1. Name of the medicinal product

Doxazosin 1mg Tablets Taj Pharma
Doxazosin 2mg Tablets Taj Pharma
Doxazosin 4mg Tablets Taj Pharma
Doxazosin 8mg Tablets Taj Pharma

2. Qualitative and quantitative composition

Each Tablet contains:
Doxazosin Mesylate equivalent to Doxazosin        1mg
Doxazosin Mesylate equivalent to Doxazosin        2mg
Doxazosin Mesylate equivalent to Doxazosin        4mg
Doxazosin Mesylate equivalent to Doxazosin        8mg

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablets

4. Clinical particulars

4.1 Therapeutic indications

Hypertension: Doxazosin is indicated for the treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. In patients inadequately controlled on single antihypertensive therapy, Doxazosin may be used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, calcium antagonist or an angiotensin-converting enzyme inhibitor.

Benign prostatic hyperplasia: Doxazosin is indicated for the treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). Doxazosin may be used in BPH patients who are either hypertensive or normotensive.

4.2 Posology and method of administration

Posology

Doxazosin may be administered in the morning or the evening.

Hypertension: Doxazosin is used in a once daily regimen: the initial dose is 1 mg to minimise the potential for postural hypotension and/or syncope (see section 4.4). Dosage may then be increased to 2 mg after an additional one or two weeks of therapy and thereafter, if necessary to 4 mg. The majority of patients who respond to Doxazosin will do so at a dose of 4 mg or less. Dosage can be further increased if necessary to 8 mg or the maximum recommended dose of 16 mg.

Benign prostatic hyperplasia: The recommended initial dosage of Doxazosin is 1mg given once daily to minimise the potential for postural hypotension and/or syncope (see section 4.4). Depending on the individual patient’s urodynamics and BPH symptomatology dosage may then be increased to 2 mg and thereafter to 4 mg and up to the maximum recommended dose of 8 mg. The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4 mg daily.

Paediatric population: The safety and efficacy of Doxazosin in children and adolescents have not been established.

Elderly patients: Normal adult dosage.

Hepatic/Renal impairment

Patients with renal impairment: Since there is no change in pharmacokinetics in patients with impaired renal function, the usual adult dose of Doxazosin is recommended.

Doxazosin is not dialysable.

Patients with hepatic impairment: There are only limited data in patients with liver impairment and on the effect of drugs known to influence hepatic metabolism (e.g. cimetidine). As with any drug wholly metabolised by the liver, Doxazosin should be administered with caution to patients with evidence of impaired liver function (see section 4.4 and section 5.2).

Method of administration

Oral administration.

4.3 Contraindications

Doxazosin is contraindicated in:

1. Hypersensitivity to the active substance or other types of quinazolines (e.g. prazosin, terazosin, doxazosin) or to any of the excipients listed in section 6.1.
2. Patients with a history of orthostatic hypotension.
3. Patients with benign prostatic hyperplasia and concomitant congestion of the upper urinary tract, chronic urinary tract infection or bladders stones.
4. During lactation (for the hypertension indication only; see section 4.6).
5. Patients with hypotension (for benign prostatic hyperplasia indication only).

Doxazosin is contraindicated as monotherapy in patients with either overflow bladder or anuria with or without progressive renal insufficiency.

4.4 Special warnings and precautions for use

Postural Hypotension/Syncope:

Initiation of Therapy– In relationwith the alpha-blocking properties of doxazosin, patients may experience postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness (syncope), particularly with the commencement of therapy (see section 4.2). Therefore, it is prudent medical practice to monitor blood pressure on initiation of therapy to minimise the potential for postural effects.

When instituting therapy with any effective alpha-blocker, the patient should be advised how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. The patient should be cautioned to avoid situations where injury could result, should dizziness or weakness occur during the initiation of Doxazosin therapy.

Use in patients with Acute Cardiac Conditions:

As with any other vasodilatory anti-hypertensive agent it is prudent medical practice to advise caution when administering doxazosin to patients with the following acute cardiac conditions:

– pulmonary oedema due to aortic or mirtal stenosis

– high – output cardiac failure

– right sided heart failure due to pulmonary embolism or pericardial effusion

– left ventricular heart failure with low filling pressure

Use in Hepatically Impaired patients:

As with any drug wholly metabolised by the liver, Doxazosin should be administered with particular caution to patients with evidence of impaired hepatic function (see section 4.2). Since there is no clinical experience in patients with severe hepatic impairment use in these patients is not recommended.

