Document: document 0 change

• document 0
• document 1

---

1

1. What Zarontin is and what it is used for

This medicine contains ethosuximide which is one of a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy.

Zarontin can be used for the treatment of absence seizures (a form of epilepsy) and may be taken with other anti-epileptic drugs.

You should consult your doctor if you are unsure why you have been given Zarontin 250 mg/5 ml Syrup, if you do not feel better or if you feel worse.

2. What you need to know before you take Zarontin

Do not take Zarontin

•    if you are allergic (hypersensitive) to ethosuximide, or any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Zarontin if you suffer from or have suffered in the past from any of the following conditions:

•    Liver disease.

•    Kidney disease.

•    Bruising, fever, looking pale or a severe sore throat. These may be the first signs of a potentially serious blood disorder, which could be fatal if not detected.

Your doctor may take regular blood and/or urine samples to test for these.

If you are taking anti-epileptic drugs, your doctor will routinely assess you for depression, anxiety and suicidality. If you are taking anti-epileptic drugs and you feel depressed and anxious, the symptoms of which are feeling low, loss of interest in everyday activities, lack of energy and a general feeling of unease, please consult your doctor.

A small number of people being treated with anti-epileptics such as ethosuximide have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Other medicines and Zarontin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines can affect the way Zarontin works, or Zarontin itself can reduce the effectiveness of other medicines taken at the same time. These include:

• Other medicines used for epilepsy (phenytoin, sodium valproate and valproic acid).

Your doctor may need to test the amount of these medicines in your blood to help decide if any of these medicines are affecting your treatment.

Zarontin with food and drink

Zarontin can be taken before or after food and drink.

Pregnancy and Breast-feeding

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

You should not take Zarontin if you are breastfeeding.

Driving and using machines

Zarontin may cause dizziness or drowsiness. If you experience these symptoms, do not drive or use any tools or machinery.

Zarontin contains sucrose and glucose

Sucrose and glucose are types of sugars. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine may be harmful to the teeth.

3. How to take Zarontin

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

Shake the bottle vigorously before you measure your dose. Always use a medicine spoon or measure. It is best to take Zarontin at the same time each day. Zarontin can be taken before or after food and drink.

Adults and children over 6 years

The amount of Zarontin needed varies from one person to another. Most adults and children over 6 years usually start on two 5 ml spoonfuls (500 mg) a day and build up to four to six 5 ml spoonfuls (1000 mg to 1500 mg) a day, with increments of 250 mg every 5 to 7 days. Occasionally eight 5 ml spoonfuls (2000 mg) a day may be necessary.

Children under 6 years

Infants and children usually start on one 5 ml spoonful (250 mg) a day and build up to a dose that controls their symptoms gradually by small increments every few days until control is achieved. The maximum dose is four 5 ml spoonfuls (1000 mg) a day.

If you take more Zarontin than you should

If you accidentally take too much Zarontin contact your doctor at once or go to the nearest hospital casualty department. Always take the labelled medicine package with you, whether there is any Zarontin left or not.

If you forget to take Zarontin

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.

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

If you stop taking Zarontin

Do not stop taking Zarontin unless your doctor tells you to. If you suddenly stop taking this medicine you may have a seizure. Should you need to stop taking Zarontin, your doctor will decide which method is best for you.

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

4. Possible side effects

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

Tell your doctor immediately if you experience any

of the following symptoms after taking this medicine.

Although they are very rare, these symptoms can be

serious.

•    If you develop a severe skin rash that causes blistering, this can affect the mouth and tongue. These may be signs of a condition known as Stevens Johnson Syndrome. Your doctor will stop your treatment in this case.

•    If you notice bruising, fever, you are looking pale or you have a severe sore throat. These may be the first signs of an abnormality of the blood, including decreases in the number of red cells, white cells or platelets and bone marrow suppression, please consult your doctor. Your doctor may take regular blood samples to test for these effects.

•    Skin rash and fever with swollen glands, as these may be signs of a hypersensitivity reaction or

a particular allergic reaction known as DRESS syndrome. If these are severe and you also experience pain and inflammation of the joints this could be related to a condition called Systemic Lupus Erythematosus.

•    If you experience an increase in the number of your generalized fits (tonic-clonic seizures).

Other side-effects that may occur are:

•    Common side effects (may affect up to

1 in 10 people): decreased appetite, headaches, unsteadiness, difficulty in controlling movements,