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PACKAGE LEAFLET: INFORMATION FOR THE USER

LLOYDS PHARMACY INDIGESTION RELIEF TABLETS

(Ranitidine Hydrochloride)


Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without prescription.

However, you still need to take Ranitidine carefully

to get the best results from it.

*    Keep this leaflet, You may need to read it again

*    Ask your pharmacist if you need more information or advice.

*    You must contact a doctor if your symptoms worsen or do not improve after 6 days,

*    If any of the side effects gets 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 is and what it is used for

2.    Before you take Ranitidine

3.    How to take Ranitidine

4.    Possible side effects

5.    How to store Ranitidine

6.    Further information

WHAT RANITIDINE IS AND WHAT IT IS USED FOR

Ranitidine belongs to a group of medicines called H2 antagonists which works by reducing the amount of acid in your stomach which helps in the short term relief of acid related indigestion and heartburn.

VX BEFORE YOU TAKE RANITIDINE

Do not take Ranitidine

* if you are, or have ever been told you are allergic to Ranitidine or to any of the other ingredients in these tablets (an allergic reaction may include rash, itching, swollen face or lips, or breathing difficulties), See section 6 for a list of ingredients,

* if you are under 16 years of age,

Take special care with Ranitidine if:

* you have been diagnosed with or told you are at risk from a duodenal (part of the small intestine) ulcer * you are middle aged or older with new or recently changed symptoms of indigestion * you are suffering from any other illness or taking medicines either prescribed by your doctor or have been taking on your own * you have unexplained weight loss or have associated indigestion

* you are receiving medical attention for any reason * you have kidney and or liver problems.

* you suffer from porphyria (excess protein in the urine)

If any of the above applies to you, please talk to your doctor or pharmacist for advice if you have not already done so before taking Ranitidine.


Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, This particularly applies to the following:

-    If you are taking medicines known as non-steroidal anti-inflammatory drugs (NSAiDs) such as aspirin or ibuprofen (a pain relieving medicine). This advice is even more important if you are elderly

-    Ketoconazole (an antifungal agent)

-    Glipizide (a drug used to treat diabetes)

-    Theophylline (used in the treatment of asthma)

-    Sucralfate (an ulcer healing drug)

-    Antacids (for your stomach)

-    Procainamide (used to treat an irregular heart beat)

-    Toiazoline (used to treat spasm of blood vessels that supply blood to the hands and feet)

if you are taking antacids or Sucralfate (having discussed this with your doctor) ensure that Lloyds Pharmacy indigestion Relief Tablets are taken at least two hours before you take them.

Taking Ranitidine with food and drink:

Ranitidine should be swallowed whole with a glass of water, You should not drink alcohol when taking this medicine. The effects of alcohol may be increased by taking Ranitidine,

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Ranitidine should not be taken during pregnancy. If you become pregnant while taking Ranitidine you should talk to your doctor immediately.

It is also not advised to take this medicine while breast-feeding as Ranitidine passes into breast milk.

Driving or using machines:

There have been no reported effects on the ability to drive or operate machinery, However, side effects like severe dizziness, blurred vision and fatigue have been reported in patients whilst on Ranitidine, it is advisable to exercise caution when driving or operating machinery, If you get these side effects, do not drive or use machines or do anything else where you need to be alert and concentrate.

Important information about some of the ingredients of Lloyds Pharmacy Indigestion Relief Tablets

This medicinal product contains 0,31 mg of sodium (salt) per dose, This should be taken into consideration by patients on a controlled sodium (salt) diet. The tablets also contain castor oil. This may cause stomach upset and diarrhoea.

FI HOW TO TAKE RANITIDINE

Check the label to see how many tablets to take and how often to take them. The tablets should be swallowed whole with a glass of water.


The usual doses of Ranitidine are:

Adults, the elderly and children over the age of 16 years:

Take one tablet whenever the symptoms of acid-reiated indigestion and heartburn appear, day or night.

Do not take more than two tablets in 24 hours.

You should not take the tablets for more than 6 days continuously. You should not purchase a second pack of tablets without the advice of a pharmacist or doctor,

If you are unsure about how many tablets to take or when to take them, ask your doctor or pharmacist.

