Inspra 25mg Film-Coated Tablets
Out of date information, search anotherInspra® 25mg Film-coated Tablets
(eplerenone)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Inspra 25mg film-coated Tablets but will be referred to as Inspra Tablets throughout this leaflet. Another strength (50mg) is also available.
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 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.
In this leaflet:
1. What Inspra Tablets are and what they are used for
2. Before you take Inspra Tablets
3. How to take Inspra Tablets
4. Possible side effects
5. How to store Inspra Tablets
6. Further information
1. What Inspra Tablets are and what they are used for
Inspra Tablets belong to a group of medicines known as selective aldosterone blocking agents. These blocking agents inhibit the action of aldosterone, a substance produced within the body, which controls your blood pressure and heart function. High levels of aldosterone can cause changes in your body that lead to heart failure.
Inspra Tablets are used to treat your heart failure to prevent worsening and reduce hospitalisations if you have:
1. had a recent heart attack, in combination with other drugs that are used to treat your heart failure, or
2. have persistent, mild symptoms despite the treatment you have been receiving so far.
2. Before you take Inspra Tablets
Do not take Inspra Tablets
■ if you are hypersensitive (allergic) to eplerenone or to any other ingredients of Inspra Tablets
■ if you have high levels of potassium in your blood (hyperkalemia)
■ if you are taking groups of drugs which help you to excrete excessive body fluid, (potassium sparing diuretics) or "salt tablets" (potassium supplements)
■ if you have severe kidney disease
■ if you have severe liver disease
■ if you are taking medicines that are used to treat fungal infection (ketoconazole or itraconazole)
■ if you are taking antiviral medication for treating HIV (nelfinavir or ritonavir)
■ if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
■ if you are taking nefazodone used to treat depression
■ if you are taking medicines used to treat certain heart conditions or hypertension (so called angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)) together.
Take special care with Inspra Tablets
■ if you have kidney or liver disease (see also "Do not take Inspra Tablets")
■ if you are taking lithium (usually given for manic depressive disorder, also called bipolar disorder)
■ if you are taking tacrolimus or cyclosporin (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection after organ transplantation)
Taking 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.
You must not take Inspra Tablets with the following medications (see section "Do not take Inspra Tablets"):
■ Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medication for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression) as these drugs reduce the break-down of Inspra Tablets, thereby prolonging its effect on the body.
■ Potassium sparing diuretics (drugs which help you to excrete excess body fluid) and potassium supplements (salt tablets) as these drugs increase the risk of high potassium levels in your blood.
■ Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) together (which are used to treat high blood pressure, heart disease or particular kidney conditions) as these drugs may increase the risk of high potassium levels in your blood.
Please inform your doctor if you are taking any of the following medicines:
■ Lithium (usually given for manic depressive disorder, also called bipolar disorder). Use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause levels of lithium in the blood to become too high, which may cause side effects of: loss of appetite; visual impairment; tiredness; muscle weakness; muscle twitches.
■ Cyclosporin or tacrolimus (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection after organ transplantation). These drugs can cause kidney problems and therefore increase the risk of high potassium levels in your blood.
■ Non-steroidal anti-inflammatory drugs (NSAIDs- certain pain killers such as ibuprofen, used to relieve pain, stiffness and inflammation). These drugs may lead to kidney problems and therefore increase the risk of high potassium levels in your blood.
■ Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in your blood.
■ Alpha l blockers, such as prazosin or alfuzosin (used to treat high blood pressure and particular prostate conditions) may lead to a fall in blood pressure and dizziness upon standing.
■ Tricyclic antidepressants such as amitryptyline or amoxapine (for treatment of depressions), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders), amifostine (used during cancer chemotherapy) and baclofen (used to treat muscle spasm). These drugs may lead to a fall in blood pressure and dizziness upon standing.
■ Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (mainly used for diagnosing and treating disorders of the adrenal cortex) may reduce the blood-pressure lowering effect of Inspra Tablets.
■ Digoxin (used in the treatment of heart conditions). Digoxin blood levels may be increased when taken together with Inspra Tablets.
