CIMETIDINE 200MG/5ML ORAL SOLUTION

Active substance: CIMETIDINE

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Page 2
52mm x 95mm

Page 3

Page 4

52mm x 97mm

52mm x 96mm

Cimetidine 200mg/5ml Oral Solution
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 your 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 these 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 is Cimetidine Oral Solution and what is it used for
2. Before you take Cimetidine Oral Solution
3. How to take Cimetidine Oral Solution
4. Possible side effects
5. How to store Cimetidine Oral Solution
6. Further information

Each 5ml contains 200mg Cimetidine.
This product also includes methyl and
propyl hydroxybenzoates (E218 and E216), liquid
maltitol (E965) (contains sorbitol), propylene glycol
(E1520) and E110.
See leaflet for further information.

This medicine is used to:
● heal and stop ulcers in the stomach, or the part it empties into, the duodenum
● heal and stop problems caused by acid in the gullet (oesophagus) or too much
acid in the stomach. This can cause pain or discomfort known as indigestion or
heartburn
● prevent ulcers from bleeding
● prevent ulcers which may be caused by medicines called non-steroidal
anti-inflammatories (NSAIDs), often used to treat arthritis
● improve absorption of food and reduce fluid loss in short bowel syndrome
● be given before an operation to prevent acid coming up from the stomach whilst
under anaesthetic.

Tell your doctor if you are taking any of these medicines
● non-steroidal anti-inflammatories (NSAIDs) e.g. indometacin, aspirin
● strong painkillers such as morphine
● phenytoin, used for epilepsy
● tricyclic antidepressants, used to treat depression, such as amitriptyline
● medicines to stop the blood clotting such as warfarin
● medicines that cause a fall in blood cell count
● theophylline, used for asthma
● heart medicines such as lidocaine, diltiazem, nifedipine, metoprolol or
procainamide

You should see your doctor regularly especially if you are taking Cimetidine Oral
Solution as well as medicine for arthritis. This is particularly important in the elderly
or those with a history of ulcers.
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking cimetidine.

If you forget to take Cimetidine Oral Solution
Do not take a double dose (two doses at the same time) to make up for forgotten
doses. Skip the missed dose, then go on as before.

Adults and older people
The usual doses for adults are given below:
● The usual dose is 400mg (two 5ml spoonfuls) at breakfast and at bedtime. This may
be altered by your doctor depending upon what this medicine is being prescribed
for.

Admistration:
For oral use.
Read the package before use.

People with severe kidney problems
The dose may be lowered if you have kidney problems as you may be more sensitive
to the effects of the medicine.

MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds, LS11 9XE, UK.

If you take more Cimetidine Oral Solution than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so
the doctor knows what you have taken.

4. Possible side effects
Like all medicines, cimetidine can cause side effects, although not everybody gets
them.

An allergic reaction may include:
● any kind of skin rash or “hives”, flaking skin, boils or sore lips, swelling (of the
face, eyelids, lips, mouth or tongue), fever, swollen blood vessels
● sudden wheezing, fluttering or tightness of the chest, chest pain, feeling faint
especially when standing up or collapse.

PL 00427/0131
LXXXX

Page 1

Page 8

52mm x 100mm

Tell your doctor if you get any of these side effects:
● diarrhoea
● feeling tired
● breast swelling in men and impotence
● headache, fever and dizziness
● hallucinations (seeing or hearing things that are not there)
● hair loss
● skin rash
● joint or muscle pain.

If you have an allergic reaction to this medicine, STOP taking the medicine and see a
doctor immediately.

Page 9

52mm x 97mm

Storage:
Do not store above 25°C. Use within 1 month of
opening. Keep out of the reach and sight of children.

ga
st
ro
-in
tes
tinal s
ystem

MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds, LS11 9XE, UK.
PL 00427/0131

Base Page

52mm x 144mm

5 0 161 19 171 390 >

Admistration:
For oral use.
Read the package before use.

