Doxazosin Zentiva: detailed information

Package leaflet: Information for the patient

Doxazosin Zentiva

2 mg tablets
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Doxazosin Zentiva is and what it is used for
What you need to know before taking Doxazosin Zentiva
How to take Doxazosin Zentiva
Possible side effects
How to store Doxazosin Zentiva
Contents of the pack and other information

1. What Doxazosin Zentiva is and what it is used for

Doxazosin Zentiva contains the active substance doxazosin, which belongs to a group of medicines called alpha-blockers, also known as vasodilators. These medicines dilate the blood vessels, resulting in a lowering of blood pressure. Doxazosin Zentiva can also reduce muscle tension in the prostate and urinary tract.
Doxazosin Zentiva is used in the treatment of:

High blood pressure
Benign enlargement of the prostate.

2. What you need to know before taking Doxazosin Zentiva

Do not take Doxazosin Zentiva

If you are allergic to doxazosin, to other types of quinazolines (such as prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6).
If you are breastfeeding.
If, in addition to benign enlargement of the prostate (benign prostatic hyperplasia), you suffer from excessively low blood pressure.
If, in addition to benign enlargement of the prostate (benign prostatic hyperplasia), you suffer from orthostatic hypotension, a form of low blood pressure that causes dizziness or lightheadedness when standing up from a sitting or lying position.
If, in addition to benign enlargement of the prostate (benign prostatic hyperplasia), you suffer from an upper urinary tract infection, chronic urinary infection, or bladder stones.
If you have a particular type of urinary incontinence involving involuntary urine leakage due to an overfilled bladder (overflow incontinence), or if you produce insufficient urine or no urine at all (anuria), with or without progressive loss of kidney function (deteriorating nephropathy).

Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosin Zentiva.
At the beginning of treatment, especially if you are elderly or have kidney or liver disease, if you regularly follow a low-sodium diet, or if you are taking diuretics, you may be more sensitive to the effects of Doxazosin Zentiva. This sensitivity may result in increased episodes of dizziness, weakness, or fainting (syncope) (see section 4). If you feel weak, dizzy, or faint, sit or lie down until you feel better and avoid situations where dizziness or weakness could lead to injury, such as while driving or operating machinery. Your doctor may decide to monitor your blood pressure regularly at the start of treatment to reduce the risk of these side effects. Contact your doctor if dizziness or weakness worsens.
If you are scheduled for cataract surgery (a condition involving clouding of the lens), inform your ophthalmologist before the procedure that you are currently taking or have previously taken Doxazosin Zentiva. This is because Doxazosin Zentiva may cause complications during surgery, which can be managed if the specialist is informed in advance.
Inform your doctor or pharmacist before taking Doxazosin Zentiva if any of the following apply to you, as Doxazosin Zentiva should be used with caution in these cases:

If you have a serious heart condition. In cases of severe heart disease, symptoms may worsen due to a pronounced or sudden drop in blood pressure.
If you are taking Doxazosin Zentiva together with a medicine that affects liver metabolism (e.g. the anti-acid cimetidine). Inform your doctor about all medicines you are taking.
If you are diabetic and also have nerve fiber degeneration (diabetic autonomic neuropathy).
If you have impaired liver function. In this case, the use of Doxazosin Zentiva is not recommended.
If you are taking medicines for erectile dysfunction (impotence), known as phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil, and vardenafil), as both medicines lower blood pressure by dilating blood vessels. Taking Doxazosin Zentiva together with these medicines may cause excessive lowering of blood pressure (see "Other medicines and Doxazosin Zentiva"). To reduce the likelihood of symptoms occurring, you should first start treatment with Doxazosin Zentiva by taking a regular daily dose. Once your Doxazosin Zentiva treatment is stabilized, you may then begin taking medicines for erectile dysfunction.

Prolonged painful erections of the penis
These may occur very rarely. If this happens, contact a doctor immediately.
Children and adolescents
Doxazosin Zentiva is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of the treatment have not been established.
Other medicines and Doxazosin Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist before use if you are taking any of the following medicines, as they may affect the action of Doxazosin Zentiva:

Medicines called phosphodiesterase type 5 inhibitors used to treat erectile dysfunction (impotence), such as sildenafil, tadalafil, and vardenafil (see "Warnings and precautions").
Medicines that stimulate a specific part of the nervous system (sympathomimetics), which may reduce the blood pressure-lowering effect. Examples of such medicines include natural substances such as dopamine, ephedrine, and epinephrine, the antihypertensive drug metaraminol, and eye drops used to dilate the pupils (phenylephrine).
Medicines that lower blood pressure, as Doxazosin Zentiva may influence the hypotensive effect of these medicines.
Vasodilators and medicines (nitrates) used to treat cramp-like chest pain (angina pectoris), which may enhance the hypotensive effect.
Medicines used to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
Medicines used for the treatment of HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
Nefazodone, a medicine used to treat depression.

