Monday 23 July 2012

Ranitidine 150mg / 10ml Oral Solution





Ranitidine 150mg/10ml Oral Solution




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 pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet



  • 1. What Ranitidine Oral Solution is and what it is used for

  • 2. Before you take Ranitidine Oral Solution

  • 3. How to take Ranitidine Oral Solution

  • 4. Possible side effects

  • 5. How to store Ranitidine Oral Solution

  • 6. Further information





What Ranitidine Oral Solution is and what it is used for



Ranitidine belongs to a group of medicines called H2 antagonists, which reduce the amount of acid in your stomach.



For adults, this medicine is used to:



  • Heal and stop ulcers in the stomach, or 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.

    This can cause pain or discomfort known as indigestion or heartburn

  • Prevent ulcers from bleeding

  • Prevent ulcers which may be caused by medicines called Non-Steroidal Anti-Inflammatories (NSAIDs), often used to treat arthritis

  • Be given before an operation to prevent acid coming up from the stomach whilst under anaesthetic.

For children (3 to 18 years), this medicine is used to:



  • Heal ulcers in the stomach, or 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.

    This can cause pain or discomfort known as indigestion or heartburn.




Before you take Ranitidine Oral Solution




Do not take this medicine and speak to your doctor if you have ever had an allergic reaction to:



  • ranitidine

  • anything else in this liquid (listed in Further Information on the back page).

An allergic reaction can include a rash, itching or shortness of breath.



Do not take this medicine if you are pregnant or likely to become pregnant soon and if you are breast-feeding.





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 lost weight recently and also have stomach ache, stomach pain or indigestion at the same time

  • you are over 40 and recently had stomach ache, stomach pain or indigestion for the first time or which has recently changed.

You should see your doctor regularly especially if you are taking Ranitidine syrup as well as medicine for arthritis. This is particularly important in the elderly or those with a history of ulcers.





Taking other medicines



Tell your doctor if you are taking any of these medicines:



  • Non-steroidal anti-inflammatories (NSAIDs) e.g. indometacin, aspirin

  • glipizide or glibenclamide (diabetes medicine)

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



The amount of alcohol in this medicine (8%w/v) may affect your ability to drive or use machines.





Important information about some of the ingredients of this medicine:



This medicine contains:



  • Ethanol (alcohol) - each 5ml spoonful contains 8% w/v ethanol which is equal to 11ml of beer or 5ml of wine. Speak to the doctor before taking this medicine if you have an addiction to alcohol, liver disease, epilepsy, brain injury or disease, you are pregnant or if this medicine has been prescribed for a child.


  • This medicine contains sorbitol, a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


  • This medicinal product contains 11mg of sodium per 5ml dose. It is to be taken into consideration by patients on a controlled sodium diet.





How to take Ranitidine 150mg/10ml Oral Solution



  • 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

  • Ranitidine Oral Solution contains 75mg of ranitidine (as hydrochloride) in one 5ml spoonful

  • Take this medicine by mouth only.


Adults and children aged 12 years and above



For stomach or duodenal ulcers, adults usually take 150mg (two 5ml spoonsful) twice a day in the morning and evening or 300mg (four 5ml spoonsful) at bedtime for 4 weeks.



The doctor may change the dose.



There are rare diseases in which the acid production is very excessive and these are usually treated with a dose of 600mg to 900mg (40 to 60ml) or even higher.



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 Oral Solution in order to prevent the pain and discomfort returning. Depending on the disease you are being treated for, the usual dosage may be 150mg (two 5ml spoonsful) or 300mg (four 5ml spoonsful) once daily or 150mg (two 5ml spoonsful) twice daily.





Children (3 to 11 years)



Your doctor will work out the right dose in mls based on your child's weight. Make sure you follow the instructions on the label.



Treatment of stomach and duodenal ulcers:



The usual dose is 2mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4mg 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 2.5mg for each kg of body weight, twice a day for two weeks. This dose may be increased to 5mg for each kg, twice a day. Take each dose about 12 hours apart.



Please note that this medicine contains alcohol. See Section 2, Important information about some of the ingredients of this medicine for more details.





If you take more ranitidine than you should (overdose):



Taking more than it says on the label is unlikely to be dangerous, unless a lot of syrup is 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.






Possible side effects



Like all medicines, ranitidine 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 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 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

  • skin rash - occasionally severe (red spots/purple spots or rash) or itching

  • feeling confused

  • hallucinations (seeing, feeling or hearing things that are not there)

  • feelings of depression

  • inflamed blood vessels (vasculitis)

  • blurred vision

  • diarrhoea or constipation

  • kidney problems (symptoms may include a change in the amount of urine passed and its colour, nausea, vomiting, confusion, fever and rash)

  • recurring infections

  • fainting.




Tell your doctor if you get any of these side effects:



  • headache or dizziness

  • tiredness

  • pains in muscles or joints

  • uncontrolled movements. This usually stops once you stop taking this medicine

  • hair loss

  • if you are a man, breast tenderness, breast enlargement or sexual impotence. This sexual impotence usually gets better once you stop taking this medicine.



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.



Tell your doctor that you are taking ranitidine if you have a blood, urine or other test carried out as the medicine may affect the result.






How to store Ranitidine 150mg/10ml Oral Solution



  • Keep out of the reach and sight of children

  • Do not store above 25°C

  • Do not use 1 month from the date you first open it

  • Do not use after the expiry date (month, year) on the label and carton

  • 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 Oral Solution 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.




Further information




What Ranitidine 150mg/10ml Oral Solution contains



The active substance is Ranitidine Hydrochloride.



The other ingredients are disodium hydrogen phosphate, sodium dihydrogen phosphate, saccharin sodium, sorbitol solution, ethanol (alcohol) 8%w/v, garden mint flavour and purified water. Total sodium content 11mg/5ml.





What Ranitidine 150mg/10ml Oral Solution looks like and contents of the pack



Ranitidine 150mg/10ml Oral Solution is a white to pale yellow liquid which smells of mint.



It comes in a brown glass bottle holding either 100ml or 300ml of solution.





Marketing Authorisation Holder and Manufacturer




Rosemont Pharmaceuticals Ltd

Rosemont House

Yorkdale Industrial Park

Braithwaite Street

Leeds

LS11 9XE

UK

Tel: +44 (0)113 244 1400





This leaflet was last approved in November 2009.



P0485






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