Doxazosin Normon 4 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxazosina Normon 4 mg tablets EFG

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Doxazosin belongs to a group of medicines called α-adrenergic blockers. It is indicated for the treatment of:

• Hypertension (high blood pressure).
• Urinary flow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). It can be used in patients with BPH, whether they are hypertensive or normotensive (normal blood pressure). Patients suffering from both hypertension and BPH may be effectively treated with doxazosin.

2. What you need to know before starting Doxazosina Normon

Do not take Doxazosina Normon:

• If you are allergic to doxazosin, to quinazolines, or to any of the components of this medicine (listed in section 6).
• During breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting Doxazosina Normon.

Take special care with Doxazosina Normon:

• If you have evident hepatic insufficiency or if you are being treated with drugs that affect hepatic metabolism.
• If you have any kind of heart disease.

Treatment with doxazosin may cause marked hypotension (low blood pressure), especially postural hypotension (drop in blood pressure upon standing), particularly after the first dose or initial doses. If this occurs, consult your doctor.

Treatment with doxazosin requires periodic monitoring by your doctor. If you experience symptoms such as dizziness, drowsiness, lightheadedness, or palpitations, consult your doctor, who may consider adjusting the dose.

• If you are scheduled for cataract eye surgery, please inform your doctor before the procedure if you are currently taking or have previously taken doxazosin. This is because doxazosin may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.

Children

There is no experience regarding the use of doxazosin in children.

Elderly people

The safety and efficacy profile of doxazosin is similar in elderly and younger patients.

Other medicines and Doxazosina Normon

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

Doxazosin interacts with:

• Other antihypertensive medicines: Doxazosin increases the blood pressure-lowering effect of other antihypertensive drugs.
• Vasodilators and nitrates: These enhance the antihypertensive effect of doxazosin.
• Non-steroidal anti-inflammatory drugs (NSAIDs) or estrogens: These may reduce the antihypertensive effect of doxazosin.
• Doxazosin may reduce blood pressure and vascular responses to dopamine, ephedrine, epinephrine, metaraminol, and phenylephrine.

Doxazosin does not interact when administered concomitantly with: digoxin, warfarin, phenytoin, or indomethacin. No adverse interactions have been observed between doxazosin and thiazide diuretics, furosemide, beta-blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycemics, uricosuric agents, or anticoagulants. Caution is recommended when administering doxazosin together with drugs that may influence hepatic metabolism. However, if you are taking any of the medicines listed above, you should consult your doctor.

Some patients receiving an alpha-blocker for the treatment of high blood pressure or benign prostatic hyperplasia may experience dizziness or fainting caused by a drop in blood pressure when sitting down or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) together with alpha-blockers such as doxazosin. To reduce the likelihood of these symptoms occurring, you should already be on a regular daily dose of the alpha-blocker before starting treatment for erectile dysfunction.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist.

Pregnancy:

Since the safety of doxazosin during pregnancy has not been established, it should only be used if, in the opinion of the doctor, no safer therapeutic alternative exists and when the underlying condition poses a greater risk to the mother or the fetus.

Breastfeeding:

Doxazosin accumulates in breast milk. As the safety of doxazosin during breastfeeding has not been established, it is contraindicated in nursing mothers.

Driving and using machines

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

Doxazosina Normon contains lactose and sodium.

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free.”

3. How to take Doxazosina Normon

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

Remember to take your medicine. Your doctor will tell you how long to take Doxazosina Normon. Do not stop treatment early. If you think that the effect of Doxazosina Normon is too strong or too weak, inform your doctor or pharmacist.

Doxazosin may be taken either in the morning or at night. Swallow the tablets with a sufficient amount of liquid.

The dose will be determined by your doctor according to each patient's individual needs.

The tablets may be divided into two equal doses.

High blood pressure (hypertension):

The usual dose is half to one tablet (2 mg to 4 mg) once daily. Treatment should be initiated with half a tablet of Doxazosina Normon 2 mg (1 mg) once daily for 1 or 2 weeks. Depending on the patient's response, the dose may be increased to half a tablet (2 mg), one tablet (4 mg), two tablets (8 mg), or up to four tablets (16 mg) daily as the maximum dose, at intervals of 1 or 2 weeks, until the desired reduction in blood pressure is achieved.

Doxazosin may be administered together with other medicines prescribed by your doctor for the treatment of high blood pressure.

Benign prostatic hyperplasia:

The usual dose is half to one tablet (2 mg to 4 mg) once daily. Treatment should be initiated with half a tablet of Doxazosina Normon 2 mg (1 mg) once daily. Depending on the patient's response, the dose may be increased to half a tablet (2 mg), one tablet (4 mg), or up to two tablets (8 mg) daily as the maximum dose, at intervals of 1 or 2 weeks.

If you take more Doxazosina Normon than you should

Contact your doctor or pharmacist. Hypotension may occur. In case of overdose or accidental ingestion, contact the Toxicology Information Service (Tel. 91 562 04 20), indicating the product and the amount ingested.

Information for the physician: The most important aspect in treating overdose is cardiovascular support. Change the patient from a horizontal position. In case of severe hypotension, administer plasma expanders and vasopressors. Dialysis is not recommended.

If you forget to take Doxazosina Normon

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Doxazosin is a drug that is usually well tolerated. The most commonly reported reactions associated with doxazosin are of a postural and nonspecific nature, including: dizziness, headache, fatigue, malaise, vertigo, postural dizziness, oedema (fluid retention causing swelling), weakness, somnolence, nausea, and rhinitis (inflammation of the nasal mucosa). Occasionally, nonspecific gastrointestinal disturbances such as abdominal pain, diarrhoea, and vomiting may occur, and very rarely agitation and tremor.

Isolated cases of impotence, allergic reactions such as skin redness, pruritus (itching), purpura (appearance of skin spots due to blood extravasation), jaundice (yellowing of the skin and mucous membranes), and elevated liver transaminases have been reported. Nasal bleeding has also been reported.

A very rare adverse effect is persistent and painful penile erection. Consult a doctor immediately.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Normon

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

No special storage conditions are required. Store in the original container.

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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Normon 4 mg

• The active substance is doxazosin mesilate. Each tablet contains 4 mg of doxazosin (mesilate).
• The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium carboxymethylstarch (from potato), and magnesium stearate.

Nature of the product and pack contents

Doxazosina Normon 4 mg is presented as tablets. Each pack contains 28 tablets. The tablets are white or slightly cream-coloured, round, biconvex, with a break line on one side and printed on the other.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Doxazosina Normon 2 mg tablets

Date of the most recent revision of this leaflet: December 2016

Other sources of information

Detailed 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/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/63788/P_63788.html