10 mg prolonged-release tablets. 
alfuzosin hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this product information. See section 4.

In this leaflet: 
1. What Alfuzosin Teva is and what it is used for 
2. What you need to know before you take Alfuzosin Teva 
3. How to take Alfuzosin Teva 
4. Possible side effects 
5. How to store Alfuzosin Teva 
6. Contents of the packaging and other information 

1. What Alfuzosin Teva is and what it is used for

Alfuzosin Teva belongs to a group of medicines called adrenergic alpha-receptor blockers or alpha-receptor blockers. It is used to treat moderate to severe symptoms from an enlarged prostate, in other words, benign growth of the prostate. An enlarged prostate can cause urination problems such as a frequent need to urinate and difficulty urinating, especially at night. The alpha receptor blockers relax the muscles in the prostate, bladder, and urethra, which improves urine flow from the bladder.

Alfuzosin contained in Alfuzosin Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Alfuzosin Teva

Do not use Alfuzosin Teva

  • if you are allergic to alfuzosin, other quinazolines (eg terazosin, doxazosin ), or any of the other ingredients of this medicine (listed in section 6).
  • if you suffer from a condition that can cause a noticeable drop in blood pressure when you get up.
  • if you have liver problems.
  • if you are taking other medicines that belong to the group of alpha-receptor blockers.

Warnings and cautions

Talk to your doctor or pharmacist before taking Alfuzosin Teva

  • if you have severe renal impairment
  • if you are taking other medicines to treat high blood pressure. In this case, your doctor will regularly check your blood pressure, especially at the beginning of treatment.
  • if you experience a sudden drop in blood pressure when you get up which manifests itself as dizziness, feeling weak, or sweating within a few hours after taking Alfuzosin Teva. If you get a drop in blood pressure, lie down with your legs in an elevated position until the symptoms have passed. These effects are usually short-lived and occur at the beginning of treatment. Treatment usually does not need to be stopped.
  • if you have previously experienced noticeable drops in blood pressure in connection with the use of any other medicine from the group alpha-receptor blockers. In such cases, your doctor will start the alfuzosin treatment with a low dose that is gradually increased.
  • if you suffer from acute heart failure.
  • if you have angina ( angina pectoris ) and are being treated with a nitrate medicine as this may increase the risk of a drop in blood pressure. You should discuss with your doctor whether you should continue treatment for angina or discontinue the use of Alfuzosin Teva, especially if angina recurs or gets worse.
  • if you are known to have a deviation from your heart activity, so-called QTprolongation (seen on an ECG ), or if you are taking medicines before or during treatment with Alfuzosin Teva that may also lead to QT prolongation.
  • If you already have risk factors (such as underlying heart disease and/or concomitant treatment with antihypertensive drugs) as these have been reported to cause a drop in blood pressure
  • If you are over 65 years old. This is due to the increased risk of developing low blood pressure ( hypotension ) and related side effects in elderly patients.
  • if you are going to undergo eye surgery due to cataracts (turbidity of the lens of the eye), inform your eye specialist before the operation that you are using or have used Alfuzosin Teva. This is because the use of Alfuzosin Teva can cause complications during the surgery which can be managed if your specialist is informed.

The tablets should be swallowed whole. Do not crush, split, or chew the tablets as too much of the active substance alfuzosin may be absorbed too quickly into your body. This may increase the risk of side effects.

Other medicines and Alfuzosin Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Alfuzosin should not be used if you are taking other medicines that belong to the alpha-receptor blocker group.

Alfuzosin Teva may affect or be affected by certain other medicines. Such medications are:

  • antihypertensive drugs (see section 2 “Warnings and Precautions”).
  • medicines (nitrates) for the treatment of angina pectoris (see section 2 “Warnings and precautions”).
  • concomitant use of Alfuzosin Teva 10 mg and medications used to treat high blood pressure and nitrates used e.g. for the treatment of heart disease can lead to low blood pressure.
  • ketoconazole and itraconazole (medicines used to treat fungal infections) and ritonavir (medicines used to treat HIV ).
  • medications are given before surgery (general anesthetic). Your blood pressure can drop dramatically. If you are going to have an operation, tell your doctor that you are using Alfuzosin Teva.

