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RANITIDINE 50MG/2ML SOLUTION FOR INJECTION AND INFUSION

Active substance: RANITIDINE HYDROCHLORIDE

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Artwork Information
Product Title:

Ranitidine PIL

Date:

11-12-14

Label Number:

14-069

Fonts Used:

Arial Narrow

Font size (min):

8 point

Product Size:
Version 9

170mm x 330mm

Colours Used:

Black, PMS 273

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ranitidine 50mg/2ml Solution for Injection and Infusion
ranitidine hydrochloride
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 nurse.
• 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 nurse.
This includes any possible side effects not listed in this
leaflet. See section 4.
The name of this medicine is Ranitidine 50mg/2ml Solution
for Injection and Infusion (referred to as Ranitidine
Injection throughout this leaflet).
What is in this leaflet:
1. What Ranitidine Injection is and what it is used for
2. What you need to know before you have Ranitidine Injection
3. How to have Ranitidine Injection
4. Possible side effects
5. How to store Ranitidine Injection
6. Contents of the pack and other information
1. WHAT RANITIDINE INJECTION IS AND WHAT IT IS
USED FOR
Ranitidine Injection is a solution for injection or infusion into a
vein, or injection into a muscle. It contains ranitidine as the active
substance. Ranitidine is one of a group of medicines called
H2-antagonists that lowers the amount of acid in your stomach.
It is used in adults (including the elderly) to:
• Heal and stop ulcers of the stomach or duodenum
(the stomach empties into this part of the intestine)
• Improve 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'
• Stop ulcers from bleeding
• Stop acid coming up from the stomach while under anaesthetic
during an operation.
It is used in children (6 months to 18 years) to:
• Heal ulcers in the stomach or the part of the gut that it
empties into (the 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 HAVE
RANITIDINE INJECTION
Do not have Ranitidine Injection if:
• You are allergic to ranitidine or to any of the other ingredients
in this medicine (listed in Section 6 of this leaflet).
If you are not sure talk to your doctor or pharmacist before
having Ranitidine Injection.

Warnings and precautions
Talk to your doctor or pharmacist before having Ranitidine
Injection if:
• You have stomach cancer
• You have kidney problems. You will need to have a different
amount of Ranitidine Injection.
• You have a heart problem or a history of heart trouble
• You have a rare condition called acute porphyria
• You have had stomach ulcers before
• You are over 65 years old
• You have lung disease
• You are diabetic
• You have problems with your immune system
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before having this medicine.
Other medicines and Ranitidine Injection
Tell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicines, including medicines
that you buy without a prescription and herbal medicines. This
is because ranitidine can affect the way some other medicines
work. Also some other medicines can affect the way ranitidine
works. In particular tell your doctor or pharmacist if you are
taking any of the following medicines:
• lidocaine, a local anaesthetic
• anticoagulants (such as warfarin), used to thin the blood
• propranolol, procainamide or n-acetylprocainamide, for heart
problems
• diazepam, for worry or anxiety problems
• phenytoin, for epilepsy
• theophylline, for breathing problems (asthma)
• glipizide, for lowering blood glucose
• atazanavir or delaviridine, for treating HIV infection
• gefitnib for lung cancer
• ketoconazole for fungal infections or thrush
• triazolam for insomnia.
Midazolam may also be given before an operation.Tell your
doctor you are taking ranitidine before you have an operation
in case he or she wants to give you midazolam.
If you are not sure if any of the above applies to you, talk to your
doctor, pharmacist or nurse before having Ranitidine Injection.
Pregnancy and breast-feeding
If you are pregnant, might become pregnant or breast-feeding
you should not be given this medicine unless your doctor advises
it is essential. Ask your doctor, pharmacist or nurse for advice
before taking any medicine, if you are pregnant or breast-feeding.
Driving and using machines
Ranitidine Injection is unlikely to affect your ability to drive or
operate machinery.
Ranitidine Injection contains Sodium
This medicinal product contains less than 1 mmol sodium
(23 mg) per 50 mg, i.e essentially sodium-free.

----------------------------------------------------------The following information is intended for medical or healthcare professionals only:

Ranitidine 50mg/2ml Solution for Injection and Infusion
Please read this information carefully before giving Ranitidine
50mg/2ml Solution for Injection and Infusion (referred to as Ranitidine
Injection throughout this leaflet). Please refer to the Summary of
Product Characteristics for further details on this product.
Presentation
Each 2ml ampoule of Ranitidine Injection contains 50mg of ranitidine as
ranitidine hydrochloride. Product provided in amber glass ampoules,
5 ampoules in a carton.
Pharmaceutical Form
Solution for Injection and Infusion
Clear, colourless solution
Indications
Ranitidine Injection is indicated for the treatment of duodenal
ulcer, benign gastric ulcer, post-operative ulcer, and of Zollinger Ellison Syndrome.
In the management of conditions where reduction of gastric secretion
and acid output is desirable, such as reflux oesophagitis.
As prophylaxis against:
• gastrointestinal haemorrhage from stress ulceration in seriously ill patients
• recurrent haemorrhage in patients with bleeding peptic ulcers
• acid aspiration (Mendelson's Syndrome) before anaesthesia in
patients at risk, particularly obstetric patients during labour.
Children (6 months 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.

