Ranitidine 300mg Tablets
Ranitidine 150mg and Ranitidine 300mg Tablets Ranitidine hydrochloride Ph. Eur
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist or nurse
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ranitidine is and what it is used for
2. What you need to know before you take Ranitidine
3. How to take Ranitidine
4. Possible side effects
5. How to store Ranitidine
6. Contents of the pack and other information
1. What Ranitidine is and what it is used for
The name of your medicine is Ranitidine 150mg and 300mg Tablets (called Ranitidine in this leaflet).
This belongs to a group of medicines called “H2 antagonists”.
Ranitidine works by lowering the amount of acid in your stomach. It can be used for the following:
Adults and the elderly (65 years and over)
• To treat or prevent ulcers in your stomach and duodenum (the part of the gut the stomach empties into)
• To treat or prevent ulcers caused by medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). This includes medicines such as aspirin, ibuprofen, ketoprofen and piroxicam
• To treat ulcers that can happen after an operation
• To help prevent ulcers from bleeding in seriously ill people or people who are known to have ulcers that bleed
• For an inflamed food pipe (oesophagitis) where stomach acid has travelled up into your food pipe
• For other problems due to too much acid in your stomach such as chronic indigestion or heartburn
• The management of Zollinger-Ellison Syndrome. This is a problem with your pancreas where too much acid in the stomach can cause ulcers in your stomach, duodenum, gut and food pipe
• For people at risk of breathing in acid from their stomach (aspiration). This might happen during an operation with a general anaesthetic or in women during labour
• To help clear up infection in your stomach when taken with antibiotic medicines.
Children (3 to 18 years)
• To treat ulcers in the stomach or the part of the gut it empties into (the duodenum) over a short period of time
• To treat and stop problems caused by acid in the food pipe or too much acid in the stomach with symptoms of indigestion, excessive burping or heartburn
Neonates
Safety and efficacy in new-born patients has not been established.
Ranitidine is the common (generic) name. Your doctor may have given you this medicine before from
another company and it may have looked slightly different. Either brand will have the same effect.
2. What you need to know before you take Ranitidine
Do not take Ranitidine if:
• You are allergic (hypersensitive) to Ranitidine or any of the other ingredients of this medicine (listed in Section 6).
Do not take Ranitidine if the above applies to you. If you are not sure, talk to your doctor or pharmacist or nurse before taking Ranitidine.
Warnings and precautions
Check with your doctor or pharmacist or nurse before taking your medicine if:
• You have stomach cancer
• You have kidney problems. Your doctor may reduce your dose if your kidneys do not work properly
• You have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory medicines (NSAIDs)
• You have a rare condition called acute porphyria
• You are over 65 years old
• You have lung disease
• You are diabetic
• You have any problems with your immune system.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ranitidine.
Other medicines and Ranitidine
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Ranitidine can affect the way some other medicines work. Also some other medicines can affect the way Ranitidine works.
In particular, please tell your doctor or pharmacist if you are taking any of the following:
• Medicines such as ibuprofen or aspirin, known as NSAIDs (non-steroidal anti-inflammatory drugs)
• Lidocaine, a local anaesthetic
• Propranolol, procainamide or n-acetylprocainamide, for heart problems
• Diazepam, for worry or anxiety problems
• Phenytoin, for epilepsy
• Theophylline, for breathing problems (asthma)
• Warfarin, for thinning your blood
• Glipizide, for lowering blood glucose
• Atazanavir or delaviridine, for treating HIV infection
• Triazolam, for insomnia
• Gefitnib, for lung cancer
• Ketoconazole, an anti fungal medicine, sometimes used for treating thrush
• Sucralfate, for treating stomach ulcers.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. You should not take this medicine unless your doctor advises it is essential.
Driving and using machines
You may feel dizzy or see things that are not there while taking this medicine. If this happens, do not drive or use any tools or machines.
3. How to take Ranitidine
Always take Ranitidine exactly as your doctor has told you. You should check with your doctor if you are not sure.
Taking this medicine
• Swallow the tablets whole with a full glass of water
• Your treatment may last between 4 and 12 weeks
• Keep taking your tablets until your doctor tells you to stop. Do not stop taking them because you feel better.
How much to take - adults and the elderly
Depending on what you are taking Ranitidine for, there are different doses. The usual doses are:
To heal or prevent ulcers caused by NSAID medicines or an operation
• 150mg twice a day. For serious ulcers you may be given 300mg twice a day
To prevent ulcers bleeding
• 150mg twice a day
Inflamed food pipe
• Either 150mg twice a day or just 300mg at night
• For longer term treatment you may use 150mg twice a day
• If the inflammation is severe, you may be given 150mg four times a day
How much to take - adults and the elderly (continued) Chronic indigestion
• 150mg twice a day Heart burn
• 150mg twice a day or just 300mg at night Zollinger-Ellison Syndrome
• 150mg three times a day
• If you need more, your doctor may give you up to 6g a day. They will tell you how many times a day you will need to take your medicine.
