Alfuzosin  Zentiva lp 10mg Details

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist for more information.
  • This medication has been prescribed to you personally. Never give it to anyone else, even if the symptoms are the same, it could be harmful.
  • 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.

Review summary

In this notice :

  1. WHAT IS ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet AND WHAT IT IS USED FOR?
  2. BEFORE YOU TAKE ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet?
  3. HOW TO TAKE ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet?
  4. WHAT ARE POSSIBLE SIDE EFFECTS?
  5. HOW TO STORE ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet?
  6. ADDITIONAL INFORMATION
  7. WHAT IS ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

DRUGS USED IN BENIGN HYPERTROPHY OF PROSTATE / ALPHA BLOCKERS

(G04CA01: genitourinary system and sex hormones)

This drug belongs to the class of alpha-blockers.

Therapeutic indications

This medication is recommended for the symptomatic treatment of functional manifestations of benign hypertrophy (increase in volume) of the prostate gland.

This medication is also recommended as adjuvant treatment for bladder sampling in acute urinary retention related to benign prostatic hypertrophy.

  1. BEFORE YOU TAKE ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet?

List of information needed before taking the medication

Not applicable.

Contraindications

Do not take ALFUZOSINE ZENTIVA LP 10 mg prolonged release tablets if:

  • If you are allergic to the active substance (alfuzosin) or to any of the other ingredients of ALFUZOSINE ZENTIVA LP. You will find the list of components in section 6.
  • If you suffer from orthostatic hypotension (drop in blood pressure when standing up, which may be accompanied by dizziness and / or discomfort).
  • If you have severe liver disease (hepatic impairment) or severe kidney disease (severe renal insufficiency).
  • If you are taking certain medicines used in the treatment of HIV (eg, protease inhibitor associated with ritonavir or cobicistat), or used in the treatment of hepatitis C (eg telaprevir or boceprevir), or used in (Eg ketoconazole, itraconazole, posaconazole), or used in certain bacterial infections (eg, clarithromycin, erythromycin, telithromycin), see section “Take or use other medicinal products”.

Precautions for use; special warnings

Take special care with ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet:

Before starting treatment: tell your doctor if you have heart disease (especially if you suffer from angina pectoris, acute heart failure, heart rhythm disorders) or if you have had a significant decrease in heart rate Blood pressure with another drug from the same family as ALFUZOSINE ZENTIVA LP (alpha-blockers).

During treatment

Orthostatic hypotension (decreased blood pressure when standing) may occur within hours of taking the drug and may be accompanied by dizziness, fatigue and sweating.

In this case, lie down until complete disappearance of these effects that are temporary and contact your doctor.

This effect is especially observed in the elderly and in persons who receive at the same time a drug to treat high blood pressure or nitrates (drugs used for angina pectoris.

The use of this medication should be avoided in combination with certain medicines used in the treatment of high blood pressure (antihypertensives such as doxazosin, prazosin and urapidil), see section “Take or use other medicines”.

If you have an eye surgery (cataract) , tell your ophthalmologist before surgery if you are being treated or have recently been treated with ALFUZOSINE ZENTIVA LP. ALFUZOSINE ZENTIVA LP is likely to cause an effect on the pupil (perioperative flaccid iris syndrome) which may complicate the operation.

However, if the surgeon is notified in advance, he may take appropriate precautions.

This medicine contains castor oil and can cause digestive problems (mild laxative effect, diarrhea).

Interaction with other medicines

Taking or using other medicines

This medicinal product should NOT be associated with certain medicines used in the treatment of HIV (eg, ritonavir or cobicistat-associated protease inhibitor) or used in the treatment of hepatitis C (eg telaprevir or boceprevir) , Used in the treatment of certain fungal infections (eg ketoconazole, itraconazole, posaconazole), used in certain bacterial infections (eg clarithromycin, erythromycin, telithromycin) (see section Contraindications).

This medication MUST BE AVOIDED IN ASSOCIATION WITH certain drugs used in the treatment of high blood pressure (antihypertensives such as doxazosin, prazosin and urapidil), (see Warnings).

IF YOU TAKE OR HAVE RECENTLY TAKEN ANY OTHER MEDICINE, INCLUDING ANY DRUG, WITHOUT ORDER, TALK TO YOUR DOCTOR OR YOUR PHARMACIST.

Interactions with food and beverages

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

Pregnancy

This medicine does not affect women.

Ask your doctor or pharmacist for advice before taking any medicine

Breastfeeding

This medicine does not affect women.

Ask your doctor or pharmacist for advice before taking any medicine

Sporting

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

Attention is drawn to the risk of orthostatic hypotension (drops in blood pressure when standing up, which may be accompanied by dizziness), dizziness, sensation of Fatigue or visual disturbance especially at the start of treatment.

List of excipients with known effect

List of excipients with a known effect: hydrogenated castor oil.

  1. HOW TO TAKE ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Oral use.

The usual dosage is 1 tablet per day, to be taken immediately after the evening meal.

The tablet should be swallowed whole with a glass of water. It should not be chewed, chewed or powdered.

In case of bladder sampling, the tablet will be taken from the first day of urethral catheterization.

If you suspect that the effect of ALFUZOSINE ZENTIVA LP 10 mg prolonged release tablet is too strong or too weak, talk to your doctor or pharmacist.

Symptoms and Instructions for Overdose

If you take more ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet than you should:

  • Immediately consult your doctor or pharmacist.
  • Instructions for omission of one or more doses
  • If you forget to take ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet:
  • Do not take a double dose to make up for the single dose you have forgotten to take.
  • Risk of withdrawal syndrome
  • Not applicable.
  1. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablets may have side effects, although not everyone is exposed to them.

Frequently:

  • Dizziness, dizziness, discomfort, headache;
  • Digestive disorders such as nausea, stomach pain;
  • Feeling tired.

Uncommonly:

  • Dizziness, drowsiness, syncope (sudden loss of consciousness);
  • Drop in blood pressure from lying to standing;
  • Heartbeat acceleration, palpitations;
  • Diarrhea;
  • Dry mouth;
  • Stuffy nose or runny nose (rhinitis);
  • Rashes on the skin or itching;
  • Edema, chest pains;
  • Redness of the face.

Very rarely :

Angina pectoris in patients with a history of coronary artery disease (see “Be careful with”);

Urticaria, sudden swelling of an organ, face and / or neck can cause difficulty breathing and endanger the patient (angioedema).

Frequency not known:

  • Liver diseases (hepatitis), especially due to obstruction of the bile ducts;
  • Painful and prolonged erection;
  • Flaccid pupil during cataract surgery (see section “Be careful with”),
  • Irregular heartbeat (atrial fibrillation);
  • Vomiting;
  • Reduction in the number of white blood cells (neutropenia).

Declaration of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers of Pharmacovigilance – Website: www.ansm.sante.fr. By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

  1. HOW TO STORE ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use ALFUZOSINE ZENTIVA LP 10 mg prolonged release tablets after the expiry date which is stated on the carton.

Storage conditions

No special storage conditions.

If necessary, warnings against certain visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

  1. ADDITIONAL INFORMATION

Complete list of active substances and excipients

What contains ALFUZOSINE ZENTIVA LP 10 mg prolonged-release tablet?

The active substance is:

Alfuzosin hydrochloride 10 mg

For a sustained release tablet.

Other components are:

Hypromellose, hydrogenated castor oil, ethylcellulose, yellow iron oxide, hydrated colloidal silica, magnesium stearate, mannitol, povidone, microcrystalline cellulose.

Pharmaceutical form and content

What is ALFUZOSINE ZENTIVA LP 10 mg prolonged release tablet and contents of the pack?

This medication is in the form of a sustained release tablet.

Box of 28, 30, 50, 90 or 100 tablets.

 

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