Prolonged-release tablet 5 mg
(Not provided)(White, round, uncoated tablet with a rounded edge.)
1. What the medicine is and what it is used for
Alfuzosin Hexal belongs to a group of medicines called alpha-1 receptor blockers or alpha-receptor blockers.
Used in the treatment of moderate or severe symptoms caused by an enlarged prostate gland, a condition also known as benign prostatic hyperplasia. The enlarged prostate gland can cause urination problems, such as frequent and difficulty urinating, especially at night. Alpha receptor blockers cause the muscles in the prostate and bladder to relax. This in turn makes it easier to throw water.
Alfuzosin contained in Alfuzosin Hexal may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using this medicine
Do not use this medicine
If you are allergic (hypersensitive) to alfuzosin hydrochloride, other quinoline derivatives (eg terazosin, doxazosin, and prazosin), or any of the other ingredients of Alfuzosin Hexal.
• If you suffer from a sharp drop in your blood pressure when you get up.
• If you have impaired liver function.
• If you are taking other medicines that belong to the group of alpha-receptor blockers.
Warnings and cautions
• if you suffer from severe renal impairment, as the safety of Alfuzosin Hexal has not been established in these patients.
• if you are taking any medicine for high blood pressure. If this is the 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, shown as dizziness, weakness, or sweating within a few hours after taking Alfuzosin Hexal. If you experience a sudden drop in blood pressure, lie down with your legs and feet up in the air until the symptoms have completely disappeared. These symptoms usually last only a short time and occur at the beginning of treatment. Normally, it is not necessary to end the treatment.
• if you have experienced a severe drop in blood pressure or a hypersensitivity (allergic) reaction before taking another medicine belonging to the group alpha-receptor blockers. In this case, your doctor will start treatment with alfuzosin at a low dose and gradually increase the dose.
• if you have acute heart failure.
• If you have angina ( angina pectoris ) and are being treated with a nitrate medicine, this may increase the risk of a drop in blood pressure. Your doctor will decide if he should treat your angina with nitrate medicines or stop the treatment with Alfuzosin Hexal if your angina recurs or gets worse.
• If you are going to have eye surgery due to cataracts (turbidity of the eye lens), inform your eye specialist before the operation that you are using or have used Alfuzosin Hexal. This is because the use of Alfuzosin Hexal can cause complications during the surgery which can be managed if your eye specialist is informed.
• If you suffer from irregular heartbeat known as “prolonged QT interval”.
Swallow the tablets whole. Do not crush, grind, or chew the tablets as the active substance alfuzosin may then be absorbed by your body more quickly. This may increase the risk of side effects.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Alfuzosin Hexal should not be used if you are taking other medicines that belong to the group of alpha-receptor blockers.
Some other medicines may affect or be affected by Alfuzosin Hexal. Some of these drugs are:
Medicines containing ketoconazole or itraconazole (for fungal infections) or ritonavir (for HIV ).
• Medicines used to treat high blood pressure.
Nitrates (for chest pain/angina). Please note that treatment with Alfuzosin Hexal together with medicines for high blood pressure and nitrates for the treatment of, for example, heart disease can lead to low blood pressure.
• Medications given before surgery (general anesthetic). Your blood pressure can drop sharply. If you are going to have an operation, tell your doctor that you are using Alfuzosin Hexal. It is recommended that you stop treatment with Alfuzosin Hexal 24 hours before surgery.
• Medicines that are known to increase the QT interval.
Taking the medicine with food, drink, and alcohol
Alfuzosin Hexal 5 mg can be taken with or without food.
Pregnancy, breastfeeding, and fertility
Alfuzosin Hexal is for the treatment of men only.
Driving and using machines
At the beginning of treatment with Alfuzosin Hexal, you may have feelings of unreality and confusion, dizziness, or weakness. 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.
The medicine contains excipients
Alfuzosin Hexal contains small amounts of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use the medicine
Always take Alfuzosin Hexal exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is 1 prolonged-release tablet (5 mg alfuzosin) twice a day. Take the first dose just before bedtime. Swallow the tablet whole with a sufficient amount of liquid. Do not crush, grind, or divide the tablets.