■ Warfarin (an anti-clotting drug): Caution is warranted when taking warfarin because high levels of warfarin in the blood may cause changes in the effect of Inspra Tablets on the body.
■ Erythromycin (used to treat bacterial infections), saquinavir (antiviral medication for treating HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem and verapamil (for the treatment of heart problems and high blood pressure) reduce the break-down of Inspra Tablets thereby prolonging the effect of Inspra Tablets on the body.
■ St John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the break-down of Inspra Tablets and thus decrease its effect.
Taking Inspra Tablets with food and drink
Inspra Tablets may be taken with or without food.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. The effect of Inspra Tablets has not been evaluated during pregnancy in humans.
It is not known if eplerenone is excreted in human breast milk. A decision should be made with your doctor, whether to discontinue breast-feeding or to discontinue the drug.
Driving and using machines
You may feel dizzy after taking Inspra Tablets. If this should happen, do not drive or operate machinery.
Important information about some of the ingredients of Inspra Tablets
One of the ingredients of Inspra Tablets is lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Inspra Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Inspra Tablets may be taken together with food or on an empty stomach. Swallow the tablets whole with plenty of water.
Inspra Tablets are usually administered together with other medication for heart failure e.g. beta blockers. The usual starting dose is one 25 mg tablet once daily, increasing after about 4 weeks to 50 mg once daily (either as one 50 mg tablet or two 25 mg tablets). The maximum dose regimen is 50mg daily.
Blood potassium levels should be measured before starting Inspra Tablets therapy, within the first week and at one month after the start of treatment or after a change in dose. The dose may be adjusted by your doctor, depending on the potassium levels in your blood.
If you have mild kidney disease, you should start on one 25mg tablet every day. And if you have moderate kidney disease, you should start on one 25mg tablet every other day. These doses may be adjusted if your doctor recommends and according to your blood potassium levels.
In patients with severe kidney disease, Inspra Tablets are not recommended
In patients with mild-to-moderate liver disease no adjustment of the starting dose is required. If you have liver or kidney problems, you may need more frequent testing of your blood potassium levels (see also "Do not take Inspra Tablets").
For the elderly: no adjustment of the starting dose is required.
For children and adolescents: Inspra Tablets are not recommended.
If you take more Inspra Tablets than you should
If you take more Inspra Tablets than you should, tell your doctor or pharmacist immediately. If you have taken too much of your medicine, the most likely symptoms will be low blood pressure (expressed as a light feeling in your head, dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalemia, high levels of potassium in the blood (expressed by muscle cramps, diarrhoea, nausea, dizziness or headache).
If you forget to take Inspra Tablets
If it is almost time for your next tablet, skip the tablet you missed and take your next tablet when it is due.
Otherwise take the tablet as soon as you remember, providing there is more than 12 hours to when you are due to take your next tablet. Then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Inspra Tablets
It is important to keep taking Inspra Tablets as prescribed unless your doctor tells you to stop your treatment.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
Like all medicines Inspra Tablets can cause side effects, although not everybody gets them.
If you experience any of the following:
You should seek immediate medical attention
■ swollen face, tongue or throat
■ difficulty swallowing
■ hives and difficulties breathing
These are the symptoms of angioneurotic oedema.
Other reported side effects include:
Common side-effects (occurs between 1 and 10 out of every 100 patients):
■ heart attack
■ elevated potassium level in your blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
■ dizziness
■ fainting
■ infection
■ cough
■ constipation
■ low blood pressure
■ diarrhoea
■ nausea
■ abnormal functioning of your kidney
■ rash
■ itching
■ muscle spasm and pain
■ increased urea level in the blood
Uncommon side-effects (occurs between 1 and 10 out of every 1,000 patients):
■ eosinophilia (increase in certain white blood cells)
■ dehydration
■ elevated quantity of cholesterol or triglycerides (fats) in your
blood
■ low sodium blood levels
■ insomnia (difficulty sleeping)
■ headache
■ heart complaints e.g. irregular heart beat, fast heart beat and heart failure
■ inflammation of the gall bladder
■ decreased blood pressure that can cause dizziness upon standing
■ thrombosis (blood clot) in the leg
■ sore throat
■ flatulence
■ vomiting
■ underactive thyroid
■ increase in blood glucose
■ reduced sense of touch
■ increased sweating
■ back pain
■ feeling weak and generally unwell
■ increased creatinine blood levels which may indicate kidney problems
■ kidney inflammation
■ enlargement of breasts in men
■ changes in some blood test results.
