KAMIREN XL

Patient Information Leaflet

Kamiren XL, 4 mg, modified-release tablets
Doxazosinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as 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 you personally. Do not share it with others. It may harm other people, 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.

Table of contents

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

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

Kamiren XL reduces blood pressure by decreasing resistance in blood vessels. Additionally, it reduces symptoms related to difficulty in urine flow.
Kamiren XL is indicated for the treatment of hypertension. It can be used as monotherapy (as a single medicine) or in combination with other antihypertensive medicines such as thiazide diuretics, beta-blockers, calcium antagonists, or angiotensin-converting enzyme inhibitors.
Kamiren XL is also indicated for the treatment of symptoms caused by benign prostatic hyperplasia. It can be used in patients both with and without hypertension. In patients with hypertension, it may simultaneously reduce blood pressure. In patients with normal blood pressure, the effect on blood pressure is usually negligible.

2. Important information before using Kamiren XL

When not to use Kamiren XL:

• if the patient is allergic to doxazosin, other quinazoline derivatives (prazosin, terazosin), or to any of the other ingredients of this medicine (listed in section 6); such allergic reactions may include itching, skin redness, or difficulty breathing;
• in patients with gastrointestinal obstruction, esophageal stricture, or a history of reduced gastrointestinal lumen diameter;
• in patients with enlarged prostate gland (benign prostatic hyperplasia) and low blood pressure;
• in patients who previously experienced orthostatic hypotension, i.e. low blood pressure causing dizziness or disorientation upon standing up from a sitting or lying position;
• in patients with enlarged prostate gland and one of the following symptoms: urinary tract obstruction or urethral embolism of any type, chronic urinary tract infection, or bladder stones;
• in patients with overflow incontinence (without sensation of needing to urinate) or anuria (body not producing urine), with or without kidney function disorders.

Warnings and precautions
Before starting treatment with Kamiren XL, consult a doctor or pharmacist.
In particular, inform the doctor about:

• liver function disorders; in patients with diagnosed liver insufficiency, doxazosin is not recommended.
• heart disorders (pulmonary edema caused by aortic stenosis or mitral valve sten enosis, heart failure with high cardiac output, right-sided heart failure due to pulmonary embolism or pericardial effusion, left-sided heart failure with low filling pressure); rapid and significant reduction in arterial pressure may exacerbate angina symptoms.
• concomitant use of other medicines, e.g. sildenafil, tadalafil, vardenafil (medicines used in erectile dysfunction), as symptomatic arterial hypotension may occur.

Patients undergoing cataract surgery (clouding of the eye lens) should inform the ophthalmologist before surgery whether they are currently taking or have recently taken Kamiren XL. This will allow the doctor to apply appropriate precautions or modify the surgical technique to prevent possible complications.
Prolonged, painful erections (priapism) may very rarely occur. In such a case, contact a doctor immediately.
At the beginning of treatment with Kamiren XL, when standing up from a sitting or lying position, the patient may experience fainting sensations or dizziness due to low blood pressure. If fainting sensations or dizziness occur, sit or lie down and wait until symptoms subside, to avoid falls or injuries. At the beginning of treatment, the doctor may regularly monitor blood pressure to reduce this risk.
Before starting treatment with Kamiren XL, the doctor may perform tests to rule out other diseases, including prostate cancer, which may cause symptoms similar to benign prostatic hyperplasia.

Children and adolescents
Kamiren XL is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of doxazosin in this age group have not been established.

Kamiren XL and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Ask your doctor or pharmacist before using Kamiren XL if the patient is taking any of the following medicines, as they may alter the effect of Kamiren XL:

• In some patients taking alpha-adrenergic drugs to lower high blood pressure or treat benign prostatic hyperplasia, dizziness or a sensation of "emptiness in the head" due to low blood pressure may occur when standing up quickly from a lying or sitting position. These symptoms may occur in some patients taking erectile dysfunction medications (impotence) together with alpha-adrenergic drugs. To reduce the likelihood of these symptoms,

patients should take alpha-adrenergic drugs, including Kamiren XL, at least 6 hours before taking an erectile dysfunction medication.

• Kamiren XL may further lower blood pressure in patients already taking other antihypertensive drugs, such as terazosin and prazosin.
• 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.
• Vasodilators or nitrates (medicines used in heart diseases).

In vitro studies have shown that doxazosin does not affect the protein binding of digoxin, warfarin, phenytoin, or indomethacin.
In clinical studies, no interactions were observed between doxazosin and thiazide diuretics, furosemide, beta-blockers, nonsteroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic agents (used in diabetes), uricosuric agents, or anticoagulants.
Kamiren XL enhances the blood pressure-lowering effect of other alpha-adrenolytic drugs and other antihypertensive agents.
Clinical studies have shown that doxazosin favorably affects lipid levels, significantly reducing total serum triglycerides, total cholesterol, and LDL cholesterol fraction. Treatment with doxazosin beneficially influences arterial hypertension and lipid levels, thereby reducing the risk of coronary artery disease.

