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 information, 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 information. See section 4.

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

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

Alfuzosin Orion belongs to a group of medicines called alpha-1 blockers. Alfuzosin is used to treat moderate to severe symptoms of benign prostatic hyperplasia. This is a condition in which the prostate gland is enlarged ( hyperplasia ), but the growth itself is not the same as cancer (it is benign). This is more common in older men.

The prostate gland is located below the bladder, around the urethra (the tube that takes your urine to the outside of the body). With age, the prostate gland can grow and press on the urethra so that it becomes narrower. This can cause problems with urination, such as frequent urination and difficulty urinating.

Alfuzosin relaxes the muscles in the prostate gland. This reduces the narrowing of the urethra and makes it easier to empty the bladder.

You need to talk to a doctor if you do not feel better or if you feel worse.

Alfuzosin hydrochloride contained in Alfuzosin Orion 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.

What you need to know before you take Alfuzosin Orion

Do not take Alfuzosin Orion

  • If you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include rash, swelling of the lips, throat, or tongue, difficulty swallowing or breathing.
  • If you have or have previously had, low blood pressure when standing up from a sitting or lying position (the medical term for this is orthostatic hypotension ). It can make you feel dizzy, dizzy, or faint when you stand or sit up quickly.
  • If you have liver problems
  • If you are already taking another alpha-1 blocker (such as terazosin, doxazosin ). See the section below “Other medicines and Alfuzosin Orion”. If you are not sure, talk to your doctor or pharmacist. 

Warnings and cautions

Talk to your doctor or pharmacist before taking this medicine if:

  • you have severe kidney problems
  • you have heart disease.
  • you have chest pain (angina).
  • it is known that you have an abnormality on the electrocardiogram ( ECG ), so-called QT prolongation.

Some patients, especially those who are also taking medicines for high blood pressure or medicines for chest pain (angina), may experience dizziness, weakness, or sweating within a few hours after taking a dose. If this happens, you should lie down until the symptoms have completely disappeared. Tell your doctor as dose one may need to be adjusted.

Other medicines and Alfuzosin Orion

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 use Alfuzosin Orion if you are taking:

  • other alpha-blockers such as doxazosin , indoramine, prazosin, terazosin, tamsulosin or phenoxybenzamine.

Talk to your doctor or pharmacist before taking your medicine if:

  • you have previously experienced a sharp drop in blood pressure while taking other alpha-blockers (this may include previous use of alfuzosin). See the section directly above this for examples of other alpha-blockers.
  • you are taking any blood pressure-lowering medicine as you may experience dizziness, weakness, or sweating within a few hours of taking this medicine. 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.
  • you are taking medicines for chest pain (angina).
  • you are taking medicines for fungal infections (such as ketoconazole, itraconazole).
  • you are taking medicines for HIV (such as ritonavir).
  • you are taking medicines for bacterial infection (such as clarithromycin, telithromycin).
  • you are taking medicines to treat depression (such as nefazodone).

Operations while taking Alfuzosin Orion

  • If you are going to have an operation that requires anesthesia (anesthesia), tell your doctor before the operation that you are taking Alfuzosin Orion. This is because it can be dangerous as the drug can lower your blood pressure.
  • If you are going to have eye surgery due to cataracts (turbidity of the lens of the eye), you should inform your eye specialist before the operation that you are taking or have taken Alfuzosin Orion. This is because the use of Alfuzosin Orion can cause complications during the surgery which can be managed if your specialist is informed.

Driving and using machines

You may feel dizzy and weak when you take Alfuzosin Orion. If this happens, do not drive or use any tools or machines.

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.

3. How to use Alfuzosin Orion

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

  • Swallow the tablets with plenty of liquid (for example, a glass of water).
  • The tablets should not be crushed, divided, or chewed. This can affect the release of one of the drugs in the body.
  • Take this medicine just before bedtime.

Adults

The recommended dose is 10 mg once a day.

Elderly patients (> 65 years)

The recommended dose is 10 mg once a day. Dose one does not need to be adjusted for elderly patients (over 65 years of age).

Patients with mild to moderate kidney problems

The recommended dose is 10 mg once a day. Dose one does not need to be adjusted for mild to moderate kidney problems.

If you have the impression that Alfuzosin Orion is too strong or too weak, talk to your doctor or pharmacist.

Use in children

Alfuzosin Orion is not recommended for use in children (16 years or younger).

If you forget to take Alfuzosin Orion

Do not take a double dose to make up for a forgotten tablet. Skip it and then continue as usual

If you stop using Alfuzosin Orion

Keep taking the tablets even if the symptoms improve. Stop only if your doctor tells you to. The symptoms are better controlled if you continue to take the same dose of medicine.

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. These side effects usually occur at the beginning of treatment.

Stop taking the tablets and contact a doctor or go to the hospital immediately if you experience any of the following serious side effects:

  • Chest pain (angina) (may affect up to 1 in 10,000 people.)Normally this only happens if you have had angina before.
  • Severe allergic reactions (may affect up to 1 in 10,000 people.)You may experience symptoms of angioedema, such as red and lumpy skin rash, swelling (of eyelids, face, lips, mouth, and tongue), difficulty breathing or swallowing.

Other side effects include:

Common (may affect up to 1 in 10 people)

  • Dizziness
  • Headache
  • General malaise (nausea)
  • The feeling of discomfort in the stomach and indigestion ( dyspepsia )
  • Magnet
  • Weakness or fatigue

Uncommon (may affect up to 1 in 100 people)

  • Dizziness or fainting when you get up or stand or sit up quickly
  • Fast heart rate ( tachycardia )
  • Drowsiness
  • Runny nose, itchy nose, sneezing, and stuffy nose.
  • Diarrhea and vomiting
  • Dry mouth
  • Skin rash and itching
  • Retention of water in the body (may cause swollen arms or legs)
  • Chest pain
  • Hot flashes

Another side effect s (frequency can not be estimated from available data) that may occur are:

  • Irregular and fast heartbeats.
  • Decreased white blood cell count. Symptoms of this can be frequent infections, sore throats, or cold sores.
  • Low platelet count. Signs of this can be bleeding from the gums and nose, bruising, prolonged bleeding time at cuts, rashes (punctate red spots called petechiae ).
  • Abnormal liver function (liver problem). Symptoms may include yellowing of the skin or whites of the eyes.
  • 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 Orion, the pupil may dilate badly and the iris (the colored part of the eye) may lose 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 a different way (see section “Operations while taking Alfuzosin Orion”).
  • Abnormal, often painful, persistent erection of the penis that can not be related to sexual activity (priapism).

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala


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 Orion

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 tablet, can, or carton after EXP. The expiration date is the last day of the specified month.

This medicine does not require any special storage instructions.

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

What Alfuzosin Orion contains

  • The active substance is alfuzosin hydrochloride. Each tablet contains 10 mg of alfuzosin hydrochloride.
  • The other ingredients are in the tablet core: Hypromellose, hydrogenated vegetable oil, povidone (K-30), anhydrous calcium hydrogen phosphate, carbomer, colloidal anhydrous silicon, magnesium stearate, and in the film coating: Hypromellose, propylene glycol, titanium dioxide (E171).

What the medicine looks like and the contents of the pack

Prolonged-release tablet

White to off-white round, biconvex, film-coated tablets marked with “X” on one side and “47” on the other side. The diameter of the tablets is 8.1 millimeters.

Pack sizes:

Blister pack: 10, 20, 30, 50, 60 and 90 tablets.

Can pack: 30 and 90 tablets.

The jar contains silica gel as a desiccant.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Muhammad Nadeem

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