Package Insert: Information for the User

Progandol 4 mg Tablets

doxazosina mesilato

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional informationl

Progandol is a medication thatbelongs to the group of alpha-adrenergic blockers andis used:

• in the treatment of high blood pressure (high blood pressure),
• in the obstruction of urinary tracts and symptoms associated with the increase in size of the prostate (benign prostatic hyperplasia).

Progandol can be used in patients with benign prostatic hyperplasia, with high or normal blood pressure.

Patients with both diseases may be treated with Progandol as a single therapy.

The treatment with Progandol requires periodic monitoring by your doctor.

Do not take Progandol

• if you are allergic to doxazosin, other quinazolines (for example, prazosin, terazosin) or any of the other components of this medication (listed in section 6),
• if you have experienced hypotension (low blood pressure) when taking other medications to treat high blood pressure,
• if you have an enlarged prostate along with urinary tract obstruction, chronic infection, or bladder stones,
• if you have low blood pressure.

Warnings and precautions

Consult your doctor before starting to use 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 disease), such as pulmonary edema or heart failure,
• if you are about to undergo cataract surgery, inform your doctor if you are taking or have taken Progandol previously. This medication may cause complications during the operation that your ophthalmologist can control if informed beforehand.

Prolonged and painful erectionsmay occur with very low frequency. If this happens, consult a doctor urgently.

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

Use of Progandol with other medications

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

Progandol has been administered with other anti-hypertensives, other medications such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetic drugs, uric acid-lowering drugs, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosin potentiates the action of other medications to lower blood pressure (thiazide diuretics, furosemide, beta-blockers).

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

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

Taking Progandol with food and drinks

Progandol can be taken with meals or outside of them.

Children and adolescents

Progandol is not recommended for use in children and adolescents under 18 years old as its safety and efficacy have not been established.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Doxazosin, the active ingredient in Progandol, may appear in breast milk in small amounts. Do not take Progandol while breastfeeding unless your doctor recommends it.

Driving and operating machinery

The ability to develop activities such as driving or operating machinery may be reduced, especially at the beginning of treatment with Progandol.

Progandol contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for Progandol as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not take more tablets than specified by your doctor.

Progandol is administered orally.

High Blood Pressure

The usual dose is 2 - 4 mg once a day. It is recommended to start treatment with the administration of 1 mg once a day, for 1 or 2 weeks. According to the response of each patient, the doctor may gradually increase the dose to 2 mg, 4 mg, 8 mg, or up to 16 mg per day as the maximum dose, at intervals of 1 or 2 weeks between each dose increase, until blood pressure is reduced.

Progandol may be administered with other medications prescribed by your doctor for the treatment of high blood pressure.

Benign Prostatic Hyperplasia

The usual dose is 2 - 4 mg once a day. It is recommended to start treatment with the administration of 1 mg once a day. Depending on the response of each patient, the doctor may gradually increase the dose to 2 mg, 4 mg, or up to 8 mg per day as the maximum dose.

If You Take More Progandol Than You Should

If you have taken more Progandol than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 915 620 420 (indicating the medication and the amount ingested).

If You Forget to Take Progandol

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects vary in intensity from one person to another and should be taken into account especially at the beginning of treatment or when changing medication, being generally mild.

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

• Respiratory tract infection, urinary tract infection;
• Dizziness, headache, tendency to sleep (somnolence);
• Dizziness;
• Feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia);
• Low blood pressure and postural hypotension (drop in blood pressure caused by a sudden change in body position);
• Inflammation of the bronchi (bronchitis), cough, difficulty breathing (dyspnea), inflammation of the nasal mucosa (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).

Less frequent (can affect up to 1 in 100 people):

• Allergic reaction;
• Abnormal loss of appetite (anorexia), gout, increased appetite;
• Anxiety, depression, difficulty initiating or maintaining sleep (insomnia), agitation, nervousness;
• Interrupted blood supply to the brain (stroke), decreased sensitivity (hypoaesthesia), temporary loss of consciousness (syncope), tremor;
• Ringing in the ears (tinnitus);
• Chest pain or pressure (angina pectoris, myocardial infarction);
• Nosebleed (epistaxis);
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis;
• Abnormal liver function tests;
• Rash;
• Joint pain (arthralgia);
• Difficulty urinating (dysuria), blood in urine (hematuria), and frequent urination;
• Impotence;
• Pain, swelling of the face;
• Weight gain.

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

• Increased frequency of urination (polyuria);
• Obstruction of the digestive tract.

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

• Decreased white blood cell count (leucopenia), decreased platelet count (thrombocytopenia);
• Postural dizziness, tingling (paresthesia);
• Blurred vision;
• Decreased heart rate (bradycardia), cardiac arrhythmias;
• Seizures;
• Difficulty breathing (bronchospasm);
• Bile duct obstruction (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice);
• Hair loss (alopecia), purpura, itchy red rashes (urticaria);
• Muscle cramps, muscle weakness;
• Urination disorders, nocturia, or diuresis;
• Male breast enlargement (gynecomastia);
• Fatigue, general malaise;
• Persistent and painful erection of the penis. Consult a doctor urgently.

Side effects of unknown frequency (frequency cannot be established with available data):

• Intraoperative Flaccid Iris Syndrome, an eye disorder that can occur during cataract surgery;
• Semen entering the bladder during ejaculation (retrograde ejaculation).

No differences were observed regarding side effects between young and elderly patients.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Progandol tablets

• The active ingredient is 4 mg of doxazosina.
• The other components are: lactose, carboxymethylcellulose sodium (from potato), microcrystalline cellulose, magnesium stearate, and lauryl sulfate sodium.

Appearance of the product and content of the packaging

The tablets are round, flat with a smooth face and the other face engraved with “4”.

Progandol 4 mg is presented in packaging containing 28 tablets.

Other presentations:Progandol 2 mg tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

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

Date of the last review of this leaflet: May 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.