Leaflet: Information for the user

Doxazosina Neo ratiopharm 4 mg prolonged-release tablets EFG

doxazosina

Read this leaflet carefully before you start taking the 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 give it 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.

Contents of the pack and additional information

Your doctor has prescribed Doxazosina Neo ratiopharm because your blood pressure is high, which, without treatment, increases the risk of heart disease or stroke. The active ingredient in your tablets, doxazosina, belongs to a group of medicines known as alpha blockers. These drugs work by dilating blood vessels, making it easier for the heart to pump blood through them. In this way, it is easier to reduce high blood pressure.

You may also have been prescribed Doxazosina Neo ratiopharm because you have an enlarged prostate (prostatic hyperplasia), which makes it difficult to urinate. The prostate is located immediately below the bladder in men. Doxazosina Neo ratiopharm works by relaxing the muscle that surrounds the exit of the bladder and the prostate, making it easier to urinate.

Do not take Doxazosina Neo ratiopharm

• if you are allergic to doxazosina or any of the other components of this medication (listed in section 6),
• if you know you are sensitive to quinazolines (such as prazosina or terazosina), which is 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 may be accompanied by dizziness
• if, in addition to benign prostatic hyperplasia, you have an infection or obstruction of the urinary tract or bladder stones
• if you suffer from or have suffered from any type of obstruction of the digestive system (only for patients taking the 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 suffer from kidney insufficiency (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 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 medication to treat erectile dysfunction (see also the section “Other medications and Doxazosina Neo ratiopharm”)

At the beginning of treatment, avoid situations where injuries may occur due to dizziness or weakness, and in rare cases, fainting.

If you are to undergo eye surgery for cataracts (opacity of the crystalline lens), please inform your ophthalmologist before the operation that you are using or have used Doxazosina Neo ratiopharm previously. This is because Doxazosina Neo ratiopharm may cause complications during surgery that can be controlled if your ophthalmologist is previously notified.

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

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

Children and adolescents

Doxazosina Neo ratiopharm is not recommended for children or adolescents under 18 years old as its safety and efficacy have not been established.

Other medications and Doxazosina Neo ratiopharm

Always discuss the medications you are taking with your doctor. This includes any medication you have purchased yourself and also any medication prescribed by a doctor. Some medications interact with Doxazosina Neo ratiopharm. These include:

• other medications used to treat high blood pressure
• medications used to treat erectile dysfunction (e.g. sildenafilo [Viagra], tadalafilo [Cialis], vardenafilo [Levitra]), see section “Warnings and precautions”. Some patients taking alpha-blockers to treat high blood pressure or prostate enlargement 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 medications (impotence) with alpha-blockers. In order to reduce the possibility of these symptoms occurring, you should be taking a regular daily dose of alpha-blockers before starting to take erectile dysfunction medication.
• medications used to treat bacterial or fungal infections, for example, claritromicina, itraconazol, ketoconazol, telitromicina, voriconazol.
• medications used to treat HIV, for example, indinavir, nelfinavir, ritonavir, saquinavir.
• nefazodona, a medication used to treat depression.

Doxazosina Neo ratiopharm with food and drinks

Doxazosina Neo ratiopharm can be taken with or after food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Small amounts of doxazosina, the active ingredient in Doxazosina Neo ratiopharm, may appear in breast milk. Do not take Doxazosina Neo ratiopharm while breastfeeding your baby unless your doctor recommends it.

Driving and operating machinery

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

Doxazosina Neo ratiopharm contains sodium

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

Always take this medication exactly as your doctor has told you to. If you have any doubts, consult your doctor or pharmacist. The packaging label 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 Seniors

The dose of Doxazosina Neo ratiopharm is the same whether you take the medication 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 be achieved. Your doctor may increase your dose up to the maximum recommended dose of two tablets per day.

If you take more Doxazosina Neo ratiopharm than you should

If you take too many tablets, the most likely symptoms would be dizziness or lightheadedness due to a drop in blood pressure. You should lie down on your back with your feet higher than your head. Immediately contact the nearest emergency service or consult with 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forget to take Doxazosina Neo 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 interrupt treatment with Doxazosina Neo ratiopharm

Do not stop taking this medication without consulting your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Common side effects that may occur (can 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, decrease in blood pressure when standing that causes dizziness, drowsiness, or fainting,
• bronchitis, cough, difficulty breathing, runny nose, or congestion,
• abdominal pain, indigestion, dry mouth, sensation of dizziness,
• pruritus,
• back pain, muscle pain,
• urinary tract inflammation, inability to control urination,
• sensation of weakness, chest pain, flu-like symptoms, peripheral edema (swelling of the ankles, feet, or fingers)

Rare side effects that may occur (can 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,
• nasal bleeding,
• constipation, diarrhea, flatulence, vomiting, gastroenteritis,
• abnormal liver function tests,
• skin rash,
• joint pain,
• difficulty or pain urinating, blood in the urine, frequent urination,
• impotence (inability to achieve an erection, persistent painful erections),
• pain, facial swelling (facial edema),
• weight gain

Very rare side effects (can affect up to 1 in 1,000 people) are:

• obstruction of the digestive tract

Very rare side effects that may occur (can 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 standing up from sitting or lying down, tingling in the hands and feet,
• blurred vision,
• slow heart rate, irregular heartbeats,
• flushing,
• difficulty breathing,
• bile duct obstruction, liver inflammation (hepatitis), jaundice (yellowing of the skin or white of the eyes caused by liver problems or blood issues).
• hair loss, skin bruises, urticaria,
• muscle cramps, muscle weakness,
• urinary problems, increased nocturnal urine production, increased urine volume, increased need to urinate,
• breast enlargement in men,
• persistent and painful penile erection. Consult a doctor urgently,
• fatigue (tiredness), feeling dizzy.

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

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

Reporting of side effects

If you experience any type of side effects, consult your doctor or pharmacist, even if it's a side effect that doesn't appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister and on the packaging after the abbreviation of the expiration date. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Doxazosina Neo ratiopharm

• The active ingredient is doxazosin (as mesilate).

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

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

Appearance of the product and content of the packaging

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

They are marketed in PVC/PVDC/aluminum blister packaging of 20, 28, 20, 50, 98, 100, and 500 prolonged-release tablets, (normal blister: 20, 30, 50, 100, 500; blister with calendar: 28, 98; blister of single doses: 30x1, 50x1, and 100x1).

Only some sizes of packaging may be marketed.

Holder of the marketing authorization

Teva Pharma, S.L.U

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

LudwigMerckle Strasse, 3

89143 - Blaubeuren (Germany)

Last review date of this leaflet: September 2022

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS) http: //www.aemps.gob.es/