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Ranitidine 150mg Tablets

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Document: leaflet MAH GENERIC_PL 04077-0229 change

Package leaflet: Information for the patient

Ranitidine 150 & 300 mg Tablets

Ranitidine Hydrochloride

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.

What is in this leaflet

1.    What Ranitidine Tablets are and what they are used for

2.    What you need to know before you take Ranitidine Tablets

3.    How to take Ranitidine Tablets

4.    Possible side effects

5.    How to store Ranitidine Tablets

6.    Contents of the pack and other information

1.    What Ranitidine Tablets are and what they are used for

Ranitidine 150 & 300 mg Tablets contain 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 Tablets are used to:

-    heal and stop ulcers in the stomach, or 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 Tablets are 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.    What you need to know before you take Ranitidine Tablets Do not take Ranitidine Tablets if:

-    you are allergic (hypersensitive) to ranitidine or to any of the other ingredients of this medicine (listed in section 6).

If you are not sure talk to your doctor or pharmacist before taking Ranitidine Tablets.

Warnings and precautions

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 Tablets

-    you have had stomach ulcers before and you are taking Non-Steroidal Anti-Inflammatory (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 Tablets

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you will buy without a prescription and herbal medicines. This is because Ranitidine Tablets can affect the way some other medicines work. Also some other medicines can affect the way Ranitidine Tablets work.

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 an operation. Tell the doctor you are taking Ranitidine Tablets 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 Tablets.

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.

3. How to take Ranitidine Tablets

Always take Ranitidine Tablets exactly as your doctor has told you. You should always check with your doctor or pharmacist if you are not sure.

Taking this medicine

-    Take this medicine by mouth.

-    Swallow each tablet whole with a glass of water.

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

-    150 mg in the morning and 150 mg in the evening, or

-    300 mg at bedtime.

Your exact dose will depend on your particular stomach condition, your doctor will tell you the dose you should take.

Children over 30 kg of weight and from 3 to 11 years:

Your doctor will work out the right dose for you based on your child’s weight.

Treatment of stomach or duodenal (small intestine) 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. 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 Tablets than you should

Ranitidine Tablets are not normally harmful if you take more than you should, unless you take many tablets 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 Tablets

-    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 Tablets

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 cause side effects, although not everybody gets them.

The following side effects may happen with this medicine.

Stop taking Ranitidine Tablets 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 Tablets

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 that month.

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 150 & 300 mg Tablets contain

-    The active substance is ranitidine hydrochloride 168.0 mg (equivalent to 150 mg Ranitidine) or 336.0 mg (equivalent to 300 mg Ranitidine).

-    The other ingredients are microcrystalline cellulose, polyvidone, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide (E171), talc, macrogol 6000 and methacrylic acid copolymer.

Cartons contain push through double foil blister strips. 150 mg strength cartons contain 60 tablets and the 300 mg strength cartons contain 30 tablets.

Marketing Authorisation Holder and Manufacturer

M&A Pharmachem Ltd, Wigan Road, Westhoughton, Bolton, Lancashire, BL5 2AL This leaflet was last revised in May 2015

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