Use with PDE-5 Inhibitors:

Concomitant administration of doxazosin with phosphodiesterase-5-inhibitors (e.g. sildenafil, tadalafil and vardenafil) should be done with caution as both drugs have vasodilating effects and may lead to symptomatic hypotension in some patients. To reduce risk of orthostatic hypotension it is recommended to initiate the treatment with phosphodiesterase-5-inhibitors only if the patient is hemodynamically stabilized on alpha-blocker therapy. Furthermore, it is recommended to initiate phosphodiesterase-5-inhibitor treatment with the lowest possible dose and to respect a 6-hour time interval from intake of doxazosin.

Use in patients undergoing cataract surgery: The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

Priapism

Prolonged erections and priapism have been reported with alpha-1 blockers including doxazosin in post marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance.

Screening for Prostate Cancer:

Carcinoma of the prostate causes many of the symptoms associated with BPH and the two disorders can co-exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with doxazosin for treatment of BPH symptoms.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Phosphodiesterase-5-inhibitors (eg. sildenafil, tadalafil, vardenafil):

Concomitant administration of doxazosin with a PDE-5 inhibitor may lead to symptomatic hypotension in some patients (see section 4.4: Special warnings and precautions for use).

Doxazosin is highly bound to plasma proteins (98%). In vitro data in human plasma indicates that doxazosin has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin or indomethacin).

In vitro studies suggest that doxazosin is a substrate of cytochrome P450 3A4 (CYP 3A4). Caution should be exercised when concomitantly administering doxazosin with a strong CYP 3A4 inhibitor, such as clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole (see section 5.2).

Conventional doxazosin has been administered without any adverse drug interaction in clinical experience with thiazide diuretics, furosemide, beta-blocking agents, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycaemic drugs, uricosuric agents or anticoagulants. However, data from formal drug/drug interaction studies are not present.

Doxazosin potentiates the blood pressure lowering activity of other alpha-blockers and other antihypertensives.

In an open-label, randomized, placebo-controlled trial in 22 healthy male volunteers, the administration of a single 1 mg dose of doxazosin on day 1 of a four-day regimen of oral cimetidine (400 mg twice daily) resulted in a 10% increase in mean AUC of doxazosin, and no statistically significant changes in mean C_max and mean half-life of doxazosin. The 10% increase in the mean AUC for doxazosin with cimetidine is within intersubject variation (27%) of the mean AUC for doxazosin with placebo.

4.6 Fertility, pregnancy and lactation

For the hypertension indication:

Pregnancy: As there are no adequate and well-controlled studies in pregnant women, the safety of doxazosin during pregnancy has not yet been established. Accordingly, during pregnancy doxazosin should be used only when, in the opinion of the physician, the potential benefit outweighs potential risk. Although no teratogenic effects were seen in animal testing, reduced foetal survival was observed in animals at extremely high doses (see section 5.3).

Breast-feeding: The excretion of doxazosin in breast milk was demonstrated to be very low (with the relative infant dose less than 1%) however human data is very limited. A risk to the newborn or infant cannot be excluded and therefore doxazosin should be used only when in the opinion of the physician, the potential benefit outweighs the potential risk.

For the benign prostatic hyperplasia indication: This section is not applicable.

4.7 Effects on ability to drive and use machines

The ability to drive or use machinery may be impaired, especially when initiating therapy.

4.8 Undesirable effects

Hypertension: In clinical trials involving patients with hypertension, the most common reactions associated with Doxazosin therapy were of a postural type (rarely associated with fainting) or non-specific.

Benign prostatic hyperplasia: Experience in controlled clinical trials in BPH indicates a similar adverse event profile to that seen in hypertension.

The following undesirable effects have been observed and reported during treatment with Doxazosin with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.

4.9 Overdose

Should overdosage lead to hypotension, the patient should be immediately placed in a supine, head down position. Other supportive measures may be appropriate in individual cases.

If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressor should then be used. Renal function should be monitored and supported as needed.

Since Doxazosin is highly protein bound, dialysis is not indicated.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Mechanism of action

Doxazosin is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results in a decrease in systemic blood pressure. Doxazosin is appropriate for oral administration in a once daily regimen in patients with essential hypertension.

Pharmacodynamic effects

Doxazosin has been shown to be free of adverse metabolic effects and is suitable for use in patients with co-existent diabetes mellitus, gout and insulin resistance.

Doxazosin is suitable for use in patients with coexistent asthma, left ventricular hypertrophy and in elderly patients. Treatment with Doxazosin has been shown to result in regression of left ventricular hypertrophy, inhibition of platelet aggregation and enhanced activity of tissue plasminogen activator. Additionally, Doxazosin improves insulin sensitivity in patients with impairment.

Doxazosin, in addition to its antihypertensive effect, has in long term studies produced a modest reduction in plasma total cholesterol, LDL-cholesterol and triglyceride concentrations and therefore may be of particular benefit to hypertensive patients with concomitant hyperlipidaemia.