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.
5. How to store Inspra Tablets
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Inspra Tablets after the expiry date (EXP) stated on the pack and blister. The expiry date refers to the last day of that month.
If your doctor decides to stop treatment, return any left over tablets to your pharmacist. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.
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 Inspra Tablets contain
The active ingredient of Inspra Tablets is eplerenone.
Each film-coated tablet contains 25mg of eplerenone.
Inspra Tablets also contain the following ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium laurilsulfate, talc, magnesium stearate, titanium dioxide (E171), macrogol 400, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).
What Inspra Tablets look like and contents of the pack
Inspra Tablets are yellow, diamond shaped, film-coated tablets marked with 'Pfizer' on one side and nsr on the other side.
25
Inspra Tablets are available in blister packs containing 20 and 30 tablets.
Manufacturer:
Manufactured by: Pfizer PGM, Zone Industrielle-29 route des Industries, 37530 Poce-sur-Cisse, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0323 | POM |
Leaflet revision date: 05.09.12
Inspra® is a registered trademark of Pfizer Caribe Ltd.
Eplerenone 25mg Film-coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Eplerenone 25mg film-coated Tablets but will be referred to as Eplerenone Tablets throughout this leaflet. Another strength (50mg) is also available.
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 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.
In this leaflet:
1. What Eplerenone Tablets are and what they are used for
2. Before you take Eplerenone Tablets
3. How to take Eplerenone Tablets
4. Possible side effects
5. How to store Eplerenone Tablets
6. Further information
1. What Eplerenone Tablets are and what they are used for
Eplerenone Tablets belong to a group of medicines known as selective aldosterone blocking agents. These blocking agents inhibit the action of aldosterone, a substance produced within the body, which controls your blood pressure and heart function. High levels of aldosterone can cause changes in your body that lead to heart failure.
Eplerenone Tablets are used to treat your heart failure to prevent worsening and reduce hospitalisations if you have:
1. had a recent heart attack, in combination with other drugs that are used to treat your heart failure, or
2. have persistent, mild symptoms despite the treatment you have been receiving so far.
2. Before you take Eplerenone Tablets
Do not take Eplerenone Tablets
■ if you are hypersensitive (allergic) to eplerenone or to any other ingredients of Eplerenone Tablets
■ if you have high levels of potassium in your blood (hyperkalemia)
■ if you are taking groups of drugs which help you to excrete excessive body fluid, (potassium sparing diuretics) or "salt tablets" (potassium supplements)
■ if you have severe kidney disease
■ if you have severe liver disease
■ if you are taking medicines that are used to treat fungal infection (ketoconazole or itraconazole)
■ if you are taking antiviral medication for treating HIV (nelfinavir or ritonavir)
■ if you are taking antibiotics used to treat bacterial infections (clarithromycin or telithromycin)
■ if you are taking nefazodone used to treat depression
■ if you are taking medicines used to treat certain heart conditions or hypertension (so called angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB)) together.
Take special care with Eplerenone Tablets
■ if you have kidney or liver disease (see also "Do not take Inspra Tablets")
■ if you are taking lithium (usually given for manic depressive disorder, also called bipolar disorder)
■ if you are taking tacrolimus or cyclosporin (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection after organ transplantation)
Taking 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.
You must not take Eplerenone Tablets with the following medications (see section "Do not take Eplerenone Tablets"):
■ Itraconazole or ketoconazole (used to treat fungal infections), ritonavir, nelfinavir (antiviral medication for treating HIV), clarithromycin, telithromycin (used to treat bacterial infections) or nefazodone (used to treat depression) as these drugs reduce the break-down of Eplerenone Tablets, thereby prolonging its effect on the body.
