Doxar Xl

Package Leaflet: Information for the User

Doxar XL

4 mg, prolonged-release tablets

Doxazosin

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, ask your doctor or pharmacist.
• 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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Doxar XL is and what it is used for
• 2. Before you take Doxar XL
• 3. How to take Doxar XL
• 4. Possible side effects
• 5. How to store Doxar XL
• 6. Contents of the pack and other information

1. What Doxar XL is and what it is used for

Doxar XL is a medicine that belongs to a group of medicines called alpha-blockers. It is used to treat high blood pressure in men and women, or symptoms caused by an enlarged prostate gland in men.

Doxar XL may be used to treat high blood pressure by relaxing blood vessels so that blood can flow more easily. This helps to lower blood pressure.

In men with an enlarged prostate gland, Doxar XL is used to treat weak or frequent urination. This is a common problem in patients with an enlarged prostate gland. Doxar XL works by relaxing the muscles in the prostate gland and the opening of the bladder, making it easier to urinate.

2. Before you take Doxar XL

When not to take Doxar XL:

• if you are allergic to doxazosin, other quinazolines (e.g. prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
• if you have a mild to moderate enlargement of the prostate gland (prostatic hyperplasia) with a history of kidney stones, urinary retention, or urinary tract infections
• if you have a mild to moderate enlargement of the prostate gland (prostatic hyperplasia) with urinary incontinence, urinary retention, or worsening kidney function
• if you have any obstruction of the gastrointestinal tract
• if you have orthostatic hypotension (a fall in blood pressure when standing up or sitting up quickly)
• if you have low blood pressure

Warnings and precautions

Before taking Doxar XL, tell your doctor or pharmacist if:

• you are going to have surgery
• at the start of treatment, you may feel dizzy or lightheaded due to low blood pressure when standing up or sitting up quickly. If you feel dizzy or lightheaded, sit or lie down until you feel better. Your doctor will monitor your blood pressure at the start of treatment
• you have a history of heart disease, such as heart failure or angina
• you have a history of liver disease
• you are taking medicines for erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil), as taking these medicines with doxazosin may cause low blood pressure. Your doctor will advise you to take these medicines with a time interval between them and doxazosin
• you are having cataract surgery, as Doxar XL may cause complications during surgery. Your doctor may be able to prevent these complications if they know you are taking Doxar XL
• you are having blood or urine tests, as you should tell your doctor or nurse that you are taking Doxar XL

Before starting treatment with Doxar XL, your doctor may perform tests to rule out other conditions, including prostate cancer, which can cause the same symptoms as an enlarged prostate gland.

Doxar XL is a prolonged-release tablet. This medicine has a non-absorbable coating that allows the active ingredient to be released slowly from the tablet. The empty tablet shell may be passed in your stool and may be visible as a residue that looks like a tablet. This is normal and should not cause concern.

Children and adolescents

Doxar XL is not recommended for children and adolescents under 18 years of age, as its safety and efficacy have not been established in this age group.

Doxar XL and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including:

• medicines for erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil), as taking these medicines with doxazosin may cause low blood pressure
• other medicines that lower blood pressure, as the blood pressure-lowering effect of these medicines may be increased
• 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Doxazosin passes into breast milk in small amounts. Breastfeeding mothers should not take this medicine unless their doctor advises them to do so.

Driving and using machines

Be careful when driving or operating machinery, as Doxar XL may affect your ability to drive or operate machinery safely, especially at the start of treatment. If you experience dizziness or lightheadedness, do not drive or operate machinery and contact your doctor immediately.

Doxar XL contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Doxar XL

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Take this medicine by mouth.

Swallow the tablets whole with a glass of water. Do not chew, divide, or crush the tablets. The tablets can be taken with or without food.

Doxar XL can be used to treat high blood pressure and an enlarged prostate gland. Both conditions can be treated at the same time.

Adults, including the elderly

Treatment of high blood pressure in adult men and women

The recommended dose is 4 mg of doxazosin (1 prolonged-release tablet) once daily. If necessary, the dose may be increased to 8 mg of doxazosin (2 prolonged-release tablets) once daily. It may take up to 4 weeks to achieve the full effect.

Treatment of symptoms of an enlarged prostate gland (prostatic hyperplasia) in adult men

The recommended dose is 4 mg of doxazosin (1 prolonged-release tablet) once daily. If necessary, the dose may be increased to 8 mg of doxazosin (2 prolonged-release tablets) once daily.

