Summary of Product Characteristics (SmPC) - Ellura, capsules
1 NAME OF THE MEDICINAL PRODUCT
Ellura Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One capsule contains 195-216 mg of extract (as dry extract, refined) from the juice of cranberry fruit (Vaccinium macrocarpon Ait. Fructus), corresponding to 36 mg of proanthocyanidins (PAC), calculated as PAC A2.
Extraction solvent: Ethanol 70% (v/v)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard 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
only, after serious conditions have been excluded by a medical doctor, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Ellura capsules should always be taken with a large glass of water (at least 300 ml).
Adult women over 18 years including the elderly
Ellura is to be used in women who suffer from recurrent 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.
One capsule of Ellura to be taken per day for 15 consecutive days after the most recent UTI episode.
The capsules should then be used preventatively for up to a further 4 times per year to help avoid recurrence of the infection.
If UTIs recur more often, a doctor should be consulted for advice on adjusting the frequency of treatment.
The use in men is not recommended (see section 4.4 ‘Special warnings and precautions for use’).
Children and adolescents under 18 years old:
This product is not recommended in children and adolescents under 18 years old (see section 4.4 ‘Special warnings and precautions for use’).
4.3 Contraindications
Hypersensitivity to cranberry (Vaccinium macrocarpon Ait.) fruit or to any of the excipients.
Oedema secondary to heart failure or impaired renal function.
Current or previous kidney disease including kidney stones.
Patients with kidney disorders who have experienced recurrent urinary tract infections.
Conditions where a reduced fluid intake is recommended e.g. severe cardiac or renal diseases.
Concomitant use of warfarin and other anticoagulant medicines (see section 4.5).
Concomitant use of tacrolimus and immunosuppressant drugs (see section 4.5)
Concomitant use with chemotherapy (see section 4.5).
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children and adolescents under 18 years old is not recommended because data is not sufficient and medical advice should be sought.
Medical advice should be sought or usual treatment should be taken if the symptoms of a UTI appear. Medical advice should be sought if the patient is not sure if she has a UTI.
A doctor should be consulted immediately, if any of the following symptoms develop: fever, rigors, abdominal pain, spams, back pain, haematuria, dysuria, urinary retention or urinary incontinence.
The use in men and pregnant women is not recommended because lower urinary tract symptoms in these populations require medical supervision.
This product is not suitable for patients with current or previous kidney disease including kidney stones because cranberry contains oxalate, and there may be an increased risk of stone formation in the urinary tract in patients with stone history.
This medicine is not suitable for patients with kidney disorders who experience recurrent urinary tract infections because medical supervision is required in these cases.
4.5 Interaction with other medicinal products and other forms of interaction
Individual case reports suggest a possible interaction between warfarin and cranberry juice, in most cases leading to an increase in INR or bleeding event. Other vitamin K antagonists such as acenocoumarol and phenindione are occasionally used instead of warfarin and could also potentially interact with cranberry juice.
There are no reports to date of interactions between cranberry and the new direct-acting oral anticoagulants which are not vitamin K antagonists (such as apixaban, edoxaban, dabigatran, and rivaroxaban) or parenteral anticoagulants (such as heparin, dalteparin, enoxaparin and tinzaparin); however, a clinical study demonstrates a potential pharmacodynamic interaction between cranberry and warfarin.
Therefore the concomitant use of anticoagulant medicines and cranberry juice products is contraindicated (see section 4.3).
There is no evidence that cranberry juice has a clinically relevant effect on the pharmacokinetics of amoxicillin or cefaclor.
A recent case study reported that concurrent administration of tacrolimus and cranberry juice resulted in a significant reduction in tacrolimus levels. Therefore patients taking immunosuppressant drugs should not take cranberry preparations (see section 4.3).
An in vitro study has suggested that cranberry inhibits CYP2C8, an enzyme pathway for metabolizing many drugs, including paclitaxel. Although there are no human studies showing an interaction between cranberry and paclitaxel, patients receiving chemotherapy should not take cranberry products (see section 4.3).
4.6 Fertility, pregnancy and lactation
The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
No studies on the effects on fertility have been performed.
4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Gastrointestinal disorders: nausea, or vomiting, diarrhoea, dyspepsia, constipation, abdominal pain or discomfort.
Skin and subcutaneous tissue disorders: urticaria and rash (hypersensitivity reaction)
The frequency is unknown and cannot be estimated from the available data.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of a medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store".
4.9 Overdose
No cases of overdose have been reported.
Supportive and symptomatic treatment should be provided as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: other urologicals. ATC code: G04BX
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
The results of an Ames test on the cranberry extract in the product did not give any reason for concern.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol
Magnesium stearate
Silica, colloidal anhydrous
Hypromellose (capsule shell)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
48 months
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original packaging.
6.5 Nature and contents of container
Blister packs of 15 or 30 capsules (PVC/PE/PVDC film - Aluminium foil with PVC/PVA copolymer, and butylmethylacrylate coating).
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Laboratoire Pharmaceutique Pharmatoka S.A.S
20-22 Avenue de la République
92500 Rueil Malmaison
France
8 MARKETING AUTHORISATION NUMBER(S)
THR 46825/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/11/2016
10 DATE OF REVISION OF THE TEXT
24/09/2024