MYSOLINE 250 mg Coated Tablet

Зміст інструкції

1. Mysoline 250 mg tablets
   1. What is Mysoline and what is it used for
   2. What you need to know before taking Mysoline
   3. How to take Mysoline
   4. Possible side effects
   5. How to store Mysoline
   6. Contents of the pack and other information

Mysoline 250 mg tablets

primidone

Read this leaflet carefully before you start taking this medicine because 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 Mysoline is and what it is used for
• 2. What you need to know before you take Mysoline
• 3. How to take Mysoline
• 4. Possible side effects
• 5. How to store Mysoline
• 6. Contents of the pack and other information

1. What is Mysoline and what is it used for

Mysoline contains the active ingredient primidone, which belongs to a group of drugs used to treat seizures.
Mysoline is used in the treatment of certain types of epilepsy and convulsions, such as:

• Grand mal
• Psychomotor epilepsy (temporal lobe epilepsy)
• Idiopathic, post-traumatic epilepsies, associated with clear signs of brain injury or with modifications of the EEG tracing (if you have resistance to other therapies)
• Focal and Jacksonian seizures
• Myoclonic and akinetic seizures

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Mysoline

Do not take Mysoline

• if you are allergic to the active ingredient, to barbiturates (medicines used for insomnia or to treat epilepsy) or to any of the other ingredients of this medicine (listed in section 6);
• if you have porphyria (a rare inherited disorder of blood metabolism).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mysoline.

Pay particular attention:

• in case of prolonged treatment because this medicine can cause dependence;
• if you are a woman and are taking oral contraceptives, because during treatment with this medicine you may no longer be protected from pregnancy and you may experience bleeding between periods (see section 2 “Other medicines and Mysoline”);
• if you have or have had thoughts of harming yourself (self-injuring) or of suicide. If you have these thoughts at any time, contact your doctor immediately;
• if you are elderly or debilitated or if you have problems with your breathing, kidneys or liver (see section 3 “How to take Mysoline” - “Use in the elderly and patients with breathing problems, kidney or liver problems”).

Children
Caution is required in children, to whom the doctor may prescribe a lower dose.

Other medicines and Mysoline
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
This is important because some medicines can alter the way Mysoline works, or Mysoline can alter the action of other medicines.
In particular, tell your doctor if you are taking:

• medicines used to thin the blood (anticoagulants),
• medicines containing steroids
• medicines against bacterial infections (antibiotics)
• oral contraceptives
• medicines used against convulsions (anticonvulsants) such as phenytoin, because Mysoline reduces its effectiveness;
• medicines that depress the central nervous system such as barbiturates or alcohol, because the effect may be increased.

Mysoline with alcohol
This medicine can increase the effects of alcohol. Ask your doctor for advice before drinking alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you are planning a pregnancy it is important that you talk to your doctor first about how to continue your antiepileptic therapy.
This medicine should not be used during pregnancy unless strictly necessary and under the control of your doctor.
Take this medicine during pregnancy only if your doctor prescribes it, as it can increase the risk of birth defects in your baby (cleft lip, heart and blood vessel malformations, problems with the development of the nervous system).
Taking Mysoline, pregnant women may have a reduction in blood folic acid.
In addition, newborns of mothers who have taken this medicine during the last period of pregnancy may develop withdrawal symptoms after birth.
Occasionally, coagulation problems have been observed in the children of mothers who had taken an anti-convulsant drug during pregnancy.
Do not suddenly stop taking this medicine because this can cause the sudden onset of seizures, which can have serious consequences for you and your baby (see section 3 “If you stop taking Mysoline”).

Breastfeeding
The primidone contained in this medicine passes into breast milk and can cause drowsiness or weakness in the newborn. If you notice these symptoms in your baby, stop breastfeeding.

Driving and using machines
This medicine can reduce your alertness and the speed of your reflexes. These effects can impair your ability to drive vehicles or use machines.
Do not drive vehicles or use machines if any of these effects occur.

3. How to take Mysoline

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The dose, frequency of administration and duration of therapy will be established by your doctor based on your
condition.
The dose is generally divided into two administrations per day (morning and evening).
The start of treatment will be gradual.
Treatment will begin with a low dose, which may be half a tablet (125 mg) per day to
be taken in the late evening, for the first 3 days.
This dose will be modified by the doctor until they have achieved control of your condition:
Adults: increase the daily dosage by half a tablet every 3 days up to a dose of 2 tablets
per day, to be taken in the morning and evening. Subsequently increase by one tablet every 3 days until the
optimal dosage for seizure control is reached (maximum dose 6 tablets/day) Children: the
daily dosage may be increased by half a tablet at intervals of 3 days, until the therapeutic effect is achieved
(maximum dose 4 tablets/day).
The recommended doses for maintenance treatment are:

Use in the elderly and in patients with respiratory problems, kidney or liver problems
If you are elderly or have respiratory problems, kidney or liver problems, you will be prescribed a reduced dose.

If you take more Mysoline than you should
If you take a dose of Mysoline higher than that prescribed immediately inform your doctoror go to the
nearest hospital. Bring this leaflet with you.
Symptoms of an overdose may include: coordination disorders (ataxia), loss
of consciousness, severe difficulty breathing (respiratory depression) and coma.

If you forget to take Mysoline
Do not take a double dose to make up for a missed dose.

If you stop taking Mysoline
Do not abruptly stop treatmentwith this medicine without first talking to your doctor,
as this may cause the sudden onset of epileptic seizures.
Treatment must be reduced gradually and under medical supervision.
If you have any doubts about 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.
At the beginning of treatment with Mysoline, the following may occur: drowsiness, irritability, inattention.
Reported side effects include:

• symptoms of toxicity to the nervous system, in particular disorders in the coordination of movements (ataxia), dizziness, headache;
• rhythmic and involuntary eye movements (nystagmus);
• visual disturbances;
• nausea and vomiting; These effects tend to pass spontaneously, but, in case of high individual sensitivity to the medicine, they may be so severe as to require discontinuation of treatment;
• serious skin reactions, including severe rashes.

Rarely have the following also been reported:

• a serious alteration of the organism called “systemic lupus erythematosus”;
• joint pain (arthralgia);
• personality changes, including psychotic reactions;
• swollen legs (edema of the lower limbs);
• thirst;
• excessive urine production (polyuria);
• reduced sexual potency;
• anemia characterized by abnormally shaped red blood cells (megaloblastic anemia) and other alterations affecting the blood (blood dyscrasias).

Cases of bone disease including osteopenia and osteoporosis (thinning of the bones) and
fractures have been reported. Contact your doctor or pharmacist if you have been on long-term therapy with an
antiepileptic drug, or if you have a history of osteoporosis, or if you are taking steroids.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly via the website:
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Mysoline

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Expiry“. The expiry
date refers to the last day of that month.
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. Contents of the pack and other information

What Mysoline contains

• The active ingredient is primidone. Each tablet contains 250 mg of primidone.
• The other ingredients are: povidone, gelatin, calcium carmellose, magnesium stearate, stearic acid.

Description of the appearance of Mysoline and contents of the pack
Mysoline is presented in a carton containing 30 tablets in blisters.

Marketing authorisation holder and manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)