DOXAR XL

Package leaflet: Information for the user

Doxar XL
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Doxar XL is and what it is used for
2. What you need to know 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 belonging to a group called alpha-blockers. It is used in the treatment of 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 (hypertension) by relaxing blood vessels so that blood can flow through them more easily. This helps lower blood pressure.
In men with an enlarged prostate gland, Doxar XL is used to treat a weak and/or frequent need to pass urine. This is a common problem in patients with an enlarged prostate gland. Doxar XL works by relaxing the muscles around the opening of the bladder, making it easier to pass urine.

2. Important information before using Doxar XL

When not to use Doxar XL:

• if the patient is 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 the patient has benign prostatic hyperplasia (enlarged prostate) together with urinary stones or obstruction of urine flow or urinary tract infections
• if the patient has benign prostatic hyperplasia (enlarged prostate) and urinary incontinence, problems with urine production or worsening kidney function
• if the patient has any gastrointestinal obstruction
• if the patient has orthostatic hypotension (low blood pressure caused by changing to an upright or sitting position too quickly)
• if the patient has abnormally low blood pressure (applies only to patients treated for enlarged prostate).

Warnings and precautions
Before starting treatment with Doxar XL, discuss this with your doctor or pharmacist.

• If the patient is undergoing surgery.
• At the beginning of treatment, the patient may experience weakness or dizziness due to low blood pressure when standing up from a sitting or lying position. If the patient feels weak or dizzy, they should sit or lie down until they feel better. The doctor will monitor blood pressure at the beginning of treatment.
• If the patient has an acute heart condition, such as swelling and (or) fluid accumulation in the lungs (pulmonary edema) and heart failure.
• The patient should be cautious if they have acute heart failure caused by blood clot or fluid accumulation around the heart.
• If the patient has severe liver disease.
• If the patient is a man taking medicines used to treat erectile dysfunction, such as sildenafil, tadalafil or vardenafil, because taking these medicines together with doxazosin may lead to low blood pressure. The doctor should advise the patient to take the medicines with a time interval between the above-mentioned medicines and doxazosin.
• If the patient is undergoing cataract surgery (clouding of the eye lens), they should inform the ophthalmologist about current or past use of Doxar XL before the procedure. Doxar XL may cause complications during surgery. The doctor can manage them if prepared for their occurrence.
• If the patient undergoes blood or urine tests, they should remember to tell the doctor or nurse that they are taking Doxar XL.

Before starting treatment with Doxar XL, the doctor may perform tests to rule out other diseases, including prostate cancer, which causes symptoms similar to those of benign prostatic hyperplasia.
Doxar XL is a prolonged-release tablet. This medicine has a non-absorbable coating that allows slow release of the drug from the tablet. The empty tablet shell is excreted and may be visible in the stool as remnants resembling the tablet. This is expected and should not cause concern.
Children and adolescents
Doxar XL is not recommended for children and adolescents under 18 years of age, as efficacy and safety have not been established in this age group.
Doxar XL and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The course of treatment may be altered if Doxar XL is used with certain other medicines.
It is especially important that the treating doctor knows if the patient is taking the following medicines:

• Medicines used to treat erectile dysfunction in men (sildenafil, tadalafil and vardenafil), taken at the same time as doxazosin, may lead to low blood pressure.
• Some patients who take alpha-blockers used to treat high blood pressure or enlarged prostate may experience dizziness or a feeling of emptiness in the head, caused by low blood pressure resulting from a rapid change in position when sitting or standing up. Some patients may experience such symptoms when taking medicines for erectile dysfunction (impotence) together with alpha-adrenolytics. To reduce the likelihood of these symptoms occurring,

the patient should take their usual daily dose of alpha-adrenolytic before taking the erectile dysfunction medicine.

• Other medicines that lower blood pressure – because the antihypertensive effect of these medicines may be enhanced.
• 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, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Doxazosin passes into human milk in small amounts. Breastfeeding women should not use this medicine unless otherwise decided by the doctor.
Driving and using machines
Exercise caution when driving or operating machinery. The tablets may affect the ability to drive or operate machinery safely, especially at the beginning of treatment. If the patient experiences this, they should not drive or operate machinery and should contact their doctor immediately.
Doxar XL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Doxar XL

