Braille Detail TOR Title: Retinol 4500 IU and Colecalciferol GENERICS r e t i n o l a n d 450 IU Capsules Retinol and Ref: RETCOL/TG/V1
Client: Tor Generics / Sabine De Swaaf c o l e c a l c i f e r o l Base Label 150 x 38mm Date: 18/04/16 Amended 10/02/17 Colecalciferol Item code: TBA TOR PRODUCT INFORMATION c a p s u l e , s o f t Excipients: Re ned sun ower oil, all-rac-α-Tocopherol, Gelatin, Size: 38mm x 150mm (Label Leaflet) GENERICS Glycerol, Puri ed Water. Each capsule provides: 2645 micrograms retinol palmitate (equivalent to 4500 IU vitamin A) and 11 capsule1 soft Retinol and micrograms colecalciferol (equivalent to 450 IU vitamin D3) Colours (label/leaflet) Non-Printed Emboss Read the package lea et before use. Colecalciferol For oral use. Swallow whole, do not chew. 4500 IU/450 IU Use as directed by your doctor. Process Process GUIDE BRAILLE This container is tted with a tamper evident top, if damaged CYAN Black Capsule, soft or missing do not use. Replace cap rmly after use. 84 Capsules Please store the capsules in the original pot. UPDATE o Do not store above 30 C. PL20491/0002 Tor Generics Ltd; DO NOT EXCEED THE STATED DAILY DOSE
BN: EXP: Northwood HA6 2TH, UK
Keep out of sight and reach of children. but do not remove here Peel Represents max text print area
Leaflet sits here
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Package lea et: Information for the user - Keep this lea et. You may need to read it again. What is in this lea et 6. Contents of the pack and other information Vitamin A is found in the diet. Vitamin A helps your Vitamins A and D may be prescribed by your doctor to are listed in section 6, Further information) need to measure the levels of calcium in your blood or Children and adolescents - Contraceptive pills increase the level of vitamin A in abciximab, clopidogrel, heparin, warfarin) may result - Glucocorticoids (steroid hormones such as used to treat fungal diseases) as they may interfere - Retinoids, including bexarotene - If you have any further questions, ask your doctor 1. What Retinol and Colecalciferol 4500 IU/450 IU immune system to work against infections, helps vision prevent vitamin A and D de ciencies. De ciency of - Have high levels of vitamin A and/or D in your blood urine Retinol and Colecalciferol 4500 IU/450 IU Capsules are your blood. in longer bleeding time. hydrocortisone or prednisolone). These can decrease with the metabolism of vitamin D. Retinol and Colecalciferol 4500 or pharmacist. Capsules are and what they are used for 1. What Retinol and Colecalciferol 4500 IU/450 IU and helps to keep your skin and linings of some body vitamins A and D may occur when your diet or lifestyle (hypervitaminosis A and/or D) - You su er from liver disease not suitable for children under 6 years. - Heart medicines (cardiac glycosides such as digoxin). Taking Retinol and Colecalciferol 4500 IU/450 IU - Medicines to treat epilepsy (such as phenytoin) or the e ect of vitamin D. - Medicines that can cause pseudotumor cerebri (a IU/450 IU Capsule, Soft - This medicine has been prescribed for you only. 2. What you need to know before you take Retinol and Capsules are and what they are used for parts, such as the nose, healthy. does not provide you enough vitamins A and D. - Have high blood levels of calcium (hypercalcaemia) - You are being treated for heart disease Your doctor may monitor your heart with an Capsules with food and drink Other medicines and Retinol and Colecalciferol medicines to make you sleep (barbiturates such