Ellura hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cranberry fruit juice refined dry extract

Available from:

Laboratoire Pharmaceutique Pharmatoka SAS

ATC code:

G04BX

INN (International Name):

Cranberry fruit juice refined dry extract

Pharmaceutical form:

Capsule, hard

Therapeutic area:

Other urologicals

Authorization date:

2023-10-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
Ellura
®
hard
capsules
Cranberry fruit juice refined dry
extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse
has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor, pharmacist or nurse
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ellura is and what it is used for
2.
What you need to know before you take Ellura
3.
How to take Ellura
4.
Possible side effects
5.
How to store Ellura
6.
Contents of the pack and other information
1.
WHAT ELLURA IS AND WHAT IT IS USED FOR
Ellura is a traditional herbal medicinal product containing a refined
dry extract from the juice of
cranberry fruit.
Ellura is used to prevent recurrent uncomplicated acute urinary tract
infections (UTIs) such as cystitis in
adult women over the age of 18 years exclusively based on longstanding
use.
Ellura is for use in women only.
Ellura is to be used if you suffer from recurrent uncomplicated acute
UTIs, meaning that you have had
at least 3 or more episodes in the past 12 months or 2 or more
episodes in the past 6 months
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ELLURA
2.1 DO NOT TAKE ELLURA
-If you are allergic (hypersensitive) to the active substance or any
of the other ingredients of this
medicine (listed in section 6).
-if you are a man
-If you are under 18 years old.
-If you are pregnant or breastfeeding
- If you suffer from:
•
Fluid retention caused by a kidney or heart problem
•
Current or previous kidney problems including kidney stones
•
A condition which requires you to restrict your fluid intake e.g.
severe heart or
kidney
disease.
- If you are taking any anticoagulant medicine used to help prevent
blood clots e.g. warfarin

Summary of Product characteristics

Health Products Regulatory Authority
24 October 2023
CRN009L3H
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ellura hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 195.7 to 216.9 mg of extract (as dry extract,
refined) from the juice of _Vaccinium macrocarpon _Ait., fructus
(cranberry fruit), corresponding to 36 mg of proanthocyanidins (PAC),
calculated as PAC A2.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule).
Colourless capsule containing a dark purple powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used to prevent recurrent
uncomplicated acute urinary tract infections (UTIs) such as
cystitis in women exclusively based on long standing use. Ellura hard
capsules are indicated in adult women over the age of 18
years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use only.
Ellura hard capsules should always be taken with a large glass of
water.
_ADULT WOMEN OVER 18 YEARS INCLUDING THE ELDERLY_
Ellura hard capsules are indicated for use in women who suffer from
recurrent uncomplicated acute UTIs, meaning those who
have had at least 3 or more episodes in the past 12 months or 2 or
more episodes in the past 6 months.
If these acute uncomplicated UTIs recur more often, a doctor should be
consulted for advice including advice on the frequency
of this prophylactic treatment.
DURATION OF TREATMENT
One capsule of Ellura to be taken per day as prophylactic treatment
for a minimum of 15 consecutive days after the most
recent UTI.
Maximum duration of use is 6 months.
If the patient experiences symptoms of a UTI during the use of the
medicinal product, a doctor should be consulted.
_CHILDREN AND ADOLESCENTS UNDER 18 YEARS OLD:_
_ _
This product is not recommended in children and adolescents under 18
years old (see section 4.4)
_MEN:_
The use of Ellura hard capsules in men is not recommended (see section
4.4)
4.3 CONTRAINDICATIONS
Hypersensitivity to cranberry (_V