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MYSOLINE 250 MG TABLETS

Active substance(s): PRIMIDONE

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Package Leaflet: Information for the user

Mysoline® 250mg Tablets
(primidone)
Read all of this leaflet carefully before you start using this medicine.

Taking Mysoline® with food and drink





Alcohol can react with Mysoline®. Ask your doctor for advice if you want to
drink alcohol.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
The name of this medicine is Mysoline® 250mg Tablets but it will be
referred to as Mysoline® throughout the remainder of the leaflet.
Mysoline® is also available in other strengths.

Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine. The use of
Mysoline® in pregnancy is associated with an increased risk of
abnormalities in babies. Therefore, you must tell your doctor if you are
pregnant, or trying to become pregnant because Mysoline® has the
potential to harm your unborn child. Pregnant women can have reduced
folic acid in their blood whilst taking Mysoline®. In addition, the new born
child may develop withdrawal symptoms if the mother has taken
Mysoline® in the late stages of pregnancy. Blood clotting problems have
occurred occasionally in children born to women who were previously
taking anticonvulsant drugs. Tell your doctor if you are breast-feeding
because Mysoline® may cause your baby to be very sleepy.

In this leaflet:
1. What Mysoline® is and what it is used for
2. Before you use Mysoline®
3. How to use Mysoline®
4. Possible side effects
5. How to store Mysoline®
6. Further information

Driving and using machines
Mysoline® can make you feel sleepy. If so, do not drive or operate
machinery.

1. WHAT MYSOLINE IS AND WHAT IT IS USED FOR

3. HOW TO USE MYSOLINE

Mysoline® contains primidone as the active ingredient; this belongs to a
group of medicines used to treat seizures.
Mysoline® is used for the treatment of certain types of epilepsy, seizures
(fits) or shaking attacks (essential tremor).

Always take Mysoline® exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. Swallow the
tablets whole with a drink of water. Mysoline® is normally taken twice a
day. Try to take your tablets at the same time each day.

2. BEFORE YOU USE MYSOLINE

Epilepsy

Do not take Mysoline® if you:




At first, your dose may be as little as 125mg (half a 250mg tablet). This
will be adjusted by your doctor until your condition is controlled. Typical
maintenance doses are as follows:

are allergic (hypersensitive) to primidone, a substance called
phenobarbitone, or to any of the other ingredients of Mysoline® (these
are listed in Section 6: Further information).
have porphyria (a rare inherited disorder of metabolism) or anyone in
your family has it.

Age group

Daily dose (milligrams)

Take special care with Mysoline® if you:

Adults and children over 9 years

750 to 1500

• have ever had problems with your breathing, kidneys or liver.
• are pregnant or are trying to become pregnant (see beneath for further
information)

Children 6 to 9 years

750 to 1000

Children 2 to 5 years

500 to 750

Children up to 2 years

250 to 500

®

If you go into hospital, tell the medical staff that you are taking Mysoline .
A small number of people being treated with anti-epileptics such as
primidone have had thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact your doctor.

Elderly / Patients with low physical strength

Taking other medicines

Lower doses may be prescribed.

Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This is
important because some medicines may affect the way Mysoline® works,
or Mysoline® may affect the way other medicines work. In particular, tell
your doctor if you are taking any of the following:
• Other medicines used to treat epilepsy and other types of seizures
(such as phenytoin, felbamate, sodium valproate, carbamazepine,
ethosuxamide, oxcarbazepine, tiagabine, topiramate, zonisamide)
• Anticoagulants to prevent blood clots (such as warfarin)
• Barbiturates (such as sleeping tablets)
• Methadone (used to treat severe pain, cough, or as a substitute for
morphine addiction)
• Herbal remedies containing St John’s Wort
• Antibiotics (such as chloramphenicol, metronidazole, doxycycline)
• Antiviral medicines (such as nelfinavir)
• Asthma medicines (such as theophylline, montelukast)
• Hormone containing medicines (such as the oral contraceptive pill)
• Medicines used to treat high blood pressure or heart conditions (such
as beta-blockers, digitoxin, losartan, nimodipine, quinidine)
• Cyclosporin (used to prevent rejection of an organ transplant and also
for other diseases of the body’s immune system)
• Medicines used to treat mental health problems or depression (such
as clozapine, lamotrigine, mianserin, tricyclic antidepressants)
• Steroid-containing medicines
• Medicines used to treat cancer (such as cyclophosphamide,
etoposide)
• Granisetron (used to treat severe nausea and vomiting)
• Medicines used during an anesthetic for surgery (such as rocuronium,
vecuronium)
• Medicines containing morphine, or similar medicines called opiates
Mysoline® may increase the toxic effect on the liver of an overdose of
paracetamol.

