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RANITIDINE 30MG/ML ORAL SOLUTION

Active substance(s): RANITIDINE HYDROCHLORIDE / RANITIDINE HYDROCHLORIDE / RANITIDINE HYDROCHLORIDE

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Package leaflet: Information for the user

The usual dose for an adult (including the elderly) is
either:
• one 5 ml in the morning and one 5ml in the
evening, or
• two 5ml at bedtime.

Ranitidine 30mg/ml Oral Solution
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, pharmacist 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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ranitidine 30mg/ml Oral Solution is and
what it is used for
2. What you need to know before you take
Ranitidine 30mg/ml Oral Solution
3. How to take Ranitidine 30mg/ml Oral Solution
4. Possible side effects
5. How to store Ranitidine 30mg/ml Oral Solution
6. Contents of the pack and other information

1. What Ranitidine 30mg/ml Oral Solution
is and what it is used for
Ranitidine Oral Solution contains a medicine called
ranitidine. This belongs to a group of medicines
called H2-receptor antagonists. It lowers the
amount of acid in your stomach.
For adults (including the elderly) Ranitidine Oral
Solution is used to:
• heal and stop ulcers in the stomach or the part
of the gut it empties into (the duodenum)
• help clear up infection in your stomach, when
taken with antibiotic medicines (medicines
taken to treat germs)
• stop stomach ulcers when they are a side effect
of some medicines
• stop ulcers from bleeding
• 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 acid coming up from the stomach while
under anaesthetic during an operation.
For children (3 to 18 years) Ranitidine Oral Solution
is used to:
• heal ulcers in the stomach or the part of the gut
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 take
Ranitidine 30mg/ml Oral Solution
Do not take Ranitidine Oral Solution:
• if you are allergic to ranitidine or any of the other
ingredients of this medicine (listed in section 6).
If you are not sure, talk to your doctor or
pharmacist before taking Ranitidine Oral Solution.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ranitidine 30mg/ml Oral Solution if:
• you have stomach cancer
• you have kidney problems. You will need to take
a different amount of Ranitidine Oral Solution
• you have had stomach ulcers before and you are
taking Non-Steroidal Anti-Inflammatory (NSAID)
medicines
• you have a rare condition called acute porphyria
• you are over 65 years old
• you have lung disease
• you are diabetic
• you have any problems with your immune
system.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using this
medicine.

without a prescription and herbal medicines. This is
because Ranitidine Oral Solution can affect the way
some other medicines work. Also some other
medicines can affect the way Ranitidine Oral
Solution works.

Your exact dose will depend on your particular
stomach condition, your doctor will tell you the
dose you should take.

In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
• Non-Steroidal Anti-Inflammatory (NSAID)
medicines, for pain and inflammation
• lidocaine, a local anaesthetic
• propranolol, procainamide or
n-acetylprocainamide, for heart problems
• diazepam, for worry or anxiety problems
• phenytoin, for epilepsy
• theophylline, for breathing problems (asthma)
• warfarin, for thinning your blood
• glipizide, for lowering blood glucose
• atazanavir or delaviridine, for treating HIV
infection
• triazolam, for insomnia
• gefitnib, for lung cancer
• ketoconazole, an anti-fungal medicine,
sometimes used for treating thrush
• Sulcralfate for treating stomach ulcers.

Use in children from 3 to 11 years:
Your doctor will work out the right dose in mls
based on your child’s weight. Make sure you follow
the instructions on the label.

Midazolam is a medicine that may be given to you
just before you have an operation. Tell the doctor
you are taking Ranitidine Oral Solution before your
operation in case he or she wants to give you
midazolam.
If you are not sure if any of the above apply to you,
talk to your doctor, pharmacist or nurse before
taking Ranitidine Oral Solution.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
You should not take this medicine unless your
doctor advises it is essential.
Driving and using machines
Ranitidine oral solution is unlikely to affect your
ability to drive or operate machinery.
Ranitidine Oral Solution contains ethanol
(alcohol), sorbitol and sodium
Ranitidine Oral Solution contains ethanol (alcohol),
i.e. up to 400mg per dose (5 ml). For this reason, it
may be harmful for those suffering from
alcoholism. The ethanol content should also be
taken into account if Ranitidine Oral Solution is to
be given to pregnant or breast-feeding women,
children and high risk groups such as those
suffering from:
• alcoholism
• liver disease
• epilepsy
• brain injury or disease.
Each 2.5 ml contains approximately 200 mg of
alcohol which is equivalent to about 5ml of beer or
2.5ml of wine. Talk to your doctor or pharmacist if
you are concerned. He/she may be able to suggest
an alternative formulation.
This medicine also contains 18.45 mg sodium per
dose (5ml solution). To be taken into consideration
by patients on a controlled sodium diet.
This medicine also contains sorbitol. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.

3. How to take Ranitidine 30mg/ml Oral
Solution
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth.
• Use the syringe provided to carefully measure
the dose needed.
• Do not mix Ranitidine Oral Solution with
anything (not even water) before swallowing it.

