DEDRALEN 2 mg Таблетки

Содержание инструкции

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

DEDRALEN 2 mg tablets, 4 mg tablets

Doxazosina

Read this leaflet carefully before you start 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 they have the same symptoms as you, as it may 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 Dedralen is and what it is used for
• 2. What you need to know before you take Dedralen
• 3. How to take Dedralen
• 4. Possible side effects
• 5. How to store Dedralen
• 6. Contents of the pack and other information

1. What is Dedralen and what is it used for

Dedralen contains the active substance doxazosin, which belongs to a group of medicines
called alpha-blockers. It is used for the treatment of high blood pressure
(essential hypertension).
Dedralen works by relaxing the blood vessels, allowing blood to pass more easily
through them. This helps to lower blood pressure.

2. What you need to know before you take Dedralen

Do not take Dedralen

• If you are allergic to doxazosin, to other types of quinazolines (such as prazosin or terazosin) or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or think you may be pregnant or if you are breastfeeding.
• If you have an enlarged prostate gland (benign prostatic hyperplasia) together with difficulty urinating, chronic urinary tract infection, or bladder stones.
• If you have suffered from a condition known as "orthostatic hypotension", a form of low blood pressure that causes dizziness or a feeling of lightheadedness when getting up from a sitting or lying position.
• If you suffer from a particular form of urinary incontinence in which there is involuntary loss of urine that occurs as a result of an overfull bladder, or if you do not produce an adequate amount of urine, with or without a progressive loss of kidney function.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dedralen.
When you start taking Dedralen you may feel a sense of weakness, dizziness and, rarely,
fainting caused by a drop in blood pressure when getting up from a sitting or lying position. If you feel weak, dizzy or faint, you should sit or
lie down until you feel better and avoid situations where you could fall or
get injured. Your 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 Dedralen. This medicine can cause complications during
surgery that can be managed if the specialist is warned in advance.
Tell your doctor or pharmacist before taking Dedralen if any of the following conditions apply to
you, because in these cases Dedralen 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 Dedralen and these other medicines could cause an excessive drop in blood pressure (see “Other medicines and Dedralen”). To reduce the likelihood of symptoms occurring, you will need to start therapy with Dedralen first, taking a daily dose regularly. Then, when therapy with Dedralen is stabilized, you can start taking medicines for erectile dysfunction.

During treatment with Dedralen, very rarely, prolonged and sometimes painful erections may occur.
If you have an erection that lasts more than 4 hours, contact a
doctor immediately.

Children and adolescents
Dedralen is not recommended for use in children and adolescents under 18 years of age as the
tolerability and efficacy of treatment have not been established.

Other medicines and Dedralen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
The following medicines may interact with Dedralen if taken at the same time:

• Some medicines used to treat high blood pressure or enlarged prostate (called alpha-blockers) may enhance the blood pressure lowering effect of doxazosin.
• Some medicines used for erectile dysfunction (impotence) (called phosphodiesterase type 5 inhibitors, such as sildenafil, tadalafil and vardenafil) may cause an excessive drop in blood pressure accompanied by symptoms (see “Warnings and precautions”).
• Some medicines used for the pre-treatment of heart failure, called diuretics, may enhance the blood pressure lowering effect of other alpha-blockers and other antihypertensives. Particular caution is recommended when used in combination with DEDRALEN (doxazosin).

Pregnancy and breastfeeding
Pregnancy
Dedralen is contraindicated during pregnancy (see section “Do not take Dedralen”).
Breastfeeding
Do not take Dedralen if you are breastfeeding. Breastfeeding must be stopped if
you need to start treatment with Dedralen.

Driving and using machines
Be careful if you drive or operate machinery. These tablets may impair your
ability to drive or operate machinery safely, especially at the beginning of treatment.
They may cause you to feel weak or dizzy. If you experience these symptoms, do not drive
or operate machinery and contact your doctor immediately.

