Pentasa 1g Suppositories
Pentasa® 1g suppositories
(mesalazine)
Patient Information
Read all of this leaflet carefully before you start using 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.
The name of your medicine is Pentasa 1g suppositories but it will be referred as Pentasa throughout this leaflet.
In this leaflet:
1. What Pentasa is and what it is used for
2. Before you use Pentasa
3. Howto use Pentasa
4. Possible side effects
5. How to store Pentasa
6. Further Information
1. What Pentasa is and what it is used for
Each suppository contains mesalazine 1 g as the active ingredient. Mesalazine belongs to a group of medicines called salicylates.
Pentasa is used to treat inflammation in the gut caused by conditions such as ulcerative colitis. Sometimes ulcerative colitis only affects the back passage (rectum), this is known as ulcerative proctitis. Pentasa is used to treat ulcerative proctitis and are intended for rectal use only.
The suppositories release the active ingredient slowly which then acts locally to reduce the inflammation and help relieve or stop the pain.
2. Before you use Pentasa
Do Not use Pentasa if you:
• are allergic to mesalazine or any of the other ingredients in Pentasa
• are allergic to any other salicylates e.g. aspirin
• have severe liver or kidney problems
• are under the age of 15 years
Take special care with Pentasa
You should consult your doctor before using these suppositories if:
• you currently have, or have previously had liver or kidney disease
• you are on any medication that may affect kidney function e.g. azathioprine
• you have ever had an allergy to a medication called sulphasalazine
You should make sure that you don’t become dehydrated, while you are using this medicine. This can occur after severe or prolonged attacks of vomiting and/or diarrhoea, high fever or heavy sweating. If this does occur, you should speak to a doctor or pharmacist for advice as soon as possible.
While you are using Pentasa your doctor may occasionally want to check your kidney function.
Using with 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. This is especially important if you are taking any of the following:
• Non-steroidal anti-inflammatories (NSAIDS)
• Azathioprine or6-mercaptopurine Pregnancy and Breast-feeding
If you are pregnant, are planning to become pregnant or are breast-feeding you should speak to your doctor or pharmacist before taking this medicine.
3. How to use Pentasa
Always use Pentasa exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The suppository should be inserted into the back passage (rectum) only. It is intended to be left in place for as long as possible and is therefore best inserted before going to sleep.
To treat an attack of proctitis your doctor will usually prescribe one suppository to be used daily for two to four weeks.
To help prevent further attacks it may be used for longer.
How to insert the suppository
You should make sure that you empty your bowels before inserting the suppository.
a. Tear along the perforation to remove one suppository blister from a blister strip
b. Put a protector on the finger with which you will insert the suppository
c. Remove the suppository from the blister before insertion. This is done by pushing the suppository through the printed foil
d. Insertion may be made easier if you moisten the suppository with water first
e. Insert the suppository gently and fully into the back passage. It may help to lie down on one side and raise the other knee
f. Remain still for a few minutes after insertion to help keep the suppository in place. If it comes out within 10 minutes, a new one should be inserted
g. Dispose of the empty blister and used finger protector safely and wash your hands
If you use more Pentasa than you should
If you accidentally use too many suppositories, you should go to your nearest emergency department or contact your doctor immediately. Take the pack and any remaining suppositories with you.
If you forget to use Pentasa
If you forget to use a dose, use the next dose as soon as you remember, unless it is less than 6 hours until your next dose. Do not use a double dose to make up for the forgotten one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Pentasa can cause side effects, although not everyone gets them.
Following rectal administration local reactions such as itching, rectal discomfort and urge may occur.
STOP taking Pentasa if you notice:
• itching, skin rashes, swelling of the face, lips or throat, difficulty in breathing, wheeziness or coughing (signs of an allergic reaction).
• skin disorder due to an allergic reaction or infection (Erythema Mulitforme or Stevens-Johnson syndrome). Symptoms include severe rash, blisters or red splotches on the skin.