Administration of doxazosin in standard formulations does not result in interactions with thiazide diuretics, furosemide, beta-blockers, NSAIDs, antibiotics, oral hypoglycemics, uricosuric agents, or anticoagulants.
Some patients receiving alpha-blockers for the treatment of high blood pressure or prostate enlargement may experience dizziness or a sensation of lightheadedness, which may be caused by a drop in blood pressure upon sitting or standing up quickly.
Doxazosin Zentiva with food, drinks, and alcohol
The effect of Doxazosin Zentiva is not altered by food or drinks.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of Doxazosin Zentiva during pregnancy has not been established. Therefore, your doctor will prescribe Doxazosin Zentiva only if the potential benefits outweigh the risks.
Breastfeeding
Small amounts of doxazosin may pass into breast milk. Do not take Doxazosin Zentiva if you are breastfeeding. Breastfeeding must be discontinued if you need to start treatment with Doxazosin Zentiva (see "Do not take Doxazosin Zentiva").
Driving and using machines
Be cautious if driving or operating machinery. These tablets may cause weakness or dizziness and may impair your ability to drive or operate machinery safely, especially at the beginning of treatment. If you experience side effects such as dizziness or weakness, do not drive or operate machinery and contact your doctor immediately.
Doxazosin Zentiva 2 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Doxazosin Zentiva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Doxazosin Zentiva should be taken once daily with water. It is advisable to take it at the same time each day.
It is recommended to take the first dose at bedtime due to possible side effects at the beginning of treatment (such as dizziness and weakness).

Usual dose:
High blood pressure
The recommended starting dose is 1 mg once daily. The dose is usually increased at intervals of 1 or 2 weeks.
After one or two weeks, your doctor may increase the dose to 2 mg daily. If necessary, after a further period of one or two weeks, your doctor may increase the dose again to 4 mg daily. After another one or two weeks, and if needed, your doctor may further increase the dose to 8 mg daily, until the blood pressure is reduced to the desired level. In some cases, the dose may be increased up to a maximum of 16 mg daily.
The usual dose range is 2–4 mg daily. The maximum recommended dose is 16 mg daily. If necessary, your doctor may prescribe additional medicines to be taken together with Doxazosin Zentiva to achieve the desired effect.

Benign prostatic hyperplasia
The recommended starting dose is 1 mg once daily. The dose is usually increased at intervals of 1 or 2 weeks. The usual dose range is between 2 and 4 mg daily. The maximum dose is 8 mg daily.

Use in paediatric patients
Doxazosin Zentiva is not indicated for use in children and adolescents.

Duration of treatment
Your doctor will provide further information. Depending on your blood pressure, your doctor will decide whether or not the dose should be reduced. It is not advisable to stop treatment with Doxazosin Zentiva without first consulting your doctor.

If you take more Doxazosin Zentiva than you should
If you realize you have taken more than the prescribed amount, contact your doctor immediately, as low blood pressure may make you feel unwell. Lie down immediately in a supine position with your head low. Contact your doctor or go immediately to the nearest hospital emergency department, taking any remaining tablets with you.

If you forget to take Doxazosin Zentiva
If you forget to take your dose, do not take it later. Simply skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Doxazosin Zentiva
It is not advisable to stop treatment with Doxazosin Zentiva without consulting your doctor. If your doctor decides that treatment can be stopped, the dose should be reduced gradually. Abruptly stopping Doxazosin Zentiva may cause an increase in blood pressure.

For further information on the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them. If any of the side effects worsen or if you notice any side effects not listed in this leaflet, consult your doctor or pharmacist.
If you experience any of the following symptoms, STOP treatment with Doxazosin Zentiva and call an
ambulance immediately:

chest pain, pain in the chest (angina, myocardial infarction);
shortness of breath (dyspnea), accompanied by discomfort and tightness in the chest (bronchospasm);
sudden headache, feeling of fainting, weakness in arms or legs, or difficulty speaking, which could be symptoms of a stroke;
swelling of the face and allergic reactions.