Dedralen contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

Dedralen contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Dedralen

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Dedralen is available in two dosages: 2 mg and 4 mg.
The initial doseof Dedralen is 1 mg administered as a single dose every day.
After one or two weeks, your doctor may increase the dose to 2 mg per day. If necessary,
after a further period of one or two weeks, your doctor may decide to increase the dose again to
4 mg per day. Your doctor, after a further period of one or two weeks and if
necessary, may further increase the dose to 8 mg per day, until lowering blood
pressure to the desired level. In some cases, the dose may be increased up to a maximum of 16 mg
per day.
The usual doseis 2 – 4 mg per day. The maximum recommended dose is 16 mg per day. If
necessary, your doctor will tell you to take Dedralen together with other medicines to achieve
the desired effect.

• Dedralen can be taken indifferently in the morning or in the evening.

If you take more Dedralen than you should
Taking too many tablets together can make you feel unwell, as your blood pressure drops
excessively. If this happens, lie down. Taking
many tablets can be dangerous. If you take more Dedralen than you should, inform
your doctor immediately or go to the nearest hospital emergency room.

If you forget to take Dedralen
If you forget to take Dedralen, completely skip the dose. Do not take a double dose to
make up for a missed dose.
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 Dedralen and call an
ambulance immediately:

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

Inform immediatelyyour doctor if, after taking Dedralen, you experience any of the following
symptoms:

• 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 a greater predisposition to contract infections or increased bruising or a tendency to bleed, respectively.

The following adverse events have also been reported in patients treated with Dedralen:

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

• feeling of dizziness or spinning around (vertigo), headache;
• low blood pressure or a drop in pressure when moving from a sitting or lying position to a standing position;
• swelling of feet, ankles, or toes;
• bronchitis, cough, respiratory tract infection (nose, throat, lungs);
• stuffy nose, sneezing and/or runny nose due to inflammation of the nasal mucosa (rhinitis);
• abdominal pain, nausea;
• urinary tract infection, 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;
• flu-like symptoms.

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

• constipation, flatulence, inflammation of the stomach and intestines (gastroenteritis) which can cause diarrhea and vomiting;
• 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, generalized pain;
• swelling of the face;
• insomnia, agitation, anxiety, depression, or nervousness;
• temporary loss of consciousness;
• reduced or altered sensitivity to touch in hands and feet;
• increase or loss of appetite, weight gain;
• nosebleeds;
• skin rash;
• ringing or buzzing in the ears, tremor;
• inability/incapacity to achieve or maintain an erection of the penis;
• increased liver enzymes, which may alter some medical tests.

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

• increased number of times you need to urinate;
• muscle cramps, muscle weakness.

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

• hepatitis (inflammation of the liver) or bile disorder (cholestasis);
• urticaria, hair loss, red or purple patches 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;
• hot flashes;
• urinary disorders, needing to urinate at night, increased urine volume;
• enlargement of the breasts in men;
• persistent and painful erection of the penis;
• sudden dizziness accompanied by loss of balance.

Other side effects(frequency cannot be determined based on available data)

• retrograde ejaculation (semen is ejaculated not externally but into the bladder), which may cause cloudy urine after orgasm;
• problems with the eyes may occur during cataract surgery (clouding of the lens). See section "Warnings and precautions".

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through
adverse. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Dedralen

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 “Exp.”. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater 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 Dedralen contains
The active ingredient is doxazosin.
Each 2 mg tablet contains 2.43 mg of doxazosin mesylate equivalent to 2 mg of doxazosin.
Each 4 mg tablet contains 4.85 mg of doxazosin mesylate equivalent to 4 mg of doxazosin.
The other ingredients are: microcrystalline cellulose, lactose, sodium carboxymethylstarch, magnesium
stearate, sodium lauryl sulfate.

Description of the appearance of Dedralen and contents of the pack
Blisters in PVC-PVDC/Aluminium with titanium dioxide opacity.
Pack containing 30 divisible 2 mg tablets in blisters.
Pack containing 20 4 mg tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Italfarmaco S.p.A. – Viale Fulvio Testi, 330 – 20126 Milan
Manufactured under license from Pfizer Italia S.r.l.

Manufacturer
Italfarmaco S.p.A.
Viale Fulvio Testi, 330
20126 Milan