10 mg prolonged-release tablet is
alfuzosin hydrochloride. For adult men

What Lafunomyl is and what it is used for

Lafunomyl contains the active substance alfuzosin, which 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. The prostate gland is located below the bladder. It surrounds the urethra, which transports your urine out of the body. If the prostate is enlarged, it presses on the urethra and makes it smaller. 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 the flow of urine from the bladder.

In a few patients with benign prostatic hyperplasia, the prostate gland becomes so large that it stops the flow of urine completely. It is called acute urinary retention. This is very painful and you may need to see a hospital. A thin flexible tube ( catheter ) is inserted into the bladder. It empties the urine and relieves the pain. Lafunomyl can be used to help the urine pass again.

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

What you need to know before you take Lafunomyl

Do not use Lafunomyl

  • if you are allergic to alfuzosin, other quinazoline medicines (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 (your doctor may have said that this is called “postural” or “orthostatic” hypotension ). This can make you dizzy.
  • if you have liver problems.
  • if you are taking other medicines that belong to a group called alpha-receptor blockers (see section “Other medicines and Lafunomyl” below).

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Lafunomyl.

Warnings and cautions

Talk to your doctor or pharmacist before taking Lafunomyl:

  • if you have severe kidney problems.
  • if you are taking 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 have previously experienced noticeable drops in blood pressure associated with the use of any other medicine from the group called alpha-receptor blockers. In such cases, your doctor will start alfuzosin treatment with a low dose that is gradually increased.
  • if you suffer from heart failure (a weakening of the heart muscle), or other heart problems
  • if you have or have had problems with decreased blood flow to parts of the brain (cerebral circulatory disorders)
  • if you have angina ( angina pectoris ) and are being treated with a nitrate medicine. Using nitrate medicines and alfuzosin at the same time may increase the risk of a drop in blood pressure. Your doctor may stop treatment with alfuzosin if the angina recurs or worsens.
  • if you have been congenital, or have had any condition associated with an abnormal heart rhythm (which may have been seen on an ECG that examines the electronic activity of the heart) or if you are taking medicines that are known to affect your heart rhythm.

When you take this medicine, you may experience a sudden drop in blood pressure when you get up (you may feel dizzy, tired, weak, or sweaty), especially in the first hours after taking it. If this happens, lie down with your legs and feet up in the air until the symptoms have disappeared. These effects usually last only a short time and occur at the beginning of treatment. Normally, it is not necessary to discontinue treatment. Tell your doctor as dose one may need to be adjusted.

In case of erection (often painful), which is not related to sexual activity and which lasts longer than 4 hours, you should contact a doctor or go to the hospital immediately as you may need treatment. See the section below “Possible side effects”.

If you need to undergo eye surgery due to cataracts (turbidity of the lens of the eye), inform your eye specialist before the operation that you are taking or have previously taken Lafunomyl. This is because Lafunomyl can cause complications during surgery, which can be managed if your specialist is informed.

Children and young people

Lafunomyl is not recommended for use in children and adolescents (patients under 16 years of age).

Other medicines and Lafunomyl

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Do not take Lafunomyl if you are taking other medicines that belong to a group called alpha-blockers, such as doxazosin, indoleamine, terazosin, prazosin, or tamsulosin.

Lafunomyl may affect or be affected by certain other medicines. Talk to your doctor or pharmacist if you are taking any of the following:

  • medicines for fungal infections (such as ketoconazole , itraconazole)
  • medicines used to treat HIV (such as ritonavir)
  • drugs against bacterial infections (such as clarithromycin, telithromycin)
  • antidepressants (such as nefazodone)
  • blood pressure lowering medications
  • medicines for chest pain (angina)
  • drugs commonly used to treat impotence ( erectile dysfunction )
  • Concomitant use of Lafunomyl and medicines used to treat high blood pressure , or nitrates used to treat heart problems such as chest pain (angina) or medicines to treat impotence , can lead to low blood pressure . If this happens, you should lie down until the symptoms have completely disappeared. Contact your doctor as the dose of one of your medicines may need to be changed.

If you are going to have an operation and need to be anesthetized, tell your doctor or hospital staff that you are taking this medicine. Your doctor may recommend that you stop taking this medicine 24 hours before the operation, to prevent the risk of changes in blood pressure.

Pregnancy and breastfeeding

Lafunomyl is only indicated for use in men.

Lafunomyl with food and drink

Take Lafunomyl after a meal.

Driving and using machines

Especially at the beginning of treatment with Lafunomyl, you may feel dizzy, dizzy, 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 sharpened attention. 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.

