DOXAZOSIN NORMON 4 mg TABLETS

Introduction

Package Leaflet: Information for the User

Doxazosina Normon 4 mg tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

Doxazosina belongs to a group of medicines called alpha-blockers. It is used to treat:

• High blood pressure (hypertension).
• Obstruction to the flow of urine 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 who suffer from hypertension and BPH can be effectively treated with doxazosina.

2. What you need to know before taking Doxazosina Normon

Do not take Doxazosina Normon:

• If you are allergic to doxazosina, quinazolines or any of the other ingredients of this medicine (listed in section 6).
• During breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Doxazosina Normon.

Be especially careful with Doxazosina Normon:

• If you have obvious liver failure or if you are being treated with drugs that affect liver metabolism.
• If you have any type of heart disease.

Treatment with doxazosina may cause a marked hypotension (drop in blood pressure), especially postural hypotension (drop in blood pressure when standing up), associated with the administration of the first or first few doses. If this happens, consult your doctor.

Treatment with doxazosina requires periodic monitoring by your doctor. If you notice symptoms such as dizziness, drowsiness, fainting or palpitations, consult your doctor, who will consider adjusting the dose.

• If you are going to undergo cataract surgery, please inform your doctor before surgery if you are taking or have taken doxazosina previously. This is because doxazosina can cause complications during surgery, which can be taken into account and controlled by your ophthalmologist if they have been informed beforehand.

Children

There is no experience with the use of doxazosina in children.

Elderly

The safety and efficacy profile of doxazosina is similar in the elderly and in young people.

Other medicines and Doxazosina Normon

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Doxazosina interacts with:

• other antihypertensive medicines: Doxazosina increases the blood pressure-lowering effect of other antihypertensive medicines.
• vasodilators and nitrates: increase the antihypertensive effect of doxazosina.
• non-steroidal anti-inflammatory drugs or estrogens: may reduce the antihypertensive effect of doxazosina.
• doxazosina may reduce blood pressure and vascular reactions to dopamine, ephedrine, epinephrine, metaraminol and phenylephrine.

Doxazosina does not interact when administered together with: digoxin, warfarin, phenytoin and indomethacin. No adverse effects have been observed due to interaction of doxazosina with thiazide diuretics, furosemide, beta-blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycemics, uricosuric agents and anticoagulants. Caution is recommended when doxazosina is administered with drugs that may affect liver metabolism. However, if you are taking any of the aforementioned drugs, you should consult your doctor.

Some patients who are receiving an alpha-blocker for the treatment of high blood pressure or prostatic hyperplasia may experience dizziness or fainting that can be caused by a drop in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers like doxazosina. In order to reduce the likelihood of these symptoms occurring, you should be receiving your daily dose of alpha-blockers regularly before starting treatment for erectile dysfunction.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice.

Pregnancy:

Because the safety of doxazosina during pregnancy has not been established, its use is only recommended when, in the doctor's opinion, there is no safer alternative therapy and when the disease itself poses a greater risk to the mother or fetus.

Breast-feeding:

Doxazosina accumulates in breast milk. As the safety of doxazosina during breast-feeding has not been established, it is contraindicated in breast-feeding mothers.

Driving and using machines

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

Doxazosina Normoncontains lactose and sodium.

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

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

3. How to take Doxazosina Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

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

Doxazosina can be taken 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 the needs of each patient.

The tablets can be divided into two equal doses.

Hypertension:

The usual dose is half to 1 tablet (2 mg to 4 mg) once a day. It is recommended to start treatment with the administration of half a Doxazosina Normon 2 mg tablet (1 mg) once a day for 1 or 2 weeks. Depending on the response of each patient, the dose can be increased to half a tablet (2 mg), 1 tablet (4 mg), 2 tablets (8 mg) or 4 tablets (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 can be administered with other medicines that your doctor has prescribed for the treatment of hypertension.

Benign prostatic hyperplasia:

The usual dose is half to 1 tablet (2 mg to 4 mg) once a day. It is recommended to start treatment with the administration of half a Doxazosina Normon 2 mg tablet (1 mg) once a day. Depending on the response of each patient, the dose can be increased to half a tablet (2 mg), 1 tablet (4 mg) or 2 tablets (8 mg) per day as the maximum dose, at intervals of 1 or 2 weeks between them.

If you take more Doxazosina Normon than you should

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

Information for the doctor:As treatment for overdose, the most important thing is to provide cardiovascular support. Change the patient's position to horizontal. 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 forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Doxazosina is a medicine that is usually well tolerated. The most common reactions associated with doxazosina are postural and non-specific, including: dizziness, headache, fatigue, general malaise, vertigo, postural dizziness, edema (fluid retention that causes swelling), weakness, drowsiness, nausea and rhinitis (inflammation of the nasal mucosa). It can also cause exceptional cases of non-specific gastrointestinal disorders, such as abdominal pain, diarrhea and vomiting, exceptionally agitation and tremor.

Isolated cases of impotence, allergic reactions such as skin redness, pruritus (itching), purpura (appearance of spots on the skin with blood extravasation), jaundice (yellow color of the skin and mucous membranes) and elevation of liver transaminases; nasal bleeding has also been reported.

A very rare side effect has been reported: persistent and painful erection of the penis. Consult a doctor urgently.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this package leaflet, please tell your doctor or pharmacist.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (Website: www.notificaram.es). By reporting side 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 package.

Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date refers to 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 further information

Composition of Doxazosina Normon 4 mg

• The active substance is doxazosina mesylate. Each tablet contains 4 mg of doxazosina (mesylate)
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium carboxymethylcellulose (potato) and magnesium stearate.

Appearance of the product and contents of the pack

Doxazosina Normon 4 mg is presented in the form of tablets. Each pack contains 28 tablets. The tablets are white or slightly creamy in color, round, biconvex, with a break line on one face and engraved 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 last revision of this package leaflet:December 2016

Other sources of information

Detailed information on this medicine 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 the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address:

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