Leaflet: information for the user

ELLURAhard capsules

Extract of Red Currant (Vaccinium macrocarponAiton)

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

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

1. What Ellura is and what it is used for

2. What you need to know before you start taking Ellura

3. How to take Ellura

4. Possible side effects

5. Storage of Ellura

6. Contents of the pack and additional information

Itisa traditional herbal medicine to prevent the recurrence ofacute uncomplicated lower urinary tract infections (cystitis), based exclusively on its traditional use.

This medication is indicated for adult women.

Do not take Ellura:

• If you are allergic to red raspberry (Vaccinium macrocarpon Ait) or to any of the other components of this medication (listed in section 6).

• If you are taking anticoagulant medications (warfarina, acenocumarol, apixaban, edoxaban, dabigatran, and rivaroxaban) or if you are undergoing treatment with parenteral anticoagulants (heparinas) (see Taking Ellura with other medications).

• If you have a serious heart condition or renal insufficiency

• If you have or have had kidney problems, including kidney stones.

• If you are following a low-liquid 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 to consult your doctor if you experience symptoms that you had in previous cases of cystitis.

Children and adolescents

This medication is not recommended for children and adolescents under 18 years old since there is not enough information available on its use in these age groups.

Taking Ellura with other medications

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

Do not use this medication if you are undergoing treatment with anticoagulants or are about to start anticoagulant treatment, consult your doctor before taking Ellura. There is information on some cases of interaction between warfarina and red raspberry juice, causing changes in blood coagulation in most cases.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you might be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

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

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

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

Use this medication when you suffer from recurrent urinary tract 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 for the last urinary tract infection to keep your urinary tract clean and prevent the recurrence of the infection.

Treatment can be repeated up to 4 times a year.

It is essential to maintain regular medication intake in the recommended form to support the effectiveness 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.

There is no need 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 Toxicological Information Service, phone: 915620420 indicating the medication and the amount ingested.

If you forgot to take Ellura

Do not take a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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

Reporting Adverse Effects

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

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

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

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

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ellura

- The active principle isby acapsule: 195-216 mg of fruit juice extract (as dry, refined extract) ofVaccinium macrocarponAiton(Red Currant) corresponding to 36 mg of proanthocyanidins (PAC), calculated as PAC-A2.

- The other components are: hypromellose (vegetable capsule body), mannitol, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

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

This medication is presented in a PVC/PE/PVDC – Alu blister pack, in packaging of 15 or 30 capsules, or in plastic bottles (HDPE with desiccant, sealed with an aluminum foil and a PP stopper) containing 90 capsules.

Not all packaging 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

Responsible for Manufacturing

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

Last review date of this leaflet: November 2017

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