Doxazosin Xr Genoptim

Leaflet attached to the packaging: patient information

Doxazosin XR Genoptim, 4 mg, prolonged-release tablets

Doxazosin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Doxazosin XR Genoptim and what is it used for
• 2. Important information before taking Doxazosin XR Genoptim
• 3. How to take Doxazosin XR Genoptim
• 4. Possible side effects
• 5. How to store Doxazosin XR Genoptim
• 6. Package contents and other information

1. What is Doxazosin XR Genoptim and what is it used for

Doxazosin XR Genoptim belongs to a group of alpha-adrenergic blockers.
It is used to treat:

• high blood pressure
• symptoms caused by an enlarged prostate gland in men.

In patients taking Doxazosin XR Genoptim to treat high blood pressure (hypertension), the medicine works by relaxing blood vessels and making it easier for blood to flow through them. This helps to lower blood pressure.
In patients with an enlarged prostate gland, the medicine is used to treat reduced or frequent urination. This is a common symptom of an enlarged prostate gland (benign prostatic hyperplasia). The medicine works by relaxing the muscles surrounding the urethra and prostate gland, making it easier to urinate.

2. Important information before taking Doxazosin XR Genoptim

When not to take Doxazosin XR Genoptim

• if the patient is allergic to doxazosin, related quinazolines (e.g., prazosin or terazosin), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had any form of intestinal obstruction;
• if the patient has prostate enlargement with retention in the upper urinary tract, chronic urinary tract infections, or bladder stones;
• if the patient has uncontrolled urination (urinary incontinence), cannot urinate, or has kidney failure;
• if the patient is being treated for prostate enlargement and has low blood pressure;
• if the patient has experienced a sudden drop in blood pressure when standing up, which has caused dizziness, fainting, or lightheadedness.

Warnings and precautions

Before starting to take this medicine, the patient should discuss it with their doctor if:

• the patient has liver disease;
• the patient has heart disease, especially heart failure or pulmonary edema (fluid accumulation in the lungs);
• the patient is going to have cataract surgery (clouding of the eye lens);
• the patient is pregnant or trying to become pregnant;
• the patient is taking medicines for erectile dysfunction (PDE-5 inhibitors, e.g., sildenafil, tadalafil, vardenafil) (see section "Doxazosin XR Genoptim and other medicines").

Dizziness, weakness, and rarely fainting may occur, especially when starting to take the medicine. Therefore, the patient should be careful and avoid situations where these symptoms could cause injury. If the patient experiences dizziness or fainting, they should lie down until the symptoms pass.
Very rarely, prolonged and sometimes painful erectionsmay occur. In such cases, the patient should contact their doctor immediately.
Before starting treatment for an enlarged prostate gland with Doxazosin XR Genoptim, the doctor may order tests to rule out other diseases, e.g., prostate cancer, which may cause similar symptoms to benign prostatic hyperplasia.

Doxazosin XR Genoptim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. It is especially important to inform them about taking:

• medicines for erectile dysfunction (such as sildenafil, tadalafil, or vardenafil); when taken with Doxazosin XR Genoptim, they may lower blood pressure. Some patients may experience dizziness or lightheadedness, which may be caused by low blood pressure due to a rapid change in position when sitting or standing. To reduce the likelihood of these symptoms, the patient should regularly take their normal daily dose of Doxazosin XR Genoptim before starting to take a medicine for erectile dysfunction (impotence). The doctor may recommend starting with the smallest possible dose and taking it at least 6 hours after taking Doxazosin XR Genoptim,
• medicines for high blood pressure (so-called antihypertensive medicines),
• medicines for bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole,
• medicines for HIV infection, e.g., indinavir, nelfinavir, ritonavir, saquinavir,
• nefazodone, a medicine for depression.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• Pregnant women should not take the medicine without consulting their doctor first. The safety of its use during pregnancy has not been established.
• The active substance of this medicine, doxazosin, passes into human milk in small amounts. The medicine should not be taken during breastfeeding, unless the doctor decides otherwise.

Driving and using machines

The patient should be careful when driving or operating machines. The medicine may affect their ability to drive or operate machines safely, especially when taken for the first time. It may cause weakness or dizziness. If these symptoms occur, the patient should not drive or operate machines and should contact their doctor immediately.

Doxazosin XR Genoptim contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Doxazosin XR Genoptim

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Adults (including elderly patients)
The recommended dose of Doxazosin XR Genoptim is 4 mg once daily.
The doctor may decide to increase the dose to 8 mg once daily. This is the maximum dose of Doxazosin XR Genoptim.
Doxazosin XR Genoptim is available in the form of prolonged-release tablets. The medicine is in a non-absorbable coating, specially designed for slow release of the active substance.
After swallowing the tablet, doxazosin is slowly released into the body until the tablet is empty.
The empty tablet is eliminated from the body with the feces, so occasionally, its remains may be seen in the stool, resembling a tablet. This is normal and should not cause concern.