Do not give these tablets to children under 16 years of age,

Do not take any other medicine (including non-prescription medicines) without first checking with your doctor.

If you take more Ranitidine than you should:

If you have taken too much Ranitidine, or if someone else has taken your medicine, you / they should contact your doctor or your nearest hospital casualty department immediately. Please take any remaining medicine with you in the carton in which it came so that staff will know what has been taken,

If you forget to take Ranitidine

Take it as soon as you remember then continue as before, if it is nearly time for your next tablet, leave the missed dose and continue as before. Do not take more than two tablets in 24 hours, Do not take a double dose to make up for a missed dose.

If you have any further questions on the use of this product, ask your doctor,

[] POSSIBLE SIDE EFFECTS

Like all medicines, Ranitidine can have side effects, although not everybody gets them.

Stop taking the tablets and tell your doctor immediately if you experience any of the following rare effects:

*    Sudden wheeziness or tightness in the chest or throat, difficulty in breathing, speaking and swallowing,

*    itchy skin rash (hives) or swelling on the eyelids, face, neck or lips

*    Feeling faint,

These are all possible signs of a severe allergic reaction,

If you notice any of the following side effects, tell your doctor immediately.

*    Severe stomach pain, nausea, loss of appetite, diarrhoea or constipation

*    Unusual tiredness, shortness of breath, tendency to bruising, unexplained fever or frequent interactions

*    Slow or irregular heart beat

*    Skin rash, itching or, jaundice (yellow skin or whites of eyes)

*    Depression, hallucinations, confusion or feeling agitated

*    Fieadache, dizziness, blurred vision


*    Pain in muscles and joints

*    in men swollen or tender breasts, difficulty in achieving or maintaining an erection

There have been a few isolated reports of blood abnormalities. This would only usually be seen after you have had a blood test, Your doctor may perform blood tests to check for abnormalities while you are taking Ranitidine.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please teii your doctor or pharmacist,

El HOWTO STORE RANITIDINE

Do not store above 25°C. Store in the original container to protect them from light.

Keep out of the reach and sight of children.

Do not use Ranitidine after the expiry date which is stated on the blister and outer carton after EXP,

The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required, These measures will help to protect the environment.

n FURTHER INFORMATION

What Lloyds Pharmacy Indigestion Relief Tablets contain

The active ingredient is: Ranitidine Hydrochloride

Each film-coated tablet contains 83,75mg of ranitidine hydrochloride, equivalent to 75mg of ranitidine, as the active ingredient,

The other ingredients are:

The tablets also contain some inactive ingredients: microcrystaliine ceiluiose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and talc, Film-coating on the tablets contain: castor oil & Opadry OY-S-54902 Pink which contains hypromellose, talc, titanium dioxide (E171) and red ferric oxide (E172). The Printing ink contains Opacode-S-l-27794 Black which contains Shellac, iron oxide black (E172), n-butyl alcohol and propylene glycol.

What Lloyds Pharmacy Indigestion Relief Tablets look like and contents of the pack

Lloyds Pharmacy Indigestion Relief Tablets are light pink, round, biconvex, film coated tablets printed with “75” in black edible ink on one side,

Lloyds Pharmacy Indigestion Relief Tablets are available in packs containing 6,10,12, 20, 24 or 28 tablets, Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Fiolder: Ranbaxy (UK) Limited, 20, Balderton Street, London W1K 6TL, United Kingdom,

Manufacturer: Ranbaxy Ireland Limited, Spafield,

Cork Road, Cashel, Co. Tipperary, Ireland.

Leaflet revision date: August 2009


Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription for you to treat a mild illness without a doctor’s help. Nevertheless, you still need to use Lioydspharmacy Indigestion Relief Tablets carefully to get the best results from them.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must see a doctor if your symptoms worsen or do not improve after 6 days.

In this leaflet:

1.    What are Lioydspharmacy Indigestion Relief Tablets and what are they used for

2.    Before you take Lioydspharmacy Indigestion Relief Tablets

3.    How to take Lioydspharmacy Indigestion Relief Tablets

4.    Possible side effects

5.    Storing Lioydspharmacy Indigestion Relief Tablets

Your medicine is called Lioydspharmacy Indigestion Relief Tablets.