• unexplained bleeding, bruising, skin rashes, fever or sore throat (signs of blood disorder).
• change in colour or amount of urine produced (signs of kidney problems).
If you experience any of the above side effects, you should contact your doctor or go to the nearest hospital immediately.
Common side effects (affecting upto 1 in 100 people) include:
|
• vomiting |
• stomach pain |
|
* nausea |
• diarrhoea |
|
• headache |
Rare side effects (affecting between 1 in 100 and 1 in 10,000) include:
|
• tingling or numbness in the hands and feet |
• inflammation ofthe liver and liver failure |
|
• inflammation of the heart or area surrounding the heart |
• Lupus erythematosis (an auto-immune disorder affecting the skin) |
|
• inflammation ofthe pancreas |
• kidney failure |
|
• raised liver enzymes |
• muscle pain |
|
• hair loss (reversible) |
• joint pain |
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via at: vwvw.mhra.aov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pentasa
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package in order to protect from light.
• Do not use Pentasa after the expiry date which is stated on the blisters label after ‘Exp’. The expiry date refers to the last day of that month.
• If the suppositories become discoloured or show any signs of deterioration, seek the advice of 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.
6. Further information
What Pentasa contains
The active ingredient in Pentasa is mesalazine.
Each suppository contains 1g mesalazine.
The other ingredients are magnesium stearate, talc, povidone, and macrogol 6,000.
What Pentasa looks like and the contents of the pack
Pentasa are oblong, compressed, white to light tan speckled suppositories.
Each pack contains 28 suppositories (4 blister x 7 suppositories), with a cap in aluminum foil and Finger cots.
Manufactured by: Ferring GmbH, Wittland 11, D-24109 Kiel,
Germany.
Procured from within the EU and repackaged by the product licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Pentasa® 1g suppositories PL 18799/2923
Leaflet date: 12.05.2016 -
Mesalazine 1g suppositories
Patient Information
Read all of this leaflet carefully before you start using 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.
The name of your medicine is Mesalazine 1 g suppositories but it will be referred as Mesalazine throughout this leaflet.
In this leaflet:
1. What Mesalazine is and what it is used for
2. Before you use Mesalazine
3. Howto use Mesalazine
4. Possible side effects
5. Howto store Mesalazine
6. Further Information
1. What Mesalazine is and what it is used for
The name of this medicine is Mesalazine Suppositories. Each suppository contains mesalazine 1 g as the active ingredient. Mesalazine belongs to a group of medicines called salicylates.
Mesalazine is used to treat inflammation in the gut caused by conditions such as ulcerative colitis. Sometimes ulcerative colitis only affects the back passage (rectum), this is known as ulcerative proctitis. Mesalazine is used to treat ulcerative proctitis and are intended for rectal use only.
The suppositories release the active ingredient slowly which then acts locally to reduce the inflammation and help relieve or stop the pain.
2. Before you use Mesalazine
Do Not use Mesalazine if you:
• are allergic to mesalazine or any of the other ingredients in Mesalazine
• are allergic to any other salicylates e.g. aspirin
• have severe liver or kidney problems
• are under the age of 15 years
Take special care with Mesalazine
You should consult your doctor before using these suppositories if:
• you currently have, or have previously had liver or kidney disease
• you are on any medication that may affect kidney function e.g. azathioprine
• you have ever had an allergy to a medication called sulphasalazine
You should make sure that you don’t become dehydrated, while you are using this medicine. This can occur after severe or prolonged attacks of vomiting and/or diarrhoea, high fever or heavy sweating. If this does occur, you should speak to a doctor or pharmacist for advice as soon as possible.
While you are using Mesalazine your doctor may occasionally want to check your kidney function.