as - Laxatives (such as paran oil) or a cholesterol condition in which the pressure around the brain Do not pass it on to others. It may harm them, even Colecalciferol 4500 IU/450 IU Capsules or high urine levels of calcium (hypercalciuria) - You have sarcoidosis (an immune system disorder electrocardiogram (ECG) and measure the levels of You can take Vitamins A and D3 with or without food Retinol (Vitamin A) and Colecalciferol Retinol and Colecalciferol 4500 IU/450 IU Capsules Vitamin D is found in the diet and is also produced in 4500 IU/ 450 IU Capsules phenobarbitone) as these medicines can decrease lowering drug called colestyramine may reduce the increases causing headaches and vision problems), if their signs of illness are the same as yours. 3. How to take Retinol and Colecalciferol 4500 IU/450 IU 2. What you need to know before you take Retinol - Have kidney stones or serious kidney problems which may a ect your liver, lungs, skin or lymph nodes) calcium in your blood. and drink. contain the active ingredients Vitamin A or retinol the skin after exposure to the sun. Often vitamin D is the e ect of vitamin D. absorption of vitamins A and D. including certain tetracycline antibiotics, as the (Vitamin D3) - If you get any side e ects, talk to your doctor or Capsules and Colecalciferol 4500 IU/450 IU Capsules - You are already taking additional doses of calcium or - Antiplatelet drugs, such as aspirin, and Vitamin E, the palmitate (2645 micrograms of retinol palmitate are given in combination with calcium. Vitamin D helps to Warnings and precautions Tell your doctor or pharmacist if you are taking, have - Thiazide diuretics (“water” pills) and vitamin D can - Actinomycin (a medicine used to treat some forms of pseudotumor cerebri symptoms may increase. Pregnancy, breast-feeding and fertility pharmacist. This includes any possible side e ects 4. Possible side e ects vitamin D. Whilst you are taking colecalciferol your e ects of antiplatelet drugs may be increased Read all of this lea et carefully before you start equivalent to 4500 IU Vitamin A) and Vitamin D3 or regulate the amount of calcium and phosphate in the Do not take Vitamins A and D if: Talk to your doctor before taking Vitamins A and D if: recently taken or might take any other medicines. increase the levels of calcium in your blood and may cancer), drugs to treat HIV/AIDS (such as efavirenz - Excessive alcohol consumption increases the risk If you are pregnant or breast-feeding, think you may be not listed in this lea et. See section 4. 5. How to store Retinol and Colecalciferol 4500 IU/450 doctor will monitor your blood levels of calcium to resulting in longer bleeding time. taking this medicine because it contains colecalciferol (11 micrograms of colecalciferol are body; these are needed to keep bones and teeth - You are allergic (hypersensitive) to vitamin A and/or D - You have kidney damage or disease. Your doctor will In particular the following medicines may interact with result in high blood levels of calcium and zidovudine) and imidazole antifungals of liver damage due to Vitamin A pregnant or are planning to have a baby, ask your doctor important information for you. IU Capsules equivalent to 450 IU of Vitamin D3). healthy. or any of the other ingredients in the capsules (these make sure they are not too high. Vitamin A and D3: - Medicines with an anticoagulant e ect (such as (hypercalcaemia). (medicines such as clotrimazole and ketoconazole or pharmacist for advice before taking this medicine.
