ZARONTIN 250 mg Soft Capsules

Зміст інструкції

1. ZARONTIN 250 mg soft capsules, 250 mg/5 ml syrup
   1. What is Zarontin and what is it used for
   2. What you need to know before you use Zarontin
   3. How to use Zarontin
   4. Possible side effects
   5. How to store Zarontin
   6. Package Contents and Other Information

ZARONTIN 250 mg soft capsules, 250 mg/5 ml syrup

etosuccimide

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Zarontin is and what it is used for
• 2. What you need to know before you use Zarontin
• 3. How to use Zarontin
• 4. Possible side effects
• 5. How to store Zarontin
• 6. Contents of the pack and other information

1. What is Zarontin and what is it used for

Zarontin contains the active ingredient ethosuccimide. Ethosuccimide is a succinimide derivative and acts
against convulsions.
Zarontin is used in adults and children for the treatment of a form of epilepsy called
“petit mal”, characterized by brief seizures in which you become absent and unresponsive to
external stimuli, but without convulsions.

2. What you need to know before you use Zarontin

Do not use Zarontin

• if you are allergic to ethosuccimide or any of the other ingredients of this medicine (listed in section 6);
• if you are or think you may be pregnant and if you are breastfeeding with breast milk (see section “Pregnancy and breastfeeding”);
• if you are allergic to peanuts or soy (see section “Warnings and precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before using Zarontin:

• if you suffer from a mixed form of epilepsy. In this case, Zarontin must be administered together with other medicines against convulsions;
• if you have kidney problems;
• if you have liver problems

During treatment with this medicine you may experience:

• symptoms of infections (e.g. sore throat and fever). Tell your doctor because this may be a sign of changes in blood components;
• systemic lupus erythematosus, a chronic autoimmune disease involving several organs of the body;
• severe skin reactions and changes in blood values. Tell your doctor immediately, who,

if necessary, will modify your treatment by prescribing a medicine with a different active
ingredient. These symptoms may indicate a serious condition that in some circumstances may
be life-threatening.

• suicidal thoughts. Warn your family members to inform your doctor immediately if you have a tendency to harm yourself or express suicidal thoughts.

Other medicines and Zarontin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Tell your doctor if you are taking other medicines against epilepsy(e.g. phenytoin and valproic acid).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Zarontin if you are or think you may be pregnant. If you are a woman of childbearing potential, you should
use effective contraceptive methods to avoid the start of a pregnancy during treatment with
this medicine. If you take this medicine during pregnancy, you may increase the risk of the baby being born with congenital malformations of the lips, gums, heart, blood
vessels, brain and spinal cord by 2-3 times.
Talk to your doctor if you wish to plan a pregnancy.
Zarontin should not be taken during breastfeeding because this medicine passes into breast
milk. The doctor will decide whether it is preferable for you and your baby to stop breastfeeding or the treatment with this medicine.

Driving and using machines
Zarontin can cause mental disorders, dizziness and drowsiness. If you experience these symptoms, do not drive
vehicles or use machinery.

Zarontin 250 mg soft capsules contains:

Soy lecithin
This medicine contains soy. If you are allergic to peanuts or soy, do not use this medicine.

Sodium ethyl parahydroxybenzoate (E 215) and sodium propyl parahydroxybenzoate (E 217)
May cause allergic reactions (even delayed).

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per soft capsule 5 ml, which is
essentially ‘sodium-free’.

Zarontin 250 mg/5 ml syrup contains:

Sucrose and glucose
Zarontin syrup contains 3 g of sucrose (sugar) and 5 mg of glucose per dose. To be taken into
consideration in people affected by diabetes mellitus. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.
May be harmful to teeth.

Sodium benzoate (E 211)
This medicine contains 12 mg of sodium benzoate (E 211) per 5 ml, equivalent to 2.4 mg/ml.
Benzoic acid/Benzoate salt (E 211) can increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

Propylene glycol (E 1520)
This medicine contains 42 mg of propylene glycol per 5 ml equivalent to 8.4 mg/ml. If the
child is less than 4 weeks of age, talk to your doctor or pharmacist before administering
this medicine, especially if the child is taking other medicines containing propylene
glycol or alcohol.
If the child is less than 5 years of age, talk to your doctor or pharmacist before administering
this medicine, especially if the child is taking other medicines containing propylene
glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. The doctor may perform further checks during therapy.

Sodium
This medicine contains 5.8 mg of sodium (the main component of table salt) per 5 ml.
This is equivalent to 0.3% of the maximum recommended daily intake with the diet of an adult.

3. How to use Zarontin

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The doses of Zarontin vary from person to person. The doctor will establish the most suitable dose based on age and
condition.

Children over 6 years of age
The recommended starting dose is 500 mg per day (corresponding to 2 soft capsules or 2 teaspoons
of syrup).