Lafunomyl contains lactose

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

How to use Lafunomyl

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

Dosage

Benign prostate enlargement

  • The recommended dose is one tablet (10 mg alfuzosin) once daily.
  • Take the tablet after supper.

Acute urinary retention

  • Lafunomyl will be given to you by your doctor on the same day as the catheter is inserted.
  • You should continue to take Lafunomyl once daily after a meal. Follow the doctor’s instructions on the prescription.

Swallow the tablets whole with a sufficient amount of liquid. Do not crush, grind or divide 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.

If you have kidney problems

If you have mild to moderate kidney disease, your doctor may recommend that you start with a lower dose, to begin with. If a lower dose does not work for you, they may recommend that you take a prolonged-release tablet (10 mg alfuzosin) once a day. Take the tablet after supper.

If you take more Lafunomyl than you should

If you take too large a dose of Lafunomyl, 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. Do not try to drive to the hospital yourself.

If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center (tel. 112) for risk assessment and advice.

If you forget to take Lafunomyl

Do not take a double dose to make up for a forgotten tablet as it may cause a sudden drop in blood pressure. Take the following tablet normally according to the dosing instructions.

If you stop taking Lafunomyl

You should not stop or stop taking Lafunomyl medication without talking to your doctor first. 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.

Use for children

Lafunomyl is not indicated for use in children.

Possible side effects

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

If you notice any of the following side effects, stop taking this medicine and contact your doctor or go to the nearest emergency room immediately:

  • Deterioration or onset of angina ( angina pectoris ). Normally this only happens if you have had angina before.
  • Red and raised rash ( hives ), swelling of the eyelids, face, lips, mouth or tongue, difficulty breathing or swallowing. These are symptoms of severe allergic reactions.
  • Increased number of infections (eg sore throat, cold sores, etc. and fever) that you can get. This may be a sign of a decrease in the number of white blood cells .
  • An unusual or abnormal heart rhythm – you may notice a very fast or irregular heart rhythm, which may make you feel short of breath, dizzy or faint
  • Liver problems, which may be due to a blockage in the bile duct. You may feel nauseous, notice loss of appetite, light stools, dark urine or yellowing of the skin or whites of the eyes.
  • Sudden collapse, numbness or weakness in the arms or legs, dizziness and confusion, visual disturbances, difficulty swallowing, slurred speech or inability to speak (these may be signs of stroke or ministroke caused by altered blood flow to parts of the brain). This is more likely in patients with previous problems with blood supply to the brain.
  • Persistent erection (priapism). Priapism is an abnormal, often painful, persistent erection of the penis that is not related to sexual activity. If you get an erection like the one described here and which lasts longer than 4 hours, contact a doctor or go to the hospital immediately as you may need treatment. This condition can lead to permanent impotence if not treated properly.

Other possible side effects are

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

Fatigue, dizziness, headache, lethargy, stomach pain, nausea, indigestion, general feeling of weakness, general malaise.

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

Drowsiness, visual impairment/eye problems, palpitations, fainting (especially if treatment is started with too high a dose or when treatment is resumed), feeling of heart beating or pounding hard, dry mouth, runny nose, rash, itching, urinary incontinence, fluid retention (ie swelling of ankles and feet), redness of the face or body (hot flashes), sweating, dizziness ( vertigo ), nausea (vomiting), diarrhea, sharp drop in blood pressure when you get up to stand (especially if the treatment starts with too high a dose or when the treatment resumed).

Has been reported (occurs in an unknown number of users):

A painful or prolonged erection (priapism), unexplained bruising, or bleeding (this may be a sign of a reduced number of platelets in the blood, which helps the blood to clot).

If you are going to have eye surgery due to cataracts (when the eye’s lens is cloudy) and have already taken or have taken Lafunomyl before, the pupil may dilate badly and the iris (the colored part of the eye) may become flabby during the operation. This only happens during the operation and the ophthalmologist must be aware of this as the operation may be performed differently (see “Warnings and Precautions”).

How to store Lafunomyl

Do not store above 30 ° C.

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

Do not use this medicine after the expiry date which is stated on the blister and the outer carton after EXP. 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.

Contents of the pack 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, povidone K25 and magnesium stearate.

What the medicine looks like and contents of the pack

Lafunomyl is white, round, beveled, and uncoated tablets.

They are packed in blister packs of 10, 20, 30, 30 x 1, 50, 60, 60 x 1, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK

McDermott Laboratories Ltd. t / a Gerard Laboratories, Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft, Mylan utca 1, H-2900 Komarom, Hungary

Muhammad Nadeem

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