DOXAZOSIN ALTER 4 mg TABLETS

2. What you need to know before you take Doxazosina Alter

Do not take Doxazosina Alter

• if you are allergic to doxazosina 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 dizziness (hypotension) when taking other medicines for high blood pressure,
• if you have an enlarged prostate and at the same time an obstruction of the urinary tract, a chronic infection or stones in the bladder,
• if you are breastfeeding,
• if you have low blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before taking Doxazosina Alter:

• if you have liver problems. As there is no clinical experience in patients with severe hepatic impairment, its use is not recommended in these patients,
• if you have benign prostatic hyperplasia and are hypotensive,
• if you suffer from acute heart disease (such as pulmonary edema or heart failure).

Especially at the start of treatment with this medicine, dizziness, weakness and, in rare cases, fainting can occur. Therefore, caution should be exercised when starting treatment and situations that could cause injury if such symptoms occur should be avoided.

If you are going to undergo cataract surgery, inform your doctor if you are taking or have previously taken doxazosina. This medicine can cause complications during surgery that your ophthalmologist can control if informed beforehand.

Taking Doxazosina Alter with other medicines

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

Doxazosina 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. Doxazosina enhances the action of other medicines to lower blood pressure (thiazide diuretics, furosemide, beta-blockers).

Doxazosina should be used with caution in patients receiving medicines for erectile dysfunction (e.g. sildenafil, tadalafil, vardenafil) as hypotension with symptoms such as pallor, dizziness or fainting can occur in some patients.

Taking Doxazosina Alter with food and drinks

Doxazosina can be taken with or without food.

Children and adolescents

The use of doxazosina is not recommended in children and adolescents under 18 years of age as its 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.

Do not take doxazosina 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 start of treatment.

Doxazosina Alter contains lactose

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

3. How to take Doxazosina Alter

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

Do not take more tablets than prescribed by your doctor. Doxazosina 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. 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.

Doxazosina 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 Doxazosina Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Doxazosina Alter

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

If you stop taking Doxazosina Alter

Your doctor will indicate the duration of your treatment with Doxazosina Alter. Do not stop treatment before.

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 considered at the start of treatment or when changing medication, being generally mild.

Common side effects (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 accelerated heartbeats (palpitations), increased heart rate (tachycardia);
• hypotension, postural hypotension (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);
• cystitis, urinary incontinence;
• fatigue (asthenia), chest pain, flu-like illness, swelling of hands, feet or ankles (peripheral edema).

Uncommon side 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); agitation and nervousness.
• stroke, decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor;
• ringing in the ears (tinnitus);
• chest pain or tightness (angina pectoris, myocardial infarction);
• nasal bleeding (epistaxis);
• constipation, diarrhea, flatulence, vomiting, gastroenteritis;
• abnormal liver function tests;
• rash;
• joint pain (arthralgia);
• urination disorders (dysuria), blood in urine (hematuria) and frequent urination;
• impotence;
• pain, swelling of the face;
• weight gain.

Rare side effects (may affect up to 1 in 10,000 patients):

• Increased number of times you need to urinate (polyuria).

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

• 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 confluent spots on the skin (purpura), red, elevated, and itchy rashes on the skin surface (urticaria);
• muscle cramps, muscle weakness;
• urination disorders, need to urinate at night (nocturia), or changes in urine quantity (diuresis);
• increase in male breast tissue (gynecomastia);
• painful and persistent erection of the penis. Consult your doctor urgently;
• fatigue, general malaise.

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Doxazosina Alter

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 is 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 protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Alter

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

Appearance of the product and pack contents

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

Each pack contains 28 tablets.

Marketing authorisation 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 last revision of this leaflet: June 2017.

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/