PACKAGE LEAFLET: INFORMATION FOR THE USER Xylo-COMOD 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 Xylo-COMOD 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 after 7 days. - If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Xylo-COMOD is and what it is used for 2. Before you use Xylo-COMOD 3. How to use Xylo-COMOD 4. Possible side effects 5. How to store Xylo-COMOD 6. Further information 1. WHAT XYLO-COMOD IS AND WHAT IT IS USED FOR Xylo-COMOD is a medicinal product for nasal application (nasal preparation) which contains the alpha-sympathomimetic agent xylometazoline. Xylometazoline has vasoconstrictive properties and thus effects decongestion of the nasal mucosa. Xylo-COMOD is used for - short term treatment in case of congestion of the nasal mucosa. Xylo-COMOD is intended for use by adults and school children. 2. BEFORE YOU USE XYLO-COMOD Do not use Xylo-COMOD in case of - hypersensitivity to xylometazoline hydrochloride or to any of the excipients of Xylo- COMOD, - dry inflammation of the nasal mucosa (rhinitis sicca), - after pinealectomy through the nose or other surgical interventions laying bare the dura mater, - babys and children under the age of 6 years.
Take special care with Xylo-COMOD Babies and young infants should be treated with special care. In single cases, severe side effects (particularly apnoea) have been reported after administration of the recommended dose in this age group. Overdose must unconditionally be avoided. In case of the following diseases and situations, Xylo-COMOD must be used only after consultation of your doctor: - elevated intraocular pressure, particularly narrow-angle glaucoma, - severe cardiovascular diseases (e.g. coronary heart disease) and hypertension, - in case you take mono-amino oxidase inhibitors (MAO inhibitors) or other drugs which potentially increase the blood pressure - if you suffer from a tumor of the suprarenal gland (pheochromocytoma) - metabolic disorders (e.g. hyperthyroidism and diabetes) - prostata enlargement - porphyria Permanent use of decongestive nasal preparations agents may lead to chronical swelling and finally atrophy of the nasal mucosa. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. The concomittant use of Xylo-COMOD and certain antidepressant medicinal products (monoamino oxidase (MAO-) inhibitors of the tranylcypromine type or tricyclic antidepressants) and hypertensive drugs can lead to an increased blood pressure. Please consider that this might apply as well for medicinal products which were used recently. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Since there are only limited data available on the safety profile of Xylo-COMOD during pregnancy and breast-feeding, Xylo-COMOD must only be used during pregnancy and breast feeding after advice by your doctor and after a careful consideration of benefit and risk through your doctor. The recommended dose must not be exceeded during pregnancy and breast feeding, as overdosing can impair the blood supply of the unborn child and might reduce the production of breast milk. Driving and using machines If used as recommended, no adverse effects are to be expected.
3. HOW TO USE XYLO-COMOD Always use Xylo-COMOD exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is: Adults and children above the age of 6 years apply one spray of Xylo-COMOD into each nostril up to three times a day. Mode of administration: Xylo-COMOD is intended only for local administration to the nose. Remove the protective cap (1) before first use. Hold the spray flask as shown and press the pump mechanism until a fine spray is emitted. Insert the nose adapter ("nozzle") (2) into each nostril and apply one spray into each nostril. In order to avoid solidification of the solution within the pump mechanism, the protective cover should be attached again after each usage. Duration of treatment: Xylo-COMOD should not be used longer than 7 days without consultation of a doctor. A renewed administration should take place only after a therapy-free interval of a couple of days. Use during chronic cold must be controlled by a doctor due to the risk of atrophy of the nasal mucosa. Please speak to your doctor or pharmacist if you feel that the effect of Xylo-COMOD is too strong or too weak. If you use more Xylo-COMOD than you should, please inform your doctor immediately. Intoxications can occur after excessive overdosing or due to intake of the medicinal product by mistake. The clinical picture of intoxication with Xylo-COMOD can be confusing, since periods of stimulation can alternate with periods of depression of the central nervous system and of the cardiovascular system. Especially in children, overdose can cause dominating central effects with convulsions and coma, bradycardia, apnoea as well as hypertension, which can alternate with hypotension.
Signs of a stimulation of the central nervous system are anxiety, excitement, hallucinations and convulsions. Signs of a depression of the central nervous system are: reduced blood heat, lethargy, sleepiness and coma. The following other symptoms can occur: miosis, mydriasis, fever, sweating, paleness, cyanosis, palpitation, respiratory depression and apnoea, sickness and nausea, psychogenic disturbances, hypertonia, hypotonia, cardiac arrhythmia, tachycardia, bradycardia. In case of intoxication, a doctor must be informed immediately, monitoring and control of the affected patient in a hospital is necessary. If you forget to use Xylo-COMOD Do not administer more than 1 spray in each nostril in case that you forgot the last administration. Rather, please continue with the administration as recommended. If you have any questions on the use of this product please ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Xylo-COMOD can cause side effects, although not everybody gets them. For the assessment of side effects the following frequencies of occurrence are defined: Very common: more than 1 of 10 treated patients Common: 1 to 10 of 100 treated patients Uncommon: 1 to 10 of 1000 treated patients Rare: 1 to 10 of 10 000 treated patients Very rare: less than 1 of 10 000 treated patients Not known: frequency on basis of the available data not assessable Nervous system: Very rare: restlessness, insomnia, tiredness (sleepiness, sedation), headache, hallucinations (particularly in children) Cardiovascular system: Rare: palpitations, tachycardia, increase in blood pressure Very rare: cardiac arrhythmia Respiratory tracts: Common: burning or dryness of the nasal mucosa, sneezing Uncommon: experience of an increased swelling of the mucosa after subsiding of the effect, nose bleeding Muscular and skeletal system: Very rare: convulsions (particularly in children) Immune system: Uncommon: hypersensitivity reactions (angioedema, exanthema, itching)
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE XYLO-COMOD Keep out of the reach and sight of children. Do not use Xylo-COMOD after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Storage conditions Do not store above 25 C. Shelf life after opening: Xylo-COMOD can be used for 8 weeks after first opening. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Xylo-COMOD contains The active substance is xylometazoline hydrochloride. The other ingredients are disodium edetate (Ph.Eur.); sodium dihydrogen phosphate dihydrate; disodium phosphate dodecahydrate (Ph.Eur.); sorbitol (Ph.Eur.); purified water. What Xylo-COMOD looks like and contents of the pack Xylo-COMOD is a clear, colourless solution, filled in a multiple dose container with gas-free pump-system. A pre-package contains one bottle with 15 ml of solution. Marketing Authorisation Holder and Manufacturer URSAPHARM Industriestraße 66129 Saarbrücken Tel: (+49) (0)6805/92 92-0 Fax: (+49) (0)6805/92 92-88 e-mail: info@ursapharm.de This leaflet was last approved in May 2007.