PROGANDOL 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Progandol 4 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 and other information

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

Contents of the pack and other information

1. What is Progandol and what is it used for

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

• in the treatment of arterial hypertension (high blood pressure),
• 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 hypotension (low blood pressure) 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.

Use of 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, contact 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.

Arterial Hypertension

The usual dose is 2-4 mg once a day. It is recommended to start treatment with 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 can be administered with other medicines prescribed by your doctor for the treatment of arterial hypertension.

Benign Prostatic Hyperplasia

The usual dose is 2-4 mg once a day. It is recommended to start treatment with 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 especially taken into account 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;
• palpitations, increased heart rate (tachycardia);
• hypotension and postural hypotension (drop in blood pressure caused by a sudden change in body position);
• bronchitis, cough, difficulty breathing (dyspnea), nasal mucosa inflammation (rhinitis);
• abdominal pain, indigestion (dyspepsia), dry mouth, nausea;
• itching (pruritus);
• back pain, muscle pain (myalgia);
• 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;
• 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;
• tinnitus;
• chest pain or tightness (angina pectoris, myocardial infarction);
• nasal bleeding (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;
• facial pain, facial swelling;
• weight gain.

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

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

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

• decrease in white blood cell count (leucopenia), decrease in platelet count (thrombocytopenia);
• postural dizziness, tingling (paresthesia);
• blurred vision;
• decreased heart rate (bradycardia), heart rhythm disorders (cardiac arrhythmias);
• hot flashes;
• breathing difficulties (bronchospasm);
• bile flow stoppage (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice);
• hair loss (alopecia), purple-colored skin spots of vascular origin (purpura), red itchy rashes (urticaria);
• muscle cramps, muscle weakness;
• urination disorders, need to urinate at night (nocturia), or changes in urine amount (diuresis);
• breast enlargement in men (gynecomastia);
• fatigue, general malaise;
• persistent and painful erection. 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 (semen entering 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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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.

Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Composition of Progandol tablets

• The active ingredient is 4 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 pack contents

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 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 Healthcare Products (AEMPS) http://www.aemps.gob.es/.