Ranitidine 150mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ranitidine 150mg Tablets Ranitidine 300mg Tablets (ranitidine hydrochloride)
Read all of this leaflet carefully before you start taking 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.
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 ofthe pack and other information
1. WHAT RANITIDINE TABLETS ARE AND WHAT THE YARE USED FOR
Ranitidine Tablets belong to a group of medicines called "H2-antagonists". They reduce the amount of acid in your stomach and are used to:
• treat ulcers in the stomach or first part ofthe small intestine (duodenum)
• stop ulcers form bleeding
• help clear up infections in your stomach, when taken with antibiotic medicines
• treat problems caused by acid in the food passage (reflux oesophagitis)
• treat a condition in which there is increased production of the hormone gastrin (Zollinger-Ellison syndrome)
• 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'.
• to prevent stomach ulcers when they are a side effect of some medicines
• to stop acid coming up from the stomach while under anaestetic during an operation For children (3 to 18 years) Ranitidine is used to:
• Treat ulcers in the stomach, or first part of the small intestine (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 hydrochloride or any ofthe other ingredients in the product {see Section 6 and end of section 2)
Warning and precautions
Speak to your doctor before taking Ranitidine Tablets if:
• you have stomach cancer
• you have kidney problems. You may need different dose of Ranitidine Tablets
• you have had stomach ulcer and you are taking non-steroidal anti-inflammatory medicines (NSAID) such as aspirin or ibuprofen
• you have rare condition called acute porphyria (a rare inherited metabolism disorder which causes
abdominal pains)
• 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 taking this medicine.
Other medicines and Ranitidine Tablets
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
In particular, tell your doctor if you are taking any of the following as they may not work effectively if taking RanitidineTablets:
• Ketoconazole (an antifungal agent)
• Dmgs used for HIV: Atazanavir, Delaviridine.
• Gefitnib (drug used in the treatment of certain types of cancer.)
• Dmgs which induce sleep: Triazolam, Midazolam. Midazolam may be given to you before surgery. Tell your doctor that you are taking Ranitidine Tablets before surgery m case your doctor wants to give you midazolam.
• Glipizide (used to treat diabetes)
• Theophylline (used in the treatment of asthma)
• Lidocaine (local anaesthetic),
• Phenytoin (treatment of epilepsy.)
• Propanolol (treatment ofhypertension)
• Antacids (drug that reduces or neutralizes stomach acid)
• Procainamide (for irregular heart beat).
• Blood thinning agents: warfarin
• Non-steroidal anti-inflammatory medicines (NSAIDS) such as aspirin or ibuprofen
• Diazepam, medicine used to treat anxiety
If you are not sure that any of the above apply to you, talk to your doctor before taking this medicine. Pregnancy and breast-feeding
Ask your doctor for advice before taking Ranitidine Tablets if you are pregnant, planning to become pregnant or are breast-feeding.
Important information about some of the ingredients of Ranitidine Tablets
Castor oil-may cause stomach upsets and diarrhoea.
3. HOWTO TAKE RANITIDINE TABLETS
Ranitidine Tablets should be swallowed whole with a glass of water.
Always take Ranitidine Tablets exactly as your doctor has told you. Your exact dose will depend on the particular stomach condition, the doctor will tell you the dose you should take.
The usual doses are as follows:
ADULTS
Treatment of stomach or duodenal ulcers:
Take one 150mg tablet twice a day, one in the morning and one in the evening OR one 300mg tablet at bedtime. For maintenance, the usual dose is 150mg at bedtime.
Treatment of reflux oesophagitis:
Take one 150mg tablet twice a day OR one 300mg tablet at bedtime
In severe oesophagitis, take one 150mg tablet four times a day for a maximum of 12 weeks.
Zollinger-Ellison syndrome:
Take one 150mg tablet three times a day. This may be increased if necessary, to 300mg three times a day ormore.
PATIENTS WITH KIDNEY DISEASE
Your doctor may prescribe a lower dosage and will tell you how long to take the tablets for. The dose is usually 150mg at night for 4-8 weeks but will depend on the type andseverity of your disease. If healing
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has not occurred, take 150 mg twice daily, followed by 150mg at night for maintenance.
Children 12 years and over:
The adult dose is given CHILDREN
Children over 30kg 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 2mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4mg of each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment maybe increased to 8 weeks.