Dosage and Method of Administration See SPC section 5.2
Pharmacokinetic Properties - Special Patient Populations.
Recommended rates of administration should not be exceeded as
bradycardia in association with rapid administration of ranitidine has
been reported rarely.
Adults (including elderly) and adolescents (12 years and older)
Ranitidine Injection may be given as:
• a slow (over two minutes) intravenous injection up to a maximum of 50
mg after dilution to a volume of 20 ml per 50 mg dose, which may be
repeated every 6 to 8 hours; or
• an intermittent intravenous infusion at a rate of 25 mg per hour for two
hours, the infusion may be repeated at 6 to 8 hours intervals; or
• an intramuscular injection of 50 mg (2ml) every 6 to 8 hours.
In the prophylaxis of haemorrhage from stress ulceration in seriously ill
patients or the prophylaxis of recurrent haemorrhage in patients bleeding
from peptic ulceration, parenteral administration may be continued until
oral feeding commences. Patients considered to be still at risk may then
be treated orally with Ranitidine tablets 150 mg twice daily.
In the prophylaxis of upper gastro-intestinal haemorrhage from stress
ulceration in seriously ill patients a priming dose of 50 mg as a slow
intravenous injection followed by a continuous intravenous infusion of
0.125 - 0.250 mg/kg/hr may be preferred.
Prophylaxis of Mendelson's syndrome:
In patients considered to be at risk of developing acid aspiration,
Ranitidine Injection may be given intramuscularly or by slow intravenous
injection 45 to 60 minutes before induction of general anaesthesia.

3. HOW TO HAVE RANITIDINE INJECTION
You will never be expected to give yourself this medicine. It will always
be given to you by someone who is trained to do so.
Your doctor will decide the correct dose of Ranitidine Injection for you.
Adults (including the elderly) and adolescents (12 years
and older):
This can be given by the doctor or nurse in one of three ways:
• As a single injection into a muscle
• As a slow infusion into a vein. This is where the drug is slowly
given to you over a few minutes
• As a continuous infusion into a vein. This is where the drug is
slowly given to you over a few hours.
The usual dose for an adult (including the elderly) and
adolescents (12 years and older) is 50 mg every 6 to 8 hours,
as a single injection into a muscle.
Different doses may also be given to you as a slow infusion or
continuous infusion, depending on what condition you are being
treated for.
Children and infants (6 months to 11 years): The dose will
be given by a slow injection into a vein. The maximum dose is
50mg every 6 or 8 hours. It is usually only given if your child is
unable to take ranitidine by mouth.
Kidney impairment: If your kidneys are not working properly
your doctor may give you a lower dose.
Your doctor or nurse will give you Ranitidine Injection so it is
unlikely that you will receive too much. If you have the impression
that the effect of Ranitidine Injection is too strong or too weak or
you have missed a dose, talk to your doctor or nurse.
If you have any further questions on the use of this product, ask
your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ranitidine Injection 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
as you may need urgent medical attention:
• Severe itching of the skin, rash or hives on the skin
• Swelling of the hands, feet, ankles, face, lips, tongue, mouth or
throat, which may cause difficulties in swallowing or breathing.
• Swelling on other parts of the body
• Chest pain, shortness of breath, wheezing or having trouble
breathing
• Unexpected fever and feeling faint especially when standing up
• Kidney problems which can lead to back pain, fever, pain when
passing urine, blood in the urine and changes in blood tests
• Severe stomach pains, this may be a sign of something called
'pancreatitis'
• A slow or irregular heartbeat
• Collapse
You may have had a serious allergic reaction to Ranitidine Injection.
Tell your doctor at your next visit if you notice any of the
following:
Uncommon side effects (less than 1 in 100)
• Stomach pain
• Constipation
• Feeling sick (nausea).
Rare side effects that may show up in blood tests:
• Increase of serum creatinine in blood (kidney function test)
• Changes to liver function

