Ranitidine Effervescent 300mg Effervescent Tablets
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Ranitidine 150mg & 300mg effervescent tablets
Ranitidine
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, please 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 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 effervescent tablets are and what they are used for
2. Before you take Ranitidine effervescent tablets
3. How to take Ranitidine effervescent tablets
4. Possible side effects
5. How to store Ranitidine effervescent tablets
6. Further information
1. WHAT RANITIDINE EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR
Ranitidine hydrochloride is one of a group of medicines called histamine H2 antagonists. It works by reducing the amount of acid produced in your stomach.
Ranitidine effervescent tablets may be used for the:
• treatment of ulcers in the stomach or duodenum (part of the small intestine).
• prevention of recurrent ulcers in the duodenum (part of the small intestine).
• treatment of inflammation of the gullet (oesophagus) caused by reflux (leaking back into the gullet from the stomach) of gastric acid (reflux oesphagitis).
• treatment of a disease in which the stomach produces too much acid (Zollinger-Ellison Syndrome).
This medicine is not meant for the treatment of mild stomach aches or intestinal complaints, such as an irritated stomach due to tension.
Children (3 to 18 years)
• Short term treatment of peptic ulcer
• Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.
2. BEFORE YOU TAKE RANITIDINE EFFERVESCENT TABLETS Do not take Ranitidine effervescent tablets if you:
• are allergic (hypersensitive) to ranitidine or any of the ingredients in the tablet, an allergic reaction may include a rash, itching or difficulty breathing (see section 6).
• have a history of a blood problem known as porphyria.
Take special care with Ranitidine effervescent tablets (check with your doctor or pharmacist before taking) if you:
• suffer from reduced kidney or liver function
• are elderly, suffer from a chronic lung disease, diabetes or an immunological disorder.
There may be an increased risk of developing community acquired pneumonia.
• have stomach ulcers caused by a certain bacteria (Helicobacterpylori). If your doctor finds out that this applies to you, he/she will prescribe other medicines (antibiotics) that are able to kill these bacteria.
• have had stomach ulcers before and you are taking Non-Steroidal Anti Inflammatory (NSAID) medicines
• on a sodium restricted diet.
Please note
Before starting treatment with Ranitidine effervescent tablets, your doctor will check that the stomach or intestinal ulcer is not malignant as Ranitidine may mask the symptoms of stomach cancer
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. Especially:
• certain medicines that prevent your blood from clotting (like warfarine); the blood must be controlled regularly.
• certain medicines used at heart problems (procainamid and N-acetylprocainamid); the efficacy of these drugs can be increased at high doses ranitidine.
• medicines for which the availability in the blood depend on the acidity in the stomach. The efficacy can be increased for certain medicines (like triazolam, midazolam, glipizid) or decreased (like ketoconazol, atazanavir, delaviridine, gefitnib).
• certain medicines that prevent the stomach against gastric acid (sucralfate). Sucralfate must be taken two hours after ranitidine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Only use this medicine during pregnancy or breast-feeding after consulting your doctor.
Driving and using machines
This medicine can sometimes cause side effects. Use extreme caution when driving or operating heavy machinery until you’re aware of how this drug affects you.
Important information about some of the ingredients of Ranitidine effervescent tablets
Ranitidine effervescent contains Lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ranitidine effervescent 150 mg contains 120 mg sodium per tablet. Ranitidine effervescent 300 mg contains 240 mg sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO TAKE RANITIDINE EFFERVESCENT TABLETS
Always take Ranitidine effervescent tablets exactly as your doctor as told you. If you are not sure, check with your doctor or pharmacist.
Dosage
The usual doses are:
Adults:
• Stomach or duodenal ulcers - 300mg after supper or at bedtime; or 150mg in the morning and evening for four weeks. If your ulcer is not fully healed the doctor may give you another four weeks treatment. If you have a history of repeated ulcers your doctor may continue your treatment for up to 12 months with 150mg ranitidine at bedtime.
• Reflux oesophagitis - 150mg in the morning and evening or 300mg after supper or at bedtime for up to 8 or 12 weeks (if necessary, up to 300 mg twice a day may be prescribed by your doctor).
• Patients with Zollinger-Ellison Syndrome - 150mg three times a day. If necessary your doctor may increase the dose, to a maximum of 6g a day.
• If you have a kidney disease your doctor may prescribe a lower dose.
Children from 3 to 11 years and over 30 kg of weight:
o Peptic Ulcer - The recommended oral dose for the treatment of peptic ulcer in children is 4 to 8 mg/kg body weight per day, administered as two divided doses to a maximum of 300 mg ranitidine per day.
o Gastro-Oesophageal Reflux - The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5 to 10 mg/kg body weight per day administered as two divided doses in a maximum dose of 600 mg.
Method of administration
The effervescent tablets should be dissolved in a large quantity of water (1 full glass) without breaking them, wait until the effervescent tablets are completely dissolved and then drink the solution.
