PONSTAN FORTE TABLETS 500MG

Ponstan Forte Tablets 500 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 Forte or they may affect how well Ponstan Forte will work. Tell your doctor or pharmacist if you are taking: imedicines that can increase a 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 (human immunodeficiency virus) iprobenecid, a medicine used in special cases, to protect the kidneys imedicines which bind to protein in the blood - (check with your pharmacist). 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 six months of pregnancy. DO NOT take the tablets in the last trimester (after 28 weeks or 7 months) of pregnancy as they may delay and prolong giving birth and may increase the likelihood of bleeding in the mother and in the baby. If you need to take these tablets, your doctor can help you decide whether or not to take them during the first two trimesters of pregnancy. Breast-feeding: Mefenamic acid passes into breast milk and can affect the baby. You should not take the tablets while breast-feeding unless advised by your doctor. Fertility: DO NOT take the tablets 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 Forte may cause drowsiness, dizziness, fatigue and visual disturbances. 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 Forte tablets ilactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. isunset yellow This may cause allergic reactions.
Continued over page 7/L/e/6

3. How to take
Always take Ponstan Forte tablets 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 tablets with or immediately after a meal. iDo NOT drink alcohol while taking Ponstan Forte. Alcohol and smoking can irritate the stomach and make some of the side effects worse. Doses Adults and the elderly: the usual dose is 1 tablet 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 your doctor. Children: this medicine is NOT suitable for children under 12 years. If you take more than you should If you take more tablets 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 tablets 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 Forte tablets 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 ipainful or heavy periods.

Tell your doctor if you get any of the following side effects: ihead-spins (vertigo) idepression ifatty stools iinability to sleep isweating ihallucinations irapid heartbeat (palpitation) inervousness imental confusion iear pain 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 Forte 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. iStore below 30C. 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 Forte if you: iare allergic to mefenamic acid, to any other antiinflammatory 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 iare more than 28 weeks (7 months) pregnant. If any of the above apply to you, speak to your doctor or pharmacist. Take special care with Ponstan Forte Before taking the tablets, 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 reuptake inhibitors (SSRIs) (e.g. paroxetine) ihave kidney or liver problems. Your doctor may check your kidney or liver function before and during treatment iare over the age of 65 (see Section 3) iare trying to become pregnant (see Section on Fertility) ihave stomach or digestive tract problems or if you ever had an upset stomach after taking pain killers such as aspirin. Bleeding in the stomach or gut can occur in patients taking Ponstan Forte ihave a bleeding disorder or if you are going to have a major operation. Ponstan Forte 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 Forte 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 Forte tablets 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 tablets 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 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 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 iseizures (fits) 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 isevere or worsening diarrhoea 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.
7/L/e/5

6. Further information
What Ponstan Forte Tablets contains iThe active ingredient is mefenamic acid. (500 mg) iThe other ingredients are: lactose monoyydrate, maize starch, povidone, silicon dioxide, talc, magnesium stearate, croscarmellose sodium type A, sodium laurilsulfate, purified water. The film coating contains: hypromellose, titanium dioxide, lactose monohydrate, macrogol 4000, vanillin, quinoline yellow, sunset yellow (E110). The polish contains: purified water, beeswax white, carnauba wax yellow, polysorbate 20, sorbic acid. (See end of Section 2 for further information on lactose and sunset yellow). What Ponstan Forte Tablets look like and contents of the pack Ponstan Forte Tablets are yellow, film-coated tablets, marked 'Ponstan Forte' on one side. They are available in blister packs of 100 tablets, plastic containers of 100 or 500 tablets, and in plastic bottles of 6, 12, 84, 100 and 500 tablets. 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 November 2009
'Ponstan' and 'Chemidex' are trade marks.

FRONT

BACK