Ranitidine 150mg/10ml Oral Solution
TEUZD
TEVA UK LIMITED
Ranitidine 150mg/10ml Oral Solution
(Ranitidine hydrochloride)
Read all of this leaflet carefully before
you start using 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 get 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 150mg/10ml 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
1. What Ranitidine 150mg/10ml Oral Solution is and what it is used for
Your medicine is called Ranitidine 150mg/10ml Oral Solution (simply called Ranitidine Oral Solution throughout the rest of this leaflet).
Ranitidine Oral Solution is used to lower the amount of acid produced in your stomach.
Ranitidine Oral Solution is one of a group of medicines called acid antagonists or H2 antagonists. They lower the amount of acid produced in your stomach.
What this medicine does
Your doctor has prescribed Ranitidine Oral Solution for one or more of the following reasons:
If you are an adult:
a) to heal existing ulcers, either in your stomach or in your intestines;
b) to help stop ulcers occurring, either in your stomach, or in your intestines;
c) to stop an existing ulcer from bleeding;
d) for long-term treatment of healed ulcers;
e) to reduce the symptoms of indigestion or heartburn caused by acid in your stomach coming up into your gullet;
f) to reduce the symptoms of indigestion or heartburn which could be caused by food or may disturb your sleep;
g) because your stomach is producing too much acid;
h) because you are going to have an operation and it is important not to bring up acid from your stomach when you have the anaesthetic.
If you are a child between 3 and 18 years:
a) for the short term treatment of ulcers either in the child's stomach or gullet;
b) to reduce the symptoms of indigestion or heartburn caused by acid in the child's stomach coming up into their gullet.
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2. Before you take Ranitidine Oral Solution
- If your doctor has told you that you have a very rare hereditary condition called porphyria. Ranitidine Oral Solution can make the condition worse. You should not take it unless your doctor tells you to.
Using other medicines
Tell your doctor or pharmacist if you are taking any of the following medicines:
- diazepam, used to treat worry or anxiety problems;
- lidocaine, used as a local anaesthetic;
- phenytoin, used to treat epilepsy;
- propranolol, procainamide or n-acetylprocain-
amide, used to treat heart problems;
- theophylline, used to treat breathing problems such as asthma;
- warfarin, used to thin the blood;
- triazolam or medazolam, used to treat insomnia;
- glipizide, used to lower blood glucose levels;
- ketoconazole, an anti fungal medicine, sometimes used to treat thrush;
- atazanavir or delaviridine, used to treat HIV infection;
- gefitnib, used to treat lung cancer.
Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including any that you have obtained without a prescription.
It is important your doctor knows if you are taking drugs known as NSAIDS (Nonsteroidal AntiInflammatory Drugs).
- aspirin, ibuprofen, ketoprofen and naproxen are four of the most common NSAIDS but there are others. If you are taking any of them your doctor may need to give you regular check ups.
Pregnancy and breast-feeding
- If you are pregnant, thinking of becoming pregnant or breast-feeding ask your doctor or pharmacist for advice before you take Ranitidine Oral Solution.
- In pregnant women, ranitidine can cross into the unborn baby. It has also been found in breast milk.
- Ranitidine Oral Solution contains alcohol. The following section, "Important information about some of the ingredients in Ranitidine Oral Solution" tells you more about this.
Driving and using machinery
Ranitidine Oral Solution contains alcohol. Please remember this if you are driving or using machinery. The following section, "Important information about some of the ingredients in Ranitidine Oral Solution" tells you more about this.
Important information about some of the ingredients in Ranitidine Oral Solution Each 5ml spoonful of your medicine contains approximately 400mg of alcohol (8% w/v). This is about the same as drinking 8ml of beer or 3ml of wine for each 5ml spoonful. Take advice from your doctor if you have liver disease, epilepsy, brain injury, brain disease or drink a lot of alcohol.
Take advice from your doctor if Ranitidine Oral Solution is to be taken by a child, as they may recommend an alternative medicine.
If you are taking a large dose of Ranitidine Oral Solution, more than 35ml, this can be harmful if you are an alcoholic. Take advice from your doctor if you have liver disease, epilepsy, brain injury, brain disease, or you are pregnant or breast-feeding.
The amount of alcohol in a large dose of Ranitidine Oral Solution may alter the effects of other medicines. Please consult your doctor if you are taking large doses.
The amount of alcohol in a large dose of Ranitidine Oral Solution may affect your ability to drive or use machines.
Do not take Ranitidine Oral Solution:
- If you are allergic (hypersensitive) to ranitidine or any of the other ingredients. A list of the ingredients is given in Section 6 of this leaflet.
Take special care with Ranitidine Oral Solution
- If you have problems with your kidneys. Your doctor may put you on a lower dose.
- If you are over 65 years old.
- If you have lung disease.
- If you have diabetes.
- If you have problems with your immune system.
Your medicine contains sodium. If you have one or two 5ml spoonfuls, each dose will contain less than 23mg (less than 1 mmol) of sodium, i.e. it is essentially sodium free. If you have four 5ml spoonfuls, this will contain 39mg (1.68 mmol) of sodium. Tell your doctor if you are on a controlled sodium diet.
