Ponstole 500 mg

1. Dosage:

- Each tablet contains Mefenamic Acid 500 mg.

2. What Ponstole is and what is it used for:

Ponstole contains an active substance called Mefenamic Acid. This belongs to the group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs).  Ponstole is used for the relief of mild to moderate pain and inflammation associated with rheumatic, muscular or arthritic disorders, trauma, headache, dental pain, and pain following surgery or childbirth. Ponstole is also used for the relief of period pains, management of excessively heavy periods, and symptoms of premenstrual syndrome (PMS).

3. What you need to know before you take Ponstole:

Do not take Ponstole:

- If you are allergic to Mefenamic Acid or any of the other ingredients of this medicine.

- If you are allergic to aspirin (acetylsalicylic acid), ibuprofen, or other NSAIDs.

- If you are pregnant or breastfeeding.

- If you suffer from kidney or liver impairment or heart failure.

- If you are seeking pain relief after heart bypass surgery.

- If you are taking another medicine known as a cyclooxygenase-2-inhibitor.

- If you have ever had peptic ulceration (ulcer in the stomach or duodenum), bleeding in the digestive tract, or inflammatory bowel disease.

- If you are a child under 12 years of age.

Other Medicines and Ponstole:

- Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy Breastfeeding:

- Pregnancy: Mefenamic Acid may be passed to your unborn baby. Do not take these tablets if you are pregnant or planning to become pregnant unless advised by your doctor.

- Breastfeeding: Mefenamic Acid passes into breast milk and can affect the baby. You should not take the tablets while breastfeeding unless advised by your doctor.

- Fertility: Do not take these 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.

- If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and Using Machines:

- This medicine may cause drowsiness, dizziness, and impaired vision. If you are affected, you should not drive or operate machinery.

4. Warnings and Precautions:

- Talk to your doctor before taking Ponstole.

- Discontinue at the first sign of skin rash, lesions, or signs of hypersensitivity.

- If you are elderly and/or taking Ponstole for a long time you should visit your doctor regularly to monitor adverse effects as the elderly are more prone to adverse events.

- If you are trying to become pregnant.

- Medicines such as Ponstole may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment.

- If you have heart problems, or a previous stroke or think that you might be at risk of these conditions, you should discuss your treatment with your doctor.

- If you are dehydrated, have or had asthma, high blood pressure, heart failure, systemic lupus erythematosus, epilepsy, a bleed in your brain, or a tendency to bleed easily, discuss with your doctor.

- If you notice any signs of bleeding or side effects which affect the stomach or intestine or signs of a skin rash or blistering of the skin, inform your doctor immediately.

- If the tablets cause any of the side effects listed, it may be necessary to stop taking them.

- Use of painkillers for headaches over a long time may make them worse. If this occurs, contact your doctor.

- Stomach ulcers, perforation of the stomach and/or intestinal bleeding, sometimes fatal, have been reported for NSAIDs.

Smoking and drinking alcohol are added risk factors.

- The risk of stomach ulcers, perforation of the stomach and/or intestinal bleeding increases with higher doses, in patients with a history of ulcers and the elderly. If any of these apply to you, your treatment should be started at the lowest available dose. Your doctor may also ask you to take a medicine that reduces the risk of developing ulcers. If you require a low-dose aspirin or other drugs which may increase the risk to your stomach you may also be asked to take a medicine to reduce the risk of developing ulcers.

- If you have a history of stomach and/or intestinal toxicity, especially if you are elderly, you should report any stomach symptoms, especially stomach and/or intestinal bleeding. If stomach and/or intestinal bleeding or ulceration occurs your treatment should be withdrawn.

- If you are taking Ponstole for a long time you should be regularly monitored by your doctor, paying particular attention to the development of diarrhoea, rash, liver dysfunction, and abnormal condition of the blood. Treatment should be stopped immediately if any of these conditions appear.

5. How and when to take Ponstole:

- Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

- Ponstole is for oral use. The tablets should be taken whole with a glass of water, with or after meals.

- Adults only: The usual daily dose is 1 tablet taken 3 times a day.

- Older patients: Caution should be used in older patients as they are more prone to the side effects of Ponstole.

- Use in children (under 12 years): Ponstole is not recommended.

- If you take more Ponstole then you should talk to your doctor or go to the hospital straight away. Take the medicine pack with you.

The following effects may happen acute renal failure and coma.

- If you forget to take Ponstole, skip the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

6. Possible Side Effects:

Stop taking the tablets and seek medical help immediately if you experience:

- Any of the following symptoms of a serious allergic reaction, anaphylaxis, wheezing and feeling of tightness in the chest, uncomfortable breathing, swelling of the face, lips, mouth, tongue or throat, blistering or peeling of the skin or mucous membrane.

- A serious skin reaction such as rash, blistering or peeling of the skin or mucous membrane (erythema multiforme, Lyell’s syndrome, and Stevens-Johnson syndrome).

- Diarrhoea, passing black tarry stools, or vomiting blood.

Tell your doctor if you get any of the following side effects.

Side effects with unknown frequency:

- Gastrointestinal: Stomach pain, feeling sick, flatulence, constipation, heartburn, mouth ulcers, loss of appetite, inflammation of large and small intestine, Crohn’s disease, inflammation of the pancreas, or stomach ulcers.

- Kidney: Kidney disorders including painful urination, difficulty passing urine, blood in the urine, protein in the urine, or kidney failure.

- Blood: Anaemia, reduction in certain types of blood cells including lowering of white blood cells, which increases the risk of infection, or low sodium levels in the blood.

- Neurological: Disturbance of vision, reversible loss of colour vision, eye irritation, a sensation of prickling or burning, inflammation of the tissues that cover the brain or spinal cord, particularly in patients with Systemic Lupus Erythematosus or a mixed connective tissue disorder (with symptoms such as a stiff neck, headache, feeling sick, vomiting, fever and disorientation, depression, confusion, hallucinations, ringing in the ear, ear pain, vertigo, malaise, fatigue, drowsiness convulsion, dizziness, difficulty in sleeping).

- Cardiovascular: Palpitation, drop in blood pressure, swelling of feet, ankles or legs, or high blood pressure. Medicines like Ponstole especially in long-term use have been associated with a small increase in the risk of heart attack or stroke.

- Skin: Sweating, rash, sensitivity to light, hives, swelling of the lips, face, tongue, or larynx.

- Other:

Nervousness, elevation of liver function test and other liver disorders, allergic reactions, asthma, uncomfortable breathing following exercise, changes in blood sugar control in diabetic patients, fever, and yellowing of the skin.