Using with 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. This is especially important if you are taking any of the following:
• Non-steroidal anti-inflammatories (NSAIDS)
• Azathioprine or 6-mercaptopurine Pregnancy and Breast-feeding
If you are pregnant, are planning to become pregnant or are breast-feeding you should speak to your doctor or pharmacist before taking this medicine.
3. How to use Mesalazine
Always use Mesalazine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The suppository should be inserted into the back passage (rectum) only. It is intended to be left in place for as long as possible and is therefore best inserted before going to sleep.
To treat an attack of proctitis your doctor will usually prescribe one suppository to be used daily for two to four weeks.
To help prevent further attacks it may be used for longer.
How to insert the suppository
You should make sure that you empty your bowels before inserting the suppository.
a. Tear along the perforation to remove one suppository blister from a blister strip
b. Put a protector on the finger with which you will insert the suppository
c. Remove the suppository from the blister before insertion. This is done by pushing the suppository through the printed foil
d. Insertion may be made easier if you moisten the suppository with water first
e. Insert the suppository gently and fully into the back passage. It may help to lie down on one side and raise the other knee
f. Remain still for a few minutes after insertion to help keep the suppository in place. If it comes out within 10 minutes, a new one should be inserted
g. Dispose of the empty blister and used finger protector safely and wash your hands
If you use more Mesalazine than you should
If you accidentally use too many suppositories, you should go to your nearest emergency department or contact your doctor immediately. Take the pack and any remaining suppositories with you.
If you forget to use Mesalazine
If you forget to use a dose, use the next dose as soon as you remember, unless it is less than 6 hours until your next dose. Do not use a double dose to make up for the forgotten one.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Mesalazine can cause side effects, although not everyone gets them.
Following rectal administration local reactions such as itching, rectal discomfort and urge may occur.
STOP taking Mesalazine if you notice:
• itching, skin rashes, swelling of the face, lips or throat, difficulty in breathing, wheeziness or coughing (signs of an allergic reaction).
• skin disorder due to an allergic reaction or infection (Erythema Mulitforme or Stevens-Johnson syndrome). Symptoms include severe rash, blisters or red splotches on the skin.
• unexplained bleeding, bruising, skin rashes, fever or sore throat (signs of blood disorder).
• change in colour or amount of urine produced (signs of kidney problems).
If you experience any of the above side effects, you should contact your doctor or go to the nearest hospital immediately.
Common side effects (affecting upto 1 in 100 people) include:
|
• vomiting |
• stomach pain |
|
* nausea |
• diarrhoea |
|
• headache |
Rare side effects (affecting between 1 in 100 and 1 in 10,000) include:
|
• tingling or numbness in the hands and feet |
• inflammation ofthe liver and liver failure |
|
• inflammation of the heart or area surrounding the heart |
• Lupus erythematosis (an auto-immune disorder affecting the skin) |
|
• inflammation ofthe pancreas |
• kidney failure |
|
• raised liver enzymes |
• muscle pain |
|
• hair loss (reversible) |
• joint pain |
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via at: vwvw.mhra.aov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Mesalazine
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Store in the original package in order to protect from light.
• Do not use Mesalazine after the expiry date which is stated on the blisters label after ‘Exp’. The expiry date refers to the last day of that month.
• If the suppositories become discoloured or show any signs of deterioration, seek the advice of 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.
6. Further information
What Mesalazine contains
The active ingredient in Mesalazine is mesalazine.
Each suppository contains 1g mesalazine.
The other ingredients are magnesium stearate, talc, povidone, and macrogol 6,000.
What Mesalazine looks like and the contents of the pack
Mesalazine are oblong, compressed, white to light tan speckled suppositories.
Each pack contains 28 suppositories (4 blister x 7 suppositories), with a cap in aluminum foil and Finger cots.
Manufactured by: Ferring GmbH, Wittland 11, D-24109 Kiel,
Germany.
Procured from within the ELI and repackaged by the product licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Mesalazine 1g suppositories PL 18799/2923
Leaflet date: 12.05.2016 -