Doxazosin Doc Generici

Italy
Brand name Doxazosin Doc Generici
Form tablets
Active substance / Dosage
DOXAZOSIN MESYLATE
Prescription type Prescription only
ATC code
C02CA04
Registration number 037397
Manufacturer DOC GENERICI SRL

Table of Contents

Patient Information Leaflet

DOXAZOSIN DOC Generici 2mg tablets

Generic medicine
Please read all of this leaflet carefully before you start taking 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 other people, even if they have the same symptoms as you, because it may be harmful to them.
  • If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What DOXAZOSIN DOC Generici is and what it is used for
  2. What you need to know before taking DOXAZOSIN DOC Generici
  3. How to take DOXAZOSIN DOC Generici
  4. Possible side effects
  5. How to store DOXAZOSIN DOC Generici
  6. Contents of the pack and other information

1. What DOXAZOSIN DOC Generici is and what it is used for

DOXAZOSIN DOC Generici belongs to a group of medicines known as vasodilators. These
substances cause widening of the blood vessels, thereby reducing blood pressure.
DOXAZOSIN DOC Generici may also reduce the tension of the muscle tissue in the prostate
and urinary tract.
It is used for:

  • high blood pressure;
  • treatment of symptoms of benign prostatic hyperplasia (enlarged prostate).

2. What you need to know before taking DOXAZOSIN DOC Generici

Do not take DOXAZOSIN DOC Generici

  • If you are allergic to doxazosin, to other medicines in the same group (known as quinazolines, e.g. prazosin and terazosin) or to any of the other ingredients of this medicine (listed in section 6);
  • If you are breastfeeding;
  • If you have an enlarged prostate (benign prostatic hyperplasia) and have low blood pressure;
  • If you have a history of a condition known as "orthostatic hypotension", a form of low blood pressure causing dizziness or lightheadedness when standing up from sitting or lying down;
  • If you have an enlarged prostate with any of the following consequences: any type of urinary tract congestion or blockage, a persistent urinary tract infection, or bladder stones;
  • You must not take doxazosin alone as monotherapy if you have overflow incontinence (you do not feel the urge to urinate) or anuria (your body does not produce urine), with or without progressive kidney problems.

Warnings and precautions
The following are reasons why DOXAZOSIN DOC Generici may not be suitable for you:

  • If you have liver disease;
  • If you are taking other medicines (see section 2 “Other medicines and DOXAZOSIN DOC Generici”);
  • If you have heart conditions.

If you are undergoing eye surgery due to cataract
(opacification of the lens), please inform your ophthalmologist before the procedure that you are
currently taking or have previously taken doxazosin. This is because doxazosin may cause
intraoperative complications during surgery, which can be managed if your doctor is informed
in advance.
Talk to your doctor before taking DOXAZOSIN DOC Generici.
When you start taking doxazosin, you may experience weakness or dizziness caused by
low blood pressure when standing up from a sitting or lying position. If you feel weak or dizzy,
sit or lie down until you feel better and avoid situations where you might fall or injure yourself.
Your doctor may want to monitor your blood pressure at regular intervals at the beginning of
treatment to reduce the likelihood of these effects occurring.

Children and adolescents
The use of DOXAZOSIN DOC Generici is not recommended in children or adolescents under
18 years of age, as safety and efficacy have not yet been established.

Other medicines and DOXAZOSIN DOC Generici
Some medicines may interact with doxazosin:

  • Some patients taking alpha-blockers for high blood pressure or enlarged prostate have reported dizziness or mental confusion, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) together with alpha-blockers. To reduce the likelihood of such symptoms, you should already be on a stable daily dose of the alpha-blocker before starting treatment with erectile dysfunction medicines. In addition, your doctor should start you on the lowest possible dose of erectile dysfunction medicines, and you should take them at least six hours after taking doxazosin. No studies have been conducted with doxazosin in prolonged-release formulations.
  • Doxazosin may further lower your blood pressure if you are already taking other medicines for high blood pressure, such as terazosin and prazosin.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
The safety of using doxazosin during pregnancy has not been established. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Do not take doxazosin if you are breastfeeding.

Driving and using machines
Be cautious if driving or operating machinery. The tablets may affect your ability to drive and use machines safely, especially when you first start taking them. The tablets may make you feel weak or cause dizziness. In such cases, do not drive or operate machinery and contact your doctor immediately.

