Doxazosin 4mg Tablets
TEXT FOR NON-MARKETED PACKS PIL FOR
DOXAZOSIN 1MG, 2MG AND 4MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Doxazosin 1mg, 2mg and 4mg Tablets
Doxazosin Mesilate
Read all of this leaflet carefully before you start taking this medicine.
- 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 symptoms are the same as yours.
- If any of the side-effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Doxazosin Tablets are and what they are used for
2. Before you take Doxazosin Tablets
3. How to take Doxazosin Tablets
4. Possible side-effects
5. How to store Doxazosin Tablets
6. Further information
1. What Doxazosin Tablets are and what they are used for
The active ingredient in your tablets, doxazosin belongs to a group of medicines know as alpha-1 antagonists. Doxazosin is used to treat the following conditions:
- High blood pressure. If left uncontrolled, high blood pressure can increase the risk of heart disease or stroke.
Doxazosin works by widening your blood vesssels making it easier for your heart to pump blood through them. This helps to lower raised blood pressure and reduce the risk of heart disease.
2. Before you take Doxazosin Tablets
Doxazosin is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established.
Do not take Doxazosin Tablets
- if you have ever suffered an allergic reaction to the active ingredient, doxazosin, or any of the other ingredients listed at the end of the leaflet. Allergic reactions may be, for example, itching, reddening of the skin or difficulty breathing.
- if you know that you are sensitive to quinazolines (e.g. prazosin, terazosin). Quinazolines is the chemical family of medicines to which doxazosin belongs.
- if you are breast-feeding
- if you have any form of obstruction of the digestive tract.
- if you have a history of blood pressure dropping on standing
- if you suffer from enlarged prostate gland
- if you have a problem with your bladder or passing urine
- if you are under 16 years of age.
Take special care with Doxazosin Tablets
- if you have liver problems
- if you have a heart condition
- if you have a disorder of the blood vessels of the brain
- if you have a tendency to fainting or dizziness (hypotension)
- if you suffer from accumulation of fluid on the lungs.
Before surgery and anaesthesia (even at the dentist), you should tell the doctor or dentist that you are taking Doxazosin Tablets.
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 Tablets. This is because Doxazosin Tablets may cause complications during the surgery which can be managed if your specialist is prepared in advance.
Taking other medicines
Tell your doctor if you are already taking any of the following:
-Non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen
- Other medicines used in the treatment of high blood pressure, e.g. ramipril, bisoprolol, nifedipine, tamsulosin
- Oestrogens (female hormones)
- Dopamine, ephedrine, adrenaline, metaraminol, methoxamine, phenylephrine (medicines used for the treatment of heart problems)
- Drugs called monoamine oxidase inhibitors (MAOI’s) used to treat depression
- Drugs used for the treatment of erection problems (PDE-5 inhibitors, e.g. sildenafil (viagra), 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 erection problems (impotence) with alpha-blockers such as Doxazosin. In order to reduce the likelihood of these symptoms occurring, you should be on a regular daily dose of your alpha-blocker before you start drugs for erection problems.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Doxazosin with food and drink
Doxazosin can be taken with or after food.
Pregnancy and breast-feeding
Do not take Doxazosin if you are pregnant, trying to become pregnant or if you are breast-feeding. Speak to your doctor first.
Driving and using machines
Doxazosin may influence your ability to drive and use machines. If you feel dizzy or light-headed, you must not drive or operate machinery. Be especially careful when you take your first dose or if your dose is increased. Also be careful if you are starting to take your medicine again after not having taken it for some time.
Important information about the ingredients of Doxazosin Tablets
Doxazosin tablets contain lactose. If you have been told by your doctor that you have an intolerance to some
DOXAZOSIN 1MG, 2MG AND 4MG TABLETS
sugars, contact your doctor before taking this medicinal product. Doxazosin 2 and 4mg tablets also contain the colouring agent sunset yellow FCF (E110). This ingredient may cause allergic reactions.
3. How to take Doxazosin Tablets
You must keep taking your Doxazosin Tablets exactly as your doctor has told you. The directions should be given on the label. You should check with your doctor or pharmacist if you are not sure.
Adults and the elderly
Doxazosin is taken once daily. The dose is adjusted according to your blood pressure decrease and your response to Doxazosin. The initial dose is 1mg once daily. Thereafter the dose will be gradually increased (e.g. 2, 4 or 8mg daily) for up to four weeks. The maximum daily dose of Doxazosin is 16mg. Doxazosin can 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.
Children
Doxazosin should not be used in children under 16 years of age.
If you take more Doxazosin Tablets than you should
If you take too many tablets you should lie down on your back with your feet higher than your head. The most likely symptoms of overdose would be a feeling of light-headedness or dizziness due to a fall in blood pressure. If you have any of these symptoms you should tell your doctor or pharmacist or go to your accident and emergency department immediately
If you forget to take Doxazosin Tablets
If you miss a dose, do not worry. Simply take the next day’s tablet when it is due. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Doxazosin Tablets
Keep taking your tablets until your doctor tells you to stop.
