Ranitidine 150mg/10ml Oral Solution
Patient Information Leaflet Ranitidine 150mg/10ml Oral Solution
This leaflet contains important information about Ranitidine 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 further questions, please ask your doctor or your 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.
• You must see your doctor if the symptoms worsen or do not improve after 3 days.
• If any of the side effects gets serious, or if you have 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 taking Ranitidine Oral Solution
3. How to take Ranitidine Oral Solution
4. Possible side effects
5. How to store Ranitidine Oral Solution
6. Further information
1. 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 (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).
• help clear up infection in your stomach, when taken with antibiotic medicines (medicines taken to treat germs)
• 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, 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. Both of these can cause pain or discomfort sometimes known as “indigestion”,”dyspepsia” or “heartburn”.
2. Before taking Ranitidine Oral Solution Do not use this medicine if you.....
• have ever had a bad reaction to ranitidine or any of the ingredients listed in section 6 (Further Information).
If you are not sure, talk to your doctor or pharmacist before taking Ranitidine Oral Solution.
Take special care with Ranitidine Oral Solution
Check with your doctor or pharmacist before taking your medicine if:
• you have stomach cancer
• you have kidney problems. You will need to take a different amount of Ranitidine Oral Solution
• you have had stomach ulcers before and you are taking Non-Steroidal Antiinflammatory (NSAID) medicines
• 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 using this medicine.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ranitidine Oral Solution can affect the way some medicines work. Also some other medicines can affect the way Ranitidine Oral Solution works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:
• Non-Steroidal Anti-inflammatory (NSAID) medicines, for pain and inflammation
• lidocaine, a local anesthetic
• 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
Midazolam is a medicine that may be given to you just before you have an operation. Tell the doctor you are taking Ranitidine before your operation in case he or she wants to give you midazolam.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ranitidine Oral Solution.
Pregnancy and Breast-feeding
If you are pregnant, might become pregnant or are breast feeding, you should not take this medicine unless your doctor advises it is essential. Ask your doctor or pharmacist for advice before any medicine if you are pregnant or breast feeding.
Driving and using machines
Your medicine is unlikely to affect your ability to drive or to operate machinery.
Important information about some of the ingredients of Ranitidine Oral Solution
• Maltitol liquid: If you have been told by your doctor that you have intolerance to some sugars contact your doctor before taking this medicinal product.
• Sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217): May cause allergic reactions (possibly delayed).
• This medicinal product contains 0.134mmol/ml (30.8mg per 10ml) of sodium. To be taken into consideration by patients on a controlled sodium diet.
• The peppermint flavour used in this medicinal product contains small amounts of ethanol (alcohol). The total ethanol (alcohol) content is less than 100 mg per 10ml of Ranitidine Oral solution.
3. How to take Ranitidine Oral Solution
Ranitidine Oral Solution should be swallowed. Follow your doctor's instructions about when and how to take your medicine. Also read the label. Your pharmacist can also help if you are not sure.
Your doctor will have decided what dose you should take each day depending on your condition. The usual daily dosages are:
Adults (including the elderly) and adolescents (12 years and over) is either:
• two 5ml spoonfuls in the morning and two 5ml spoonfuls in the evening, or
• four 5 ml spoonfuls at bedtime.
Your exact dose will depend on your particular stomach condition, your doctor will tell you the dose you should take.
Children from 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 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. Give 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. Give each dose about 12 hours apart.
If you take more Ranitidine Oral Solution than you should
Ranitidine is not normally harmful if you take more than you should, unless you take a lot of it at once. If this applies to you (or someone else taking this medicine) you should go to your nearest hospital casualty department straight away. Take the medicine pack or any remaining medicine, with you, so that the doctor knows what you have taken.
If you forget to take Ranitidine Oral Solution
• If you forget a dose, take it as soon as you remember it ,unless it is nearly time for your next one.
• Don't take a double dose to make up for a forgotten dose.
If you stop taking Ranitidine Oral Solution
After a few days of taking your medicine you should start to feel much better. Do not stop taking Ranitidine Oral Solution 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, Ranitidine Oral Solution can have side effects, although not everybody gets them
The following side effects may happen with this medicine.
Stop taking Ranitidine Oral Solution and see a doctor straight away, if you notice any of the following serious side effects, you may need urgent medical treatment:
• Allergic reactions, the signs may include:
- rash, itching or hives on the skin
- swelling of you face, lips tongue or other parts of the body
- chest pain, shortness of breath, wheezing or having trouble breathing
- unexplained fever and feeling faint, especially when standing up
• kidney problems, which can lead to back pain, fever, pain when passing urine, blood in the urine and changes in blood tests
• severe stomach pain, this may be a sign of something called ‘pancreatitis’
• a slow or irregular heartbeat
Check with your doctor at your next visit if you notice any of the following:
Uncommon (affects less than 1 in 100 people)
• stomach pain
• constipation
• feeling sick
Rare (affects 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 (affects less than 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
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 directly via www.mhra.gov.uk/yellowcard or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.
5. Storing Ranitidine Oral Solution
• Keep out of the reach and sight of children
• Do not store above 25°C. Store in the outer carton.
• Do not use Ranitidine Oral Solution after the expiry date which is stated on the bottle after Exp:. The expiry date refers to the last day of that month.
• Medicines should not be disposed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• Always keep the medicine in the bottle in which it was originally given to you.
6. Further information
Ranitidine Oral Solution is a clear colourless solution.
Each 10 ml of Ranitidine Oral Solution contains ranitidine hydrochloride 168mg as the active ingredient equivalent to 150mg of ranitidine.
It also contains the following inactive ingredients:
Glycerol, maltitol liquid, sodium saccharin, citric acid monohydrate, potassium dihydrogen phosphate, disodium hydrogen phosphate dihydrate, sodium chloride, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, peppermint flavour (contains ethanol) and purified water.
Each bottle contains 150ml or 300ml of oral solution.
A double ended 5ml and 2.5ml polypropylene spoon is also included to help measure the dose.
The Marketing Authorisation for Ranitidine Oral Solution (PL 35517/0015) is held by Percuro Medica Limited, Cunard Road, Park Royal, London NW10 6PN.
Ranitidine Oral Solution is manufactured and distributed by Percuro Medica Limited, Cunard Road, Park Royal, London NW10 6PN.
Leaflet updated October 2015 XXXX/XX