Ranitidine 150mg/10ml Oral Solution

(Ranitidine hydrochloride)

Read all of this leaflet carefully before you start using 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, 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 150mg/10ml Oral Solution is and what it is used for

2.    What you need to know 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.    Contents of fhe pack and ofher information

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1.    What RanHfdlne ISOmg/IOmI 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 contains a medicine called ranitidine. This belongs to a group of medicines called acid antagonists or H₂ antagonists. They lower the amount of acid produced in your stomach.

For adults Including the elderly. Ranitidine Oral Solution 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; to 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 'heartburn¹;

•    stop acid coming up from the stomach while under anaesthetic during an operation.

For children (3 to 18 years) Rantidtne Oral Solution b 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".

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2.    What you need to know before you take RanHidtne Oral Solution

Do not take RaniHdlne Oral Solution:

-    if you are allergic to ranitidine hydrochloride or any of the other ingredients of this medicine listed in Section 6.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ranitidine Oral Solution

•    if you have stomach cancer;

•    if you have problems with your kidneys. You will need to take a different amount of Ranitidine Oral Solution;

•    if you have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory (NSAID) medicines;

•    if you are over 65 years old;

•    if you have lung disease;

•    if you are diabetic;

•    if you have any problems with your immune system;

•    if you have a rare condition called acute porphyria.

Other medicines and Ranitidine Oral Solution

Tell your doctor or pharmacist if you are taking, 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 other medicines work. Also some other medicines can affect the way Ranitidine Oral Solution works. In particular tell your doctor or pharmacist if you are taking any of the following medicines:

-    non-steroidal Anti-Inflammatory (NSAID) medicines, for pain and inflammation (such as aspirin, ibuprofen, ketoprofen and naproxen). These 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.

-    diazepam, used to treat worry or anxiety problems;

-    Ildocaine, used as a local anaesthetic;

-    phenytoln, used to treat epilepsy;

-    propranolol procainamide or n-acetylprocatnamlde, for heart problems;

-    theophylline, for breathing problems (asthma);

-    warfarin, for thinning your blood;

-    triazolam for insomnia;

-    glipizide, for lowering blood glucose;

-    ketoconazole, an anti fungal medicine, sometimes used to treat thrush;

-    atazanavir or delavlrldine, for treating HIV infection;

-    gefltnlb, for lung cancer.

Midazolam is a medicine that may be given to you Just before you have an operation. Tell the doctor you are taking Ranitidine Oral Solution before your operation in case he or she wants to give you midazolam.

Pregnancy and breast-feeding Pregnancy

-    if you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine;

-    in pregnant women, ranitidine can cross into the unborn baby.

Breast-Feeding

-    Ranitidine has also been found in breast milk.

Driving and using machines

The amount of alcohol in a large dose of Ranitidine Oral Solution may affect your ability to drive or use machines.

Important Information about some of the Ingredients In RanHfdlne Oral Solution

Ranitidine Oral Solution contains alcohol. Please remember this if you are driving or using machinery.

Each 5ml spoonful of your medicine contains approximately 400mg of alcohol (8% w/v). This is about the same as drinking 8m I 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.

Ranitidine Oral Solution 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.

Ranitidine Oral Solution 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.

Dimension: Commodity No.: Pharma Code: Core Spec Ref: DCMF:

Print Colours;

146x260 mm

F1274

N/A

N/A

N/A

302 C

Non-Print Colours: Cutter

Tech App. Date:    17/08/2015

Min. Font Size:    7 pt

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3.    How to take Ranitidine Oral Solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults (Including the elderly) and children aged 12 years and over

The usual dose for an adult (including the elderly) or child aged 12 years and over is either:

-    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.

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

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

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 1 Omg/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;

-    do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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4.    Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 you produce less urine;

-    diarrhoea;

-    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;

-    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 this medicine after the expiry date which is 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

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6.    Contents of the pack and other 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 08/2015

103483/LF/035/01

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