DOXAZOSINA 2 mg Таблетки

Содержание инструкции

1. Doxazosina Pensa 2 mg tablets
   1. What is Doxazosina Pensa and what is it used for?
   2. What you need to know before taking Doxazosina Pensa
   3. How to take Doxazosina Pensa
   4. Possible side effects
   5. How to store Doxazosina Pensa
   6. Further information

Doxazosina Pensa 2 mg tablets

Doxazosina Pensa 4 mg tablets
Generic medicine

Active ingredient: doxazosin mesylate
Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Doxazosina Pensa is and what it is used for
• 2. Before you take Doxazosina Pensa
• 3. How to take Doxazosina Pensa
• 4. Possible side effects
• 5. How to store Doxazosina Pensa
• 6. Further information

1. What is Doxazosina Pensa and what is it used for?

Doxazosina Pensa belongs to a group of medicines called vasodilators. These medicines
dilate blood vessels, causing a decrease in blood pressure. Doxazosina
Pensa can also reduce muscle tension at the level of the prostate and urinary tract.
Doxazosina Pensa is used in the treatment of:

• high blood pressure.
• benign prostatic hyperplasia.

2. What you need to know before taking Doxazosina Pensa

Do not take Doxazosina Pensa
if you are allergic(hypersensitive) to doxazosina, or to any other medicine belonging
to the same group (so-called quinazolines such as prazosin and terazosin) or to any
of the excipients of Doxazosina Pensa (see section 2. “Important information
on some excipients of Doxazosina Pensa” and section 6 “What contains Doxazosina
Pensa”).

• if your blood pressure is too low(valid only if you are taking doxazosina for benign prostatic hyperplasia).
• If you have a history of orthostatic hypotension. Orthostatic hypotension is the lowering of blood pressure that occurs when you stand up, which causes dizziness, lightheadedness or fainting.
• if, in addition to benign prostatic hyperplasia, you suffer from congestion or blockageat the level of the upper urinary tract,from recurrent (chronic) urinary infectionor bladder stones.
• if you suffer from continuous urinary leakage(overflow incontinence), absence ofurine production(anuria) or have a deteriorating nephropathy. In these casesyou should not use Doxazosina Pensa alone as monotherapy.
• if you are breastfeeding(valid only if you are taking doxazosina for high blood pressure).

Pay particular attention with Doxazosina Pensa

• at the beginning of treatment. Especially if you are elderly or suffering from kidney or liver disease, if you regularly follow a low-sodium diet, or if you are taking diuretics. In the aforementioned cases, at the beginning of treatment, you may be more sensitive to the effect of Doxazosina Pensa. This sensitivity may manifest with an increase in episodes of dizziness or weakness(possible side effects of Doxazosina Pensa). At the beginning of treatment, those situations in which dizziness or weakness can cause personal injury should therefore be avoided, for example, while driving or operating machinery. If you feel faint or dizzy, you should sit or lie down until you feel better. Contact your doctor if the dizziness or weakness worsens.
• if you have an acute heart condition. In the presence of acute heart disease, symptoms may worsen with an excessively marked or sudden lowering of blood pressure. Consult your doctor before using the medicine.
• if you take Doxazosina Pensa in combination with a medicine capable of altering liver metabolism(e.g., cimetidine antacid). Tell your doctor the name of the medicines you are taking.
• if you are diabeticand also suffer from nerve fiber degeneration(diabetic autonomic neuropathy). Consult your doctor before using the medicine.
• if you have a reduced liver function. In this case, the use of Doxazosina Pensa is not recommended.
• If you are to undergo cataract surgery(clouding of the lens). Before the operation, inform the surgeon that you are taking, or have recently taken doxazosina. Doxazosina may cause complications during surgery, which can be better controlled if the surgeon is informed.
• if you take Doxazosina Pensa in combination with a medicine for erectile dysfunction(e.g., sildenafil, tadalafil and vardenafil) as both drugs have a vasodilating effect and this may cause symptomatic hypotension in some patients. At the beginning of treatment, the lowest possible dose of medicines for erectile dysfunction should be used, waiting at least 6 hours after taking doxazosina.