During an operation - to stop you breathing in acid from your stomach
• 150mg the evening before your operation, then 150mg two hours before your general anaesthetic.
During labour - to stop you breathing in acid from your stomach
• 150mg when you start labour, then 150mg for every 6 hours that you are in labour.
How much to take - children from 12 to 18 years
Your doctor will decide the correct dose, the usual doses are:
To treat stomach ulcers, inflamed food pipe, heartburn or indigestion
• 150mg twice a day (morning and evening), or 300mg at night.
How much to take - children from 3 to 11 years and over 30 kilogram (kg) bodyweight Your doctor will calculate the correct dose for your child based on your child's weight.
To treat stomach ulcers
• The usual dose is 4 to 8mg for each kilogram (kg) of bodyweight per day
• 150mg twice a day (morning and evening)
• The most that can be taken in a day is 300mg
• Treatment may last 4 to 8 weeks depending on the child's response.
To treat an inflamed food pipe, heartburn or indigestion
• The usual dose is 5 to 10mg for each kilogram (kg) of bodyweight per day
• 150mg or 300mg twice a day (morning and evening)
• The most that can be taken in a day is 600mg.
If you take more than you should
If you take more Ranitidine than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Ranitidine
• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Ranitidine
After a few days of taking the tablets you should start to feel much better. Do not stop taking the tablets without talking to your doctor or pharmacist first, otherwise the original pain and discomfort may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them. The following side effects may happen with this medicine:
See a doctor straight away, if you notice any of the following serious side effects:
• Allergic reactions - the signs include a skin rash, swollen or lumpy skin, you have difficulty breathing, chest pain, shortness of breath,have a fever or feel faint
• You have yellow skin or eyes. This could be a sign of inflammation of the liver (jaundice)
• You have severe abdominal pains. This could be a sign of inflammation of the pancreas (pancreatitis)
• You notice that you bruise more easily or have more nose bleeds than usual. You may also get more infections than usual such as a sore throat. These could be signs of changes in your blood cells
• You feel sick (nausea), more tired than usual, with a loss of appetite
• You develop a slow or uneven heart beat
• Inflammation of the liver (hepatitis) with flu-like symptoms or symptoms such as nausea
• Kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests.
Check with your doctor at your next visit if you notice any of the following:
Uncommon (may affect up to 1 in 100 people)
• Stomach pain, constipation, feeling sick (nausea).
Rare (may affect up to 1 in 1,000 people)
• Skin rash.
Rare side effects that may show up in blood tests:
• Increase of serum creatinine in the blood (kidney function test)
• Changes to liver function.
Check with your doctor as soon as possible if you notice any of the following:
Very rare (may affect up to 1 in 10,000 people)
• There can be changes in the level of certain substances in your blood. This can lead to you feeling unusually tired or short of breath and being more likely to bruise or get an infection
• Feeling depressed, confused, seeing or hearing unexplained things (hallucinations)
• Headache (sometimes severe), feeling dizzy or having blurred vision
• Your joints or muscles are painful or swollen or you cannot control their movement
• Your small blood vessels can become swollen (known as ‘vasculitis'). Signs of this can include: a rash, swollen joints or kidney problems
• Your liver can become swollen. This can lead to: nausea (feeling sick) or vomiting (being sick), loss of appetite or generally feeling unwell, itching, fever, yellowing of the skin and eyes or dark coloured urine
• Flushing or marks on your skin that look like targets
• Unexplained hair loss
• Diarrhoea
• Impotence
• Breast tenderness and/or breast enlargement, breast discharge
• Awareness of the heart beat and/or increased heart rate.
Not known (frequency cannot be estimated from the available data)
• Shortness of breath.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide information on the safety of this medicine.
5. How to store Ranitidine
Keep out of the sight and reach of children
• Do not use the tablets after the expiry date which is stated on the carton and blister strip after EXP. The expiry date refers to the last day of that month
• Do not store above 25°C. Store in the original packaging
• 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. Contents of the pack and other information
What Ranitidine contains
• The active substance is ranitidine hydrochloride. The tablets come in two strengths, containing equivalent to 150mg or 300mg ranitidine Ph. Eur
• The other ingredients are croscarmellose sodium, magnesium stearate, macrocrystalline cellulose (E460), polymethacrylate, hydroxypropylmethylcellulose, polyethylene glycol 6000, purified talc, titanium dioxide (E171)
• The 150 mg tablets are circular in shape, marked with a triangle on one side and a straight line on the other
• The 300 mg tablets are oblong in shape, marked with a triangle on one side and a straight line on the other.
Ranitidine is only available from your pharmacist on prescription in pack sizes of 30s (300mg) and 60s (150mg).
MA holder: Medley Pharma Limited, Unit 2A, Olympic Way, Sefton Business Park, Liverpool, L30 IRD, UK
366/03