DOXAZOSIN 2 MG TABLETS - patient leaflet, side effects, dosage

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Package leaflet: Information for the user Doxazosin 1 mg tablets Doxazosin 2 mg tablets Doxazosin 4 mg tablets Doxazosin 8 mg tablets

Doxazosin

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 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

1. what doxazosin is and what it is used for

Doxazosin belongs to the group known as vasodilators. These substances cause the blood vessel to widen, which reduces the blood pressure. Doxazosin can also reduce tension in the muscle tissues of the prostate and the urinary tract.

Doxazosin is used to treat:

• high blood pressure;
• symptoms of an enlarged prostate.

2. what you need to know before you take doxazosindo not take doxazosin if you are allergic to doxazosin, other types of quinazolines (such as prazosin and terazosin) or any of the other ingredients of this medicine (listed in section 6). this may have been itching, reddening of the skin or difficulty in breathing.

• if you are breast-feeding
• if you are under 18 years of age
• if you have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure.
• If 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 light-headed when you stand up from sitting or lying down.
• If 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.
• if 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 or pharmacist before taking Doxazosin if:

• you are pregnant or trying to become pregnant
• you have liver disease
• you are also taking other medicines
• you have heart disease

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.

Before starting treatment with Doxazosin 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 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.

Other medicines and Doxazosin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may interact with Doxazosin.

• 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.
• Doxazosin may lower your blood pressure even more if you are already taking other medicines to treat high blood pressure.

• – Medicines to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole

• – Medicines used in the treatment of HIV e.g. indinavir, nelfinavir, ritonavir, saquinavir.

• – Nefazodone, a medicine used to treat depression.

Doxazosin with food and drink

Please refer to section 3.

Pregnancy, breast-feeding and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

The safety of using doxazosin during pregnancy has not been established. If you are pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Doxazosin if you are breast feeding.

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 contains 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 tablet contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. 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 recommended dose of Doxazosin is one tablet taken once a day.
• If you are taking Doxazosin for the first time the normal dose is 1mg daily. Your doctor may increase this after a couple of weeks to the usual dose of 2mg or 4mg daily. In some circumstances this may be increased to a maximum of 8mg daily if you are being treated for prostate enlargement, or to a maximum of 16mg if you are being treated for high blood pressure.
• Doxazosin may be taken in the morning or the evening.
• It is best to take your tablets at about the same time each day with a drink of water.
• Doxazosin can be taken with or without food.
• Take your tablet as your doctor told you or by following the days and arrows on the blister foil.
• It is important to keep taking your tablets. They help to control your blood pressure.
• Do not change the dose or stop taking the tablets without first checking with your doctor.
• Do not wait until your tablets are finished before seeing your doctor.

Use in children

The safety and efficacy of Doxazosin in children have not been established.

If you take more Doxazosin than you should

Too many tablets at once may make you unwell. If several tablets are taken it may be dangerous. Tell your doctor immediately or go to your nearest hospital casualty department.

If you forget to take Doxazosin

Do not worry. If you forget to take a tablet, leave that dose out completely. Then go on as before. Do not take a double dose to make up for a forgotten tablet.

4. possible side effects

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

STOP taking Doxazosin and call an ambulance immediately if you experience any of the following:

• Heart attack
• Weakness of arms, legs or problems speaking which may be symptoms of a stroke
• Swelling of the face, tongue or throat which may be the result of an allergic reaction to this medicine

Tell your doctor immediately if you experience any of the following symptoms after taking Doxazosin:

• Shortness of breath, difficulty breathing (common: may affect up to 1 in 10 people)
• Increased or decreased heartbeat (common: may affect up to 1 in 10 people)
• Feeling your heartbeat (palpitations) (common: may affect up to 1 in 10 people)
• Chest pain, angina (uncommon: may affect up to 1 in 100 people)
• Irregular heartbeat (very rare: may affect up to 1 in 10,000 people)
• Yellowing of the skin or the eyes (jaundice) (very rare: may affect up to 1 in 10,000 people)
• Low numbers of white blood cells or blood platelets, which may result in bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people)
• Persistent painful erection of the penis. Seek urgent medical advice (very rare: may affect up to 1 in 10,000 people)