Kamiren XL with food and drink
Kamiren XL can be taken regardless of meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
As the safety of doxazosin use during pregnancy has not been established, Kamiren XL should be used during pregnancy only if the potential benefits to the mother outweigh the potential risk to the fetus.
Doxazosin passes into human milk in small amounts. Breastfeeding women should not use this medicine unless otherwise decided by a doctor.

Driving and operating machinery
Due to the possible occurrence of dizziness, especially at the beginning of treatment with Kamiren XL, after dose increase, switching to another product, or when consuming alcohol, driving vehicles or operating machinery is not recommended.

Kamiren XL contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Kamiren XL

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
The initial dose of Kamiren XL is 4 mg taken once daily. The daily dose of 4 mg is effective in most patients.
If the desired blood pressure reduction is not achieved after 4 weeks of treatment and the patient tolerates the treatment well,
your doctor may increase the dose to 8 mg once daily. The maximum recommended daily dose is 8 mg taken once daily.

Use in elderly patients
There is no need to reduce the dose in elderly patients.

Use in patients with renal impairment
There is no need to reduce the dose in patients with impaired kidney function.

Use in patients with hepatic impairment
Kamiren XL should be used with particular caution in patients with impaired liver function.
Administration of doxazosin is not recommended in patients with established liver failure.

Tablets should be swallowed whole with sufficient liquid; they should not be chewed, broken, or crushed.

If you feel that the effect of Kamiren XL is too strong or too weak, you should consult your doctor.

Taking more Kamiren XL than recommended
In case of overdose, a significant drop in blood pressure may occur.
Your doctor will provide symptomatic treatment. Dialysis is ineffective because doxazosin is almost completely protein-bound.
If you take more than the recommended dose, seek immediate medical advice from your doctor or pharmacist.

Missing a dose of Kamiren XL
If you miss a dose, do not take a double dose to make up for the missed dose. Take the next dose according to the prescribed schedule.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in up to 1 in 10 patients):

• respiratory tract infections (nose, throat, lungs), urinary tract infections,
• dizziness, headache, drowsiness,
• sensation of spinning (vertigo),
• rapid heartbeat (tachycardia), awareness of heartbeat,
• low blood pressure or drop in blood pressure upon standing, causing dizziness, feeling of "emptiness in the head" or fainting (orthostatic hypotension),
• bronchitis, cough, shortness of breath, nasal mucosa swelling, sneezing and/or nasal discharge due to inflammation of the nasal mucosa,
• stomach/abdominal pain, indigestion, dry mouth, nausea,
• itching,
• back pain, muscle pain,
• cystitis, urinary incontinence,
• general weakness, chest pain, flu-like symptoms, swelling of feet, ankles or fingers.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• drug-induced hypersensitivity reactions,
• increased or decreased appetite, joint inflammation (gout),
• anxiety, depression, insomnia,
• stroke, fainting, tremor, sensory disturbances in hands and feet,
• tinnitus,
• myocardial infarction, chest pain (angina pectoris),
• nosebleeds,
• constipation, flatulence, gastritis, diarrhoea, vomiting,
• abnormal liver function laboratory test results,
• skin rash,
• joint pain,
• pain or discomfort during urination, increased frequency of urination, blood in urine,
• impotence,
• facial swelling, general pain,
• weight gain.

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

• gastrointestinal obstruction.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• low white blood cell or platelet count, which may lead to bruising or increased tendency to bleed (leukopenia, thrombocytopenia),
• restlessness, nervousness,
• fainting or dizziness caused by low blood pressure when rising from sitting or lying position, tingling or numbness in hands and feet,
• visual disturbances,
• slowed or irregular heartbeat,
• hot flushes,
• wheezing (caused by bronchospasm),
• hepatitis or biliary tract disorders, yellowing of the skin or eyes (jaundice),
• urticaria, alopecia,
• red or purple spots on the skin, subcutaneous bleeding (purpura),
• muscle cramps, decreased muscle strength,
• urinary disorders, nocturia, increased urine volume,
• breast enlargement in men (gynaecomastia),
• prolonged, painful erection (priapism) – urgent medical advice should be sought,
• fatigue, general malaise.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• eye disorders which may occur during cataract surgery (lens opacification), see "Warnings and precautions",
• absence or reduced amount of semen during ejaculation, passage of cloudy urine after ejaculation.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Kamiren XL

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

6. Contents of the pack and other information

What Kamiren XL contains

• The active substance is doxazosin. Each modified-release tablet contains 4 mg of doxazosin in the form of doxazosin mesilate.
• Other ingredients are hypromellose, calcium hydrogen phosphate, monohydrate lactose, magnesium stearate; coating composition: Opadry White Y-1-7000 [hypromellose, titanium dioxide (E 171), polyethylene glycol 400].

What Kamiren XL looks like and contents of the pack
White, round, biconvex modified-release tablets
Pack sizes: 30, 60 or 90 modified-release tablets in blister packs contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw, Poland
Telephone: +48 22 573 75 00