DOXAZOSIN NEO AUROVITAS SPAIN 8 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Doxazosina Neo Aurovitas Spain

Do not take Doxazosina Neo Aurovitas Spain

• If you are allergic to doxazosin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines of the same class as doxazosin, such as prazosin and terazosin.
• If you have low blood pressure or if you have ever had a drop in blood pressure that has caused dizziness or fainting when standing up from lying down or sitting.
• If you have BPH and at the same time have an obstruction of the upper urinary tract, chronic urinary tract infection, or bladder stones.
• If you have a blockage of the digestive tract.
• If you are using this medicine for the treatment of BPH and you have low blood pressure.
• If you have overflow incontinence or no urine production with or without increased deterioration of kidney function.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo Aurovitas Spain:

• At the start of treatment. You may experience a drop in blood pressure accompanied by dizziness, weakness, and in rare cases, fainting. Avoid any situation that may cause injury if such symptoms occur.
• If you have acute heart disease, such as heart failure.
• If you have liver disease. In the case of severe liver disease, the use of Doxazosina Neo Aurovitas Spain is not recommended.
• If you are also taking medicines for the treatment of erection problems (PDE-5 inhibitors, e.g., sildenafil, tadalafil, vardenafil), as this may cause a significant drop in blood pressure. This is more likely to occur at the start of treatment with the PDE-5 inhibitor. This means that you should have stabilized on your doxazosin treatment before starting treatment with PDE-5 inhibitors. Your doctor may consider using a lower initial dose of PDE-5 inhibitor.
• If you are going to have eye surgery for cataracts, inform your eye specialist before the operation that you are taking or have previously taken Doxazosina Neo Aurovitas Spain. This is because Doxazosina Neo Aurovitas Spain may cause complications during surgery that can be avoided if your specialist is informed beforehand.

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 BPH.

Occasionally, you may notice that tablet residues appear in your stool. This is normal. The active substance of the prolonged-release tablets is contained in a non-absorbable coating that has been specially designed to release the substance slowly in the body. When this process is complete, the empty coating is eliminated from the body through the stool.

Consult your doctor or pharmacist before starting to take Doxazosina Neo Aurovitas Spain.

Children and adolescents

Doxazosina Neo Aurovitas Spain is not recommended for use in children or adolescents under 18 years of age, as the safety and efficacy have not been established.

Other medicines and Doxazosina Neo Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some patients who take alpha-blockers for the treatment of high blood pressure or for BPH may experience dizziness or vertigo, which may be caused by a drop in blood pressure when sitting or standing up quickly. Certain patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) along with alpha-blockers. In order to reduce the likelihood of these symptoms occurring, the daily dose of your alpha-blocker should be stabilized before starting to use medicines for erectile dysfunction.

Tell your doctor if you are taking any of the following medicines in particular:

• Other alpha-blockers and other medicines used in the treatment of high blood pressure.
• Non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen.
• Medicines used to treat bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used in the treatment of HIV, e.g., indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Pregnancy, breastfeeding, and fertility

Only for the indication of hypertension:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The experience of using doxazosin during pregnancy is limited.

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

Consult your doctor or pharmacist before using any medicine.

There are no reports on the effects caused by doxazosin on reproduction in males.

Driving and using machines

Doxazosina Neo Aurovitas Spain may cause dizziness. Be particularly careful when taking the first dose, if your dose is increased, or if you start taking the medicine again after an interruption in treatment. If you feel dizzy or vertiginous, do not drive or use machines.

It is your responsibility to assess whether you are in a fit state to drive or perform work that requires special attention. One of the factors that can affect your ability in this respect is the use of medicines, due to their effects and/or adverse reactions. The description of these effects and reactions can be found in other sections. Therefore, read all of this leaflet carefully. Consult your doctor or pharmacist if you have any doubts.

Doxazosina Neo Aurovitas Spain contains sodium

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

3. How to take Doxazosina Neo Aurovitas Spain

Follow exactly the administration instructions of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Method of administration

Doxazosina Neo Aurovitas Spain has been produced in a special way that makes the active substance release slowly throughout the day. Choose a time of day that is most convenient for you and take your tablets at that time every day.

The tablets should be swallowed whole with a sufficient amount of liquid. Do not chew, break, or crush the tablets.

Treatment of high blood pressure and symptoms of BPH:

Adults (including elderly patients)

The usual dose of doxazosin is 4 mg per day, although your doctor may increase your dose to 8 mg of doxazosin (one tablet) per day.

The maximum recommended dose is 8 mg of doxazosin per day. It may take up to 4 weeks to achieve the optimal effect.

Patient with liver problems

Your doctor may reduce your dose or monitor your progress carefully. The use of doxazosin is not recommended in patients with severe liver problems.

If you take more Doxazosina Neo Aurovitas Spain than you should

If you take too many tablets or, for example, a child takes the medicine by mistake, contact your doctor or go to the emergency department of a hospital immediately. If you have taken too many tablets, you may experience dizziness or vertigo due to a drop in blood pressure. Lie down with your feet elevated above the level of your head.

