Mefast-P Suspension

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others.
• It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse.
• This includes any possible side effects not listed in this leaflet. See section 4.

1. What MEFAST P® suspension is and what it is used for

2. What you need to know before you are given MEFAST P® suspensions

3. How MEFAST P® suspensions is given

4. Possible side effects

5. How to store MEFAST P® suspensions

6. Contents of the pack and other information

MEFAST P® is a suspension that contains:

Mefenamic acid, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), act to relieve the symptoms of pain. Paracetamol, an anti-pyretic, analgesic, acts to relieve pain and reduce fever.

This product is intended for children but may be given to adults.

Mefast P Suspension is used for fever and pain treatment. It can help to relieve:

- symptoms of inflammation, such as redness and swelling

- pain and discomfort caused by arthritis, muscular or rheumatic disorders

- headache or toothache

- pain after operations, trauma - fever in children

- painful or heavy periods in girls.

Do not take MEFAST P® Suspension

- if you are allergic to mefenamic acid, paracetamol, to any other anti-inflammatory medicines (such as aspirin, ibuprofen, celecoxib), or to any of the other ingredients (listed in section 6)

- if you have, or have ever had, stomach or intestinal conditions such as peptic ulcer, bleeding in the stomach or severe gastritis

- if you have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)

- if you have severe heart, liver or kidney problems

- if you have just had heart bypass surgery

- if you are more than 6 months pregnant.

If any of the above apply to you, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your pharmacist or doctor:

Mefenamic acid

Before taking the suspension, tell your doctor if you:

• are taking any other NSAIDs (e.g. ibuprofen, diclofenac)
• are taking any other anti-inflammatory medicines including steroids (e.g. prednisolone)
• are taking aspirin or medicines that thin the blood (e.g. warfarin, clopidogrel)
• are taking antidepressants called selective serotonin re-uptake inhibitors (SSRIs) (e.g. paroxetine)
• have kidney or liver problems. Your doctor may check your kidney or liver function before and during treatment
• have 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 Mefenamic Acid
• have a bleeding disorder or if you are going to have a major operation. Mefenamic Acid can affect the clotting of your blood. It can make you bleed more and for longer than usual
• have asthma, or a history of asthma, as this medicine may cause breathing difficulties
• have a connective tissue disorder, e.g. Systemic Lupus Erythematosus (SLE)
• have epilepsy
• are dehydrated (thirsty with dry skin, dark urine, dry mouth, headache)
• have 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 Mefenamic Acid 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.

Paracetamol

• If your child has liver or kidney problems
• If your child takes any other medicines (see “If your child takes other medicines”)

Other medicines and MEFAST P®

Mefenamic acid

Some medicines may be affected by Mefenamic Acid or they may affect how well Mefenamic Acid will work. Tell your doctor or pharmacist if you are taking:

• medicines 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)
• aspirin including low doses of aspirin used to prevent your blood from clotting in certain heart conditions
• medicines used for high blood pressure (e.g. atenolol, ramipril, valsartan)
• diuretics (water tablets) or heart medicines (e.g. digoxin, sotalol, diltiazem)
• some diabetic medicines (e.g. glipizide, glibenclamide)
• medicines which suppress the immune system (e.g. ciclosporin, tacrolimus, methotrexate)
• lithium, a medicine used to treat mood swings and some types of depression
• a medicine usually prescribed through hospitals, called mifepristone (taken within the last 12 days)
• quinolone antibiotics (antibiotics used to treat infections)
• aminoglycoside antibiotics, used under medical
• supervision in hospitals
• zidovudine, a medicine used for HIV
• probenecid, a medicine used in special cases, to protect the kidneys
• medicines which bind to protein in the blood - (check with your pharmacist).

Paracetamol

Before you give this medicine, make sure that you tell your pharmacist about ANY other medicines you might be giving your child at the same time, particularly the following:

• Domperidone or metoclopramide (for feeling sick or being sick)
• Colestyramine (to reduce blood fat levels)
• Medicines to thin the blood (e.g. warfarin)
• Medicines for epilepsy (e.g. barbiturates)

If you are unsure about interactions with any other medicines, talk to your pharmacist or doctor. This includes medicines prescribed by your doctor and medicine you have bought for your child, including herbal and homeopathic remedies.

Blood tests

Your doctor may test your blood during treatment.

Pregnancy, breast-feeding and fertility

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

Pregnancy

Mefenamic acid will be passed to your unborn baby. You should not take Mefenamic Acid during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, Mefenamic Acid can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

DO NOT take the suspension in the last 3 months of pregnancy as it may harm your unborn child and cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected.

