The name of this medicine is Mycosat Oral Suspension. This medicine contains Nystatin as the active ingredient. Nystatin belongs to a group of medicines called anti-fungal antibiotics. Mycosat Oral Suspension is used to prevent and treat candidal infections of the oral cavity, oesophagus and intestinal tract. It also provides effective prevention against oral candidosis in those born of mothers with vaginal candidosis. This medicine works by killing the yeast or fungus that has caused your symptoms.

Do not use Mycosat if:

• You are allergic to Nystatin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Mycosat Oral Suspension.

Talk to your doctor or pharmacist as Mycosat should not be used if you have a fungal infection in the lungs or on the skin (systemic mycoses).

Mycosat Oral Suspension contains sucrose.

Do not take Mycosat for patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency.

Other medicines and Mycosat

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

Pregnancy and 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 or pharmacist for advice before taking this medicine.

It is not known whether Mycosat can cause harm to your unborn baby when taken by a pregnant woman or if Mycosat can affect your ability to conceive, however absorption of Mycosat from the digestive system is small. Mycosat should be prescribed during pregnancy only if the potential benefits to be derived outweigh the potential risk to the foetus.

It is not known whether Mycosat is excreted in breast milk. Caution should be used when Mycosat is given to women who are breast-feeding.

Driving and using machines

Mycosat Oral Suspension should not affect your ability to drive.

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

The recommended dose for adults and children is 1 ml of suspension dropped into the mouth four times a day. In the case of newborn babies, the recommended dose is 1ml once a day dropped into the mouth.

There are no specific dosage recommendations or precautions for older people.

Shake the bottle well before use.

Use the measuring dropper provided.

Doses should be equally spaced throughout the day.

If you are taking this medicine for an infection in the mouth or throat, try not to swallow the suspension too quickly, as the longer the medicine is in contact with the site of infection the better.

Your doctor will normally have given you sufficient medicine to enable you to continue treatment for 48 hours after all symptoms have disappeared. This will help to clear up your infection completely and prevent a relapse. If signs and symptoms worsen or persist (beyond 14 days of treatment), you should talk to your doctor.

If you take more Mycosat Oral Suspension than you should

Taking more Mycosat than recommended should not cause any severe effects as the amount of Mycosat absorbed by the body is very small. With very high doses, nausea and gastrointestinal upset were reported. However, in the case of a child, you may wish to check with your doctor or hospital emergency department.

If you forget to use Mycosat:

If you forget to take Mycosat, take your medicine as soon as you remember, unless it is close to the time you would normally take your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop using Mycosat:

Please speak to your doctor or pharmacist before stopping any medicine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If irritation or sensitisation develops, treatment should be discontinued. Nausea has also been reported occasionally during therapy.

Large oral doses can occasionally cause:

• Sickness, and diarrhea
• gastrointestinal distress
• bloating
• Nausea and vomiting
• Stomach cramps, indigestion

Rash including urticaria (itching) have been reported rarely. Hypersensitivity, angioedema (swelling of the lips or tongue) and facial oedema (swelling of the face) have also been reported.

There have been very rare cases of a more serious allergic reaction called Steven-Johnson Syndrome (a serious illness with blistering of the skin, mouth, eyes and genitals).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can refer to the address of the NPC in Saudi Arabia to report any side affects you get.

To reports any side effect(s)

- Jordan:

-  Shake well before use

 - Don’t store above 30°C.

- Don’t freeze

- keep out of reach of children

- Don’t use if cap seal is broken.

 - Discard content one week after opening.

- Do not use Mycosat after the expiry date which is stated on the box. This expiry date refers to the last day of that month.

- Do not throw away any 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.