DOXAZOSIN DOC Generici contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your
doctor before taking this medicine.

3. How to take DOXAZOSIN DOC Generici

Take this medicine exactly as directed by your doctor. If you
have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
HIGH BLOOD PRESSURE
The initial dose is 1 mg once daily (= 24 hours). After 1, 2
weeks, the dose is generally increased to 2 mg once daily (= 24 hours).
This dose is maintained for 1, 2 weeks. If necessary, the dose may be
further increased up to 4, 8, or 16 mg daily, until the desired
reduction in blood pressure is achieved. The maximum daily dose is 16 mg. The initial dose
should preferably be taken before going to bed; this helps ensure that any dizziness that may
occur does not become problematic.
ENLARGED PROSTATE
The initial dose is 1 mg once daily (= 24 hours) from day 1 to day 8.
From day 8 to day 14, take one 2 mg tablet daily. If the effect after 1, 2 weeks
is not sufficient, the dose may be increased to 4 mg daily. In some cases, the dose
may be increased up to a maximum of 8 mg daily (= 24 hours).
The tablets should be taken as a single daily dose (= 24 hours). The tablets should be taken
with plenty of water (± one full glass). The tablet may be divided into equal parts.
If you take more DOXAZOSIN DOC Generici than you should
If you have taken more doxazosin than prescribed, you must immediately
contact your doctor and/or pharmacist. If you feel extremely dizzy or think you might faint,
lie down immediately with your head low.
If you forget to take DOXAZOSIN DOC Generici
If you forget to take a tablet, skip the missed dose and take the next tablet at your usual time. You should consult your doctor or pharmacist if you are unsure. Do
not take a double dose to make up for a forgotten tablet.
If you stop taking DOXAZOSIN DOC Generici
If you stop taking DOXAZOSIN DOC Generici suddenly, the problems you had before starting
treatment may return. Therefore, it is better not to stop taking the medicine abruptly. Your doctor will gradually reduce the dose.
Always check with your doctor or pharmacist if you are unsure.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone experiences them.
If you experience any of the following symptoms, STOP treatment with DOXAZOSIN DOC
Generics and call an ambulance immediately:

  • heart attack
  • weakness in arms, legs, or difficulty speaking, which could be symptoms of a stroke;
  • swelling of the face, tongue, or throat, which could be due to an allergic reaction to this medicine.

Inform your doctor immediately if you experience any of the following symptoms after taking DOXAZOSIN DOC Generics:

  • chest pain, angina
  • shortness of breath, difficulty breathing
  • rapid, slow, or irregular heartbeat
  • awareness of your heartbeat (palpitations)
  • fainting
  • yellowing of the skin or eyes (jaundice)
  • low white blood cell or platelet count in the blood, which may lead to increased bruising or tendency to bleed.

The following side effects have been reported in patients treated with Doxazosin Doc Generics. If any of these effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor.
Common side effects (may affect from 1 in 10 to 1 in 100 patients)

  • respiratory tract infection (nose, throat, lungs)
  • urinary tract infection
  • drowsiness, dizziness, headache
  • sensation that the surroundings are spinning or rotating (vertigo)
  • low blood pressure, weakness, or dizziness caused by low blood pressure when standing up from sitting or lying down
  • bronchitis, cough, runny nose due to inflammation of the nasal mucosa (rhinitis)
  • abdominal pain, indigestion, dry mouth, feeling unwell
  • itching
  • back pain, muscle pain
  • bladder inflammation, urinary incontinence (inability to control urination)
  • general weakness, flu-like symptoms, swelling of feet, ankles, or fingers

Uncommon side effects (may affect from 1 in 100 to 1 in 1,000 patients)

  • allergic reactions
  • gout, increased appetite, anorexia
  • agitation, depression, anxiety, insomnia, nervousness
  • stroke, reduced or altered sense of touch or sensation in hands and feet, malaise, tremor
  • noises or ringing in the ears
  • nosebleeds
  • constipation, flatulence, vomiting, inflammation of the stomach and intestine (gastroenteritis), diarrhea
  • increased liver enzymes, which may affect certain diagnostic tests
  • skin rash
  • painful joints
  • pain or discomfort during urination, increased frequency of urination, blood in urine
  • failure/inability to achieve erection
  • general pain, swelling of the tongue or throat
  • weight gain

Rare side effects (may affect from 1 in 1,000 to 1 in 10,000 patients)