Alfuzosin Teva with food and drink

Alfuzosin Teva 10 mg should be taken after a meal.

Pregnancy and breastfeeding

This information is not relevant as the medicine is only prescribed for men.

Driving and using machines

At the beginning of treatment with Alfuzosin Teva, you may feel dizzy, confused, or weak. Do not drive, use machines, or perform tasks that could give rise to dangerous situations before you know how your body reacts to the treatment.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Alfuzosin Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before using this medicine.

How to take Alfuzosin Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is 1 prolonged-release tablet (10 mg alfuzosin) once daily. Take the first tablet at bedtime. Take the tablets immediately after the same meal each day and swallow them whole with a sufficient amount of liquid. Do not crush, chew, or divide the tablets.

The recommended dose for elderly patients (over 65 years) is 1 prolonged-release tablet (10 mg alfuzosin) once daily

The recommended dose for patients with mild to moderate kidney disease is 1 prolonged-release tablet (10 mg alfuzosin) once daily.

Children and adolescents 
Alfuzosin Teva is not recommended for use in children and adolescents.

If you take more Alfuzosin Teva than you should

If you have taken too large a dose of Alfuzosin Teva, your blood pressure suddenly drops and you may experience symptoms such as dizziness or fainting. If you feel dizzy, sit or lie down until you feel better. If the symptoms do not go away, consult a doctor as the drop in blood pressure may require hospitalization.

If you forget to take Alfuzosin Teva

Do not take a double dose to make up for a forgotten tablet as it may cause a sudden drop in blood pressure, especially if you are taking antihypertensive medicines. Take the following tablet normally according to the dosing instructions.

If you stop taking Alfuzosin Teva

You should not stop or stop taking Alfuzosin Teva medication without first talking to your doctor. If you want to stop taking this medicine or if you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people) 
Dizziness, tiredness, dizziness, headache, vertigo ( vertigo ), stomach pain, nausea, indigestion, diarrhea, dry mouth, feeling weak and unwell.

Uncommon (may affect up to 1 in 100 people) 
Drowsiness, visual impairment, palpitations, fainting (especially at the beginning of treatment), a sharp drop in blood pressure when you get up to standing (especially if you start treatment with too high a dose or when resuming treatment), feeling that the heart is beating or pounding hard, runny nose, skin side effects (hives, rash), itching, incontinence, swelling of the ankles and feet ( edema ), flushing, chest pain.

Very rare side effects are (may affect up to 1 in 10 000 people) 
Worsening or recurrence of chest pain ( angina ) (see section 2 “warnings and precautions”), swelling of the skin and mucous membranes, especially in the face and around the mouth (angioedema), persistent and painful erection.

No known frequency (frequency cannot be estimated from the available data) 
Changes in the number of certain white blood cells ( neutropenia ), life-threatening irregular heartbeat ( atrial fibrillation ), vomiting, liver damage, impaired bile flow.

If you are going to have eye surgery due to cataracts and if you are taking or have previously taken Alfuzosin Teva, it may cause problems during the operation (see section 2 “Warnings and precautions”).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Alfuzosin Teva

Do not store above 30 ° C.

Keep out of sight and reach of children.

Used before the expiration date specified as EXP. on the blister pack and on the outer pack. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is alfuzosin hydrochloride. One prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
  • The other ingredients are lactose monohydrate, hypromellose (E464), povidone K25, and magnesium stearate (E470b).

What the medicine looks like and the contents of the pack

Alfuzosin Teva 10 mg prolonged-release tablet s is white, round non -coated tablets with beveled edges.

The medicine is available in PVC / PVDC aluminum blister packs of pack sizes of 10, 10×1, 15, 20, 30, 30×1, 50, 60, 60×1, 90, 90×1 and 100 tablets and in HDPE plastic cans of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

Muhammad Nadeem

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