Each film-coated tablet contains 83.75mg of ranitidine hydrochloride, equivalent to 75mg of ranitidine, as the active ingredient. The tablets also contain some inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and talc.

Film-coating on the tablets contain: castor oil & Opadry OY-S-54902 Pink which contains hypromellose, talc, titanium dioxide (El71) and red ferric oxide (El72).

The Printing ink contains Opacode-S-I-8152HV Black which contains Shellac, black ferric oxide (El72), n-butyl alcohol, Soya lecithin MC thin and Antifoam DC 1510.

Marketing Authorisation Holden Ranbaxy (UK) Ltd., 95 Park Lane, Mayfair, London WIY 3TA. Manufacturer: Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co. Tipperary, Republic of Ireland.


I. What are Lioydspharmacy Indigestion Relief Tablets and what are they used for


These tablets contain ranitidine, one of a group of medicines called Histamine H2 antagonists. These work by reducing the amount of acid in your stomach, which can help in the short-term to relieve the symptoms of acid-related indigestion and heartburn.

Lioydspharmacy Indigestion Relief Tablets are light pink, round, biconvex tablets printed with 75’ black ink on one side.

Lioydspharmacy Indigestion Relief Tablets come in the following packs: Blister sheets of 6 or 10 film-coated tablets each, in boxes of 6, 10 or 12 tablets. Not all pack sizes may be marketed.


2. Before you take Lioydspharmacy Indigestion Relief Tablets


Do not take this medicine if any of the following apply to you.

•    you have ever had an allergic reaction (this may include rash, itching, swollen face or lips, or breathing difficulties) to ranitidine hydrochloride or to any of the ingredients listed above.

•    you are under 16 years of age.

Before taking this medicine tell your doctor or pharmacist if:

•    you have been diagnosed with or told you are at risk from a stomach or duodenal (part of the small intestine) ulcer

•    you are middle aged or older and have new or recently changed indigestion symptoms

•    you have lost weight unintentionally and have associated indigestion

•    you have liver or kidney problems

•    you are receiving regular medical attention for any reason

•    you are suffering from any other illness or taking any other medicines either prescribed by your doctor, bought from the pharmacist or self-prescribed

•    you are regularly taking medicines known as non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin or ibuprofen, especially if you are elderly

•    you suffer or have suffered on occasion with an excess of protein in the urine (porphyria)

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, breast-feeding or trying to become pregnant.

Important information about some of the ingredients of this medicine

This medicinal product contains 0.31 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet. The tablets also contain castor oil. This may cause stomach upset or diarrhoea. Driving and operating machinery

There have been no reported effects on the ability to drive or operate machinery.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed but bought/obtained without a prescription._


Care is needed if you are taking any of the following medicines:

•    NSAIDS (e.g. aspirin or ibuprofen)

•    antacids (help neutralize stomach acid)

•    sucralfate (an ulcer healing drug)

•    procainamide (a medicine used in treating abnormal heartbeat)

•    theophylline (used in the treatment of asthma)

•    ketoconazoie (an anti-fungai medicine)

•    glipizide (a medicine used to treat diabetes).

If you are taking antacids or sucralfate having discussed this with your doctor, please ensure that Lloyds pharmacy Indigestion Relief Tablets are taken at least two hours before such medicines.

Since the effects of alcohol may be enhanced by these tablets, talk to your doctor about how much alcohol you may consume whilst taking this medicine.


3. Howto take Lloydspharmacy Indigestion Relief Tablets


Check the medicine label to see how many tablets to take and how often to take them. The tablets should be swallowed whole with a glass of water. The usual doses are as follows:

Adults, the elderly and children over the age of I 6 years

Take one tablet whenever the symptoms of acid-related indigestion and heartburn appear, day or night.

Do not take more than two tablets in 24 hours.

You should not take the tablets for more than 6 days continuously. If the symptoms deteriorate or persist after 6 days, consult your doctor or pharmacist. You should not purchase a second pack of tablets without the advice of a pharmacist or doctor.

