Doxzogen Xl 4 Mg Prolonged-Release Tablets
• decreased feeling or sensitivity, especially in the skin
• passing blood in the urine (haematuria)
• failure or inability to get and maintain erection
• pain
• painful urination
• abnormal sensitivity or intolerance of your eyes to light
• increase in tear flow
• weight gain
•reduced blood flow to your arms and feet
Rare (may affect up to 1 in 1,000 people)
• swelling of the voice box (larynx) causing a hoarse voice
• low blood sugar
Very rare (affects less than 1 user in 10,000)
• blood changes
• an increase in blood of creatinine levels and urea
• low white blood cells which may cause infections
• agitation
• nervousness
• blurred vision
• aggravated wheezing and coughing (bronchospasm)
• condition in which the flow of the bile from the liver is blocked (cholestasis)
• yellowing of skin or the eyes (jaundice)
• passing more urine than normal
• disorder in passing urine
• needing to pass urine at night
• enlargement of breasts in men
• persistent painful erection
• sensation of tingling, pricking or numbness of skin (paraesthesia)
• dizziness on standing. This is more likely to happen at the beginning of treatment
• hair loss
• hives
• bruising because of bleeding into the skin (purpura)
• muscle cramps
• muscle weakness
• hot flushes
• fatigue
• generally feeling unwell
• low body temperature in the elderly
Not known (frequency cannot be estimated from the available data)
• eye problems during eye surgery for cataract which is a condition with cloudiness of the lens of the eye (intraoperative floppy iris syndrome (IFIS)
• abnormal ejaculation
If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.
5. HOWTO STORE DOXZOGEN XL 4 mg PROLONGED-RELEASE TABLETS
Keep this medicine out of the sightand reach of children. Do not use this medicine after the expiry date which is stated on the blister and carton.
This medicinal product does not require any special storage conditions.
Do not throw any medicines via wastewater or household waste. Askyour 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 Doxzogen XL 4 mg Prolonged-Release Tablets contains: The active substance is 4 mg of doxazosin as doxazosin mesilate.The other ingredients are macrogol, microcrystalline cellulose, povidone, butylhydroxytoluene (E321), alpha-tocopherol, anhydrous colloidal silica, sodium stearyl fumarate, methacrylic acid copolymerand titanium dioxide (El 71).
What Doxzogen XL 4 mg Prolonged-Release Tablets looks like and contents of the pack:
Doxzogen XL Prolonged-Release Tablets are white, round, biconvex tablets with bossing 'DL'.
PVC/PVDC/aluminium blisters:
Pack sizes: 10, 28, 20,30, 50, 56,60, 90,98,100,140
(10x14) tablets
Calendar packs of 28 and 98
Unit dose 50 x 1
HDPE tablet container:
Pack sizes: 100,250 tablets
Not all packs sizes may be marketed
Marketing Authorisation Holder: Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer:
Gerard Laboratories, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary
This leaflet was last revised in 12/2013.
365521
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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, askyour 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 side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Package leaflet: Information for the user
DOXZOGEN XL 4 mg PROLONGED-RELEASE TABLETS
(doxazosin)
What is in this leaflet:
1. What Doxzogen XL 4 mg Prolonged-Release Tablets is and what it is used for
2. What you need to know before you take Doxzogen XL 4 mg Prolonged-Release Tablets
3. How to take Doxzogen XL 4 mg Prolonged-Release Tablets
4. Possible side effects
5. How to store Doxzogen XL 4 mg Prolonged-Release Tablets
6. Contents of the pack and other information
1. WHAT DOXZOGEN XL 4 mg PROLONGED-RELEASE TABLET IS AND WHAT IT IS USED FOR
Your medicine is in the form of a 'prolonged-release' tablet. It contains Doxazosin, which belongs to a group of medicines called alpha-blockers. Doxzogen XL 4 mg Prolonged-Release Tablets can treat high blood pressure (hypertension) by relaxing the blood vessels in the body and lowering blood pressure.
Doxzogen XL 4 mg Prolonged-Release Tablets can also be given to men suffering from an enlarged prostate gland, as it can relax the muscles allowing urine to be passed more easily.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXZOGEN XL 4 mg PROLONGED-RELEASE TABLETS
Do not take Doxzogen XL 4 mg Prolonged-Release Tablets:
• if you are allergic to doxazosin, or any of the other ingredients of this medicine (listed in section 6) or other quinazolines (e.g. prazosin, terazosin)
• have a history of a condition known as 'orthostatic hypotension' which is a form of low pressure that causes you to feel dizzy or light-headed when you stand up from sitting or lying down
• if you have or have had constipation
• if you have low pressure
• if you have benign prostate hyperplasia and simultaneous regular infections of the upper urinary tract, impeded urinary flow or bladder stones
• during breast-feeding (see Pregnancy and lactation)
• 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
• if you have kidney problems such as bladder stones, difficulty passing urine or suffer from frequent urine infections.
Warnings and precautions
• Talk to you doctor or pharmacist before taking Doxzogen XL 4 mg Prolonged-ReleaseTablets:if you have heart disease or a heart condition
• if you have liver problems
• if you have diabetes
• if you need a blood test as Doxzogen XL 4 mg Prolonged-Release Tablets can affect some test results.
Tell your doctor if any of the above apply to you.
When you start to take Doxzogen XL 4 mg Prolonged-Release Tablets you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting 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 hurtyourself.Your doctor may want to measure your blood pressure regularly at the start of therapy to reduce the possibility of these effects happening.