Since the safety and efficacy of doxazosina in children has not been established, the use of
doxazosina in children is not recommended.

Taking Doxazosina Pensa with other medicines
Doxazosina Pensa can alter the effectiveness of other medicines. Which, in turn, can
alter the effectiveness of Doxazosina Pensa.
Doxazosina Pensa can influence the hypotensive effect of other medicines used to
lower blood pressure.
The hypotensive effect of doxazosina may be potentiated when associated with
vasodilatormedicines and medicines (nitrates) used for the treatment of a painful sensation
of constriction in the chest (angina pectoris).
The blood pressure lowering effect may be reduced when used in conjunction with

some pain relieversfor the control of rheumatism (non-steroidal anti-rheumatic drugs).
Medicines that stimulate a specific part of the nervous system (sympathomimetics)
can reduce the blood pressure lowering effect. Examples of such medicines are
natural substances such as dopamine,ephedrine,and epinephrine, the hypotensive drug

metaraminoland eye drops for pupillary dilation (phenylephrine).
Some patients treated with alpha-blockers for high blood pressure or
prostate enlargement may experience dizziness or confusion, which may
be caused by low blood pressure when sitting or standing up
quickly. Some patients have experienced these symptoms when taking medicines for
erectile dysfunction (impotence) together with alpha-blockers.
To reduce the likelihood of these symptoms occurring, you should be in treatment
with a regular daily dose of alpha-blocker before starting to take medicines for
erectile dysfunction.

Inform your doctor or pharmacistif you are taking or have recently taken any
of the medicines listed above or any other medicine, including over-the-counter
medicines.

Taking Doxazosina Pensa with food and drink
The effect of Doxazosina Pensa is not altered by food or drink.

Pregnancy and breastfeeding
This paragraph is not relevant if you are taking doxazosina for benign prostatic hyperplasia.
Doxazosina Pensa can be used during pregnancy only if the doctor believes that the
benefits of treatment withdoxazosina outweighthe possible risks.
If you are planning a pregnancy or suspect you are pregnant, contact
your doctor immediately.
The safety of Doxazosina Pensa during breastfeeding has not been established. Studies on
animals have shown that doxazosina is excreted in breast milk. During
breastfeeding, you should not take doxazosina.If necessary, you should temporarily interrupt
taking doxazosina, in agreement with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and operating machinery
If you experience side effects such as dizziness and weakness, do not drive any vehicle and do not use
machinery. In the absence of such side effects, you can drive and/or use machinery. The medicine
may negatively affect the ability to drive or use machinery, especially at the beginning
of treatment with doxazosina.

Important information on some excipients of Doxazosina Pensa
Doxazosina Pensa tablets contain lactose monohydrate,a sugar present in
milk. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine.

3. How to take Doxazosina Pensa

Always take Doxazosina Pensa exactly as your doctor has instructed.
If you have any doubts, consult your doctor or pharmacist.
Doxazosina Pensa should be taken once a daywith water. To this end, it is advisable to
set a time of day.
It is recommended to take the first dose before bedtime due to possible undesirable effects
at the beginning of treatment (dizziness and weakness).
The usual dose is:

High blood pressure
The recommended initial dose is 1 mg once a day. Normally the dose is
increased by your doctor at intervals of 1 or 2 weeks until the desired hypotensive
effect is obtained. The usual dose is between 1 and 8 mg per day. The maximum dose is 16 mg per
day.

Benign prostatic hyperplasia
The recommended initial dose is 1 mg once a day. Normally the dose is
increased by your doctor at intervals of 1 or 2 weeks. The usual dose is between 2 and 4
mg per day. The maximum dose is 8 mg per day.

Use in children
The use of Doxazosina Pensa is not recommended in children under the age of 12 years.

Duration of treatment
Your doctor can provide you with further information. Based on blood pressure, your doctor will decide
whether or not to lower the dose. It is not advisable to stop treatment
with Doxazosina Pensa without first consulting your doctor.

