Doxazosin 4mg Tablets
Package leaflet: Information for the patient Doxazosin 1 mg, 2 mg and 4 mg Tablets.
Read all of this leaflet carefully before you start 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 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 of the 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 is one of a group of medicine called alpha-blockers. It is used to treat high blood pressure or the symptoms caused by enlargement of the prostate gland in men.
Doxazosin is used to treat the following:
• High blood pressure (hypertension), they works by relaxing blood vessels so that blood passes through them more easily, and helps to lower blood pressure.
• Urinary outflow obstruction and symptoms associated with an enlarged prostate gland (benign prostatic hyperplacia). It works by relaxing muscle around the bladder exit and the prostate gland so urine is passed more easily.
2. What you need to know before you take Doxazosin Do not take Doxazosin if:
You are allergic (hypersensitive) to Doxazosin or any of the other ingredients of this medicine (listed in section 6).This may have been itching, reddening of skin or difficulty in breathing.
• You are breast feeding
• You have history of a condition known as “orthostatic hypotension” which is a form of low blood pressure that causes you to feel dizzy and light-headed when you stand up from sitting or lying down
• You have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure
• You have an enlarged prostate gland and you have any kind of congestion or blockage of the urinary tract, a long standing 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 urine) with or without kidney problems.
Warnings and precautions
Talk to your doctor before taking Doxazosin:
• If you are pregnant or trying to become pregnant or breast-feeding.
• If you have liver disease.
• If you are taking other medicines (See section “Other medicines and Doxazosin).
• 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 taking or have previously taken Doxazosin Tablets. This is because Doxazosin may cause complication during surgery which can be managed in your specialist is prepared in advance.
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 when 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.
Children and adolescents
Doxazosin tablets are not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established.
Other medicines and Doxazosin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
• Medicines which may interact with or be affected by Doxazosin:
• Other blood pressure lowering medicines as the blood pressure lowering effect of these medicines may be increased
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
• Oestrogens (female hormones)
• Dopamine, ephedrine, epinephrine, metaramizol, methoxamine and phenylephrine. (medicines used for the treatment of heart problems and low blood pressure)
• Medicines used to treat erection problems e.g. 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.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Do not take Doxazosin if you are pregnant or planning to become pregnant. Doxazosin should be used in pregnant women only after the doctor has carefully weighed expected benefits against potential risks.
Breast-feeding
Do not take Doxazosin if you are breast-feeding as it is not known if Doxazosin is passed into breast milk.
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. In some people Doxazosin can cause side effects such as drowsiness, dizziness. If you have these side effects do not drive or use machinery.
Doxazosin Tablets contains 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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
The usual dose of Doxazosin is one tablet taken as a single daily dose each day.
Normally you will start this therapy with 1 mg doxazosin once daily. Your doctor may increase this, after 1-2 weeks to the usual dose of 2 mg or 4 mg daily.. If necessary this may be increased to a maximum daily dose of 8 mg doxazosin if you are being treated for prostate enlargement and 16 mg doxazosin if you are being treated for high blood pressure.
• These tablets are to be taken orally.
• The tablets can be taken either in the morning or evening.
• It is best to take your tablets at about the same time each day with a drink of water.
• The score line on the tablet (2mg & 4mg strengths only) is only there to help you break the tablet if you have difficulty swallowing it whole.
If you take more Doxazosin than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. The most likely symptoms of overdose would be a feeling of light-headedness or dizziness due to a fall in blood pressure.
