Cimetidine 200mg/5ml Oral Solution
Page 3
52mm x 97mm
Page 7
52mm x 100mm
Page 2
52mm x 95mm
Page 5
52mm x 96mm
Page 6
52mm x 97mm
Page 4
52mm x 96mm
Rnsemnnf]
Patient Information Leaflet
• 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
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.
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.
©
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.
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.
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.
Do not take this medicine if you are going into hospital today for an operation or to give birth.
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.
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
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
• dicines to treat cancer such as carmustine, fluorouracil, epirubicin, or therapies such as radiation
• medicines used to treat diabetes such as metformin or glipizide.
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.
Driving and using machines
This product should not affect your ability to drive or to use machinery.
©
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.
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.
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.
©
SUGAR FREE 300ml O
Cimetidine 200mg/5ml Oral Solution
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.
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. MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds, LS11 9XE, UK.
PL 00427/0131 LXXXX
Page 1
52mm x 100mm
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.
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.
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.
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.
Page 8
52mm x 97mm
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, cimetidine can cause side effects, although not everybody gets them.
If you have an allergic reaction to this medicine, STOP taking the medicine and see a doctor immediately.
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.
Page 9
52mm x 96mm
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.
Tell your doctor if you get any of these side effects:
• diarrhoea
• feeling tired
• breast swelling in men and impotence
• headache, fever and dizziness
• hall ucinations (seeing or hearing things that are not there)
• hair loss
• skin rash
• joint or muscle pain. (9)
Page 10 52mm x 96mm
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.
Page 11 52mm x 97mm
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 12 52mm x 95mm
SUGAR FREE 300ml e
Cimetidine 200mg/5ml Oral Solution
PL 00427/0131
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.
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. MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds, LS11 9XE, UK.
RosEmanf
LXXXX
Base Page 52mm x 144mm
Rosemont TM
|
Product: |
Cimetidine 200mg/5ml Oral Solution | ||
|
Strength: |
200mg/5ml | ||
|
New Item Code: |
CMS_S SPC 4.5 update | ||
|
Previous Item Code: |
L1095 | ||
|
Design Icon: |
GIS |
Sugar-Free |
YES |
|
Cutter Ref: |
Pack Size |
300ml | |
|
Dimensions: |
Base Label: 52 x 144mm Leaflet Page 1: 52mm x 100mm Core size:76.2mm. Max dia_of_reel: 800 labels Right Hand Opening EZI Left Hand Opening | ||
|
Number of colours used: |
3 + Varnish ■ Black | 430 | 7474 | ||
Date:
Proof Number:
Page:
10.04.12
TWO
1 of: 3
Name:
Signature:
Date:
New Pharmacode:
Barcode:
5 "016119" 171390">
Name:
Signature:
Date:
Braille Q Keyline
Artwork produced by:
Ptarmigari9
pronounced design
Rnsemnnf]
Patient Information Leaflet
• 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
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.
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.
©
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.
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.
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.
Do not take this medicine if you are going into hospital today for an operation or to give birth.
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.
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
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
• dicines to treat cancer such as carmustine, fluorouracil, epirubicin, or therapies such as radiation
• medicines used to treat diabetes such as metformin or glipizide.
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.
Driving and using machines
This product should not affect your ability to drive or to use machinery.
©
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.
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.
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.
©
SUGAR FREE 300ml O
Cimetidine 200mg/5ml Oral Solution
PL 00427/0131 LXXXX
Rosemont Pharmaceuticals Ltd., Leg®, ijll 9^^lJ
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.
|9 Admiration: • •
For oral use. •
Read the package before use.
• ‘Storage:
Do not stole above 25°c. Use within 1 month of opening. Keep out of the reach and sight of children. MA Hold
Page 1
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.
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.
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.
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.
Page 8
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, cimetidine can cause side effects, although not everybody gets them.
If you have an allergic reaction to this medicine, STOP taking the medicine and see a doctor immediately.
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.
Page 9
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.
Tell your doctor if you get any of these side effects:
• diarrhoea
• feeling tired
• breast swelling in men and impotence
• headache, fever and dizziness
• hall ucinations (seeing or hearing things that are not there)
• hair loss
• skin rash
• joint or muscle pain. (9)
Page 10
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.
Page 11
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 12
PL 00427/0131
100mm
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.
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. MA Holder:
Rosemont Pharmaceuticals Ltd.,
Leeds, LS11 9XE, UK.
RosEmanf
52mm x 97mm
52mm x 96mm
52mm x 96mm
52mm x 97mm
52mm x 95mm
Tick
applicable
box
Base Page 52mm x 144mm
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Rosemont TM
|
Product: |
Cimetidine 200mg/5ml Oral Solution | ||
|
Strength: |
200mg/5ml | ||
|
New Item Code: |
CMS_S SPC 4.5 update | ||
|
Previous Item Code: |
L1095 | ||
|
Design Icon: |
GIS |
Sugar-Free |
YES |
|
Cutter Ref: |
Pack Size |
300ml | |
|
Dimensions: |
Base Label: 52 x 144mm Leaflet Page 1: 52mm x 100mm Core size:76.2mm. Max dia_of_reel: 800 labels Right Hand Opening EZI Left Hand Opening | ||
|
Number of colours used: |
3 + Varnish ■ Black | 430 | 7474 | ||
Date:
Proof Number:
Page:
New Pharmacode:
Barcode:
5 "016119" 171390">
Braille Q Keyline
Name:
Signature:
Date:
Name:
Signature:
Date:
Artwork produced by:
|
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Page 1
52mm x 100mm
Page 8
52mm x 97mm
Page 9
52mm x 96mm
Page 10 52mm x 96mm
Page 11 52mm x 97mm
Page 12 52mm x 95mm
Tick
applicable
box
Base Page 52mm x 144mm
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RdsEmont TM
|
Product: |
Cimetidine 200mg/5ml Oral Solution | ||
|
Strength: |
200mg/5ml | ||
|
New Item Code: |
CMS_S SPC 4.5 update | ||
|
Previous Item Code: |
L1095 | ||
|
Design Icon: |
GIS |
Sugar-Free |
YES |
|
Cutter Ref: |
Pack Size |
300ml | |
|
Dimensions: |
Base Label: 52 x 144mm Leaflet Page 1: 52mm x 100mm Core size:76.2mm. Max dia_of_reel: 800 labels Right Hand Opening EZI Left Hand Opening | ||
|
Number of colours used: |
3 + Varnish ■ Black | 430 | 7474 | ||
Date:
Proof Number:
Page:
New Pharmacode:
Barcode:
5 "016119" 171390">
••
••
10.04.12
TWO
3 of: 3
Name:
Signature:
Date:
Name:
Braille Q Keyline
Signature:
Date:
Artwork produced by:
Tel: 0113 261 3172
info@ptarmigan-design.co.uk