Noradox

Patient Information Leaflet: Information for the User

NORADOX 2 mg tablets, 4 mg tablets

Doxazosin mesylate
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, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 NORADOX is and what it is used for

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

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

NORADOX works by relaxing the blood vessels, allowing blood to flow more easily through them. This helps lower blood pressure.
In patients with enlargement of the prostate gland, NORADOX is used to treat weak and/or frequent urine flow. NORADOX works by relaxing the muscle around the outlet of the bladder and the prostate gland to facilitate the passage of urine.

2. What you need to know before taking NORADOX

Do not take NORADOX

• if you are allergic to doxazosin, to medicines similar to doxazosin known as 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 standing up, which may cause dizziness, lightheadedness, or fainting;
• if, in addition to benign enlargement of the prostate, you suffer from congestion or blockage of the upper urinary tract, chronic recurrent urinary infection, or bladder stones;
• if you are breastfeeding and need to take this medicine for the treatment of high blood pressure (See section “Pregnancy and breastfeeding”);
• if you suffer from excessively low blood pressure (this applies only if you are taking doxazosin for benign prostatic enlargement).
• if you suffer from continuous urinary leakage (reflux incontinence) or absence of urine production (anuria), with or without kidney problems (progressive renal failure). In this case, you should take this medicine only in combination with other medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking NORADOX.
Exercise particular caution in the following cases:

• at the beginning of treatment, because this medicine may cause a drop in blood pressure (orthostatic hypotension) characterized by dizziness and weakness, or rarely, loss of consciousness. Your doctor should monitor your blood pressure in such cases (see section “Possible side effects”). In particular, you should be especially careful if you are elderly, or suffer from kidney problems (renal failure), liver problems (hepatic impairment), follow a low-salt diet, or take medicines to increase urine production (diuretics);
• if you suffer from heart problems;
• if you have liver problems (hepatic impairment). If you suffer from severe hepatic impairment, taking this medicine is not recommended (See section “Use in patients with liver problems”);
• if you are taking medicines used to treat erectile dysfunction such as sildenafil, tadalafil, and vardenafil. In this case, inform your doctor, who will advise you on the appropriate dose. Take these medicines at least 6 hours after taking NORADOX (see section “Other medicines and NORADOX”);
• if you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist before the procedure that you are currently taking or have previously taken NORADOX. NORADOX may cause complications during eye surgery, which can be managed if the specialist is informed in advance.

Prolonged painful erections of the penis – may occur very rarely. If this happens, contact a doctor immediately.
Before starting treatment with NORADOX, your doctor may perform tests to rule out other diseases such as prostate cancer, which could cause symptoms similar to 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 treatment have not been established.

Other medicines and NORADOX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• medicines for erectile dysfunction called PDE-5 inhibitors, such as sildenafil, tadalafil, vardenafil (see section “Warnings and precautions”);
• medicines used for high blood pressure (alpha-blockers and other medicines used to treat high blood pressure such as vasodilators and nitrates);
• medicines used to treat bacterial or fungal infections, such as clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole;
• medicines used to treat HIV, such as indinavir, nelfinavir, ritonavir, saquinavir;
• nefazodone, a medicine used to treat depression.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

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

Breastfeeding
Small amounts of doxazosin may pass into breast milk. Do not breastfeed unless your doctor advises you to do so.

Driving and using machines
NORADOX may impair your ability to drive or operate machinery, especially at the beginning of treatment. If this occurs, avoid driving and using machinery.

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

3. How to take NORADOX

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablets once daily with a sufficient amount of water. Your doctor will determine the
dose and 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 daily. The maximum
dose is 16 mg daily.
At the beginning of therapy, take 1 mg (half a 2 mg tablet daily) before going to bed for one or two weeks. The dose may then be increased to 2 mg once daily for one or two weeks. If necessary, your doctor may instruct you to increase the dose to 4, 8, or 16 mg daily, depending on your condition.
Treatment of benign prostatic hyperplasia: The recommended dose ranges from 2 to 4 mg daily. At the beginning of therapy, take 1 mg (half a 2 mg tablet daily) for the first 8 days. From day 9 to day 14, take 2 mg daily (1 tablet of 2 mg). If necessary, your doctor may instruct you to increase the dose to 4 mg (1 tablet of NORADOX 4 mg), and subsequently to the maximum recommended dose of 8 mg daily (2 tablets of NORADOX 4 mg). The recommended interval between dose increases is 1 to 2 weeks.
If you take more NORADOX than you should
Taking too many tablets at once may make you feel unwell, as your blood pressure may drop excessively. If this happens, lie down in a supine position. Taking many tablets may be dangerous.
If you take more NORADOX than you should, contact your doctor immediately or go to the nearest hospital.
If you forget to take NORADOX
If you forget to take NORADOX, skip the missed dose completely. Do not take a double dose to make up for the forgotten dose.
If you stop taking NORADOX
If you interrupt treatment with doxazosin for a few days, inform your doctor first. In this case, it is recommended to restart treatment at the lowest initial dose of 1 mg.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following symptoms, STOP treatment with NORADOX and call an ambulance immediately:

• Chest pain, chest discomfort (angina, myocardial infarction);
• Feeling of shortness of breath (dyspnoea), accompanied by discomfort and a sensation of tightness in the chest (bronchospasm);
• Sudden headache, feeling faint, weakness in arms or legs, or difficulty speaking, which could be symptoms of a stroke;
• Swelling of the face and allergic reactions.

Immediately inform your doctor if, after taking NORADOX, 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 or tendency to bleed, respectively.

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

• Sensation of spinning or dizziness (vertigo), headache;
• Low blood pressure or drop in blood pressure upon changing 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 infection, urinary incontinence (inability to control or retain urine),
• Bladder inflammation (cystitis);
• Drowsiness, generalized 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 may cause diarrhoea and vomiting;
• Pain or discomfort when urinating, need to urinate more frequently than usual, blood in the urine;
• Swelling and inflammation of the joints (gout), joint pain, generalized pain;
• Swelling of the face;
• 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/inability to achieve or maintain penile erection;
• Increase in liver enzymes, which may affect certain medical tests.

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

• Muscle cramps, muscle weakness;
• Increased frequency of needing to urinate.

Very rare (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, feeling of general malaise;
• Blurred vision;
• Hot flushes;
• Urination disorders, need to urinate at night, increased urine volume;
• Enlargement of the breasts in men;
• Persistent painful erection of the penis. Seek immediate medical attention;
• 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 at the website: 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 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 NORADOX 2 mg tablets contain

• The active substance is doxazosin. One tablet contains 2.43 mg of doxazosin mesilate (equivalent to 2 mg of doxazosin base).
• The other components are: microcrystalline cellulose, monohydrate lactose, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

What NORADOX 4 mg tablets contain

• The active substance is doxazosin. One tablet contains 4.85 mg of doxazosin mesilate (equivalent to 4 mg of doxazosin base).
• The other components are: microcrystalline cellulose, monohydrate lactose, sodium glycolate starch, magnesium stearate, sodium lauryl sulfate.

Description of the appearance of NORADOX and contents of the pack
NORADOX 2 mg tablets - Carton containing 30 2 mg divisible tablets in blister packs.
NORADOX 4 mg tablets - Carton containing 20 4 mg divisible tablets in blister packs.
Marketing Authorization 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 (Milan) - Italy
Special Product’s Line S.p.A. - via Fratta Rotonda Vado Largo, 1 - Anagni (Frosinone)