PATIENT INFORMATION LEAFLET

Transcription

1 PATIENT INFORMATION LEAFLET BEVIT-B12 film tablet For oral use. Active substance: Each film-coated tablet contains 250 mg pyridoxine hydrochloride (Vitamin B 6 ), 250 mg thiamine hydrochloride (Vitamin B 1 ) and 1 mg cyanocobalamin (Vitamin B 12 ). Excipients: Lactose monohydrate (obtained from cow milk), microcrystalline cellulose, polyvinyl prolidone (povidone) K30, talc, hydroxypropyl methylcellulose, copovidone, polydextrose, polyethylene glycol, medium chain triglycerides, titanium dioxide (E 171), carmosine lacquer (E 122) and ponso 4R lacquer (E 124) Read all of this PATIENT INFORMATION LEAFLET carefully before you start using this medicine because it contains important information for you. Keep this PATIENT INFORMATION LEAFLET. You may need to read it again. If you have any additional questions, please contact your physician or pharmacist. This medicine has been prescribed personally for you. Do not pass it on to others. When you go to doctor or hospital while using this medicine, tell your doctor that you are using this medicine. Please completely follow the instructions in this information leaflet. Do not use higher or lower doses other than what is recommended to you. What is in this leaflet: 1. What is BEVIT-B12 and what is it used for? 2. Before you use BEVIT-B12 3. How to use BEVIT-B12 4. Possible side effects 5. How to store BEVIT-B12 1. What is BEVIT-B12 and what is it used for? BEVIT-B12 is a vitamin B complex containing 250 mg Vitamin B 1, 250 mg Vitamin B 6 and 1 mg Vitamin B 12 as active ingredient. Each box contains blister packs of 30 or 60 tablets. BEVIT-B12 composed of vitamins B 1, B 6 and B 12 have analgesic properties. BEVIT-B12 has an effect far exceeding that which would be achieved by the use of the respective vitamins. - It is used; In patients with a risk factor for Vitamin B1, B6 & B12 deficiency syndrome. - In patients with general complaints such as fatigue, forgetfulness, nervousness, weakness, tremor - In cases of nerve inflammation, nerve damage due to diabetes, nerve pain, shingles - In other aching conditions such as joint inflammation, periarticular inflammations, sciatica, low back pain, joint pain, muscle aches, cramps and rheumatic aches - As adjuvant treatment of heart muscle impairment, post-operative vomiting, radiation disease, rheumatic fever and especially alcoholism associated poisoning. 1/6

2 2. Before you use BEVIT-B12 DO NOT USE BEVIT-B12 in the following conditions: If, You are allergic to any of the ingredients of this medicine You are pregnant or breastfeeding You are younger than 12 You have liver or kidney failure TAKE SPECIAL CARE with BEVIT-B12 in the following conditions If, You are taking the medicine called Levodopa alone for Parkinson s Disease, you should not exceed several times the 2 mg dose which is the daily required dose of vitamin B 6. You have Leber disease (hereditary optic neuropathy) You have severe megaloblastic anemia (type of anemia that results from vitamin B 12 and/or folic acid deficiency) Irreversible neurological damage can develop in case of decreased concentration of vitamin B 12 or an abnormal decrease in concentration with maximum dose intake, inadequate treatment for longer than 3 months. Folate deficiency has not been demonstrated, but the result may not be the expected response. Because of the high concentration of pyridoxine hydrochloride (vitamin B6)1, the recommended dosage and duration of treatment should not be exceeded. Because, if not taken as suggested, serious neurotoxicity (undesirable side effect occurring in the nervous system) can be seen. Please consult your doctor even if these warnings apply to you at any time in the past. Using BEVİT-B12 with food and drink Excessive consumption of alcohol for more than 2 weeks may reduce the absorption of Vitamin B 12 through gastrointestinal system. Pregnancy Before using this medicine consult your doctor or pharmacist. It should not be used during pregnancy, as it contains high-dose vitamin B 6 which greatly exceed the recommended Daily Nutrient Intake. Women with childbearing potential should use effective contraception during treatment. Vitamin B 1, B 6 and / or B 12 have no effect on hormonal birth control methods. However no study is available on other control methods. If you notice that you have been pregnant during treatment, consult immediately your doctor or pharmacist. Breastfeeding Before using this medicine consult your doctor or pharmacist. It should not be used during breastfeeding, as it contains high-dose vitamin B 6 which greatly exceed the recommended Daily Nutrient Intake. Driving and using machinery No effects on ability to drive and use machine have been observed. 2/6

