Mezodol P Suspension

1. What Mezodol P Suspension is and what it is used for

Mezodol P Suspension contains two medicines called mefenamic acid and paracetamol.

Mefenamic acid belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Paracetamol is a medicine used to relieve pain and reduce fever.

Mezodol P Suspension is used for the relief of fever and pain.

It is intended for oral use in children above 6 months of age.

2. What you need to know before giving Mezodol P Suspension

Do not give Mezodol P Suspension if:

your child is allergic to mefenamic acid, paracetamol or any of the other ingredients of this medicine;
your child has previously had asthma, hives or an allergic reaction after taking aspirin or another NSAID;
your child has an ulcer or inflammation in the stomach or intestine;
your child has kidney disease;
your child has severe liver problems;
the medicine is being used to treat pain around coronary artery bypass surgery.

Warnings and precautions

Talk to your doctor or pharmacist before giving Mezodol P Suspension if your child:

has liver or kidney problems;
has asthma, particularly asthma that is triggered by aspirin or other NSAIDs;
has high blood pressure;
has heart problems or tends to retain fluid or develop swelling;
has previously had stomach ulcers or gastrointestinal bleeding;
has a bleeding or blood-clotting disorder;
is taking medicines that increase the risk of bleeding;
is dehydrated.

Mefenamic acid may cause stomach or intestinal bleeding, ulceration or, rarely, perforation. These problems can occur without warning.

Stop the medicine and seek medical advice if your child develops a skin rash or other signs of an allergic reaction.

Important information about paracetamol

Do not give Mezodol P Suspension together with any other medicine containing paracetamol.

Taking more than the recommended dose of paracetamol can cause serious liver damage, even if the child initially feels well.

Always check the ingredients of other medicines before giving them with Mezodol P Suspension. If you are unsure, ask your doctor or pharmacist.

Other medicines and Mezodol P Suspension

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.

In particular, tell your doctor if your child is taking:

medicines containing paracetamol;
warfarin or other medicines that reduce blood clotting;
aspirin or other NSAIDs;
medicines for high blood pressure, including ACE inhibitors;
diuretics ("water tablets");
lithium;
methotrexate;
digoxin;
ciclosporin or tacrolimus;
corticosteroids;
medicines for diabetes;
medicines used to treat infections such as quinolone antibiotics;
zidovudine;
metoclopramide or domperidone;
cholestyramine.

Your doctor may need to monitor your child or adjust treatment.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, talk to your doctor before taking this medicine.

Mezodol P Suspension should not be used during the last 3 months of pregnancy, as mefenamic acid may harm the unborn baby and may affect labour.

Small amounts of mefenamic acid may pass into breast milk. Your doctor will decide whether the medicine should be used while breast-feeding.

Driving and using machines
Mefenamic acid may cause dizziness, drowsiness, tiredness or visual disturbances. If affected, the person taking the medicine should not drive or operate machinery.

3. How to give Mezodol P Suspension

Always give this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose

Children 6 months to 2 years:
5 mL three times daily.

Children over 2 years to 6 years:
5 mL to 10 mL three times daily, depending on body weight.

Your doctor may determine the appropriate dose according to your child's body weight.

Do not give more than the recommended dose.

How to give the medicine

Shake the bottle well before each use.
Measure the prescribed amount carefully.
Give the medicine by mouth.
Follow the dose and frequency prescribed by your doctor.

If you give more Mezodol P Suspension than you should

Giving too much of this medicine can be dangerous.

An overdose may cause nausea, vomiting, stomach pain, drowsiness or other serious problems. Too much paracetamol can cause severe liver damage. Severe overdose of mefenamic acid may also cause gastrointestinal bleeding, kidney problems, breathing problems or loss of consciousness.

If you have given more than the recommended dose, seek immediate medical advice, even if your child appears well.

Take the medicine bottle or pack with you if possible.

If you forget to give Mezodol P Suspension

Do not give a double dose to make up for a forgotten dose.

Give the next dose at the usual time.

4. Possible side effects

Like all medicines, Mezodol P Suspension can cause side effects, although not everybody gets them.

Stop giving the medicine and seek medical help immediately if:

swelling of the face, lips, mouth, tongue or throat occurs;
there is difficulty in breathing or wheezing;
a severe skin rash, blistering or peeling of the skin occurs;
there are signs of severe allergic reaction;
there is severe or persistent stomach pain;
vomiting of blood or passing black, tarry stools occurs.

These may be signs of serious allergic reactions, severe skin reactions or bleeding in the stomach or intestine.

Other possible side effects

Stomach and intestine:

nausea;
vomiting;
diarrhoea;
constipation;
indigestion;
heartburn;
stomach or abdominal pain;
inflammation of the stomach or intestine;
stomach ulcer or gastrointestinal bleeding.

Nervous system:

headache;
dizziness;
drowsiness;
tiredness;
tingling or abnormal sensations;
blurred or disturbed vision.

Skin and allergic reactions:

rash;
itching;
hives;
swelling;
increased sensitivity to sunlight;
asthma or difficulty breathing.

Rarely, serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur.

Heart and blood vessels:

swelling;
increased blood pressure;
heart failure;
palpitations.

Long-term or high-dose use of NSAIDs may be associated with an increased risk of heart attack or stroke.

Liver:

changes in liver function tests;
jaundice;
hepatitis or other liver problems.

Kidneys and urinary system:

blood or protein in the urine;
kidney inflammation;
reduced kidney function or kidney failure.

Blood:

Changes in blood cell counts, including anaemia, reduced white blood cells or platelets, may rarely occur.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist.

You can also report suspected side effects to the manufacturer at:

Email: medico@zorvia.com

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mezodol P Suspension

Keep this medicine out of the sight and reach of children.
Store protected from light.
Store at a temperature not exceeding 30°C.
Shake well before use.
Do not use this medicine after the expiry date stated on the pack.
Do not use this medicine if you notice any visible change in the appearance of the suspension.

6. Contents of the pack and other information

What Mezodol P Suspension contains

Each 5 mL contains:

Mefenamic Acid IP 50 mg
Paracetamol IP 125 mg

Other ingredients are present as required.

What Mezodol P Suspension looks like and contents of the pack

Mezodol P Suspension is an oral suspension supplied in a bottle.