frequency cannot be estimated from the available data)

• complications during surgery for cataract (see section "take special care with doxazosin")

• little or no semen ejaculated at sexual climax, cloudy urine following sexual climax (retrograde ejaculation).

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.

How to store Doxazosin

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 label and carton. The term "Exp.” on the strip means: "do not use after". 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.

What Doxazosin tablets contain:

• The active substance is doxazosin mesylate. Each tablet contains doxazosin mesylate equivalent to 1 mg, 2 mg or 4 mg doxazosin.

• The other ingredients are microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, magnesium stearate, sodium laurilsulfate, colloidal anhydrous silica.

What Doxazosin Tablets look like and contents of the pack:

• 1 mg: white round convex tablet, "D1" engraved on one side

• 2 mg: white oblong scored tablet, "D2" engraved on one side

• 4 mg: white oblong scored tablet, "D4" engraved on one side

• The product is available packed in PVC/PVDC-Aluminium blister strips in pack sizes of, 2, 3, 5, 10, 20 or 50 x 10 tablets or 1, 2 or 7 x 14 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9Ag, United Kingdom

This leaflet was last approved in May 2015

PL 00289/0357-0359

TEUZD 85104-Y

TEVA UK LIMITED 323 x 160

REG0062717

Version 3.3

Approved

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