PONSTAN CAPSULES 250MG
Active substance: MEFENAMIC ACID
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Ponstan Capsules 250 mg
Mefenamic acid
Read all of this leaflet carefully before you start using this medicine.
iKeep this leaflet. You may need to read it again. iIf you have any further questions, ask your doctor or pharmacist. iThis 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. iIf 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. In this leaflet: 1. What this medicine is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 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, and herbal preparations. Some medicines may be affected by Ponstan or they may affect how well Ponstan will work. Tell your doctor or pharmacist if you are taking: imedicines that can increase the chance of getting ulcers or a bleed in the stomach or gut, such as: - corticosteroids used to treat arthritis and inflammation - medicines such as anti-platelet agents, used to thin the blood (e.g. warfarin, aspirin, clopidogrel) - antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine) - any other anti-inflammatory medicines (e.g. diclofenac, celecoxib) imedicines used for high blood pressure (e.g. atenolol, ramipril, valsartan) idiuretics (water tablets) or heart medicines (e.g. digoxin, sotalol, diltiazem) isome diabetic medicines such as (e.g. glipizide, glibenclamide) imedicines which suppress the immune system (e.g. ciclosporin, tacrolimus, methotrexate) ilithium, a medicine used to treat mood swings and some types of depression ia medicine usually prescribed through hospitals, called mifepristone (taken within the last 12 days) iquinolone antibiotics (antibiotics used to treat infections) iaminoglycoside antibiotics, used under medical supervision in hospitals izidovudine, a medicine used for HIV iprobenecid, a medicine used in special cases, to protect the kidneys imedicines which bind to protein in the blood - (check with your pharmacist). Blood tests Your doctor may test your blood during treatment. Pregnancy and breast-feeding Pregnancy Mefenamic acid will be passed to your unborn baby. It is not known how much it will affect your unborn baby in the first 6 months of pregnancy. DO NOT take the capsules in the last 3 months of pregnancy as they may delay the onset of labour and prolong its duration. They may also increase the likelihood of bleeding in the mother and in the baby. If you need to take these capsules, your doctor can help you decide whether or not to take them during the first 6 months of pregnancy. Breast-feeding Mefenamic acid passes into breast milk and can affect the baby. You should not take the capsules while breast-feeding unless advised by your doctor. Fertility DO NOT take the capsules if you are trying to become pregnant, as they may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Ask your doctor for advice before taking any medicine. Driving and using machines Ponstan may cause drowsiness, dizziness, fatigue or affect your vision. If any of these occur do not drive, use machinery, or perform any tasks that may require you to be alert. Important information about some of the ingredients of Ponstan Capsules ilactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Continued over page
6/L/e/8
3. How to take
Always take Ponstan capsules exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. iTake the capsules with or immediately after a meal. iDo NOT drink alcohol while taking Ponstan. Alcohol and smoking can irritate the stomach and make some of the side effects worse. Doses Adults and the elderly: the usual dose is 2 capsules three times a day. Elderly patients are at a higher risk of side effects and should take the lowest effective dose for the shortest possible time, with additional monitoring carried out by their doctor. Children: this medicine is NOT suitable for children under 12 years. If you take more than you should If you take more capsules than you should you may harm your stomach, kidneys and you may get seizures (fits). 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the container and any remaining capsules with you so that people can see what you have taken. 3. Do this even if you feel well. If you forget to take If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual. Do not use a double dose to make up for a missed dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
1. What this medicine is and what it is used for
Ponstan capsules contain mefenamic acid which is a non-steroidal anti-inflammatory drug (NSAID). They can help to relieve: isymptoms of inflammation, such as redness and swelling ipain and discomfort caused by arthritis, muscular or rheumatic disorders iheadache, muscle ache or toothache ipain after operations, trauma ichildbirth pain ifever in children ipainful or heavy periods.