  • muscle cramps, muscle weakness
  • increased volume of urine

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

  • tingling or numbness in hands and feet
  • blurred vision
  • hot flushes
  • worsening of dyspnea (shortness of breath)
  • biliary disorders, hepatitis (liver inflammation), jaundice
  • urticaria, hair loss, red or purple spots on the skin
  • increased urine production, urinary disorders, need to urinate at night
  • breast enlargement in men, prolonged painful erection
  • fatigue, general feeling of malaise

Side effects not known (frequency cannot be estimated from available data)

  • intraoperative floppy iris syndrome
  • taste disturbance
  • cloudy urine after orgasm

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report side effects
directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DOXAZOSIN DOC Generici

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The first two digits indicate the month; the following ones the year.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What DOXAZOSIN DOC Generici contains

  • The active substance is doxazosin mesylate. One tablet of DOXAZOSIN DOC Generici 2 mg contains doxazosin mesylate equivalent to 2 mg of doxazosin.
  • The other components are microcrystalline cellulose, anhydrous lactose, sodium starch glycolate (type A), magnesium stearate, sodium lauryl sulfate, and anhydrous colloidal silica.

Description of the appearance of DOXAZOSIN DOC Generici and the contents of the pack
DOXAZOSIN DOC Generici 2 mg tablets: white, elongated tablet, with a break line on one side and engraved "D2" on the other.
The tablets are packaged in PVC/PVDC-aluminum blisters.
Pack size: 30 tablets in 3 PVC/PVDC-aluminum blisters containing 10 tablets each.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan – Italy

Manufacturers
TEVA Pharmaceutical Works Ltd
Pallagi út 13, H-4042, Debrecen
Hungary
S.I.I.T. S.R.L. Servizio Internazionale Imballaggi Termosaldanti
Via Ariosto – 20090 Trezzano Sul Naviglio (MI)
Italy
Lamp S. Prospero S.p.A.
Via della Pace, 25/A – 41030 San Prospero (MO)
Italy
LACHIFARMA S.r.l. LABORATORIO CHIMICO SALENTINO
S.S. 16 Zona Industriale
73010 Zollino (LE)
Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: DOXAZOSINE DOC Generici 2 mg, tabletten
Italy: DOXAZOSIN DOC Generici, 2 mg tablets

Patient Information Leaflet

DOXAZOSIN DOC Generici 4mg tablets

Generic medicine
Please read this leaflet carefully before 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 may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What DOXAZOSIN DOC Generici is and what it is used for
  2. What you need to know before taking DOXAZOSIN DOC Generici
  3. How to take DOXAZOSIN DOC Generici
  4. Possible side effects
  5. How to store DOXAZOSIN DOC Generici
  6. Contents of the pack and other information

1. What DOXAZOSIN DOC Generici is and what it is used for

DOXAZOSIN DOC Generici belongs to a group of medicines known as vasodilators. These
substances cause widening of the blood vessels, thereby reducing blood pressure.
DOXAZOSIN DOC Generici may also reduce the tension of the muscle tissue in the prostate
and urinary tract.
It is used for:

  • high blood pressure;
  • treatment of symptoms of benign prostatic hyperplasia.

2. What you should know before taking DOXAZOSIN DOC Generici

Do not take DOXAZOSIN DOC Generici

  • If you are allergic to doxazosin, to other medicines in the same group (known as quinazolines, e.g. prazosin and terazosin) or to any of the other ingredients of this medicine (listed in section 6);
  • If you are breastfeeding;
  • If you have an enlarged prostate (benign prostatic hyperplasia) and have low blood pressure;
  • If you have a history of a condition known as "orthostatic hypotension", which is a form of low blood pressure causing dizziness or lightheadedness when standing up from sitting or lying down;
  • If you have an enlarged prostate with any of the following complications: urinary tract obstruction or congestion, persistent urinary tract infection, or bladder stones;
  • You must not take doxazosin alone as monotherapy if you have overflow incontinence (you do not feel the urge to urinate) or anuria (your body does not produce urine), with or without progressive kidney problems.

Warnings and precautions
The following are reasons why DOXAZOSIN DOC Generici may not be suitable for you:

  • If you have liver disease;
  • If you are taking other medicines (see section 2 "Other medicines and DOXAZOSIN DOC Generici");
  • If you have heart conditions.

