PATIENT INFORMATION LEAFLET. Excipients: Sorbitol 70% (E420), glycerol, hydroxyethyl cellulose, mint flavor, purified water.

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1 HEKSOBEN gargle For oral rinse PATIENT INFORMATION LEAFLET Active substance: 100 ml solution contains 120 mg (0.12%) chlorhexidine digluconate and 150 mg (0.15%) benzydamine hydrochloride. Excipients: Sorbitol 70% (E420), glycerol, hydroxyethyl cellulose, mint flavor, purified water. Please read THIS LEAFLET carefully before you start to take your medicine. It contains important information for you. Keep the leaflet in a safe place because you may want to read it again. If you have any other questions, please ask your doctor or pharmacist. This medicine has been prescribed for you; never give it to someone else. Tell the doctor that you use this medicine when you go to hospital or doctor. Follow the instructions exactly. Do not take higher or lower doses than prescribed for you. This leaflet contains: 1. What HEKSOBEN is and used for? 2. Before you start to take HEKSOBEN 3. How to use HEKSOBEN? 4. Possible side effects 5. How to store HEKSOBEN 1 - What HEKSOBEN is and used for? * HEKSOBEN is an oral preparation which is used for the treatment of oral cavities. * HEKSOBEN is a colorless and clear solution with a mint taste and odor. It is presented in amber-colored PET bottles of 200 ml with 15 ml scale. Each box contains 1 gargle of 200 ml. * HEKSOBEN is used for the prevention of infectious diseases causing inflammation in the mouth and throat, relief of swallowing function and relief of symptoms of gum disease. In dentistry HEKSOBEN may be used for preventive purpose before intervention. 2 - Before you start to use HEKSOBEN DO NOT USE HEKSOBEN in following conditions If; * You have hypersensitivity to benzydamine and chlorhexidine or other excipients. * You are pregnant or nursing. Use HEKSOBEN CAREFULLY in following conditions * It is only to rinse your mouth, do not swallow. * Due to the lack of clinical trials, HEKSOBEN is not recommended in children under 6 years of age. * Only use for the mouth. Avoid contacting with eyes and ears. 1

2 * There may reversible discoloration in the mouth, tongue, and teeth. Tooth staining is harmless and can be minimized by brushing teeth before the use of HEKSOBEN. * HEKSOBEN should not be swallowed and it should be removed by spiting. Use it as undiluted. * If sore throat is associated with the bacterial infection your doctor may consider adding antibacterial therapy. Please contact your doctor if these warnings apply to you even in the past. Taking HEKSOBEN with food and drink: Due to the method of administration there is no interaction with food or drink. Pregnancy: Before using the medicine, consult your doctor or pharmacist. Do not use HEKSOBEN if you are pregnant. If you notice that you are pregnant during treatment, consult your doctor or pharmacist immediately. Breastfeeding: Before using the medicine, consult your doctor or pharmacist. Do not use HEKSOBEN if you are nursing. Driving and using machines There is no effect on the ability to drive or use machines. Important information about some of the ingredients of HEKSOBEN Due to the sorbitol content, if you have already been told by your doctor that you are intolerant to some sugars please contact your doctor before using HEKSOBEN. HEKSOBEN contains glycerol. Because of the dose there is no need for a warning. Using other medicines * Chlorhexidine salts are incompatible with soap and other anionic compounds. * Chlorhexidine salts are compatible with cationic and nonionic surfactants, but when used with high concentrations the efficiency of chlorhexidine may decrease because of binding. * With the substances reducing the surface resistance such as cetrimide and lissapol NX the resolution can be increased. * Incompatible with anionic polyelectrolyte such as Arabic gum, sodium alginate, sodium carboxymethyl cellulose, starch and gum tragacanth and the effects are reduced by such materials. * Incompatible with brilliant green, chloramphenicol, copper sulfate, fluorescein sodium, formaldehyde, silver nitrate and zinc sulfate. * When diluted with hard water, because of the interaction with Ca +2 and Mg +2, it may precipitated as insoluble salts. * Chlorhexidine salts may precipitate with benzoate, bicarbonate, carbonate, borates, nitrates, phosphates and sulfate because the resolution less than 0.05% will form less salts. Because cetrimide increase the solubility of these salts, when it is combined with cetrimide no precipitation occurs. * Chlorhexidine is compatible with gluconate, cetrimide and benzalkonium chloride. These increase the bactericidal effect with coordination. Cetrimide prevents precipitation of 2