Tell your doctor if you get any of the following side effects: ihead-spins (vertigo) ifatty stools isweating irapid heartbeat (palpitations) imental confusion iloss of appetite iconstipation or bloating iblurred vision, eye irritation ifeeling ill (malaise) iringing or buzzing in the ears (tinnitus) inumbness or tingling in hands or feet isudden poor blood sugar control if you have diabetes. Your doctor or pharmacist can measure your sugar levels iasthma or asthma that is worse than usual iswelling of your hands and feet (around the ankles) isore mouth (pain or ulcers on the tongue, cheeks, lips, throat or gums) idizziness, drowsiness, feeling lethargic and tired isigns of low blood pressure such as light-headedness ireactions to the sun. Your skin may become red, painful and swollen - do not sunbathe, use a sun bed, or expose your skin to artificial UV light. Medicines such as Ponstan may be associated with a small increased risk of heart attack or stroke. (See Section 2 - end of 'Take special care'). Urine tests: Tell the doctor if you are having urine tests, as your medicine may affect the results. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store
iKeep out of the reach and sight of children. iDo not take after the expiry date which is stated on the blister, carton/bottle/container. The expiry date refers to the last day of that month. iDo not store above 25C. Store in the original package. iDo not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
2. Before you take
Do NOT take Ponstan if you: iare allergic to mefenamic acid, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or to any of the other ingredients (see Section 6) ihave, or have ever had, stomach or intestinal conditions such as peptic ulcer, bleeding in the stomach or severe gastritis ihave an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) ihave severe heart, liver or kidney problems ihave just had heart bypass surgery iare more than 6 months pregnant. If any of the above apply to you, speak to your doctor or pharmacist. Take special care with Ponstan Before taking the capsules, tell your doctor if you: iare taking any other NSAIDs, (e.g. ibuprofen, diclofenac) iare taking any other anti-inflammatory medicines including steroids (e.g. prednisolone) iare taking aspirin or medicines that thin the blood (e.g. warfarin, clopidogrel) iare taking antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine) ihave kidney or liver problems. Your doctor may check your kidney or liver function before and during treatment iare elderly (see Section 3) iare trying to become pregnant (see Section on Fertility) ihave stomach or digestive tract problems or if you have ever had an upset stomach after taking pain killers such as aspirin. Bleeding in the stomach or gut can occur in patients taking Ponstan ihave a bleeding disorder or if you are going to have a major operation. Ponstan can affect the clotting of your blood. It can make you bleed more and for longer than usual ihave asthma, or a history of asthma, as this medicine may cause breathing difficulties ihave a connective tissue disorder, e.g. Systemic Lupus Erythematosus (SLE) ihave epilepsy iare dehydrated (thirsty with dry skin, dark urine, dry mouth, headache) ihave heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker). Additional monitoring may be carried out by your doctor. Medicines such as Ponstan may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
4. Possible side effects
Like all medicines, Ponstan capsules can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the capsules and seek medical help immediately if you have any of the following allergic reactions: idifficulty breathing or swallowing, swelling of the face, lips, tongue or throat isevere itching of the skin, with a red rash or raised lumps iblistering of the mouth, eyes, and genital region, and patchy areas of rash, peeling skin or any of the following reactions idiarrhoea ipassing blood in your stools (faeces/motions) ipassing black tarry stools ivomiting any blood or dark particles that look like coffee grounds. Seek immediate medical attention if you have any of the following symptoms: iindigestion or heartburn, abdominal pain (pain in your stomach) or other abnormal stomach symptoms, nausea (feeling sick), vomiting iany unusual bruising or bleeding, for example nose-bleeds, pinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth isigns of anaemia such as feeling tired, breathless, and looking pale ifever, sore throat, mouth ulcers, repeated infections or infections that will not go away. This may be due to a low level of white blood cells iseizures (fits) isigns of low sodium levels such as headache, nausea, vomiting, tiredness, muscle cramps isudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash ifever, rash, nausea, aches and pains, passing more or less urine than usual, passing red urine or passing urine at night. This may be due to changes in your kidneys isudden loss or blurring of vision, loss of colour vision, eye pain which worsens with eye movement iheadache, in particular on waking in the morning. This may be due to high blood pressure ipain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas iyellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness. This may be due to changes in your liver.
6/L/e/8
6. Further information
What Ponstan Capsules contain iThe active ingredient is mefenamic acid (250 mg). iThe other ingredients are: lactose monohydrate, sodium laurilsulfate, gelatin, water. The capsule shell contains: gelatin, erythrosine, quinoline yellow, titanium dioxide, patent blue V. The printing ink contains either shellac, black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527), or shellac, propylene glycol (E1520), strong ammonia solution, potassium hydroxide (E525), black iron oxide (E172). (See end of Section 2 for further information on lactose). What Ponstan Capsules look like and contents of the pack Ponstan Capsules are ivory and blue hard gelatin capsules marked 'Ponstan 250'. They are available in blister packs containing 6, 10, 12, 20, 30, 50, 100, or 168 capsules and in containers of 100 or 500 capsules. Not all types and pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. Manufacturer Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton BD23 2RW. This leaflet was last revised in December 2011
'Ponstan' and 'Chemidex' are trade marks.