If you are unsure about how many tablets to take or when to take them, ask your doctor or pharmacist. Do not give these tablets to children under 16 years of age.

Do not take any other medicine (including non-prescription medicines) without first checking with your doctor. If you take more Lloydspharmacy Indigestion Relief Tablets than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.


4. Possible side effects


As with all medicines, as well as benefits, these tablets may cause unwanted effects.

Rare side effects (i.e. between I in 1,000 and I in I 0,000 patients are affected) include:

•    slow, rapid or irregular heart beat

•    skin rash which may be severe, hair loss, itching

•    muscle and joint pain, blurred vision, severe stomach pain (caused by inflamed pancreas)

•    allergic reactions including: difficulty breathing, speaking or swallowing, tightness or pain in the chest, lumpy skin rash, swelling of the eyelids, face, lips, tongue or throat, unexplained fever, fainting, anaphylactic shock (i.e. severe allergic reactions).

Some people may be allergic to these tablets. If you experience any allergic reaction soon after taking these tablets, tell your doctor at once and stop taking the tablets immediately.

Other side effects include:

•    feeling sick, constipation, diarrhoea, headache, dizziness, fatigue

•    upset blood counts resulting in a tendency to bruise easily, unusual tiredness, shortness of breath or frequent infections

•    confusion, restlessness, depression and hallucinations, mainly reported in the severely ill and elderly

•    results of laboratory tests on your liver may have altered

•    inflammation of the liver which may be associated with yellowing of the skin or whites of eyes (jaundice)

•    isolated cases of swollen or tender breasts in men.

If you suffer any of the above side-effects, stop taking the tablets and consult your doctor.


If you notice any other side effects which are not mentioned in this leaflet please speak with your doctor or pharmacist.


Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription for you to treat a mild illness without a doctor’s help. Nevertheless, you still need to use Lioydspharmacy Indigestion Relief Tablets carefully to get the best results from them.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must see a doctor if your symptoms worsen or do not improve after 2 weeks.

In this leaflet:

1.    What are Lioydspharmacy Indigestion Relief Tablets and what are they used for

2.    Before you take Lioydspharmacy Indigestion Relief Tablets

3.    How to take Lioydspharmacy Indigestion Relief Tablets

4.    Possible side effects

5.    Storing Lioydspharmacy Indigestion Relief Tablets

Your medicine is called Lioydspharmacy Indigestion Relief Tablets.

Each film-coated tablet contains 83.75mg of ranitidine hydrochloride, equivalent to 75mg of ranitidine, as the active ingredient. The tablets also contain some inactive ingredients: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and talc.

Film-coating on the tablets contain: castor oil & Opadry OY-S-54902 Pink which contains hypromellose, talc, titanium dioxide (El71) and red ferric oxide (El72).

The Printing ink contains Opacode-S-I-8152HV Black which contains Shellac, black ferric oxide (El72), n-butyl alcohol, Soya lecithin MC thin and Antifoam DC 1510.

Marketing Authorisation Holden Ranbaxy (UK) Ltd., 95 Park Lane, Mayfair, London WIY 3TA. Manufacturer: Ranbaxy Ireland Limited, Spafield, Cork Road, Cashel, Co. Tipperary, Republic of Ireland.


I. What are Lioydspharmacy Indigestion Relief Tablets and what are they used for


These tablets contain ranitidine, one of a group of medicines called Histamine H2 antagonists. These work by reducing the amount of acid in your stomach, which can help in the short-term to relieve the symptoms of acid-related indigestion and heartburn.

Lioydspharmacy Indigestion Relief Tablets are light pink, round, biconvex tablets printed with 75’ black ink on one side.

The tablets come in blister sheets of 6 or 10 and are available in pack sizes of 20, 24 or 28 tablets. These pack sizes are available from your pharmacist only. Not all pack sizes may be marketed.


2. Before you take Lioydspharmacy Indigestion Relief Tablets


Do not take this medicine if any of the following apply to you.

•    you have ever had an allergic reaction (this may include rash, itching, swollen face or lips, or breathing difficulties) to ranitidine hydrochloride or to any of the ingredients listed above.

