Package Leaflet: Information for the User

Doxazosina Normon 4 mg Tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on 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.

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

2. What you need to know before you start taking Doxazosina Normon

3. How to take Doxazosina Normon

4. Possible side effects

5. Storage of Doxazosina Normon

6. Contents of the pack and additional information

Doxazosina belongs to a group of medicines called alpha-adrenergic blockers.

-High blood pressure (hypertension).

-Obstruction of urine flow 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 treated effectively with doxazosina.

Do not take Doxazosina Normon:

• If you are allergic to doxazosina, quinazolines, or any of the components of this medication (including those listed in section 6).
• During lactation.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Normon.

Be especially careful with Doxazosina Normon:

• If you have evident liver insufficiency or if you are being treated with medications that affect liver metabolism.
• If you have any type of heart disease.

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

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

- If you are about to undergo cataract surgery, please inform your doctor before the operation if you have taken 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.

Children

No experience is available on the use of doxazosina in children.

Older people

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

Other medications and Doxazosina Normon

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Doxazosina interacts with:

• Other anti-hypertensive medications: Doxazosina increases the effect of blood pressure reduction of other anti-hypertensive medications.
• Vasodilators and nitrates: increase the anti-hypertensive effect of doxazosina.
• Non-steroidal anti-inflammatory drugs or estrogens: may reduce the anti-hypertensive 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 by the interaction of doxazosina with diuretics, furosemide, beta-blockers, non-steroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic agents, uricosuric agents, and anticoagulants. Precaution is recommended when administering doxazosina with medications that may affect liver metabolism. However, if you are taking any of the medications mentioned above, consult your doctor.

Some patients receiving an alpha-blocker for the treatment of high blood pressure or prostate hypertrophy may experience dizziness or fainting caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medications for erectile dysfunction (impotence) with alpha-blockers such as doxazosina. In order to reduce the likelihood of these symptoms, you should be receiving your daily dose of alpha-blockers regularly before starting treatment for erectile dysfunction.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist.

Pregnancy:

Due to the lack of safety data on doxazosina during pregnancy, its use is only recommended when, in the opinion of the doctor, there is no safer alternative treatment and when the disease itself poses a greater risk to the mother or the fetus.

Lactation:

Doxazosina accumulates in breast milk. Since the safety of doxazosina during lactation has not been established, it is contraindicated in breastfeeding women.

Driving and operating machinery

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

Doxazosina Normoncontains lactose and sodium.

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

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

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

Remember to take your medication. Your doctor will indicate the duration of treatment with Doxazosina Normon. Do not discontinue treatment prematurely. If you estimate that the action of Doxazosina Normon is too strong or too weak, inform your doctor or pharmacist.

Doxazosina can be administered both in the morning and at night. Swallow the tablets with a sufficient amount of liquid.

The dose will be established by the 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 tablet of Doxazosina Normon 2 mg (1 mg) once a day for 1 or 2 weeks. According to the response of each patient, the dose may 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 medications prescribed by your doctor 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 tablet of Doxazosina Normon 2 mg (1 mg) once a day. Depending on the response of each patient, the dose may 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

Consult your doctor or pharmacist. Hypotension may occur. In case of overdose or accidental ingestion, consult the Toxicological 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 from horizontal. In case of severe hypotension, administer plasma expanders and vasodepressors. Dialysis is not recommended.

If you forgot to takeDoxazosina Normon

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Doxazosina is a medication that is usually well tolerated. The most commonly associated reactions with doxazosina are postural and nonspecific, including: dizziness, headache, fatigue, general discomfort, vertigo, postural dizziness, edema (fluid retention causing swelling), weakness, drowsiness, nausea, and rhinitis (inflammation of the nasal mucosa). It may also cause exceptional cases of nonspecific gastrointestinal discomfort, 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 skin spots with blood extravasation), jaundice (yellow discoloration of the skin and mucous membranes) and elevation of liver transaminases have been reported; also, nasal bleeding has been reported.

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use (Website:www.notificaram.es). By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

Do not use this medication after 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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Doxazosina Normon 4 mg

- The active ingredient is doxazosina mesilato. Each tablet contains 4 mg of doxazosina (mesilato)

- The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, sodium carboxymethyl starch (from potato) and magnesium stearate.

Appearance of the product and content of the packaging

Doxazosina Normon 4 mg is presented in the form of tablets. Each package contains 28 tablets. The tablets are white or slightly cream-colored, round, biconvex, with a breaking bar on one face and printed on the other.

Holder of the marketing authorization and responsible for manufacturing

Normon S.A. Laboratories

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

Other presentations

Doxazosina Normon 2 mg tablets

Last review date of this leaflet: December 2016

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/