Rantral Mr 10 10 mg Tablets

RANTRAL MR 10 is indicated for the treatment of functional symptoms of benign prostatic hyperplasia. Adjunctive therapy with urethral catheterisation for acute urinary retention (AUR) related to benign prostatic hyperplasia (BPH).

Posology

Adults

Benign prostatic hyperplasia (BPH): The recommended dose for RANTRAL MR 10 is one tablet daily to be taken after meals as bioavailability in the fasting state is less than in the fed state.

Acute urinary retention (AUR): One 10 mg tablet daily after a meal to be taken from the first day of catheterisation.

Special populations

Elderly population

Elderly, treated hypertensive patients and renal insufficiency RANTRAL MR 10 is not indicated in these patient populations as a 5 mg dosage form is not available.

Paediatric population

Efficacy and safety of RANTRAL MR 10 in children less than 18 years has not been established. RANTRAL MR 10 is contraindicated in children (see section 4.3).

Method of administration

Tablet should be swallowed whole. See section 4.4.

RANTRAL MR 10 is contra-indicated in:

• hypersensitivity to alfuzosin or any of the ingredients in the medicine
• orthostatic hypotension
• combination with other alpha 1 -adrenoceptor blockers
• hepatic insufficiency
• severe renal insufficiency
• children
• pregnancy and lactation

In some subjects, in particular patients receiving antihypertensive medications, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are usually transient, occur at the beginning of treatment and do not usually prevent the continuation of treatment. The patient should be warned of the possible occurrence of such events.

In coronary patients, RANTRAL MR 10 (alfuzosin hydrochloride) should not be prescribed alone. In patients with coronary artery disease and ischaemic heart disease/angina pectoris, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or gets worse, RANTRAL MR 10 should be discontinued. Patients with a known hypersensitivity to alpha 1 -adrenoceptor blockers should be closely monitored.

Intraoperative Floppy Iris Syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with some alpha1-blockers (including RANTRAL 10 MR). Although the risk of this event with RANTRAL 10 MR appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of alpha1-blockers, as IFIS may lead to increased procedural complications.

Tablet should be swallowed whole. Any other mode of administration, such as crunching, crushing, chewing, grinding or pounding to powder should be prohibited. These actions may lead to inappropriate release and absorption of the drug and therefore possible early adverse reactions.

As with all alpha1-receptor blockers, RANTRAL 10 MR should be used with caution in patients with acute cardiac failure.

Concomitant use of RANTRAL 10 MR and potent CYP3A4 inhibitors (such as itraconazole, ketoconazole, protease inhibitors, clarithromycin, telithromycin and nefazodone) should be avoided (see section 4.5). RANTRAL 10 MR should not be used concomitantly with CYP3A4 inhibitors that are known to increase the QTc interval (e.g. itraconazole and clarithromycin) and a temporary interruption of RANTRAL 10 MR treatment is recommended if treatment with such medicine is initiated.

Prolonged erections and priapism have been reported with alpha-1 blockers including alfuzosin in post marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance (see section 4.8).

RANTRAL MR 10 contains lactose as an inactive ingredient. Patients with a rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take RANTRAL MR 10.

Concomitant use with alpha 1 -adrenoceptor blockers may result in hypotension (see section 4.3).

Combinations to be taken into account:

• Antihypertensive medicines (section 4.4).
• Nitrates
• General anaesthetics: Administration of general anaesthetics to a patient treated with RANTRAL MR 10 may lead to decrease in blood pressure.
• Potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir since RANTRAL MR 10 blood levels are increased.

Safety and efficacy in pregnancy and lactation have not been established.

There are no data available on the effect of driving vehicles. As side-effects such as vertigo, dizziness and asthenia may occur, these should be taken into account when driving vehicles and operating machinery.

b) Tabulated list of adverse reactions

System Organ Class Frequency Adverse event

Nervous system disorders Frequent: Less frequent: Faintness, vertigo, dizziness and headache Drowsiness, malaise and syncope

Eye disorders Unknown Frequency Intraoperative Floppy Iris Syndrome (IFIS) Vision abnormal

Cardiac disorders Less frequent Unknown Frequency Symptomatic hypotension (postural), tachycardia, palpitations, oedema, flushes and chest pain (See section 4.4). Syncope, angina pectoris in patients with pre-existing coronary artery disease Atrial fibrillation

Vascular disorders Less frequent Hypotension (postural) Flushing

Blood and lymphatic system disorders Unknown Frequency Neutropenia Thrombocytopenia

Respiratory, thoracic and mediastinal disorders Less frequent Rhinitis

Gastro-intestinal Frequent Nausea, gastralgia, abdominal pain and diarrhoea system disorders Less frequent Dry mouth, vomiting

Hepato-biliary disorders Unknown Frequency Hepatocellular injury, cholestatic liver disease

Skin and subcutaneous tissue disorders Less frequent: Dry mouth, rash, pruritus, urticaria, angioedema

Reproductive system and breast disorders Unknown Frequency Priapism

General disorders Less frequent Asthenia, malaise, flushes, oedema, chest pain

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

In case of overdosage, the patient should be hospitalised, kept in the supine position and conventional treatment of hypotension should take place. RANTRAL 10 MR is not easily dialysable because of its high degree of protein binding. Treatment is symptomatic and supportive.