The following events have been reported in patients being treated with Doxazosin. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Common: may affect up to 1 in 10 people

• Dizziness, feeling of spinning or rotation of surroundings (vertigo), headache
• Low blood pressure
• Swelling of feet, ankles or fingers
• Chest cold, coughing, respiratory tract (nose, throat, lungs) infection
• Nasal stuffiness, sneezing and/or runny nose caused by inflammation of the lining of the nose (rhinitis)
• Stomach/abdominal pains, feeling/being sick
• Urinary tract infection, urinary incontinence (inability to control passing urine), inflammation of bladder (cystitis)
• Sleepiness, general weakness
• Indigestion, heartburn, dry mouth
• Itching
• Back pain, painful muscles
• Flu-like symptoms

Uncommon: may affect up to 1 in 100 people

• Constipation, wind, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhoea and vomiting
• Pain or discomfort on passing urine, increased frequency in passing urine, blood in urine
• Inflammation of the joints (gout), painful joints, general pain
• Swelling of the face
• Sleeplessness, agitation, anxiety, depression or nervousness
• Reduced or altered sense of touch or sensation of the hands and feet
• Increased appetite or loss of appetite, weight gain
• Nose bleeds
• Skin rash
• Ringing or noise in the ears, tremor
• Failure / inability to achieve penile erection
• Liver enzyme increases which may have an effect on some medical tests
• Stroke

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

• Increased number of times of passing urine
• Muscle cramps, muscle weakness

Very Rare: may affect up to 1 in 10,000 people

• Faintness or dizziness caused by low blood pressure when getting up from a sitting or lying position
• Hepatitis (liver inflammation) or bile disorder
• Hives, hair loss, red or purple patches on the skin, bleeding under the skin
• Tingling or numbness of the hands and feet
• Tiredness, generally feeling unwell
• Aggravated wheezing
• Blurred vision
• Hot flushes
• Disorder in passing urine, needing to pass urine at night, increased volume of urine passed
• Discomfort or enlargement of the breasts in men

Not known: frequency cannot be estimated from available data

• Little or no semen ejaculated at sexual climax, cloudy urine following sexual climax
• Eye problems may occur during eye surgery for cataract (cloudiness of the lens of the eye). See section “Warnings and precautions”.

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.

This medicinal product does not require any special storage condition.

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 informationwhat doxazosin contains- the active substance is doxazosin. each tablet contains 1/2/4/8 mg doxazosin (as doxazosin mesilate).

• – The other ingredients are: Cellulose microcrystalline, lactose anhydrous, sodium starch glycollate, magnesium stearate

What Doxazosin looks like and contents of the pack

Doxazosin 1mg tablets:

White to off-white coloured, circular biconvex shaped uncoated tablet debossed with H on one side and 01 on other side.

Doxazosin 2mg tablets:

White to off-white coloured, caplet shaped uncoated tablet debossed with H02 on one side and breakline on other side.

The tablet can be divided into equal halves.

Doxazosin 4mg tablets:

White to off-white coloured, diamond shaped uncoated tablet debossed with H03 on one side and breakline on other side.

The tablet can be divided into equal halves.

Doxazosin 8mg tablets:

White to off-white coloured, caplet shaped uncoated tablet debossed with H04 on one side and breakline on other side.

The tablet can be divided into equal halves.

PVC-PVDC Aluminium blisters:

Pack size: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets

HDPE bottle:

Pack size: 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park,

West End Road, South Ruislip HA4 6QD. United Kingdom

Manufacturer

Milpharm Limited

Ares, Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD.

United Kingdom

or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate

Hal Far, Birzebbugia, BBG 3000

Malta

This leaflet was last revised in 03/2021.

5. How to store Doxazosin

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 blister, label, bottle and carton after EXP. The expiry date refers to the last day of that month.