RANITIDINE 300MG TABLETS
Active substance: RANITIDINE HYDROCHLORIDE
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Product: Ranitidine 150/300mg Tablets Country: Version: Originated : Size: SKU No: Item Code: UK 6 (Req. by Meheka)
17/07/08
Bar Code: Pharma Code: Crease Code: Origination by: Revision by: Revision date: Cols:
N/A N/A N/A Siddhesh Telang Siddhesh Telang 18/09/09 Black
G OLDSHIELD
A/Work sign Off: Final signatures:
Component: Leaflet
140 X 210mm (In-house) 10091-92/LF/A N/A
Date: Black
Account handler: Pradeep Oza
PATIENT INFORMATION LEAFLET
RANITIDINE 150mg/300mg TABLETS
Ranitidine Hydrochloride
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed only for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours. If any of these side effects gets serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. The name of your medicine is Ranitidine 150mg/300mg Tablets but will be referred to as Ranitidine Tablets throughout the remainder of this leaflet. In this leaflet: 1. What Ranitidine Tablets are and what they are used for 2. Before you take Ranitidine Tablets 3. How to take Ranitidine Tablets 4. Possible side effects 5. How to store Ranitidine Tablets 6. Further information 1. WHAT RANITIDINE TABLETS ARE AND WHAT THEY ARE USED FOR Ranitidine belongs to a group of medicines called H2 antagonists, which reduce the amount of acid in your stomach. For adults (including the elderly) Ranitidine is used to: heal and stop ulcers in the stomach, or the part of the gut it empties into (the duodenum) stop stomach ulcers when they are a side effect of some medicines stop ulcers from bleeding improve problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as indigestion, dyspepsia or heartburn stop acid coming up from the stomach while under anaesthetic during an operation. For children (3 to 18 years) Ranitidine is used to: heal ulcers in the stomach, of the part of the gut it empties into (the duodenum) heal and stop problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as indigestion, dyspepsia or heartburn. 2. BEFORE YOU TAKE RANITIDINE TABLETS Do not take this medicine and speak to your doctor if you have ever had an allergic reaction to: ranitidine anything else in these tablets (listed in Further Information on the back page). An allergic reaction can include a rash, itching or shortness of breath. Take special care with this medicine. Talk to your doctor before taking if: you have kidney problems you have a rare illness called porphyria you have been told that you have a gastric ulcer you are elderly and/or are taking non-steroidal antiinflammatories (NSAIDs) e.g. indometacin, aspirin you have breathing or heart problems you have weak immune system you suffer from diabetes You should see your doctor regularly especially if you are taking Ranitidine tablets as well as medicine for arthritis. This is particularly important in the elderly or those with a history of ulcers. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and Breast-feeding If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor before taking this medicine. Driving and using machines Ranitidine Tablets may cause dizziness. You should not drive or operate machinery if you experience this effect. Talk to your doctor if this effect becomes worse. 3. HOW TO TAKE RANITIDINE TABLETS Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure. Take this medicine by mouth only. Adults (including the elderly) and adolescents (12 years and over) For stomach or duodenal ulcers, adults usually take 150mg twice a day in the morning and evening or 300mg at bedtime. The doctor may change the dose. You will normally have to take this medicine for between four and eight weeks depending on how quickly your condition clears up. For inflammation of the gullet (oesophagitis) you may need to take this medicine for 12 weeks.
It is important that you keep taking the medicine until you finish the full course of treatment prescribed. Even when you feel better, your doctor may decide to continue your treatment with Ranitidine Tablets in order to prevent the pain and discomfort returning. Depending on the condition you are being treated for, the usual dosage may be 150mg or 300mg once daily or 150mg twice daily. Children over 30 kg of weight and from 3 to 11 years: Your doctor will work out the right dose for you based on your childs weight. Treatment of stomach or duodenal (small intestine) ulcers: The usual dose is 2 mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4 mg for each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment may be increased to 8 weeks. Treatment of heartburn due to too much acid: The usual dose is 2.5 mg for each kg of body weight, twice a day for two weeks. This dose may be increased to 5 mg for each kg, twice a day. Take each dose about 12 hours apart. If you take more Ranitidine Tablets than you should (overdose): Taking more than it says on the label is unlikely to be dangerous, unless many tablets are taken at once. In that case, phone your doctor or go to your nearest accident and emergency department straight away. If you forget to take this medicine: Take another dose as soon as you remember. Then go on as before. Do not take a double dose to make up for a forgotten dose. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ranitidine Tablets can cause side effects, although not everybody gets them. The side effects below may sometimes happen. If you have an allergic reaction to this medicine see a doctor immediately. An allergic reaction may include: any kind of skin rash occasionally severe (red spots/purple spots or rash), itching or "hives", flaking skin, boils or sore lips, swelling (of the face, eyelids, lips, mouth or tongue), fever. sudden wheezing, fluttering or tightness of the chest, chest pain, feeling faint especially when standing up or collapse. If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible: feeling sick, loss of appetite with or without jaundice (yellow colour of skin and white of eyes) as this may be due to hepatitis (inflammation/ infection of the liver) unusual tiredness, shortness of breath, bruising more easily, continual sore throat or fever or other signs of infection this could be a sign of blood problems slow or irregular heartbeats severe stomach pain rarely caused by an inflamed pancreas or a change in the type of stomach pain
