Leaflet: information for the user

Doxazosin cinfa 4 mg tablets EFG

doxazosina mesilato

Read this 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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Doxazosina is a medication with vasodilatory action for the treatment of high blood pressure and benign prostatic hyperplasia.

Doxazosina is indicated for the treatment of elevated blood pressure in the arteries (hypertension) and for the treatment of urinary flow obstruction and irritative symptoms associated with benign prostatic hyperplasia (BPH).

Doxazosina may be used in patients with BPH, hypertensive or normotensive patients. Those patients with both pathologies may be treated with doxazosina as monotherapy.

The treatment with doxazosina requires periodic monitoring by your doctor.

Do not take doxazosina cinfa

• If you are allergic to doxazosina, quinazolines, or any of the other components of this medication (listed in section 6).
• If you have experienced hypotension (dizziness) when taking other blood pressure medications.
• If you have an enlarged prostate gland along with urinary tract congestion, chronic urinary tract infections, or bladder stones.
• If you have any form of gastrointestinal obstruction.
• If you have low blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take doxazosina cinfa if:

• You haveliver problems. As there is no clinical experience in patients with severe liver insufficiency, it is not recommended for use in these patients
• You suffer from aserious heart problem, such as heart failure or pulmonary edema.

At the beginning of taking this medication, dizziness, weakness, and in rare cases, fainting may occur. Therefore, proceed with caution, especially at the beginning of treatment, and avoid situations that could cause injuries in the event of these symptoms appearing.

Before starting treatment with doxazosina, your doctor may perform tests to rule out other diseases such as prostate cancer, which can cause the same symptoms as benign prostatic hyperplasia.

If you are to undergo eye surgery for cataracts, please inform your doctor before the operation if you are taking or have taken doxazosina previously. This is because doxazosina may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if you have been informed in advance.

Prolonged and painful erectionsmay occur with very low frequency. If this happens, consult a doctor urgently.

Children and adolescents

Do not recommend the use of doxazosina in children and adolescents under 18 years of age, as the safety and efficacy have not been established.

Other medications and doxazosina cinfa

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

Doxazosina has been administered with other anti-hypertensives, other medications such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetic drugs, uric acid-lowering drugs, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without any negative consequences. Doxazosina potentiates the action of other anti-hypertensives in reducing blood pressure.

Consult your doctor or pharmacist before taking doxazosina if you are taking any of the following medications, as they may change the effect of doxazosina:

• Medications to treat erectile dysfunction (e.g., sildenafilo, tadalafilo, vardenafilo).
• Medications to reduce blood pressure.
• Medications used to treat bacterial or fungal infections, for example, claritromicina, itraconazol, ketoconazol, telitromicina, voriconazol.
• Medications used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodona, a medication used to treat depression.

Taking doxazosina cinfa with food and drinks

Doxazosina can be taken with meals or without them

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Doxazosina may appear in breast milk in small amounts. Do not take doxazosina while breastfeeding your baby unless your doctor recommends it.

Driving and operating machines

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

doxazosina cinfa contains lactose

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

doxazosina cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Your doctor will decide what dose of doxazosina is most advisable for you. Do not take more tablets than specified by your doctor.

Depending on the individual response, the doctor may modify the dosing of doxazosina.

Doxazosina is administered orally.

Doxazosina can be administered both in the morning and at night.

Hypertension

Doxazosina is administered orally.The recommended 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 dose may be increased to 2 mg, 4 mg, 8 mg, or 16 mg per day as the maximum dose, at intervals of 1 or 2 weeks between them, until the desired reduction in blood pressure is achieved in the patient.

Doxazosina may be administered with other medications that your doctor has prescribed for the treatment of hypertension.

Benign Prostatic Hyperplasia

Doxazosina is administered orally.The recommended 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 dose may be increased to 2 mg, 4 mg, or 8 mg per day as the maximum dose, at intervals of 1 or 2 weeks between them.

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with doxazosina. Do not discontinue treatment prematurely, as it may be harmful to your health.

If you feel that the effect of doxazosina is too strong or too weak, consult your doctor or pharmacist. Do not take more tablets than recommended by your doctor.

IfYou Take More Doxazosina Cinfa Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

A doxazosina overdose may cause a drop in blood pressure. In this case, sit with your head down.

If You Forget to Take Doxazosina Cinfa

Do not take a double dose to compensate for the missed doses. It is essential to take doxazosina regularly at the same time every day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, do not take the missed tablet.

If You Interrupt Treatment with Doxazosina Cinfa

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Respiratory tract infection, urinary tract infection
• Dizziness, headache, tendency to sleep (somnolence)
• Dizziness
• Feeling of strong or rapid heartbeats (palpitations), increased heart rate (tachycardia)
• Hypotension, postural hypotension
• Inflammation of the bronchi (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, peripheral edema

Less frequent (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)
• Interruption of blood supply to the brain (stroke), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor
• Tinnitus
• Chest pain or pressure (angina pectoris, myocardial infarction)
• Nosebleed (epistaxis)
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis
• Abnormal liver function tests
• Dermatological eruption
• Joint pain (arthralgia)
• Discomfort while urinating (dysuria), blood in urine (hematuria), and frequent urination
• Impotence
• Chest pain, facial swelling
• Weight gain

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

• Obstruction of the digestive tract

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

• Decreased white blood cell count (leucopenia), decreased platelet count (thrombocytopenia)
• Restlessness, nervousness
• Postural dizziness, paresthesia
• Blurred vision
• Decreased heart rate (bradycardia), cardiac arrhythmias
• Hot flashes
• Difficulty breathing (bronchospasm)
• Bile duct obstruction (cholestasis), liver inflammation (hepatitis), yellowing of the skin (jaundice)
• Hair loss (alopecia), confluent purpuric skin lesions (purpura), itchy, elevated, and confluent skin lesions (urticaria)
• Muscle cramps, muscle weakness
• Urination disorders, nocturia, polyuria, or increased urine volume (diuresis)
• Male breast enlargement (gynecomastia)
• Fatigue, general malaise
• Persistent and painful penile erection. Consult a doctor urgently.

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

IFIS (Intraoperative Floppy Iris Syndrome, a certain eye disorder that can occur during cataract surgery)

Semen entry into the bladder during ejaculation (retrograde ejaculation)

No differences were observed regarding adverse events between young patients and elderly patients.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.By doing so, you will help protect the environment.

Doxazosin cinfa composition

• The active ingredient isdoxazosina. Each tablet contains 4 mg of doxazosina as doxazosina mesilate.
• The other components are: microcrystalline cellulose, lactose, carboxymethylstarch sodium (type A) (potato), anhydrous colloidal silica, sodium lauryl sulfate, and magnesium stearate.

Product appearance and packaging contents

White, oval-shaped, uncoated tablets, with the code D4 on one face and a groove on the same face.

It is presented in PVC-PVDC/ALU blisters, and is available in packs of 28 tablets.

Marketing authorization holder and manufacturer responsible

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:November 2020

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/63068/P_63068.html

QR code link to:https://cima.aemps.es/cima/dochtml/p/63068/P_63068.html