Doxazosin 4mg Tablets
DOXAZOSIN 1mg, 2mg and 4mg TABLETS
(doxazosin mesilate)
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 Tablets are and what they are used for.
2. What you need to know before you take Doxazosin Tablets.
3. How to take Doxazosin Tablets.
4. Possible side effects.
5. How to store Doxazosin Tablets.
6. Contents of the pack and other information
1. WHAT DOXAZOSIN IS AND WHAT IT IS USED FOR
Doxazosin is one of a group of medicines called alpha-blockers. It is used to treat high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.
Doxazosin can be used to treat high blood pressure (hypertension), by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.
In patients with an enlarged prostate gland, Doxazosin is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. Doxazosin works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXAZOSIN
“ Do not take Doxazosin:
- If you have had an allergic (hypersensitive) reaction in the past to Doxazosin tablets, the active ingredient doxazosin, other types of quinazolines (such as prazosin or terazosin) or any of the other ingredients 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, as safety and efficacy have not yet been established
- 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 long standing 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 or nurse before taking this medicine
The following are reasons why doxazosin may not be suitable for you:
- If you are pregnant or trying to become pregnant
^_If you have liver disease_
- If you are also taking other medicines
- If 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.
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. This is more likely to happen when you are starting treatment or increasing the dose, 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:
You should always tell your doctor if you are taking or have recently taken any other medicine, even those not prescribed, because they might interact with doxazosin.
It is particularly important to tell your doctor or pharmacist if you are taking the following medications:
• medicines used to treat high blood pressure
• phoshodiesterase inhibitors, such as sildenafil (Viagra), tadalafil and vardenafil for erectile dysfunction
There are some medicines that may interact with doxazosin 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.
- Doxazosin may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure such as terazosin and prazosin.
DOXAZOSIN with food and drink:
Doxazosin Tablets can be taken with or without food.
□ Pregnancy and breast-feeding and fertility:
- Pregnancy
The safety of using doxazosin during pregnancy has not been established. If you are pregnant or trying to become pregnant speak to your doctor and he/she will decide if doxazosin is suitable for you.
- Breast-feeding:
Do not take doxazosin if you are breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning on having a baby, ask your doctor or pharmacist for advice before taking this medicine.
□ 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 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 medicine.
3. HOW TO TAKE DOXAZOSIN
Always take your medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults and the elderly
The recommended dose of Doxazosin Tablets is one tablet taken as a single daily dose each 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 Tablets 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.
It is important to keep taking your tablets. They help to control your blood pressure.
Doxazosin Tablets are not recommended for children If you take more Doxazosin Tablets than you should:
tell your doctor immediately or go to your nearest hospital casualty department. Too many tablets at once may make you unwell. If several tablets are taken it may be dangerous.
If you forget to take Doxazosin Tablets:
Do not worry. If you forget to take a tablet, leave that dose out completely, do not take a double does to make up for the forgotten tablets, wait and then go on as before.
If you stop taking your Doxazosin Tablets
Don't change the dose or stop taking the tablets without first checking with your doctor.
Don't wait until your tablets are finished before seeing your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Doxazosin Tablets can cause side effects although not everybody gets them.
STOP taking Doxazosin Tablets 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: Very common: (may affect more than 1 in 10 people)
Dizziness, headache
Common: (may affect up to 1 in 10 people)
- Loss of appetite, anxiety, difficulty sleeping, nervousness, drowsiness; sleepiness, spinning or movement sensation; loss of balance, dizziness on standing due to low blood pressure, shortness of breath, difficulty breathing, rapid/abnormal heartbeat, low blood pressure, feeling sleepy or tending to fall asleep, inflammation of the medium and large-sized airways of the lungs, cough, nose, throat, lungs infections, indigestion, inflammation of the nose, stomach pain, dry mouth, feeling sick, itching, back pain, muscle pain, loss of bladder control and inability to control the flow of urine, inflammation of the bladder, urinary tract infection, chest pain, weakness, flu like symptoms, extreme tiredness, swelling of the lower limbs,
Uncommon: (may affect up to 1 in 100 people)
- gout a painful build-up of uric acid in joins, increased appetite, state of anxiety or nervous excitement low mood, rapid loss of brain function due to disturbance in the blood supply to the brain, stroke ringing or buzzing in the ears, reduced sense of touch or numbness, fainting, tremor, chest pain due to lack of oxygen heart-attack, hot flushes, nose-bleed, constipation diarrhoea, passing wind, vomiting, inflammation of the stomach and intestines, abnormal liver function, skin rash, joint pain, hair loss, appearance of red or purple discolorations on the skin, muscle weakness, muscle cramps, painful or difficult urination, blood in urine, increased frequency in passing urine inability to achieve or maintain an erection, pain, swelling of the face and in some cases a hypersensitivity reaction with the closure of the throat, weight increase.
Rare: (may affect up to 1 in 1,000 people)
Passing large volumes of urine Very rare: (may affect up to 1 in 10,000 people)
- Reduction in the number of white blood cells or platelets in the blood, dizziness on standing, sensation of tingling, tickling, prickling or burning of the skin, blurred vision, slow heartbeat irregular heartbeat, wheezing, little or no bile production, inflammation of the liver, yellowing of the skin and eyes, itchy red skins welts, increased urination, inability to control urine frequency and flow, night urination, enlargement of male breast tissue, persistent and painful erection of the penis, tiredness, feeling of discomfort, illness, or uneasiness.
Not known: frequency cannot be estimated from the available data
- Post eye-surgery cataract complication (cloudiness of the lens of the eye see section 2 above), change in taste, semen entering the bladder during ejaculation.
Reporting Side Effects:
If any of the 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.
5. HOW TO STORE DOXAZOSIN TABLETS
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. The expiry date refers to the last day of that month.
There are no special storage conditions for this medicine.
Do not use this medicine if you notice any of the tablets are broken or discoloured.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFORMATION
What Doxazosin Tablets contain: The active substance is doxazosin mesilate.
Doxazosin 1mg Tablets: Each tablet contains 1.21mg doxazosin mesilate equivalent to 1mg doxazosin.
Doxazosin 2mg Tablets: Each tablet contains 2.42mg doxazosin mesilate equivalent to 2mg doxazosin.
Doxazosin 4mg Tablets: Each tablet contains 4.85mg doxazosin mesilate equivalent to 4mg doxazosin
The other ingredients are lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate and
sodium starch glycollate.
The tablets are supplied in blister packs of 28 and 30 tablets. Not all pack sizes may be marketed
What Doxazosin Tablets look like and the contents of the pack:
Doxazosin 1mg Tablets are white coloured, round and biconvex.
Doxazosin 2mg Tablets are white coloured, and capsule shaped with a break line on one side.
Doxazosin 4mg Tablets are white coloured, capsule shaped biconvex and plain on both sides.
Marketing Authorisation Holder:_
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release: Fannin (UK) Limited,
57 High Street, Odiham, Hampshire, RG29 1LF, UK.
This leaflet was last revised in July 2016_