Acino Pharma AG


Ceutical Trading
Chong Ruan Trading
Full Prescribing Info
Doxazosin mesylate.
Each tablet contains 4.85 mg or 9.70 mg doxazosin mesilate equivalent to 4 mg or 8 mg doxazosin, respectively.
Excipients/Inactive Ingredients: Tablet core: polyethylene oxide, microcrystalline cellulose, povidone, α-tocopherol, colloidal anhydrous silica and sodium stearyl fumarate.
Tablet coating: methacrylic acid-ethyl acrylate copolymer, colloidal anhydrous silica, macrogol and titanium dioxide (E171).
DOXINO is one of a group of medicines called alpha-blockers.
DOXINO 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 male patients with an enlarged prostate gland, DOXINO is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. DOXINO works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.
DOXINO is used to treat high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.
Dosage/Direction for Use
Always take DOXINO exactly as prescribed by the doctor. Patient should check with the doctor or pharmacist if not sure.
DOXINO is a modified release tablet. The medicine is contained within a non-absorbable shell that has been specially designed to slowly release the medicine. Once swallowed, DOXINO is slowly released into the body from the tablet, until the tablet is empty.
Since the empty tablet is eliminated from the body in bowel movements, something that looks like a tablet may occasionally be observed in the stools. This is to be expected and nothing to be concerned about.
The recommended dose is: The usual dose of DOXINO is one 4 mg modified release tablet taken as a single daily dose each day.
The doctor may wish to increase the dose to 8 mg. This is the maximum dose of DOXINO.
Swallow DOXINO whole with water. Do not chew, divide or crush the tablets.
Take the tablets as prescribed by the doctor.
If still not sure, ask the doctor or pharmacist.
It is important to keep taking the tablets. They help to control the blood pressure or urinary problems.
Don't change the dose or stop taking the tablets without first checking with the doctor.
Don't wait until the tablets are finished before seeing the doctor.
If the patient forgets to take DOXINO: Do not take a double dose to make up for a forgotten tablet. Skip the missed dose and take the next tablet at the usual time.
If the patient stops taking DOXINO: Unless the doctor recommends, the patient should not stop taking the tablets even if he/she feels better. The doctor will advise the patient on how long he/she should continue to take the tablets.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Taking too many tablets at once may make the patient unwell. If several tablets are taken it may be dangerous. Tell the doctor immediately or go to the nearest hospital casualty department immediately.
Do not take DOXINO: If the patient have had an allergic reaction in the past to DOXINO, the active ingredient doxazosin, other types of quinazolines (such as prazosin or terazosin), or any of the other ingredients listed in Description. This may have been itching, reddening of the skin or difficulty in breathing.
If the patient is breast-feeding.
If the patient has any form of obstruction of the digestive tract.
If the patient is under 18 years of age.
If the patient has a history of a condition known as 'orthostatic hypotension' which is a form of low blood pressure that causes the patient to feel dizzy or light-headed when he/she stands up from sitting or lying down.
If the patient is male and have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure.
If the patient has an enlarged prostate gland with one of the following: any kind of congestion or blockage in the patient's urinary tract, a longstanding infection of the urinary tract or the patient have bladder stones.
If the patient have overflow incontinence (the patient do not feel the urge to urinate), or anuria (the patient's body is not producing any urine) with or without kidney problems.
Special Precautions
Talk to the doctor or pharmacist before taking this medicine.
The following are reasons why DOXINO may not be suitable for the patient: If the patient is pregnant or trying to become pregnant; if the patient has liver disease; if the patient has heart disease; if the patient is also taking other medicines.
If the patient is undergoing eye surgery because of cataract (cloudiness of the lens of the eye) the eye specialist must be informed before the operation that the patient is using or have previously used DOXINO. This is because DOXINO may cause complications during the surgery which can be managed if the specialist is prepared in advance.
If any of these apply to the patient he/she should speak to the doctor before taking this medicine.
When the patient starts to take DOXINO the patient may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If the patient feels faint or dizzy, the patient should sit or lie down until the patient feels better and avoid situations where the patient might fall or hurt himself/herself.
The doctor may want to measure the patient's blood pressure regularly at the start of therapy to reduce the possibility of these effects happening.