Please read the back of this leaflet.
*Trademark
4.Possible side-effects
Like all medicines, Doxazosin can cause side-effects, although not everybody gets them. The evaluation of the side-effects is based on the following frequencies:
|
Not known: |
Frequency cannot be estimated from the available data |
|
Very rare: |
In less than 1 in 10,000 patients treated, including single reports |
|
Rare: |
In less than 1 in 1,000, but more than 1 in 10,000 patients treated |
|
Uncommon: |
In less than 1 in 100, but more than 1 in 1,000 patients treated |
|
Common: |
In less than 1 in 10, but more than 1 in 100 patients treated |
|
Very common: |
In more than 1 in 10 patients treated |
If you experience any of the following very rare or uncommon unwanted effects you should tell your doctor immediately:
- slow heartbeat
- bronchial spasms (wheezing and tightness in the chest)
- raised red patches on the skin
- increased passing of urine
- excessive urination at night
- changes in the number of cells in the blood, which may result in easy bleeding
- blurred vision
-jaundice (yellowing of the skin)
- hepatitis (inflammation of the liver)
- blocked bile flow (yellowing of the skin, clay or white coloured faeces, stomach pain)
- abnormal liver function tests
- development of breasts in males
- painful persistent erection in males
Uncommon side-effects include:
- ringing or noise in the ears
- increased appetite
- wind
- being sick
- gastroenteritis (upset stomach)
- delayed or difficult passage of faeces
- pain
- muscle cramps
- muscle weakness
- gout (painful inflammation of the joints)
- painful joints
- trembling or shaking
- reduced sense of touch
- fainting
- stroke (sudden loss of consciousness)
- nosebleed
- a feeling or irregular heartbeat
- angina pectoris (sudden brief attacks of pain in the centre of the chest)
- heart attack
- facial swelling
- loss of hair
- skin rash
- purple rash caused by bleeding under the skin
- pain when passing urine or a change to the frequency of urination
- urinary incontinence (leakage or urine)
- increased volume of urine passed
- blood in the urine
- hot flushes (redness of the face)
- allergic drug reaction
- weight increase
- abnormal liver function tests
- agitation
- depression
- erection problems.
Other side-effects whose frequency is not know include:
- little or no semen ejaculated at sexual climax in males; cloudy urine following sexual climax
- altered sense of taste or loss of taste
- Intraoperative Floppy Iris Syndrome (leads to problems in cataract surgery).
However you should tell your doctor if any of the following common symptoms are severe or become troublesome:
- vertigo (a feeling of dizziness or ‘spinning’)
- mouth dryness
- stomach pain
- diarrhoea (upset stomach)
- feeling sick or being sick
- indigestion (difficulty digesting food and a burning sensation at top of stomach)
- malaise (feeling unwell)
- flu-like symptoms
- oedema (swelling)
- fatigue
- weakness
- painful muscles and back pain
- headache
- dizziness
- postural dizziness (dizziness as a result of getting up from a sitting or lying position)
- drowsiness
- insomnia (inability to sleep)
- sensation of prickling or tingling on the skin with unknown cause
- cough
- difficulty in breathing
- bronchitis
- nasal stuffiness and/or runny nose
- infection in the lungs, windpipe or urinary tray
- heart palpitations
- increased heart rate
- chest pain
- itching
- cystitis
- inability to pass urine
- low blood pressure
- anorexia (loss of appetite)
- nervousness.
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: 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 out of the sight and reach of children.
Do not use Doxazosin Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month. Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Further information What Doxazosin Tablets contain
The active substance is doxazosin mesilate.
The other ingredients are microcrystalline cellulose, lactose monohydrate sodium starch glycolate, magnesium stearate, sodium lauryl sulphate and colloidal silicon dioxide.
Sunset yellow FCF (E110) is an additional ingredient present in the 2mg and 4mg tablets.
What Doxazosin Tablets look like and the contents of the pack
Doxazosin 1mg tablets are white to off-white biconvex uncoated tablets, scored with a division mark and embossed with ‘DZS1’ on one side.
Doxazosin 2mg tablets are light orange to pink biconvex uncoated tablets, scored with a division mark and
DOXAZOSIN 1MG, 2MG AND 4MG TABLETS
embossed with ‘DZS2’ on one side.
Doxazosin 4mg tablets are light orange to pink biconvex uncoated tablets, scored with a division mark and embossed with ‘DZS4’ on one side.
They are supplied in cartons of 28 or 56 tablets in foil blister strips.
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PL 06831/0091 Doxazosin 1mg Tablets
PL 06831/0092 Doxazosin 2mg Tablets
PL 06831/0093 Doxazosin 4mg Tablets
Marketing Authorisation Holder:
Genus Pharmaceuticals Linthwaite Huddersfield HD7 5QH, UK
Manufacturer:
Synthon BV
Microweg 22, 6545 CM Nijmegen The Netherlands.
Synthon Hispania SL
Castello 1, Poligono Las Salinas
08830 Sant Boi de Llobregat, Spain.
This leaflet was last revised in June 2015
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