Ellura hard capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
ELLURA hard capsules
Cranberry extract (Vaccinium macrocarpon Aiton)
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Ellura is and what it is used for
- What you need to know before taking Ellura
- How to take Ellura
- Possible side effects
- How to store Ellura
- Contents of the pack and other information
1. What Ellura is and what it is used for
It is a traditional herbal medicinal product used to help prevent the recurrence of uncomplicated acute lower urinary tract infections (cystitis), based solely on its traditional use.
This medicine is intended for use in adult women.
2. What you need to know before starting to take Ellura
Do not take Ellura:
- If you are allergic to cranberry (Vaccinium macrocarpon Ait) or to any of the other components of this medicine (listed in section 6).
- If you are taking anticoagulant medicines (warfarin, acenocoumarol, apixaban, edoxaban, dabigatran, and rivaroxaban) or if you are being treated with parenteral anticoagulants (heparins) (see Taking Ellura with other medicines).
- If you have severe heart disease or renal insufficiency.
- If you have or have had kidney problems, including kidney stones.
- If you are following a fluid-restricted diet due to fluid retention, edema, or swollen legs.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take Ellura.
Consult your doctor if you develop any of the following symptoms: fever, rigidity, abdominal pain, back pain, hematuria (blood in the urine), urinary retention, or urinary incontinence.
It is important that you consult your doctor if symptoms you previously experienced with cystitis reappear.
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age, as there is insufficient information on its use in these age groups.
Taking Ellura with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
You must not use this medicine if you are being treated with anticoagulant medicines or if you need to start treatment with an anticoagulant. Consult your doctor before taking Ellura. There is information from some cases of interaction between warfarin and cranberry juice, which in most cases caused changes in blood coagulation.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been conducted.
3. How to take Ellura
Follow exactly the administration instructions for this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adult and elderly women is: one capsule once daily.
The capsules should be taken orally, accompanied by a large glass of water.
Use this medicine when you suffer from recurrent urinary tract infections, meaning 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 daily for at least 15 consecutive days, after completing antibiotic treatment for the most recent urinary infection, to help maintain a clean urinary tract and prevent recurrence of infection.
The treatment may be repeated up to 4 times per year.
It is important to maintain regular, continuous use of the medicine as recommended to support treatment effectiveness. The frequency of treatment should be managed according to the number of previous infections or as advised by your healthcare professional.
There is no need to interrupt treatment with Ellura during episodes of cystitis.
If you take more Ellura than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 915620420, indicating the medicine and the amount ingested.
If you forget to take Ellura
Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
Cases of diarrhoea and nausea have been reported with cranberry juice. The frequency of occurrence 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 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 leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ellura
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice any signs of deterioration, such as damaged capsules.
No special storage conditions are required. Keep the capsules in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Ellura
- The active substance per capsule: 195-216 mg of extract (as dry, refined extract) from the juice of the fruit of Vaccinium macrocarpon Aiton (Red cranberry), corresponding to 36 mg of proanthocyanidins (PAC), calculated as PAC-A2.
- Other components: hypromellose (vegetable capsule shell), mannitol, magnesium stearate and colloidal anhydrous silica.
Appearance of the product and contents of the pack
Ellura capsules are hard, colorless capsules containing a purple-colored powder.
This medicine is available in PVC/PE/PVDC – Alu blisters, in pack sizes of 15 or 30 capsules, or in plastic bottles (HDPE with desiccant, sealed with an aluminum foil and 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
Or
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 most recent revision of this leaflet: November 2017
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.