If you forget to take Doxazosin
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Doxazosin
It is important that you keep taking Doxazosin Tablets for as long as your doctor has told you to. They help to control your blood pressure. Do not change the dose or stop taking the tablets without first checking with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms:
• Chest pains, shortness of breath, difficulty breathing
• Rapid, slow or irregular heartbeat, feeling your heartbeat
• Fainting (Syncope)
• Weakness of arms, legs or problems speaking (Cerebrovascular accident)
• Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness
• Inflammation of liver (Hepatitis) or yellowing of the skin or the eyes (Jaundice)
Common side effects (may affect up to 1 in 10people)
• bronchitis, coughing, respiratory tract (nose, throat and lungs) infection
• urinary tract infection, urinary incontinence (inability to control passing urine), inflammation
of bladder (cystitis)
• sleepiness, general weakness
• sleepiness or drowsiness (somnolence), dizziness, feeling of spinning or rotation of surroundings (vertigo), headachelow blood pressure
• faintness or dizziness caused by low blood pressure when getting up from a sitting or lying position
• nasal stuffiness, sneezing and/or runny nose caused by inflammation of the lining of the nose (rhinitis)
• stomach/abdominal pains, feeling/being sick
• indigestion, heartburn, dry mouth
• itching
• back pain, painful muscles
• swelling of feet, ankles or fingers
• flu-like symptoms
• weakness or lack of strength
Uncommon side effects (may affect up to 1 in 100 people)
• inflammation of the joints (gout), painful joints, general pain
• increase appetite or loss of appetite, weight gain
• sleeplessness, agitation, anxiety, depression or nervousness
• reduced or altered sense of touch or sensation of the hands and feet
• shaking (tremor)
• ringing in the ears (tinnitus)
• nose bleeds
• constipation, wind, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhea and vomiting
• abnormal results for blood tests which show changes in the way the liver is working
• pain or discomfort on passing urine, needing to pass urine more often than usual, blood in urine
• failure/inability to maintain an erection
• swelling of the face
Rare side effects (may affect up to 1 in 1,000 people)
• muscle cramps, muscle weakness
• increased number of times of passing urine
Very rare side effects (may affect up to 1 in 10,000 people)
• reduction in white blood cells, which may make infections more likely (leucopenia)
• reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• tingling or numbness of the hands and feet
• blurred vision
• hot flushes
• build up of bile acids in the bloodstream causing persistent itch (cholestasis)
• hives, hair loss, red or purple patches on the skin, bleeding under the skin
• an increased desire or need to pass urine, disorder in passing urine, needing to pass urine at night
• discomfort or enlargement of the breasts in men
• painful persistent erection of the penis
• tiredness, generally feeling unwell
Not known: frequency cannot be estimated from the 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 “Warning and precautions”.
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 internet 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
• 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/blister after EXP. The expiry date refers to the last day of that month.
• Do not store above 30 °C
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 to protect the environment.
6. Contents of the pack and other information What Doxazosin contains:
• Each 1 mg tablet contains 1.21 mg of doxazosin mesilate equivalent to 1 mg of doxazosin.
• Each 2 mg tablet contains 2.42 mg of doxazosin mesilate equivalent to 2 mg of doxazosin.
• Each 4 mg tablet contains 4.85 mg of doxazosin mesilate equivalent to 4 mg of doxazosin.
The other ingredients are: Lactose monohydrate, microcrystalline cellulose, sodium starch glycollate (Type A), sodium laurilsulfate, magnesium stearate.
What Doxazosin look like and the contents of the pack:
• Doxazosin 1mg are round, biconvex, white tablets with no marking and an approximate diameter of 6.8-7.2 mm.
• Doxazosin 2 mg are oblong, biconvex, scored, white tablets with no marking and an approximate diameter of 8.8-9.2 mm x 4.3-4.7 mm.
• Doxazosin 4 mg are oblong, biconvex, scored, white tablets with no marking and an approximate diameter of 11.8-12.2 mm x 5.8-6.2 mm.
Doxazosin tablets are available in blister pack of 28 tablets
Marketing Authorisation Holder:
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St Neots
Cambridgeshire
PE19 8ET
UK
Manufacturer:
Salutas Pharma GmbH Otto-von-Guericke Allee 1 D-39179 Barleben Germany
Doxazosin 1 mg Tablets PL11311/0128 Doxazosin 2 mg Tablets PL11311/0129 Doxazosin 4 mg Tablets PL11311/0130
This leaflet was last revised in October 2015 TiU-Ver.Us