If you are undergoing eye surgery due to cataracts
(clouding of the lens), please inform your ophthalmologist before the procedure that you are
currently taking or have previously taken doxazosin. This is because doxazosin may cause
intraoperative complications during surgery, which can be managed if your doctor is informed
in advance.
Talk to your doctor before taking DOXAZOSIN DOC Generici.
When you start taking doxazosin, you may experience weakness or dizziness due to low
blood pressure when standing up from a sitting or lying position. If you feel weak or dizzy,
sit or lie down until you feel better and avoid situations where you might fall or injure
yourself. Your doctor may want to monitor your blood pressure at regular intervals at the
beginning of treatment to reduce the likelihood of these effects occurring.

Children and adolescents
The use of DOXAZOSIN DOC Generici is not recommended in children or adolescents under
18 years of age, as safety and efficacy have not yet been established.

Other medicines and DOXAZOSIN DOC Generici
There are some medicines that may interact with doxazosin:

  • Some patients taking alpha-blockers for high blood pressure or enlarged prostate have reported dizziness or mental confusion, which may be caused by low blood pressure when sitting or standing up quickly. Some patients experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers. To reduce the risk of such symptoms, you should already be on a regular daily dose of the alpha-blocker before starting treatment with erectile dysfunction medications. Additionally, your doctor will start you on the lowest possible dose of erectile dysfunction medication, and you should take it at least six hours after taking doxazosin. Studies have not been conducted with doxazosin in extended-release formulations.

  • Doxazosin may further lower your blood pressure if you are already taking other medicines for high blood pressure, such as terazosin and prazosin.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
The safety of using doxazosin during pregnancy has not been established. If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Do not take doxazosin if you are breastfeeding.

Driving and using machines
Be cautious if driving or operating machinery. The tablets may affect your ability to drive and operate machinery safely, especially when you first start taking them. The tablets may make you feel weak or cause dizziness. In such cases, do not drive or operate machinery and contact your doctor immediately.

DOXAZOSIN DOC Generici contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your
doctor before taking this medicine.

3. How to take DOXAZOSIN DOC Generici

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose:
HIGH BLOOD PRESSURE
The initial dose is 1 mg once daily (= 24 hours). After 1 to 2
weeks, the dose is generally increased to 2 mg once daily (= 24 hours).
This dose should be maintained for 1 to 2 weeks. If necessary, the dose may be
further increased up to 4, 8, or 16 mg daily, until the desired reduction in blood pressure is achieved. The maximum daily dose is 16 mg. The initial dose should preferably be taken before going to bed; this helps ensure that any dizziness that may occur does not cause problems.
ENLARGED PROSTATE
The initial dose is 1 mg once daily (= 24 hours) from day 1 to day 8.
From day 8 to day 14, take one 2 mg tablet daily. If after 1 to 2 weeks the effect is not sufficient, the dose may be increased to 4 mg daily. In some cases, the dose may be increased up to a maximum of 8 mg daily (= 24 hours).
Tablets should be taken once daily (= 24 hours). Tablets should be taken with plenty of water (± a full glass). The tablet may be divided into equal parts.
If you take more DOXAZOSIN DOC Generici than you should
If you have taken more doxazosin than prescribed, contact your doctor and/or pharmacist immediately. If you feel extremely dizzy or feel as though you might faint, lie down immediately with your head low.
If you forget to take DOXAZOSIN DOC Generici
If you forget to take a tablet, skip the missed dose and take the next tablet at your usual time. Consult your doctor or pharmacist if you are unsure. Do not take a double dose to make up for the forgotten tablet.
If you stop taking DOXAZOSIN DOC Generici
If you suddenly stop taking DOXAZOSIN DOC Generici, the problems you had before starting treatment may return. Therefore, it is better not to stop taking the medicine abruptly. Your doctor will gradually reduce your dose. Always check with your doctor or pharmacist if you are unsure.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following symptoms, STOP treatment with DOXAZOSIN DOC
Generics and call an ambulance immediately:

  • heart attack
  • weakness in arms, legs, or difficulty speaking, which could be signs of a stroke;
  • swelling of the face, tongue, or throat, which could be due to an allergic reaction to this medicine.

Inform your doctor immediately if, after taking DOXAZOSIN DOC Generics,
you experience any of the following symptoms:

  • chest pain, angina
  • shortness of breath, difficulty breathing
  • fast, slow, or irregular heartbeat;
  • awareness of your heartbeat (palpitations);
  • fainting;
  • yellowing of the skin or eyes (jaundice);
  • low white blood cell or platelet count in the blood, which may lead to increased bruising or tendency to bleed.

