Patient Information Leaflet Please read this leaflet carefully before Echinacea using Irish Botanica Oral Liquid Echinacea. It contains important Echinacea Purpurea Root Tincture information about this product. Always take this medicine exactly as described in this • Suffer from a disorder which affects your leaflet or as your doctor or pharmacist have told you. white blood cells such as agranulocytosis (low • Keep this leaflet. You may want to read it white blood cell count due to bone marrow again. disorders) or leukaemia (blood cell cancer) • Ask your pharmacist if you need more • Are having treatment that reduces the information or advice. response of your immune system e.g. chemotherapy, radiotherapy. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side • Have had an organ or bone marrow effects not listed in this leaflet. See section 4. transplant • You must talk to a doctor if you do not feel better or if you feel worse after 14 days. Warnings and precautions • Do not exceed the recommended dosage What is in this leaflet • Talk to your doctor or pharmacist before taking this medicine if you have a tendency 1. What is Irish Botanica Echinacea Oral Liquid to allergies such as hives, allergic eczema or and what it is used for asthma. 2. What you need to know before you take Irish • If symptoms worsen, or you get a high fever Botanica Echinacea Oral Liquid while using this product, or symptoms persist 3. How to take Irish Botanica Echinacea Oral for more than 10 days, consult a doctor or Liquid pharmacist 4. Possible side effects 5. How to store Irish Botanica Echinacea Oral Children and adolescents Liquid Do not give this medicine to children or adolescents under the age of 18 years as it is not known if it is safe 6. Contents of the pack and other information to do so. Other medicines and Irish Botanica Echinacea Oral 1. What this product is and what it is used for Liquid: Irish Botanica Echinacea Oral Liquid contains Do not take this medicine if you are taking any tincture of Echinacea purpurea root. It is a traditional medicines that affect your immune system. herbal medicinal product used in adults to relieve Do not take this medicine if you are already taking common cold and flu-like symptoms, exclusively another medicine which is affected by alcohol. based on long-standing use. Always remember to tell your doctor or pharmacist about any medicines you are taking including herbal 2. Before you take this product medicines such as this one. Pregnancy and breast-feeding Do not take this product if you: Do not take this medicine if you are pregnant, breast- • Are allergic to Echinacea or to plants of feeding or planning to have a baby as it is not known if the Asteracea (Compositae) family such as it is safe to do so. daisies, marigolds or artichokes or to any of Driving and using machines the other ingredients of this medicine (listed in This product contains alcohol (see below for alcohol section 6). content). Overdose of this product may result in • Are under 18 years of age. alcohol intoxication. • Suffer from TB (the infection tuberculosis) Irish Botanica Echinacea Oral Liquid contains • Suffer from Sarcoidosis (connective tissue disease alcohol (ethanol) which causes the formation of clumps of cells This medicinal product contains 45% v/v ethanol mainly in the lymph nodes, lungs and liver) (alcohol), i.e. up to 0.9g per dose, equivalent to • Suffer from an autoimmune disease such as approximately 23ml beer, or 9ml wine per dose. collagenoses (inflammation of the connective Harmful for those suffering from alcoholism. To be tissue) or multiple sclerosis taken into account in pregnant or breast-feeding • Suffer from HIV, AIDS or another condition women, children and high-risk groups such as patients which decreases your resistance to infection with liver disease or epilepsy. Patient Information Leaflet • Destruction of blood cells by antibodies (Evans 3. How to take this product Syndrome) • Dryness in the mouth and eyes with kidney Always take this medicine exactly as described in dysfunction (Sjögren’s Syndrome) this leaflet or as your doctor or pharmacist has told you. The frequency of the above side effects is not known. Check with your doctor or pharmacist if you are not Reporting of side effects sure. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side Adults and older people: effects not listed in this leaflet. You can also report Take one 2.5ml spoonful in water, three times a day. side effects directly via Start at the first signs of a common cold. HPRA Pharmacovigilance, Earlsfort Terrace, IRL - For oral short-term use only. Dublin 2; Tel:+353 1 6764971; Do not use this product for more than 10 days. Fax:+353 1 6762517 If symptoms persist for more than 10 days, or worsen, Website: www.hpra.ie; or you get a high fever while using this product, E-mail: [email protected] consult a doctor or pharmacist. By reporting side effects you can help provide more Do not exceed the stated dose. information on the safety of this medicine. If you take more of this product than you should If you take more than the recommended dose, 5. Storing this product speak to a doctor or pharmacist and take this leaflet with you. Keep all medicines out of the reach and sight Overdose of this product may result in alcohol of children. intoxication and should be treated accordingly. Do not use this product after the expiry date stated (See Section 2 for alcohol content). on the bottle and carton. The expiry date refers to If you forget to take this product the last day of that month Continue to take your usual dose at the usual time. It Store in the original packaging. Do not store above does not matter if you have missed a dose. 25°C. Return any out of date medicine to your pharmacist who will dispose of it for you. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this 6. Product Description medicine, ask your doctor or pharmacist. Irish Botanica Echinacea is a medium to dark brown, clear oral liquid - a measuring cup, capable of 4. Possible side effects measuring 2.5 ml., is supplied with this product Like all medicines, this product can cause side Ingredients: Each 2.5 ml of oral liquid contains effects, although not everybody gets them. Stop 2.5 ml of tincture from dried Echinacea purpurea taking this product and check with your doctor (L.) Moench, radix (Purple Coneflower, root) (1:3). or pharmacist immediately if any of the following Extraction solvent: Ethanol 45 % v/v. The product also occur: contains purified water. This product is available in amber glass bottles of 100ml Allergic reactions such as: and 200ml. Not all pack sizes may be marketed. • Skin rash Manufacturer: • Red, itchy skin (hives) Rutland Biodynamics Ltd, Town Park Farm, Brooke, • Blistering of the skin, mouth, eyes or groin Rutland LE15 8DG, UK. (Stevens-Johnson-Syndrome) TR1723/001/001 • Swelling of the face or skin Traditional Herbal Registration Holder • Difficulty breathing Irish Botanica, 3-5 Charvey Business Park, Rathnew, • Asthma and life-threatening allergic reactions Co. Wicklow (anaphylactic shock). Echinacea can trigger allergic reactions in Leaflet prepared April 2018 patients who have a tendency to develop allergic conditions. Stop taking this medicine immediately if you experience any allergic reaction. Association with autoimmune diseases has been reported such as: • Inflammation of the brain and spinal cord (multiple sclerosis) • Painful lumps on the shins (erythema nodosum) • Low blood platelet count v1_12.