Administration of Doxazosin to patients with symptomatic BPH results in a significant improvement in urodynamics and symptoms. The effect in BPH is thought to result from selective blockade of the alpha-adrenoceptors located in the muscular stroma and capsule of the prostate, and in the bladder neck.

5.2 Pharmacokinetic properties

Absorption: Following oral administration in humans (young male adults or the elderly of either sex), Doxazosin is well absorbed and approximately two thirds of the dose is bioavailable.

Biotransformation/Elimination: Approximately 98% of doxazosin is protein-bound in plasma. Doxazosin is extensively metabolised in man and in the animal species tested, with the faeces being the predominant route of excretion.

The mean plasma elimination half-life is 22 hours thus making the drug suitable for once daily administration.

After oral administration of doxazosin the plasma concentrations of the metabolites are low. The most active (6′ hydroxy) metabolite is present in man at one fortieth of the plasma concentration of the parent compound which suggests that the antihypertensive activity is in the main due to doxazosin.

There are only limited data in patients with liver impairment and on the effects of drugs known to influence hepatic metabolism (e.g. cimetidine). In a clinical study in 12 subjects with moderate hepatic impairment, single dose administration of doxazosin resulted in an increase in AUC of 43% and a decrease in apparent oral clearance of 40%. As with any drug wholly metabolised by the liver, doxazosin should be administered with caution to patients with impaired liver function (see section 4.4).

Doxazosin is extensively metabolized in the liver. In vitro studies suggest that the primary pathway for elimination is via CYP 3A4; however CYP 2D6 and CYP 2C9 metabolic pathways are also involved for elimination, but to a lesser extent.

5.3 Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional animal studies in safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.

Although no teratogenic effects were seen in animal testing, reduced foetal survival was observed in animals at doses approximately 300 times greater than the maximum human recommended dose.

Studies in lactating rats given a single oral dose of radioactive doxazosin indicate that doxazosin accumulates in rat milk with a maximum of concentration about 20 times greater than the maternal plasma concentration.

6. Pharmaceutical particulars

6.1 List of excipients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, sodium starch glycolate (type A) & colloidal anhydrous silica.

6.2 Incompatibilities

None.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Aluminium PVC/PVDC blister:

Available in pack of 10, 20, 28, 50, 60, 100 Tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Doxazosin 1mg, 2mg, 4mg, 8mg Tablets Taj Pharma

Patient Leaflet: Information for the User

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.
• Doxazosin is a treatment for high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.
• 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.
• You should take Doxazosin regularly to get the maximum benefit, even if you are feeling well.
• Most people do not have serious problems when taking Doxazosin but side effects can occur. If you experience swelling of the face, tongue or windpipe, see your doctor immediately. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines.
• If you are, or are trying to become pregnant, do not take Doxazosin and tell your doctor or pharmacist.

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 medicines called alpha-blockers. Doxazosin tablets are used to treat high blood pressure (hypertension) or the symptoms caused by enlargement of the prostate gland in men. In patients taking Doxazosin to treat high blood pressure (hypertension) Doxazosin works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure. In patients with enlargement of the prostate gland, Doxazosin is taken to treat frequent and/ or poor passing of urine. This is common in patients with enlargement of the 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:

• are allergic to doxazosin, other types of quinazolines (such as prazosin or terazosin) or any of the other ingredients of Doxazosin tablets listed in section 6. This may have been itching, reddening of the skin or difficulty in breathing.
• are breastfeeding
• have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure
• 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
• have an enlarged prostate gland with one of the following: any kind of congestion or blockage in your urinary tract, a longstanding infection of the urinary tract or you have bladder stones
• 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 before taking Doxazosin:

• If you have liver disease
• If you are pregnant or trying to become pregnant
• 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.

Before starting treatment with Doxazosin your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia (enlargement of the prostate gland). Persistent painful erections may occur very rarely. If this happens you should contact a doctor immediately.

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. 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 is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established. Benign prostate hyperplasia is not relevant in children.

Other medicines and Doxazosin:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. There are some medicines that may interact with Doxazosin. Ask your doctor or pharmacist before use if you are taking any of these medicines as they may change the effect of Doxazosin. 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 medicines called PDE 5 inhibitors for the treatment of erectile dysfunction (impotence) with alpha-blockers e.g. sildenafil, tadalafil, vardenafil (please see Section “Warnings and precautions”. 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 high blood pressure.

• Medicines to treat bacterial or fungal infections, e.g. clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole
• Medicines used in the treatment of HIV e.g. indinavir, nelfinavir, ritonavir, saquinavir
• Nefazodone, a medicine used to treat depression

Doxazosin with food and drink

Please refer to section 3.

Pregnancy, breast-feeding and fertility:

The safety of using Doxazosin during pregnancy has not been established. If you are pregnant or planning to have a baby, ask your doctor or pharmacist for advise before taking this medicine. Do not take Doxazosin if you are breast-feeding.

