10 mg prolonged-release tablet is 
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 Rivopharm is and what it is used for 
2. What you need to know before you use Alfuzosin Rivopharm 
3. How to use Alfuzosin Rivopharm 
4. Possible side effects 
5. How to store Alfuzosin Rivopharm 6. Contents of the pack 
and other information 

What Alfuzosin Rivopharm is and what it is used for

Alfuzosin Rivopharm relaxes the muscles in the prostate, bladder, and urethra, which improves urine flow. Alfuzosin Rivopharm is used for benign prostate enlargement and for complementary treatment with a catheter in the urethra. Alfuzosin Rivopharm belongs to a group of medicines called alpha-1-blocking medicines.

Alfuzosin hydrochloride contained in Alfuzosin Rivopharm 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 use Alfuzosin Rivopharm

Do not use Alfuzosin Rivopharm

  • if you are allergic to alfuzosin hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you are taking other alpha-1 blocking drugs (used for prostate enlargement and high blood pressure )
  • if you have orthostatic hypotension. This is a drop in blood pressure that usually occurs when you stand up. It may make you feel dizzy or faint when you get up or sit up quickly.
  • if you have impaired liver function.

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 Alfuzosin Rivopharm.

Warnings and cautions

Talk to your doctor or pharmacist before using Alfuzosin Rivopharm. This is especially true:

  • if you have severe renal impairment
  • if you are taking medicines for high blood pressure
  • if you are taking medicines for angina (so-called nitrates)
  • if you have previously reacted with a sharp drop in blood pressure during treatment with similar drugs.
  • if you have any heart disease.
  • if you have a deviation from the activity of the heart, so-called QT prolongation (seen on ECG ), or if you are using medicines that can lead to a QT prolongation

Within a few hours of taking Alfuzosin Rivopharm, you may feel a drop in blood pressure when you get up or sit up. You may also feel dizzy, tired, or sweating. If this happens, you should lie down until the symptoms have completely disappeared. This usually occurs at the beginning of treatment and is transient. Tell your doctor as someone may need to be adjusted.

In patients who have any heart disease or are being treated with antihypertensive drugs, a pronounced drop in blood pressure has been reported. The risk of developing low blood pressure and related side effects may be greater in the elderly.

In case of an 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”.

Other medicines and Alfuzosin Rivopharm

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

You should not use Alfuzosin Rivopharm if you are taking other alpha-1 blocking drugs (used for prostate enlargement and high blood pressure ).

Alfuzosin Rivopharm may affect and be affected by certain other medicines such as:

  • medicines for high blood pressure
  • vasodilators
  • medicines for chest pain (angina)
  • medicines for fungal infections ( ketoconazole, itraconazole)
  • medicines used to treat HIV (ritonavir), as medicines of this type can lead to increased levels of alfuzosin in the blood
  • drugs against bacterial infections (such as clarithromycin, telithromycin)
  • medicines used to treat depression (such as nefazodone)
  • you take ketoconazole tablets (used to treat Cushing’s syndrome – when the body produces an excess of cortisol ).

Operations while taking Alfuzosin Rivopharm

If you are about to get anesthesia Tell your doctor that you are taking Alfuzosin Rivopharm, as the combination of alfuzosin and anesthetic may cause unstable blood pressure.

If you are going to undergo eye surgery due to cataracts (turbidity of the lens of the eye), you must inform your eye specialist before the operation that you are using or have used Alfuzosin Rivopharm. This is because the use of Alfuzosin Rivopharm can cause complications during the surgery which can be managed if your specialist is informed.

Pregnancy and breastfeeding

Not relevant.

Driving and using machines

At the beginning of treatment, Alfuzosin Rivopharm may impair the ability to react in some patients, which should be taken into account when increased attention is required, for example when driving and precision work.

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.

3. How to use Alfuzosin Rivopharm

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

The recommended dose for adults is 1 prolonged-release tablet daily after evening meals.

It is important that you swallow the tablet whole, as otherwise there is an increased risk of side effects.

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

Use for children

Alfuzosin Rivopharm is not recommended for use in children.

If you forget to use Alfuzosin Rivopharm

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

If you stop using Alfuzosin Rivopharm

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.

Stop taking Alfuzosin Rivopharm and contact a doctor immediately or go to the hospital if you get any of the following symptoms:

  • chest pain (angina). Normally this only happens if you have had angina before. If you get chest pain, stop taking the tablets, and contact a doctor or go to the hospital immediately. This can occur in up to 1 in 10,000 users.
  • allergic reactions. You may experience symptoms of angioedema such as hives, swelling of the face, tongue, or throat, difficulty swallowing, and difficulty breathing. If this happens, stop taking the tablets and contact a doctor or go to the hospital immediately. This can occur in up to 1 in 10,000 users.
  • a residual erection (priapism). Priapism is an abnormal, often painful, persistent erection of the penis that is not related to sexual activity. If you get an election like the one described here that 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.

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

  • Headache.
  • Dizziness.
  • Nausea
  • Unpleasant feeling in the stomach and indigestion ( dyspepsia ).
  • Abdominal pain.
  • Weakness or fatigue.

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

  • Dizziness or feeling of intoxication when you get up or sit up quickly.
  • Drowsiness.
  • Increased heart rate ( tachycardia ).
  • Hot flashes.
  • Runny nose, itchy nose, sneezing, and stuffy nose.
  • Diarrhea, vomiting.
  • Dry mouth.
  • Skin rash and itching.
  • Urinary incontinence.
  • Swelling ( edema ).
  • Chest pain.

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

  • Decreased white blood cell count. Symptoms of this can be frequent infections, sore throats, or cold sores.
  • Low platelet count. Signs of this may be bleeding from the gums and nose, bruising,
  • prolonged bleeding at cuts, rash (punctate red spots called petechiae ).Atrial fibrillation. Irregular and fast heartbeats.
  • Liver damage, liver disease. Symptoms may include yellowing of the skin or
  • the whites of the eyes …
  • Spasmodic and prolonged erection.
  • Eye Disease Intraoperative Floppy Iris Syndrome. 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 Rivopharm, 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 Operations while taking Alfuzosin Rivopharm ).

Reporting of side effects is
if you get side effects are, speak with your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via

The Medical Products Agency

Box 26

751 03 Uppsala


By reporting side effects, you can help increase drug safety information.

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 Rivopharm

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the 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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is alfuzosin hydrochloride 10 mg per prolonged-release tablet.
  • The other ingredients are hypromellose, povidone, hydrogenated vegetable oil, calcium hydrogen phosphate dihydrate, magnesium stearate, propylene glycol, colloidal, anhydrous silica, titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Round, biconvex, white film-coated tablet.

Pack size:

7, 10, 14, 20, 21, 28, 30, 30×1, 50, 56, 60, 84, 90, 98, 100, 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Rivopharm Ltd.

17 Corrig Road, Sandyford

Dublin 18

Ireland

Manufacturer:

Actavis Group hf.

Reykjavikurvegur 76-78

IS-220 Hafnarfjordur

Iceland

Agent:

SanoSwiss UAB

Aukstaiciu str. 26A

LT-44169 Kaunas,

Lithuania

Muhammad Nadeem

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