Doxazosin xr genoptim

Package leaflet: Information for the patient

Doxazosin XR Genoptim, 4 mg, prolonged-release tablets
Doxazosinum
Please read all of 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Doxazosin XR Genoptim is and what it is 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. Contents of the pack and other information

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

Doxazosin XR Genoptim belongs to a group of medicines called alpha-adrenolytic agents.
It is used to treat:

• high blood pressure (hypertension)
• symptoms caused by benign enlargement of the prostate gland in men.

In patients taking Doxazosin XR Genoptim for high blood pressure (hypertension), the medicine works by relaxing blood vessels, allowing blood to flow through them more easily. This helps reduce blood pressure.
In patients with an enlarged prostate gland, the medicine is used to treat reduced and/or frequent urination. These are common symptoms of benign prostate enlargement (benign prostatic hyperplasia). The medicine works by relaxing the muscles around the bladder outlet and prostate gland, making it easier to pass urine.

2. Important information before using Doxazosin XR Genoptim

When not to use Doxazosin XR Genoptim

• if the patient is allergic to doxazosin, related quinazolines (e.g. prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had any form of gastrointestinal obstruction;
• if the patient has been diagnosed with benign prostatic hyperplasia with urinary retention in the upper urinary tract, chronic urinary tract infections, or bladder stones;
• if the patient has urinary incontinence due to bladder overfilling, is unable to pass urine, or has renal failure;
• if the patient is being treated for benign prostatic hyperplasia and has low blood pressure;
• if the patient currently has or has previously experienced a sudden drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting.

Warnings and precautions
Before starting treatment with this medicine, discuss with your doctor if:

• the patient has liver disease;
• the patient has heart disease, particularly heart failure or pulmonary edema (fluid accumulation in the lungs);
• the patient is scheduled for cataract surgery (clouding of the eye lens);
• the patient is pregnant or trying to become pregnant;
• the patient is also taking medicines used to treat 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 treatment. Therefore, caution should be exercised at the beginning of treatment, and situations in which these symptoms could lead to injury should be avoided. If the patient experiences dizziness or fainting, they should lie down until symptoms subside.
Very rarely, prolonged and sometimes painful erections may occur. In such a case, immediate medical advice must be sought.
Before starting treatment for benign prostatic hyperplasia with Doxazosin XR Genoptim, the doctor may order tests to rule out other conditions, such as prostate cancer, which may cause similar symptoms to benign prostatic hyperplasia.

Doxazosin XR Genoptim and other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take. It is especially important to inform them about:

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

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

• Pregnant women should not use this medicine without prior consultation with a doctor. The safety of its use during pregnancy has not been sufficiently established.
• The active substance of this medicine, doxazosin, passes into human milk in small amounts. This medicine should not be used during breastfeeding unless otherwise decided by the doctor.

Driving and operating machinery
Caution should be exercised when driving or operating machinery. This medicine may affect the ability to drive safely or operate machinery, especially when used for the first time. It may cause weakness or dizziness. If these occur, the patient should not drive or operate machinery and should contact their doctor immediately.

Doxazosin XR Genoptim contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Doxazosin XR Genoptim

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, you should contact your doctor or pharmacist.

Adults (including elderly patients)
The recommended dose of Doxazosin XR Genoptim is 4 mg once daily.
Your 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 in the form of extended-release tablets. The medicine is contained within a non-absorbable shell specially designed to slowly release the active substance. After swallowing the tablet, doxazosin is gradually released into the body until the tablet becomes empty. The empty tablet shell is eliminated from the body in the faeces, so occasionally you may notice what appears to be an intact tablet in your stool. This is normal and should not cause concern.

Instructions for administration

• Do not chew, divide or crush the tablets.
• Swallow the tablets whole with water.
• The tablets can be taken independently of meals.

Patients with hepatic impairment
In patients with impaired liver function, your doctor will closely monitor your condition during treatment. Doxazosin XR Genoptim is not recommended for use in patients with severe hepatic impairment (see section "Warnings and precautions").