The usual dose for elderly patients (over 65 years) is 1 prolonged-release tablet (5 mg alfuzosin) once a day. Take the first dose just before bedtime. The dose may need to be increased to twice daily according to the doctor’s prescription.
The usual dose for patients with mild to moderate kidney problems is 1 prolonged-release tablet (5 mg alfuzosin) once a day. Take the first dose just before bedtime.
If you use more medicine than you should
If you have invested large amounts of Alfuzosin Hexal, your blood pressure may drop rapidly and you may feel dizzy and even faint. If you start to feel dizzy, sit, or lie down until you feel better. If the symptoms do not go away, contact your doctor as the drop in blood pressure may need to be treated in the hospital.
If you forget to use the medicine
Do not take a double dose to make up for the forgotten dose as this may cause a sudden drop in blood pressure, especially if you are taking blood pressure-lowering medicines. Then continue taking the next dose at the regular dosing time.
If you stop using the medicine
You should not stop or stop taking Alfuzosin Hexal 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.
4. Possible side effects
Like all medicines, Alfuzosin Hexal can cause side effects, although not everybody gets them.
Assessment of side effects is based on the following frequencies:
Very common: more than 1 in 10 patients treated
Common: more than 1 in 100 and less than 1 in 10 patients treated
Uncommon: more than 1 in 1,000 and less than 1 in 100 patients treated
Rare: more than 1 in 10,000 and less than 1 in 1,000 patients treated
Very rare: less than 1 in 10,000 patients treated including isolated cases
Contact a doctor immediately if you get any of the following symptoms:
• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing
The above symptoms are signs of angioedema, which is a very rare side effect.
Other side effects that can occur with Alfuzosin Hexal are:
Usual:
Headache, dizziness, vertigo ( vertigo ), the severe drop in blood pressure when you get up (especially if the dose is too high at the beginning of treatment and when resuming treatment), abdominal pain, nausea, indigestion, diarrhea, dry mouth, feeling weak, feeling unwell.
Uncommon:
Drowsiness, visual disturbances, rapid heartbeat, fainting (especially at the beginning of treatment), feeling that the heart is beating or pounding hard, runny nose, vomiting, skin rash, hives, itching, urinary incontinence, swelling of ankles and feet, flushing, chest pain.
Very rare:
Exacerbated or recurrent angina pectoris, liver damage, a spasmodic or prolonged erection.
No known frequency:
If you are going to have eye surgery due to cataracts (turbidity of the lens of the eye) and if you are taking or have previously taken Alfuzosin Hexal, the pupil may dilate badly and the iris (the colored part of the eye) may lose its elasticity during the operation. This only occurs during the operation and it is important that the ophthalmologist is aware of this possibility as the operation may need to be performed in another way (see section Take special care with Alfuzosin Hexal).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store the medicine
No special storage instructions.
Keep out of sight and reach of children.
Used before the expiration date specified after the Expiration Date. on the box and EXP on the blister card. The expiration date is the last day of the specified month.
The medicine 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 5 mg of alfuzosin hydrochloride.
The other ingredients are lactose monohydrate, hypromellose (E 464), povidone K 25, magnesium stearate (E 470 b).
What the medicine looks like and the contents of the pack
Alfuzosin Hexal is a white, round, uncoated tablet with a rounded edge.
Pack sizes in blisters:
20, 28, 30, 50, 56, 60, 60×1, 100 and 180 release tablet s
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
HEXAL A / S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
This medicinal product is authorized under the European Economic Area under the names:
Austria: Alfuzosin Hexal 5 mg – Retard tablets
Belgium: Alfuzosin Sandoz 5 mg Controlled-Release Tablets
Hungary: Alfuzosin Sandoz SR 5 mg retard tablets
Slovakia: Alfuzosin Sandoz 5mg tablets with predolzenym uvolnovanim
Spain: Alfuzosina Bexal 5 mg prolonged-release pills