Kamiren

Package Leaflet: Information for the Patient

Kamiren, 2 mg, tablets

Kamiren, 4 mg, tablets

Doxazosin

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Kamiren and what is it used for

Kamiren belongs to a group of medicines called alpha-adrenergic blockers. It works by relaxing the blood vessels. This leads to a decrease in blood pressure due to a decrease in peripheral resistance.
Kamiren is also an alpha-adrenergic receptor antagonist in the prostate and bladder neck. It reduces the symptoms associated with difficulty in urinating and improves urodynamic parameters (related to urine flow).
Kamiren is indicated for the treatment of:

• essential hypertension,
• symptomatic benign prostatic hyperplasia (BPH).

The medicine can be used as monotherapy (as the only medicine) or in combination with other antihypertensive medicines, such as thiazide diuretics, beta-adrenergic blockers, calcium antagonists, or angiotensin-converting enzyme inhibitors.

2. Important information before taking Kamiren

When not to take Kamiren

• if you are allergic to doxazosin, other quinazolines (prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6),
• in patients with benign prostatic hyperplasia (BPH) and low blood pressure,
• in patients who have previously experienced orthostatic hypotension, i.e., low blood pressure, causing dizziness or fainting when standing up,
• in patients with benign prostatic hyperplasia and obstruction of the urinary tract of any type, chronic urinary tract infections, or bladder stones,
• in patients with urinary incontinence due to overflow or anuria (lack of urine production) with or without renal impairment.

Warnings and precautions

Before starting treatment with Kamiren, consult your doctor or pharmacist.
In particular, inform your doctor about:

• liver function disorders (in patients with known liver failure, doxazosin is not recommended),
• heart disorders (pulmonary edema caused by aortic stenosis or mitral stenosis, heart failure with high ejection fraction, right ventricular heart failure caused by pulmonary embolism or pericardial effusion, left ventricular heart failure with low filling pressure), a rapid and significant decrease in blood pressure may worsen angina symptoms,
• the use of other medicines, e.g., sildenafil, tadalafil, vardenafil (medicines used for impotence), as symptomatic hypotension may occur.

Patient undergoing eye surgery for cataracts should inform the ophthalmologist before the operation that they are taking or have recently taken Kamiren, so that the doctor can take appropriate precautions or use surgical techniques if complications occur that may be caused by the medicine.
Prolonged, painful erections can occur very rarely. In such a case, you should immediately consult a doctor.

Before starting treatment with Kamiren, the doctor may perform tests to rule out other diseases, including prostate cancer, which can cause symptoms similar to those of benign prostatic hyperplasia.

At the beginning of treatment with Kamiren, you may experience dizziness or lightheadedness due to low blood pressure when standing up quickly. If you experience dizziness or lightheadedness, sit or lie down until the symptoms pass and avoid situations where you may fall or get injured. The doctor may recommend regular blood pressure measurements at the beginning of treatment to reduce the risk of such symptoms.

Children and adolescents

Kamiren should not be used in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

Kamiren and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Ask your doctor or pharmacist before taking Kamiren if you are taking any of the following medicines, as they may affect the action of Kamiren:

• In some patients taking alpha-adrenergic blockers to lower high blood pressure or treat prostatic hyperplasia, dizziness or a feeling of "emptiness in the head" may occur due to a sudden decrease in blood pressure. Similar symptoms may also occur in some patients taking medicines for erectile dysfunction (impotence) simultaneously with alpha-adrenergic blockers. To reduce the likelihood of such symptoms, patients should take alpha-adrenergic blockers daily before starting to take medicines for erectile dysfunction. Kamiren may further lower blood pressure in patients taking other antihypertensive medicines.
• 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.
• Neefazodone, a medicine used to treat depression,
• Medicines that dilate blood vessels or nitrates (medicines used for heart diseases).

The blood pressure-lowering effect of doxazosin may be weakened by:

• NSAIDs (non-steroidal anti-inflammatory drugs),
• estrogens,
• sympathomimetics.

Doxazosin may weaken the effect of dopamine, ephedrine, epinephrine, metaraminol, methoxyamine, and phenylephrine on blood pressure, as well as blood vessels. Since there is no data on interactions with liver metabolism-affecting medicines (e.g., cimetidine), caution is advised when administering these medicines with doxazosin.
In vitro studies have not shown that doxazosin affects the binding of digoxin, warfarin, phenytoin, or indomethacin to plasma proteins.
During clinical trials with doxazosin, no interactions were found with thiazide diuretics, furosemide, beta-adrenergic blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic agents (used for diabetes), uricosuric agents, or anticoagulants.
Doxazosin may increase plasma renin activity and vanillylmandelic acid excretion in urine. This should be taken into account when interpreting laboratory test results.
Kamiren enhances the blood pressure-lowering effect of other alpha-adrenergic blockers and other antihypertensive medicines.
Clinical trials have shown that doxazosin has a beneficial effect on lipids, significantly reducing total triglyceride, total cholesterol, and LDL fraction levels in plasma. Treatment with doxazosin has a beneficial effect on hypertension and lipid levels, resulting in a reduced risk of coronary artery disease.

Taking Kamiren with food and drink

Kamiren can be taken with or without food.

Pregnancy and breastfeeding

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.
The safety of doxazosin in pregnancy has not been established.
The doctor may prescribe Kamiren during pregnancy only if the potential benefits to the mother outweigh the risks to the fetus.
Doxazosin passes into breast milk in small amounts. Breastfeeding women should not take this medicine unless the doctor decides otherwise.

Driving and using machines

Due to the possibility of dizziness, especially at the beginning of treatment with Kamiren, after increasing the dose, switching to another medicine, or when consuming alcohol, it is not recommended to drive vehicles or operate machines.

