DOXAZOSINA 2 mg Коированная Таблетка

Содержание инструкции

1. Doxazosina Mylan Generics 2 mg tablets, 4 mg tablets
   1. What is Doxazosina Mylan Generics and what is it used for
   2. What you need to know before taking Doxazosina Mylan Generics
2. Doxazosina Mylan Generics has been prescribed to treat enlargement of the
3. Doxazosina Mylan Generics may interfere with the ability to drive vehicles or use
   1. How to take Doxazosina Mylan Generics
   2. Possible side effects
   3. How to store Doxazosina Mylan Generics
   4. Contents of the pack and other information

Doxazosina Mylan Generics 2 mg tablets, 4 mg tablets

Equivalent Medicinal Product
Read this leaflet carefully before taking 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 you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Doxazosina Mylan Generics and what is it used for

Doxazosina Mylan Generics belongs to a group of medicines known as
vasodilators. These substances cause a dilation of the blood vessels which reduces
blood pressure. Doxazosina Mylan Generics can also reduce the tension of the
muscular tissues of the prostate and urinary tract.
It is used for:

• high blood pressure;
• treatment of the symptoms of enlarged prostate.

2. What you need to know before taking Doxazosina Mylan Generics

Do not take Doxazosina Mylan Generics

• if you are allergic to the active substance, to other medicines of the same group (known as quinazolines, such as prazosin and terazosin) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer (or have suffered) from orthostatic hypotension, a condition in which there is a drop in blood pressure that causes dizziness when getting up from a lying or sitting position;
• if you suffer from an enlarged prostate together with difficulty urinating, chronic inflammation of the urinary tract, bladder stones;
• if you are unable to retain urine or do not feel the need to urinate (suffer from overflow incontinence) or if you are unable to produce urine (anuria) with or without kidney problems;
• if you suffer (or have suffered) from low blood pressure, this only applies if

Doxazosina Mylan Generics has been prescribed to treat enlargement of the

prostate.

Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosina Mylan Generics

• At the start of treatment or when the dose is increased. In these cases, the likelihood of a too rapid drop in blood pressure is greater. You may experience this as dizziness and weakness or, more rarely, fainting when changing position. To reduce this risk, your doctor will carefully monitor your blood pressure at the start of treatment and when the dose is increased.

Before taking this medicine, consult your doctor:

• If you are following a strict low-salt diet or are using diuretics;
• If you are elderly;
• If you have reduced kidney or liver function. In any of these cases, situations in which dizziness or fainting can cause injury should be avoided at the start of treatment.
• If you suffer from heart disease;
• If you are taking doxazosina and medicines that treat stomach problems such as cimetidine at the same time;
• If you have been told by your doctor that you have an intolerance to certain sugars;
• If you have nervous system disorders as a result of diabetes;
• If you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist before the operation that you are being treated or have already been treated with Doxazosina Mylan Generics. Doxazosina Mylan Generics can, in fact, cause complications during the operation. However, these complications can be managed by the ophthalmologist if informed in advance.

Some patients taking alpha-blockers for the treatment of high blood pressure or prostate enlargement may experience dizziness or a feeling of lightheadedness, which may be caused by a lowering of blood pressure when sitting or standing up quickly. Certain patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) together with alpha-blockers. In order to prevent these symptoms, you should be stabilized on a regular daily dose of alpha-blocker before starting erectile dysfunction therapy.

Children and adolescents
Doxazosina Mylan Generics is not recommended for use in children or adolescents under 18 years of age since safety and efficacy have not yet been established.

Other medicines and Doxazosina Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Note: the following comments may also apply to the use of medicines in the recent past or near future.
You may be more familiar with the medicines mentioned in this leaflet under a different name, often the trade name. This leaflet refers only to the active ingredient of the drug, or the group of drugs, but not the trade name. Therefore, you should know what the active substance of the medicines you are using is.
A drug interaction means that medicines or substances can influence each other in their way of acting or in undesirable effects, when taken at the same time. Interactions can occur when Doxazosina Mylan Generics is used together with:

