Prospect: information for the patient

Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets EFG

alfuzosin hydrochloride

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

• Keep this prospect 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 prospect. See section 4.

1. What is Alfuzosina Teva-ratiopharm 10 mg and for what it is used

2. What you need to know before starting to take Alfuzosina Teva-ratiopharm 10 mg

3. How to take Alfuzosina Teva-ratiopharm 10 mg

4. Possible adverse effects

5. Storage of Alfuzosina Teva-ratiopharm 10 mg

6. Contents of the package and additional information

This medication belongs to a group of medicines called alpha-blockers.

It is used to treat the functional symptoms of benign prostatic hyperplasia (enlarged prostate). An enlarged prostate can cause urinary problems such as frequent urination and difficulty urinating.

Do not take Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets

• If you are allergic to alfuzosina, another quinazoline (e.g. terazosina, doxazosina) or to any of the other components of this medicine (described in section 6)
• If you have diseases that cause a sudden drop in blood pressure when standing up
• If you are taking other medicines belonging to a group called alpha1-blockers (such as tamsulosina)
• If you have liver disease (liver disease)
• If you have severe kidney disease (severe kidney disease)

Warnings and precautions

Before starting treatment with Alfuzosina Teva-ratiopharm 10 mg, your doctor may perform some tests to rule out the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before treatment and at regular intervals, a rectal examination may be performed and, if necessary, blood tests may be done.

Consult your doctor or pharmacist before starting to take Alfuzosina Teva-ratiopharm 10 mg

• If you have severe kidney problems.
• If you have mild to moderate liver disease, your doctor will prescribe lower doses
• If you are taking other medicines to treat high blood pressure. In this case, your doctor will check your blood pressure regularly, especially at the beginning of treatment.
• If you experience a sudden drop in blood pressure when standing up, characterized by dizziness, weakness or sweating a few hours after taking Alfuzosina Teva-ratiopharm 10 mg. If you experience a sudden drop in blood pressure, lie down with your legs and feet up until the symptoms have disappeared.

Normally, these effects only last a short time and occur at the beginning of treatment.

Normally, it is not necessary to interrupt treatment.

• If you have experienced a sudden drop in blood pressure in the past after taking another medicine belonging to the group of alpha-blockers. In this case, your doctor will start treatment with alfuzosina at low doses and gradually increase the dose.
• If you have acute heart failure.
• If you have chest pain (angina) and are being treated with a nitrate, as this may increase the risk of a drop in blood pressure. You should consult your doctor if you need to continue or interrupt your treatment with Alfuzosina Teva-ratiopharm 10 mg, especially when chest pain reappears or worsens.
• If you have an abnormal heart rhythm called prolonged QTc (long QT) or are taking medicines that may increase the risk of prolonged QTc.

Consult your doctor if you suffer from this disease or are taking other medicines.

• If you are an elderly patient (over 65 years old). This is due to the increased risk of developing a drop in blood pressure (hypotension) and related adverse effects in elderly patients.

Alfuzosina, like other medicines in the same family, may cause priapism (persistent and painful erection of the penis). If this happens, go immediately to an emergency service to be treated.

Consult your doctor or pharmacist even if any of the circumstances mentioned above have occurred at any time.

Surgery while taking Alfuzosina

• If you are to undergo surgery, which requires general anesthesia, you must inform the anesthetist before the operation that you are taking Alfuzosina Teva-ratiopharm (See section “Other medicines and Alfuzosina Teva-ratiopharm”)
• If you are to undergo eye surgery due to cataract surgery (clouding of the lens), please inform your ophthalmologist before the operation that you have been using Alfuzosina Teva-ratiopharm. This is because treatment with Alfuzosina Teva-ratiopharm may cause complications during the operation that can be controlled if your specialist has been previously warned.

Other medicines and Alfuzosina Teva-ratiopharm

Inform your doctor or pharmacist if you are taking, have taken recently other medicines or may need to take any other medicine, even those purchased without a prescription.

Certain medicines, such as those listed below, may increase the risk of hypotension (drop in blood pressure) when taken at the same time as Alfuzosina Teva-ratiopharm.

Medicines that should not be used:

• Medicines that belong to the group of alpha-blockers: do not take these medicines at the same time as Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets (see above “Do not take Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets”)

Medicines that should be taken with caution:

• Blood pressure-lowering medicines (medicines that lower blood pressure)
• Nitrates (medicines for the treatment of angina)
• Medicines for fungal infections (such as itraconazole or ketoconazole)
• Medicines for HIV (HIV virus) (such as ritonavir)
• Medicines for bacterial infections (antibiotics such as clarithromycin, erythromycin and telithromycin)
• Medicines for the treatment of depression (such as nefazodone)

In addition, the administration of general anesthetics to patients treated with alfuzosina may cause instability of blood pressure, so, in the event of surgical intervention, you should inform the anesthetist of the use of Alfuzosina Teva-ratiopharm.

Alfuzosina Teva-ratiopharm 10 mg with food and drinks

The tablets should be taken after a meal.

Pregnancy and Breastfeeding

Alfuzosina Teva-ratiopharm 10 mg is only indicated for men.