If you take more Ranitidine effervescent tablets than you should
Do not take more tablets than your doctor tells you to. If you have accidentally taken more than the prescribed dose, go to the nearest hospital casualty department or tell your doctor/pharmacist immediately.
If you forget to take Ranitidine effervescent tablets
If you forget to take a dose, take it as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking Ranitidine effervescent tablet
Do not stop taking the tablets until your doctor tells you to as the pain and discomfort may return.
If you notice that the effect of this medicine is too strong or inadequate, consult your doctor of pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine effervescent tablets can cause side effects, although not everybody gets them. The frequencies of occurrence of side effects are indicated as rare (in more than 1 patient in 10 000 and less than 1 patient in 1000), very rare (less than 1 patient in 10 000).
Effects on blood/blood vessels: Very rarely, ranitidine may alter the number or type of blood cells, may give inflammation of your blood vessels or affect your lymphatic system. If you notice increased bruising, nosebleeds, an infection, fever, sore throats or urinary problems, you should tell your doctor immediately that you take this medicine. It may be necessary to perform a blood test to check your white blood cell count (agranulocytosis).
Allergic reaction on skin and body: In rare cases skin rash, itching, fever shortness of breath and/or swollen face, tongue and body may occur. Very rarely an anaphylactic shock occurs which lead to fainting. In this case immediate medical advice should be sought.
Effects on muscles, joints and scalp: In very rare cases patients experience hair loss or pain in muscles or joints.
Psychological effects: Very rarely, predominantly in severely ill and elderly patients, confusion, depression and hallucinations have been reported.
Effects on the nervous system: Very rarely headache (sometimes severe), dizziness and reversible involuntary movement disorders.
Eye Disorders: Very rarely reversible blurred vision has been reported.
Effects on the Heart: Low Blood pressure and chest pain. Irregular or slow heart beats have occurred on very rare occasions.
Effects on stomach and guts: In some cases abdominal pain, diarrhoea, constipation and nausea (these symptoms mostly improved during continued treatment).
Effects on the liver, kidney and pancreas: In rare cases elevation of plasma creatinine has been reported (usually slight; normalised during continued treatment). In rare cases inflammation of the liver (sometimes leading to jaundice), kidney or pancreas has been reported. Liver enzyme count may alter, indicating a change in liver function. These symptoms disappear on stopping treatment with ranitidin.
Reproductive- and breast disorders: There have been very rare reports of side effects like breast disorders, enlarged breasts in men, and impaired potency.
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.
5. HOW TO STORE RANITIDINE EFFERVESCENT TABLETS
Keep Ranitidine effervescent tablets out of the reach and sight of children.
Do not store the tablets above 30°C and keep in the well-closed package.
Do not use Ranitidine effervescent tablets after the expiry date, stated on the carton and on the tube. The expiry date refers to the last day of that month.
Do not take the effervescent tablets if you notice the effervescent tablets become discoloured or show any other signs of deterioration.
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. FURTHER INFORMATION
What Ranitidine effervescent tablets contain
• the active substance (the ingredient that makes the tablets work) is ranitidine hydrochloride.
• each 150mg and 300 mg tablet contains ranitidine hydrochloride, equivalent to 150mg and 300 mg ranitidine respectively.
• the other ingredients are tartaric acid (E334), sodium hydrogen carbonate, lactose monohydrate, polyvidone, Riboflavin (E101), simethicone emulsion (contains simethicone, methylcellulose, sorbic acid, purified water), sodium cyclamate, saccharin sodium, lemon flavour (contains citral, citronella oil, coriander oil, lime, acacia), macrogol, sodium hydroxide.
What Ranitidine effervescent tablets look like and contents of the pack
Ranitidine effervescent tablets are yellow-white to light yellow, circular, flat tablets with bevelled edges.
The product is packed in polypropylene tubes closed with a polyethelene cap containing a desiccant. The tubes are packed in carton outer boxes.
Ranitidine 150mg and 300mg effervescent tablets are available in pack sizes of 15, 30 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis B.V.
Baarnsche Dijk 1 3741 LN Baarn The Netherlands
Manufacturer:
Actavis B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands or
Alpharma A.S. Gjellebekkstubben 10 3420 Lierskogen Norway or
Losan Pharma GmbH Otto-Hahn Strasse 13 79395 Neuenburg Germany
Ranitidina Alpharma
Ranitidine Actavis Bruis 150 mg / 300 mg Ranitidin Alpharma (150 mg strength only) Ranitidina Alpharma
Ranitidin Alpharma (150 mg strength only) Ranitidine 150mg / 300mg Effervescent Tablet
This medicinal product is authorised in the Member States of the EEA under the following names
Italy
The Netherlands
Norway
Spain
Sweden
United Kingdom
This leaflet was last approved in December 2011
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