DOXAZOSIN NEO TEVA-RATIOPHARM 8 mg PROLONGED-RELEASE TABLETS

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

Do not takeDoxazosina Neo Teva-ratiopharm

• If you are allergic to doxazosina, other quinazolines (e.g., prazosin, terazosin), or any of the other ingredients of this medicine (listed in section 6).
• 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 a sitting or lying position.
• If you have benign prostatic hyperplasia and at the same time, an obstruction of the upper urinary tract, chronic urinary tract infection, or stones in the bladder.
• If you have a blockage or narrowing of the digestive tract.
• If you have urinary incontinence due to overflow or do not produce urine with or without an increase in kidney function deterioration.

Warnings and precautions

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

• At the beginning of treatment, you may experience a drop in blood pressure accompanied by dizziness, weakness, and, in rare cases, fainting. Avoid any situation that may lead to injury if these symptoms occur.
• If you have any acute heart disease, such as heart failure.
• If you have any liver disease. In cases of severe liver disease, the use of Doxazosina Neo Teva-ratiopharm is not recommended.
• If you are also taking medications used to treat erection problems (PDE-5 inhibitors, e.g., sildenafil, tadalafil, vardenafil), as they may cause a significant decrease in blood pressure. This is likely to occur shortly after taking the PDE-5 inhibitor. This means that treatment with doxazosina should be established before starting treatment with PDE-5 inhibitors. Your doctor may consider using a lower initial dose of the PDE-5 inhibitor.
• If you are going to undergo eye surgery for cataracts (clouding of the lens), you should inform your ophthalmologist that you are taking or have taken Doxazosina Neo Teva-ratiopharm before surgery. This is because Doxazosina Neo Teva-ratiopharm may cause complications during surgery, which can be treated if this information is communicated to the specialist.

During treatment with doxazosina, prolonged and painful erectionscan occur very rarely. If this happens, consult a doctor urgently.

On occasion, you may observe in your stool something that looks like a tablet. This is normal. The active substance of the prolonged-release tablets is contained in a non-absorbable coating, which is specially designed to release the medicine slowly into the body. When the process is complete, the empty coating is eliminated from the body in the stool.

Consult your doctor or pharmacist if you have any doubts.

Children and adolescents

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

Other medicines and Doxazosina Neo Teva-ratiopharm

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. Inform your doctor specifically if you are taking any of the following medicines:

• Other alpha blockers and other medicines used to treat high blood pressure.
• Medicines called PDE-5 inhibitors for the treatment of erectile dysfunction, e.g., sildenafil, tadalafil, vardenafil (see section “Warnings and precautions”).
• Medicines used to treat bacterial or fungal infections, e.g., clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole.
• Medicines used to treat HIV, e.g., indinavir, nelfinavir, ritonavir, saquinavir.
• Nefazodone, a medicine used to treat depression.

Doxazosina Neo Teva-ratiopharm with food, drinks, and alcohol

Doxazosina Neo Teva-ratiopharm can be taken with or without food.

Pregnancy and breastfeeding

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.

Pregnancy

Do not take Doxazosina Neo Teva-ratiopharm without first talking to your doctor if you are pregnant or trying to become pregnant. The experience related to the use of doxazosina during pregnancy is limited.

Breastfeeding

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

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

Doxazosina Neo Teva-ratiopharm 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 Teva-ratiopharm

Follow the instructions for administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Method of administration

Doxazosina Neo Teva-ratiopharm has been specially formulated so that the release of the active substance is slow throughout the day. Choose a time of day that is convenient for you and always take the tablets at that time. The tablets should be swallowed whole with a sufficient amount of liquid. They should not be chewed, broken, or crushed.

Treatment of high blood pressure and symptoms of benign prostatic hyperplasia:

Adults (including the elderly)

The recommended dose of doxazosina is 4 mg of doxazosina per day, although your doctor may increase the dose to a maximum of 8 mg of doxazosina (one tablet) per day.

The maximum recommended dose is 8 mg of doxazosina once a day. The optimal effect may take up to four weeks to achieve.

Patient with liver problems

Your doctor may reduce the dose or monitor your progress more closely. Doxazosina is not recommended for use in patients with severe liver problems.

