Doxazosin Alter 2 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Doxazosina Alter 2 mg tablets EFG

Doxazosin, mesilate

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 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 a single therapy.

2. What you need to know before starting Doxazosina Alter

Do not take Doxazosina Alter

• if you are allergic to doxazosin or other quinazolines (e.g., prazosin or terazosin), or to any of the other ingredients of this medicine (listed in section 6),
• if you have experienced hypotension (dizziness) 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 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, weakness, and rarely fainting may occur. 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 undergoing 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 concomitantly 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 medicines 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 drinks

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 him before taking this medicine.

3. How to take Doxazosina Alter

Follow exactly the instructions for use given to you by your doctor. If in doubt, consult your doctor or pharmacist again.

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

High blood pressure

The usual dose is 2–4 mg once daily. Treatment should be started at 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 of 16 mg daily, increasing the dose every 1 or 2 weeks until blood pressure is adequately reduced.

Doxazosin 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 started at 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 of 8 mg daily, increasing the dose every 1 or 2 weeks.

If you take more Doxazosina Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication 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 missed dose.

If you stop taking Doxazosina Alter

Your doctor will determine the duration of your treatment with 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 can cause adverse effects, although not everyone experiences them.

Adverse effects vary in intensity from one individual to another and should be especially considered at the beginning of treatment or when changing medication, being generally 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 heartbeat (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 falling or staying asleep (insomnia), restlessness and nervousness;
• interruption of blood supply to the brain (stroke), decreased sensation (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), 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), disturbances in heart rhythm (cardiac arrhythmias);
• hot flushes;
• difficulty breathing (bronchospasm);
• interruption or suppression of bile flow (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice);
• hair loss (alopecia), confluent purplish skin spots (purpura), red raised itchy rashes appearing on the skin surface (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);
• prolonged and painful penile erection. Consult your doctor immediately;
• 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 container after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to 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 2 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 line on one side and the mark D2 on the other, packed in PVC/PVDC/Al blisters.

Each pack contains 28 tablets.

Marketing Authorization Holder Responsible for Manufacturing

Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain

Responsible for Manufacturing

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/