Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Labetalol hydrochloride
Viatris UK Healthcare Ltd
C07AG01
Labetalol hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5016695640082
21 Apr 2021 II/II 13:27 Braille labeta- lol #100 mg tablets labeta- lol #100 mg tablets 1 PEEL HERE BUT DO NOT REMOVE 100 MG LABETALOL 100 MG FILM-COATED TABLETS 56 film-coated tablets Each film-coated tablet contains labetalol hydrochloride 100 mg. Contains sucrose . For Oral use as directed by a doctor. Read the package leaflet before use. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. WARNING: Do not take this medicine if you have wheezing or asthma. Store in a dry place below 25 °C. Store in the original package in order to protect from light. PL 04569/0052 POM Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. LL0425AI 2438840 21 Apr 2021 2/32 13:27 2 100 MG LABETALOL 100 MG FILM-COATED TABLETS 56 film-coated tablets Each film-coated tablet contains labetalol hydrochloride 100 mg. Contains sucrose. For Oral use as directed by a doctor. Read the package leaflet before use. Keep out of the sight and reach of children. WARNING: Do not take this medicine if you have wheezing or asthma. Store in a dry place below 25 °C. Store in the original package in order to protect from light. PL 04569/0052 POM Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. LL0425AI 2438840 21 Apr 2021 3/32 13:27 3 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LABETALOL 100 MG FILM-COATED TABLETS LABETALOL 200 MG FILM-COATED TABLETS LABETALOL 400 MG FILM-COATED TABLETS (labetalol hydrochloride) 4 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. 5 IN THIS LEAFLET: 1. What Labetalol is and what it is used for 2. What you need to know befor Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Labetalol 100 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg labetalol hydrochloride Excipients with known effect: Each film-coated tablet contains 8.0 mg sucrose For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Round orange biconvex film-coated tablets marked “LL 100” on one side and blank on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Labetalol is a combined alpha and beta-adrenoceptor blocker indicated for: - Hypertension, including hypertension in pregnancy. - Angina pectoris with existing hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. Labetalol tablets should be taken with food. Adults: Hypertension: Initially, 100 mg twice daily. In patients already being treated with antihypertensives and in those of low body weight this may be sufficient to control blood pressure. In others, increases in dose of 100 mg twice daily should be made at intervals of 14 days. Many patients blood pressure is controlled by 200 mg twice daily. If necessary up to 800 mg daily may be given, as a twice daily regimen. In severe refractory hypertension, daily doses of up to 2400 mg have been given, divided into three or four times a day regimens. Hypertension in Pregnancy: An initial dosage of 100 mg twice daily may be increased, if necessary at weekly intervals by 100 mg twice daily. During the second and third trimesters, the severity of hypertension may necessitate a further dose titration to a three times daily regimen ranging from 100 mg – 400 mg three times a day. The total daily dosage should not exceed 2400 mg. Hospital in-patients with severe hypertension, particularly in pregnancy, may have daily increases in dosage. Angina Co-Existing with Hypertension: The recommended dose is that which is necessary to control the hypertension. Paediatric population : Labetalol is not recommended for use in children due to a lack of Lees het volledige document