feeling confused hallucinations (seeing, feeling or hearing things that are not there) feelings of depression loss of appetite. Tell your doctor if you get any of these side effects: headache or dizziness tiredness pains in muscles or joints if you are a man, breast tenderness and/or breast enlargement. If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. If you have taken all the medicine and still feel unwell, or if you have not taken all the medicine but feel worse, tell your doctor. 5. HOW TO STORE RANITIDINE TABLETS Keep out of the reach and sight of children. Store below 25C in a dry place. Do not use after the expiry date. The expiry date refers to the last day of that month. If it is out of date or you no longer want it, take it back to the pharmacy. Do not use Ranitidine Tablets if you notice anything wrong with the medicine. Talk to your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your Pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Ranitidine Tablets contain: Each Ranitidine 150mg Tablet contains the active ingredient ranitidine hydrochloride, equivalent to ranitidine 150mg. Each Ranitidine 300mg Tablet contains the active ingredient ranitidine hydrochloride, equivalent to ranitidine 300mg. The other ingredients are Croscarmellose sodium, Magnesium stearate, Microcrystalline cellulose, Hydroxymethylcellulose, Titanium dioxide, Talc, Polyethylene glycol 6000 and Polymethylmethacrylic acid copolymer. What Ranitidine Tablets look like and contents of the pack: Ranitidine 150mg Tablets are round white to yellow film coated tablets. They are available in aluminium foil blister packs of 60 tablets. Ranitidine 300mg Tablets are oblong white to yellow film coated tablets. They are available in aluminium foil blister packs of 30 tablets. Marketing Authorisation Holder and Manufacturer: Goldshield Pharmaceuticals Ltd., NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK. This leaflet was last revised in September 2009. 10091-92/LF/C
17/07/08
Bar Code: Pharma Code: Crease Code: Origination by: Revision by: Revision date: Cols:
N/A N/A N/A Siddhesh Telang Siddhesh Telang 18/09/09 Black
G OLDSHIELD
A/Work sign Off: Final signatures:
Component: Leaflet
140 X 210mm (In-house) 10091-92/LF/A N/A
Date: Black
Account handler: Pradeep Oza
PATIENT INFORMATION LEAFLET
RANITIDINE 150mg/300mg TABLETS
Ranitidine Hydrochloride
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed only for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours. If any of these side effects gets serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist. The name of your medicine is Ranitidine 150mg/300mg Tablets but will be referred to as Ranitidine Tablets throughout the remainder of this leaflet. In this leaflet: 1. What Ranitidine Tablets are and what they are used for 2. Before you take Ranitidine Tablets 3. How to take Ranitidine Tablets 4. Possible side effects 5. How to store Ranitidine Tablets 6. Further information 1. WHAT RANITIDINE TABLETS ARE AND WHAT THEY ARE USED FOR Ranitidine belongs to a group of medicines called H2 antagonists, which reduce the amount of acid in your stomach. For adults (including the elderly) Ranitidine is used to: heal and stop ulcers in the stomach, or the part of the gut it empties into (the duodenum) stop stomach ulcers when they are a side effect of some medicines stop ulcers from bleeding improve problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as indigestion, dyspepsia or heartburn stop acid coming up from the stomach while under anaesthetic during an operation. For children (3 to 18 years) Ranitidine is used to: heal ulcers in the stomach, of the part of the gut it empties into (the duodenum) heal and stop problems caused by acid in the food pipe (oesophagus) or too much acid in the stomach. Both of these can cause pain or discomfort sometimes known as indigestion, dyspepsia or heartburn. 2. BEFORE YOU TAKE RANITIDINE TABLETS Do not take this medicine and speak to your doctor if you have ever had an allergic reaction to: ranitidine anything else in these tablets (listed in Further Information on the back page). An allergic reaction can include a rash, itching or shortness of breath. Take special care with this medicine. Talk to your doctor before taking if: you have kidney problems you have a rare illness called porphyria you have been told that you have a gastric ulcer you are elderly and/or are taking non-steroidal antiinflammatories (NSAIDs) e.g. indometacin, aspirin you have breathing or heart problems you have weak immune system you suffer from diabetes You should see your doctor regularly especially if you are taking Ranitidine tablets as well as medicine for arthritis. This is particularly important in the elderly or those with a history of ulcers. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and Breast-feeding If you are pregnant, planning to become pregnant or are breast-feeding, talk to your doctor before taking this medicine. Driving and using machines Ranitidine Tablets may cause dizziness. You should not drive or operate machinery if you experience this effect. Talk to your doctor if this effect becomes worse. 3. HOW TO TAKE RANITIDINE TABLETS Take this medicine as your doctor or pharmacist has told you. Look on the label and ask your doctor or pharmacist if you are not sure. Take this medicine by mouth only. Adults (including the elderly) and adolescents (12 years and over) For stomach or duodenal ulcers, adults usually take 150mg twice a day in the morning and evening or 300mg at bedtime. The doctor may change the dose. You will normally have to take this medicine for between four and eight weeks depending on how quickly your condition clears up. For inflammation of the gullet (oesophagitis) you may need to take this medicine for 12 weeks.