Check with your doctor as soon as possible if you notice
any of the following:
Very rare side effects (less than 1 in 10,000)
• Depression
• Confusion, hallucinations (seeing or hearing unexplained things)
• Blood changes that may result in unusual tiredness, shortness
of breath, being more likely to get infections, bruising more
easily
• Uncontrolled movements
• Your small blood vessels can become swollen (known as
vasculitis). Signs of this can include: a rash, swollen joints or
kidney problems
• Headaches (sometimes severe)
• Diarrhoea
• Feeling dizzy or having blurred vision
• Your liver can become swollen. This can lead to nausea
(feeling sick) or vomiting (being sick), loss of appetite or
generally feeling unwell, itching, fever, yellowing of the skin
and eyes or dark coloured urine
• Red blotches or lumps on the skin that may look like targets,
unexplained hair loss
• Your joints or muscles are painful and swollen
• If you are a man, sexual impotence (this is normally
reversible), tenderness of the breast, breast discharge and/or
breast enlargement.
Reporting of side effects
If you get any side effects talk to your doctor or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via:
UK: The Yellow Card Scheme: www.mhra.gov.uk/yellowcard.
IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie, E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information
on the safety of this medicine.
5. HOW TO STORE RANITIDINE INJECTION
Do not store above 25ºC
Keep ampoules in the carton to protect them from light.
Keep this medicine out of the sight and reach of children.
Ranitidine Injection should not be used after the expiry date
which is stated on the ampoule and carton. The expiry date
refers to the last day 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. FURTHER INFORMATION
What Ranitidine Injection contains
The active substance is ranitidine. One 2ml ampoule contains
50mg of ranitidine as ranitidine hydrochloride. Other ingredients
are sodium chloride, potassium dihydrogen phosphate, disodium
hydrogen phosphate dihydrate and water for injections.
What Ranitidine Injection looks like and contents of the pack
Ranitidine Injection is a clear, colourless liquid in amber glass
ampoules. Each carton of Ranitidine Injection contains 5 ampoules.
Marketing Authorisation Holder
Alliance Pharmaceuticals Limited, Avonbridge House,
Bath Road, Chippenham, Wiltshire, SN15 2BB, UK.
Manufacturer: Kleva S A, 189 Parnithos Avenue, 136 71
Acharnai, Athens, Greece.
This leaflet was last revised in December 2014
Alliance and associated devices are registered trademarks of
Alliance Pharmaceuticals Limited
© Alliance Pharmaceuticals Limited 2014

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Patients with renal impairment: Accumulation of ranitidine with resulting elevated
plasma concentrations will occur in patients with severe renal impairment
(creatinine clearance less than 50ml/min). Accordingly, it is recommended in such
patients that Ranitidine Injection be administered in doses of 25 mg.
Children and infants (6 months to 11 years): See SPC section 5.2
Pharmacokinetic Properties - Special Patient Populations.
Ranitidine Injection may be given as a slow (over 2 minutes) i.v. injection up to a
maximum of 50mg every 6 to 8 hours. Intravenous therapy in children with peptic
ulcer disease is indicated only when oral therapy is not possible. For acute
treatment of peptic ulcer disease and gastro-oesophageal reflux in paediatric
patients, Ranitidine injection may be administered at doses that have been shown
to be effective for these diseases in adults and effective for acid suppression in
critically ill children.
The initial dose (2.0 mg/kg or 2.5 mg/kg, maximum 50mg) may be administered
as a slow intravenous infusion over 10 minutes, either with a syringe pump
followed by a 3 ml flush with normal saline over 5 minutes, or following dilution
with normal saline to 20ml. Maintenance of pH > 4.0 can be achieved by
intermittent infusion of 1.5 mg/kg every 6 h to 8 h. Alternatively treatment can be
continuous, administering a loading dose of 0.45 mg/kg followed by a continuous
infusion of 0.15 mg/kg/hr.
Route of administration
Intravenous or intramuscular injection
Special Patient Populations
Children/infants (6 months and above): limited pharmacokinetic data show that
there were no significant differences in half-life (range for children 3 years and
above: 1.7 - 2.2 h) and plasma clearance (range for children 3 years and above:
9 - 22 ml/min/kg) between children and healthy adults receiving intravenous
ranitidine when correction is made for body weight. Pharmacokinetic data in infants is
extremely limited but appears to be in line with that for older children.
Patients over 50 years of age: In patients over 50 years of age, half-life is prolonged
(3-4 h) and clearance is reduced, consistent with the age-related decline of renal
function. However, systemic exposure and accumulation are 50% higher.

This difference exceeds the effect of declining renal function, and indicates
increased bioavailability in older patients.
Neonates (under 1 month): limited pharmacokinetic data from term babies
undergoing treatment with Extracorporeal Membrane Oxygenation (EMCO)
suggests that plasma clearance following i.v. administration may be reduced
(1.5-8.2 ml/min/kg) and the half-life increased in the new-born. Clearance of
ranitidine appeared to be related to the estimated glomerular filtration rate in the
neonates.
Pharmaceutical Information
Excipients: Sodium chloride, Potassium dihydrogen phosphate, Disodium
hydrogen phosphate dihydrate, Water for injections.
Incompatibilities: None known. Shelf-life: 2 years.
Storage Precautions: Do not store above 25ºC. Keep ampoules in the outer
carton to protect from light.
Nature of Container: 2 ml solution in amber, type 1 glass ampoules.
Instructions for Use and Handling: Ranitidine Injection has been shown to be
compatible with the following intravenous infusion fluids:
• Sodium Chloride 0.9% w/v
• Dextrose 5% w/v
• Sodium Chloride 0.18% w/v and Dextrose 4% w/v
• Sodium Bicarbonate 4.2% w/v
• Hartmann’s solution.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2 to
8°C, unless preparation of solutions has taken place in controlled and validated
aspeptic conditions.
All solutions of Ranitidine Injection should be discarded after use.
This leaflet was last revised in December 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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