Ranitidine 300 Mg Effervescent Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ranitidine 150 mg Effervescent Tablets Ranitidine 300 mg Effervescent Tablets
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 Effervescent Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information
1. What Ranitidine Effervescent Tablets are and what they are used for
Ranitidine Effervescent Tablet is a gastrointestinal drug, it contains ranitidine. It belongs to the group known as histamine H2 receptor antagonists, which reduce the secretion of stomach acid.
Ranitidine Effervescent Tablet is used in adults (from 18 years) for the treatment of diseases of stomach and duodenum, in which a reduction of gastric acid is required:
- Duodenal ulcer
- Benign gastric ulcer
- Long term treatment of Duodenal ulcers (150 mg only)
- Reflux oesophagitis (Inflammation of the gullet as a result of the backflow of stomach contents)
- Zollinger-Ellison Syndrome (a disease whereby the stomach produces too much acid).
Ranitidine Effervescent tablets used in children from 3 to 18 years for
- short-treatment of gastric and duodenal ulcers (peptic ulcer)
- to treat symptoms caused by heartburn (gastroesophageal reflux), including an inflammation of the oesophagus (reflux oesophagitis)
- relief of symptoms caused by heartburn (gastroesophageal reflux disease)
2. What you need to know before you Take Ranitidine Effervescent Tablets
Do not take Ranitidine Effervescent Tablets
- if you are allergic (hypersensitive) to ranitidine or any of the other ingredients of the effervescent tablets (listed in section 6).
Warnings and precautions
- if you suffer from a reduced kidney function; a lower dose may be needed (see 3: “How to take Ranitidine Effervescent Tablets”).
- if you suffer from severe liver impairment.
- Stomach and duodenal ulcers can be caused by a certain bacterium called Helicobacter pylori. Your doctor may therefore prescribe other medicines that can kill these bacteria (antibiotics).
- if you have ever had attacks of a disease which interfered with the production of red blood cells (porphyria, a severe illness whose symptoms include oversensitivity to light, paralysis and severe stomach pains). Very rarely, ranitidine can trigger off an attack of porphyria.
- if you have unintended weight loss associated with dyspepsia, if you are middle aged or older and are having dyspeptic symptoms for the first time or symptoms which have recently changed, consult your doctor or pharmacist.
- If you suffer from pulmonary diseases, diabetes, heart failure and if you are immunocompromised (disturbance in your immune system). A study showed an increased risk of developing community acquired pneumonia in users of H2 receptor antagonists.
- if you are on a low sodium diet.
- If you are over 65 years old
Ask your doctor if any of the above warning applies to you, or
has ever applied to you in the past.
Other medicines and Ranitidine Effervescent Tablets
Tell your doctor or pharmacist if you are taking or have
recently taken or might take any other medicines.
Avoid taking these effervescent tablets at the same time as:
- If the use of Erlotinib is considered during treatment with Ranitidine, it should be used in a staggered manner; i.e. Erlotinib must be taken at least 2 hours before or 10 hours after ranitidine dosing.
- There is a potential decrease of cyanocobalamine absorption when administered in a long-term manner with ranitidine, resulting in a vitamin B12 deficiency.
- if you are using this medicine at the same time as theophylline (an anti-asthma drug); your theophylline dose may need to be adjusted .
- Lidocaine, a local anaesthetic
- Propranolol, procainamide or n-acetylprocainamide, for heart problems
- Diazepam, for worry or anxiety problems
- Phenytoin, for epilepsy
- Warfarin, for thinning your blood
- Caution should be exercised in case of simultaneous administration with atazanavir or delaviridine, for treating HIV infection or gefitnib, for lung cancer Antacids and sucralfate (another drug used to treat complaints such as stomach and intestinal ulcers): simultaneous use can reduce ranitidine absorption into the bloodstream (thereby making it less effective). These drugs must therefore be taken about 2 hours after taking ranitidine;
- If you are taking non-steroidal anti-inflammatory painkillers (NSAIDs, such as Aspirin).
