PROGANDOL 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

Progandol 2 mg Tablets

doxazosin mesylate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Progandol is and what it is used for

Progandol is a medicine that belongs to the group of alpha-adrenergic blockers and is used:

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

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

Those patients with both diseases can be treated with Progandol as monotherapy.

2. What you need to know before you take 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 to any of the other ingredients of this medicine (listed in section 6),
• if you have suffered from low blood pressure (hypotension) when taking other medicines to treat high blood pressure,
• if you have an enlarged prostate with urinary tract obstruction, chronic infection or stones in the bladder,
• 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 (such as pulmonary edema or heart failure),
• if you are going to undergo cataract surgery, inform your doctor if you are taking or have taken Progandol previously. This medicine may cause complications during surgery that your ophthalmologist can control if informed beforehand.

Prolonged and painful erectionscan occur very rarely. 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.

Using Progandol with other medicines

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

Progandol has been administered with other antihypertensives, other medicines such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, gout medicines, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosin enhances the action of other medicines 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 medicines, as they may change the effect of Progandol:

• Medicines for treating erection disorders (e.g. sildenafil, tadalafil, vardenafil).
• Medicines that lower blood pressure.
• Medicines for treating 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 drinks

Progandol can be taken with or without food.

Children and adolescents

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Driving and using machines

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

Progandol contains lactose and sodium

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

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

3. How to take Progandol

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

Do not take more tablets than prescribed by your doctor. Progandol is administered orally.

Hypertension

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. Depending on 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 can be administered with other medicines that your doctor has prescribed for the treatment of hypertension.

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, at intervals of 1 or 2 weeks between each dose increase.

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 Toxicology Information Service, phone 915 620 420 (indicating the medicine and the amount taken).

If you forget to take Progandol

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

If you have any further questions on 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.

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

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

• respiratory tract infection, urinary tract infection;
• dizziness, headache, tendency to sleep (somnolence);
• vertigo;
• feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia);
• low blood pressure and postural low blood pressure (drop in blood pressure caused by a sudden change in body position);
• 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).

Uncommon (may 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;
• 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);
• urination disorders (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 number of times you need to urinate (polyuria);
• obstruction of the digestive tract.

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

• decrease in the number of white blood cells (leucopenia), decrease in the number of blood platelets (thrombocytopenia);
• postural dizziness, tingling (paresthesia);
• blurred vision;
• decreased heart rate (bradycardia), heart rhythm disorders (cardiac arrhythmias);
• hot flashes;
• difficulty breathing (bronchospasm);
• stop or suppression of bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice);
• hair loss (alopecia), purple-colored spots on the skin of vascular origin (purpura), red itchy rashes (urticaria);
• muscle cramps, muscle weakness;
• urination disorders, need to urinate at night (nocturia), or changes in urine output (diuresis);
• enlargement of male breast tissue (gynecomastia);
• fatigue, general malaise;
• persistent and painful erection of the penis. Consult a doctor urgently.

Side effects of unknown frequency (frequency cannot be estimated from the available data):

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

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Progandol tablets

• The active ingredient is 2 mg of doxazosin.
• The other ingredients are: lactose, sodium carboxymethyl starch (potato), microcrystalline cellulose, magnesium stearate, and sodium lauryl sulfate.

Appearance of the product and contents of the pack

The tablets are round, flat, engraved with “1/1” on one side and “2” on the other.

Progandol 2 mg is available in packs containing 28 tablets.

Other presentations:Progandol 4 mg tablets.

Marketing authorization holder and manufacturer

Marketing authorization 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 last revision of this leaflet: May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.