Kimura

Patient Information Leaflet

KIMURA 2 mg tablets, 4 mg tablets

Doxazosin mesylate
Equivalent medicine
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What KIMURA is and what it is used for

KIMURA contains the active substance doxazosin, which belongs to a group of medicines called alpha-blockers used to lower blood pressure.
KIMURA is indicated for the treatment of:

• high blood pressure (essential hypertension);
• symptoms caused by a condition called benign prostatic hyperplasia affecting the prostate gland in men.

2. What you need to know before taking KIMURA

Do not take KIMURA

• if you are allergic to doxazosin, to quinazolines (e.g. prazosin, terazosin) or to any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding and need to take this medicine for the treatment of high blood pressure (See section “Pregnancy and breastfeeding”);
• if you suffer from excessively low blood pressure (hypotension) or have a history of orthostatic hypotension. Orthostatic hypotension is a drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting;
• if, in addition to benign prostate enlargement, you have upper urinary tract congestion or obstruction, chronic recurrent urinary tract infection, or bladder stones;

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• if you suffer from continuous urinary leakage (reflux incontinence) or absence of urine production (anuria), with or without kidney problems (progressive renal failure). In this case, you should take this medicine only in combination with other medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking KIMURA.
When you start taking KIMURA, you may experience weakness, dizziness, and rarely fainting, caused by a drop in blood pressure upon rising from a sitting or lying position. If you feel weak, dizzy, or faint, sit or lie down until you feel better and avoid situations where you could fall or get injured. Your doctor may decide to monitor your blood pressure regularly at the beginning of treatment to reduce the likelihood of these side effects occurring.
If you are scheduled for cataract surgery (a clouding of the lens), inform your ophthalmologist before the procedure that you are currently taking or have previously taken KIMURA. KIMURA may cause complications during eye surgery, which can be managed if the specialist is informed in advance.
Inform your doctor or pharmacist before taking KIMURA if any of the following apply to you, as KIMURA should be used with caution in these cases:

• If you have a heart condition.
• If you have or have had a liver disease.
• If you are taking medicines for erectile dysfunction (impotence), called phosphodiesterase-5 inhibitors (e.g. sildenafil, tadalafil, vardenafil), as both medicines lower blood pressure by dilating blood vessels. Taking KIMURA together with these medicines may cause excessive lowering of blood pressure (see “Other medicines and KIMURA”). To reduce the risk of symptoms, it is recommended to start treatment with the lowest possible dose of erectile dysfunction medicines only after KIMURA therapy has been stabilized, with at least 6 hours between taking the two medicines.

You should also be particularly careful if you are elderly, or if you have kidney problems (renal insufficiency), follow a low-salt diet, or take medicines to increase urine output (diuretics); or if you have nerve damage due to diabetes (autonomic diabetic neuropathy).
Prolonged painful erections of the penis – may occur very rarely. If this happens, contact a doctor immediately.
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Before starting KIMURA treatment for symptoms of benign prostatic hyperplasia (BPH), your doctor may perform tests to rule out the presence of prostate cancer, which can cause many of the same symptoms as BPH, as both conditions may coexist.
Children and adolescents
KIMURA is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of the treatment have not been established.
Other medicines and KIMURA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines called phosphodiesterase-5 inhibitors used for erectile dysfunction, such as sildenafil, tadalafil, and vardenafil (see “Warnings and Precautions”).
• Medicines that lower blood pressure.
• Medicines used to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used for the treatment of HIV, such as indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.
• Medicines used to stimulate the sympathetic nervous system (sympathomimetics such as dopamine, ephedrine, adrenaline, metaraminol, and phenylephrine).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The safety and use of KIMURA during pregnancy have not been established. Therefore, your doctor will prescribe KIMURA only if the potential benefits outweigh the risks.
Breastfeeding
Do not take KIMURA if you are breastfeeding. Breastfeeding must be discontinued if you need to start treatment with KIMURA.
Driving and using machines
KIMURA may impair your ability to drive or operate machinery, especially at the beginning of treatment. It may cause weakness or dizziness. If you experience these symptoms, do not drive or operate machinery and contact your doctor immediately.
KIMURA contains lactose
This medicine contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take KIMURA

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
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Take the tablets once daily with a sufficient amount of water. Your doctor will determine the dose and duration of your treatment.

Treatment of high blood pressure: The recommended dose ranges from 1 to 8 mg daily. The maximum dose is 16 mg daily.
At the beginning of therapy, take 1 mg (half a 2 mg tablet daily) before going to bed for one or two weeks. The dose may then be increased to 2 mg once daily for one or two weeks. If necessary, your doctor may increase your dose to 4, 8, or 16 mg daily, depending on your condition.

Treatment of benign prostatic hyperplasia: The recommended dose ranges from 2 to 4 mg daily.
At the beginning of therapy, take 1 mg (half a 2 mg tablet) daily for the first 8 days. From day 9 to day 14, take 2 mg daily (1 tablet of 2 mg). If necessary, your doctor may increase your dose to 4 mg (1 tablet of KIMURA 4 mg), and subsequently to the maximum recommended dose of 8 mg daily (2 tablets of KIMURA 4 mg). The recommended interval between dose increases is 1 to 2 weeks.