Other medicines and Ranitidine 30mg/ml Oral
Solution
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines that you buy

Product Title
Strength
PIL Format
Pharma Code
No of Colours

Ranitidine OS
30 mg/ml
160 x 360 mm

Date
Client
Country
Job No.

10/05/2017
Creo Pharma
UK
CRE-RAN-PIL-300

1

Pantone
Pantone
Black
Black
Typefaces
Congress Black, Kohinoor Bold, Demi, Light
Artwork prepared by David Heaton +44 (0)1462 431277 dc.heaton@ntlworld.com

No. of Draft
_01
_02
_03
_04

Date
10/05/2017
11/05/2017
12/06/2017
12/06/2017

Reason for Draft
New file
Corrections
Text revisions
Correction

Use in children 12 years and over:
The adult dose is given.

Treatment of stomach and duodenal 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.
If you take more Ranitidine Oral Solution than
you should
Ranitidine Oral Solution is not normally harmful if
you take more than you should, unless you take a
lot of oral solution at once. If this applies to you (or
someone else taking this medicine), you should go
to your nearest hospital casualty department
straight away. Take the medicine pack or any
remaining medicine with you so that the doctor
knows what you have taken.
If you forget to take Ranitidine Oral Solution
• If you forget a dose, take it as soon as you
remember it, unless it is nearly time for your next
dose.
• Do not take a double dose to make up for a
forgotten dose.
If you stop taking Ranitidine Oral Solution
After a few days of taking the oral solution you
should start to feel much better. Do not stop taking
the oral solution without talking to your doctor or
pharmacist first, otherwise the original pain and
discomfort may come back.
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.
The following side effects may happen with this
medicine.
Stop taking Ranitidine Oral Solution and see a
doctor straight away if you notice any of the
following serious side effects, you may need
urgent medical treatment:
• allergic reactions, the signs may include:
- rash, itching or hives on the skin
- swelling of your face, lips, tongue or other
parts of the body
- chest pain, shortness of breath, wheezing or
having trouble breathing
- unexplained 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 pain, this may be a sign of
something called ‘pancreatitis’
• a slow or irregular heartbeat
Check with your doctor at your next visit if you
notice any of the following:
Uncommon (may affect up to 1 in 100 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 the blood (kidney
function test)
• changes to liver function

Important
Please ensure that the texts and layout are to
your satisfaction as the studio cannot accept
liability for any errors overlooked.
All Bar Codes and Braille text must be verified
by the client/manufacturer/printer. The studio is
unable to do this and cannot accept liability for
any errors.
Colours may not reproduce accurately on this
proof. You should refer to Pantone Reference
Guides for accurate colour match.

Check with your doctor as soon as possible if you
notice any of the following:
Very rare (may affect up to 1 in 10,000 people)
• there can be changes in the level of certain
substances in your blood. This can lead to you
feeling unusually tired or short of breath and
being more likely to bruise or get an infection
• feeling depressed, confused, seeing or hearing
unexplained things (hallucinations)
• headache (sometimes severe)
• feeling dizzy or having blurred vision
• your joints or muscles are painful or swollen or
you cannot control their movement
• your small blood vessels can become swollen
(known as ‘vasculitis’). Signs of this can include: a
rash, swollen joints or kidney problems
• 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
• flushing or marks on your skin that look like
targets
• unexplained hair loss
• diarrhoea
• impotence
• breast tenderness and/or breast enlargement
• breast discharge
• awareness of the heart beat and/or increased
heart rate.
Not known (frequency cannot be estimated
from the available data)
• shortness of breath
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. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Ranitidine 30mg/ml Oral
Solution
• 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 label. The expiry date
refers to the last day of the month.
• Shelf life after first opening of the bottle: Use
within 2 months.
• Store below 25°C
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 protect the environment.

6. Contents of the pack and other
information
What Ranitidine Oral Solution contains
• The active substance is ranitidine (as the
hydrochloride)
• The other ingredients are sorbitol (E420),
ethanol, disodium hydrogen phosphate
anhydrous, sodium dihydrogen phosphate
monohydrate, hydroxyethylcellulose, tutti frutti
flavour, sodium saccharin, sucralose and sodium
hydroxide solution 1.0N, purified water.
• Each 5 ml dose contains 7.5 % w/v ethanol
(alcohol) i.e. up to 400 mg per dose.
What Ranitidine 30mg/ml Oral Solution looks
like and contents of the pack
Ranitidine Oral Solution is a clear, yellowish orange
solution with characteristic fruit odour.
Cartons contain one 150 ml amber glass bottle.
A 5 ml oral syringe with 0.1 ml increments.
Marketing Authorisation Holder
Creo Pharma Limited, Felsted Business Centre
Felsted, Essex CM6 3LY
Manufacturer
RAFARM SA, Thesi Pousi- Xatzi, Agiou Louka,
Paiania, Attiki 19002, P.O. Box 37, Greece
This leaflet was last revised in June 2017
CRE-RAN-PIL-301_04
12/06/2017

Expand Transcript

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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