NORADOX 2 mg Coated Tablet

Содержание инструкции

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

NORADOX 2 mg tablets, 4 mg tablets

Doxazosina mesilato

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

1. What is NORADOX and what is it used for

NORADOX contains the active ingredient doxazosin, which belongs to a group of medicines called alpha-
blockers used to lower blood pressure and to treat a problem with the prostate.
NORADOX is indicated for the treatment:

• of high blood pressure (essential hypertension);
• of symptoms caused by a condition called benign prostatic hyperplasia (BPH) which affects the prostate gland in men.

NORADOX works by relaxing the blood vessels, allowing blood to pass more easily through
them. This helps to lower blood pressure.
In patients who have an enlarged prostate gland, NORADOX is used to
treat poor and/or frequent urine flow. NORADOX works by relaxing the muscle
around the outlet of the bladder and the prostate gland in order to facilitate urine flow.

2. What you need to know before taking NORADOX

Do not take NORADOX

• if you are allergic to doxazosin, to medicines similar to doxazosin called quinazolines (e.g. prazosin, terazosin) or to any of the other ingredients of this medicine (listed in section 6);
• if you have suffered from orthostatic hypotension. Orthostatic hypotension is a drop in 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 tract infection or bladder stones;
• if you are breastfeeding and need to take this medicine for the treatment of high blood pressure (See the section “Pregnancy and breastfeeding”);
• if you suffer from excessively low blood pressure (this only applies if you are taking doxazosin for benign prostatic enlargement).
• 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 NORADOX.
Use particular caution in the following cases:

• at the beginning of therapy, because this medicine can cause a drop in blood pressure (orthostatic hypotension) characterized by dizziness and weakness or, rarely, loss of consciousness. Your doctor should check your blood pressure in this case (see the section “Possible side effects”). In particular, you should be very careful if you are elderly, or suffer from kidney problems (renal insufficiency), or liver problems (hepatic insufficiency), or follow a low-salt diet or take medicines to increase diuresis (diuretics);
• if you suffer from heart problems.
• if you have liver problems (hepatic insufficiency). If you suffer from severe hepatic insufficiency, taking this medicine is not recommended (See the section “Use in people with liver problems”);
• if you are taking medicines used to treat impotence (erectile dysfunction) such as sildenafil, tadalafil and vardenafil. In this case, inform your doctor who will indicate the dose to be taken. Take these medicines after 6 hours from taking NORADOX (see the section “Other medicines and NORADOX”);
• if you are going to undergo eye surgery for cataracts (clouding of the lens), tell your ophthalmologist before the operation that you are using or have previously used NORADOX. NORADOX can cause complications during surgery that can be managed if the specialist is warned in advance.

Persistent painful erections of the penis –can occur very rarely. If this happens, contact
your doctor immediately.
Before starting therapy with NORADOX, your doctor may perform some tests to rule out other
diseases such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

Children and adolescents
NORADOX 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 NORADOX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, tell your doctor if you are taking any of the following medicines:

• medicines for impotence called PDE-5 inhibitors, such as sildenafil, tadalafil, vardenafil (see the section “Warnings and precautions”);
• medicines used for high blood pressure (alpha-blockers and other medicines used for the therapy of high blood pressure such as vasodilators and nitrates);
• 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.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
The safety of use of Noradox during pregnancy has not been established. Therefore, if you are
pregnant, your doctor will prescribe Noradox only if the potential benefits outweigh the risks.

Breastfeeding
Small amounts of doxazosin may be found in breast milk. Do not breastfeed your baby unless your
doctor advises you to do so.

Driving and using machines
NORADOX can impair your ability to drive vehicles and use machines, especially at the beginning of
treatment. If this happens, avoid driving and using machines.

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

3. How to take NORADOX

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take the tablets once a day with a sufficient amount of water. Your doctor will indicate the
dose and the duration of treatment. Generally, the usual recommended daily dose is 2-4 mg.

Treatment of high blood pressure:The recommended dose ranges 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 bed 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 advise you to increase the dose to 4, 8 and 16 mg per day based on your
condition.

Treatment of benign prostatic hyperplasia:The recommended dose ranges 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 advise you to
increase the dose to 4 mg (1 x NORADOX 4 mg tablet) and, subsequently, to the maximum recommended
dose of 8 mg per day (2 x NORADOX 4 mg tablets). The recommended time interval
between one dose increase and the next is from 1 to 2 weeks.

If you take more NORADOX 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 NORADOX than you should, inform your doctor immediately or go to the nearest
hospital.

If you forget to take NORADOX
If you forget to take NORADOX, completely skip the dose. Do not take a double dose to
make up for a missed dose.

If you stop taking NORADOX
If you stop treatment with doxazosina 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 everybody gets them.
If you experience any of these symptoms, STOP taking NORADOX and call an ambulance immediately:

• chest pain, chest discomfort (angina, myocardial infarction);
• feeling short of breath (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 you experience any of the following symptoms after taking NORADOX:

• fast, slow, or irregular heartbeat;
• feeling your heartbeat (palpitations);
• yellowing of the skin or eyes (jaundice);
• low number of white blood cells or platelets in the blood. These situations can respectively lead to a greater predisposition to contract infections or greater presence of bruises or a tendency to bleed.

The following side effects may occur:

Common(may affect up to 1 in 10 people)

• feeling dizzy or the surroundings spinning (vertigo), headache;
• low blood pressure or a drop in pressure when moving from a sitting or lying position to standing;
• 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(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 a penis erection;
• increased liver enzymes, which can alter some medical tests.

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

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

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

• hepatitis (inflammation of the liver) or biliary disorder (cholestasis);
• hives, 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;
• painful persistent erection of the penis. Seek immediate medical attention;
• sudden dizziness accompanied by loss of balance.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store NORADOX

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 particular storage conditions.
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 NORADOX 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 NORADOX 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 NORADOX and contents of the pack
NORADOX 2 mg tablets - Pack containing 30 divisible 2 mg tablets in blisters.
NORADOX 4 mg tablets - Pack containing 20 divisible 4 mg tablets in blisters.

Marketing Authorisation Holder
Errekappa Euroterapici S.p.A., via Ciro Menotti 1A – 20129 Milano

Manufacturer
Doppel Farmaceutici S.r.l. Via Volturno, 48 - 20089 Quinto de’ Stampi - Rozzano (Milano) - Italy
Special Product’s Line S.p.A. - via Fratta Rotonda Vado Largo, 1 - Anagni (Frosinone)