Driving and using machinery: Care must be taken if the patient drives or operates machinery. The tablets may affect the patient's ability to drive or operate machinery safely, particularly when the patient first starts to take them. DOXINO may make the patient feels weak or dizzy. If affected, do not drive or operate machinery and contact the doctor immediately.
Use in Children: Do not give this medicine to children and adolescents as the safety and efficacy of DOXINO in patients under 18 years have not been established.
Use In Pregnancy & Lactation
The safety of using DOXINO during pregnancy has not been established. If the patient is pregnant or trying to become pregnant she must speak to the doctor and the doctor will decide if DOXINO is suitable for her.
Do not take DOXINO if the patient is breast-feeding.
Side Effects
Like all medicines, DOXINO can cause side effects although not everybody gets them.
STOP taking DOXINO and call an ambulance immediately if the patient experiences 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 the doctor immediately if the patient experiences any of the following symptoms after taking DOXINO: Chest pain, angina.
Shortness of breath, difficulty breathing, wheezing.
Increased, decreased or irregular heartbeat.
Feeling the patient's heartbeat (palpitations).
Skin rash or itching (especially the whole body).
Yellowing of the skin or the eyes (jaundice).
Low numbers of white blood cells or blood platelets, which may result in bruising or easy bleeding.
The following events have been reported in patients being treated with DOXINO. If any of these side effects get serious, or if the patient notices any side effects not listed, please tell the doctor.
Common side effects: These can affect up to 1 in 10 patients: Dizziness, feeling of spinning or rotation of surroundings (vertigo), headache.
Low blood pressure.
Swelling of feet, ankles or fingers.
Bronchitis, 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 the bladder (cystitis).
Sleepiness, general weakness.
Indigestion, heartburn, dry mouth.
Back pain, painful muscles.
Flu-like symptoms.
Uncommon side effects: These can affect up to 1 in 100 patients: Constipation, wind, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhoea and vomiting.
Pain or discomfort on passing urine, needing to pass urine more often than usual, blood in urine.
Inflammation of the joints (gout), painful joints, general pain.
Swelling of the face.
Sleeplessness, anxiety, depression.
Reduced or altered sense of touch or sensation of the hands and feet.
Increased appetite or loss of appetite, weight gain.
Nose bleeds.
Ringing in the ears, tremor.
Failure/ inability to achieve penile erection.
Abnormal results for blood tests which show changes in the way the liver is working.
Very Rare side effects: These can affect up to 1 in 10,000 patients: 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.
Agitation, nervousness.
Tiredness, generally feeling unwell.
Aggravated wheezing.
Muscle cramps, muscle weakness.
Blurred vision.
Disorder in passing urine, needing to pass urine at night, increased volume of urine passed, increased production of urine causing an increase in the number of times of passing urine.
Discomfort or enlargement of the breasts in men.
Painful persistent erection of the penis.
Other side effects: The frequency of these side effects is unknown: 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 Precautions.
If any of the side effects gets serious, or if the patient notices any side effects not listed, please tell the doctor.
Drug Interactions
Tell the doctor or pharmacist if the patient is taking, have recently taken or might take any other medicines.
There are some medicines that may interact with DOXINO: Some male 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, the patient should be on a regular daily dose of alpha blocker before starting drugs for erectile dysfunction.
Doxino may lower the patient's blood pressure even more if the patient is already taking other medicines to treat high blood pressure such as terazosin and prazosin.
Always tell the doctor if the patient is taking or have recently taken any other medicine, even those not prescribed, because they might interact with DOXINO.
DOXINO with food and drink: DOXINO can be taken with or without food.
Keep the tablets out of the reach and sight of children.
Do not store above 25°C.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to throw away medicines which are no longer used. These measures will help protect the environment.
The tablets should be whole to work effectively, if the patient notices any defects (such as broken tablets) consult the pharmacist immediately.
ATC Classification
C02CA04 - doxazosin ; Belongs to the class of alpha-adrenoreceptor antagonists, peripherally-acting antiadrenergic agents. Used in the treatment of hypertension.
PR tab 4 mg (white, round, biconvex film-coated tablet with bossing "DL" on one side) x 28's, 98's. 8 mg (white to off-white, round, biconvex film-coated tablet with bossing "DH" on one side) x 28's.
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