■ Potassium sparing diuretics (drugs which help you to excrete excess body fluid) and potassium supplements (salt tablets) as these drugs increase the risk of high potassium levels in your blood.
■ Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARB) together (which are used to treat high blood pressure, heart disease or particular kidney conditions) as these drugs may increase the risk of high potassium levels in your blood.
Please inform your doctor if you are taking any of the following medicines:
■ Lithium (usually given for manic depressive disorder, also called bipolar disorder). Use of lithium together with diuretics and ACE inhibitors (used to treat high blood pressure and heart disease) has been shown to cause levels of lithium in the blood to become too high, which may cause side effects of: loss of appetite; visual impairment; tiredness; muscle weakness; muscle twitches.
■ Cyclosporin or tacrolimus (used to treat skin conditions such as psoriasis or eczema, and to prevent rejection after organ transplantation). These drugs can cause kidney problems and therefore increase the risk of high potassium levels in your blood.
■ Non-steroidal anti-inflammatory drugs (NSAIDs- certain pain killers such as ibuprofen, used to relieve pain, stiffness and inflammation). These drugs may lead to kidney problems and therefore increase the risk of high potassium levels in your blood.
■ Trimethoprim (used to treat bacterial infections) may increase the risk of high potassium levels in your blood.
■ Alpha l blockers, such as prazosin or alfuzosin (used to treat high blood pressure and particular prostate conditions) may lead to a fall in blood pressure and dizziness upon standing.
■ Tricyclic antidepressants such as amitryptyline or amoxapine (for treatment of depressions), antipsychotics (also known as neuroleptics) such as chlorpromazine or haloperidol (for the treatment of psychiatric disorders), amifostine (used during cancer chemotherapy) and baclofen (used to treat muscle spasm). These drugs may lead to a fall in blood pressure and dizziness upon standing.
■ Glucocorticoids, such as hydrocortisone or prednisone (used to treat inflammation and certain skin conditions) and tetracosactide (mainly used for diagnosing and treating disorders of the adrenal cortex) may reduce the blood-pressure lowering effect of Eplerenone Tablets.
■ Digoxin (used in the treatment of heart conditions). Digoxin blood levels may be increased when taken together with Eplerenone Tablets.
■ Warfarin (an anti-clotting drug): Caution is warranted when taking warfarin because high levels of warfarin in the blood may cause changes in the effect of Eplerenone Tablets on the body.
■ Erythromycin (used to treat bacterial infections), saquinavir (antiviral medication for treating HIV), fluconazole (used to treat fungal infections), amiodarone, diltiazem and verapamil (for the treatment of heart problems and high blood pressure) reduce the break-down of Eplerenone Tablets thereby prolonging the effect of Eplerenone Tablets on the body.
■ St John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy) may increase the break-down of Eplerenone Tablets and thus decrease its effect.
Taking Eplerenone Tablets with food and drink
Eplerenone Tablets may be taken with or without food.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. The effect of Eplerenone Tablets has not been evaluated during pregnancy in humans.
It is not known if eplerenone is excreted in human breast milk. A decision should be made with your doctor, whether to discontinue breast-feeding or to discontinue the drug.
Driving and using machines
You may feel dizzy after taking Eplerenone Tablets. If this should happen, do not drive or operate machinery.
Important information about some of the ingredients of Eplerenone Tablets
One of the ingredients of Eplerenone Tablets is lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Epierenone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Eplerenone Tablets may be taken together with food or on an empty stomach. Swallow the tablets whole with plenty of water.
Eplerenone Tablets are usually administered together with other medication for heart failure e.g. beta blockers. The usual starting dose is one 25 mg tablet once daily, increasing after about 4 weeks to 50 mg once daily (either as one 50 mg tablet or two 25 mg tablets). The maximum dose regimen is 50mg daily.
Blood potassium levels should be measured before starting Eplerenone Tablets therapy, within the first week and at one month after the start of treatment or after a change in dose. The dose may be adjusted by your doctor, depending on the potassium levels in your blood.
If you have mild kidney disease, you should start on one 25mg tablet every day. And if you have moderate kidney disease, you should start on one 25mg tablet every other day. These doses may be adjusted if your doctor recommends and according to your blood potassium levels.
