DOXAZOSIN NEO TEVA-RATIOPHARM 4 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Doxazosina Neo Teva-ratiopharm

Do not take Doxazosina Neo Teva-ratiopharm

• if you are allergic to doxazosina or any of the other ingredients of this medicine (listed in section 6),
• if you know you are sensitive to quinazolines (such as prazosina or terazosina), the chemical family to which doxazosina belongs
• if you have a history of orthostatic hypotension. Orthostatic hypotension is a drop in blood pressure that can occur when you stand up quickly from sitting or lying down, a situation that can be accompanied by dizziness
• if, in addition to benign prostatic hyperplasia, you have a urinary tract infection or obstruction, or stones in the bladder
• if you have a type of digestive tract obstruction (only for patients taking prolonged-release tablets)
• if, in addition to benign prostatic hyperplasia, your blood pressure is too low
• if you suffer from continuous urine loss (urinary incontinence), do not produce enough urine (anuria), or have kidney failure (only for patients with benign prostatic hyperplasia taking doxazosina as monotherapy)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo Teva-ratiopharm

• if you have liver problems
• if you have acute heart disease, such as pulmonary edema or heart failure
• if you take any medicine for erection problems (see also section "Other medicines and Doxazosina Neo Teva-ratiopharm")

At the start of treatment, you should avoid situations where injuries can occur as a result of dizziness or weakness, and in rare cases, fainting.

If you are going to undergo cataract surgery (clouding of the lens), please inform your ophthalmologist before the operation that you are using or have previously used Doxazosina Neo Teva-ratiopharm. This is because Doxazosina Neo Teva-ratiopharm can cause complications during surgery that can be controlled if your ophthalmologist is previously informed.

In Doxazosina Neo Teva-ratiopharm, the active substance is surrounded by an inert material, a non-absorbable coating designed to control the release of the substance over a prolonged period. After passing through the gastrointestinal tract, the empty tablet coating is separated. Do not worry if you occasionally see something in your stool that looks like a tablet.

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

Children and adolescents

Doxazosina Neo Teva-ratiopharm is not recommended for children or adolescents under 18 years of age, as safety and efficacy have not been established.

Other medicines and Doxazosina Neo Teva-ratiopharm

Always tell your doctor about the medicines you are taking. This includes any medicine you have bought yourself and those that have been prescribed by a doctor. Some medicines interact with Doxazosina Neo Teva-ratiopharm. These include:

• other medicines used to treat high blood pressure
• medicines used to treat erection problems (e.g., sildenafil [Viagra], tadalafil [Cialis], vardenafil [Levitra]), see section "Warnings and precautions". Some patients who are taking alpha-blockers to treat high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which can be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking medicines for erectile dysfunction (impotence) with alpha-blockers. To reduce the possibility of these symptoms occurring, you should be taking a regular daily dose of alpha-blockers before starting to take medicine for erectile dysfunction.
• medicines for treating bacterial or fungal infections, for example, clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• medicines used to treat HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• nefazodone, a medicine used to treat depression.

Doxazosina Neo Teva-ratiopharm with food and drinks

Doxazosina Neo Teva-ratiopharm can be taken with or after 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 medicine.

Take Doxazosina Neo Teva-ratiopharm during pregnancy if it is prescribed by a doctor after careful evaluation of the benefit-risk.

Small amounts of doxazosina, the active substance of Doxazosina Neo Teva-ratiopharm, may appear in breast milk. You should not take Doxazosina Neo Teva-ratiopharm while breastfeeding your baby unless your doctor recommends it.

Driving and using machines

Doxazosina Neo Teva-ratiopharm can cause drowsiness. Be especially careful when taking the tablets for the first time. If drowsiness appears, do not drive or use heavy machinery.

Doxazosina Neo Teva-ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per prolonged-release tablet; this is essentially "sodium-free".

3. How to take Doxazosina Neo Teva-ratiopharm

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The packaging will tell you how many tablets to take and when. You should swallow the tablets whole with a glass of water. Do not crush or chew them.

Adults andelderly

The dose of Doxazosina Neo Teva-ratiopharm is the same whether you take the medicine for high blood pressure or to treat the symptoms of benign prostatic hyperplasia. The recommended dose is one tablet per day. The optimal effect may take up to four weeks to achieve. Your doctor may increase your dose up to the maximum recommended dose of two tablets per day.