Method of administration

• Tablets should not be chewed, divided, or crushed.
• Tablets should be swallowed whole, with a glass of water.
• Tablets can be taken with or without food.

Patients with liver function disorders

In case of liver function disorders, the doctor will carefully monitor the patient's condition during treatment. Doxazosin XR Genoptim is not recommended for patients with severe liver function disorders (see section "Warnings and precautions").

Use in children and adolescents

The use of this medicine is not recommended in patients under 18 years of age.

Overdose of Doxazosin XR Genoptim

Taking too many tablets at once may cause discomfort. Taking several tablets may be dangerous. In such cases, the patient should contact their doctor or go to the nearest hospital emergency department immediately.

Missed dose of Doxazosin XR Genoptim

If a dose is missed, the patient should skip it and continue with their regular dosing schedule. They should not take a double dose to make up for the missed dose.

Stopping treatment with Doxazosin XR Genoptim

It is important to continue taking the medicine. The patient should not change the dose or stop treatment without consulting their doctor first. They should not wait until they finish the package before visiting their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects may be serious:

If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor or go to the hospital emergency department immediately:

• Allergic reactions, such as wheezing, shortness of breath, severe dizziness or fainting, facial or throat swelling, severe skin rash with red spots or blisters.
• Chest pain, rapid or irregular heartbeat, heart attack, or stroke.
• Yellowing of the skin or whites of the eyes, itching, loss of appetite, and dark urine, caused by liver function disorders.
• Unusual bruising or bleeding due to a low platelet count.
• Prolonged, painful erections.

These side effects are not very common (may affect up to 1 in 100 people) or rare (may affect up to 1 in 10,000 people).

Other side effects:

Common(may affect up to 1 in 10 people):

• respiratory and urinary tract infections
• dizziness, headaches, drowsiness
• palpitations
• low blood pressure
• decreased blood pressure when standing up, which may cause dizziness, lightheadedness, or fainting
• vertigo
• itching
• shortness of breath, nasal congestion, or runny nose (rhinitis)
• respiratory tract infections (bronchitis), cough
• abdominal pain, nausea, dry mouth, vomiting
• back pain, muscle pain
• painful or frequent urination, inability to control urination (urinary incontinence)
• weakness, chest pain, flu-like symptoms, swelling of hands, ankles, or feet

Uncommon(may affect up to 1 in 100 people):

• loss of appetite, increased appetite
• gout (painful and swollen joints)
• anxiety, depression, difficulty sleeping
• decreased skin sensitivity, fainting, tremors
• ringing or buzzing in the ears
• nosebleeds
• constipation, diarrhea, gas, vomiting, stomach and intestinal inflammation
• abnormal liver function test results
• skin rash
• joint pain
• blood in the urine, difficult or painful urination, abnormal urination frequency
• erectile dysfunction or inability to achieve an erection
• facial pain or swelling
• weight gain

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

• intestinal obstruction.

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

• low white blood cell count
• agitation, nervousness
• tingling or altered sensation in hands and feet
• blurred vision
• slow heart rate
• hot flashes
• breathing difficulties or wheezing
• hair loss, purple spots on the skin, itchy rash
• muscle cramps, muscle weakness
• urination disorders, frequent urination, increased urination, need to urinate at night (nocturia)
• breast enlargement in men
• feeling tired, general malaise

Frequency not known(cannot be estimated from available data):

• retrograde ejaculation - into the bladder instead of the urethra (so-called dry orgasm).
• certain complications that may occur during cataract surgery (intraoperative floppy iris syndrome, see also "Warnings and precautions").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw; phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Doxazosin XR Genoptim

The medicine should be stored out of sight and reach of children.
Do not take the medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Doxazosin XR Genoptim contains

The active substance of the medicine is doxazosin (in the form of doxazosin mesylate).
Each tablet contains 4 mg of doxazosin (in the form of doxazosin mesylate).
The other ingredients are: Tablet core:polyethylene oxide mixture: polyethylene oxide (MW 900,000), polyethylene oxide (MW 200,000), butylhydroxytoluene (E 321), microcrystalline cellulose, povidone K 30, all-rac-α-tocopherol (E 307), silicon dioxide, sodium stearyl fumarate;
Coating:methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, silicon dioxide, macrogol (MW 1300-1600), titanium dioxide (E171).

What Doxazosin XR Genoptim looks like and contents of the pack

Doxazosin XR Genoptim tablets are white, round, biconvex, with "DL" embossed on them.
The tablets are packaged in a PVC/PVDC/Aluminum blister pack in a cardboard box.
Package size:
30 tablets.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer

Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Doxazosin "Sandoz"
Netherlands:
DOXAZOSINE SANDOZ RETARD 4 MG, TABLETTEN MET VERLENGDE AFGIFTE
Poland:
Doxazosin XR Genoptim
Spain:
Doxazosina Neo Sandoz 4 mg comprimidos de liberación prolongada EFG
Sweden:
Doxazosin Sandoz
United Kingdom:
Colixil XL 4 mg Prolonged-release Tablets

Date of last revision of the leaflet: 08/2019