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 you are affected, do not drive or operate machinery and contact your doctor immediately.

Doxazosin contains lactose: This medicine 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

Use in adults and elderly:

Always take Doxazosin exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Doxazosin is usually taken once daily. Doxazosin may be taken in the morning or the evening. You can take your tablets before or after food. You should take your tablets at the same time each day with a small amount of water. The initial dose of Doxazosin is 1mg once daily. Thereafter the dose may be gradually increased (within 1-2 weeks interval) to the recommended dose (2mg or 4mg daily). In some circumstances the dose 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. You have been given a calendar pack that will help you remember to take your tablets. If you are taking more than one tablet a day, you must ignore the marking for the day, printed on the back of the blister. Because high blood pressure is treated in order to prevent problems from arising, you may have no symptoms at all while taking Doxazosin. Even if this is so and you feel well, you should not stop taking your blood pressure medication unless instructed to by your doctor. 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. If you have impression that the effect of Doxazosin is too strong or too weak, talk to your doctor or pharmacist.

Use in children and adolescents

The safety and efficacy of Doxazosin in children and adolescents have not been established.

If you take more Doxazosin than you should:

Too many tablets at once may make you unwell. If several tablets are taken it may be dangerous.

Tell your doctor immediately or go to your nearest hospital casualty department.

If you forget to take Doxazosin: Do not worry.

If you forget to take a tablet, leave that dose out completely. Then go on as before. Do not take a double dose to make up for a forgotten tablet.

4. Possible Side Effects

Like all medicines, Doxazosin can have side effects although not everybody gets them.

STOP taking Doxazosin 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:

• Shortness of breath, difficulty breathing (common: may affect up to 1 in 10 people)
• Increased, or decreased heartbeat (common: may affect up to 1 in 10 people)
• Feeling your heartbeat (palpitations) (common: may affect up to 1 in 10 people)
• Chest pain, angina (uncommon: may affect up to 1 in 100 people)
• Irregular heartbeat (very rare: may affect up to 1 in 10,000 people)
• Yellowing of the skin or the eyes (jaundice) (very rare: may affect up to 1 in 10,000 people)
• Low numbers of white blood cells or blood platelets, which may result in increasing frequency of infection, bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people)
• Persistent painful erection of the penis. Seek urgent medical advice (very rare: may affect up to 1 in 10,000 people)

Other side effects: The following events have been reported in patients being treated with doxazosin. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Common (may affect up to 1 in 10 people)

• Dizziness, feeling of spinning or rotation of surroundings (vertigo), headache
• Low blood pressure
• Swelling of feet, ankles or fingers
• Chest cold, 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 bladder (cystitis)
• Sleepiness, general weakness
• Indigestion, heartburn, dry mouth
• Itching
• Back pain, painful muscles
• Flu-like symptoms

Uncommon (may affect up to 1 in 100 people)

• Constipation, wind, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhoea and vomiting
• Pain or discomfort on passing urine, increased frequency in passing urine, blood in urine
• Inflammation of the joints (gout), painful joints, general pain
• Swelling of the face
• Sleeplessness, agitation, anxiety, depression or nervousness
• Reduced or altered sense of touch or sensation of the hands and feet
• Increased appetite or loss of appetite, weight gain
• Nose bleeds
• Skin rash
• Ringing or noise in the ears, tremor
• Failure/ inability to achieve penile erection
• Liver enzyme increases which may have an effect on some medical tests
• Stroke

Rare (may affect up to 1 in 1,000 people)

• Increased number of times of passing urine
• Muscle cramps, muscle weakness

Very rare (may affect up to 1 in 10,000 people)

• 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
• Tiredness, generally feeling unwell
• Aggravated wheezing
• Blurred vision
• Hot flushes
• Disorder in passing urine, needing to pass urine at night, increased volume of urine passed
• Discomfort or enlargement of the breasts in men

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 2. “Warnings 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.

5. How to Store Doxazosin

Store below 25°C. Keep out of the sight and reach of children. Check the expiry date on the label. Do not use the tablets if the expiry date has passed.

6. Contents of the Pack and Other Information

What Doxazosin contains

The active substance is: doxazosin.

Doxazosin Mesylate equivalent to Doxazosin        1mg
Doxazosin Mesylate equivalent to Doxazosin        2mg
Doxazosin Mesylate equivalent to Doxazosin        4mg
Doxazosin Mesylate equivalent to Doxazosin        8mg

The other ingredients are: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, sodium starch glycolate (type A) and colloidal anhydrous silica.

What Doxazosin looks like and contents of the pack

Aluminium PVC/PVDC blister:

Available in pack of 10, 20, 28, 50, 60, 100 Tablets.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com