Shaking attacks (essential tremor)
Your starting dose may be 50mg. This will be adjusted by your doctor until
your condition is controlled. The maximum daily dose for shaking attacks
(essential tremor) is 750mg.
If you take more Mysoline® than you should
If you take more than your normal dose, contact your doctor or nearest
hospital.
If you forget to take Mysoline®
If you miss a dose, take it as soon as you remember. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Mysoline®
Do not stop taking your Mysoline®, even if you are feeling well, unless
your doctor tells you to. You may have become dependent on Mysoline®,
and therefore you could get a withdrawal reaction if you stop treatment
too quickly. Mysoline® treatment should be reduced gradually to prevent
this.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mysoline® can cause side effects, although not
everybody gets them. When first taking Mysoline®, drowsiness and lack of
energy may occur; these usually pass.
There have been reports of bone disorders including osteopenia and
osteoporosis (thinning of the bone) and fractures. Check with your doctor
or pharmacist if you are on long-term antiepileptic medication, have a
history of osteoporosis, or take steroids.

1

Common side effects (affecting fewer than 1 in every 10 people)





Revision Date: 31.05.2016
Leaflet reference: MYS250

disturbances of vision
dizziness
jerky movements
rolling of the eyes

®

PL 16378/0575 Mysoline 250mg Tablets
Mysoline® is a registered trademark of SERB.

Uncommon side effects (affecting fewer than 1 in every 100 people)




nausea and vomiting
headache
skin rash

Rare side effects (affecting fewer than 1 in every 1000 people)




joint or bone pain
changes in mood or behaviour.
severe skin reactions affecting large portions of your body including
redness, pain, ulcers, blisters, shedding the outer layer of skin or
involvement of lips or the lining of the mouth, nostrils or ears (e.g.
toxic epidermal necrolysis, Stevens-Johnson syndrome)
• a disease called lupus erythematosus which causes inflammation of
various parts of the body including the skin, joints, lungs, kidneys,
heart, and liver.
• development of Dupuytren’s contracture (a thickening of fibrous tissue
in the palm of the hand that causes one or more fingers to draw
back).
• abnormalities of the blood cells; if you notice a pale appearance of
your skin, abnormal bleeding or tendency to bruising, fever or sore
throat please consult your doctor.
• raised levels of enzymes in your liver.
Do not be alarmed by this list of possible events. You may not have any
of them.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE MYSOLINE







Keep out of the sight and reach of children.
Do not store above 25oC.
In order to protect from light and moisture, keep the container tightly
closed and in the outer carton.
Do not use Mysoline® after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
If your tablets become discoloured or show any signs of deterioration,
return them to your pharmacist.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Mysoline® 250mg Tablets contain
Each tablet contains 250mg primidone.
The other ingredients are: carmellose calcium, gelatin, magnesium
stearate, povidone and stearic acid.
What Mysoline® 250mg Tablets look like and contents of the pack
Mysoline® 250mg Tablets are white uncoated tablets with ‘M’ on either
side of the break line on one side and plain on the other.
Mysoline® 250mg Tablets come in containers of 100 tablets.
Manufacturer:
Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire,
OL7 9RR, UK.
Procured from within the EU and repackaged by Product Licence Holder
Beachcourse Limited., 20 Alliance Court, Alliance Road, London W3 0RB,
UK.