Inform your doctor immediately if you experience any of the following symptoms after taking Doxazosin Zentiva:

fast, slow, or irregular heartbeat;
awareness of your own heartbeat (palpitations);
yellowing of the skin or eyes (jaundice);
low number of white blood cells or platelets in the blood. These conditions may lead to an increased susceptibility to infections or increased bruising or tendency to bleed, respectively.

In patients treated with Doxazosin Zentiva, the following adverse events have also been reported:

Common side effects (may affect up to 1 in 10 people)

dizziness, spinning sensation (vertigo), headache;
low blood pressure or drop in blood pressure when moving from a sitting or lying position to a standing position (orthostatic hypotension);
swelling of feet, ankles, or fingers;
bronchitis, cough, respiratory tract infection (nose, throat, lungs);
stuffy nose, sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis);
abdominal pain, nausea;
urinary tract infection, urinary incontinence (inability to control or retain urine), bladder inflammation (cystitis);
drowsiness, generalised weakness;
feeling of fullness and discomfort in the stomach, dry mouth;
itching;
accommodation disorders;
chest pain, back pain, muscle pain;
flu-like symptoms.

Uncommon side effects (may affect up to 1 in 100 people)

constipation, flatulence, inflammation of the stomach and intestine (gastroenteritis) which may cause diarrhoea and vomiting;
pain or discomfort when urinating, need to urinate more often than usual, blood in the urine;
swelling and inflammation of the joints (gout), joint pain, generalised pain;
swelling of the face;
insomnia, restlessness, anxiety, depression or nervousness;
temporary loss of consciousness;
reduced or altered sensitivity to touch in hands and feet;
increased or decreased appetite, weight gain;
nosebleeds;
skin rash;
abnormal eye tearing, photophobia;
ringing or buzzing in the ears (tinnitus), tremor;
inability/inability to achieve or maintain penile erection;
increased liver enzymes, which may affect certain medical tests.

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

increased frequency of needing to urinate;
blurred vision, conjunctivitis;
muscle cramps, muscle weakness.

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

hepatitis (liver inflammation) or biliary disorder (cholestasis);
urticaria, hair loss, red or purple spots on the skin due to bleeding under the skin or mucous membranes (purpura);
tingling or numbness in hands and feet;
fatigue, feeling of general malaise;
blurred vision;
hot flushes;
urinary problems, need to urinate at night, increased urine volume;
breast enlargement in men;
persistent painful erection of the penis. Seek immediate medical attention;
sudden dizziness accompanied by loss of balance.

Other side effects (frequency cannot be determined from available data)

retrograde ejaculation (semen is ejaculated not externally but into the bladder), which may cause cloudy urine after orgasm;
intraoperative floppy iris syndrome (IFIS) (see section "Warnings and precautions");
eye problems may occur during cataract surgery (clouding of the lens). See section "Warnings and precautions".

In some cases
Increased levels of nitrogen and creatinine in the blood, decreased red blood cells. At the start of treatment, orthostatic hypotension may occur and – in rare cases – syncope, particularly at higher doses. These events may also occur when treatment is resumed after a short interruption. At the beginning of treatment, a drop in blood pressure may occur when rapidly changing from a sitting or lying position to a standing position. This effect may be accompanied by dizziness (orthostatic hypotension) and, in rare cases, even loss of consciousness lasting from a few seconds to several hours (syncope), especially at higher doses.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Doxazosin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "exp." The expiry date refers to the last day of the month.
Store the medicine in its original packaging.
Keep the container tightly closed.

This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Doxazosin Zentiva contains

The active substance is doxazosin mesilate. One tablet contains 2.43 mg of doxazosin mesilate, equivalent to 2 mg of doxazosin.
The other excipients are microcrystalline cellulose, monohydrate lactose, sodium starch glycolate, magnesium stearate, sodium lauryl sulphate, anhydrous colloidal silica, and sunset yellow FCF (E110).

Description of the appearance of Doxazosin Zentiva and pack contents
Doxazosin Zentiva 2 mg tablet is a light pink-orange tablet, with a break line engraved on both sides and the inscription “DZS 2” engraved on one side.
Doxazosin Zentiva 2 mg is available in boxes of 30 tablets in blister packs or in hospital packs (EAV packaging) containing 50 tablets.
Doxazosin Zentiva 2 mg is also available in containers of 30, 100 or 500 tablets, with child-resistant closure.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l. - Viale Bodio 37/b, 20158 Milano, Italy

Manufacturers
Synthon B.V. - Microweg 22, 6545 CM Nijmegen, The Netherlands
Synthon Hispania, S.L. - Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat, Spain

This leaflet was last updated on:

Patient Information Leaflet

Doxazosin Zentiva

4 mg tablets
Generic medicine
Please read this leaflet carefully before using this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Doxazosin Zentiva is and what it is used for
What you need to know before taking Doxazosin Zentiva
How to take Doxazosin Zentiva
Possible side effects
How to store Doxazosin Zentiva
Contents of the pack and other information

1. What Doxazosin Zentiva is and what it is used for

Doxazosin Zentiva is used to treat:

High blood pressure
Benign enlargement of the prostate gland.

2. What you need to know before taking Doxazosin Zentiva

Do not take Doxazosin Zentiva

If you are allergic to doxazosin, to other types of quinazolines (such as prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6).
If you are breastfeeding.
If, in addition to benign enlargement of the prostate (benign prostatic hyperplasia), you suffer from excessively low blood pressure.
If, in addition to benign enlargement of the prostate (benign prostatic hyperplasia), you suffer from orthostatic hypotension, a form of low blood pressure causing dizziness or lightheadedness when standing up from a sitting or lying position.
If, in addition to benign enlargement of the prostate (benign prostatic hyperplasia), you suffer from an upper urinary tract infection, chronic urinary infection, or bladder stones.
If you suffer from a specific type of urinary incontinence involving involuntary urine leakage due to an overfilled bladder (overflow incontinence), or if you produce little or no urine (anuria), with or without progressive loss of kidney function (deteriorating nephropathy).

Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosin Zentiva.
At the beginning of treatment, especially if you are elderly or have kidney or liver disease, if you regularly follow a low-sodium diet, or if you are taking diuretics, you may be more sensitive to the effects of Doxazosin Zentiva. This sensitivity may manifest as an increased occurrence of dizziness, weakness, or fainting (syncope) (see section 4). If you experience weakness, dizziness, or fainting, sit or lie down until you feel better and avoid situations where dizziness or weakness could lead to injury, such as driving or operating machinery. Your doctor may decide to monitor your blood pressure regularly at the start of treatment to reduce the risk of these side effects. Consult your doctor if dizziness or weakness worsens.
If you are scheduled for cataract surgery (a condition involving clouding of the lens), inform your ophthalmologist before the procedure that you are currently taking or have previously taken Doxazosin Zentiva. This is because Doxazosin Zentiva may cause complications during surgery, which can be managed if the specialist is informed in advance.
Inform your doctor or pharmacist before taking Doxazosin Zentiva if any of the following conditions apply to you, as Doxazosin Zentiva should be used with caution in these cases:

If you have a serious heart condition. In cases of severe heart disease, symptoms may worsen due to a pronounced or sudden drop in blood pressure.
If you are taking Doxazosin Zentiva together with a medicine that affects liver metabolism (e.g. the anti-acid cimetidine). Inform your doctor about all medicines you are taking.
If you are diabetic and also have nerve fiber degeneration (diabetic autonomic neuropathy).
If you have impaired liver function. In this case, use of Doxazosin Zentiva is not recommended.
If you are taking medicines for erectile dysfunction (impotence), called phosphodiesterase-5 inhibitors (e.g. sildenafil, tadalafil, and vardenafil), as both medicines lower blood pressure by dilating blood vessels. Taking Doxazosin Zentiva together with these medicines may cause excessive lowering of blood pressure (see “Other medicines and Doxazosin Zentiva”). To reduce the likelihood of symptoms occurring, you should first start treatment with Doxazosin Zentiva, taking a regular daily dose. Once your treatment with Doxazosin Zentiva is stabilized, you may then begin taking medicines for erectile dysfunction.

Prolonged painful erections of the penis
These may occur very rarely. If this happens, contact a doctor immediately.
Children and adolescents
Doxazosin Zentiva is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of treatment have not been established.
Other medicines and Doxazosin Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist before use if you are taking any of the following medicines, as they may affect the action of Doxazosin Zentiva:

Medicines called phosphodiesterase-5 inhibitors used to treat erectile dysfunction (impotence), such as sildenafil, tadalafil, and vardenafil (see “Warnings and precautions”).
Medicines that stimulate a specific part of the nervous system (sympathomimetics), which may reduce the blood pressure-lowering effect. Examples include natural substances such as dopamine, ephedrine, and epinephrine, the antihypotensive drug metaraminol, and pupil-dilating eye drops (phenylephrine).
Medicines that lower blood pressure, as Doxazosin Zentiva may influence the hypotensive effect of these medicines.
Vasodilators and medicines (nitrates) used to treat cramp-like chest pain (angina pectoris), which may enhance the hypotensive effect.
Medicines used to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
Medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
Nefazodone, a medicine used to treat depression.

Administration of doxazosin in standard formulations does not result in interactions with thiazide diuretics, furosemide, beta-blockers, NSAIDs, antibiotics, oral hypoglycemics, uricosuric agents, or anticoagulants.
Some patients receiving alpha-blockers for high blood pressure or prostate enlargement may experience dizziness or a sensation of lightheadedness, which may be caused by a drop in blood pressure upon sitting or standing up quickly.
Doxazosin Zentiva with food, drinks, and alcohol
The effect of Doxazosin Zentiva is not altered by food or drinks.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety of Doxazosin Zentiva during pregnancy has not been established. Therefore, your doctor will prescribe Doxazosin Zentiva only if the potential benefits outweigh the risks.
Breastfeeding
Small amounts of doxazosin may pass into breast milk. Do not take Doxazosin Zentiva if you are breastfeeding. Breastfeeding must be discontinued if you need to start treatment with Doxazosin Zentiva (see “Do not take Doxazosin Zentiva”).
Driving and using machines
Exercise caution when driving or operating machinery. These tablets may cause weakness or dizziness and could impair your ability to drive or operate machinery safely, especially at the beginning of treatment. If you experience side effects such as dizziness or weakness, do not drive or operate machinery and contact your doctor immediately.
Doxazosin Zentiva 4 mg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Doxazosin Zentiva

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Doxazosin Zentiva should be taken once daily with water. It is advisable to take it at the same time each day.
It is recommended to take the first dose at bedtime due to possible side effects at the beginning of treatment (such as dizziness and weakness).

Normal dosage:
High blood pressure
The recommended starting dose is 1 mg once daily. The dose is usually increased at intervals of 1 or 2 weeks.
After one or two weeks, your doctor may increase your dose to 2 mg daily. If necessary, after a further period of one or two weeks, your doctor may increase the dose again to 4 mg daily. After another one- or two-week period, and if needed, your doctor may further increase the dose to 8 mg daily, until your blood pressure reaches the desired level. In some cases, the dose may be increased up to a maximum of 16 mg daily.
The usual dose is 2–4 mg daily. The maximum recommended dose is 16 mg daily. If necessary, your doctor may prescribe additional medicines to be taken together with Doxazosin Zentiva to achieve the desired effect.

Benign prostatic hyperplasia
The recommended starting dose is 1 mg once daily. The dose is usually increased at intervals of 1 or 2 weeks. The usual dose ranges between 2 and 4 mg daily. The maximum dose is 8 mg daily.

Use in paediatric population
Doxazosin Zentiva is not indicated in children and adolescents.

Duration of treatment
Your doctor will provide further information. Based on your blood pressure, your doctor will decide whether or not your dose should be reduced. It is not advisable to stop treatment with Doxazosin Zentiva without first consulting your doctor.

If you take more Doxazosin Zentiva than you should
If you realize you have taken more than the prescribed amount, contact your doctor immediately, as a drop in blood pressure could make you feel unwell. Lie down immediately in a supine position with your head low. Contact your doctor or go immediately to the nearest hospital emergency department, and bring any remaining tablets with you.

If you forget to take Doxazosin Zentiva
If you forget to take Doxazosin Zentiva, do not take it later. Simply skip the missed dose and take the next dose at your usual time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Doxazosin Zentiva
It is not advisable to stop treatment with Doxazosin Zentiva without consulting your doctor. If your doctor decides that treatment can be stopped, the dose should be gradually reduced. Stopping Doxazosin Zentiva treatment suddenly may cause an increase in blood pressure.

For further information on the use of this product, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If any of the side effects worsen or if you notice any side effects not listed in this leaflet, consult your doctor or pharmacist.
If you experience any of the following symptoms, STOP taking Doxazosin Zentiva and call an
ambulance immediately:

chest pain, pain in the chest (angina, myocardial infarction);
sensation of difficulty breathing (dyspnoea), accompanied by discomfort and tightness in the chest (bronchospasm);
sudden headache, feeling of fainting, weakness in the arms or legs, or difficulty speaking, which could be symptoms of a stroke;
swelling of the face and allergic reactions.