Your medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
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Focus Pharmaceuticals Ltd |
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Ranitidine Oral Solution Leaflet |
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Tel: 01283 495280 Fax: 01283 495290 |
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3. How to take Ranitidine Oral Solution
Always take Ranitidine Oral Solution exactly as your doctor tells you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents aged 12 years and over
- The usual dose of your medicine is two 5ml spoonfuls (150mg of ranitidine) in the morning and two 5ml spoonfuls (150mg of ranitidine) in the evening.
- The maximum dose is four 5ml spoonfuls (300mg of ranitidine) in the morning and four in the evening.
- Some patients may benefit from a single night time dose of four 5ml spoonfuls (300mg of ranitidine).
- Your doctor may alter the dose, tell you to take it at a different time or take it just once a day. If this happens, follow your doctor's instructions.
Elderly
- There is no need to alter the dose if you are elderly. You should take the adult dose.
Patients with kidney problems
- The usual dose is a single night time dose of two 5ml spoonfuls (150mg of ranitidine).
- If symptoms persist, the usual dose of two 5ml spoonfuls (150mg ranitidine) should be taken in the morning and in the evening.
Children aged 3-11 years
The dose for children is based on the child's weight. Your doctor will decide the correct dose.
Ulcers in the stomach and gullet:
- The usual dose is 4mg/kg to 8mg/kg body weight taken as two divided doses.
- The maximum dose is 300mg (20ml) per day.
Acid in the stomach and gullet:
- The usual dose is 5mg/kg to 10mg/kg body weight taken as two divided doses.
- The maximum dose is 600mg (40ml) per day.
Ranitidine Oral Solution should not be given to children under 3 years of age.
If you take more Ranitidine Oral Solution than you should
- If you take more Ranitidine Oral Solution than your doctor prescribed or you think a child has accidentally swallowed any, contact the nearest hospital Accident and Emergency Department or a doctor.
If you forget to take a dose of Ranitidine Oral Solution
- If you forget to take a dose, take another as soon as you remember.
- Then take your next dose at the normal time.
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4. Possible Side Effects
Very rarely someone may be allergic to Ranitidine Oral Solution. If you have any of the side effects listed below then you must stop taking Ranitidine Oral Solution and tell your doctor immediately:
- severe allergic reaction which may include a red and itchy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away;
- abdominal pain, fever, nausea and vomiting, which can be symptoms of pancreatitis.
Very rare (1 in 10,000 patients or less)
If you have any of the side effects listed below, please talk to your doctor immediately:
- unusual bleeding or bruising or your blood is slow to clot;
- you notice changes in your throat, mouth or skin;
- you become confused, depressed or hallucinate.
This is more likely to happen if you are elderly or very ill;
- you have a headache, this may be severe;
- dizziness;
- your vision becomes blurred;
- your heart beat slows and you feel light headed;
- you get purple spotting or bruising on your skin or you notice a rash;
- inflammation of small blood vessels causing purple spots on skin;
- hair loss;
- you get stomach pain or tenderness;
- your skin or whites of your eyes look yellow (jaundiced). This should get better once you stop taking the medicine;
- you get pain in your muscles or joints;
- you experience uncontrolled movement of your body;
- you notice blood in your urine or your produce less urine;
- problems with sexual function;
- tender or enlarged breasts.
Rare (between 1 in 1000 and 1 in 10,000 patients)
The following side effects also occur:
- skin rash;
- shortness of breath;
- changes to certain kidney or liver function tests;
- low blood pressure;
- chest pain.
Uncommon (1 in 1,000 patients or more)
- stomach ache;
- constipation;
- diarrhoea;
- feeling sick (nausea).
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 directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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5. How to store Ranitidine Oral Solution
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use after the expiry date stated on the bottle label and carton. The expiry date refers to the last day of that month.
Once the bottle has been opened you should only use it for three months.
Ask your pharmacist how to dispose of any that is left after this time or that you no longer require. Medicines should not be disposed of via wastewater or as household waste. This will help to protect the environment.
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6. Further Information
What Ranitidine Oral Solution contains
- the active substance is ranitidine hydrochloride. Each 10ml contains 150mg of ranitidine (as hydrochloride).
- the other ingredients are sorbitol solution (non crystallising), ethanol 96%, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, hydroxyethyl cellulose, peppermint flavour, saccharin sodium and water.
What Ranitidine Oral Solution looks like and contents of the pack
Ranitidine Oral Solution is a clear, pale yellow solution with a smell of peppermint. It is available in an amber glass bottle containing 300ml of medicine.
Manufacturer
Dales Pharmaceuticals Ltd, Skipton, N. Yorkshire, BD23 2RW, UK.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House, 1st Floor, 85 King William Street, London Ec4N 7BL, UK.
Tel: 01283 495 280 Fax: 01283 495 290 Email: medinfo@focuspharma.co.uk
For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.
For information in large print, audio CD or Braille please telephone 01283 495 280 or email medinfo@focuspharma.co.uk
This leaflet was last revised in 06/2015. 86344-Y