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Do not use during pregnancy and lactation unless 3. How to take Retinol and Colecalciferol Use in children and adolescents - too much calcium in your urine (hypercalciuria). directly via the Yellow Card Scheme at: Do not store above 30oC. 6. Contents of the pack and other information - Free from: Gluten, nuts, starch, sugar, yeast and PRODUCT INFORMATION irritable, feel or be sick, become constipated or have If you have any further questions on the use of this Vitamin A toxicity has been reported in children. TOR advised by your doctor. 4500 IU/450 IU Capsules The recommended dose is one capsule per day. stomach pains, weak muscles, tiredness, lack of appetite, medicine, ask your doctor or pharmacist. Children may be irritable, be sick and lose appetite. www.mhra.gov.uk/yellowcard. arachis oil Manufacturer Excipients: Re ned sun ower oil, all-rac-α-Tocopherol, Gelatin, Rare side e ects (a ecting less than 1 in 1000 people) Do not use this medicine after the expiry date which is What Retinol and Colecalciferol 4500 IU/450 IU Capsules GENERICS Glycerol, Puri ed Water. Each capsule provides: 2645 micrograms kidney problems and in severe cases irregular heartbeats. By reporting side e ects you can help provide more Thorpe Laboratories Ltd, Golf Road Industrial Estate, Retinol andretinol palmitate (equivalent to 4500 IU vitamin A) and 11 Driving and using machines Side e ects with Vitamin D3 may include: - skin rash stated on the label after EXP. The expiry date refers to contain What Retinol and Colecalciferol 4500 IU/450 IU micrograms colecalciferol (equivalent to 450 IU vitamin D3) Always take this medicine exactly as your doctor or If you take more Retinol and Colecalciferol 4. Possible side e ects information on the safety of this medicine. Mablethorpe, Lincolnshire, LN12 1NB Retinol and These capsules should not a ect your ability to drive or - itching the last day of that month. Capsules look like and contents of the pack Read the package lea et before use. pharmacist has told you. Check with your doctor or 4500IU/450 IU Capsules than you should If you forget to take Retinol and Colecalciferol 4500 IU/ Uncommon side e ects (a ecting less than 1 in 100 Colecalciferol operate machinery. pharmacist if you are not sure. If you accidentally take too many capsules tell your Like all medicines, this medicine can cause side e ects, - hives 5. How to store Retinol and Colecalciferol - The active substances are retinol palmitate or Retinol and Colecalciferol 4500 IU/450 IU Capsules are This lea et was last revised in February 2017. For oral use. Swallow whole, do not chew. 450 IU Capsules people) Colecalciferol4500 IU/450 IU Use as directed by your doctor. although not everybody gets them. 4500 IU/450 IU Capsules Do not throw away any medicines via wastewater or Vitamin A and colecalciferol or Vitamin D3 available in PP pots containing 84 capsules. Retinol and Colecalciferol 4500 IU/450 IU Capsules doctor or get other medical advice immediately. If If you forget to take your capsules, take them as soon as you - too much calcium in your blood (hypercalcaemia). Reporting of side e ects Capsule, soft This container is tted with a tamper evident top, if damaged The capsule should be swallowed whole with water, possible, take the capsules, the box and this lea et can. Do not take a double dose to make up for a forgotten household waste. Ask your pharmacist how to throw - The other ingredient in the capsule are re ned or missing do not use. Replace cap rmly after use. contain re ned sun ower oil, all-rac-α-tocopherol. preferably with the main meal of the day. Side e ects with Vitamin A at the prescribed dose are You may feel or be sick, lose your appetite, have If you get any side e ects, talk to your doctor or Keep this medicine out of the sight and reach of children. away medicines you no longer use. These measures will sun ower oil, all-rac-α-tocopherol; the capsule shell 84 Capsules Please store the capsules in the original pot. with you to show the doctor. If you take too many dose. After that, take the next capsule in accordance with Marketing Authorisation Holder UPDATE o The capsule shell consists of gelatin, glycerol, puri ed rare, however, the frequency could not be determined constipation, stomach ache, feel very thirsty, have pharmacist. This includes any possible side e ects not help protect the environment. contains gelatin, glycerol, puri ed water. capsule1 softDo not store above 30 C. PL20491/0002 The recommended dose is one capsule per day. capsules you may experience drowsiness, feel the instructions given to you by your doctor. from the available data. Please store the capsules in the original pot. TOR Generics Ltd, Northwood, HA6 2TH UK Tor Generics Ltd; DO NOT EXCEED THE STATED DAILY DOSE water. muscle weakness, drowsiness or confusion listed in this lea et. You can also report side e ects BN: EXP: Northwood HA6 2TH, UK Keep out of sight and reach of children.