Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
DILTIAZEM HYDROCHLORIDE
Sanofi-Aventis Ireland Limited T/A SANOFI
DILTIAZEM HYDROCHLORIDE
90 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER TILDIEM® RETARD 90MG AND 120MG PROLONGED RELEASE TABLETS Diltiazem hydrochloride Is this leaflet hard to see or read? Phone 01 403 5600 for help 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. • 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, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Tildiem Retard is and what it is used for? 2. Before you take Tildiem Retard 3. How to take Tildiem Retard 4. Possible side effects 5. How to store Tildiem Retard 6. Further information 1. WHAT TILDIEM RETARD IS AND WHAT IT IS USED FOR Tildiem Retard contains a medicine called diltiazem hydrochloride. This belongs to a group of medicines called ‘calcium-channel blockers’. It works by making your blood vessels wider. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around the body. This helps to prevent the chest pain caused by angina. Tildiem Retard is used for: • Angina (chest pain) • High blood pressure 2. BEFORE YOU TAKE TILDIEM RETARD DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: You are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of Tildiem Retard (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have a very slow heartbeat – less than 40 beats per minute You have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tildiem Retard 90 mg Prolonged release Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 90 mg diltiazem hydrochloride as the active ingredient. For excipients, see 6.1 3 PHARMACEUTICAL FORM Prolonged release tablet. Off-white biconvex tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mild to moderate hypertension and angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tildiem Retard tablets should be swallowed with a little water and not chewed. Patients should be advised that the tablet membrane may pass through the gastrointestinal tract unchanged. Adults: Angina and hypertension: The usual starting dose is one tablet (90mg or 120mg) twice daily. Patient responses may vary and dosage requirements can differ significantly between individual patients. Higher divided doses up to 480mg/day have been used with benefit in some angina patients especially in unstable angina. Doses of 360mg/day may be required to provide adequate BP control in hypertensive patients. Elderly and patients with impaired hepatic or renal function: Heart rate should be monitored in these patients and if it falls below 40 beats per minute the dose should not be increased. Tildiem Retard 90mg Prolonged Release Tablets should be used with caution in patients with renal or hepatic impairment (see section 4.4 Special Warnings and Precautions for Use) Angina: The recommended starting dose is one Tildiem 60mg tablet twice daily. This dose may be increased to one 90mg or 120mg Tildiem Retard tablet twice daily. Hypertension: The starting dose should be one 120mg Tildiem Retard tablet daily. Dose adjustment to one 90mg or one 120mg Tildiem Retard tablet twice daily may be required. Children: Safety and efficacy Leggi il documento completo