ZANIDIP 10 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LERCANIDIPINE HYDROCHLORIDE

Available from:

PCO Manufacturing

ATC code:

C08CA13

INN (International Name):

LERCANIDIPINE HYDROCHLORIDE

Dosage:

10 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Dihydropyridine derivatives

Authorization status:

Authorised

Authorization date:

2007-02-23

Patient Information leaflet

_ _

PACKAGE LEAFLET: INFORMATION FOR THE USER 
ZANIDIP
®
 10 MG FILM-COATED TABLETS 
ZANIDIP
®
 20 MG FILM-COATED TABLETS 
lercanidipine hydrochloride 
_(ZANIDIP IS ALSO KNOWN AS LERCANIDIPINE HCL) _

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. 
WHAT IS IN THIS LEAFLET:  
1.  What Zanidip is and what it is used for  
2.  What you need to know before you take Zanidip  
3.  How to take Zanidip  
4.  Possible side effects  
5.  How to store Zanidip  
6.  Contents of the pack and other information  

1.  WHAT ZANIDIP IS AND WHAT IT IS USED FOR  
Zanidip belongs to a group of medicines called Calcium Channel 
Blockers (dihydropyridine derivatives). Zanidip is used to treat 
high blood pressure also known as hypertension in adults over 
the age of 18 years (it is not recommended for children under
18 
years old).  

2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
ZANIDIP  

DO NOT TAKE ZANIDIP AND TELL YOUR DOCTOR IF:  


You are allergic (hypersensitive) to lercanidipine 
hydrochloride or to any other ingredients of Zanidip tablets  


You have had allergic reactions to drugs closely related to 
Zanidip tablets (such as amlodipine, nicardipine, felodipine, 
isradipine, nifedipine or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zanidip 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg lercanidipine hydrochloride which is equivalent to 9.4mg lercanidipine.
Excipient(s) with known effect: Contains lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK, Germany and Italy:_
Yellow, circular, biconvex tablets, scored on one side.
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA0812/001/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0812/001/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
TABLET CORE:
Lactose monohydrate
Microcrystalline cellulose
Sodium starch glycolate
Povidone K30
Magnesium stearate
FILM COAT:
Hypromellose
Talc
Titanium dioxide (E171)
Macrogol 6000
Iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 14/04/2016_
_CRN 2174054_
_page number: 1_
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C
Store in the original package in order to protect from light and moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs containing 28 (UK, reboxed and over-labelled & Italian reboxed) or 50 tablets (German,
reboxed) contained in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT