KIMURA 2 mg Коированная Таблетка

Содержание инструкции

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

KIMURA 2 mg tablets, 4 mg tablets

Doxazosin mesylate
Generic medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is KIMURA and what is it used for

KIMURA contains the active ingredient 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);
• of symptoms caused by a disease called benign prostatic hyperplasia which affects the prostate of men.

2. What you need to know before you take 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 if you have a history of orthostatic hypotension. Orthostatic hypotension is the lowering of blood pressure when you stand up, which causes dizziness, lightheadedness or fainting;
• if, in addition to benign prostatic enlargement, you suffer from congestion or blockage of the upper urinary tract, recurrent (chronic) urinary infection or bladder stones;

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

Warnings and precautions
Talk to your doctor or pharmacist before taking KIMURA.
When you start taking Kimura you may feel a sense of weakness, dizziness and, rarely,
fainting, caused by a lowering of blood pressure when getting up from a sitting or lying position. If
you experience a feeling of weakness, dizziness or fainting, you should sit or lie down until you
feel better and avoid situations where you could fall or get injured. The doctor may decide to
measure your blood pressure regularly at the beginning of treatment to reduce the possibility of
these side effects.
If you are about to undergo eye surgery for cataracts (clouding of the lens),
tell your ophthalmologist before the operation that you are using or have previously used
Kimura.
Kimura can cause complications during surgery that can be managed
if the specialist is warned in advance.
Tell your doctor or pharmacist before taking Kimura if any of the following conditions apply to you, because in these cases Kimura must be used with caution:

• If you suffer from a heart condition.
• If you suffer from or have suffered from a liver disease.
• If you are taking medicines for the treatment of erectile dysfunction (impotence), called phosphodiesterase 5 inhibitors (e.g. sildenafil, tadalafil and vardenafil), as both medicines have the effect of lowering blood pressure by dilating blood vessels. The simultaneous use of Kimura and these other medicines could cause an excessive lowering of blood pressure (see Other medicines and Kimura). To reduce the likelihood of symptoms occurring, it is recommended to start treatment with medicines for erectile dysfunction with the lowest possible dose only when the therapy with Kimura is stabilized, respecting a 6-hour interval between taking the two medicines.

In addition, you should be very careful if you are elderly, or suffer from kidney problems (renal insufficiency) or
follow a low-salt diet or take medicines to increase diuresis (diuretics);
if you suffer from nerve damage due to diabetes (autonomic diabetic neuropathy).

Persistent painful erections of the penis –can occur very rarely. If this happens,
contact your doctor immediately.
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Before starting therapy with Kimura for the treatment of symptoms of benign prostatic hypertrophy (BPH) the doctor may perform some tests to rule out the presence of prostate cancer which can cause many of the symptoms associated with BPH as the two conditions can
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 treatment have not been established.

Other medicines and KIMURA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines called phosphodiesterase type 5 inhibitors for the treatment of erectile dysfunction, such as sildenafil, tadalafil and vardenafil (see “Warnings and Precautions”).
• Medicines that lower blood pressure.
• Medicines for the treatment of bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat 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, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The safety and use of Kimura during pregnancy has not been established. Therefore, if you are
pregnant, 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 stopped if
you need to start treatment with Kimura.

Driving and using machines
KIMURA can impair the ability to drive vehicles and operate machinery, especially at the beginning of
treatment. It may cause you to feel weak or dizzy. If you experience these symptoms,
do not drive or operate machinery and contact your doctor immediately.

KIMURA contains lactose
This medicine contains a sugar, lactose. If your doctor has diagnosed you with
an intolerance to certain sugars, contact him before taking this medicine.

3. How to take KIMURA

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
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Take the tablets once a day with a sufficient amount of water. Your doctor will
indicate the dose and duration of treatment.

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

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

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

Use in the elderly and in people with kidney problems
Use this medicine with caution, especially at the beginning of treatment, and you do not need to
modify the recommended dosage.

Use in people with liver problems
If you suffer from liver problems, it is necessary to increase the dosage with great caution. In case of
hepatic insufficiency, the use of KIMURA is not recommended.

If you take more KIMURA than you should
In case of overdose, an excessive lowering of blood pressure may occur. In
this case, immediately lie down with your head bent and immediately inform your
doctor or go to the nearest hospital.

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

If you stop taking KIMURA
If you stop treatment with doxazosin for a few days, inform your doctor first. In this
case, it is recommended to resume treatment starting from the lowest initial dose of 1 mg.
If you have any doubts about 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 everyone will experience them.
If you experience any of these symptoms, STOP treatment with Kimura and call an ambulance immediately:

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

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

• fast, slow, or irregular heartbeat;
• perception of your own heartbeat (palpitations);
• yellowing of the skin or eyes (jaundice).
• low number of white blood cells or platelets in the blood. These situations can lead to an increased susceptibility to infection or increased bruising or a 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 a drop in blood pressure when moving from a sitting or lying position to a standing position;
• swelling due to fluid retention in the tissues, swelling of feet, ankles, and toes (edema, peripheral edema);
• bronchitis, cough, respiratory tract infection (nose, throat, lungs);
• nasal congestion, 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, general weakness;
• feeling of fullness and discomfort in the stomach, dry mouth;
• itching;
• chest pain, back pain, muscle pain;
• problems with sperm emission (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 intestines (gastroenteritis);
• pain or discomfort when urinating, needing to urinate more often than usual, blood in the urine;
• swelling and inflammation of the joints (gout), joint pain, muscle stiffness, generalized pain;
• swelling of the face; paleness of the face, redness of the face, altered taste, chills, fever;
• insomnia, agitation, 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, tremor;
• abnormal tearing, sensitivity to light (photophobia);
• lack of blood flow to the limbs (peripheral ischemia);
• inability/incapacity to achieve or maintain an erection of the penis;
• increased liver enzymes, which can alter some medical tests.

Rare side effects(may affect up to 1 in 1000 people)

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

Very rare side effects(may affect up to 1 in 10000 people)

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

Side effects of unknown frequency(frequency cannot be estimated based on available data)

• eye problems (iris flag syndrome) (see “Special warnings and precautions for use”).
• problems with sperm emission (retrograde ejaculation).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can contribute to providing more information about 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 which is stated on the pack after “Scad”.
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The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What KIMURA 2 mg tablets contain

• The active ingredient is doxazosin. 1 tablet contains 2.43 mg of doxazosin mesylate (equivalent to doxazosin base 2 mg).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

What KIMURA 4 mg tablets contain

• The active ingredient is doxazosin. 1 tablet contains 4.85 mg of doxazosin mesylate (equivalent to doxazosin base 4 mg).
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

Description of the appearance of KIMURA and contents of the pack
KIMURA 2 mg tablets - Pack containing 30 divisible 2 mg tablets in blisters.
KIMURA 4 mg tablets - Pack containing 20 divisible 4 mg tablets in blisters.

Marketing Authorisation Holder
S.F. Group Srl – via Tiburtina, 1143 – 00156 Roma

Manufacturer
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale
73010 Zollino (LE)
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