If you take more Doxazosina Pensa than you should
If you realise you have taken a quantity of medicine greater than that prescribed, consult
your doctor immediately. You should immediately lie down with your head down. Show to

If you forget to take Doxazosina Pensa
If you forget to take a dose of Doxazosina Pensa, do not take it late. Simply skip
the dose and take the next one at the usual time. Never double a dose
to make up for the missed dose.

If you stop taking Doxazosina Pensa
It is not advisable to stop treatment with Doxazosina Pensa without consulting your
doctor.If the doctor believes that treatment with doxazosine can be stopped, the
dosage should be reduced gradually.Sudden discontinuation of treatment with doxazosine
may cause high blood pressure.
If you have any doubts about the use of Doxazosina Pensa, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Doxazosina Pensa can cause side effects, although not everybody gets them. If any of these side effects gets serious, or if you notice any not listed in this leaflet, tell your doctor or pharmacist.

Common (affects 1 - 10 patients in 100)

General: fatigue, weakness, chest pain, flu-like symptoms, feeling unwell, fluid retention.

Infections and infestations:respiratory tract infections, urinary tract infections.

Heart conditions:increased heart rate (tachycardia), palpitations.

Vascular conditions:drops in blood pressure, also when getting up quickly from a sitting or lying position, possibly accompanied by dizziness (postural hypotension).

Central nervous system conditions: headache, dizziness, drowsiness.

Gastrointestinal conditions: abdominal pain, nausea, heartburn (dyspepsia), dry mouth, diarrhoea.

Skin conditions: itching.

Respiratory conditions: shortness of breath, nasal congestion, bronchitis, swelling and irritation of the nose (rhinitis), cough.

Musculoskeletal disorders:back pain, muscle pain.

Psychiatric disorders:lack of motivation (apathy).

Renal and urinary disorders: bladder infections, urinary incontinence.

Eye conditions: vision disturbances (accommodation disorders).

Ear conditions:a sensation of spinning (vertigo).

Uncommon (affects 1 - 10 patients in 1,000):

General: fluid retention in the face (facial edema), fever, chills, pallor, pain.

Immune system:allergic (hypersensitivity) reaction to the medicine.

Heart conditions:heart attack, irregular heartbeat (arrhythmia), disturbances in circulation to the arms and legs (peripheral ischemia), painful sensation of constriction in the chest (angina pectoris).

Vascular conditions:facial flushing.

Central nervous system conditions: tremors, muscle stiffness, reduced sense of touch, stroke, fainting.

Gastrointestinal conditions:flatulence, inflammation of the gastrointestinal tract, vomiting, constipation.

Liver disorders:abnormalities in liver function tests.

Respiratory conditions: nosebleeds, laryngitis.

Metabolism disorders: potassium deficiency in the blood, which in severe cases can manifest as muscle cramps, muscle weakness and fatigue (hypokalaemia), thirst, joint inflammation (gout), increased appetite, loss of appetite.

Musculoskeletal disorders:swelling/pain in the joints.

Psychiatric disorders:nightmares, memory loss, emotional instability, depression, agitation, anxiety, difficulty falling asleep, nervousness.

Reproductive system and breast disorders: impotence.

Renal and urinary disorders: difficulty or pain when urinating (dysuria), frequent urgent need to urinate, blood in the urine.

Eye conditions: excessive tearing, problems with bright light (photophobia).

Ear conditions:ringing in the ears (tinnitus).

Diagnostic tests:weight gain.

Rare (affects 1 - 10 patients in 10,000):
Systemic conditions: hypothermia (in the elderly).

Vascular conditions: disorders affecting blood vessels in the brain (cerebrovascular conditions).

Respiratory conditions: shortness of breath due to fluid accumulation in the larynx.

Musculoskeletal disorders:muscle weakness, muscle cramps.

Renal and urinary disorders: increased urine production.

Skin conditions: sweating.

Liver disorders:increased liver enzymes.

Metabolism disorders: low blood sugar levels accompanied by hunger, sweating, dizziness, palpitations (hypoglycemia).