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 Doxzogen XL 4 mg Prolonged-Release Tablets. This is because Doxzogen XL 4 mg Prolonged-Release Tablets may cause complications during the surgery which can be managed if your specialist is prepared in advance.
Other medicines and Doxzogen XL 4 mg Prolonged-Release Tablets:
Tell your doctor or pharmacist if you are already taking, have recently taken or might take any other medicines:
• other medicines to lower blood pressure
• painkillers called non-steroidal antiinflammatory medicine (NSAIDs) eg. Ibuprofen
• medicines containing estrogen
• medicines containing dopamine, metaraminol, methoxamine, adrenaline (epinephrine), cough and cold remedies as they may contain Ephedrine, Phenylephrine.
• Medicines (PDE-5 inhibitors, e.g. sildenafil, tadalafil, vardenafil) used in the treatment of sexual dysfunction characterised by the inability to develop or maintain an erection (erectile dysfunction).
Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostrate 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 the drug 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 the drugs for erectile dysfunction.
Doxzogen XL 4 mg Prolonged-Release Tablets with food and drink:
Doxzogen XL 4 mg Prolonged-Release Tablets can be taken with or without food.
Pregnancy and breast-feeding:
Do not take Doxzogen XL 4 mg Prolonged-Release Tablets if you are pregnant or breast-feeding.
If you are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, askyour doctor or pharmacist before taking this medicine.
Driving and using machines:
Do not drive or operate machinery if you feel less alert while taking this medicine. This is more likely atthe start of treatment or if the doctor increases your dose.
3. HOW TO TAKE DOXZOGEN XL 4 mg PROLONGED-RELEASE TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults including the elderly:
The recommended starting dose is one Doxzogen XL4 mg Prolonged-ReleaseTabletoncea day. If necessary, your doctor may increase this dose to the maximum of two tablets once a day.
To treat hypertension, your doctor may give you another medicine to take along with Doxzogen XL 4 mg Prolonged-Release Tablets. Doxzogen XL 4 mg Prolonged-Release Tablets is unlikely to affect your blood pressure unless you suffer from hypertension.
Your prolonged release tablets have been specially designed to slowly release the medicine from the tablet shell. The shell does not break down but passes through your body. The empty tablet will be passed out in your stools. Do not worry if sometimes you notice the tablet shell in your stools.
Use in children and adolescents
Doxzogen XL 4 mg Prolonged-Release Tablet is not recommended for use in paediatric patients under the age of 18 years due to missing data on its efficacy and safety.
Use in patients with liver problems
Your doctor may reduce your dose or monitor your progress closely. Doxazosin XL 4 mg Prolonged-Release Tablet is not recommended for use in patients with severe liver problems.
Method of administration
• Swallow the tablets whole with a full glass of water
• Take with or without food
• Do not chew, break or crush the tablets
If you take more Doxzogen XL 4 mg Prolonged-Release Tablets than you should:
Contact your doctor or nearest hospital casualty department immediately.Take any remaining tablets and the container with you.
If you forget to take Doxzogen XL 4 mg Prolonged-Release Tablets:
Take it as soon as you remember. If it is almost time for your next dose though, do not double the dose, just carry on as before.
If you stop taking Doxzogen XL 4 mg Prolonged-Release tablets:
Do not suddenly stop taking your medicine as this may cause serious changes in your blood pressure.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like most medicines, this medicine can sometimes cause side effects, although not everybody gets them.
STOP taking Doxzogen XL 4 mg Prolonged-Release Tablets and call an ambulance if you experience any of the following:
• heart attack (uncommon)
• collapse, numbness or weakness of arms or, legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, or problems speaking such
as slurred speech and loss of speech which may be symptoms of stroke (uncommon)
• swelling of the face, tongue or throat, which may be the result of an allergic reaction to this medicine (uncommon)
• angina pectoris (common)
• increased, decreased or irregular heartbeat (common, very rare)
• a liver disease causing dark urine, pale stools, yellowing of the skin, nausea, fever (hepatitis) (very rare)
Other side effects:
Common (may affect up to 1 in 10 people)
• dizziness
• sleepiness
• flu like symptoms
• indigestion
• breathlessness
• swelling of the feetand hands
• runny and blocked nose
• palpitations
• delayed ejaculation
• headache
• chest pain
• infection of the kidney or bladder (urinary tract infection)
• (nose, throat and, lungsjinfection (respiratory tract infection)
• spinning sensation (vertigo)
• unusual weakness
• low blood pressure feeling sick
light-headedness when standing up
back pain "CO"
muscle pain '
abdominal pain dry mouth
inflammation of the airways
(bronchitis)
coughing
itching
bladder infection
inability to control passing urine (urinary incontinence) difficulty in focusing or blurred vision (accommodation disturbances) apathy
swelling of different parts of the body (oedema)
Uncommon (may effect up to 1 to 100 people)
swelling of the face and body feeling faint being sick
cold fingers and toes (peripheral ischaemia) sore swollen throat low blood potassium feeling thirsty
painful, swollen joints due to accumulation of uric
acid (gout)
nightmares
loss of memory
mood changes
tremor
muscle stiffness ringing in the ears
loss of bladder control or less frequent urge to pass urine joint pain
increase in appetite changes in taste allergic drug reaction difficulty in sleeping loss of appetite feeling nervous diarrhoea paleness
fever or shivering
constipation
wind
inflammation of the stomach and intestines
(gastroenteritis)
abnormal liver function tests
skin rash
depression