Summary of Product Characteristics (SmPC) - Diaurtica tablets
1 NAME OF THE MEDICINAL PRODUCT
DiaUrtica Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
460 mg of extract (as dry extract) from Nettle root (Urtica dioica L. and/or Urtica urens L.) (7-14:1) (equivalent to 3.22-6.44 g of Nettle root).
Extraction solvent: Methanol 20% v/v
Excipients: each film-coated tablet contains 65 mg of lactose monohydrate. (See Section 4.4. ‘Special warnings and precautions for use.’)
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
White, biconvex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve the symptoms of urinary tract discomfort in men who have been told that they have an enlarged prostate (benign prostatic hyperplasia or BPH), based on traditional use only.
Prior to treatment other serious conditions should have been ruled out by a doctor.
4.2 Posology and method of administration
For oral use.
For adults and the elderly: take 1 tablet daily. Tablets should be swallowed whole with a little liquid. The tablet should not be chewed.
This medicine is not indicated for use in children and adolescents less than 18 years old (see Section 4.4. Special warnings and precautions for use).
Duration of use
Long-term use is possible on the advice of a doctor or qualified healthcare practitioner (see section 4.4 ‘Special warnings and precautions for use’).
4.3 Contraindications
Hypersensitivity to the active ingredient or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
This product is intended for use in men who have had benign prostatic hypertrophy (BPH) already diagnosed by a medical practitioner. Patients taking medication for benign prostatic hyperplasia (BPH) should consult their doctor before taking this product
If symptoms worsen, or if symptoms such as fever, spasms, blood in urine, painful urination, urinary retention, loin pain, abdominal or back pain occur during the use of the medicinal product, the patient should consult a doctor or qualified healthcare practitioner.
This product contains lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The use in children and adolescents under 18 years of age is not recommended, because lower urinary tract symptoms in these populations require medical supervision.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Fertility, pregnancy and lactation
This product is for use in men only.
No studies on the effects on fertility have been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive or use machines have been performed.
4.8 Undesirable effects
Gastrointestinal complaints (nausea, heartburn, diarrhoea, feeling of fullness, flatulence) and allergic skin reactions, such as pruritus, rash and urticaria have been reported. The frequency is not known.
If other adverse reactions occur a doctor or qualified healthcare practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the 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
None reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core
Cellulose, powdered
Silica, colloidal anhydrous
Lactose monohydrate
Croscarmellose sodium
Sodium starch glycollate (type A)
Stearic acid
Talc
Film-coating
Basic butylated methacrylate copolymer (Eudragit E 100)
Talc
Titanium dioxide E 171
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 30° C. Store in the original packaging.
6.5 Nature and contents of container
Original packages contain 30, 60, 90, 100 or 120 film-coated tablets. Not all pack sizes maybe marketed.
DiaUrtica Tablets are packed in PVC/PVDC-aluminium blisters and inserted into a carton.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Schwabe Pharma (UK) Ltd.
Alexander House, Mere Park, Dedmere Road,
Marlow SL7 1FX
8 MARKETING AUTHORISATION NUMBER(S)
THR 23056/0032
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/09/2017
10 DATE OF REVISION OF THE TEXT
30/01/2020