3 Important information on some excipients of BEVIT-B12 BEVIT-B12 contains lactose monohydrate and polydextrose, therefore if you have previously been told by your doctor that you have intolerance to certain sugars, you should consult your doctor before taking this medicinal product. Carmosine lacquer (E 122) and ponso 4R lacquer (E 124) used as colorant may cause allergic reactions. Taking other medicines Concomitant use of BEVIT-B12 with some medicines may alter the effect of either drugs. Tell your doctor if you use: Thiosemicarbazone (an antiviral, antifungal and antibacterial drug) 5-fluorouracil (used in the treatment of cancer) Antacids (drugs used for heartburn and indigestion) Levodopa (used in Parkinson's disease) Cycloserine (antibiotic) Hydralazine group medicines (used in high blood pressure and heart failure) Isoniazid (used in the treatment of tuberculosis) Desoxypyridoxine D-penicillamine (antibiotic) Birth control pill Alcohol Aminosalicylates (used in the treatment of inflammatory bowel disease) If colchicine (used in rheumatic diseases) is used with antibiotics, especially called aminoglycosides Antibiotics Folic acid Histamine (H2) receptor antagonists (used in gastric disorders) Metformin (used in non-insulin dependent diabetes) Proton pump inhibitors (used in stomach disorders) Vitamin C Effects on the tests Vitamin B1 may cause false positive results in the assay of urobilinogen using Ehrlich's reagent. High doses of B1 vitamins may inhibit the spectrophotometric assay of the concentrations of the drug called used in the treatment of respiratory tract diseases. If you are taking or have recently taken any other medicines, including medicines without a prescription, tell your doctor or pharmacist. How to use BEVIT-B12 Instructions for proper use and dosage/administration frequency: Take 1 film coated tablet a day unless otherwise recommended by your doctor. This medicine is usually prescribed for one to several weeks. In some cases the doctor may prolong the duration of treatment for a few months. 3/6

4 Route and method of administration: Swallow BEVIT-B12 tablets whole with plenty of water and use at recommended doses. Different age groups: Use in children: Do not use in children under the age of 12. In elderly: No special dosage is available. Special populations: Kidney/Liver Failure: Should not be used in patients with kidney and liver failure. If you have the impression that the effect of BEVİT-B12 is too strong or weak, talk with your doctor or pharmacist. If you use more BEVIT-B12 than you should: There is no evidence that this product may cause overdose if used as recommended. The symptoms that arise in case of an overdose are; sensory loss and impaired coordination in movements associated with nerve distruction, nausea, headache, numbness, somnolence, increased blood AST level (enzyme test used mostly in the diagnosis of heart and liver diseases) and decrease in blood folic acid concentrations. These effects are resolved if the treatment is stopped. If you used more BEVIT-B12 than was prescribed, tell your doctor or pharmacist. If you forget to use BEVIT-B12: Do not use a double dose to make up for a forgotten dose. Possible effects may occur when you stop taking BEVIT-B12: No known effect. 4. Possible side effects Like all medicines, BEVIT-B12 may cause side effects in patients sensitive to its ingredients. Side effects are classified as follows according to their frequency: Very common: may be seen in at least 1 in 10 patients; Common: may be seen less than 1 in 10 patients but more than 1 in 100 patients Uncommon: may be seen less than 1 in 100 patients but more than 1 in 1,000 patients Rare: may be seen less than 1 in 1,000 patients but more than 1 in 10,000 patients Very rare: may be seen in less than one in 10,000 patients; Not known: Cannot be estimated from the available data. 4/6

5 If any of the following reactions happen, stop taking BEVIT-B12 and tell your doctor immediately or contact the casualty department at your nearest hospital: Allergic reactions; Redness and blisters filled with water (hives) Rash Swelling of the face Difficulty in breathing with wheezing Bulging of the skin These are all very serious side effects of unknown frequency. If you experience one of these side effects, it means that you are severely allergic to BEVIT-B12. You may need urgent medical attention or to be hospitalized. If you notice any of the following side effects, tell your doctor immediately or contact the casualty department at your nearest hospital Dizziness Headache Peripheral neuropathy (condition where the nerves connected to the brain and spinal cord from other parts of the body are damaged or impaired) Somnolence (not too deep a semi-conscious drowsy state or a tendency to sleep). Paresthesia (impairment of sensory organs in sensation of touch, pain, temperature or vibration stimuli) Increased aspartate aminotransferase (an increase in the level of the enzyme called aspartate aminotransferase (ASP-SGOT) following a tissue damage in the liver, heart, muscle, kidney or brain) Decreased blood folate levels (decrease in blood serum level of folate, a water-soluble vitamin B in cases where the rate of cell division is high such as alcoholism, pregnancy, anemia, cancer or inadequate dietary intake) These are all serious side effects of unknown frequency. You may need urgent medical attention. If you notice any of the following side effects, tell your doctor: Diarrhoea Indigestion Nausea Abdominal pain Abnormal odor of urine These are mild effects of BEVIT-B12 of unknown frequency. Tell your doctor or pharmacist if you notice any other effects not listed in this leaflet. Reporting side effects Please inform your doctor, pharmacist or nurse if you get any side effect whether or not included in this leaflet. In addition, please report the side effect that you are experiencing to Turkish Pharmacovigilance Center (TÜFAM) by clicking to the icon "Reporting Drug Side Effects" at or call the reporting hotline dialing By reporting the side effects, you can help provide more information on the safety of this medicine. 5/6

6 5. How to store BEVIT-B12 Store BEVIT-B12 in its original packaging and keep out of the reach and sight of children. Store in a dry place, at room temperature below 25 C. Use in compliance with the expiry date. Use BEVIT-B12 before the date of expiry on the blister or packaging. Do not use BEVIT-B12 if you notice defects on the product and/or its packaging. Do not throw away drugs that have expired or are not used! Deliver to the collection system determined by the Ministry of Environment and Urbanism. Marketing authorization holder: Berko İlaç ve Kimya Sanayi A.Ş. Yenişehir Mah. Özgür Sok. No.: Ataşehir/İstanbul (Pbx) (Faks) info@berko.com.tr Manufacturer: Berko İlaç ve Kimya Sanayi A.Ş. Adil Mah. Yörükler Sok. No.: 2 Sultanbeyli/İstanbul (Pbx) (Faks) This patient information leaflet was last approved on 04/01/ /6