Use in children and adolescents
This medicine is not recommended for use in patients under 18 years of age.

Taking more Doxazosin XR Genoptim than prescribed
Taking too many tablets at once may cause you to feel unwell. Taking several tablets at once may be dangerous. In such a case, seek immediate medical advice from your doctor or go to the nearest hospital emergency department.

Missing a dose of Doxazosin XR Genoptim
If you miss a dose, skip that dose completely. Then continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Doxazosin XR Genoptim
It is important to continue taking this medicine as prescribed. Do not change the dose or stop treatment without first consulting your doctor. Do not wait until the pack is empty before seeing your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious:
If any of the following occur, stop taking the medicine immediately and
contact your doctor or go to the nearest hospital emergency department:

• Allergic reactions such as wheezing, shortness of breath, severe dizziness or fainting, swelling of the face or throat, severe skin rash with red patches 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 caused by a reduced number of blood platelets.
• Prolonged, painful penile erection (priapism).

These adverse effects occur uncommonly (may occur in up to 1 in 100 people) or very
rarely (may occur in up to 1 in 10,000 people).
Other adverse effects:
Common (may occur in up to 1 in 10 people):

• Respiratory and urinary tract infections
• Dizziness, headache, drowsiness
• Palpitations (awareness of heart beating)
• Low blood pressure
• Drop in blood pressure upon standing, which may cause dizziness, lightheadedness or fainting
• Sensation of spinning (vertigo)
• Itching
• Shortness of breath, nasal mucosal swelling or nasal discharge (rhinitis)
• Respiratory tract inflammation (bronchitis), cough
• Abdominal pain, indigestion, dry mouth, nausea
• Back pain, muscle pain
• Painful and frequent urination, inability to control urination (urinary incontinence)
• Weakness, chest pain, flu-like symptoms, swelling of hands, ankles or feet

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

• Loss of appetite, increased appetite
• Gout (painful and swollen joints)
• Anxiety, depression, difficulty falling asleep
• Reduced skin sensitivity, fainting, tremor
• Ringing or buzzing in the ears (tinnitus)
• Nosebleeds
• Constipation, diarrhoea, flatulence, vomiting, inflammation of the stomach and intestines (gastroenteritis)
• Abnormal liver function test results
• Skin rash
• Joint pain
• Presence of blood in urine, difficulty or pain in passing urine, abnormal frequency of urination
• Disorders or inability to achieve erection
• Pain, swelling of the face
• Weight gain

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

• Gastrointestinal obstruction

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

• Low number of white blood cells (leukopenia)
• Restlessness, nervousness
• Tingling or altered sensation in hands and feet
• Blurred vision
• Slowing of the heart rate
• Hot flushes
• Breathing difficulties or wheezing
• Hair loss, purplish skin spots, itchy rash
• Muscle cramps, muscle weakness
• Urinary disorders, need to urinate frequently, increased urination, need to wake up at night to pass urine (nocturia)
• Breast enlargement in men (gynaecomastia)
• Feeling of fatigue, 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 of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Doxazosin XR Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the pack and other information

What Doxazosin XR Genoptim contains
The active substance is doxazosin (in the form of doxazosin mesilate).
Each tablet contains 4 mg of doxazosin (as doxazosin mesilate).
Other components 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), colloidal anhydrous silica, sodium stearyl fumarate;
Coating: methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, colloidal hydrated silica,
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 one side.
The tablets are packed in PVC/PVDC/Aluminium blister packs contained in a cardboard box.
Pack size:
30 tablets.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
Krakowiaków 65 Street
02-255 Warsaw
Poland

Manufacturer/Importer
Lek S.A.
Domaniewska 50 C Street
02-672 Warsaw
Poland
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.
Rabowicka 15 Street
62-020 Swarzędz
Poland

This medicinal product is authorised for sale 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