If you take more Doxazosina Neo Teva-ratiopharm than you should

If you take too many tablets, the most likely symptoms would be dizziness or lightheadedness due to low blood pressure. You should lie down on your back with your feet higher than your head. Contact the nearest emergency service or consult your doctor or pharmacist immediately. Bring this leaflet and any remaining tablets with you so that your doctor knows what you have taken.

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 medicine and the amount administered.

If you forget to take Doxazosina Neo Teva-ratiopharm

Try to take the tablets every day as prescribed. However, if you forget a dose, take it as soon as you remember. Do not take two doses at the same time.

If you stop taking Doxazosina Neo Teva-ratiopharm

Do not stop taking this medicine without consulting your doctor.

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

4. Possible side effects

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

Common side effects that may occur (may affect up to 1 in 10 people) are:

• respiratory tract infection, urinary tract infection
• dizziness, headache, drowsiness,
• feeling of dizziness or "spinning head",
• palpitations, rapid heartbeat,
• low blood pressure, decrease in blood pressure when standing up that causes dizziness, lightheadedness, or fainting,
• bronchitis, cough, difficulty breathing, runny nose or congestion,
• abdominal pain, indigestion, dry mouth, feeling of dizziness,
• itching,
• back pain, muscle pain,
• urinary bladder inflammation, inability to control urine,
• feeling of weakness, chest pain, flu-like symptoms, peripheral edema (swelling of the ankles, feet, or fingers)

Uncommon side effects that may occur (may affect up to 1 in 100 people) are:

• allergic reaction to the medicine,
• loss of appetite, joint inflammation (gout), increased appetite
• anxiety, depression, difficulty sleeping,
• stroke, reduced sense of touch or sensation, fainting, tremors,
• ringing in the ears,
• chest pain, myocardial infarction,
• nosebleeds,
• constipation, diarrhea, flatulence, vomiting, gastroenteritis,
• abnormal liver function tests,
• skin rash,
• joint pain,
• difficulty or pain when urinating, blood in the urine, frequent urination,
• impotence (inability to achieve an erection, painful persistent erections),
• pain, swelling of the face (facial edema),
• weight gain

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

• digestive tract obstruction

Very rare side effects that may occur (may affect up to 1 in 10,000 people) are:

• decrease in the number of white blood cells, decrease in the number of platelets, which can cause bleeding or easy bruising,
• restlessness, nervousness,
• dizziness, especially when standing up from sitting or lying down, tingling in hands and feet,
• blurred vision,
• slow heartbeat, irregular heartbeats,
• flushing,
• difficulty breathing,
• cholestasis, liver inflammation (hepatitis), jaundice (yellowing of the skin or the whites of the eyes caused by liver or blood problems).
• hair loss, skin bruising, hives,
• muscle cramps, muscle weakness,
• urinary disorders, increased nocturnal urine production, increased urine volume, increased need to urinate,
• breast enlargement in men,
• persistent and painful erection of the penis. Consult a doctor urgently,
• fatigue, feeling dizzy.

Side effects of unknown frequency (cannot be estimated from the available data) are:

• IFIS (Intraoperative Floppy Iris Syndrome, a certain eye disorder that can occur during cataract surgery) (see section 2 "Warnings and precautions"),
• retrograde ejaculation.

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 through the Spanish Medicines Monitoring System for Human Use: 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 Teva-ratiopharm

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 blister and on the carton after the abbreviation "EXP". The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Doxazosina Neo Teva-ratiopharm

• The active substance is doxazosina (as mesylate).

Each prolonged-release tablet contains 4.85 mg of doxazosina mesylate, which corresponds to 4 mg of doxazosina.

• The other ingredients are polyethylene oxide, microcrystalline cellulose, povidone, α-tocopherol, anhydrous colloidal silica, hydrated colloidal silica, sodium stearyl fumarate, methacrylic acid - ethyl acrylate copolymer (1:1), macrogol, and titanium dioxide (E-171).

Appearance of the product andcontents of the pack

Doxazosina Neo Teva-ratiopharm 4 mg prolonged-release tablets are white, round, biconvex tablets with "DL" on one side.

They are available in PVC/PVDC/aluminum blister packs of 20, 28, 20, 50, 98, 100, and 500 prolonged-release tablets, (normal blister: 20, 30, 50, 100, 500; calendar blister: 28, 98; unit-dose blister: 30x1, 50x1, and 100x1).

Not all pack sizes may be marketed.

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1ª Planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig Merckle Strasse, 3

89143 - Blaubeuren (Germany)

Date of last revision of this leaflet: September 2022

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 packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66338/P_66338.html

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