Labetalol Tablets BP 100mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LABETALOL HYDROCHLORIDE

Available from:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

ATC code:

C07AG01

INN (International Name):

LABETALOL HYDROCHLORIDE 100 mg

Pharmaceutical form:

TABLET

Composition:

LABETALOL HYDROCHLORIDE 100 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Suspended

Authorization date:

2006-12-14

Patient Information leaflet

111222111
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET CAREFULLY. This leaflet 
contains a summary of the information about your medicine, Labetalol Tablets BP. 
YOUR MEDICINE
Your medicine is in the form of a tablet. There are three different 
strengths of Labetalol Tablets BP available. Each tablet contains either 
100 mg, 200 mg or 400 mg of the active ingredient Labetalol 
Hydrochloride. Each tablet also contains microcrystalline cellulose, 
pregelatinised starch, sucrose, sodium starch glycollate Type A, 
colloidal anhydrous silica, silicon dioxide, magnesium stearate, 
hypromellose, diethyl phthalate, ethylcellulose, sunset yellow (E110), 
titanium dioxide (E171) and carnauba wax. The 400 mg tablet also 
contains talc and quinoline yellow aluminium lake (E104). The 100 
mg tablet is marked ‘LL 100’; the 200 mg tablet ‘LL 200’ whilst the 
400 mg tablet is marked ‘LL 400’. Labetalol Tablets BP are available 
in containers of 56 tablets. Your pharmacist will dispense the number of tablets prescribed by your 
doctor. 
HOW DOES YOUR MEDICINE WORK ?
Labetalol belongs to a group of medicines called BETA-BLOCKERS. Labetalol helps to block the effects 
of naturally occurring substances within your body (Catecholamines). In some patients Catecholamines 
may cause high blood pressure or worsen angina. By blocking these effects, Labetalol can reduce 
blood pressure and reduce angina pain.
Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Herts, 
EN6 1TL.
WHY DO YOU NEED TO TAKE YOUR MEDICINE ?
Labetalol Tablets BP can help treat the following conditions: • High blood pressure (hypertension), 
including hypertension in pregnancy. • Angina (pain in the chest, arms, shoulders or neck caused by 
effort,�

Summary of Product characteristics

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Page 1 of 8 

SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Labetalol Tablets BP 100mg  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 100 mg Labetalol Hydrochloride  

3. PHARMACEUTICAL 
FORM 

Round orange biconvex film-coated tablets marked “LL 100” on
one side and blank on the 
other. 

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, 100mg twice daily, increased at intervals
of 14 days to usual dose of 
200mg twice daily. If necessary up to 800mg daily may be given,
as a twice daily regimen. 
In severe refractory hypertension, daily doses of up to 2400mg
have been given, divided into 
three or four times a day regimens. 

Hypertension in Pregnancy:  An  initial  dosage  of 100mg
twice daily may be increased, if 
necessary at weekly intervals by 100mg 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 100mg – 400mg three times a day. The
total daily dosage should not 
exceed 2400mg. 

Angina Co-Existing with Hypertension: The recommended dose is that
which is necessary 
to control the hypertension. 
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Page 2 of 8 

Children: 
Dosage has not been established. 

Elderly: 
An initial dose of 50mg twice daily is recommended and this has
been sufficient in some 
cases to control hypertension. 

4.3. CONTRA-INDICATIONS 

Labetalol is contraindicated in patients with hypersensitivit