3 chlorhexidine in hard water. * Chlorhexidine and salts except chlorhexidine gluconate are more soluble in alcohol than in water. When alcohol is added chlorhexidine gluconate may precipitate. The presence of ethanol in the formulation makes the solution more active against Gram-negative microorganisms. It may be absorbed while flowing by cellulosic filters. No drug interactions have been reported with benzydamine. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 3 How to use HEKSOBEN? Instructions for appropriate use and dose/frequency of administration: The dose of HEKSOBEN is 15 ml in adults. It may be used at hour interval during the day. Route and method of administration: HEKSOBEN is for oral rinse or gargling. HEKSOBEN is used without being diluted. It is kept in the mouth for at least 30 seconds. It is discarded from the mouth after use. Chlorhexidine, which is contained in HEKSOBEN, reduces plaques and gingivitis during treatment. If HEKSOBEN is used as an alternative to other oral hygienic applications, the mouth should be rinsed with HEKSOBEN. To minimize the discoloration caused by chlorhexidine brushing the teeth before using HEKSOBEN is suitable. Different age groups: Use in children (between 6 to 12 years old): 5-15 ml of HEKSOBEN is used to rinse for 30 seconds every 1.5 to 3 hours. It should not be used continuously for more than 7 days. Mouthwash must be diluted with water if burning and stinging occur. Due to the lack of clinical trials, HEKSOBEN is not recommended in children under 6 years of age. Use in the Elderly: There is no need to adjust the dose in the elderly. Special population Kidney/liver insufficiency: Kidney function impairment: Since absorbed benzydamine and degradation products excrete in the urine in patients with severe kidney impairment the effects on the whole body should be considered. Liver function impairment: Since absorbed benzydamine breaks down in the liver in patients with severe liver impairment the effects on the whole body should be considered. Please follow these instructions unless your doctor advice otherwise. Do not forget to use your medicine in a timely manner. Your doctor will tell you how long you will use HEKSOBEN. Do not stop the treatment early because you will not have the desired result. If you have an impression that the effect of HEKSOBEN is too strong or too weak, talk with your 3

4 doctor or pharmacist. If you take more HEKSOBEN than you should If you take more HEKSOBEN than you should, tell your doctor or pharmacist. If HEKSOBEN is swallowed accidentally treatment should be for symptoms. There is no specific antidote. If you forget to take HEKSOBEN Do not take a double dose to make up for the forgotten dose. Possible effects after discontinuation of HEKSOBEN No effect is expected. 4 Possible side effects Like all medicines, HEKSOBEN can cause side effects in patients having sensitivity to its ingredients. Common side effects: * Numbness in the mouth. * Changes in taste. * Staining and increased tartar formation on teeth and other oral surfaces. Rare side effects: * Burning and stinging. Very rare side effects: * Dizziness. * Headache. * Drowsiness. * Nausea. * Vomiting. * Gagging. * Gastrointestinal diseases. * Local dryness. * Thirst. * Tingling. * Sensation of coolness in the mouth. If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you have any side effects listed or not listed in this leaflet, talk to your doctor, pharmacist or nurse. In addition report the side effects to the Turkish Pharmacovigilance Center (TUFAM) via clicking the button at Drug Side Effects Reporting at: or calling By reporting side effects you can help provide more information on the safety of this medicine. 5 - How to store HEKSOBEN 4

5 Keep HEKSOBEN out of the reach and sight of children and store in its original package. Store at room temperature below 25º C. Please use in accordance with expiration dates. Do not use HEKSOBEN after the expiry date stated on the packaging. If you notice any disturbances in the drug or packaging do not use HEKSOBEN. Marketing authorization holder: Oro Ilaçlari Ltd. Sti. Mimar Sinan Mah. Uskudar Cad. No. 01 Yedpa Ticaret Merkezi H-2 Cadde No Atasehir / ISTANBUL Manufacturing site: Pharmactive Ilac San. ve Tic. A.Ş Ataturk Mah., Fatih Blv., No. 32 ÇOSB Cerkezkoy/Tekirdag This leaflet was approved on May 26,

PATIENT INFORMATION LEAFLET

FERROZINC-G syrup, 100 ml For oral use PATIENT INFORMATION LEAFLET Active substance(s): Each 5 ml (1 spoon) syrup contains 40 mg iron (as ferrous gluconate) and 15 mg zinc (as zinc gluconate). Excipient(s):