PROGANDOL 4 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Progandol 4 mg tablets

doxazosin mesylate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Progandol is and what it is used for
2. What you need to know before taking Progandol
3. How to take Progandol
4. Possible side effects
5. How to store Progandol

Pack contents and other information

1. What Progandol is and what it is used for

Progandol is a medicine that belongs to a group of medicines called alpha-blockers and is used:

• in the treatment of hypertension (high blood pressure),
• in urinary tract obstruction and symptoms associated with an enlarged prostate (benign prostatic hyperplasia).

Progandol may be used in patients with benign prostatic hyperplasia, regardless of whether they have high or normal blood pressure.

Patients with both conditions may be treated with Progandol as monotherapy.

2. What you need to know before taking Progandol

Treatment with Progandol requires periodic monitoring by your doctor.

Do not take Progandol

• if you are allergic to doxazosin, other quinazolines (e.g., prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6),
• if you have experienced hypotension (low blood pressure) when taking other medicines for high blood pressure,
• if you have an enlarged prostate together with urinary tract obstruction, chronic urinary infection, or bladder stones,
• if you have low blood pressure.

Warnings and precautions

Talk to your doctor before starting Progandol:

• if you have liver problems, Progandol should be used with caution,
• if you have benign prostatic hyperplasia and are hypotensive,
• if you suffer from acute heart disease (heart condition), such as pulmonary edema or heart failure,
• if you are scheduled for cataract surgery, inform your doctor if you are taking or have previously taken Progandol. This medicine may cause complications during surgery, which your ophthalmologist can manage if informed in advance.

Prolonged and painful erections may occur very rarely. If this happens, consult a doctor urgently.

Before starting treatment with Progandol, your doctor may perform tests to rule out other conditions such as prostate cancer, which may cause the same symptoms as benign prostatic hyperplasia.

Taking Progandol with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Progandol has been administered together with other antihypertensives and other medicines such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medications, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosin enhances the effect of other blood pressure-lowering medicines (thiazide diuretics, furosemide, beta-blockers).

Consult your doctor or pharmacist before using Progandol if you are taking any of the following medicines, as they may alter the effect of Progandol:

• Medicines for erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil).
• Medicines that reduce blood pressure.
• Medicines used to treat bacterial or fungal infections (e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole).
• Medicines used in the treatment of HIV (e.g., indinavir, nelfinavir, ritonavir, saquinavir).
• Nefazodone, a medicine used to treat depression.

Taking Progandol with food and drink

Progandol may be taken with or without food.

Children and adolescents

The use of Progandol is not recommended in children and adolescents under 18 years of age, as safety and efficacy have not been established.

Pregnancy and breastfeeding

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

Doxazosin, the active substance in Progandol, may appear in breast milk in small amounts. You should not take Progandol while breastfeeding unless your doctor advises you to do so.

Driving and using machines

Your ability to perform activities such as driving or operating machinery may be impaired, especially at the beginning of treatment with Progandol.

Progandol contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Progandol

Follow exactly the administration instructions for Progandol given by your doctor. If in doubt, consult your doctor or pharmacist again.

Do not take more tablets than those specified by your doctor.

Progandol is administered orally.

Arterial hypertension

The usual dose is 2–4 mg once daily. Treatment should be initiated with 1 mg once daily for 1 or 2 weeks. Depending on the individual patient's response, the doctor may gradually increase the dose to 2 mg, 4 mg, 8 mg, or up to a maximum daily dose of 16 mg, increasing at intervals of 1 or 2 weeks between each dose increment, until blood pressure is adequately reduced.

Progandol may be administered together with other medications prescribed by your doctor for the treatment of arterial hypertension.

Benign prostatic hyperplasia

The usual dose is 2–4 mg once daily. Treatment should be initiated with 1 mg once daily. Depending on the individual patient's response, the doctor may gradually increase the dose to 2 mg, 4 mg, or up to a maximum daily dose of 8 mg, increasing at intervals of 1 or 2 weeks between each dose increment.

If you take more Progandol than you should

If you have taken more Progandol than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420 (indicating the medication and the amount ingested).

If you forget to take Progandol

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects vary in intensity from person to person and should be especially considered at the beginning of treatment or when changing medication, being generally mild.

Frequent (may affect up to 1 in 10 people):

• respiratory tract infection, urinary tract infection;
• dizziness, headache, tendency to sleepiness (somnolence);
• vertigo;
• sensation of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia);
• hypotension and postural hypotension (low blood pressure caused by a sudden change in body position);
• bronchial inflammation (bronchitis), cough, difficulty breathing (dyspnea), nasal mucosa inflammation (rhinitis);
• abdominal pain, indigestion (dyspepsia), dry mouth, nausea;
• itching (pruritus);
• back pain, muscle pain (myalgia);
• bladder inflammation (cystitis), urinary incontinence;
• fatigue (asthenia), chest pain, flu-like illness, swelling of hands, feet or ankles (peripheral edema).

Uncommon (may affect up to 1 in 100 people):

• allergic reaction;
• abnormal loss of appetite (anorexia), gout, increased appetite;
• anxiety, depression, difficulty in falling or staying asleep (insomnia), agitation, restlessness;
• interruption of blood supply to the brain (stroke), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor;
• ringing in the ears (tinnitus);
• chest pain or tightness (angina pectoris, myocardial infarction);
• nosebleed (epistaxis);
• constipation, diarrhea, flatulence, vomiting, gastroenteritis;
• abnormal liver function tests;
• skin rash;
• joint pain (arthralgia);
• discomfort during urination (dysuria), blood in urine (hematuria), and frequent urination;
• impotence;
• pain, swelling of the face;
• weight gain.

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

• increased frequency of urination (polyuria);
• obstruction of the gastrointestinal tract.

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

• decrease in the number of white blood cells (leukopenia), decrease in the number of blood platelets (thrombocytopenia);
• postural dizziness, tingling (paresthesia);
• blurred vision;
• decreased heart rate (bradycardia), heart rhythm disorders (cardiac arrhythmias);
• hot flushes;
• difficulty breathing (bronchospasm);
• cessation or suppression of bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice);
• hair loss (alopecia), purplish skin spots of vascular origin (purpura), red itchy hives (urticaria);
• muscle cramps, muscle weakness;
• urinary disorders, need to urinate at night (nocturia), or changes in urine volume (diuresis);
• enlargement of male breast glands (gynaecomastia);
• fatigue, general malaise;
• prolonged and painful penile erection. Consult a doctor urgently.

Adverse effects with unknown frequency (frequency cannot be established from available data):

• Intraoperative Floppy Iris Syndrome, an eye disorder that may occur during cataract surgery;
• entry of semen into the bladder during ejaculation (retrograde ejaculation).

No differences in adverse effects were observed between young and elderly patients.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Progandol

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Progandol tablets

• The active substance is 4 mg of doxazosin.
• The other components are: lactose, sodium carboxymethyl starch (from potato), microcrystalline cellulose, magnesium stearate and sodium lauryl sulfate.

Appearance of the product and contents of the pack

The tablets are round, flat, with one smooth face and the other engraved with "4".

Progandol 4 mg is available in packs containing 28 tablets.

Other presentations: Progandol 2 mg tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 - Sant Andreu de la Barca – Barcelona (Spain)

Date of the most recent revision of this summary: May 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.