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Ranitidine 30mg/Ml Oral Solution

Package leaflet: Information for the user

Ranitidine 30mg/ml Oral Solution

Ranitidine

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.

•    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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Ranitidine 30mg/ml Oral Solution is and what it is used for

2.    What you need to know before you take Ranitidine 30mg/ml Oral Solution

3.    How to take Ranitidine 30mg/ml Oral Solution

4.    Possible side effects

5.    How to store Ranitidine 30mg/ml Oral Solution

6.    Contents of the pack and other information

1.What Ranitidine30mg/ml Oral Solution is and what it is used for

Ranitidine Oral Solution contains a medicine called ranitidine. This belongs to a group

of medicines called H2-receptor antagonists. It lowers the amount of acid 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

•    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 Oral Solution is 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’.

2. What you need to know before you take Ranitidine 30mg/ml Oral Solution

Do not take Ranitidine Oral Solution:

• if you are allergic to ranitidine or any of the others ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor or pharmacist before taking Ranitidine Oral Solution.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ranitidine 30mg/ml Oral Solution 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.

Other medicines and Ranitidine 30mg/ml 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

•    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. 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.

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 taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines

Ranitidine oral solution is unlikely to affect your ability to drive or operate machinery. Ranitidine Oral Solution contains ethanol

Ranitidine Oral Solution contains ethanol (alcohol), i.e. up to 400mg per dose (5 ml).

For this reason, it may be harmful for those suffering from alcoholism. The ethanol content should also be taken into account if Ranitidine Oral Solution is to be given to pregnant or breast-feeding women, children and high risk groups such as those suffering from:

•    alcoholism

•    liver disease

•    epilepsy

•    brain injury or disease.

Each 2.5 ml contains approximately 200 mg of alcohol which is equivalent to about 5ml of beer or 2.5ml of wine. Talk to your doctor or pharmacist if you are concerned. He/she may be able to suggest an alternative formulation.

This medicine also contains 18.45 mg sodium per dose (5ml solution). To be taken into consideration by patients on a controlled sodium diet.

This medicine also 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.

3. How to take Ranitidine 30mg/ml 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.

Taking this medicine

•    Take this medicine by mouth.

•    Use the syringe provided to carefully measure the dose needed.

•    Do not mix Ranitidine Oral Solution with anything (not even water) before swallowing it.

The recommended dose for an adult (including the elderly) and adolescents (12 years and over) is either:

•    one 5 ml in the morning and one 5ml in the evening, or

•    two 5ml 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 2mg 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. 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 2.5 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. Take each dose about 12 hours apart.

If you take more Ranitidine Oral Solution than you should

Ranitidine Oral Solution is not normally harmful if you take more than you should, unless you take a lot of oral solution 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 dose.

•    Do not take a double dose to make up for a forgotten dose.

If you stop taking Ranitidine Oral Solution

After a few days of taking the oral solution you should start to feel much better. Do not stop taking the 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, this medicine can cause 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 your 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 (nausea)

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 (affect 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.

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.

5. How to store Ranitidine 30mg/ml Oral Solution

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of the month.

•    Shelf life after first opening of the bottle: Use within 2 months.

•    Store below 25°C

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 protect the environment.

6. Contents of the pack and other information

What Ranitidine Oral Solution contains

•    The active substance is ranitidine (as the hydrochloride)

•    The other ingredients are sorbitol (E420), ethanol, disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate, hydroxyethylcellulose, tutti frutti flavour, sodium saccharin, sucralose and sodium hydroxide solution 1.0N, purified water.

•    Each 5 ml does contains 7.5 % w/v ethanol (alcohol) i.e. up to 400 mg per dose.

What Ranitidine 30mg/ml Oral Solution looks like and contents of the pack

Ranitidine Oral Solution is a clear, yellow orange solution with characteristic fruit odour.

Cartons contain one 150 ml amber glass bottle.

A 5 ml oral syringe with 0.1 ml increments.

Marketing Authorisation Holder

Colonis Pharma Limited Hanover Place, 8 Church Road,

Royal Tunbridge Wells Kent, TNI 1JP,

United Kingdom

Distributed by:

Quantum Pharmaceutical Hobson Industrial Estate Burnopfield, County Durham NE16 6EA,

United Kingdom

Manufacturer:

RAFARM SA, Thesi Pousi- Xatzi, Agiou Louka, Paiania,Attiki 19002, P.O. Box 37, Greece

This leaflet was last revised in April 2014.

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