DOXAZOSIN CINFA 2 mg TABLETS

Introduction

Package Leaflet: Information for the User

doxazosina cinfa 2 mg tablets EFG

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

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

1. What is doxazosina cinfa and what is it used for

Doxazosin is a medication with vasodilatory action for the treatment of arterial hypertension and benign prostatic hyperplasia.

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

Doxazosin can be used in patients with BPH, hypertensive or normotensive. Those patients with both pathologies can be treated with doxazosin as monotherapy.

2. What you need to know before you take doxazosina cinfa

Treatment with doxazosin requires periodic monitoring by your doctor.

Do not take doxazosina cinfa

• If you are allergic to doxazosin, quinazolines, or any of the other components of this medication (listed in section 6).
• If you have suffered from hypotension (dizziness) when taking other medications to lower blood pressure.
• If you have an increased size of the prostate gland along with congestion of the upper urinary tract, chronic urinary tract infections, or stones in the bladder.
• If you suffer from 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 have liver problems. As there is no clinical experience in patients with severe hepatic insufficiency, its use is not recommended in these patients
• you suffer from a serious heart problem, such as heart failure or pulmonary edema.

Especially at the beginning of taking this medication, dizziness, weakness, and, in rare cases, fainting may occur. Therefore, caution should be exercised at the start of treatment, and situations that could cause injury if such symptoms appear should be avoided.

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

If you are going to undergo eye surgeryfor cataracts, please inform your doctor before surgery if you are taking or have previously taken doxazosin. This is because doxazosin may cause complications during surgery, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Prolonged and painful erectionscan occur very rarely. If this happens, consult a doctor urgently.

Children and adolescents

The use of doxazosin is not recommended in children and adolescents under 18 years of age, as its safety and efficacy have not been established.

Other medications and doxazosina cinfa

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

Doxazosin has been administered along with other antihypertensives, other medications such as non-steroidal anti-inflammatory drugs, antibiotics, oral antidiabetics, medications for gout, anticoagulants, digoxin, warfarin, phenytoin, and indomethacin without negative consequences. Doxazosin enhances the action of other antihypertensives in reducing blood pressure.

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

• Medications to treat erectile dysfunction (e.g., sildenafil, tadalafil, vardenafil).
• Medications that lower blood pressure.
• Medications to treat bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medications used in the treatment of HIV, e.g., indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medication used to treat depression.

Taking doxazosina cinfa with food and drinks

Doxazosin can be taken with or without food

Pregnancy and breastfeeding

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

Doxazosin may appear in breast milk in small amounts. You should not take doxazosin while breastfeeding your baby unless your doctor recommends it.

Driving and using machines

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

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; this is essentially "sodium-free".

3. How to take doxazosina cinfa

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 doxazosin is most suitable for you. Do not take more tablets than specified by your doctor.

Depending on the individual response, the doctor may modify the dosage of doxazosin.

Doxazosin is administered orally.

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

Arterial hypertension

Doxazosin 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 can 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.

Doxazosin can be administered with other medications that your doctor has prescribed for the treatment of arterial hypertension.

Benign prostatic hyperplasia

Doxazosin 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 can 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 doxazosin. Do not stop treatment before, as it may be harmful to your health.

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

If you take more doxazosina cinfa 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 medication and the amount ingested.

An overdose of doxazosin can 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 make up for forgotten doses. It is important that you take doxazosin 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 stop treatment with doxazosina cinfa.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

The reactions to doxazosin 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.

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

• Respiratory tract infection, urinary tract infection
• Dizziness, headache, tendency to sleep (somnolence)
• Vertigo
• Sensation of strong or accelerated heartbeats (palpitations), increased heart rate (tachycardia)
• Hypotension, postural hypotension
• 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 (may affect up to 1 in 100 people):

• Allergic reaction
• Abnormal loss of appetite (anorexia), gout, increased appetite
• Anxiety, depression, difficulty starting or maintaining sleep (insomnia)
• Disruption of blood supply to the brain (stroke), decreased sensitivity (hypoesthesia), temporary loss of consciousness (syncope), tremor
• Ringing in the ears (tinnitus)
• Chest pain or oppression (angina pectoris, myocardial infarction)
• Nosebleed (epistaxis)
• Constipation, diarrhea, flatulence, vomiting, gastroenteritis
• Abnormal liver function tests
• Rash
• Joint pain (arthralgia)
• Difficulty urinating (dysuria), blood in urine (hematuria), and frequent urination
• Impotence
• Pain, swelling of the face
• 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 number of white blood cells (leukopenia), decreased number of blood platelets (thrombocytopenia)
• Agitation, nervousness
• 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), confluent purple spots on the skin (purpura), red, itchy, and raised rashes on the skin (urticaria)
• Muscle cramps, muscle weakness
• Urination disorders, need to urinate at night (nocturia), increased number of times you need to urinate (polyuria) or amount of urine (diuresis)
• Increased male breast tissue (gynecomastia)
• Fatigue, general malaise
• Prolonged and painful erection of the penis. 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)

Entry of semen 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 side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of doxazosina cinfa

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of doxazosina cinfa

• The active ingredient is doxazosin. Each tablet contains 2 mg of doxazosin as doxazosin mesylate.

• The other components are: microcrystalline cellulose, lactose, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, sodium lauryl sulfate, and magnesium stearate.

Appearance of the product and packaging contents

White, oblong tablets without coating, with the code D2 on one face and a notch on the same face.

They come in PVC-PVDC/ALU blisters and are available in packs of 28 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this leaflet:November 2020

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

You can access detailed and updated information about this medication 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/63067/P_63067.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63067/P_63067.html