Doxazosin Sandoz

Patient Information Leaflet

Doxazosina Sandoz 2 mg tablets, 4 mg tablets

Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it may 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 Doxazosina Sandoz is and what it is used for
2. What you need to know before taking Doxazosina Sandoz
3. How to take Doxazosina Sandoz
4. Possible side effects
5. How to store Doxazosina Sandoz
6. Contents of the pack and other information

1. What Doxazosina Sandoz is and what it is used for

Doxazosina Sandoz contains the active substance doxazosin, which belongs to a group of
medicines called alpha-blockers used to lower blood pressure.
Doxazosina Sandoz is indicated for the treatment:

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

2. What you need to know before taking Doxazosin Sandoz

Do not take Doxazosin Sandoz

• if you are allergic to doxazosin, to quinazolines (e.g. prazosin, terazosin) or to any of the other ingredients of this medicine (listed in section 6);
• if you have a history of orthostatic hypotension. Orthostatic hypotension is a drop in blood pressure upon standing, which may cause dizziness, lightheadedness or fainting;
• if, in addition to benign enlargement of the prostate, you suffer from upper urinary tract congestion or obstruction, chronic recurrent urinary tract infection, or bladder stones;
• if you have excessively low blood pressure (this applies only if you are taking doxazosin for benign enlargement of the prostate);
• if you suffer from continuous urinary leakage (overflow incontinence) or absence of urine production (anuria), with or without 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 Doxazosin Sandoz.
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”);
• if you have heart problems such as:
• fluid accumulation in the lungs (pulmonary edema) due to narrowing of heart valves (aortic or mitral stenosis);
• heart function disorders (high-output heart failure, right-sided heart failure due to pulmonary embolism or pericardial effusion; left ventricular heart failure with low filling pressure);
• 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 for 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 Doxazosin Sandoz (see section “Other medicines and Doxazosin Sandoz”);
• if you are scheduled for eye surgery (cataract surgery);
• if you are pregnant or breastfeeding.

Children and adolescents
Do not use Doxazosin Sandoz in children and adolescents under 18 years of age, as safety and efficacy have not been established.

Other medicines and Doxazosin Sandoz
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:

• erectile dysfunction medicines known as PDE-5 inhibitors (see section “Warnings and precautions”);
• medicines used for high blood pressure (alpha-blockers and other medicines used to treat high blood pressure).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor. Doxazosin Sandoz will be prescribed only if the potential benefits outweigh the risks.

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

Doxazosin Sandoz contains lactose
Doxazosin Sandoz 2 mg contains 46.07 mg of monohydrate lactose per tablet.
Doxazosin Sandoz 4 mg contains 92.14 mg of monohydrate lactose per tablet.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Doxazosin Sandoz

Take this medicine exactly as directed 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 your treatment.

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 treatment, take 1 mg (half a 2 mg tablet daily) at bedtime 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: At the beginning of treatment, take 1 mg (half a 2 mg tablet daily) for the first 8 days. From day 9 to day 14, take 2 mg daily (one 2 mg tablet). If necessary, your doctor may instruct you to increase the dose to 4 mg (one 4 mg Doxazosin Sandoz tablet), and subsequently to the maximum recommended dose of 8 mg daily (two 4 mg Doxazosin Sandoz tablets).

Use in children and adolescents
Doxazosin Sandoz is not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not been established.

Use in elderly patients and patients with kidney problems
These patients should use this medicine with caution, especially at the beginning of treatment. However, no adjustment of the recommended dosage is necessary.

Use in patients with liver problems
In these patients, dose escalation must be carried out with great caution.

If you take more Doxazosin Sandoz than you should
In case of overdose, a drop in blood pressure may occur. In such a case, the patient should immediately be placed in a lying position with the head lowered, and a doctor must be contacted immediately. The doctor will initiate appropriate therapy, with particular attention to monitoring kidney function.
In case of accidental ingestion/overdose of Doxazosin Sandoz, immediately inform your doctor or go to the nearest hospital.

If you forget to take Doxazosin Sandoz
Do not take a double dose to make up for the forgotten dose.

If you stop taking Doxazosin Sandoz
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 experiences them.
The following side effects may occur:

Common (may affect up to 1 in 10 people)

• respiratory tract and urinary tract infections (cystitis), urinary incontinence;
• dizziness, headache (cephalalgia), drowsiness, vertigo;
• palpitations, increased heart rate (tachycardia);
• low blood pressure (hypotension), feeling of dizziness when standing up (postural hypotension);
• bronchitis, cough, difficulty breathing (dyspnoea), cold symptoms (rhinitis);
• abdominal pain, digestive problems (dyspepsia), dry mouth, nausea;
• itching;
• back pain, muscle pain (myalgia);
• feeling of weakness (asthenia);
• chest pain, flu-like symptoms, swelling due to fluid accumulation in arms and legs (peripheral oedema).

Uncommon (may affect up to 1 in 100 people)

• allergic drug reactions;
• gout, a disease caused by accumulation of uric acid;
• increased appetite, anorexia;
• restlessness, nervousness, anxiety, depression, insomnia;
• stroke (cerebrovascular accident), decreased sensitivity (hypoesthesia), loss of consciousness (syncope), tremor;
• heart problems (angina pectoris, myocardial infarction);
• ringing in the ears (tinnitus);
• nosebleeds (epistaxis);
• constipation (stipsis), passing gas (flatulence), vomiting, inflammation of stomach and intestine (gastroenteritis), diarrhoea;
• changes in liver function tests;
• skin irritation (cutaneous rash);
• joint pain (arthralgia);
• difficulty urinating, frequent need to urinate, and blood in the urine;
• impotence;
• facial pain and swelling due to fluid retention (facial oedema);
• weight gain.

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

• muscle cramps, muscle weakness;
• excessive urine production (polyuria).

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

• dizziness when standing up (postural dizziness), altered sensation in limbs (paraesthesia);
• blurred vision;
• blood disorders (leucopenia, thrombocytopenia);
• heart rhythm problems (bradycardia, cardiac arrhythmias);
• hot flushes;
• bronchial constriction (bronchospasm);
• gallstones (cholestasis), liver problems (hepatitis, jaundice);
• skin irritation (urticaria), hair loss (alopecia), blood disorders (purpura);
• increased urine production, problems urinating, and need to urinate at night (nocturia);
• breast enlargement in men;
• prolonged painful erection of the penis. Seek immediate medical attention.
• fatigue, malaise.

Not known (frequency cannot be estimated from available data)

• eye problems (iris flag syndrome);
• problems with semen emission (retrograde ejaculation).

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
https://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 Doxazosina Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Doxazosina Sandoz 2 mg tablets contain

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

What Doxazosina Sandoz 4 mg tablets contain

• The active substance is doxazosin. Each tablet contains 4.85 mg of doxazosin mesylate (equivalent to 2 mg of doxazosin base).
• The other components are: microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, magnesium stearate, sodium lauryl sulfate.

Description of the appearance of Doxazosina Sandoz and contents of the pack
Doxazosina Sandoz 2 mg tablets - Box containing 30 2 mg scored tablets in blister packs.
Doxazosina Sandoz 4 mg tablets - Box containing 20, 30 or 60 4 mg scored tablets in blister packs.

Marketing Authorization Holder
Sandoz Spa - Largo U. Boccioni, 1 - 21040 Origgio (VA) - Italy

Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto de’ Stampi - Rozzano (Milan) - Italy