Use in children and adolescents
Doxazosin is not recommended for use in children and adolescents under 18 years of age due to lack of efficacy data.

Use in elderly patients and patients with kidney problems
Use this medicine with caution, especially at the beginning of treatment; however, dose adjustment is not usually required.

Use in patients with liver problems
If you have liver problems, dose escalation must be done with great caution. KIMURA is not recommended in case of hepatic insufficiency.

If you take more KIMURA than you should
Overdose may cause excessive lowering of blood pressure. In this case, lie down immediately with your head lowered and contact your doctor immediately or go to the nearest hospital.

If you forget to take KIMURA
Do not take a double dose to make up for the missed dose.

If you stop taking KIMURA
If you interrupt treatment with doxazosin for a few days, inform your doctor first. In such cases, it is recommended to restart treatment with the lowest initial dose of 1 mg.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, STOP taking Kimura and immediately call
an ambulance:

• chest pain, pain in the chest (angina, myocardial infarction); 9/9
• shortness of breath (dyspnea), accompanied by discomfort and a feeling of tightness in the chest (bronchospasm);
• sudden headache, feeling of fainting, weakness in the arms or legs, or difficulty speaking, which could be symptoms of a stroke;
• allergic reactions.

Immediately inform your doctor if, after taking Kimura, you experience any of the following
symptoms:

• fast, slow or irregular heartbeat;
• awareness of your own heartbeat (palpitations);
• yellowing of the skin or eyes (jaundice);
• low number of white blood cells or platelets in the blood. These conditions may lead to an increased susceptibility to infections or increased bruising or tendency to bleed, respectively.

The following adverse events have also been reported:
Common (may affect up to 1 in 10 people)

• dizziness, headache;
• low blood pressure or drop in blood pressure when moving from a sitting or lying position to standing (orthostatic hypotension);
• swelling due to fluid accumulation in the tissues, swelling of feet, ankles and fingers (edema, peripheral edema);
• bronchitis, cough, respiratory tract infections (nose, throat, lungs);
• stuffy nose, runny nose due to inflammation of the nasal mucosa (rhinitis);
• abdominal pain, nausea;
• urinary tract infections, urinary incontinence (inability to control and retain urine), bladder inflammation (cystitis);
• drowsiness, generalized weakness;
• feeling of fullness and discomfort in the stomach, dry mouth;
• itching;
• chest pain, back pain, muscle pain;
• problems with ejaculation (delayed ejaculation);
• apathy;
• eye problems (accommodation disorders);
• flu-like symptoms.

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

• constipation, flatulence, diarrhea and vomiting, inflammation of the stomach and intestine (gastroenteritis);
• pain or discomfort when urinating, need to urinate more often than usual, blood in the urine;
• swelling and inflammation of the joints (gout), joint pain, muscle stiffness, generalized pain;
• facial swelling; whitening of the face (pallor), facial flushing, altered taste, chills, fever;
• insomnia, restlessness, anxiety, depression or nervousness; strange dreams, memory loss (amnesia), emotional lability;
• temporary loss of consciousness;
• reduced or altered sensitivity to touch in hands and feet; 9/9
• increased or decreased appetite, weight gain; decreased potassium levels in the blood, thirst;
• nosebleeds;
• sore throat;
• skin rash;
• ringing or buzzing in the ears (tinnitus), tremor;
• abnormal tearing, light sensitivity in the eyes (photophobia);
• reduced blood flow to the limbs (peripheral ischemia);
• inability/inability to achieve or maintain penile erection;
• increased liver enzymes, which may alter certain medical test results.

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

• decreased blood sugar levels (hypoglycemia);
• swelling (edema) of the larynx;
• sweating;
• reduced body temperature in the elderly;
• increased frequency of needing to urinate;
• muscle cramps, muscle weakness.

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

• hepatitis (liver inflammation) or bile disorder (cholestasis);
• urticaria, hair loss, red or purple spots on the skin due to bleeding under the skin or mucous membranes (purpura);
• tingling or numbness in hands and feet;
• fatigue, general feeling of malaise;
• blurred vision; eye inflammation (conjunctivitis);
• hot flashes;
• urinary problems, need to urinate at night, increased urine volume;
• breast enlargement in men;
• prolonged painful erection of the penis. Seek immediate medical attention;
• sudden dizziness accompanied by loss of balance.

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

• eye problems (flag sign iris syndrome) (see "Special warnings and precautions for use").
• problems with ejaculation (retrograde ejaculation).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KIMURA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp”.
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The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What KIMURA 2 mg tablets contain

• The active substance is doxazosin. One tablet contains 2.43 mg of doxazosin mesylate (equivalent to 2 mg of doxazosin base).
• The other components are: microcrystalline cellulose, monohydrate lactose, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate.

What KIMURA 4 mg tablets contain

• The active substance is doxazosin. One tablet contains 4.85 mg of doxazosin mesylate (equivalent to 4 mg of doxazosin base).
• The other components are: microcrystalline cellulose, monohydrate lactose, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate.

Description of the appearance of KIMURA and package contents
KIMURA 2 mg tablets - Carton containing 30 2 mg scored tablets in blister packs.
KIMURA 4 mg tablets - Carton containing 20 4 mg scored tablets in blister packs.
Marketing Authorization Holder
S.F. Group Srl – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturer
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale
73010 Zollino (LE)
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