The following side effects have been reported in patients treated with Doxazosin
Doc Generics. If any of these effects worsen, or if you notice any side effects not listed
in this leaflet, inform your doctor.
Common side effects (may affect between 1 in 10 and 1 in 100 patients)

  • respiratory tract infection (nose, throat, lungs)

  • urinary tract infection

  • drowsiness, dizziness, headache

  • sensation that the environment is spinning or rotating (vertigo)

  • low blood pressure, weakness, or dizziness caused by low blood pressure when standing up from sitting or lying down

  • bronchitis, cough, runny nose due to inflammation of the nasal mucosa (rhinitis)

  • abdominal pain, indigestion, dry mouth, feeling unwell

  • itching

  • back pain, muscle pain

  • bladder inflammation, urinary incontinence (inability to control urination)

  • general weakness, flu-like symptoms, swelling of feet, ankles, or fingers

Uncommon side effects (may affect between 1 in 100 and 1 in 1,000 patients)

  • allergic reactions
  • gout, increased appetite, anorexia
  • agitation, depression, anxiety, insomnia, nervousness
  • stroke, reduced or altered sense of touch or sensation in hands and feet, malaise, tremor
  • noises or ringing in the ears (tinnitus)
  • nosebleeds
  • constipation, flatulence, vomiting, inflammation of the stomach and intestine (gastroenteritis), diarrhoea
  • increased liver enzymes, which may affect certain diagnostic tests
  • skin rash
  • painful joints
  • pain or discomfort when urinating, increased frequency of urination, blood in urine
  • failure/inability to achieve erection
  • general pain, swelling of the tongue or throat
  • weight gain

Rare side effects (may affect between 1 in 1,000 and 1 in 10,000 patients)

  • muscle cramps, muscle weakness
  • increased volume of urine

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

  • tingling or numbness in hands and feet
  • blurred vision
  • hot flushes
  • worsened shortness of breath
  • biliary disorders, hepatitis (liver inflammation), jaundice
  • urticaria, hair loss, red or purple spots on the skin
  • increased urine production, urinary disorders, need to urinate at night
  • breast enlargement in men, painful persistent erection
  • fatigue, general feeling of malaise

Side effects of unknown frequency (frequency cannot be determined from the available data)

  • intraoperative floppy iris syndrome
  • taste disturbance
  • cloudy urine after orgasm

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact your doctor or pharmacist. You may also report side effects
directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects, you can help provide more information on
the safety of this medicine.

5. How to store DOXAZOSIN DOC Generici

Keep this medicine out of the sight and reach of children.
Store below 30 °C.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The first two digits indicate the month; the following ones the year.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What DOXAZOSIN DOC Generici contains

  • The active substance is doxazosin mesylate.

One tablet of DOXAZOSIN DOC Generici 4 mg tablets contains doxazosin mesylate
equivalent to 4 mg of doxazosin.

  • The other ingredients are microcrystalline cellulose, anhydrous lactose, sodium starch glycolate (type A), magnesium stearate, sodium lauryl sulfate and anhydrous colloidal silica.

Description of the appearance of DOXAZOSIN DOC Generici and package contents
DOXAZOSIN DOC Generici 4 mg tablets: white, elongated tablet, with a break line on one side and engraved "D4" on the other.
The tablets are packaged in PVC/PVDC-aluminium blisters.
Pack size: 20 tablets in a pack containing 2 PVC/PVDC-aluminium blisters of 10 tablets each.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan – Italy

Manufacturers
TEVA Pharmaceutical Works Ltd
Pallagi út 13, H-4042, Debrecen
Hungary
S.I.I.T. S.R.L. Servizio Internazionale Imballaggi Termosaldanti
Via Ariosto – 20090 Trezzano Sul Naviglio (MI)
Italy
Lamp S. Prospero S.p.A.
Via della Pace, 25/A – 41030 San Prospero (MO)
Italy
LACHIFARMA S.r.l. LABORATORIO CHIMICO SALENTINO
S.S. 16 Zona Industriale
73010 Zollino (LE)
Italy

This medicinal product is authorised in the European Economic Area countries under the
following names:
Netherlands: DOXAZOSINE DOC Generici 4 mg, tabletten
Italy: DOXAZOSIN DOC Generici, 4 mg tablets