Package leaflet: Information for the userGeloMyrtol® forte300 mg, gastro-resistant capsules, softActive substance:Myrtol standardized to at least 75 mg limonene, 75 mg cineole and 20 mg alpha-pinene.Read all of this package leaflet carefully because it contains important information for you.This medicinal product is available without prescription. However, you still need to takeGeloMyrtol® forte 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 10 days.- If any of the side effects affects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.In this leaflet:1. What GeloMyrtol® forte is and what it is used for2. Before you take GeloMyrtol® forte3. How to take GeloMyrtol® forte4. Possible side effects5. How to store GeloMyrtol® forte6. Further informationGeloMyrtol® forte is available in packs of 20, 50 and 100 gastro-resistant capsules, soft.1. What GeloMyrtol® forte is and what it is used forEffect: GeloMyrtol® forte is a herbal medicine. It liquefies mucus and promotes its transport, makes mucus easier to cough up and reduces inflammation.Used to treatacute and chronic bronchitis and inflammation of paranasal sinuses (sinusitis)2. Before you take GeloMyrtol® forteDo not take GeloMyrtol® forte:- if you have an inflammatory disorder of the stomach, gut or bile duct region, or if you have a severe liver disorder;- if you are known to be allergic (hypersensitive) to eucalyptus oil, sweet orange oil, myrtle oil, lemon oil or cineole (the main constituent of eucalyptus oil), or to any of the other ingredients.Take special care with GeloMyrtol® forte:- if your symptoms should persist or get worse, or if you develop shortness of breath or fever, or if you start coughing up mucus containing blood or pus-like matter, you should consult a doctor immediately.- if you suffer from bronchial asthma, whooping cough or other respiratory diseases accompanied by manifest hypersensitivity of the respiratory system, always consult your doctor before you take GeloMyrtol® forte.Taking other medicinesInform your doctor or pharmacist if you take/apply other medicines or did so recently even if it is/was a non-prescription product.Pregnancy and breast feedingBefore you take any medicine ask your doctor or pharmacist.- Pregnancy:Animal studies do not indicate direct or indirect harmful effects on the foetus. Caution is basicallyadvised when taking it during pregnancy.- Breast feeding:Due to the liposoluble properties of the active ingredient it can be assumed that its constituents are also present in the breast milk at minor concentrations. So far there has been no indication of any risk when using GeloMyrtol® forte during the time of breast feedingDriving and using machinesNo special precautions are required.3. How to take GeloMyrtol® forteAlways take GeloMyrtol® forte exactly as directed in this leaflet. You should check with your doctor or pharmacist if you are not sure.Unless otherwise prescribed by your doctor, the usual dose is:Adults, juveniles and children from the age of 12 with acute inflammatory symptoms should take 1 gastro-resistant soft capsule 3 – 4 times a day. Patients with chronic symptoms should take 1 gastro-resistant capsule 2 or 3 times a day. This dose is also recommended for a long-term treatment.For children the following doses of GeloMyrtol® forte are recommended:Age group Under 6(approx. 13 – 19 kg)From 6 to 10 years(approx. 20 – 29 kg)From 10 to under 12years(approx. 30 – 43 kg)Acute symptoms 1 x 1gastro-resistant capsule2 x 1gastro-resistant capsule2 –3 x 1gastro-resistant capsuleChronic symptoms 1 x 1gastro-resistant capsule1 –2 x 1gastro-resistant capsule2 x 1gastro-resistant capsuleDirections for useGeloMyrtol® forte capsules should be taken 30 minutes before a meal, with plenty of cold liquid. The last dose of the day can be taken before bedtime.Duration of treatmentThe duration of GeloMyrtol® forte treatment depends on the medical condition. For chronic respiratory diseases a long-term treatment is possible.If you take more GeloMyrtol® forte than you shouldPlease inform your doctor. He/she can then decide on any measures that may be required. The side effects listed below may occur in a more exaggerated form.If you forget to take GeloMyrtol® forteDo not take a double dose to make up for a forgotten dose. Continue taking GeloMyrtol® forte at your next scheduled time, as prescribed by your doctor or as described in the dosage instructions.4. Possible side effectsLike all medicines GeloMyrtol® forte can cause side effects, although not everybody gets them. The frequency of occurrence of side effects is based on the following categories:Very common: more than one men in 10 Common: 1 to 10 men in 100Uncommon: 1 to 10 men in 1,000 Rare: 1 to 10 men in 10,000Very rare: less than 1 men in 10,000Not known: Frequency not assessable based on the data availablePotential side effects:In uncommon cases, gastrointestinal complaints may occur, in the stomach/upper abdomen region, for example, in rare cases nausea, vomiting or diarrhoea. There have been rare reports of hypersensitive reactions (e.g. rash, itching facial swelling, shortness of breath and circulatory problems). In very rare cases kidney stones or gallstones present may become dislodged.Inform your doctor or pharmacist if one of the listed side effects affects you considerably or you notice side effects not indicated in this leaflet.5. How to store GeloMyrtol® forteKeep out of the reach and sight of children.Do not use GeloMyrtol® forte after the expiry date which is stated on the blister pack and outer carton. The expiry date refers to the last day of the month.Storage conditions:Store in the original package, in order to protect it from moisture. Do not store above 25°C.6. Further informationWhat GeloMyrtol® forte contains:The active substance is:1 gastro-resistant soft capsule contains 300 mg Myrtol standardized to at least 75 mg limonene, 75 mg cineole and 20 mg alpha-pinene.Other ingredients are:refined rapeseed oil; gelatin; glycerol 85%; sorbitol liquid 70% (non-crystallising); hypromellose acetate succinate; triethyl citrate; sodium laurilsulfate; talc; dextrin; glycyrrhizic acid, ammonium saltHow GeloMyrtol® forte looks like and contents of the pack:GeloMyrtol® forte are long, uncoloured, naturally cloudy soft capsules.The following pack sizes are available:Pack of 20 gastro-resistant capsules, softPack of 50 gastro-resistant capsules, softPack of 100 gastro-resistant capsules, softMarketing authorisation holder and manufacturerG. POHL-BOSKAMP GmbH & Co. KG Tel.: +49 (0)48 26 59 0Kieler Strasse 11 Fax: +49 (0)48 26 59 10925551 Hohenlockstedt E-mail: i nfo@pohl-boskamp.deGermany Internet:www.pohl-boskamp.deLatest revision of these instructions in January 2009。