FRONT
BACK
Mefenamic acid
Read all of this leaflet carefully before you start using this medicine.
iKeep this leaflet. You may need to read it again. iIf you have any further questions, ask your doctor or pharmacist. iThis 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. iIf 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. In this leaflet: 1. What this medicine is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 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, and herbal preparations. Some medicines may be affected by Ponstan or they may affect how well Ponstan will work. Tell your doctor or pharmacist if you are taking: imedicines that can increase the chance of getting ulcers or a bleed in the stomach or gut, such as: - corticosteroids used to treat arthritis and inflammation - medicines such as anti-platelet agents, used to thin the blood (e.g. warfarin, aspirin, clopidogrel) - antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine) - any other anti-inflammatory medicines (e.g. diclofenac, celecoxib) imedicines used for high blood pressure (e.g. atenolol, ramipril, valsartan) idiuretics (water tablets) or heart medicines (e.g. digoxin, sotalol, diltiazem) isome diabetic medicines such as (e.g. glipizide, glibenclamide) imedicines which suppress the immune system (e.g. ciclosporin, tacrolimus, methotrexate) ilithium, a medicine used to treat mood swings and some types of depression ia medicine usually prescribed through hospitals, called mifepristone (taken within the last 12 days) iquinolone antibiotics (antibiotics used to treat infections) iaminoglycoside antibiotics, used under medical supervision in hospitals izidovudine, a medicine used for HIV iprobenecid, a medicine used in special cases, to protect the kidneys imedicines which bind to protein in the blood - (check with your pharmacist). Blood tests Your doctor may test your blood during treatment. Pregnancy and breast-feeding Pregnancy Mefenamic acid will be passed to your unborn baby. It is not known how much it will affect your unborn baby in the first 6 months of pregnancy. DO NOT take the capsules in the last 3 months of pregnancy as they may delay the onset of labour and prolong its duration. They may also increase the likelihood of bleeding in the mother and in the baby. If you need to take these capsules, your doctor can help you decide whether or not to take them during the first 6 months of pregnancy. Breast-feeding Mefenamic acid passes into breast milk and can affect the baby. You should not take the capsules while breast-feeding unless advised by your doctor. Fertility DO NOT take the capsules if you are trying to become pregnant, as they may make it more difficult to get pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Ask your doctor for advice before taking any medicine. Driving and using machines Ponstan may cause drowsiness, dizziness, fatigue or affect your vision. If any of these occur do not drive, use machinery, or perform any tasks that may require you to be alert. Important information about some of the ingredients of Ponstan Capsules ilactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Continued over page
6/L/e/8
3. How to take
Always take Ponstan capsules exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask your doctor or pharmacist if you are not sure. iTake the capsules with or immediately after a meal. iDo NOT drink alcohol while taking Ponstan. Alcohol and smoking can irritate the stomach and make some of the side effects worse. Doses Adults and the elderly: the usual dose is 2 capsules three times a day. Elderly patients are at a higher risk of side effects and should take the lowest effective dose for the shortest possible time, with additional monitoring carried out by their doctor. Children: this medicine is NOT suitable for children under 12 years. If you take more than you should If you take more capsules than you should you may harm your stomach, kidneys and you may get seizures (fits). 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately. 2. Take the container and any remaining capsules with you so that people can see what you have taken. 3. Do this even if you feel well. If you forget to take If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual. Do not use a double dose to make up for a missed dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
1. What this medicine is and what it is used for
Ponstan capsules contain mefenamic acid which is a non-steroidal anti-inflammatory drug (NSAID). They can help to relieve: isymptoms of inflammation, such as redness and swelling ipain and discomfort caused by arthritis, muscular or rheumatic disorders iheadache, muscle ache or toothache ipain after operations, trauma ichildbirth pain ifever in children ipainful or heavy periods.