Driving and operating machinery

At the beginning of treatment with Alfuzosina Teva-ratiopharm 10 mg, you may feel dizzy, lightheaded or weak. Do not drive or operate machinery or perform any hazardous task until you know how you respond to treatment.

Alfuzosina Teva-ratiopharm 10 mg contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Followexactly the administration instructions for this medication as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

AdultsThe recommended dose is one prolonged-release tablet (10 mg of alfuzosin) once a day, which is the maximum daily dose. Take the first tablet at bedtime. Take the tablets after the same meal every day and swallow them whole with a sufficient amount of liquid. Do not crush, chew, or divide the tablets.

Older patients

No dosage adjustment is required for elderly patients (over 65 years old).

Renal insufficiency

In patients with mild or moderate renal insufficiency, it is recommended to start treatment with a lower dose, which can be increased to 10 mg based on clinical response.

In patients with severe renal insufficiency, it is recommended not to use Alfuzosin Teva-ratiopharm 10 mg because there are no clinical safety data to support the safety of the medication in this patient group.

Use in children and adolescents

The efficacy of alfuzosin in children or adolescents from 2 to 16 years has not been demonstrated. Therefore, alfuzosin is not indicated in this patient group.

If you take more Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets than you should:If you take large amounts of Alfuzosin Teva-ratiopharm 10 mg, your blood pressure may drop suddenly and you may feel dizzy or even faint. If you start to feel dizzy, sit or lie down until you feel better. If symptoms do not improve, call your doctor as blood pressure drop may require hospital treatment.

Contact your doctor, pharmacist, or call the Toxicology Information Service, Phone: 91-562 04 20, indicating the medication and the amount taken.

If you forgot to take Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets:Do not take a double dose to make up for the missed dose, as this may cause a sudden drop in blood pressure, especially if you are taking blood pressure-lowering medications. Take the next tablet as instructed.

If you interrupt treatment with Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets

You should not interrupt or stop taking Alfuzosin Teva-ratiopharm 10 mg without first 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:

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

• Dizziness/dizziness, headaches, vertigo;
• Orthostatic hypotension (drop in blood pressure when changing from lying down to standing, especially at the start of treatment with a too-high dose or when treatment is resumed) (see section 2 “Warnings and precautions);
• Digestive problems such as nausea, abdominal pain, diarrhea, dry mouth;
• Feeling weak, discomfort.

Less frequent (may affect up to 1 in 100 people):

• Syncope (loss of consciousness)
• Drowsiness
• Visual disturbances;

• Fast heart rate, palpitations (the heart beats faster than normal and is also more noticeable);
• Hot flashes
• Rhinitis
• Being sick (vomiting)
• skin disorders such as skin rash or itching, pruritus;
• Edema (swelling), chest pain (see section 2 “Warnings and precautions”.

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

• Worsening or recurrence of chest pain (angina pectoris), in patients with coronary heart disease (see section 2 “Warnings and precautions”).
• Angioedema (swelling of the face, lips, tongue, and/or throat), urticaria.
• skin disorders such as urticaria

Frequency not known (cannot be estimated from available data):

• Reduction in the number of white blood cells (neutropenia), which may lead to more frequent infections than usual;
• Decrease in the number of platelets (thrombocytopenia)
• Stroke in patients with problems with blood circulation in the brain.
• Intraoperative floppy iris syndrome (IFIS) (characterized by pupil constriction and iris deformation).
• Abnormal heart rhythm (atrial fibrillation);
• Liver problems: signs may include yellow skin or the white part of the eyes;
• Abnormal and often painful erection of the penis not related to sexual activity (priapism).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website: 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 or blister after CAD. The expiration date is the last day of the month indicated.

Keep the blister in the original packaging to protect it from light.

Store below 30°C.

For HDPE bottles:

The product's expiration date after the first opening is 1 year, but not later than the expiration date included in the case or blister after CAD.

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

Composition of Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets

The active ingredient is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.

• The other components are lactose monohydrate, hypromellose (E464), povidone K25, and magnesium stearate.

Appearance of Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets and content of the container

Alfuzosina Teva-ratiopharm 10 mg is a prolonged-release round, white tablet in

blister packs (PVC/PVDC/aluminum) of 10, 28, 30, 50, 90, or 100 tablets per container, or bottles (HDPE) of 100 tablets per container. All container sizes may not be marketed.

Holder of the Marketing Authorization

Teva Pharma S.L.U.

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

28108 Alcobendas (Madrid)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle Str. 3

89143 Blaubeuren / Germany

This medicine is registered in the Member States of the EEA with the following names

Estonia: ALFUZOSIN-TEVA

Latvia: Alfuzosin-Teva 10 mg prolonged-action tablets

Lithuania: Alfuzosin-Teva 10 mg prolonged-release tablets

Portugal: Alfuzosina Teva 10 mg prolonged-release tablet

Spain: Alfuzosina Teva 10 mg prolonged-release tablets EFG

United Kingdom: Fuzatal XL 10mg prolonged-release tablets

This leaflet was revised in September 2022

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