2

POM

Package Leaflet: Information for the user

Primidone SERB 250mg Tablets


Read all of this leaflet carefully before you start using this medicine.









Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
The name of this medicine is Primidone SERB 250mg Tablets but it
will be referred to as Primidone throughout the remainder of the
leaflet.
Primidone is also available in other strengths.

Taking Primidone with food and drink
Alcohol can react with Primidone. Ask your doctor for advice if you want
to drink alcohol.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine. The use of
Primidone in pregnancy is associated with an increased risk of
abnormalities in babies. Therefore, you must tell your doctor if you are
pregnant, or trying to become pregnant because Primidone has the
potential to harm your unborn child. Pregnant women can have reduced
folic acid in their blood whilst taking Primidone. In addition, the new born
child may develop withdrawal symptoms if the mother has taken
Primidone in the late stages of pregnancy. Blood clotting problems have
occurred occasionally in children born to women who were previously
taking anticonvulsant drugs. Tell your doctor if you are breast-feeding
because Primidone may cause your baby to be very sleepy.

In this leaflet:
1) What Primidone is and what it is used for
2) Before you use Primidone
3) How to use Primidone
4) Possible side effects
5) How to store Primidone
6) Further information

Driving and using machines

1) WHAT PRIMIDONE IS AND WHAT IT IS USED FOR

Primidone can make you feel sleepy. If so, do not drive or operate
machinery.

Primidone contains primidone as the active ingredient; this belongs to a
group of medicines used to treat seizures.
Primidone is used for the treatment of certain types of epilepsy, seizures
(fits) or shaking attacks (essential tremor).

3) HOW TO USE PRIMIDONE
Always take Primidone exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. Swallow the
tablets whole with a drink of water. Primidone is normally taken twice a
day. Try to take your tablets at the same time each day.

2) BEFORE YOU USE PRIMIDONE
Do not take Primidone if you:




Medicines containing morphine, or similar medicines called opiates
Primidone may increase the toxic effect on the liver of an overdose of
paracetamol.

Epilepsy

are allergic (hypersensitive) to primidone, a substance called
phenobarbitone, or to any of the other ingredients of Primidone (these
are listed in Section 6: Further information).
have porphyria (a rare inherited disorder of metabolism) or anyone in
your family has it.

At first, your dose may be as little as 125mg (half a 250mg tablet). This
will be adjusted by your doctor until your condition is controlled. Typical
maintenance doses are as follows:

Take special care with Primidone if you:

Age group

Daily dose (milligrams)

• have ever had problems with your breathing, kidneys or liver.
• are pregnant or are trying to become pregnant (see beneath for further
information)

Adults and children over 9 years

750 to 1500

Children 6 to 9 years

750 to 1000

If you go into hospital, tell the medical staff that you are taking Primidone.
A small number of people being treated with anti-epileptics such as
primidone have had thoughts of harming or killing themselves. If at any
time you have these thoughts, immediately contact your doctor.

Children 2 to 5 years

500 to 750

Children up to 2 years

250 to 500

Taking other medicines

Elderly / Patients with low physical strength

Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. This is
important because some medicines may affect the way Primidone works,
or Primidone may affect the way other medicines work. In particular, tell
your doctor if you are taking any of the following:
• Other medicines used to treat epilepsy and other types of seizures
(such as phenytoin, felbamate, sodium valproate, carbamazepine,
ethosuxamide, oxcarbazepine, tiagabine, topiramate, zonisamide)
• Anticoagulants to prevent blood clots (such as warfarin)
• Barbiturates (such as sleeping tablets)
• Methadone (used to treat severe pain, cough, or as a substitute for
morphine addiction)
• Herbal remedies containing St John’s Wort
• Antibiotics (such as chloramphenicol, metronidazole, doxycycline)
• Antiviral medicines (such as nelfinavir)
• Asthma medicines (such as theophylline, montelukast)
• Hormone containing medicines (such as the oral contraceptive pill)
• Medicines used to treat high blood pressure or heart conditions (such
as beta-blockers, digitoxin, losartan, nimodipine, quinidine)
• Cyclosporin (used to prevent rejection of an organ transplant and also
for other diseases of the body’s immune system)
• Medicines used to treat mental health problems or depression (such
as clozapine, lamotrigine, mianserin, tricyclic antidepressants)
• Steroid-containing medicines
• Medicines used to treat cancer (such as cyclophosphamide,
etoposide)
• Granisetron (used to treat severe nausea and vomiting)
• Medicines used during an anesthetic for surgery (such as rocuronium,
vecuronium)

Lower doses may be prescribed.
Shaking attacks (essential tremor)
Your starting dose may be 50mg. This will be adjusted by your doctor until
your condition is controlled. The maximum daily dose for shaking attacks
(essential tremor) is 750mg.
If you take more Primidone than you should
If you take more than your normal dose, contact your doctor or nearest
hospital.
If you forget to take Primidone
If you miss a dose, take it as soon as you remember. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Primidone
Do not stop taking your Primidone, even if you are feeling well, unless
your doctor tells you to. You may have become dependent on Primidone,
and therefore you could get a withdrawal reaction if you stop treatment
too quickly. Primidone treatment should be reduced gradually to prevent
this.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4) POSSIBLE SIDE EFFECTS
Like all medicines, Primidone can cause side effects, although not
everybody gets them. When first taking Primidone, drowsiness and lack of
energy may occur; these usually pass.

1

There have been reports of bone disorders including osteopenia and
osteoporosis (thinning of the bone) and fractures. Check with your doctor
or pharmacist if you are on long-term antiepileptic medication, have a
history of osteoporosis, or take steroids.

Revision Date: 31.05.2016
Leaflet reference: PRIM250
PL 16378/0575 Primidone SERB 250mg Tablets

Common side effects (affecting fewer than 1 in every 10 people)





SERB is a registered trademark of SERB.

disturbances of vision
dizziness
jerky movements
rolling of the eyes

Uncommon side effects (affecting fewer than 1 in every 100 people)




nausea and vomiting
headache
skin rash

Rare side effects (affecting fewer than 1 in every 1000 people)




joint or bone pain
changes in mood or behaviour.
severe skin reactions affecting large portions of your body including
redness, pain, ulcers, blisters, shedding the outer layer of skin or
involvement of lips or the lining of the mouth, nostrils or ears (e.g.
toxic epidermal necrolysis, Stevens-Johnson syndrome)
• a disease called lupus erythematosus which causes inflammation of
various parts of the body including the skin, joints, lungs, kidneys,
heart, and liver.
• development of Dupuytren’s contracture (a thickening of fibrous tissue
in the palm of the hand that causes one or more fingers to draw
back).
• abnormalities of the blood cells; if you notice a pale appearance of
your skin, abnormal bleeding or tendency to bruising, fever or sore
throat please consult your doctor.
• raised levels of enzymes in your liver.
Do not be alarmed by this list of possible events. You may not have any
of them.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5) HOW TO STORE PRIMIDONE







Keep out of the sight and reach of children.
Do not store above 25oC.
In order to protect from light and moisture, keep the container tightly
closed and in the outer carton.
Do not use Primidone after the expiry date which is stated on the
carton. The expiry date refers to the last day of that month.
If your tablets become discoloured or show any signs of deterioration,
return them to your pharmacist.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6) FURTHER INFORMATION
What Primidone 250mg Tablets contain
Each tablet contains 250mg primidone.
The other ingredients are: carmellose calcium, gelatin, magnesium
stearate, povidone and stearic acid.
What Primidone 250mg Tablets look like and contents of the pack
Primidone 250mg Tablets are white uncoated tablets with ‘M’ on either
side of the break line on one side and plain on the other.
Primidone 250mg Tablets come in containers of 100 tablets.
Manufacturer:
Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire,
OL7 9RR, UK.
Procured from within the EU and repackaged by Product Licence Holder
Beachcourse Limited., 20 Alliance Court, Alliance Road, London W3 0RB,
UK.

2

POM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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