Rosemont

TM

52mm x 96mm

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Product:

Cimetidine 200mg/5ml
Oral Solution

Date:

10.04.12

200mg/5ml

Proof Number:

TWO

New Item Code:
LXXXX0534

Strength:

CMS_S SPC 4.5 update

Page:

1 of: 3

Previous Item Code:

L1095

Design Icon:

GIS

Pack Size

Dimensions:

Base Label:
Leaflet Page 1:

300ml

52 x 144mm
52mm x 100mm

Core size:76.2mm. Max dia of reel: 800 labels

Right Hand Opening

Number of
colours used:

3 + Varnish

Left Hand Opening

Black

54

YES

Sugar-Free

Cutter Ref:

New Pharmacode:

430

7474

5 016 119 17 1390 >
Braille

I NO I

Tick
applicable
box

Name:
Date:

Regulatory Sign-off
Name:

Barcode:

Signature:

Take this medicine as your doctor or pharmacist has told you. Look on the label and
ask the doctor or pharmacist if you are not sure.

If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. How to store Cimetidine Oral Solution
Keep out of the reach and sight of children
Do not store above 25°C and keep out of direct sunlight
Do not use 1 month from the date you first open it
Do not use after the expiry date which is stated on the label and carton (exp:
month, year)
● The expiry date refers to the last day of that month
● Do not use Cimetidine Oral Solution if you notice that the appearance or smell of
your medicine has changed. Talk to your pharmacist
● 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.





52mm x 97mm

Third Party Approval Required YES

Signature:

Pregnancy and breast-feeding
● Talk to your doctor before taking this medicine if you are pregnant, planning to
become pregnant or are breast-feeding. Cimetidine should not be used when you
are pregnant or breast feeding unless the doctor considers it necessary
● Do not take this medicine if you are in labour.

Page 11

Each 5ml contains 200mg Cimetidine.
This product also includes methyl and
propyl hydroxybenzoates (E218 and E216), liquid
maltitol (E965) (contains sorbitol), propylene glycol
(E1520) and E110.
See leaflet for further information.

Important information about what is in Cimetidine Oral Solution
This medicine contains:
● methyl and propyl parahydroxybenzoates. These may cause an allergic reaction.
This allergy may happen some time after starting the medicine
● liquid maltitol. If your doctor has told you that you cannot tolerate some sugars,
see your doctor before taking this medicine
● sunset yellow E110. This may cause an allergic reaction including asthma
● propylene glycol which may cause alcohol-like symptoms.

Date:

Keyline

Artwork produced by:

Tel: 0113 261 3172

3. How to take Cimetidine Oral Solution

Taking this medicine
● This medicine contains 200mg of cimetidine in each 5ml
● Take this medicine by mouth
● The total daily dose should not be more than 2.4g each day
● The usual length of treatment is 4 weeks.

6. Further information
What Cimetidine Oral Solution contains
● The active ingredient is cimetidine
● The other ingredients are methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), propylene glycol (E1520), liquid maltitol (E965)
(containing sorbitol), hydrochloric acid, disodium hydrogen phosphate (E339),
saccharin sodium, ammonium glycyrrhizinate, peach and peppermint flavour
(containing propylene glycol), sunset yellow (E110) and purified water.
What Cimetidine Oral Solution looks like and contents of the pack
A clear yellow/orange liquid with an odour of peppermint and peach.
It comes in a brown glass bottle holding 300ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street,
Leeds, LS11 9XE, UK.
This leaflet was last revised in 04/2012

Page 10

52mm x 96mm

52mm x 100mm

● medicines that are given after organ transplants to stop the body rejecting the
organ such as ciclosporin and tacrolimus
● medicines used to treat HIV/AIDs such as atazanavir
● medicines used to treat fungal infections such as ketoconazole, itraconazole and
posaconazole
● medicines to treat cancer such as carmustine, fluorouracil, epirubicin, or
therapies such as radiation
● medicines used to treat diabetes such as metformin or glipizide.

Driving and using machines
This product should not affect your ability to drive or to use machinery.

If you get any of the following side effects, see your doctor as soon as possible:
● unusual tiredness, shortness of breath, bruising more easily or other signs of
infection – this could be a sign of blood problems
● stomach and back pain, fever, feeling or being sick – this may be a sign that your
pancreas is swollen
● hepatitis. You may notice symptoms such as a tender stomach and abdomen, loss
of appetite and yellowing of the skin and the whites of the eyes (jaundice)
● irregular or slow heart beats
● feeling depressed or confused.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Children above 1 year old
If prescribed for a child, the dosage depends on the child’s weight. Make sure the child
takes the liquid as the doctor says. The usual dose is 25-30mg/Kg body weight each
day. The dose should not be more than 2.4g each day.