Children from 3 to 6 years of age
The recommended starting dose is 250 mg per day (corresponding to 1 soft capsule or 1 teaspoon
of syrup).

Children under 3 years of age
The doctor will establish the most suitable dose for your child.
The starting dose must be gradually increased until the optimal dose is reached to treat the
condition of you or your child.

If you use more Zarontin than you should
If you have accidentally used an excessive dose of Zarontin, inform your doctor immediately or
go to the nearest hospital.
You may experience nausea, vomiting, respiratory depression and coma.

If you forget to use Zarontin
Consult your doctor if you realize you have forgotten to use Zarontin. Do not use a double dose to
make up for the missed dose.
It is extremely important that you use exactly the dose prescribed by your doctor.

If you stop treatment with Zarontin
Do not abruptly stop treatment with Zarontin. The doctor will tell you how to gradually reduce
the doses to avoid worsening of your illness.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor immediately if you or your child experience the following side effects
because they are serious:

• reduction of bone marrow activity (bone marrow failure) with a consequent decrease in the number of all blood cells (white blood cells, red blood cells and platelets) (pancytopenia)
• suicidal thoughts
• Stevens-Johnson syndrome, a serious reaction characterized by blisters, vesicles, lesions and peeling of the superficial layer of the skin
• DRESS syndrome, a serious allergic reaction characterized by rash, fever and symptoms involving several organs of the body
• systemic lupus erythematosus, a chronic autoimmune disease involving several organs of the body

See your doctor if you experience the following side effects:

Common(may affect up to 1 in 10 people):

• loss of appetite
• headache
• problems with coordination of movements (ataxia)
• dizziness
• drowsiness
• abdominal pain or discomfort
• problems with the stomach and intestines
• nausea, vomiting
• rash, urticaria

Uncommon(may affect up to 1 in 100 people):

• increased number of eosinophils (a type of white blood cells) in the blood
• decrease in the number of white blood cells (leukopenia, agranulocytosis) and red blood cells in the blood (aplastic anemia)
• hypersensitivity
• aggression
• depression
• mental disorders
• sleep disorders, night terrors
• state of inner tension accompanied by excessive motor agitation
• excessive sleepiness (lethargy)
• impaired attention
• myopia (decreased distance vision)
• hiccups
• diarrhea
• swelling of the gums (gingival hypertrophy) and tongue (tongue edema)
• serious general health disorders associated with fever and skin rashes: DRESS syndrome
• serious reaction characterized by blisters, vesicles, lesions and peeling of the superficial layer of the skin: Stevens-Johnson syndrome
• chronic autoimmune disease involving several organs of the body: systemic lupus erythematosus
• presence of blood in the urine (hematuria)
• heavy bleeding from the vagina (vaginal hemorrhage)
• weakness (asthenia), irritability
• weight loss Not known(frequency cannot be estimated based on available data):
• euphoria
• increased sexual desire (increased libido)
• increased hair growth (hirsutism)

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 also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse. By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Zarontin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and bottle after
“Exp.”. The expiry date refers to the last day of that month.
Zarontin 250 mg soft capsules
Keep the bottle tightly closed to protect the medicine from light and moisture.
Zarontin 250 mg/5 ml syrup
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Zarontin contains
The active ingredient is ethosuximide.
Zarontin 250 mg soft capsules

• The active ingredient is ethosuximide.
• The other ingredients are: macrogol 400, gelatin, glycerin, sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), traces of medium chain triglycerides, soybean lecithin (see section 2 “Zarontin 250 mg soft capsules contains” for further information on sodium ethyl parahydroxybenzoate (E 215), sodium propyl parahydroxybenzoate (E 217), soybean lecithin and sodium). Zarontin 250 mg/5 ml syrup
• The active ingredient is ethosuximide.
• The other ingredients are: sodium citrate, sodium saccharin, sodium benzoate (E 211), sucrose, glycerin, raspberry essence (contains glucose and propylene glycol), citric acid monohydrate and purified water. (see section 2 “Zarontin 250 mg/5 ml syrup contains” for further information on sodium benzoate (E 211), sucrose, glucose and sodium).

Description of the appearance of Zarontinand package contents
Zarontin 250 mg soft capsules is available in a polypropylene bottle containing 50 or 56 capsules.
Zarontin 250 mg/5 ml syrup is available in a 200 ml glass bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Essential Pharma (M) Ltd
Vision Exchange Building
Triq it-Territorjals, Zone 1,
Central Business District,
Birkirkara, CBD 1070,
Malta

Manufacturer
Zarontin 250 mg soft capsules
Catalent France Beinheim SA
74, rue Principale
67930 Beinheim
France
Zarontin 250 mg/5 ml syrup
Delpharm Orléans
Avenue de Concyr, 5
45071 Orléans Cedex 2
France