Doxazosin Alter 4 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Doxazosina Alter 4 mg tablets EFG

Doxazosin mesilate

Read the entire leaflet carefully before you start taking this medicine, as 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Doxazosin belongs to a group of medicines called alpha-adrenergic 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).

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

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

2. What you need to know before starting Doxazosina Alter

Do not take Doxazosina Alter

• if you are allergic to doxazosin or other quinazolines (for example, prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6),
• if you have experienced hypotension (dizziness) while 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 are breastfeeding,
• if you have low blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting Doxazosina Alter:

• if you have liver problems. Since there is no clinical experience in patients with severe hepatic impairment, use in these patients is not recommended,
• 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.

Especially at the beginning of treatment with this medicine, dizziness and weakness may occur, and in rare cases fainting. Therefore, caution should be exercised when starting treatment, and situations that could lead to injury if these symptoms occur should be avoided.

If you are scheduled for cataract surgery, inform your doctor if you are currently taking or have previously taken doxazosin. This medicine may cause complications during surgery, which your ophthalmologist can manage if informed in advance.

Taking Doxazosina Alter with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Doxazosin has been administered together with other antihypertensives and other drugs 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).

Doxazosin should be used with caution in patients receiving medications for erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil), as symptomatic hypotension, including paleness, dizziness, or fainting, may occur in some patients.

Taking Doxazosina Alter with food and drink

Doxazosin may be taken with or without food.

Children and adolescents

The use of doxazosin 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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take doxazosin if you are pregnant or breastfeeding.

Driving and using machines

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

Doxazosina Alter contains lactose

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.

3. How to take Doxazosina Alter

Follow exactly the instructions for use of this medicine as prescribed by your doctor. If in doubt, consult your doctor or pharmacist again.

Do not take more tablets than specified by your doctor. Doxazosine is administered orally.

High blood pressure

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 patient's response, the doctor may gradually increase the dose to 2 mg, 4 mg, 8 mg, or up to a maximum dose of 16 mg daily, increasing at intervals of 1 or 2 weeks between each dose adjustment, until blood pressure is adequately reduced.

Doxazosine may be administered together 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 daily. Treatment should be initiated with 1 mg once daily. Depending on the patient's response, the doctor may gradually increase the dose to 2 mg, 4 mg, or up to a maximum dose of 8 mg daily, increasing at intervals of 1 or 2 weeks between each dose adjustment.

If you take more Doxazosina Alter than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Doxazosina Alter

It is important that you take this medicine at the same time each day. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Doxazosina Alter

Your doctor will advise you on how long you should take Doxazosina Alter. Do not stop treatment prematurely.

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 will experience them.

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

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

• respiratory tract infection, urinary tract infection;
• dizziness, headache, drowsiness (somnolence);
• vertigo;
• awareness of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia);
• hypotension, postural hypotension (drop in 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 adverse effects (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); restlessness and nervousness;
• 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 when urinating (dysuria), blood in urine (hematuria), and frequent urination;
• impotence;
• pain, swelling of the face;
• weight gain.

Rare adverse effects (may affect more than 1 in 10,000 patients):

• Increased frequency of urination (polyuria).

Very rare adverse effects (may affect less than 1 in 10,000 patients):

• 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), confluent purplish skin spots (purpura), raised red itchy skin lesions (urticaria);
• muscle cramps, muscle weakness;
• urinary disorders, need to urinate at night (nocturia), or changes in urine volume (diuresis);
• enlargement of male breast glands (gynecomastia);
• persistent and painful penile erection. Consult your doctor urgently;
• fatigue, general malaise.

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

• IFIS (Intraoperative Floppy Iris Syndrome, a certain 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Alter

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

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

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

6. Contents of the pack and other information

Composition of Doxazosin Alter

• The active substance is doxazosin. Each tablet contains 4 mg of doxazosin (as mesilate).
• The other components are: microcrystalline cellulose (E460i), lactose, sodium carboxymethyl starch type A (from potato), sodium lauryl sulfate, colloidal anhydrous silica (E551) and magnesium stearate (E572).

Appearance of the product and contents of the pack

White, oblong tablets, with a score on one side and the mark D4 on the other, packed in PVC/PVDC/Al blisters.

Each pack contains 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

or

Siegfried Malta Ltd

HHF070 Hal Far Industrial Estate

Hal Far BBG3000

Malta

Date of the most recent revision of this leaflet: June 2017.

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