Cranberry

Cranberry is an umbrella entry with no single licensed product. PRODUCT SCOPE: only this product is covered. Other cranberry products (juices, other extracts, other proanthocyanidin contents) differ in strength and directions and are NOT covered here; do not apply this regimen to them. POPULATION SCOPE: the SPC licenses it for women only. §4.1 (verbatim): '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.' §2 (verbatim): '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)'. VERBATIM §4.2: '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’).' §4.4: 'Do not exceed the stated dose.' The SPC prints no maximum in milligrams, so no maxDose is written. NO PAEDIATRIC DOSE: not recommended under 18 years because data are insufficient. Medical advice should be sought or usual treatment taken if the symptoms of a UTI appear, and if the patient is not sure she has a UTI. A doctor should be consulted immediately if any of the following develop: fever, rigors, abdominal pain, spasms, 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. 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. All sections 4.1 to 4.8 were retrieved without a truncation marker.