• Other medicines used against high blood pressure such as beta-blockers (e.g. atenolol);
• Nitrates (medicines for heart problems) such as nitroglycerin and isosorbide nitrate: these can increase the blood pressure lowering effect;
• Medicines that dilate blood vessels: these can increase the blood pressure lowering effect;
• Some pain relievers for rheumatism (known as non-steroidal anti-inflammatory drugs) such as naproxen, ibuprofen or any other anti-inflammatory pain reliever: these can reduce the blood pressure lowering effect;
• Medicines known as sympathomimetics (substances that have a stimulating effect on a particular part of the nervous system) such as dopamine, ephedrine, metaraminol, adrenaline and phenylephrine: these can reduce the blood pressure lowering effect;
• Medicines that may also interfere with liver metabolism, e.g. cimetidine (a medicine for stomach disorders);
• Some medicines for erectile problems such as sildenafil, tadalafil and vardenafil: these can increase the blood pressure lowering effect;
• Medicines for the treatment of 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 for the treatment of depression. Doxazosina Mylan Generics can interfere with the interpretation of some laboratory data.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are insufficient data on use in human pregnancy to formulate any judgement on possible dangers. Animal tests have not shown any harmful effects. Consult your doctor if you are pregnant or planning a pregnancy since this medicine should only be used during pregnancy if a doctor decides that the benefit to the mother outweighs the possible risk to the fetus.
Breastfeeding
Small amounts of doxazosina may be found in breast milk. Do not breastfeed your baby unless your doctor advises you to do so.

Driving and using machines

Doxazosina Mylan Generics may interfere with the ability to drive vehicles or use

machinery, particularly at the beginning of treatment. Doxazosina Mylan Generics
may sometimes cause dizziness or fainting. In such cases, caution should be exercised during
activities that require attention such as driving, using machinery or working at
heights. If you are not sure whether Doxazosina Mylan Generics has negative effects
on your ability to drive, talk to your doctor.

Doxazosina Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before
taking this medicine.

Doxazosina Mylan Generics contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially ‘sodium-free’.

3. How to take Doxazosina Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is:
HIGH BLOOD PRESSURE
The initial dose is 1 mg per day (=24 hours) in a single administration. After 1 or
2 weeks, the dose is usually increased to 2 mg in a single daily dose
(=24 hours). This dose should be maintained for 1 or 2 weeks. If necessary, the dose may
be further increased to 4, 8 or 16 mg per day, until the desired reduction in
blood pressure is obtained. The maximum daily dose is 16 mg.
The initial dose should preferably be taken before going to bed because this way
any dizziness that may occur will cause less problems.
ENLARGED PROSTATE
The initial dose is 1 mg per day (=24 hours) in a single administration from day 1 to
day 8. From day 8 to day 14, a 2 mg tablet is taken. If after 1 or 2
weeks the effect is insufficient, the dose may be increased to 4 mg per day. In
some cases, the dose may be increased up to a maximum of 8 mg per day (=24
hours).
The tablets must be taken every day (=24 hours) in a single
administration. The tablets must be swallowed with plenty of water (about
a whole glass).
If your doctor has prescribed you a dose of 1 mg of Doxazosina Mylan Generics per day,
you must break a 2 mg tablet in two halves and use one half.

If you take more Doxazosina Mylan Generics than you should
If you have taken more than the prescribed dose, consult your doctor or
pharmacist immediately. If you feel dizzy or think you are about to faint, you should lie down
immediately with your head down.

If you forget to take Doxazosina Mylan Generics
If you have forgotten to take a tablet, skip it and take the next tablet at the usual time.
Ask your doctor or pharmacist if you are not sure.
Do not take a double dose to make up for the missed tablet.

If you stop taking Doxazosina Mylan Generics
If you suddenly stop taking Doxazosina Mylan Generics, the disorders you
suffered from before starting treatment may reappear. Therefore, it is best not to
stop taking this medicine suddenly. Your doctor will reduce the dose
gradually. Always ask your doctor or pharmacist if you are not sure.
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 everyone experiences them.
The following side effects may occur when using Doxazosina Mylan
Generics:

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

• Respiratory tract infection (nose, throat, lungs) and urinary tract infection
• Headache, dizziness, drowsiness
• Delayed ejaculation, lack of energy
• Blurred vision
• Heart palpitations, increased heart rate, swelling of different parts of the body
• Low blood pressure, drop in blood pressure when changing position
• Stuffy and runny nose
• Cough, difficulty breathing
• Abdominal pain, belching, nausea, heartburn (dyspepsia), dry mouth
• Itching
• Back pain
• Loss of bladder control, bladder inflammation
• Weakness
• Flu-like symptoms
• Swelling of the hands, ankles, or feet.

