Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as shown in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. If you need advice or more information, talk to your pharmacist. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. Talk to a doctor if you get worse or if you do not get better after 48 hours. 1. What Cocculine sublingual tablets are and what they are used for. 2. What you need to know before you take Cocculine sublingual tablets. 3. How to take Cocculine sublingual tablets. 4. Possible side effects. 5. How to store Cocculine sublingual tablets. 6. Contents of the pack and other information. Homeopathic medicine with no approved therapeutic indications. Authorized through special simplified registration, which guarantees its pharmaceutical quality and safety, without the need to submit efficacy data (Directive 2001/83/EC). Consult a healthcare professional for its use and seek medical advice if symptoms persist. Do not take Cocculine sublingual tablets if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Cocculine sublingual tablets. Other medicines and Cocculine sublingual tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines not prescribed by a doctor. Taking Cocculine sublingual tablets with food and drink Take Cocculine sublingual tablets preferably away from food. Pregnancy, breast-feeding and fertility If you are pregnant, breast-feeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. Cocculine sublingual tablets contain lactose (sugar). If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine. This medicinal product contains less than 1 mmol of sodium (23 mg) per sublingual tablet; that is, essentially "sodium-free". Always take this medicine exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you are in any doubt, ask your doctor or pharmacist. The recommended dose is 1 or 2 sublingual tablets per dose. Do not exceed 6 sublingual tablets per day. Dissolve the sublingual tablet under the tongue. Although no studies have been conducted to support the paediatric dosage, the recommended dose is 1 or 2 sublingual tablets per dose. Do not exceed 6 sublingual tablets per day. For children under 4 years of age, dissolve the sublingual tablet in a little water and administer it when it has completely dissolved. In children under 2 years of age, it is recommended that this medicine be used under medical supervision. Space out doses according to improvement and stop taking this medicine if symptoms disappear. If symptoms worsen or if there is no improvement after 48 hours of starting treatment, consult your doctor or pharmacist. Cocculine sublingual tablets require an individualized dosage. Consult your pharmacist or doctor trained in homeopathy.Oral use.If you have taken more Cocculine sublingual tablets than you should, or in case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Poison Information Service at 915 620 420, indicating the medicine and the amount taken.If you forget to take Cocculine sublingual tabletsDo not take a double dose to make up for a forgotten dose.If you have any further questions on the use of this medicine, ask your doctor or pharmacist.Like all medicines, this medicine can cause side effects, although not everybody gets them.If you notice symptoms of allergy (hypersensitivity), stop taking Cocculine sublingual tablets.Reporting of side effectsIf 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 Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine. Keep this medicine out of the sight and reach of children. Store below 30°C. Do not use this medicine after the expiry date shown on the carton after "EXP". The expiry date refers to the last day of the month indicated. Do not use this medicine if you notice any visible signs of deterioration. Medicines should not be disposed of via wastewater or household waste. Deposit unused medicines at the SIGRE Point in the pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. In this way, you will help protect the environment.- The active ingredients are:Cocculus indicus 4 CH………………………0.625 mgNux vomica 4 CH……………………………0.625 mgTabacum 4 CH……………………………….0.625 mgPetroleum 4 CH………………………………0.625 mgFor one 250 mg sublingual tablet.- The other ingredients (excipients) are 246.25 mg of lactose, 2.5 mg of croscarmellose sodium (of which 0.31 mg correspond to sodium) and magnesium stearate.Appearance of the product and contents of the packCylindrical, slightly biconvex, white sublingual tablets.Box of 40 sublingual tablets packaged in blisters (PVC/Aluminium).Marketing authorisation holder:BOIRON SOCIEDAD IBÉRICA DE HOMEOPATÍA SAC/ Lanzarote, 228703 San Sebastián de los Reyes - Madrid Manufacturer responsible: BOIRON 2 Avenue de L'Ouest Lyonnais 69510 Messimy France You can request more information about this medicine by contacting the marketing authorisation holder. Date of last revision of this leaflet: November 2022 Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es