Doxazosin Neo Teva-Ratiopharm 4 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Doxazosina Neo Teva-ratiopharm 4 mg prolonged-release tablets EFG

doxazosin

Read all of this leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Doxazosina Neo Teva-ratiopharm is and what it is used for
2. What you need to know before taking Doxazosina Neo Teva-ratiopharm
3. How to take Doxazosina Neo Teva-ratiopharm
4. Possible side effects
5. How to store Doxazosina Neo Teva-ratiopharm

Pack contents and additional information

1. What Doxazosina Neo Teva-ratiopharm is and what it is used for

Your doctor has prescribed Doxazosina Neo Teva-ratiopharm because you have high blood pressure, which, if left untreated, increases the risk of heart disease or stroke. The active substance in your tablets, doxazosin, belongs to a group of medicines known as alpha-blockers. These medicines work by dilating the blood vessels, thereby making it easier for the heart to pump blood through them. This helps to reduce high blood pressure.

You may also have been prescribed Doxazosina Neo Teva-ratiopharm because you have an enlarged prostate (benign prostatic hyperplasia), which makes it difficult for urine to pass. The prostate is located just below the urinary bladder in men. Doxazosina Neo Teva-ratiopharm works by relaxing the muscle around the outlet of the bladder and the prostate, making it easier for urine to pass.

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

Do not take Doxazosina Neo Teva-ratiopharm

• if you are allergic to doxazosin or to any of the other ingredients of this medicine (listed in section 6),
• if you know you are sensitive to quinazolines (such as prazosin or terazosin), which is the chemical family to which doxazosin belongs,
• if you have a history of orthostatic hypotension. Orthostatic hypotension is a drop in blood pressure that may occur when rising quickly from a sitting or lying position, a situation that may be accompanied by dizziness,
• if, in addition to benign prostatic hyperplasia, you have a urinary tract infection or obstruction or bladder stones,
• if you suffer or have suffered from any type of gastrointestinal 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 urinary leakage (urinary incontinence), produce insufficient urine (anuria), or have renal failure (only for patients with benign prostatic hyperplasia taking doxazosin as monotherapy).

Warnings and precautions

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

• if you have liver problems,
• if you suffer from acute heart disease, such as pulmonary edema or heart failure,
• if you are taking any medicine to treat erectile dysfunction (see also section “Other medicines and Doxazosina Neo Teva-ratiopharm”).

At the beginning of treatment, avoid situations where injuries could result from dizziness or weakness, and in rare cases, fainting.

If you are undergoing cataract surgery (clouding of the lens), please inform your ophthalmologist before the operation that you are currently using or have previously used Doxazosina Neo Teva-ratiopharm. This is because Doxazosina Neo Teva-ratiopharm may cause complications during surgery, which can be managed if your ophthalmologist is informed in advance.

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 an extended period. After passing through the gastrointestinal tract, the empty tablet coating is excreted. Do not be concerned if you occasionally see something in your stools that resembles a whole tablet.

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

Children and adolescents

Doxazosina Neo Teva-ratiopharm is not recommended in 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 all medicines you are taking. This includes any medicines you have bought without a prescription and those 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 erectile dysfunction (e.g., sildenafil [Viagra], tadalafil [Cialis], vardenafil [Levitra]), see section “Warnings and precautions”. Some patients taking alpha-blockers to treat high blood pressure or enlarged prostate may experience dizziness or lightheadedness, which may be caused by low blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking erectile dysfunction medicines (impotence) together with alpha-blockers. To reduce the possibility of these symptoms occurring, you should be taking a regular daily dose of an alpha-blocker before starting treatment with an erectile dysfunction medicine,
• medicines used to treat bacterial or fungal infections, for example, clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole,
• medicines used in the treatment of HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir,
• nefazodone, a medicine used to treat depression.

Doxazosina Neo Teva-ratiopharm with food and drink

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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Take Doxazosina Neo Teva-ratiopharm during pregnancy only if prescribed by a doctor after careful assessment of the benefit-risk balance.

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

Driving and using machines

Doxazosina Neo Teva-ratiopharm may cause drowsiness. Be especially careful when taking the tablets for the first time. If drowsiness occurs, do not drive or operate 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. If you are not sure, consult your doctor or pharmacist. The label on the pack will tell you how many tablets to take and when. Swallow the tablets whole with a full glass of water. Do not crush or chew them.

Adults and elderly

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

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

If you take too many tablets, the most likely symptoms are 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 immediately or consult your doctor or pharmacist. Bring this leaflet and any remaining tablets with you so your doctor knows what you have taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Doxazosina Neo Teva-ratiopharm

Try to take the tablets every day as prescribed. However, if you miss a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If you stop taking Doxazosina Neo Teva-ratiopharm

Do not stop taking this medicine without consulting your doctor.

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

4. Possible adverse effects

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

Frequent adverse effects (may affect up to 1 in 10 people) are:

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

Uncommon adverse effects (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 urge to urinate,
• impotence (inability to achieve an erection, persistent painful erections),
• pain, swelling of the face (facial edema),
• weight gain

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

• obstruction of the gastrointestinal tract

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

• decrease in white blood cell count, decrease in platelet count, which may cause bleeding or easy bruising,
• restlessness, nervousness,
• dizziness, especially when rising 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 whites of the eyes caused by liver or blood problems),
• hair loss, bruising of the skin, urticaria,
• muscle cramps, muscle weakness,
• urinary disorders, increased nocturnal urine production, increased urine volume, increased need to urinate,
• breast enlargement in men,
• persistent and painful penile erection. Seek medical advice urgently,
• tiredness (fatigue), feeling dizzy.

Adverse effects with unknown frequency (cannot be estimated from available data) are:

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

Reporting of adverse effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the blister and on the packaging following the abbreviation for expiry date. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to a pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxazosina Neo Teva-ratiopharm

• The active substance is doxazosin (as mesilate).

Each prolonged-release tablet contains 4.85 mg of doxazosin mesilate, equivalent to 4 mg of doxazosin.

• The other components 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 and contents of the pack

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

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Teva Pharma, S.L.U
C/Anabel Segura, 11 Edificio Albatros B, 1st Floor
28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH
Ludwig Merckle Strasse, 3
89143 - Blaubeuren (Germany)

Date of the most recent revision of this leaflet: September 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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 packaging. 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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