Tell your doctor if you get any of the following side effects: ihead-spins (vertigo) ifatty stools isweating irapid heartbeat (palpitations) imental confusion iloss of appetite iconstipation or bloating iblurred vision, eye irritation ifeeling ill (malaise) iringing or buzzing in the ears (tinnitus) inumbness or tingling in hands or feet isudden poor blood sugar control if you have diabetes. Your doctor or pharmacist can measure your sugar levels iasthma or asthma that is worse than usual iswelling of your hands and feet (around the ankles) isore mouth (pain or ulcers on the tongue, cheeks, lips, throat or gums) idizziness, drowsiness, feeling lethargic and tired isigns of low blood pressure such as light-headedness ireactions to the sun. Your skin may become red, painful and swollen - do not sunbathe, use a sun bed, or expose your skin to artificial UV light. Medicines such as Ponstan may be associated with a small increased risk of heart attack or stroke. (See Section 2 - end of 'Take special care'). Urine tests: Tell the doctor if you are having urine tests, as your medicine may affect the results. If any of the side effects get troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store
iKeep out of the reach and sight of children. iDo not take after the expiry date which is stated on the blister, carton/bottle/container. The expiry date refers to the last day of that month. iDo not store above 25C. Store in the original package. iDo not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
2. Before you take
Do NOT take Ponstan if you: iare allergic to mefenamic acid, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or to any of the other ingredients (see Section 6) ihave, or have ever had, stomach or intestinal conditions such as peptic ulcer, bleeding in the stomach or severe gastritis ihave an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) ihave severe heart, liver or kidney problems ihave just had heart bypass surgery iare more than 6 months pregnant. If any of the above apply to you, speak to your doctor or pharmacist. Take special care with Ponstan Before taking the capsules, tell your doctor if you: iare taking any other NSAIDs, (e.g. ibuprofen, diclofenac) iare taking any other anti-inflammatory medicines including steroids (e.g. prednisolone) iare taking aspirin or medicines that thin the blood (e.g. warfarin, clopidogrel) iare taking antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine) ihave kidney or liver problems. Your doctor may check your kidney or liver function before and during treatment iare elderly (see Section 3) iare trying to become pregnant (see Section on Fertility) ihave stomach or digestive tract problems or if you have ever had an upset stomach after taking pain killers such as aspirin. Bleeding in the stomach or gut can occur in patients taking Ponstan ihave a bleeding disorder or if you are going to have a major operation. Ponstan can affect the clotting of your blood. It can make you bleed more and for longer than usual ihave asthma, or a history of asthma, as this medicine may cause breathing difficulties ihave a connective tissue disorder, e.g. Systemic Lupus Erythematosus (SLE) ihave epilepsy iare dehydrated (thirsty with dry skin, dark urine, dry mouth, headache) ihave heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes or high cholesterol or are a smoker). Additional monitoring may be carried out by your doctor. Medicines such as Ponstan may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
4. Possible side effects
Like all medicines, Ponstan capsules can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the capsules and seek medical help immediately if you have any of the following allergic reactions: idifficulty breathing or swallowing, swelling of the face, lips, tongue or throat isevere itching of the skin, with a red rash or raised lumps iblistering of the mouth, eyes, and genital region, and patchy areas of rash, peeling skin or any of the following reactions idiarrhoea ipassing blood in your stools (faeces/motions) ipassing black tarry stools ivomiting any blood or dark particles that look like coffee grounds. Seek immediate medical attention if you have any of the following symptoms: iindigestion or heartburn, abdominal pain (pain in your stomach) or other abnormal stomach symptoms, nausea (feeling sick), vomiting iany unusual bruising or bleeding, for example nose-bleeds, pinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth isigns of anaemia such as feeling tired, breathless, and looking pale ifever, sore throat, mouth ulcers, repeated infections or infections that will not go away. This may be due to a low level of white blood cells iseizures (fits) isigns of low sodium levels such as headache, nausea, vomiting, tiredness, muscle cramps isudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash ifever, rash, nausea, aches and pains, passing more or less urine than usual, passing red urine or passing urine at night. This may be due to changes in your kidneys isudden loss or blurring of vision, loss of colour vision, eye pain which worsens with eye movement iheadache, in particular on waking in the morning. This may be due to high blood pressure ipain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas iyellowing of your skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness. This may be due to changes in your liver.
6/L/e/8
6. Further information
What Ponstan Capsules contain iThe active ingredient is mefenamic acid (250 mg). iThe other ingredients are: lactose monohydrate, sodium laurilsulfate, gelatin, water. The capsule shell contains: gelatin, erythrosine, quinoline yellow, titanium dioxide, patent blue V. The printing ink contains either shellac, black iron oxide (E172), propylene glycol (E1520), ammonium hydroxide (E527), or shellac, propylene glycol (E1520), strong ammonia solution, potassium hydroxide (E525), black iron oxide (E172). (See end of Section 2 for further information on lactose). What Ponstan Capsules look like and contents of the pack Ponstan Capsules are ivory and blue hard gelatin capsules marked 'Ponstan 250'. They are available in blister packs containing 6, 10, 12, 20, 30, 50, 100, or 168 capsules and in containers of 100 or 500 capsules. Not all types and pack sizes may be marketed. Marketing Authorisation Holder Chemidex Pharma Ltd, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB. Manufacturer Dales Pharmaceuticals Ltd, Snaygill Industrial Estate, Keighley Road, Skipton BD23 2RW. This leaflet was last revised in December 2011
'Ponstan' and 'Chemidex' are trade marks.
FRONT
BACK
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