Inform your doctor immediately if, after taking Doxazosin Zentiva, you experience any of the following symptoms:

fast, slow or irregular heartbeat;
awareness of your own heartbeat (palpitations);
yellowing of the skin or eyes (jaundice);
low number of white blood cells or platelets in the blood. These conditions may lead to an increased susceptibility to infections or increased bruising or tendency to bleed, respectively.

The following adverse events have also been reported in patients treated with Doxazosin Zentiva.

Common side effects (may affect up to 1 in 10 people)

sensation of dizziness or spinning (vertigo), headache;
low blood pressure or drop in blood pressure when moving from a sitting or lying position to a standing position (orthostatic hypotension);
swelling of feet, ankles or fingers;
bronchitis, cough, respiratory tract infection (nose, throat, lungs);
stuffy nose, sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis);
abdominal pain, nausea;
urinary tract infection, urinary incontinence (inability to control or retain urine), bladder inflammation (cystitis);
drowsiness, generalized weakness;
feeling of fullness and discomfort in the stomach, dry mouth;
itching;
accommodation disorders;
chest pain, back pain, muscle pain;
flu-like symptoms.

Uncommon side effects (may affect up to 1 in 100 people)

constipation, flatulence, inflammation of the stomach and intestine (gastroenteritis) which may cause diarrhoea and vomiting;
pain or discomfort when urinating, need to urinate more often than usual, blood in the urine;
swelling and inflammation of joints (gout), joint pain, generalized pain;
facial swelling;
insomnia, restlessness, anxiety, depression or nervousness;
temporary loss of consciousness;
reduced or altered sensitivity to touch in hands and feet;
increased or decreased appetite, weight gain;
nosebleeds;
skin rash;
abnormal eye tearing, photophobia;
ringing or buzzing in the ears (tinnitus), tremor;
inability/inability to achieve or maintain penile erection;
increased liver enzymes, which may affect certain medical tests.

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

increased frequency of needing to urinate;
blurred vision, conjunctivitis;
muscle cramps, muscle weakness.

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

hepatitis (inflammation of the liver) or biliary disorder (cholestasis);
urticaria, hair loss, red or purple spots on the skin due to bleeding under the skin or mucous membranes (purpura);
tingling or numbness in hands and feet;
fatigue, general feeling of malaise;
blurred vision;
hot flushes;
urinary disturbances, need to urinate at night, increased urine volume;
breast enlargement in men;
prolonged painful erection of the penis. Seek medical advice immediately;
sudden dizziness accompanied by loss of balance.

Other side effects (frequency cannot be determined from available data)

retrograde ejaculation (semen is ejaculated not externally but into the bladder), which may cause cloudy urine after orgasm;
intraoperative floppy iris syndrome (IFIS) (see section "Warnings and precautions");
eye problems may occur during cataract surgery (clouding of the lens). See section "Warnings and precautions".

In some cases
Increased levels of nitrogen and creatinine in the blood, decreased red blood cells. At the start of treatment, orthostatic hypotension may occur and – in rare cases – syncope, particularly at higher doses. These events may also occur when treatment is resumed after a short interruption. At the beginning of treatment, a drop in blood pressure may occur when rapidly changing from a sitting or lying position to a standing position; this effect may be accompanied by dizziness (orthostatic hypotension) and, in rare cases, even by loss of consciousness lasting from a few seconds to several hours (syncope), especially at higher doses.

5. How to store Doxazosin Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "exp". The expiry date refers to the last day of the month.
Store the medicine in the original packaging.
Keep the container tightly closed.

6. Package contents and other information

What Doxazosin Zentiva contains

The active substance is doxazosin mesylate. One tablet contains 4.85 mg of doxazosin mesylate, equivalent to 4 mg of doxazosin.
The other excipients are microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica, and sunset yellow FCF (E110).

Description of the appearance of Doxazosin Zentiva and contents of the pack
Doxazosin Zentiva 4 mg tablet is a light pink-orange tablet, with a breakline engraved on both sides and the code "DZS4" engraved on one side.
Doxazosin Zentiva 4 mg is available in boxes of 20 and 30 tablets in blister packs, or in hospital packs (EAV packaging) containing 50 tablets.
Doxazosin Zentiva 4 mg is also available in containers of 30, 100 or 500 tablets, with child-resistant closure.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l. - Viale Bodio 37/b, 20158 Milan, Italy

Manufacturers
Synthon B.V. - Microweg 22, 6545 CM Nijmegen (The Netherlands)
Synthon Hispania, S.L. - Castelló 1, Polígono Las Salinas, 08830 Sant Boi de Llobregat (Spain)

This leaflet was last updated on: