PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Alfuzosin HCl Ranbaxy 10 mg tablets, prolonged-release tablets Alfuzosin hydrochloride Read all of this leaflet carefully before using this medicine. - Keep this leaflet, you may need to read it again. - If you have any further questions, please ask your doctor or pharmacist - This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. - If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, consult your doctor or pharmacist. In this leaflet: 1. What Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets are and what they are used for 2. Before you take Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets 3. How to take Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets 4. Possible side effects 5. How to store Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets 6. Further information 1. WHAT ALFUZOSIN HCL RANBAXY 10 MG PROLONGED RELEASE TABLETS ARE AND WHAT ARE THEY USED FOR Alfuzosin belongs to a group of medicines called alpha-1-blockers. Alfuzosin is used to treat moderate to severe symptoms of Benign Prostate Hyperplasia. This is a condition where the prostate gland enlarges (hyperplasia), but the growth in itself is not cancerous (benign). It occurs most often in older men. The prostate gland is situated under the bladder surrounding the urethra (the tube that takes your urine to the outside of the body). With age, the prostate gland may grow and press the urethra making it smaller. This may cause problems with urination such as frequent urination and difficulty in passing urine. Alfuzosin works by relaxing the prostate gland muscle. This reduces the narrowing of the urethra and so makes it easier to pass urine. 2. BEFORE YOU TAKE ALFUZOSIN HCL RANBAXY 10 MG PROLONGED RELEASE TABLETS DO NOT take Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets - If you are allergic (hypersensitive) to alfuzosin or to any one of the other ingredients in the tablets (see Section 6). Symptoms of an allergic reaction include: a rash, swelling of your lips, throat, or tongue, difficulty in swallowing or breathing. - If you are allergic (hypersensitive) to alfuzosin-equivalent substances (such as terazosin, doxazosin)

2 - If you have, or have had in the past, 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, light-headed or faint when you stand or sit up quickly. - If you are already taking another alpha-1-blocker (such as terazosin, doxazosin). See section below on Taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets with other medicines. In case of doubt please ask your pharmacist or doctor. - If you have liver problems. Take special care with Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets: - If you are taking other medicines to treat high blood pressure then your doctor will check your blood pressure regularly, especially at the beginning of treatment - If you experience dizziness, weakness or sweating within a few hours after you have taken Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets then you should lie down with your legs and feet raised up in the air until the symptoms have disappeared. Usually, these effects last for only a short time and occur at the start of the treatment. Normally, there is no need to stop treatment (see Section 4) - If you have experienced a marked drop in blood pressure in the past after taking another medicine belonging to the group of alpha-blockers. In this case your doctor will start treatment with alfuzosin at low doses and will gradually increase the dose - If you have a condition where your kidneys are hardly working at all (severe kidney problems) - If you are suffering from acute heart failure (insufficient pumping power of the heart) - If you suffer from chest pain (angina) and are treated with a nitrate (medicines that widen the tubes that circulate the blood in your body and make it easier for blood to flow), as this may increase the risk of a drop in blood pressure. You should discuss with your doctor whether to continue or stop your treatment with Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets, especially when the chest pain recurs or worsens - If you have an eye surgery for cataract (cloudiness of the eye) planned, tell your eye specialist that you are using Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets or have previously been treated with an alpha-blocker. This is because Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets may cause complications during your operation which can be managed if your eye specialist is aware of this information before carrying out the operation. - If you suffer from a defect in heart rhythm or you are taking medicines which may cause a defect in heart rhythm (the medical term for this defect is QTc prolongation). In this case your doctor should evaluate you before and during the period of administration of Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets. Taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets with other medicines

3 Inform your doctor or pharmacist if you are taking or have recently taken other medicines. This also applies to medicines obtained without prescription. - Do not use Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets at the same time as other alpha-blockers such as doxazosin, prazosin, terazosin or tamsulosin (see the section Do not take Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets ). - If you are taking a medicine for high blood pressure (antihypertensive) or medicines used to treat chest pain (nitrates) at the same time, you may get dizzy, weak or start sweating within a few hours of taking this medicine. If this happens, lie down until the symptoms have completely gone. Tell your doctor as he or she may decide to change the dose of your medicine. (See section: Take special care with Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets ). - If you are going to have an operation that needs a general anaesthetic, tell your doctor that you are taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets before the operation. Your doctor may decide to stop Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets 24 hours before the operation. This is because it can be dangerous as this medicine can lower your blood pressure. The effect and side effects of alfuzosin can be increased by certain medicines used for fungal infections (such as ketoconazole, itraconazole), certain antibiotics (such as clarithromycin, erythromycin) and medicine used to treat HIV (such as ritonavir). Taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets with food and drink Take Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets after a meal You may feel dizzy and weak while taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets. If this happens do not drink any alcohol. Pregnancy and breast-feeding This section does not apply as alfuzosin is only used by men. Effect on the ability to drive and use machines You may feel dizzy and weak while taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets. Do not drive or operate any tools or machines until you know how your body responds to the treatment. Important information about some of the ingredients of Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets. This medicine contain lactose. If your doctor has told you that you cannot tolerate certain sugars, contact your doctor before you take this medicine. 3. HOW TO TAKE ALFUZOSIN HCL RANBAXY 10 MG PROLONGED RELEASE TABLETS Always take Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets exactly as your

4 doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow your tablets whole with plenty a fluid (for instance a glass of water). Do not break, crush or chew your tablets. This can affect the release of your medicine into the body The first dose of this medicine should be taken just before going to bed Take this medicine just after eating food (immediately after the same meal each day i.e. at the same time each day). Do not take it on empty stomach. Adults: The usual dose is one Alfuzosin HCl Ranbaxy 10 mg prolonged release tablet once a day. Older patients (> 65 years): The usual dose is one Alfuzosin HCl Ranbaxy 10 mg prolonged release tablet once a day. The dose does not need to be adjusted for elderly (over 65 years). Patients with mild to moderate kidney problems Your dose does not need to be adjusted for mild to moderate kidney problems. What you must do if you have taken more Alfuzosin HCl Ranbaxy10 mg prolonged release tablets than you should have done Contact your doctor or your local hospital Accident and Emergency department straight away. Take this leaflet or some tablets with you so your doctor will know what you have taken. Tell the doctor how many tablets you have taken. Lie down as much as possible to help stop the side effects. Do not try to drive to the hospital yourself. What you must do if you have forgotten to take Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets Do not take a double dose to make up for a forgotten tablet as this may cause a sudden drop in blood pressure. Skip the missed dose and take the next tablet as directed. If you stop taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets You should not interrupt or stop taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets without speaking to your doctor first. Take your tablets as directed and for as long as directed. Do not stop taking them even if you feel better, as otherwise the symptoms may return. 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 HCl Ranbaxy 10 mg prolonged release tablets can cause side effects, although not everybody gets them. These side effects are most likely to happen at the start of treatment. The following convention has been used for determining frequency of side effects: - Very common (in more than 1 in 10 patients) - Common (in more than 1 in 100 but less than 1 in 10 patients)

5 - Uncommon (in more than 1 in 1000 but in less than 1 in 100 patients) - Rare (in more than 1 in 10,000 but less than 1 in 1000 patients) - Very rare (in less than 1 in 10,000 patients including reports of isolated cases) The following side-effects may occur: Very serious side effects Reported very rarely (affects less than 1 in 10,000 patients) Rapid swelling of the eyelids, face, lips, mouth and tongue, difficulty in breathing or swallowing, rashes, hives and itching. These are symptoms of a very serious allergic reaction. (The medical term for these symptoms is angioedema). Feeling of tightness, heaviness, discomfort, or crushing pain that is felt behind the breastbone and may spread to the arms, neck and jaw. [These may be manifestations of Angina]. Normally, this only happens if you have had angina before. If any of the above mentioned side effects occur, stop taking Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets and tell your doctor immediately or go to the Emergency department at your nearest hospital. Other side effects include: Common (affects more than 1 in 100 and less than 1 in 10 patients) Feeling dizzy, light headed, or faint when you stand or sit up quickly (postural hypotension). Headache Feeling sick (nausea) Stomach pain Loose stools (diarrhoea) Dryness of mouth Weakness or tiredness Uncommon (affects more than 1 in 1000 and less than 1 in 100 patients) Fast heart beat (tachycardia) and awareness of heart beat (palpitations) Chest pain Drowsiness Being sick (vomiting) Rashes, hives and itching Flushes Water retention (may cause swollen arms or legs) General feeling of being unwell Visual disturbances Inability to retain urine (urine incontinence) Runny nose Very rare side effects (affects less than 1 in 10,000 patients)

6 Yellowing of skin and whites of eyes with decreased appetite and stomach pain (these may be manifestations of a liver problem) Prolonged and painful erection of the penis, unrelated to sexual activity (these may be manifestations of a medical condition called priapism) 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 ALFUZOSIN HCL RANBAXY 10 MG PROLONGED RELEASE TABLETS Keep out of the sight and reach of children. This medicinal product does not require any special storage conditions. Do not use Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets after the expiry date which is stated on the carton after: Use by and on the strip after EXP (= Expiry date). The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist how to dispose of medicine no longer required. These measures are to help protect the environment. 6. FURTHER INFORMATION What Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets contain The active substance is alfuzosin hydrochloride. Each prolonged release tablet contains 10 mg of alfuzosin hydrochloride. The other ingredients are: lactose anhydrous, colloidal anhydrous silica, povidone, talc, magnesium stearate, hypromellose, hydroxypropyl cellulose. The tablet has a prolonged effect which means that after taking the active substance is not released immediately but gradually from the tablet and therefore acts longer. What Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets look like and contents of the pack Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets are white to off-white, round, uncoated, biconvex tablets with flattened edges, marked with RY 10 on one side. Alfuzosin HCl Ranbaxy 10 mg prolonged release tablets are available in boxes of 10, 30 or 90 tablets. Not all pack sizes may be marketed. Marketing authorisation holder and manufacturer Marketing authorisation holder: Manufacturer: < To be completed nationally > Ranbaxy Ireland Ltd Spafield, Cork Road, Cashel, Co-Tipperary Ireland

7 Please contact the marketing authorisation holder if you require more information about this medicine. This medicine is registered in the member states of the EEA under the following name: < To be completed nationally > This patient information leaflet was last approved in < MM/YYYY >