Storage:
Do not store above 25°C. Use within 1 month of
opening. Keep out of the reach and sight of children.

ga
st
ro
-in
tes
tinal s
ystem

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines. This includes medicines you buy without a prescription, including
herbal medicines. This is because cimetidine can affect the way some other
medicines work. Also some medicines can affect the way cimetidine works.

Take special care with Cimetidine Oral Solution
Before you take cimetidine, tell your doctor if:
● you have kidney problems
● you have lost weight recently and also have stomach ache, stomach pain or
indigestion at the same time, particularly if you are over 40.

Page 7

52mm x 97mm

Going into hospital
Do not take this medicine if you are going into hospital today for an operation or to
give birth.

Do not take Cimetidine Oral Solution and tell your doctor if:
● you are allergic (hypersensitive) to cimetidine or any other ingredients in this
liquid (listed in Section 6)
The signs of an allergic reaction include a rash, itching or shortness of breath
● you are pregnant, likely to become pregnant and if you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to
your doctor or pharmacist before taking cimetidine.

The name of your medicine is Cimetidine 200mg/5ml Oral Solution. It contains
cimetidine. This belongs to a group of medicines called H2 antagonists, which
reduce the amount of acid in your stomach.

Page 6

52mm x 96mm

2. Before you take Cimetidine Oral Solution

1. What is Cimetidine Oral Solution and what is it used for






Page 5

info@ptarmigan-design.co.uk

Page 12

52mm x 95mm

Page 2
52mm x 95mm

Page 3

Page 4

52mm x 97mm

52mm x 96mm

Cimetidine 200mg/5ml Oral Solution
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 your 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 these 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 is Cimetidine Oral Solution and what is it used for
2. Before you take Cimetidine Oral Solution
3. How to take Cimetidine Oral Solution
4. Possible side effects
5. How to store Cimetidine Oral Solution
6. Further information

Each 5ml contains 200mg Cimetidine.
This product also includes methyl and
propyl hydroxybenzoates (E218 and E216), liquid
maltitol (E965) (contains sorbitol), propylene glycol
(E1520) and E110.
See leaflet for further information.

This medicine is used to:
● heal and stop ulcers in the stomach, or the part it empties into, the duodenum
● heal and stop problems caused by acid in the gullet (oesophagus) or too much
acid in the stomach. This can cause pain or discomfort known as indigestion or
heartburn
● prevent ulcers from bleeding
● prevent ulcers which may be caused by medicines called non-steroidal
anti-inflammatories (NSAIDs), often used to treat arthritis
● improve absorption of food and reduce fluid loss in short bowel syndrome
● be given before an operation to prevent acid coming up from the stomach whilst
under anaesthetic.

If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking cimetidine.

If you forget to take Cimetidine Oral Solution
Do not take a double dose (two doses at the same time) to make up for forgotten
doses. Skip the missed dose, then go on as before.

Adults and older people
The usual doses for adults are given below:
● The usual dose is 400mg (two 5ml spoonfuls) at breakfast and at bedtime. This may
be altered by your doctor depending upon what this medicine is being prescribed
for.

Admistration:
For oral use.
Read the package before use.

Storage:
Do not store above 25°C. Use within 1 month of
opening. Keep out of the reach and sight of children.

ga
st
ro
-in
tes
tinal s
ystem

Tell your doctor if you are taking any of these medicines
● non-steroidal anti-inflammatories (NSAIDs) e.g. indometacin, aspirin
● strong painkillers such as morphine
● phenytoin, used for epilepsy
● tricyclic antidepressants, used to treat depression, such as amitriptyline
● medicines to stop the blood clotting such as warfarin
● medicines that cause a fall in blood cell count
● theophylline, used for asthma
● heart medicines such as lidocaine, diltiazem, nifedipine, metoprolol or
procainamide

You should see your doctor regularly especially if you are taking Cimetidine Oral
Solution as well as medicine for arthritis. This is particularly important in the elderly
or those with a history of ulcers.

People with severe kidney problems
The dose may be lowered if you have kidney problems as you may be more sensitive
to the effects of the medicine.

MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds, LS11 9XE, UK.

If you take more Cimetidine Oral Solution than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so
the doctor knows what you have taken.

4. Possible side effects
Like all medicines, cimetidine can cause side effects, although not everybody gets
them.

An allergic reaction may include:
● any kind of skin rash or “hives”, flaking skin, boils or sore lips, swelling (of the
face, eyelids, lips, mouth or tongue), fever, swollen blood vessels
● sudden wheezing, fluttering or tightness of the chest, chest pain, feeling faint
especially when standing up or collapse.

