RANITIDINE 300 MG EFFERVESCENT TABLETS

Active substance: RANITIDINE HYDROCHLORIDE

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Artwork No.

Colours Used

Customer

Accord

Black

Description

Ranitidine 150 & 300 mg Effervescent Tab

Market

UK

Language

English

Size

300 x 300 mm PIL

Min. Font Size

9

Version No.

3 (Page 1 of 2) (NL/H/1143/001-002/IB/004)

Date

advertising & communication services ltd.

-

06_03_12 (Ranitidine 150 mg Effervescent Tab(RA-UK)N-VAR-PIL)

Prepared By
Regulatory Affairs

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.
- 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 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 Effervescent Tablets 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 Tablets 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. 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
Take special care with Ranitidine Effervescent Tablets
- 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).

Checked By
Regulatory Affairs

Checked By
Quality Assurance

- 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.
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 and herbal 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).
Taking Ranitidine Effervescent Tablets with food and drink
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 and breast-feeding
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.

Approved By
EU Head - QA

Driving and using machines
Ranitidine has no reported influence on the ability to drive and
use machines.
Important information about some of the ingredients of
Ranitidine Effervescent Tablets
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 Ranitidine Effervescent Tablets exactly as your
doctor has told you. You should 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 usual 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 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.
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 4 mg for each
kg, twice a day. Take each dose about 12 hours apart. The
duration of treatment may be increased to 8 weeks.
Treatment of heartburn due to too much acid:
The usual dose is 2.5 mg for each kg of body weight, twice a
day for two weeks. This dose may be increased to 5 mg for
each kg, twice a day. Take each dose about 12 hours apart.
Safety and efficacy in new-born patients has not been established.

Artwork No.

Colours Used

Customer

Accord

Black

Description

Ranitidine 150 & 300 mg Effervescent Tab

Market

UK

Language

English

Size

300 x 300 mm PIL

Min. Font Size

9

Version No.

3 (Page 2 of 2) (NL/H/1143/001-002/IB/004)

Date

advertising & communication services ltd.

-

06_03_12 (Ranitidine 150 mg Effervescent Tab(RA-UK)VAR-PIL)

Prepared By
Regulatory Affairs

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, Ranitidine Effervescent Tablets can cause
side effects, although not everybody gets them.
The following descriptions of frequency have been used in the
evaluation of side effects:
Very common more than one in 10 patients treated
Common
less than one in 10, but more than one in 100
patients treated
Uncommon
less than one in 100, but more than one in
1,000 patients treated
Rare
less than one in 1,000, but more than one in
10,000 patients treated
Very rare
less than one in 10,000 patients treated,
including isolated cases
Blood and lymphatic system disorders
Very rare
Reduction in all white blood cells [leucopenia] or platelets
[thrombocytopenia]. These changes are normally reversible.
Changes in blood count (low levels of certain white blood cells
[agranulocytosis], low levels of all blood cells [pancytopenia] or
changes in bone marrow [bone marrow hypoplasia/aplasia]).
Agranulocytosis, reduced number of white blood cells, which
can cause increased infection sensitivity with fever, sore
throat/pharynx/mouth or urinary problems.
If you notice any of the above mentioned side effects, please
contact your doctor immediately

Checked By
Regulatory Affairs

Checked By
Quality Assurance

Eye disorders
Very rare
Blurred vision, which disappeared when ranitidine treatment
was discontinued.
Cardiac disorders
Very rare
Decreased heart rate and disturbances in the electrical signal
that causes the heart to beat [AV block]
Vascular Disorders
Very rare
Vasculitis, inflammation of a blood vessel or blood vessels.
Gastrointestinal disorders
Uncommon
Diarrhoea, constipation or nausea, abdominal pain. In most
cases, these symptoms improved during continued treatment.
Very rare
Acute inflammation of the pancreas (accompanied by severe
pain in the upper abdomen, shifting towards the back)
Hepatobiliary disorders
Rare
Transient (temporary) changes in liver values, which
normalised with continued treatment or after therapy had
finished.
Very Rare
Hepatitis (inflammation of the liver) with or without jaundice
(yellow colouring of the skin or the whites of the eyes). In most
cases, these changes were usually reversible on stopping
treatment.
Skin and subcutaneous tissue disorders
Rare
Skin rash
Very Rare
Erythema multiforme (a particular form of skin rash), Hair loss
Musculoskeletal and connective tissue disorders
Very Rare
Joint disorders, muscle pain
Renal and urinary disorders
Rare
Increases in plasma creatinine values. Such increases were
mostly minor and generally normalised with continued
treatment with ranitidine.
Very rare
Acute interstitial nephritis (inflammation of the kidney).

Immune system disorders
Rare
Hypersensitivity (allergic) reactions (e.g. a rise in eosinophilic
blood cells, hives, fever, drop in blood pressure, sudden
accumulation of tissue fluid in skin and mucous membranes,
spasm of the larynx, bronchial spasm, chest pain,

Reproductive system and breast disorders
Very rare
Breast formation in men, breast discharge and reversible
impotence.
It has not yet been shown whether there is an actual causal link
between use of ranitidine and such disorders.

Very rare
Circulatory shock and angioedema, swollen face, tongue or
pharynx, difficulty to swallow, hives and difficulties to breath.

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.

Psychiatric disorders
Very rare
Depression, reversible mental confusion, hallucinations
These have been reported in severely ill and elderly patients.
Nervous system disorders
Very rare
Severe headache, dizziness, Reversible involuntary moment
disorders.
Central nervous system disorders have occurred, mainly in
elderly or seriously ill patients. These symptoms subsided
when treatment with ranitidine was stopped.

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 out of the reach and sight of children.
• Do not use Ranitidine Effervescent Tablets after expiry date
stated on the tube or carton. The expiry date refers to the last
date 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.

Approved By
EU Head - QA

6. FURTHER INFORMATION
What Ranitidine Effervescent Tablets contains:
The name of your medicine is Ranitidine 150 mg Effervescent
Tablets and Ranitidine 300 mg Effervescent Tablets. Its active
ingredient is Ranitidine Hydrochloride.
Ranitidine Effervescent Tablets have either 150 mg or 300 mg
of Ranitidine in them.
Each tablet contains following inactive ingredients:
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 looks 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 leaflet was last approved in 03/2012.

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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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