Presentation: 50 ml sterile solution in a pre-filled syringe with luer lock cone for intravesical use, containing 900 mg of purified bovine colostrum extract, 300 mg of bio fermentative chondroitin sulphate and thixotropic polymer. Indications: Controcyst is useful for providing relief of painful symptoms associated with forms of chronic inflammation of the urothelium and for restoration of the bladder glycosaminoglycan layers (GAGs). Controcyst is indicated for bladder and pelvic pain syndrome, including when induced by radiotherapy or chemotherapy. Method of use: Controcyst is instilled directly into the bladder through a catheter. The catheter is usually inserted by a nurse in an outpatient procedure, but patients may be trained to insert it at home. Self-catheterisation should not be performed without suitable training by qualified staff. Make sure the product is at room temperature before use. Empty bladder completely before use. Insert the catheter and connect it to the Controcyst syringe using the supplied connector. Instil the entire volume of Controcyst (50 ml) into the bladder by pushing the plunger of the syringe with a slow, continuous action to ensure steady instillation. Controcyst should remain in the bladder for at least 60-80 minutes and as long as possible; during this time, the patient should lie on one side, changing sides every 15-20 minutes to ensure the solution’s distribution over the surface of urothelium. Dosage: It is recommended to perform 1 instillation per week for four weeks of therapy after which treatment should be stopped and the patient reassessed. Contraindications: Hypersensitivity to chondroitin sulphate or to any of the ingredients of Controcyst. Precautions for use: Controcyst is designed for instillation in the bladder and must not be applied systemically. Controcyst must only be used according to the instructions. For single use only. Do not re-use. Discard any unused product after instillation. Do not use if the packaging is damaged, as the product may no longer be sterile. Do not use in pregnancy or breastfeeding. Do not use in children. Do not use if there is hypersensitivity to any of the ingredients. Patients whose clinical condition does not improve following the use of Controcyst should be reassessed. Interaction with other medicinal products has not been evaluated. Use in combination with other medicinal products should be based on clinical judgement. Self-catheterisation should not be performed without suitable training from a qualified healthcare professional. Keep out of the sight and reach of children. Side effects: Local irritation following the catheterisation and instillation procedure. Storage: Controcyst may be kept at room temperature in its own unopened packaging until the expiry date indicated. Avoid exposure to sources of heat. Do not freeze. Product classification/Legal Category: Class IIA Medical Device Cost: £85 CE Number: CE0426 Legal Manufacturer: Alfakjn S.r.l, P.zza della Repubblica, 22, 27026 Garlasco (PV) – Italy Distributor: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK. Version number: MAT-UK-CON-0008-1 | May 2026