Patients with liver function impairment

A dose reduction may be necessary. Follow your doctor's instructions carefully.

If you take more Doxar XL than you should

If you (or someone else) swallow a lot of tablets at the same time or if you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose may include: headache, dizziness, fainting, difficulty breathing, low blood pressure, fast or irregular heartbeat, nausea, or vomiting.

If you forget to take Doxar XL

If you miss a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

If you stop taking Doxar XL

Do not stop taking Doxar XL without talking to your doctor first. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Doxar XL can cause side effects, although not everybody gets them.

Stop taking Doxar XL and tell your doctor immediately if you experience any of the following symptoms: allergic reactions, rash, itching, difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, or a severe allergic reaction.

Tell your doctor immediately if you experience any of the following symptoms: liver problems (e.g. nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, dark-colored urine), or jaundice (yellowing of the skin and eyes).

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

respiratory tract infections, urinary tract infections, dizziness, weakness, headache, drowsiness, balance problems when standing up quickly, fast or irregular heartbeat, low blood pressure, dizziness or lightheadedness, especially when standing up quickly, bronchitis, cough, shortness of breath, stuffy or runny nose, sneezing, facial pain or pressure, abdominal pain, indigestion or heartburn, dry mouth, nausea, itching, back pain, muscle pain, urinary tract infections, incontinence, chest pain, weakness, swelling of the feet or ankles, flu-like symptoms.

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

loss of appetite, gout, increased appetite, anxiety, depression, difficulty sleeping, stroke, numbness or tingling, fainting, tremors, ringing or buzzing in the ears, chest pain (angina), constipation, nosebleeds, gas, vomiting, diarrhea, abnormal liver function tests, stomach flu, skin rash, joint pain, blood in the urine, painful urination, frequent urination, impotence, pain, swelling of the face.

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

intestinal obstruction.

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

low white blood cell count (which may increase the risk of infections) or low platelet count (which may increase the risk of bruising or bleeding), agitation, restlessness, numbness, dizziness when standing up quickly, blurred vision, slow heartbeat, irregular heartbeat, narrowing of the airways (which may cause difficulty breathing, wheezing, or coughing), liver problems, hot flashes, hair loss, itchy skin rash, red or purple spots on the skin, muscle cramps, muscle weakness, tingling or numbness, frequent urination at night, increased urine production, urinary problems, prolonged and painful erections (if you experience this, seek medical attention immediately), breast enlargement in men, fatigue, general feeling of being unwell.

Unknown frequency (cannot be estimated from the available data):

Intraoperative Floppy Iris Syndrome (IFIS), a condition that may occur during cataract surgery, retrograde ejaculation (when semen enters the bladder instead of exiting through the penis during ejaculation).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the website: https://smz.ezdrowie.gov.pl.

5. How to store Doxar XL

This medicinal product does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Doxar XL contains

• The active substance is doxazosin (each tablet contains 4.85 mg of doxazosin mesylate, equivalent to 4 mg of doxazosin).
• The other ingredients are: polyethylene oxide, microcrystalline cellulose, povidone K 29-32, butylhydroxytoluene (E321), all-rac-α-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate

Coating: methacrylic acid - ethyl acrylate copolymer (1:1), colloidal hydrated silica, macrogol (MW 1300-1600), and titanium dioxide (E171).

What Doxar XL looks like and contents of the pack

Doxar XL, prolonged-release tablets are white, round, biconvex tablets with the inscription “DL”. The pack sizes are 28, 30, or 90 prolonged-release tablets.

Marketing Authorisation Holder

Actavis Group PTC ehf., Dalshraun 1, 220 Hafnarfjörður, Iceland

Manufacturer

Actavis Group PTC ehf., Dalshraun 1, 220 Hafnarfjörður, Iceland

For further information on this medicine, contact:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.

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

Austria: Doxazosin Actavis 4 mg Tabletten, Denmark: Cardosin Retard, Lithuania: Doxazosin Actavis 4 mg pailginto atpalaidavimo tabletes, Latvia: Doxazosin Actavis, Poland: Doxar XL, Sweden: Doxazosin Actavis, Iceland: Cardosin Retard

Date of revision of the leaflet:December 2023