In patients with severe kidney disease, Eplerenone Tablets are not recommended
In patients with mild-to-moderate liver disease no adjustment of the starting dose is required. If you have liver or kidney problems, you may need more frequent testing of your blood potassium levels (see also "Do not take Eplerenone Tablets").
For the elderly: no adjustment of the starting dose is required.
For children and adolescents: Eplerenone Tablets are not recommended.
If you take more Epierenone Tablets than you should
If you take more Eplerenone Tablets than you should, tell your doctor or pharmacist immediately. If you have taken too much of your medicine, the most likely symptoms will be low blood pressure (expressed as a light feeling in your head, dizziness, blurred vision, weakness, acute loss of consciousness) or hyperkalemia, high levels of potassium in the blood (expressed by muscle cramps, diarrhoea, nausea, dizziness or headache).
If you forget to take Epierenone Tablets
If it is almost time for your next tablet, skip the tablet you missed and take your next tablet when it is due.
Otherwise take the tablet as soon as you remember, providing there is more than 12 hours to when you are due to take your next tablet. Then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Eplerenone Tablets
It is important to keep taking Eplerenone Tablets as prescribed unless your doctor tells you to stop your treatment.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
Like all medicines Eplerenone Tablets can cause side effects, although not everybody gets them.
If you experience any of the following:
You should seek immediate medical attention
■ swollen face, tongue or throat
■ difficulty swallowing
■ hives and difficulties breathing
These are the symptoms of angioneurotic oedema.
Other reported side effects include:
Common side-effects (occurs between 1 and 10 out of every 100 patients):
■ heart attack
■ elevated potassium level in your blood (symptoms include muscle cramps, diarrhoea, nausea, dizziness or headache)
■ dizziness
■ fainting
■ infection
■ cough
■ constipation
■ low blood pressure
■ diarrhoea
■ nausea
■ abnormal functioning of your kidney
■ rash
■ itching
■ muscle spasm and pain
■ increased urea level in the blood
Uncommon side-effects (occurs between 1 and 10 out of every 1,000 patients):
■ eosinophilia (increase in certain white blood cells)
■ dehydration
■ elevated quantity of cholesterol or triglycerides (fats) in your
blood
■ low sodium blood levels
■ insomnia (difficulty sleeping)
■ headache
■ heart complaints e.g. irregular heart beat, fast heart beat and heart failure
■ inflammation of the gall bladder
■ decreased blood pressure that can cause dizziness upon standing
■ thrombosis (blood clot) in the leg
■ sore throat
■ flatulence
■ vomiting
■ underactive thyroid
■ increase in blood glucose
■ reduced sense of touch
■ increased sweating
■ back pain
■ feeling weak and generally unwell
■ increased creatinine blood levels which may indicate kidney problems
■ kidney inflammation
■ enlargement of breasts in men
■ changes in some blood test results.
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.
5. How to store Eplerenone Tablets
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Eplerenone Tablets after the expiry date (EXP) stated on the pack and blister. The expiry date refers to the last day of that month.
If your doctor decides to stop treatment, return any left over tablets to your pharmacist. Only keep them if your doctor tells you to.
If your tablets appear to be discoloured or show any other signs of deterioration, please return to your pharmacist who will advise you.
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 Eplerenone Tablets contain
The active ingredient of Eplerenone Tablets is eplerenone.
Each film-coated tablet contains 25mg of eplerenone.
Eplerenone Tablets also contain the following ingedients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, sodium laurilsulfate, talc, magnesium stearate, titanium dioxide (E171), macrogol 400, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172).
What Eplerenone Tablets look like and contents of the pack
Eplerenone Tablets are yellow, diamond shaped, film-coated tablets marked with 'Pfizer' on one side and N2S5R on the other side.
Eplerenone Tablets are available in blister packs containing 20 and 30 tablets.
Manufacturer:
Manufactured by: Pfizer PGM, Zone Industrielle-29 route des Industries, 37530 Poce-sur-Cisse, France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence Holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX
PL No: 21828/0323 POM
Leaflet revision date: 05.09.12
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