•    you are under 16 years of age.

Before taking this medicine tell your doctor or pharmacist if:

•    you have been diagnosed with or told you are at risk from a stomach or duodenal (part of the small intestine) ulcer

•    you are middle aged or older and have new or recently changed indigestion symptoms

•    you have lost weight unintentionally and have associated indigestion

•    you have liver or kidney problems

•    you are receiving regular medical attention for any reason

•    you are suffering from any other illness or taking any other medicines either prescribed by your doctor, bought from the pharmacist or self-prescribed

•    you are regularly taking medicines known as non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin or ibuprofen, especially if you are elderly

•    you suffer or have suffered on occasion with an excess of protein in the urine (porphyria)

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant, breast-feeding or trying to become pregnant.

Important information about some of the ingredients of this medicine

This medicinal product contains 0.31 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet. The tablets also contain castor oil. This may cause stomach upset or diarrhoea. Driving and operating machinery

There have been no reported effects on the ability to drive or operate machinery.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed but bought/obtained without a prescription._


Care is needed if you are taking any of the following medicines:

•    NSAIDS (e.g. aspirin or ibuprofen)

•    antacids (help neutralize stomach acid)

•    sucralfate (an ulcer healing drug)

•    procainamide (a medicine used in treating abnormal heartbeat)

•    theophylline (used in the treatment of asthma)

•    ketoconazoie (an anti-fungai medicine)

•    glipizide (a medicine used to treat diabetes).

If you are taking antacids or sucralfate having discussed this with your doctor, please ensure that Lloyds pharmacy Indigestion Relief Tablets are taken at least two hours before such medicines.

Since the effects of alcohol may be enhanced by these tablets, talk to your doctor about how much alcohol you may consume whilst taking this medicine.


3. Howto take Lloydspharmacy Indigestion Relief Tablets


Check the medicine label to see how many tablets to take and how often to take them. The tablets should be swallowed whole with a glass of water. The usual doses are as follows:

Adults, the elderly and children over the age of I 6 years

Take one tablet whenever the symptoms of acid-related indigestion and heartburn appear, day or night.

Do not take more than two tablets in 24 hours.

You should not take the tablets for more than 2 weeks continuously. If the symptoms deteriorate or persist after 2 weeks, consult your doctor or pharmacist. You should not purchase a second pack of tablets without the advice of a pharmacist or doctor.

If you are unsure about how many tablets to take or when to take them, ask your doctor or pharmacist. Do not give these tablets to children under 16 years of age.

Do not take any other medicine (including non-prescription medicines) without first checking with your doctor. If you take more Lloydspharmacy Indigestion Relief Tablets than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.


4. Possible side effects


As with all medicines, as well as benefits, these tablets may cause unwanted effects.

Rare side effects (i.e. between I in 1,000 and I in I 0,000 patients are affected) include:

•    slow, rapid or irregular heart beat

•    skin rash which may be severe, hair loss, itching

•    muscle and joint pain, blurred vision, severe stomach pain (caused by inflamed pancreas)

•    allergic reactions including: difficulty breathing, speaking or swallowing, tightness or pain in the chest, lumpy skin rash, swelling of the eyelids, face, lips, tongue or throat, unexplained fever, fainting, anaphylactic shock (i.e. severe allergic reactions).

Some people may be allergic to these tablets. If you experience any allergic reaction soon after taking these tablets, tell your doctor at once and stop taking the tablets immediately.

Other side effects include:

•    feeling sick, constipation, diarrhoea, headache, dizziness, fatigue

•    upset blood counts resulting in a tendency to bruise easily, unusual tiredness, shortness of breath or frequent infections

•    confusion, restlessness, depression and hallucinations, mainly reported in the severely ill and elderly

•    results of laboratory tests on your liver may have altered

•    inflammation of the liver which may be associated with yellowing of the skin or whites of eyes (jaundice)

•    isolated cases of swollen or tender breasts in men.

If you suffer any of the above side-effects, stop taking the tablets and consult your doctor.


If you notice any other side effects which are not mentioned in this leaflet please speak with your doctor or pharmacist.