Doxazosina neo ratiopharm 8 mg comprimidos de liberacion prolongada efg

Package Insert: Information for the User

Doxazosina Neo ratiopharm 8mg prolonged-release tablets EFG

doxazosina

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Your doctor may have prescribed Doxazosina Neo ratiopharm because you have high blood pressure and it may increase your risk of suffering from heart disease or a stroke if left untreated. The active ingredient in the tablets, doxazosina, belongs to a group of medicines called alpha 1 antagonists. These medicines work by widening blood vessels, making it easier for the heart to pump blood through them. This helps to lower high blood pressure and reduce the risk of heart disease.

It is also possible that you have been prescribed Doxazosina Neo ratiopharm to treat the symptoms of benign prostatic hyperplasia (BPH). This condition means that the prostate, which is located just below the bladder in men, is enlarged. This makes it difficult to empty the bladder. Doxazosina Neo ratiopharm works by relaxing the muscles around the exit of the bladder and the prostate gland, making it easier to empty the bladder.

The doxazosina in Doxazosina Neo ratiopharm may also be authorized to treat other conditions not listed in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any other questions and always follow their instructions.

Do not takeDoxazosina Neo ratiopharm

• If you are allergic to doxazosina, other quinazolines (for example, prazosina, terazosina), or any of the other components of this medication (listed in section 6).
• If you have low blood pressure or if you have ever had a drop in blood pressure that caused dizziness or fainting when standing up while sitting or lying down.
• If you have benign prostatic hyperplasia and, at the same time, an obstruction of the upper urinary tract, chronic urinary tract infection, or bladder stones.
• If you have or have had an obstruction 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 renal function deterioration.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxazosina Neo 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 ratiopharm is not recommended.
• If, in addition, you are taking medications used to treat erectile dysfunction (PDE-5 inhibitors, e.g., sildenafilo, tadalafilo, vardenafilo), 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 doxazosina treatment should be stable before starting PDE-5 inhibitor treatment. Your doctor may consider using a lower initial dose of the PDE-5 inhibitor.
• If you are to undergo eye surgery for cataracts (opacity of the crystalline lens), you should inform your ophthalmologist that you are taking or have taken Doxazosina Neo ratiopharm beforehand. This is because Doxazosina Neo ratiopharm may cause complications during surgery, which can be treated if this information is communicated to the specialist.

Prolonged and painful erections during treatment with doxazosinamay occur with very low frequency. If this happens, consult a doctor urgently.

You may occasionally observe something in the stool that resembles a tablet. This is normal. The active ingredient of the prolonged-release tablets is contained in a non-absorbable coating, which is specifically designed to slowly release the medication in 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 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 medications and Doxazosina Neo ratiopharm

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription. Inform your doctor in particular if you are taking any of the following medications:

• Other alpha blockers and other medications used to treat high blood pressure.
• Medications called PDE-5 inhibitors for the treatment of erectile dysfunction, e.g., sildenafilo, tadalafilo, vardenafil (see section “Warnings and precautions”).
• 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, drinks, and alcohol

Doxazosina Neo ratiopharm can be taken with or without food.

Pregnancy and breastfeeding

Only for the indication of hypertension:

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

Pregnancy

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

Breastfeeding

Small amounts of doxazosina, the active ingredient of 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

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

Doxazosina ratiopharm contains sodium

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

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

Administration Form

Doxazosina Neo ratiopharm has been specially formulated to provide slow release of the active ingredient throughout the day. Choose a time of day that is convenient for you and take the tablets at the same time every day. The tablets should be swallowed whole with sufficient liquid. They should not be chewed, broken, or crushed.

Treatment of High Blood Pressure and Symptoms of Benign Prostatic Hyperplasia:

Adults (including elderly)

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

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

Patients with Liver Problems

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

If You Take More Doxazosina Neo ratiopharm Than You Should

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

If You Forget to TakeDoxazosina Neo ratiopharm

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

If You Interrupt Treatment withDoxazosina Neo ratiopharm

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

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.

Some side effects could be serious:

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

• Allergic reactions such as wheezing, difficulty breathing, extreme dizziness or fainting, swelling of the face or throat, or a severe skin rash with red patches or blisters (may affect up to 1 in 100 people).

• Chest pain (angina; may affect up to 1 in 100 people), increased heart rate or irregular heartbeat (affects fewer than 1 in 10,000 users), cardiac arrest or stroke (may affect up to 1 in 100 people).

• Yellowing of the skin or the white 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 heartbeat), increased heart rate.
• Dizziness, headache, drowsiness.
• Sensation of dizziness or feeling like 'the head is spinning'.
• Inflammation of the respiratory tract (bronchitis), cough, difficulty breathing (dyspnea), rhinitis (itching, nasal discharge, and nasal congestion).
• Abdominal discomfort, stomach discomfort (dyspepsia), dry mouth, nausea.
• Inflammation of the bladder (cystitis), uncontrolled urination.
• Skin itching.
• Back pain, muscle pain.
• Pulmonary infection (respiratory tract infection), urinary tract infection or kidney 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 extremities (edema).

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

• Weight gain.
• Reduced senses, fainting, tremors.
• Tinnitus (ringing in the ears).
• Nasal bleeding.
• Constipation, diarrhea, gas, vomiting, inflammation of the stomach and intestines.
• Painful urination, blood in the urine, increased frequency of urination.
• Skin rash.
• Joint pain and stiffness (arthralgia).
• Increased or decreased appetite, gout (painful form of arthritis).
• Pain, swelling, especially of the face (facial edema).
• Increased liver enzyme concentration.
• 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 concentration of certain blood cells (leucopenia, thrombocytopenia).
• Dizziness when standing up, sensation of numbness with tingling.
• Blurred vision.
• Constriction of the respiratory tract with difficulty breathing or wheezing (bronchospasm).
• Difficulty urinating, increased need to urinate at night, increased production and volume of urine.
• Hair loss, unusual bleeding or hematomas under the skin, rashes.
• Muscle cramps, muscle weakness.
• Hot flashes.
• Fatigue, general malaise.
• Bile duct obstruction from the liver (cholestasis), liver inflammation (hepatitis).
• Enlargement of the breasts in men.
• Persistent and painful erection of the penis. Consult a doctor urgently.
• Agitation, nervousness.

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

• Complications (Intraoperative Flaccid Iris Syndrome) during cataract surgery (see section 2: "Warnings and precautions").
• Delayed ejaculation – occurs when semen is redirected to the urinary bladder instead of the normal ejaculation through the urethra.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for the 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 box and on the blister after ‘CAD’. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDoxazosina Neo ratiopharm

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

The other components are:

Tablet core: polyethylene oxide (PM 900.000), polyethylene oxide (PM 200.000), microcrystalline cellulose, povidone (K29-32), butylhydroxytoluene (E321), all-rac-α-tocopherol, anhydrous colloidal silica, sodium stearate fumarate.

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

Appearance of the product and contents of the package

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

The medication is packaged in:

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

Only some package 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)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

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

GermanyDoxazosina-ratiopharm 8 mg Retardtabletten

AustriaDoxarutis 8 mg Retardtabletten

SpainDoxazosina Neo ratiopharm 8mg prolonged-release tablets EFG

PortugalDoxazosina ratiopharm 8 mg prolonged-release tablets

Last review date of this leaflet: August 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/