- Medicines whose absorption is dependent on the amount of acid in the stomach may be affected, since ranitidine affects stomach acidity, absorption of this type of substances into the bloodstream may be altered (thereby altering their effect). This can result in either an increase in absorption e.g. triazolam, midazolam, (used to help you sleep and/or relieve anxiety), glipizide (a drug used to reduce blood sugar levels) or decrease in absorption e.g. ketoconazole, itraconazole and Posaconazole (medicines are used to treat fungal infections).
Ranitidine Effervescent Tablets with food ,drink and alcohol
The effects of small amounts of alcohol may increase when taken together with Ranitidine. You may take the tablets with or without a meal.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant or thinking of becoming pregnant or are breastfeeding, consult your doctor or pharmacist. So far, no side effects have been observed with ranitidine use during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine. Ranitidine should only be used during pregnancy if considered essential.
Breast-feeding
Ranitidine is excreted in human breast milk. Like other drugs ranitidine should only be used during nursing if considered essential. Ask your doctor or pharmacist for advice.
Driving and using machines
Ranitidine has no reported influence on the ability to drive and use machines.
Ranitidine Effervescent Tablets contains
Ranitidine Effervescent Tablets contains 23 mmol (or 533 mg) sodium. To be taken into consideration by patients on a controlled sodium diet.
3. How to Take Ranitidine Effervescent Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage and method of administration Dissolve an effervescent tablet in a glass of water. Do not break the effervescent tablet. Wait until the effervescent tablet has been completely dissolved and drink the solution directly.
The recommended dose is
Adults: (including the elderly) / Adolescents (12 years and older) Intestinal or benign gastric ulcer:
Two Ranitidine 150 mg Effervescent Tablets (= 300 mg ranitidine) a day (=24 hours), in a single dose after an evening meal or in the evening before bedtime; alternatively, in two doses, i.e. 150 mg at breakfast and 150 mg in the evening before bedtime. Treatment lasts for 4 weeks, but can be extended to 8 weeks.
Long term treatment of duodenal ulcers, patients with recurrent ulcers
One Ranitidine 150 mg Effervescent Tablet per day (= 24 hours), in the evening before bedtime. Treatment lasts for 12 months or less, depending on the instructions of the doctor.
Inflammation of the gullet as a result of the backflow of stomach contents (reflux oesophagitis):
Two Ranitidine 150 mg Effervescent tablets (= 300 mg ranitidine) a day (=24 hours), in a single dose after an evening meal or in the evening before bedtime. Alternatively, these tablets may be taken in two doses, i.e. 150 mg at morning and 150 mg in the evening before bedtime. Treatment lasts for 8 weeks.
Zollinger-Ellison Syndrome (a disease whereby the stomach produces too much acid):
Starting dose: One Ranitidine 150 mg Effervescent tablet three times a day (=24 hours). If necessary, dosage can be increased to 600 - 900 mg (4-6 tablets) a day (=24 hours). Length of treatment: according to your doctor's instructions
Patients with reduced kidney function:
Your dosage will be lowered by your doctor, depending on the extent to which your kidney function is impaired.
Children 12 years and over
For children 12 years and over the adult dosage is given.
Children from 3 to 11 years and over 30 kg of weight
Your doctor will work out the right dose for you based on your child's weight.
Peptic Ulcer Acute Treatment
The recommended oral dose for the treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300mg ranitidine per day for a duration of 4 weeks. For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.
Gastro-Oesophageal Reflux The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses in a maximum dose of 600mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms).
Ireland
Italy
The Netherlands UK
Neonates
Safety and efficacy in new-born patients has not been established.
If you take more Ranitidine Effervescent Tablets than you should
If you have taken more than the prescribed dose or you are on a low sodium diet. In that case, don't delay; ask your doctor what to do or contact your nearest hospital emergency department.
If you forget to take Ranitidine Effervescent Tablets
If you have missed a dose, take this dose as soon as you remember. However, if it is nearly time for your next dose, skip the forgotten dose and carry on with your normal dosage schedule. Do not take double doses. You should check with your doctor or pharmacist if you are not sure.