Treatment of heartburn due to too much acid:
The usual dose is 2.5mg for each kg of weight, twice a day for two weeks. This dose may be increased to 5mg for each kg, twice a day. Take each dose about 12 hours apart.
If you take more Ranitidine Tablets than you should
If you or someone else swallows more tablets than they should, contact a doctor or the nearest hospital emergency department immediately, taking any remaining tablets and the box if possible.
If you forget to take Ranitidine Tablets
If you miss a dose, take your dose as soon as you can, then carry on as before. Do not take an extra dose to make up for the forgotten one.
If you stop taking Ranitidine Tablets
Take the Tablets as directed for as long as your doctor has told you. Do not stop taking them, even if you feel better, because your symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine Tablets can cause side effects, although not everybody gets them. You may suffer an allergic reaction; If any of the following side effects come on soon after taking these tablets, stop the tablets and tell your doctor immediately:
• Sudden wheeziness or tightness in the chest
• Swelling of eyelids, face or lips; with or without a lumpy skin rash ("hives") anywhere on the body
• Unexplained fever
• Feeling faint, especially on standing up
• Kidney problems, which, can lead to back pain, fever, pain when passing urine, blood in the urine and changes in the blood tests
• Severe stomach pain, this may be sign of something called 'pancreatitis'
• Aslowirregularheartbeat
The following have also been reported:
Uncommon side effects (affects less than 1 in 100 people)
• Stomach pain
• Constipation
• Feeling sick
Rare side effects (affects up to 1 in 1000 people):
• Skin rash
• Allergic reactions like skin rash, swelling of you face, eye lids, lips or throat, fever, chest pain and increased blood pressure
• Changes in liver functions
• Increase in creatinine in the blood (kidney function test)
Very rare side effects (affects less than 1 in 10,000people):
• Anaphylactic shock (severe allergic reaction)
• Slow or irregular heart beat
• Severe stomach pain caused by inflamed pancreas - inflammation of the liver. The symptoms may include feeling or being sick, loss of appetite, feeling generally unwell, itching, fever, yellowing of the skin and whites of the eyes and dark coloured urine
• Diarrhoea
• Feelingdepressedorconfiised
• Hallucinations (seeing or hearing things that doesn't exist)
• Blurred Vision (reversible)
• Paininmusclesorjoints
• Uncontrolled movements
• Inflammation ofblood vessels (vasculitis)
• Hair loss (alopecia)
• Breast enlargement in men
• Impotence (inability to attain or sustain an erection for the performance of a sexual act.)
• Headache (sometimes severe)Dizziness
• Erythema multiforme (a red rash caused by hypersensitivity to a drug or disease or other allergen)
• Blood count changes (Leucopenia (abnormally low number of white blood cells in the circulating blood.), thrombocytopenia (abnormally small number of platelets in the blood))
Reporting of side effects
Ifyou get any side effects, talk to your doctor, pharmacist or nurse. 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 thismedicine
5. HOWTO STORE RANITIDINE TABLETS Keep out of the reach and sight of children.
Store tablets in the original package and do not use after the expiry date is stated on the label. 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.
6. CONTENTS OFTHE PACKAND OTHER INFORMATION What Ranitidine Tablets contains
The active substance is ranitidine hydrochloride 150mg or 300mg per tablet.
The other ingredients are microcrystalline cellulose, hypromellose, croscarmellose sodium, castor oil, colloidal anhydrous silica, purified talc, magnesium stearate, ferric oxide yellow (E172) and titanium dioxide (El 71) (see Section 2 Important information about some of the ingredients of Ranitidine Tablets).
What Ranitidine Tablets look like and contents of the pack
Ranitidine Tablets are round, film-coated, creamish yellow tablets. The Ranitidine 150mg and 300mg tablets are embossed with "MR150" or "MR300".
The Ranitidine tablets are available in blister packs of5,7,8,10,14,15,16,20,24,28,30,32,40,45, 48,50,56,60,64,72,75,80,88,90,96,98,100,105,112,120 and 150 tablets (not all pack sizes maybe marketed).
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip, HA4 6QD, United Kingdom Manufacturers:
Milpharm Limited
Ares, Odyssey Business park, West End Park, South Ruislip, HA4 6QD, United Kingdom or
APL Swift Services (Malta) Ltd.,
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia BBG 3000, Malta.
This leaflet was last revised in {03/2015}