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RANITIDINE 300 MG EFFERVESCENT TABLETS

Active substance: RANITIDINE HYDROCHLORIDE

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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.

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

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).

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.

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.

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.

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.

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.

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).

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
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.

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.

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.

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
member state

Name of the medicinal product

Ireland

Ranitidine 150 mg/ 300 mg
Effervescent Tablets
Italy
Ranitidine AHCL 150 mg/ 300 mg
compresse effervescenti
The Netherlands Ranitidine Accord 150 mg/ 300 mg
bruistabletten
UK
Ranitidine 150 mg/ 300 mg
Effervescent Tablets
This leaflet was last revised in 12/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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