Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lidocaine hydrochloride; Hydrocortisone
Bayer Plc
C05AX03
Lidocaine hydrochloride; Hydrocortisone
10mg/1gram ; 2mg/1gram
Spray
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 01070200; GTIN: 5010605829857
PATIENT INFORMATION LEAFLET HYDROCORTISONE PLUS LOCAL ANAESTHETIC Germoloids HC Spray BayerCross Hydrocortisone and Lidocaine READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Germoloids HC Spray carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET: 1. What is Germoloids HC Spray and what is it used for? 2. Before you use Germoloids HC Spray 3. How to use Germoloids HC Spray 4. Possible side effects 5. How to store Germoloids HC Spray 6. Further information 1. WHAT IS GERMOLOIDS ® HC SPRAY AND WHAT IS IT USED FOR? Haemorrhoids (also known as piles) are swollen or enlarged blood vessels, which can cause discomfort, itching and irritation, particularly after a bowel movement. They may be either internal (inside the anus) or external (outside the anus). Germoloids HC Spray is used to relieve the symptoms of external haemorrhoids, which include pain, itching and irritation immediately around the anus. The Spray contains two active substances: • Hydrocortisone - a steroid that occurs naturally in the body. When applied to the skin, steroids have been shown to reduce itching, redness and inflammation associated with certain skin problems. • Lidocaine hydrochloride - a local anaesthetic that relieves pain. 2. BEFORE YOU USE GERMOLOIDS ® HC SPRAY This medicine should only be sprayed outside the anal area (not inside the anus). DO NOT USE GERMOLOIDS HC SPRAY: • If you are allergic (hypersensitive) to hydrocortisone or lidocaine hydrochloride, or any of the other ingredients in the product (see section 6, Further Information). • On broken or infected skin. • If you are pregnant or breast-feeding. • If you are under 16 years o Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Germoloids ® HC Spray 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone 0.2% w/w Lidocaine Hydrochloride 1.0% w/w For excipients, see 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray solution. Colourless to pale yellow. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the symptomatic relief of anal and perianal itch, irritation and pain, associated with external haemorrhoids. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The product is for cutaneous use. Prime pump before initial use by depressing its top once or twice. Adults The product is applied by parting the buttocks if necessary, spraying once over the affected area, up to three times daily depending on the severity of the condition. The spray will operate in any orientation. Wash hands and replace cap after use. Elderly The same dose applies to the elderly. Children The spray should not be used in children under 16 years. 4.3. CONTRA-INDICATIONS Not to be used if sensitive to lidocaine or any of the other ingredients. Not to be used on broken or infected skin. Not to be used internally (inside the anus), or anywhere other than the anal area. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Germoloids HC Spray is intended for use for limited periods and should not be used continuously for longer than 7 days. Patients should be instructed to seek medical advice if they experience persistent pain or bleeding from the anus, especially where associated with a change in bowel habit, abdominal pain, if the stomach is distended or if they are losing weight. Prompt medical treatment may be very important under such circumstances. Germoloids HC Spray should be kept away from the eyes, nose and mouth. VISUAL DISTURBANCE: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which Soma hati kamili