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

• Insufficient levels of potassium in the blood (hypokalemia, which, in severe cases, may manifest as muscle cramps or muscle weakness and fatigue), thirst, joint swelling due to uric acid crystals
• Increased appetite
• Nightmares, memory loss, emotional instability, agitation, depression, nervousness, difficulty falling asleep
• Tremors, muscle stiffness, stroke, decreased sense of touch or sensitivity, especially of the skin, weakness
• Tinnitus (ringing in the ears)
• Excessive tearing, increased sensitivity to light
• Constricting and painful sensation in the chest (angina pectoris), myocardial infarction (heart attack)
• Diarrhea, vomiting, constipation, inflammation of the stomach and intestines, presence of air
• Nosebleeds, sore throat
• Abnormal liver function tests
• Skin rash, sweating
• Pain when passing urine, blood in urine, frequent need to urinate
• Inability to achieve or maintain an erection (impotence)
• General swelling or of the face, facial flushing, fever, pallor
• Weight gain
• Changes in taste.

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

• Low blood sugar levels
• Numbness or tingling of the hands or feet
• Dizziness when changing position
• Problems with blood vessels in the brain (cerebrovascular events)
• Passing much more urine than normal
• Reduced body temperature in the elderly
• Itchy eye discharge and grainy sensation of the eyelids (conjunctivitis)
• Dyspnea (shortness of breath) due to swelling of the larynx
• Stomach pain
• Increased urine production

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

• Lack of white blood cells and decreased platelets associated with increased susceptibility to infections and unexpected bleeding or bruising
• Low heart rate, irregular heartbeat
• Hot flashes
• Dyspnea due to cramps in the muscles of the respiratory tract (bronchospasm)
• Blurred vision
• Yellowing of the skin or eyes (jaundice), liver inflammation, bile problems
• Hair loss, bruising under the skin (purpura), hives
• Muscle cramps, muscle weakness
• Increased urine production, urinary disorders, need to urinate at night
• Painful persistent erection of the penis. Seek immediate medical attention.
• Enlargement of the breasts in men
• Fatigue, general malaise.

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

• Eye disease called “Intraoperative Floppy Iris Syndrome (IFIS)”
• Retrograde ejaculation

At the beginning of treatment, a drop in blood pressure (when changing
position) may occur, which can lead to dizziness and lightheadedness, in rare cases, temporary loss of consciousness may occur, particularly at high doses.
These phenomena may also occur if treatment is resumed after a
brief interruption.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side
effects directly through the national reporting system at
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 Doxazosina Mylan Generics

Keep this medicine out of the sight and reach of children .
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the packaging
after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Doxazosina Mylan Generics contains
The active ingredient is doxazosin mesylate.
One Doxazosina Mylan Generics 2 mg tablet contains doxazosin mesylate
equivalent to 2 mg of doxazosin.
The other ingredients are: microcrystalline cellulose, anhydrous lactose, sodium starch
glycolate (type A), magnesium stearate, sodium lauryl sulfate and anhydrous colloidal silica.
One Doxazosina Mylan Generics 4 mg tablet contains doxazosin mesylate
equivalent to 4 mg of doxazosin.
The other ingredients are: microcrystalline cellulose, anhydrous lactose, sodium starch
glycolate (type A), magnesium stearate, sodium lauryl sulfate and anhydrous colloidal silica

Description of the appearance of Doxazosina Mylan Generics and contents of the
pack
2 mg: oblong, white tablet with a fracture line on one side and the inscription “D2”
on the other.
4 mg: oblong, white tablet with a fracture line on one side and the inscription “D4”
on the other.
The tablets are packaged in PVC/PVDC-Aluminum blisters.
2mg: packs of 30 tablets.
4mg: packs of 20, 30 and 60 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124, Milan

Manufacturer
TEVA Pharmaceutical Works Company Ltd, 13 Pallagi H-4042, Debrecen, Hungary