Package Leaflet: Information for the User

Transcription

1 Package Leaflet: Information for the User Tempocol Gastro-resistant soft capsules Peppermint Oil Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told to you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You must talk to a doctor if you do not feel better or if you feel worse within 14 days. What is in this leaflet 1. What Tempocol, capsules is and what it is used for 2. What you need to know before you take Tempocol, capsules 3. How to take Tempocol, capsules 4. Possible side-effects 5. How to store Tempocol, capsules 6. Contents of the pack and other information 1. What Tempocol, capsules is and what it is used for Tempocol, capsules is a Herbal Medicinal Product which is used to relieve the symptoms of minor spasms (light cramps) of the gastrointestinal tract, flatulence and abdominal pain. You must talk to a doctor if you do not feel better or if you feel worse within 14 days. 2. What you need to know before you take Tempocol, capsules Do not take Tempocol, capsules: - if you are allergic to peppermint oil or menthol or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your doctor or pharmacist before taking Tempocol, capsules - if you already suffer from heartburn (acid ingestion) or hiatal hernia (protrusion of the upper part of the stomach) symptoms sometimes worsen after taking Tempocol, capsules. You must stop using Tempocol, capsules in these cases. - The use of Tempocol, capsules is not recommended in children under 8 years of age, as there is no sufficient experience available. Status May 2015 Page 1 of 5

2 - The capsules should be swallowed whole, i.e. not broken or chewed, because this would release the peppermint oil prematurely possibly causing local irritation of the mouth and gullet (oesophagus). - If you suffer from liver disease - If you have inflammation of the bile duct (cholangitis), - If you suffer from a low production of gastric acid in the stomach(achlorhydria) - If you suffer from gallstones and any other biliary disorders. Other medicines and Tempocol, capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Other medicinal products used to decrease stomach acid, like histamine-2 blockers and proton pump inhibitors or antacids may cause premature dissolution of the enteric coating and should be avoided. Tempocol, capsules with food, drink and alcohol Use of food or antacids (medication to neutralize stomach acidity) administered at the same time could cause early release of capsule content. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Studies in animals have shown no effects disturbing the growth and development of an embryo or fetus (teratogenic effects) for Menthol It is unknown if peppermint constituents are excreted in human breast milk. In the absence of sufficient data, you should not take Tempocol, capsules during pregnancy and lactation. It is unknown if peppermint oil affects fertility. Driving and using machines No data on the effects on the ability to drive and use machines are available. Make sure you know how it affects you before you drive. If affected do not drive. 3. How to take Tempocol, capsules Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adolescents over 12 years of age, adults and the elderly The starting dose is 1 capsule taken 1-3 times daily. The dosage may be increased as necessary up to a maximum dose of 2 capsules 3 times daily. Children between 8 to 12 years of age 1 capsule up to three times daily Not for use in children under 8 years of age Special groups of patients: There is no information available regarding a dosing recommendation for patients with reduced kidney or liver function. Status May 2015 Page 2 of 5

3 The capsules should be swallowed whole, i.e. not broken or chewed, Do not exceed the stated dose The capsule(s) must be taken on an empty stomach before meals with a sufficient amount of cold liquid (preferably a glass of cold water). Duration of treatment The gastro-resistant capsules should be taken until symptoms (signs of illness) resolve, usually within two or four weeks. At times when the symptoms are more persistent, the intake of gastro-resistant capsules can be continued for periods of no longer than 3 months per course. Inform your doctor if symptoms persist. If you take more Tempocol, capsules than you should If you take more than the recommended dose speak to a doctor, pharmacist or healthcare practitioner and take this leaflet with you. Overdose may cause: severe symptoms in stomach and small and large intestine, diarrhoea, injuries of the rectum nausea (wamble), epileptic convulsions, loss of consciousness, apnoea (cessation of breathing), disturbances in rhythms of heartbeat, lack of coordination of muscle movement and other problems with the nervous system In the event of overdose, the stomach should be emptied by astic lavage. Observation should be carried out with symptomatic treatment, if necessary. If you forget to take Tempocol, capsules Continue to take your usual dose at the usual time, it does not matter if you have missed a dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Tempocol, capsules The use of this product can be stopped at any time. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side-effects, although not everybody gets them. The following adverse reactions were reported: - Urine and stools with an odour of menthol were observed. The frequency is not known. - Painful urination (dysuria) and inflammation of the glans of the penis have been reported. The frequency is not known. - Allergic reactions to menthol were reported, with headache, too low heart beat frequency (bradycardia), trembling (muscle tremor), lack of coordination of muscle movement (ataxia), anaphylactic shock and red skin eruptions (erythematous skin rash). The frequency is not known. - Acid ingestion (heartburn), perianal burning, blurred vision, nausea (wamble) and vomiting were reported. The frequency is not known. Discontiue use if the side effects are troubling. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting Status May 2015 Page 3 of 5

4 side effects you can help provide more information on the safety of this medicine. 5. How to store Tempocol, capsules Keep this medicine out of the sight and reach of children Do not use this medicine after the expiry date which is stated on the carton and the blister pack. The expiry date refers to the last day of that month. This product does not require any special storage conditions Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Status May 2015 Page 4 of 5

5 6. Content of the pack and other informations What Tempocol, capsules contains The active substance is peppermint oil. Each gastro-resistant soft capsule contains 182 mg of peppermint oil (Mentha piperita aetheroleum) The other ingredients are: Gelatin, Glycerol, Ethylcellulose, Sodiumalginate (E401), Medium-chain triglycerides, Stearic acid, Oleic acid. What Tempocol, capsules looks like and contents of the pack Tempocol, capsules are oval shaped, transparent-opaque soft capsule containing a clear liquid. Each pack contains 10, 15, 30, 60, 90 or 120 capsules Marketing Authorisation Holder and Manufacturer To be completed nationally Manufacturer of the finished product and batch release site: C.P.M. Contract Pharma GmbH & Co KG Frühlingstr. 7 D Feldkirchen-Westerham Germany Wievelhove GmbH Dörnebrink 19 D Ibbenbüren Germany Telephone: Telefax: This medicinal product is authorised in the Member States of the EEA under the following names: Belgium: Tempocol. Luxemburg: Tempocol.. Netherlands: Tempocol This leaflet was last revised Status May 2015 Page 5 of 5