Kamiren contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Kamiren

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The doctor will determine the dose of the medicine, individually for each patient.

Essential hypertension

Treatment starts with a dose of 1 mg once a day. In individual cases, the doctor may increase the dose to 2 mg once a day after 1 to 2 weeks, and then to 4 mg once a day, finally to 8 mg of doxazosin once a day.
Usually, the maintenance dose is 2 mg to 4 mg of doxazosin once a day.
The maximum recommended daily dose is 16 mg.
The following dosing schedule is recommended for starting treatment:
day 1-8:
morning
1 mg of doxazosin
day 9-14:
morning
2 mg of doxazosin
Then the dose can be increased to the effective maintenance dose.

Benign prostatic hyperplasia

Treatment starts with a dose of 1 mg once a day. After 1 to 2 weeks, if necessary, the doctor may increase the dose to 2 mg once a day, and then to 4 mg once a day, depending on the patient's response.
The maximum recommended daily dose is 8 mg.
The following dosing schedule is recommended for starting treatment:
day 1-8:
1 mg of doxazosin once a day
day 9-14:
2 mg of doxazosin once a day
Then the dose can be individually increased to the effective maintenance dose.
Tablets should be swallowed with water.
The doctor determines the duration of treatment.
If you feel that the effect of Kamiren is too strong or too weak, ask your doctor.
Use in children and adolescents
Kamiren should not be used in children and adolescents under 18 years of age.
Use in patients with renal impairment
No dose reduction is necessary in patients with renal impairment. However, the dose of the medicine should be as low as possible, and any dose increase should be done under close medical supervision.
Use in patients with hepatic impairment
Caution is advised. There is a lack of clinical experience with the use of the medicine in patients with severe liver failure.
Elderly patients
No dose adjustment is necessary in elderly patients. However, the dose of the medicine should be as low as possible, and any dose increase should be done under close medical supervision.

Overdose of Kamiren

In case of overdose, Kamiren may cause symptomatic hypotension.
Immediately consult a doctor, who will provide symptomatic treatment. Dialysis is not effective, as doxazosin is almost completely bound to plasma proteins.

Missed dose of Kamiren

If you miss a dose of Kamiren, take it as soon as possible, unless it is almost time for the next dose. In this case, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• respiratory tract infections, urinary tract infections,
• drowsiness, dizziness, headache,
• accommodation disorders, peripheral dizziness (vertigo),
• palpitations, rapid heart rate (tachycardia), chest pain,
• low blood pressure (hypotension) or decreased blood pressure when standing up (orthostatic hypotension),
• edema, bronchitis, cough, dyspnea, rhinitis,
• abdominal pain, nausea, dry mouth, vomiting,
• pruritus,
• back pain, muscle pain,
• urinary tract infection, urinary incontinence, increased need to urinate, frequent urination,
• general weakness, chest pain, flu-like symptoms, edema, peripheral edema.

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

• allergic reactions to the medicine,
• anorexia, gout (uric acid crystal deposition, especially in joints), increased appetite, decreased appetite,
• agitation, depression, anxiety, insomnia, nervousness, emotional instability
• cerebrovascular incident, paresthesia, fainting, tremor, apathy, lacrimation, photophobia,
• tinnitus,
• angina pectoris (chest pain due to reduced blood flow to the heart muscle), myocardial infarction, fainting, peripheral hypoperfusion,
• epistaxis (nosebleed), pharyngitis
• constipation, flatulence, vomiting, gastroenteritis, diarrhea,
• abnormal liver function test results, increased liver enzyme activity,
• skin rash,
• arthralgia,
• painful urination, frequent urination, hematuria (blood in urine),
• impotence,
• pain, fever, chills, facial edema, hot flashes, pallor, hypokalemia,
• weight gain, hypokalemia.

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

• cerebrovascular disorders, laryngeal edema, hypoglycemia, muscle cramps, muscle weakness, polyuria.

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

• leukopenia (low white blood cell count), thrombocytopenia (low platelet count), which can cause easy bruising or increased bleeding tendency,
• orthostatic dizziness, paresthesia (tingling sensation),
• anemia, hypersensitivity, muscle stiffness, taste disorders, nightmares, memory loss, orthostatic dizziness,
• blurred vision,
• bradycardia (slow heart rate), arrhythmia (irregular heartbeat),
• hot flashes,
• bronchospasm,
• cholestasis (bile flow obstruction), hepatitis, jaundice (yellowing of skin and eyes),
• urticaria, alopecia (hair loss), purpura (bleeding into skin),
• increased urination, urinary disorders, nocturia (urination at night), increased creatinine levels in urine and plasma,
• gynecomastia (breast enlargement in men),
• prolonged, painful erections (priapism) - seek medical attention immediately,
• fatigue, general malaise, decreased body temperature in elderly patients.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• eye disorders that may occur during cataract surgery (lens clouding), see "Warnings and precautions",
• retrograde ejaculation ( semen entering the bladder instead of the urethra during ejaculation).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Kamiren

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kamiren contains

• The active substance is doxazosin. Each tablet contains 2 mg or 4 mg of doxazosin, in the form of doxazosin mesylate.
• The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, sodium lauryl sulfate, lactose monohydrate. See section 2 "Kamiren contains lactose and sodium".

What Kamiren looks like and contents of the pack

Kamiren, 2 mg: white, round, flat tablets with a score line on one side. The tablet can be divided into equal doses.
Kamiren, 4 mg: white, round, flat tablets with a score line on one side. The tablet can be divided into equal doses.
Packaging: 30 tablets in blisters in a cardboard box

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: