DOXAZOSIN TABLETS 4 MG - patient leaflet, side effects, dosage

In patients taking this medicine to treat high blood pressure (hypertension), it works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

In patients with an enlargement of the prostate gland, this medicine is taken to treat poor and/or frequent passing of urine. This medicine works by relaxing the muscle around the bladder exit and prostate gland so the urine is passed more easily.

Do not take Doxazosin Tablets if:

! You are allergic to doxazosin, related quinazolines (such as prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6)

! You are breast-feeding

! You have an enlarged prostate

gland (benign prostatic hyperplasia) and have low blood pressure

! You have a history of a condition known as ‚orthostatic hypotension‘ which is a form of low blood pressure that causes you to feel dizzy or lightheaded when you stand up from sitting or lying down

! You have an enlarged prostate gland with one of the following: any kind of congestion or blockage in your urinary tract, a longstanding infection of the urinary tract or you have bladder stones

! You have overflow incontinence (you do not feel the urge to urinate), or anuria (your body is not producing any urine) with or without kidney problems.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Doxazosin Tablets if:

! You are pregnant or trying to become pregnant

! You have liver disease

! You have heart disease

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

Before starting treatment with Doxazosin Tablets your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia (enlargement of the prostate gland).

Persistent painful erections may occur very rarely. If this happens you should contact a doctor immediately.

When you start to take Doxazosin Tablets you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If you feel faint or dizzy, you should sit or lie down until you feel better and avoid situations where you might fall or hurt yourself. Your doctor may want to measure your blood pressure regularly at the start of therapy to reduce the possibility of these effects happening.

Driving and using machines

Take care if you drive or operate machinery. Your tablets may affect your ability to drive or operate machinery safely, particularly when you first start to take them. They may make you feel weak or dizzy. If you are affected, do not drive or operate machinery and contact your doctor immediately.

Doxazosin Tablets contain 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.

Doxazosin 2mg and 4mg Tablets also contain sunset yellow (E110) This may cause allergic reactions.

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

The usual dose of Doxazosin Tablets is:

Adults and the elderly

For high blood pressure:

! The initial dose is 1mg once daily

! Your doctor may increase your dose after 1 or 2 weeks to 2mg daily and then again if necessary, to 4mg daily

! In some cases, the dose may be further increased to 8mg daily or to the maximum dose of 16mg daily if necessary.

To relieve the symptoms of an enlarged prostate gland:

! The initial dose is 1mg once daily

! Your doctor may increase your dose after 1 or 2 weeks to 2mg daily and then again if necessary, to 4mg daily

! In some cases, the dose may be further increased to the maximum dose of 8mg daily if necessary

! The usual recommended dose is 2mg to 4mg daily.

Use in children and adolescents

Doxazosin Tablets are not recommended for children or adolescents. The safety and efficacy of doxazosin mesilate has not been established.

Doxazosin Tablets may be taken in the morning or evening. It is best to take your tablets at about the same time each day with a drink of water. Doxazosin Tablets can be taken with or without food. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Doxazosin Tablets than you should

If you have taken more than the prescribed dose, you should consult your doctor and/or pharmacist immediately. If you feel extremely dizzy or think you might faint, you should lie down immediately with your head down.

If you forget to take Doxazosin Tablets

Do not worry. 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.

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

If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the nearest hospital casualty department: ! Allergic reaction such as wheezing, shortness of breath, extreme dizziness or collapse, swelling of the face or throat, or a serious skin rash with red spots or blisters (especially affecting the whole body)

! Chest pain (angina pectoris), increased or irregular heartbeat, heart attack or stroke (symptoms may include collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech)

! Yellowing of the skin or whites of the eyes caused by liver problems (jaundice)

! Unusual bruising or bleeding caused by low blood platelets

! Presence of blood in the urine

! Hepatitis (liver disease with nausea, vomiting, loss of appetite, generally feeling unwell, fever)

! Cholestasis (blocked flow of bile – can cause itchy skin, pale stool and dark urine)

! Leukopenia (reduced number of white blood cells. Symptoms may include frequent infections such as fever, severe chills, sore throat or mouth ulcers)

! Persistent painful erection of the penis. Seek urgent medical advice.

Common (may affect up to 1 in 10 people)

! Respiratory tract infection (nose, throat, lung)

! Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate)

! Urinary incontinence (inability to

control passing urine)

! Dizziness, sleepiness

(somnolence), headache

! Feeling of dizziness or

“spinning” (vertigo)

! Low blood pressure and low

blood pressure as a result of getting up from a sitting or lying position (postural hypotension)

! Inflammation of the air passages within the lungs, cough, shortage of breath, nasal stuffiness and/or runny nose

! Abdominal pain, indigestion, dry mouth, feeling sick (nausea)

! Itching (pruritus)

! Back pain, muscle pain (myalgia)

! Inflammation of the bladder (cystitis)

! Feeling of weakness (asthenia), chest pain,

influenza like symptoms

! Swelling of the ankles, feet or fingers (peripheral oedema).

Uncommon (may affect up to 1 in 100 people)

! Gout, increased appetite, anorexia (loss of appetite)

! Agitation, depression, anxiety, sleeplessness (insomnia), nervousness, tremor

! Stroke, reduced sense of touch or sensation, fainting

! Ringing or noise in the ears (tinnitus)

! Nose bleed

! Constipation, flatulence, vomiting (being sick),

inflammation of the gastrointestinal tract, diarrhoea

! Abnormal liver function test

! Skin rash

! Joint pain

! Painful or difficult urination

! Difficulty to develop an erection (impotence)

! Pain, swelling of the face

! Weight increase

! Need to urinate more often than usual (micturition frequency).

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

! Muscle cramps, muscle weakness

! Polyuria (passing large volumes of urine).

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

! Dizziness postural (dizziness as a result of getting up from a sitting or lying position), tingling or numbness of the hands and feet (paraesthesia)

! Blurred vision

! Reduced heart rate

! Hot flushes

! Bronchial spasm (difficulty in breathing, wheezing

or coughing)

! Hives (urticaria), hair loss (alopecia), rash caused

by bleeding under the skin (purpura)

! Disorder in passing urine, needing to pass urine at night, increased volume of urine passed

! Temporary enlargement of the breasts in men (gynecomastia)

! Feeling tired (fatigue), malaise (general feeling of being unwell).

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

! Eye problems may occur during eye surgery for cataracts (cloudiness of the lens of the eye). See section 2, “Warnings and precautions”

! 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton or blister. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not use this medicine if you notice any defects in the tablets such as chipped or broken tablets, take them to your pharmacist for advice before taking them.

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

Each tablet contains 1mg, 2mg, 4mg or 8mg of the active ingredient doxazosin (as mesilate).

The tablets also contain microcrystalline cellulose (E460), sodium lauryl sulphate, lactose monohydrate (see section 2), sodium starch glycollate, colloidal silicon dioxide and magnesium stearate.

Doxazosin 2mg and 4mg tablets also contain sunset yellow (E110) (see section 2).

ENV03

240 mm