It is important that you keep taking the medicine until you finish the full course of treatment prescribed. Even when you feel better, your doctor may decide to continue your treatment with Ranitidine Tablets in order to prevent the pain and discomfort returning. Depending on the condition you are being treated for, the usual dosage may be 150mg or 300mg once daily or 150mg twice daily. Children over 30 kg of weight and from 3 to 11 years: Your doctor will work out the right dose for you based on your childs weight. Treatment of stomach or duodenal (small intestine) ulcers: The usual dose is 2 mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4 mg for each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment may be increased to 8 weeks. Treatment of heartburn due to too much acid: The usual dose is 2.5 mg for each kg of body weight, twice a day for two weeks. This dose may be increased to 5 mg for each kg, twice a day. Take each dose about 12 hours apart. If you take more Ranitidine Tablets than you should (overdose): Taking more than it says on the label is unlikely to be dangerous, unless many tablets are taken at once. In that case, phone your doctor or go to your nearest accident and emergency department straight away. If you forget to take this medicine: Take another dose as soon as you remember. Then go on as before. Do not take a double dose to make up for a forgotten dose. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ranitidine Tablets can cause side effects, although not everybody gets them. The side effects below may sometimes happen. If you have an allergic reaction to this medicine see a doctor immediately. An allergic reaction may include: any kind of skin rash occasionally severe (red spots/purple spots or rash), itching or "hives", flaking skin, boils or sore lips, swelling (of the face, eyelids, lips, mouth or tongue), fever. sudden wheezing, fluttering or tightness of the chest, chest pain, feeling faint especially when standing up or collapse. If you get any of the following side effects, stop taking this medicine and see your doctor as soon as possible: feeling sick, loss of appetite with or without jaundice (yellow colour of skin and white of eyes) as this may be due to hepatitis (inflammation/ infection of the liver) unusual tiredness, shortness of breath, bruising more easily, continual sore throat or fever or other signs of infection this could be a sign of blood problems slow or irregular heartbeats severe stomach pain rarely caused by an inflamed pancreas or a change in the type of stomach pain
feeling confused hallucinations (seeing, feeling or hearing things that are not there) feelings of depression loss of appetite. Tell your doctor if you get any of these side effects: headache or dizziness tiredness pains in muscles or joints if you are a man, breast tenderness and/or breast enlargement. If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist. If you have taken all the medicine and still feel unwell, or if you have not taken all the medicine but feel worse, tell your doctor. 5. HOW TO STORE RANITIDINE TABLETS Keep out of the reach and sight of children. Store below 25C in a dry place. Do not use after the expiry date. The expiry date refers to the last day of that month. If it is out of date or you no longer want it, take it back to the pharmacy. Do not use Ranitidine Tablets if you notice anything wrong with the medicine. Talk to your pharmacist. Medicines should not be disposed of via wastewater or household waste. Ask your Pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Ranitidine Tablets contain: Each Ranitidine 150mg Tablet contains the active ingredient ranitidine hydrochloride, equivalent to ranitidine 150mg. Each Ranitidine 300mg Tablet contains the active ingredient ranitidine hydrochloride, equivalent to ranitidine 300mg. The other ingredients are Croscarmellose sodium, Magnesium stearate, Microcrystalline cellulose, Hydroxymethylcellulose, Titanium dioxide, Talc, Polyethylene glycol 6000 and Polymethylmethacrylic acid copolymer. What Ranitidine Tablets look like and contents of the pack: Ranitidine 150mg Tablets are round white to yellow film coated tablets. They are available in aluminium foil blister packs of 60 tablets. Ranitidine 300mg Tablets are oblong white to yellow film coated tablets. They are available in aluminium foil blister packs of 30 tablets. Marketing Authorisation Holder and Manufacturer: Goldshield Pharmaceuticals Ltd., NLA Tower, 12-16 Addiscombe Road, Croydon, Surrey, CR0 0XT, UK. This leaflet was last revised in September 2009. 10091-92/LF/C
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