Eye conditions: inflammation of the conjunctiva (conjunctivitis).

Very rare (affects less than 1 patient in 10,000):

Cardiovascular conditions:slowing of the heartbeat, irregular heartbeat (arrhythmia).

Blood disorders: changes in the blood: reduction in the number of white blood cells, accompanied by increased susceptibility to infections, unexpected bleeding or bruising (reduction in the number of leukocytes and platelets).

Respiratory conditions: breathing caused by contraction of the respiratory muscles (bronchospasm).

Vascular conditions:facial flushing.

Central nervous system conditions: dizziness when getting up quickly from a sitting or lying position, itching or a tingling sensation without cause (paresthesia).

Skin conditions: hives, hair loss (alopecia), skin redness.

Liver disorders: obstruction of bile flow, inflammation of the liver (hepatitis), jaundice.

Reproductive system and breast disorders: persistent erection of the penis without sexual desire (priapism), breast enlargement in men (gynecomastia).

Renal and urinary disorders: increased urine production, difficulty urinating, need to urinate during the night.

Eyes:blurred vision.

General: fatigue, feeling unwell

Not known (frequency cannot be estimated from the available data)

Gastrointestinal conditions: altered taste.

Eyes:a condition of the eye that occurs during surgery (iris flag sign syndrome).

Reproductive system and breast disorders: abnormal ejaculation in which semen goes into the bladder (retrograde ejaculation).
During the initiation of therapy, a drop in blood pressure caused by getting up quickly from a sitting or lying position may occur; this may be accompanied by dizziness (orthostatic hypotension), and in rare cases even sudden loss of consciousness lasting from a few seconds to a few hours (syncope), particularly at high doses.
If any of these side effects gets worse or if you notice any not listed in this leaflet, tell your doctor or pharmacist.

5. How to store Doxazosina Pensa

• Keep out of the reach and sight of children.
• Store in the original package.
• Keep the container tightly closed.

The tablets of Doxazosina Pensa do not require any particular storage temperature.
Do not use Doxazosina Pensa after the expiry date which is stated on the package after
‘EXP’. The first two digits indicate the month and the last four digits indicate the year. The expiry
date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Further information

What Doxazosina Pensa contains

• The active ingredient is doxazosin mesylate. One Doxazosina Pensa 2 mg tablet contains 2.43 mg of doxazosin mesylate, equivalent to 2 mg of doxazosin. One Doxazosina Pensa 4 mg tablet contains 4.85 mg of doxazosin mesylate, equivalent to 4 mg of doxazosin.
• The excipients are microcrystalline cellulose, sodium lauryl sulfate, lactose monohydrate, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate and sunset yellow FCF (E110). (see section 2, Important information about some excipients of Doxazosina Pensa).

Description of the appearance of Doxazosina Pensa and contents of the pack
Doxazosina Pensa 2 mg: the Doxazosina Pensa 2 mg tablet is a light pink-orange tablet, with a score line on both sides and the inscription “DZS 2” engraved on only one side.
Doxazosina Pensa 4 mg: the Doxazosina Pensa 4 mg tablet is a light pink-orange tablet, with a score line on both sides and the inscription “DZS 4” engraved on only one side.
Doxazosina Pensa 2 mg: available in packs of 30 tablets in blisters or in hospital packs of 50 tablets (EAV packaging).
Doxazosina Pensa is also available in containers of 30, 100 or 500 tablets, with a child-resistant closure.
Doxazosina Pensa 4 mg: available in packs of 20 or 30 tablets in blisters or in hospital packs of 50 tablets (EAV packaging).
Doxazosina Pensa is also available in containers of 30, 100 or 500 tablets, with a child-resistant closure.
Not all pack sizes may be marketed.

Marketing authorisation holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturers responsible for batch release
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania, S.L.
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain

This medicinal product is authorised in the member states of the EEA with the following names:
Netherlands Doxazosine 2 mg
Doxazosine 4 mg
Italy Doxazosina Pensa 2 mg
Doxazosina Pensa 4 mg