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Oral administration.
Tablets should be swallowed whole with a glass of water. Do not chew, divide or crush the tablets.
Tablets may be taken with or without food.
Doxar XL may be used in the treatment of high blood pressure and benign prostatic hyperplasia (enlargement of the prostate gland). Both of these conditions will be treated simultaneously.
Adult patients, including elderly patients
Treatment of high blood pressure in adult male and female patients
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. Optimal effect may take up to 4 weeks to be achieved.
Treatment of symptoms of benign prostatic hyperplasia (enlargement of the prostate gland) in male patients
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 impaired liver function
Dose reduction may be necessary. Follow your doctor's instructions carefully.
Taking more Doxar XL than recommended
If a patient (or someone else) has swallowed a large number of tablets at once, or if a child has swallowed any of the tablets, contact the nearest hospital emergency department or a doctor immediately.
If more Doxar XL has been taken than recommended, symptoms such as headache, dizziness, fainting, loss of consciousness, breathing difficulties, low blood pressure, palpitations, fast or irregular heartbeat, nausea or vomiting may occur.
Missing a dose of Doxar XL
If a dose of Doxar XL is missed, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Stopping Doxar XL
Doxar XL should be taken for as long as recommended by your doctor. Do not stop taking Doxar XL or change the dosage without first consulting 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.
If the patient develops allergic reactions to the medicine, the doctor should be informed immediately and treatment should be discontinued. If the patient develops a skin rash, swelling of the face, lips, tongue, throat, difficulty breathing or swallowing, treatment with Doxar XL should be stopped and medical advice should be sought immediately. The patient may require urgent medical attention or hospitalization.
Contact the doctor immediately if the patient experiences a heart attack. This is a very serious, but uncommon adverse effect.
Contact the doctor immediately if the patient develops hepatitis (liver disease with nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and passing dark-coloured urine) or jaundice (yellowing of the skin and whites of the eyes) or bronchospasm (narrowing of the airways). This is a very serious, but rare adverse effect.

Common (may affect up to 1 in 10 people)
respiratory tract infections
urinary tract infection
dizziness and weakness, rarely fainting
headache
drowsiness
balance disturbance upon sudden standing
palpitations (increased awareness of heartbeat) or rapid heartbeat
low blood pressure
dizziness/spinning sensation, especially when standing up quickly
bronchitis
cough
shortness of breath
nasal congestion, runny or stuffy nose, sneezing, facial pressure or pain
abdominal pain (stomach pain and discomfort)
indigestion or heartburn
dry mouth
nausea
itching
back pain
muscle pain
cystitis
involuntary urination
chest pain
weakness and loss of strength
fluid retention in the lower limbs
flu-like symptoms

Uncommon (may affect up to 1 in 100 people)
loss of appetite
gout
increased appetite
generalized anxiety
anxiety, restlessness
a mental state characterized by extreme sadness (depression)
difficulty falling asleep
stroke (inability to move one or both limbs on one side of the body, inability to understand or speak, or inability to see in one half of the visual field)
reduced sensitivity to touch
loss of consciousness
fainting
tremor
involuntary tremor
ringing or buzzing in the ears
central chest pain (angina)
constipation
nosebleeds
flatulence
vomiting
diarrhoea
abnormal liver function test results (detected in blood tests)
gastroenteritis
skin rash
joint pain
blood in urine
pain during urination
increased frequency of urination
reduced potency in men (impotence)
pain
facial swelling
weight gain

Rare (may affect more than 1 in 1,000 patients)
gastrointestinal obstruction

Very rare (may affect up to 1 in 10,000 people)
decreased number of white blood cells (may lead to increased susceptibility to infections, e.g. fever, severe chills, sore throat or mouth ulcers) or platelets (may lead to increased tendency to bruise or bleed) in the blood
agitation and restlessness (agitation)
nervousness
numbness
dizziness related to body position
blurred vision
slower heartbeat
irregular heartbeat
bronchoconstriction, e.g. asthma (may cause difficulty breathing, wheezing or coughing)
impaired bile flow
hot flushes
hair loss, alopecia
itchy skin rash
red or purple skin discoloration (purpura)
muscle cramps
muscle weakness
tingling or numbness and pins and needles
frequent urination at night
increased urine production
urination disorders
prolonged, painful erection; urgent medical advice should be sought
gynaecomastia (enlargement of breasts in men)
fatigue
general feeling of being unwell and unwell (malaise)

Unknown (frequency cannot be estimated from available data)
intraoperative floppy iris syndrome (IFIS), a type of small pupil syndrome, which may occur during cataract surgery
retrograde ejaculation – occurs when semen enters the bladder instead of being expelled normally through the urethra.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 this medicine.

5. How to store Doxar XL

This medicinal product does not require special storage conditions.
The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the blister or carton following: EXP.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices 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 mesilate, equivalent to 4 mg of doxazosin).
• The other ingredients are: polyethylene glycol, 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 an embossed mark “DL”.

Packs contain 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 more detailed information about the medicinal product and its names in the European Economic Area member states, please contact the local representative of the Marketing Authorisation Holder:

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

This medicinal product is authorised for sale in the European Economic Area member states under the following names:

| Member State | Name of the medicinal product | |--------------|-------------------------------| | Austria | Doxazosin Actavis 4 mg Tabletten | | Denmark | Cardosin Retard | | Lithuania | Doxazosin Actavis 4 mg pailginto atpalaidavimo tabletės | | Latvia | Doxazosin Actavis | | Poland | Doxar XL | | Sweden | Doxazosin Actavis | | Iceland | Cardosin Retard |