If you stop taking Ranitidine Effervescent Tablets
If you suddenly stop using this medicine, the symptoms that existed before your treatment may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Many of these side effects are reversible and go away once ranitidine treatment is stopped.
The safety of ranitidine has been assessed in children aged 0 to 16 years with acid-related disease and was generally well tolerated with an adverse event profile resembling that in adults. There are limited long term safety data available, in particular regarding growth and development.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.By reporting side effects you can help provide more information on the safety of this medicine.
For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
For Ireland - You can also report side effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie.
Marketing Authorisation Holder and Manufacturer:
Accord Healthcare Limited Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom.
This medicinal product is authorized in the Member States of the eEa under the following names:
Name of the Name of the medicinal product member state
Ranitidine 150 mg/ 300 mg Effervescent Tablets Ranitidine AHCL 150 mg/ 300 mg compresse effervescenti Ranitidine Accord 150 mg/ 300 mg bruistabletten
Ranitidine 150 mg/ 300 mg Effervescent Tablets
This leaflet was last revised in 12/2014
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
A few people can be allergic to some medicines. If any of the
following happen, tell your doctor or nurse immediately:
• Severe itching of the skin, rash
• swelling of the hands, feet, ankles, face, lips, tongue, mouth or throat, which may cause difficulties in swallowing or breathing
• Chest tightness
• Collapse
Tell your doctor if you notice any of the following:
Uncommon: may affect up to 1 in 10 people)
• stomach pain
• constipation
• feeling sick (nausea) .
Rare :may affect up to 1 in 1,000 people
• skin rash
Rare side effects that may show up in blood tests:
• increase of serum creatinine in blood (kidney function test)
• changes to liver function
Very rare: may affect up to 1 in 10,000 people
• Depression
• Confusion, hallucinations (mainly reported in severely ill or elderly patients)
• Blood disorders that may result in unusual tiredness, shortness of breath, more infections than usual, bruising more easily
• Uncontrolled movements
• Heart problems (slow or irregular heart rhythm)
• Inflammation of the blood vessels which may cause reddening of areas of skin, localised pain and tenderness
• Headaches (sometimes severe), dizziness
• Diarrhoea
• Blurred vision
• Inflammation of the pancreas (which may cause severe stomach pain)
• Liver problems which may lead to jaundice (yellow colour of skin and the whites of eyes)
• Red blotches or lumps on the skin, hair loss
• Pain in the joints or muscles
• Kidney problems that may cause changes in the amount and colour of water you pass
• If you are a man, sexual impotence that is normally reversible, tenderness of the breast, breast discharge and/or breast enlargement.
5. How to store Ranitidine Effervescent Tablets
• Store below 30°C. Keep the container tightly closed in order to protect from moisture and light.
• Use within 1 month from the date of first opening.
• 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 tube or carton. The expiry date refers to the last date 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 to protect the environment.
6. Contents of the pack and other information
What Ranitidine Effervescent Tablets contain:
The active substance is ranitidine hydrochloride.
Ranitidine Effervescent Tablets have either 150 mg or 300 mg of Ranitidine in them.
The other ingredients are:
Sodium dihydrogen citrate, sodium hydrogen carbonate, povidone 30, simethicone, sunset yellow supra (E 110) (only for 150 mg strength) glycine, powdarome peppermint premium, sodium benzoate, saccharin sodium.
What Ranitidine Effervescent Tablets look like and content of the pack:
Ranitidine Accord 150 mg Effervescent Tablets
Light orange colored, round, flat faced and bevelled edges
tablets, plain on both sides with faint odour of peppermint.
Ranitidine Accord 300 mg Effervescent Tablets
White to pale yellow, round, flat faced and bevelled edges
tablets plain on both sides with faint odour of peppermint
Ranitidine Effervescent Tablets 150 mg and 300 mg are packed in-polypropylene tubes with desiccant as part of polyethylene tamper evident cap, each tube contains 20 tablets is packed in a carton of 60 (3 x 20) tablets along with package inserts.