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

If you forget to take Doxazosina Neo Aurovitas Spain

If you forget to take a dose, do not worry. Simply take the tablet the next day when it is due. Do not take a double dose to make up for forgotten doses.

If you stop taking Doxazosina Neo Aurovitas Spain

Continue taking the tablets until your doctor tells you to stop.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects may be serious:

Stop taking this medicine and consult your doctor immediately or go to the nearest hospital if you experience any of the following:

• Allergic reactions such as wheezing, difficulty breathing, severe dizziness, or collapse, swelling of the face or throat, or severe skin rash with red spots or blisters (may affect up to 1 in 100 people).
• Chest pain (angina pectoris; may affect up to 1 in 100 people), rapid or irregular heartbeat (may affect up to 1 in 10,000 people), heart attack or infarction (may affect up to 1 in 100 people).
• Yellowing of the skin or the whites of the eyes (jaundice), caused by liver problems (may affect up to 1 in 10,000 people).

Frequent side effects: may affect up to 1 in 10 people

• Palpitations (strong heartbeats), increased heart rate,
• dizziness, headache, drowsiness,
• feeling of vertigo or spinning,
• inflammation of the airways (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (itching, runny, and congested nose),
• abdominal discomfort, stomach upset (dyspepsia), dry mouth, nausea,
• inflammation of the bladder (cystitis), loss of bladder control,
• itching of the skin,
• back pain, muscle pain,
• lung infection (respiratory tract infection), kidney or bladder infection (urinary tract infection),
• low blood pressure, sudden drop in blood pressure when standing up,
• weakness, flu-like symptoms, swelling, particularly of the feet and lower limbs (edema).

Uncommon side effects: may affect up to 1 in 100 people

• weight gain,
• reduced sensitivity, fainting, tremors,
• tinnitus (ringing in the ears),
• nosebleeds,
• constipation, diarrhea, gas, vomiting, stomach and intestine inflammation,
• pain when urinating, blood in the urine, increased frequency of urination,
• skin rashes,
• joint pain and stiffness (arthralgia),
• increased or decreased appetite, gout (a painful form of arthritis),
• facial pain and swelling (facial edema),
• increased liver enzyme levels,
• impotence,
• anxiety, depression, insomnia.

Rare side effects:may affect up to 1 in 1,000 people

• Blockage of the digestive tract.

Very rare side effects: may affect up to 1 in 10,000 people

• reduced heart rate,
• reduced levels of certain blood cells (leukopenia, thrombocytopenia),
• dizziness when standing up, tingling with loss of sensation,
• blurred vision,
• narrowing of the airways with difficulty breathing or wheezing (bronchospasm),
• urination problems, increased need to urinate at night, increased urine production and volume,
• hair loss, unusual bleeding or bruising, rash,
• muscle cramps, muscle weakness,
• hot flashes,
• fatigue, usually with malaise,
• blockage of bile excretion from the liver (cholestasis), liver inflammation (hepatitis),
• breast growth in men,
• persistent and painful erection of the penis. Consult a doctor urgently,
• agitation, nervousness.

Frequency not known: the frequency cannot be estimated from the available data

• complications (“Intraoperative Floppy Iris Syndrome”) during cataract surgery (see section 2 “Warnings and precautions”),
• retrograde ejaculation – this occurs when semen is redirected to the urinary bladder instead of being normally ejaculated through the urethra.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxazosina Neo Aurovitas Spain

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

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. Container Content and Additional Information

Composition of Doxazosina Neo Aurovitas Spain

• The active ingredient is doxazosina (as mesylate). Each prolonged-release tablet contains 8 mg of doxazosina (as mesylate).

• The other components are:

Tablet core: polyethylene oxide (MW 900,000), polyethylene oxide (MW 200,000); microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-α-tocopherol, anhydrous colloidal silica, sodium stearyl fumarate.

Tablet coating: 30% dispersion of methacrylic acid - ethyl acrylate copolymer (1:1), hydrated colloidal silica, macrogol 1300-1600, titanium dioxide (E171).

Appearance of the Product and Container Content

The tablets are white, round, biconvex, with the letters "DH" engraved on one face.

The medication is packaged in:

• PVC/PVDC/aluminum blisters of 7, 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 tablets.
• Calendar blisters: 7, 14, 28, 56, and 98 tablets.
• Unit dose containers: 50 x 1 tablet.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

Aurobindo Pharma B.V

Baarnsche Dijk 1

LN Baarn, 3741

Netherlands

Or

Arrow Generiques

26 Avenue Tony Garnier

69007 Lyon

France

This medication is authorized in the member states of the European Economic Area under the following names:

Spain Doxazosina Neo Aurovitas Spain 8 mg prolonged-release tablets EFG

France Doxazosine Arrow LP 8 mg, prolonged-release tablet

Ireland Raporsin 8 mg Prolonged Release Tablets

Netherlands Doxazosine Aurobindo Retard 8 mg, prolonged-release tablets

Portugal Doxazosina Ritisca

Date of the Last Revision of this Leaflet:July 2023

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)