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

If you take too many tablets or if, for example, a child has taken the medicine by mistake, call your doctor immediately, go to the hospital emergency department, or call the Toxicology Information Service, telephone: 91 562 04 20. If you have taken too many tablets, you may experience dizziness or dizziness due to low blood pressure. Lie down on your back with your feet raised higher than your head.

If you forget to takeDoxazosina Neo Teva-ratiopharm

If you forget to take a dose, do not worry. Simply take the next day's dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop takingDoxazosina Neo Teva-ratiopharm

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

If you have any other questions about 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 of the side effects could be serious:

If you experience any of the following side effects, stop taking this medicine and inform your doctor immediately or go to the emergency department of the nearest hospital:

• Allergic reactions such as wheezing, difficulty breathing, extreme dizziness or fainting, swelling of the face or throat, or a 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), increased heart rate or irregular heartbeat (affects less than 1 user in 10,000), cardiac arrest or stroke (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).

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

• Palpitations (strong heartbeat), increased heart rate.
• Dizziness, headache, drowsiness.
• Feeling of dizziness or that ‘the head is spinning’.
• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (itching, nasal discharge, and nasal congestion).
• Abdominal discomfort, stomach upset (dyspepsia), dry mouth, nausea.
• Inflammation of the bladder (cystitis), uncontrolled urination.
• Itching of the skin.
• Back pain, muscle pain.
• Respiratory tract infection (infection of the respiratory tract), kidney or bladder infection (urinary tract infection).
• Low blood pressure, sudden drop in blood pressure when standing up.
• Weakness, flu-like symptoms, swelling especially of the feet and lower limbs (edema).

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

• Weight gain.
• Reduced senses, fainting, tremors.
• Ringing in the ears (tinnitus).
• Nosebleeds.
• Constipation, diarrhea, gas, vomiting, stomach and intestine inflammation.
• Painful urination, blood in the urine, increased frequency of urination.
• Skin rash.
• Pain and stiffness in the joints (arthralgia).
• Increased or decreased appetite, gout (a painful form of arthritis).
• Pain, swelling especially of the face (facial edema).
• Increased liver enzyme levels.
• Impotence.
• Anxiety, depression, insomnia.

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

• Obstruction of the digestive tract

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

• Decreased heart rate.
• Decreased levels of certain blood cells (leukopenia, thrombocytopenia).
• Dizziness when standing up, feeling of tingling with numbness.
• Blurred vision.
• Narrowing of the airways with difficulty breathing or wheezing (bronchospasm).
• Urination problems, increased need to urinate at night, increased production and volume of urine.
• Hair loss, unusual bleeding or bruising under the skin, rashes.
• Muscle cramps, muscle weakness.
• Hot flashes.
• Fatigue, general malaise.
• Obstruction of bile excretion from the liver (cholestasis), liver inflammation (hepatitis).
• Enlargement of the breasts in men.
• Prolonged and painful erection of the penis. Consult a doctor urgently.
• Agitation, nervousness.

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

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

Reporting of side effects

If you experience any of the side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System, 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 expiration date that appears on the box and on the blister pack after ‘EXP’. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofDoxazosina Neo Teva-ratiopharm

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

The other ingredients are:

Core of the tablet: polyethylene oxide (PM 900,000), polyethylene oxide (PM 200,000), microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-α-tocopherol, colloidal anhydrous silica, sodium stearyl fumarate.

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

Appearance of the product and pack contents

The tablets are white, round, and biconvex, with the inscription “DH” on one side.

The medicine is packaged in:

• PVC/PVDC/aluminum blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 tablets.
• Calendar packs: 7, 14, 28, 56, and 98 tablets.
• Single-dose packaging: 50 x 1 tablets.

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

This medicine is authorized in the Member States of the European Economic Area under the following names

Germany Doxazosina-ratiopharm 8 mg Retardtabletten

Austria Doxarutis 8 mg Retardtabletten

Spain Doxazosina Neo Teva-ratiopharm 8 mg prolonged-release tablets EFG

Portugal Doxazosina ratiopharm 8 mg prolonged-release tablets

Date of the last revision of this leaflet: August 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.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/74978/P_74978.html

QR code + URL