ELLURA Hard Capsules

Introduction

Package Leaflet: Information for the User

ELLURAhard capsules

Extract of Red Cranberry (Vaccinium macrocarponAiton)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Ellura is and what it is used for
2. What you need to know before taking Ellura
3. How to take Ellura
4. Possible side effects
5. Storage of Ellura
6. Contents of the pack and further information

1. What Ellura is and what it is used for

It is a traditional herbal medicinal product to prevent the recurrence of acute uncomplicated lower urinary tract infections (cystitis), based solely on its traditional use.

This medication is indicated in adult women.

2. What you need to know before taking Ellura

Do not take Ellura:

• If you are allergic to red cranberry (Vaccinium macrocarpon Ait) or to any of the other components of this medication (listed in section 6).
• If you are taking anticoagulant medications (warfarin, acenocoumarol, apixaban, edoxaban, dabigatran, and rivaroxaban) or if you are being treated with parenteral anticoagulants (heparins) (see Taking Ellura with other medications).
• If you have a severe heart condition or renal insufficiency
• If you have or have had kidney problems, including kidney stones.
• If you are following a fluid intake reduction diet because you have fluid retention, edema, or swollen legs.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Ellura.

Consult your doctor if you develop any of the following symptoms: fever, stiffness, abdominal pain, back pain, hematuria (blood in the urine), urinary retention, or urinary incontinence.

It is essential that you consult your doctor if the symptoms you have had in previous cases of cystitis appear.

Children and adolescents

This medication is not recommended in children and adolescents under 18 years of age, as there is insufficient information on its use in these age groups.

Taking Ellura with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not use this medication if you are being treated with anticoagulant medications or need to start treatment with an anticoagulant; consult your doctor before taking Ellura. There is information available on some cases of interaction between warfarin and red cranberry juice, causing a modification of blood coagulation in most cases.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

3. How to take Ellura

Follow the administration instructions of this medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adult and elderly women is: one capsule once a day.

The capsules should be taken orally, accompanied by a large glass of water.

Use this medication when you suffer from recurrent urinary infections, which means you have had at least 3 or more episodes in the last 12 months or 2 or more episodes in the last 6 months.

Take one capsule per day for at least 15 consecutive days, after completing the antibiotic treatment of the last urinary infection to maintain a clean urinary tract and prevent the recurrence of the infection.

The treatment can be repeated up to 4 times a year.

It is essential to maintain regular intake of the medication in the recommended form to support the efficacy of the treatment. The frequency of treatment should be managed according to the number of previous infections or following the advice of your healthcare professional.

It is not necessary to discontinue treatment with Ellura during cystitis.

If you take more Ellura than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forget to take Ellura

Do not take a double dose to make up for the forgotten dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Cases of diarrhea and nausea with red cranberry juice have been reported. The frequency of these cases is unknown.

Cases of skin rash due to allergic reaction (hypersensitivity) have been reported. The incidence of these cases is unknown.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ellura

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you notice signs of deterioration, such as damaged capsules.

No special storage conditions are required. Keep the capsules in their original packaging.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ellura

• The active ingredient is per capsule: 195-216 mg of extract (as dry, refined extract) of the fruit of Vaccinium macrocarpon Aiton (Red Cranberry) corresponding to 36 mg of proanthocyanidins (PAC), calculated as PAC-A2.
• The other components are: hypromellose (vegetable capsule shell), mannitol, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and packaging contents

Ellura capsules are hard, colorless capsules. They contain a purple powder.

This medication is presented in PVC/PE/PVDC-Alu blisters, in packs of 15 or 30 capsules, or in plastic bottles (HDPE with desiccant, sealed with an aluminum foil and a PP cap) containing 90 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder: November 2017

Laboratoire Pharmaceutique Pharmatoka S.A.S

20-22 Avenue de la République

92500 Rueil Malmaison

France

Manufacturer

Centre Spécialités Pharmaceutiques

35, Rue de la Chapelle

F-63450 St Amant Tallende

France

O

Laboratoire Pharmaceutique Pharmatoka S.A.S.

20-22 Avenue de la République

92500 Rueil Malmaison

France

Local representative of the marketing authorization holder:

Atika Pharma, S.L.

Calle Arena, 1, 2nd floor,

35002 Las Palmas De Gran Canaria

Spain

Date of the last revision of this package leaflet: November 2017

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es/.