PL 00427/0131
LXXXX

Page 1

Page 8

52mm x 100mm

Tell your doctor if you get any of these side effects:
● diarrhoea
● feeling tired
● breast swelling in men and impotence
● headache, fever and dizziness
● hallucinations (seeing or hearing things that are not there)
● hair loss
● skin rash
● joint or muscle pain.

If you have an allergic reaction to this medicine, STOP taking the medicine and see a
doctor immediately.

Page 9

52mm x 97mm

Storage:
Do not store above 25°C. Use within 1 month of
opening. Keep out of the reach and sight of children.

ga
st
ro
-in
tes
tinal s
ystem

MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds, LS11 9XE, UK.
PL 00427/0131

Base Page

52mm x 144mm

5 0 161 19 171 390 >

Admistration:
For oral use.
Read the package before use.

Rosemont

TM

52mm x 96mm

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Product:

Cimetidine 200mg/5ml
Oral Solution

Date:

200mg/5ml

Proof Number:

TWO

New Item Code:
LXXXX0534

Strength:

CMS_S SPC 4.5 update

Page:

2 of: 3

Previous Item Code:

L1095

Design Icon:

GIS

Pack Size
Base Label:
Leaflet Page 1:

New Pharmacode:

300ml

52 x 144mm
52mm x 100mm

Core size:76.2mm. Max dia of reel: 800 labels

Right Hand Opening

Number of
colours used:

3 + Varnish

Left Hand Opening

Black

54

YES

Sugar-Free

Cutter Ref:
Dimensions:

cimetidine
#200 mg/#5 ml
oral solution

10.04.12

430

7474

5 016 119 17 1390 >
Braille

I NO I

Tick
applicable
box

Name:
Date:

Regulatory Sign-off
Name:

Barcode:

Signature:

Take this medicine as your doctor or pharmacist has told you. Look on the label and
ask the doctor or pharmacist if you are not sure.

If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. How to store Cimetidine Oral Solution
Keep out of the reach and sight of children
Do not store above 25°C and keep out of direct sunlight
Do not use 1 month from the date you first open it
Do not use after the expiry date which is stated on the label and carton (exp:
month, year)
● The expiry date refers to the last day of that month
● Do not use Cimetidine Oral Solution if you notice that the appearance or smell of
your medicine has changed. Talk to your pharmacist
● 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.





52mm x 97mm

Third Party Approval Required YES

Signature:

Pregnancy and breast-feeding
● Talk to your doctor before taking this medicine if you are pregnant, planning to
become pregnant or are breast-feeding. Cimetidine should not be used when you
are pregnant or breast feeding unless the doctor considers it necessary
● Do not take this medicine if you are in labour.

Page 11

Each 5ml contains 200mg Cimetidine.
This product also includes methyl and
propyl hydroxybenzoates (E218 and E216), liquid
maltitol (E965) (contains sorbitol), propylene glycol
(E1520) and E110.
See leaflet for further information.

Important information about what is in Cimetidine Oral Solution
This medicine contains:
● methyl and propyl parahydroxybenzoates. These may cause an allergic reaction.
This allergy may happen some time after starting the medicine
● liquid maltitol. If your doctor has told you that you cannot tolerate some sugars,
see your doctor before taking this medicine
● sunset yellow E110. This may cause an allergic reaction including asthma
● propylene glycol which may cause alcohol-like symptoms.

Date:

Keyline

Artwork produced by:

Tel: 0113 261 3172

3. How to take Cimetidine Oral Solution

Taking this medicine
● This medicine contains 200mg of cimetidine in each 5ml
● Take this medicine by mouth
● The total daily dose should not be more than 2.4g each day
● The usual length of treatment is 4 weeks.

6. Further information
What Cimetidine Oral Solution contains
● The active ingredient is cimetidine
● The other ingredients are methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), propylene glycol (E1520), liquid maltitol (E965)
(containing sorbitol), hydrochloric acid, disodium hydrogen phosphate (E339),
saccharin sodium, ammonium glycyrrhizinate, peach and peppermint flavour
(containing propylene glycol), sunset yellow (E110) and purified water.
What Cimetidine Oral Solution looks like and contents of the pack
A clear yellow/orange liquid with an odour of peppermint and peach.
It comes in a brown glass bottle holding 300ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street,
Leeds, LS11 9XE, UK.
This leaflet was last revised in 04/2012

Page 10

52mm x 96mm

52mm x 100mm

● medicines that are given after organ transplants to stop the body rejecting the
organ such as ciclosporin and tacrolimus
● medicines used to treat HIV/AIDs such as atazanavir
● medicines used to treat fungal infections such as ketoconazole, itraconazole and
posaconazole
● medicines to treat cancer such as carmustine, fluorouracil, epirubicin, or
therapies such as radiation
● medicines used to treat diabetes such as metformin or glipizide.

Driving and using machines
This product should not affect your ability to drive or to use machinery.

If you get any of the following side effects, see your doctor as soon as possible:
● unusual tiredness, shortness of breath, bruising more easily or other signs of
infection – this could be a sign of blood problems
● stomach and back pain, fever, feeling or being sick – this may be a sign that your
pancreas is swollen
● hepatitis. You may notice symptoms such as a tender stomach and abdomen, loss
of appetite and yellowing of the skin and the whites of the eyes (jaundice)
● irregular or slow heart beats
● feeling depressed or confused.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Children above 1 year old
If prescribed for a child, the dosage depends on the child’s weight. Make sure the child
takes the liquid as the doctor says. The usual dose is 25-30mg/Kg body weight each
day. The dose should not be more than 2.4g each day.

cimetidine
#200 mg/#5 ml
oral solution

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines. This includes medicines you buy without a prescription, including
herbal medicines. This is because cimetidine can affect the way some other
medicines work. Also some medicines can affect the way cimetidine works.

Take special care with Cimetidine Oral Solution
Before you take cimetidine, tell your doctor if:
● you have kidney problems
● you have lost weight recently and also have stomach ache, stomach pain or
indigestion at the same time, particularly if you are over 40.

Page 7

52mm x 97mm

Going into hospital
Do not take this medicine if you are going into hospital today for an operation or to
give birth.

Do not take Cimetidine Oral Solution and tell your doctor if:
● you are allergic (hypersensitive) to cimetidine or any other ingredients in this
liquid (listed in Section 6)
The signs of an allergic reaction include a rash, itching or shortness of breath
● you are pregnant, likely to become pregnant and if you are breast-feeding.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to
your doctor or pharmacist before taking cimetidine.

The name of your medicine is Cimetidine 200mg/5ml Oral Solution. It contains
cimetidine. This belongs to a group of medicines called H2 antagonists, which
reduce the amount of acid in your stomach.

Page 6

52mm x 96mm

2. Before you take Cimetidine Oral Solution

1. What is Cimetidine Oral Solution and what is it used for






Page 5

info@ptarmigan-design.co.uk

Page 12

52mm x 95mm

Page 2
52mm x 95mm

Page 3

Page 4

52mm x 97mm

Page 5

52mm x 96mm

Page 6

52mm x 96mm

Page 7

52mm x 97mm

52mm x 100mm

Page 11

Page 12

cimetidine
#200 mg/#5 ml
oral solution
Page 1

52mm x 100mm

Page 8

Page 9

52mm x 97mm

Page 10

52mm x 96mm

Rosemont

TM

52mm x 96mm

Rosemont Pharmaceuticals Ltd. Printed Packaging Origination and Approval

Product:

Cimetidine 200mg/5ml
Oral Solution

Date:

10.04.12

Strength:

TWO

CMS_S SPC 4.5 update

Page:

3 of: 3

Previous Item Code:

52mm x 144mm

Proof Number:

New Item Code:

Base Page

200mg/5ml

L1095

Design Icon:

GIS

Pack Size

Dimensions:

Base Label:
Leaflet Page 1:

300ml

52 x 144mm
52mm x 100mm

Core size:76.2mm. Max dia of reel: 800 labels

Right Hand Opening

cimetidine
#200 mg/#5 ml
oral solution

Number of
colours used:

3 + Varnish

Left Hand Opening

Black

54

YES

Sugar-Free

Cutter Ref:

New Pharmacode:

430

7474

Third Party Approval Required YES

I NO I

Tick
applicable
box

Name:
Signature:

Date:

Regulatory Sign-off
Name:

Barcode:
5 016 119 17 1390 >
Braille

52mm x 97mm

Signature:

Date:

Keyline

Artwork produced by:

Tel: 0113 261 3172

info@ptarmigan-design.co.uk

52mm x 95mm

Expand view ⇕

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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