Breast-feeding

Mefenamic acid passes into breast milk and can affect the baby. You should not take the suspension while breast-feeding unless advised by your doctor.

Fertility

DO NOT take the suspension if you are trying to become pregnant, as it 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

Driving and using machines

Mefenamic acid 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.

Always take this medicine exactly as your doctor has told you. Your doctor will decide on the appropriate dose to suit your condition. Check with your doctor or pharmacist if you are not sure.

- Shake the bottle before taking the medicine.

- Take the suspension with or immediately after a meal.

- After taking the suspension, rinse the mouth

– this medicine contains sucrose which may be harmful to the teeth if taken for more than 2 weeks.

- Do not drink alcohol while taking Mefenamic Acid.

Alcohol and smoking can irritate the stomach and make some of the side effects worse.

Dosages

Adults and the elderly

This medicine is intended for children. Contact your doctor for dosage advice if you are an adult taking this suspension.

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.

Use in children

The recommended dose may be given up to 3 times per day.

Do not take Mefenamic Acid for more than 7 days unless advised to do so by your doctor.

If you take more MEFAST P® than you should

If you take more of the suspension than you should, you may harm your stomach, kidneys and you may get seizures (fits).

Symptoms of overdose may also include headache, nausea, stomach pain, vomiting, rarely diarrhoea, disorientation, excitation, coma (loss of consciousness for a period of time), tiredness, ringing in the ears, fainting and occasionally convulsions.

1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.

2. Take the bottle and any remaining suspension 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 take 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.

Most people will not have problems, but some may get some.

Mefenamic acid

Stop taking the suspension and seek medical help immediately if you have any of the following allergic reactions:

• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the mouth, eyes, and genital region, patchy areas of rash, peeling skin or any of the following reactions
• diarrhoea
• passing blood in your stools (faeces/motions)
• passing black tarry stools vomiting any blood or dark particles that look like coffee grounds.

Seek immediate medical attention if you have any of the following symptoms:

indigestion or heartburn, abdominal pain (pain in your stomach) or other abnormal stomach symptoms, nausea (feeling sick), vomiting

any 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

signs of anaemia such as feeling tired, breathless, and looking pale

fever, 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

seizures (fits)

signs of low sodium levels such as headache, nausea, vomiting, tiredness, muscle cramps

sudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash

fever, 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

sudden loss or blurring of vision, loss of colour vision, eye pain which worsens with eye movement

headache, in particular on waking in the morning. This may be due to high blood pressure

pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever. This may be due to inflammation of your pancreas

yellowing 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

low body temperature (below 35ºC), feeling cold with pale-looking skin, especially in children.

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

head-spins (vertigo)

hallucinations

rapid heartbeat (palpitations)

mental confusion

constipation or bloating

blurred vision, eye irritation

feeling ill (malaise)

ringing or buzzing in the ears (tinnitus)

depression

inability to sleep

nervousness

sweating

fatty stools

loss of appetite

ear pain

numbness or tingling in hands or feet

sudden poor blood sugar control if you have diabetes. Your doctor or pharmacist can measure your sugar levels

asthma or asthma that is worse than usual

swelling of your hands and feet (around the ankles)

sore mouth (pain or ulcers on the tongue, cheeks, lips, throat or gums)

dizziness, drowsiness, feeling lethargic and tired

signs of low blood pressure such as light-headedness

reactions 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 Mefenamic Acid may be associated with a small increased risk of heart attack or stroke.

Urine tests: Tell the doctor if you are having urine tests, as your medicine may affect the results.

Paracetamol

If your child gets any of these serious side effects, stop giving the medicine. See a doctor at once:

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
• Very rare cases of serious skin reactions have been reported. This may include peeling,
• blistering and lesions of the skin.
• If your child gets any of the following side effects, see your pharmacist or doctor.
• Other allergic reactions (e.g. skin rash)
• Unusual bruising, or infections such as sore throats. This may be a sign of very rare changes in the blood

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.co.in and click the tab “Safety Reporting” located on the top of the home page. By reporting side effects, you can help provide more information on the safety of this medicine. You can also report the side effect with the help of your treating physician.

Do not store above 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton or on the foil edge. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What MEFAST P® contains

Each 5 ml suspension contains:

Mefenamic Acid, IP, 50 mg; Paracetamol, IP, 125 mg; and Flavoured suspension base (q.s.)

A bottle of 60 ml.