Package leaflet: Information for the patient

DEDRALEN 2 mg tablets, 4 mg tablets

Doxazosin
Please 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 others, even if their symptoms are the same as yours, as 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:

What Dedralen is and what it is used for
What you need to know before taking Dedralen
How to take Dedralen
Possible side effects
How to store Dedralen
Contents of the pack and other information

1. What Dedralen is and what it is used for

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

2. What you need to know before taking 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) associated with difficulty urinating, chronic urinary tract infection, or bladder stones.
If you have previously suffered from a condition known as "orthostatic hypotension", a form of low blood pressure that causes dizziness or a feeling of lightheadedness when standing up from a sitting or lying position.
If you have a particular type of urinary incontinence involving involuntary urine leakage occurring as a result of an overfilled bladder, or if you are not producing an adequate amount of urine, with or without progressive loss of kidney function.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dedralen.
When you start taking Dedralen, you may experience weakness, dizziness, and, rarely, fainting due to a drop in blood pressure upon standing 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.
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 Dedralen. This medicine may cause complications during surgery, which can be managed if the specialist is informed in advance.
Inform your doctor or pharmacist before taking Dedralen if any of the following apply to you, as Dedralen should be used with caution in these cases:

If you suffer from heart disease.
If you suffer or have suffered from liver disease.
If you are taking medicines for erectile dysfunction (impotence), known as phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, and vardenafil), as both medicines lower blood pressure by dilating blood vessels. Taking Dedralen together with these medicines may cause excessive lowering of blood pressure (see "Other medicines and Dedralen"). To reduce the risk of symptoms, you should first start Dedralen therapy, taking a regular daily dose. Once Dedralen treatment is stabilized, you may then begin taking medicines for erectile dysfunction.

Very rarely, prolonged and sometimes painful erections may occur during treatment with Dedralen.
If you have an erection lasting 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 safety and efficacy of the treatment have not been established.
Other medicines and Dedralen
Inform 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 prostate enlargement (called alpha-blockers) may enhance the blood pressure-lowering effect of doxazosin.
Some medicines used for erectile dysfunction (impotence) (called phosphodiesterase-5 inhibitors, such as sildenafil, tadalafil, and vardenafil) may cause excessive lowering of blood pressure accompanied by symptoms (see "Warnings and precautions").
Some medicines used in the pretreatment of heart failure, called diuretics, may enhance the blood pressure-lowering effect of other alpha-blockers and antihypertensive agents. Particular caution is advised when combining these 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 discontinued if you need to start treatment with Dedralen.
Driving and using machines
Be careful if you drive or use machines. 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 use machinery and contact your doctor immediately.
Dedralen contains lactose
If your doctor has diagnosed you with an 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 exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dedralen is available in two strengths: 2 mg and 4 mg.
The starting dose of Dedralen is 1 mg given as a single daily dose.
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. After another period of one or two weeks, and if needed, your doctor may further increase the dose to 8 mg per day, until blood pressure is lowered to the desired level. In some cases, the dose may be increased up to a maximum of 16 mg per day.
The usual dose is 2 – 4 mg per day. The maximum recommended dose is 16 mg per day. If necessary, your doctor may tell you to take other medicines together with Dedralen to achieve the desired effect.

Dedralen may be taken either in the morning or in the evening.

If you take more Dedralen than you should
Taking too many tablets at the same time may make you feel unwell, as your blood pressure may drop too much. If this happens, lie down flat. Taking many tablets may be dangerous. If you take more Dedralen than you should, contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Dedralen
If you forget to take Dedralen, skip the missed dose completely. Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use 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 treatment with Dedralen and call an
ambulance immediately:

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

Inform your doctor immediately if, after taking Dedralen, 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 and tendency to bleed, respectively.

In patients treated with Dedralen, the following adverse events have also been reported:
Common side effects (may affect up to 1 in 10 people)

sensation of spinning or dizziness, headache;
low blood pressure or drop in blood pressure when moving from a sitting or lying position to standing;
swelling of feet, ankles or fingers;
bronchitis, cough, respiratory tract infections (nose, throat, lungs);
stuffy nose, sneezing and/or 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, generalised 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 intestine (gastroenteritis), which may cause diarrhoea and vomiting;
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, generalised pain;
facial swelling;
insomnia, restlessness, anxiety, depression or nervousness;
temporary loss of consciousness;
reduced or altered sensitivity to touch in hands and feet;
increased or decreased appetite, weight gain;
nosebleeds;
skin rash;
ringing or buzzing in the ears (tinnitus), tremor;
inability to achieve or maintain penile erection;
increased liver enzymes, which may affect certain medical tests.

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

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;
hot flushes;
urinary disturbances, need to urinate at night, increased urine volume;
breast enlargement in men;
prolonged and painful penile erection;
sudden dizziness accompanied by loss of balance.

Other side effects (frequency cannot be estimated from the available data)

retrograde ejaculation (semen is ejaculated not externally but into the bladder), which may cause cloudy urine after orgasm;
eye problems 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, talk to your doctor or
pharmacist. You can also report side effects directly via the national reporting system. 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 packaging 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 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 Dedralen contains
The active substance 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 components are: microcrystalline cellulose, lactose, sodium carboxymethyl starch, magnesium stearate, sodium lauryl sulfate.

Description of the appearance of Dedralen and packaging contents
PVC-PVDC/Aluminum blisters opacified with titanium dioxide.
Carton pack containing 30 2 mg scored tablets in blister.
Carton pack containing 20 4 mg tablets in blister.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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