Package leaflet: Information for the patient

Mysoline 250 mg tablets

primidone
Please read all of this leaflet carefully before you take 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Mysoline is and what it is used for
What you need to know before you take Mysoline
How to take Mysoline
Possible side effects
How to store Mysoline
Contents of the pack and other information

1. What Mysoline is and what it is used for

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

Grand mal
Psychomotor epilepsy (temporal lobe epilepsy)
Idiopathic, post-traumatic epilepsy, epilepsy associated with clear signs of brain damage or with changes in the EEG tracing (in patients who are resistant to other therapies)
Focal and Jacksonian seizures
Myoclonic and akinetic seizures

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

2. What you should know before taking Mysoline

Do not take Mysoline

if you are allergic to the active substance, 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.
Exercise particular caution:

during prolonged treatment, because this medicine may lead to dependence;
if you are a woman taking oral contraceptives, as you may no longer be protected against pregnancy and breakthrough bleeding may occur during treatment with this medicine (see section 2 “Other medicines and Mysoline”);
if you have or have had thoughts of harming yourself (self-harming) or of suicide. If you experience such thoughts at any time, contact your doctor immediately;
if you are elderly or debilitated, or if you have respiratory, kidney, or liver problems (see section 3 “How to take Mysoline” – “Use in the elderly and in patients with respiratory, kidney, or liver problems”).

Children
Caution is required in children, for whom the doctor may prescribe a lower dose.
Other medicines and Mysoline
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is important because some medicines may alter how Mysoline works, or Mysoline may alter the effects of other medicines.
In particular, inform your doctor if you are taking:

medicines used to thin the blood (anticoagulants),
medicines containing steroids,
medicines for bacterial infections (antibiotics),
oral contraceptives,
medicines used to treat seizures (anticonvulsants) such as phenytoin, as Mysoline reduces their effectiveness;
medicines that depress the central nervous system such as barbiturates or alcohol, as their effects may be increased.

Mysoline and alcohol
This medicine may enhance the effects of alcohol. Ask your doctor for advice before drinking alcoholic beverages.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you are planning a pregnancy, it is important that you discuss with your doctor how to continue your antiepileptic therapy.
This medicine must not be used during pregnancy unless strictly necessary and under medical supervision.
Take this medicine during pregnancy only if prescribed by your doctor, as it may increase the risk of birth defects in your baby (cleft lip, heart and blood vessel malformations, nervous system development problems).
Women taking Mysoline during pregnancy may experience reduced folic acid levels in the blood.
Moreover, newborns whose mothers took this medicine during the last stage of pregnancy may develop withdrawal symptoms after birth.
Occasionally, coagulation problems have been observed in babies born to mothers who took an anticonvulsant medicine during pregnancy.
Do not stop taking this medicine suddenly, as this may cause sudden onset of seizures, which could have serious consequences for you and your baby (see section 3 “If you stop taking Mysoline”).
Breastfeeding
Primidone contained in this medicine passes into breast milk and may cause drowsiness or weakness in the newborn. If you observe these symptoms in your baby, discontinue breastfeeding.
Driving and using machines
This medicine may reduce your level of alertness and slow your reflexes. These effects may impair your ability to drive or operate machinery.
Do not drive or operate machinery if you experience any of these effects.

3. How to take Mysoline

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose, frequency of administration, and duration of treatment will be determined by your doctor according to your condition.
The dose is generally divided into two daily intakes (morning and evening).
Treatment will be started gradually.
Treatment will begin with a low dose, which may be half a tablet (125 mg) per day taken in the late evening for the first 3 days.
Your doctor will adjust this dose until control of your condition is achieved:
Adults: increase the daily dose by half a tablet every 3 days up to a dose of 2 tablets per day, taken in the morning and evening. Subsequently, increase by one tablet every 3 days until the optimal dose for seizure control is reached (maximum dose 6 tablets/day).
Children: the daily dose may be increased by half a tablet at intervals of 3 days, up to the dose achieving the therapeutic effect (maximum dose 4 tablets/day).
The recommended doses for maintenance treatment are:

Age	Daily dose (dose in mg)
Adults and children above 9 years of age	3 – 6 tablets (750 mg – 1500 mg)
Children between 6 and 9 years of age	3 – 4 tablets (750 mg – 1000 mg)
Children between 2 and 5 years of age	2 – 3 tablets (500 mg – 750 mg)
Children up to 2 years of age	1 – 2 tablets (250 mg – 500 mg)

Use in elderly patients and in patients with respiratory, renal or hepatic problems
If you are elderly or have respiratory, renal or hepatic problems, you will be prescribed a reduced dose.
If you take more Mysoline than you should
If you take more Mysoline than prescribed, contact your doctor immediately or go to the nearest hospital.
Take this leaflet with you.
Symptoms of an overdose may include: lack of coordination in movement (ataxia), loss of consciousness, severe
difficulty in breathing (respiratory depression) and coma.
If you forget to take Mysoline
Do not take a double dose to make up for the missed dose.
If you stop taking Mysoline
Do not stop treatment abruptly with this medicine without first talking to your doctor, as this may cause
sudden onset of epileptic seizures.
Treatment must be gradually reduced and under medical supervision.
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 will experience them.
At the beginning of treatment with Mysoline, the following may occur: drowsiness, irritability, lack of attention.
Reported side effects include:

symptoms of toxicity affecting the nervous system, particularly disturbances in movement coordination (ataxia), dizziness, headache (cephalaea);
rhythmic, involuntary eye movements (nystagmus);
visual disturbances;
nausea and vomiting; These effects tend to resolve spontaneously, but in cases of high individual sensitivity to the medicine, they may become so severe as to require discontinuation of treatment;
severe skin reactions, including severe rashes.

Rarely reported side effects also include:

a serious systemic disorder 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;
anaemia characterised by abnormally shaped red blood cells (megaloblastic anaemia), and other blood abnormalities (haematological 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 are on long-term treatment with an antiepileptic medicine, if you have a history of osteoporosis, or if you are taking steroids.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Expiry”. The expiry date refers to the
last day of that month.
Do not dispose of any medicine via 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 Mysoline contains

The active substance is primidone. Each tablet contains 250 mg of primidone.
The other components 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 blister packs.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)