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PRIMIDONE 250MG TABLETS CHEMILINES

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S728 LEAFLET Mysoline 20140304

PACKAGE LEAFLET: INFORMATION FOR USER

MYSOLINE 250mg TABLETS
(primidone)
Your medicine is known as Mysoline 250mg Tablets but will be
referred to as Mysoline throughout the following leaflet.
Information regarding other strength (Mysoline 50mg Tablets) is
also present in this leaflet.
Read all of this leaflet carefully before you start using this
medicine



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 betablockers, 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 cloazepine, lamotrigine, mianserin, tricyclic
antidepressants)



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.



Steroid-containing medicines



Medicines used to treat cancer (such as cyclophosphamide,
etoposide)

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.



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



In this leaflet:
1. What Mysoline is and what it is used for
2. Before you use Mysoline

Mysoline may increase the toxic effect on the liver of an overdose of
paracetamol.

3. How to use Mysoline
4. Possible side effects

Taking Mysoline with food and drink

5. How to store Mysoline
6. Further information

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

1. WHAT MYSOLINE IS AND WHAT IT IS USED FOR

Pregnancy and breast-feeding

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).

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.



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).

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.



have porphyria (a rare inherited disorder of metabolism) or
anyone in your family has it.

Driving and using machines

2. BEFORE YOU USE MYSOLINE
Do not take Mysoline if you:

Take special care with Mysoline if you:


have ever had problems with your breathing, kidneys or liver.



are pregnant or are trying to become pregnant (see beneath for
further information)

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

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.

3. HOW TO USE MYSOLINE
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.

Taking other medicines

Epilepsy

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.

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

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

Age group

Daily dose (milligrams)

Adults and children over 9 years

750 to 1500

Children 6 to 9 years

750 to 1000

Children 2 to 5 years

500 to 750

Children up to 2 years

250 to 500

Elderly / Patients with low physical strength
Lower doses may be prescribed.

Shaking attacks (essential tremor)

Reporting of side effects

Your starting dose may be 50 mg. This will be adjusted by your
doctor until your condition is controlled. The maximum daily dose
for shaking attacks (essential tremor) is 750 mg.

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.

If you take more Mysoline than you should

By reporting side effects, you can help provide more information on
the safety of this medicine.

If you take more than your normal dose, contact your doctor or
nearest hospital.

5. HOW TO STORE MYSOLINE
If you forget to take Mysoline



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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.



Do not store above 25°C.



Do not use after the expiry date printed on the carton label or
blister strip. The expiry date refers to the last day of that month.

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 the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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

6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS

What Mysoline contains

Like all medicines, Mysoline can cause side effects, although not
everybody gets them.



Each tablet contains 250mg primidone as the active ingredient.



Mysoline Tablets also contain the following inactive ingredients:
povidone, gelatin, calcium carboxymethylcellulose, magnesium
stearate and stearic acid.

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


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)


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, StevensJohnson syndrome),

Mysoline Tablets are available as blister packs of 30, 90 or 120
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.
Manufacturer
This product is manufactured by Laboratorio Farmaceutico SIT
(Specialita Igienico-Terapeutiche srl), Via Cavour, 70, Mede, Italy.
POM

PL No: 19488/0728

joint or bone pain



What Mysoline looks like and contents of the pack
The tablets are white, round, uncoated tablet has a score line on
one side and is plain on the other.



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.
If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Leaflet revision date: 4 March 2014
Mysoline® is a registered trade mark of Acorus Therapeutics Ltd,
S728 LEAFLET Mysoline 20140304

S728 LEAFLET Primidone 20140304

PACKAGE LEAFLET: INFORMATION FOR USER

PRIMIDONE SERB 250mg TABLETS
(primidone)
Your medicine is known as Primidone Serb 250mg Tablets but will
be referred to as Primidone throughout the following leaflet.
Information regarding other strength (Primidone Serb 50mg
Tablets) is also present in this leaflet.
Read all of this leaflet carefully before you start using this
medicine



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 betablockers, 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 cloazepine, lamotrigine, mianserin, tricyclic
antidepressants)



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.



Steroid-containing medicines



Medicines used to treat cancer (such as cyclophosphamide,
etoposide)

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.



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



In this leaflet:
1. What Primidone is and what it is used for
2. Before you use Primidone

Primidone may increase the toxic effect on the liver of an overdose
of paracetamol.

3. How to use Primidone
4. Possible side effects

Taking Primidone with food and drink

5. How to store Primidone
6. Further information

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

1. WHAT PRIMIDONE IS AND WHAT IT IS USED FOR

Pregnancy and breast-feeding

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).

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.



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).

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.



have porphyria (a rare inherited disorder of metabolism) or
anyone in your family has it.

Driving and using machines

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

Take special care with Primidone if you:


have ever had problems with your breathing, kidneys or liver.



are pregnant or are trying to become pregnant (see beneath for
further information)

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

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.

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.

Taking other medicines

Epilepsy

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.

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

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

Age group

Daily dose (milligrams)

Adults and children over 9 years

750 to 1500

Children 6 to 9 years

750 to 1000

Children 2 to 5 years

500 to 750

Children up to 2 years

250 to 500

Elderly / Patients with low physical strength
Lower doses may be prescribed.

Shaking attacks (essential tremor)

Reporting of side effects

Your starting dose may be 50 mg. This will be adjusted by your
doctor until your condition is controlled. The maximum daily dose
for shaking attacks (essential tremor) is 750 mg.

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.

If you take more Primidone than you should

By reporting side effects, you can help provide more information on
the safety of this medicine.

If you take more than your normal dose, contact your doctor or
nearest hospital.

5. HOW TO STORE PRIMIDONE
If you forget to take Primidone



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

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.



Do not store above 25°C.



Do not use after the expiry date printed on the carton label or
blister strip. The expiry date refers to the last day of that month.

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 the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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

6. FURTHER INFORMATION
4. POSSIBLE SIDE EFFECTS

What Primidone contains

Like all medicines, Primidone can cause side effects, although not
everybody gets them.



Each tablet contains 250mg primidone as the active ingredient.



Primidone Tablets also contain the following inactive
ingredients: povidone, gelatin, calcium carboxymethylcellulose,
magnesium stearate and stearic acid.

When first taking Primidone, 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.
Common side effects (affecting fewer than 1 in every 10 people)


disturbances of vision



dizziness



jerky movements

 rolling of the eyes
Uncommon side effects (affecting fewer than 1 in every 100
people)

What Primidone looks like and contents of the pack
The tablets are white, round, uncoated tablet has a score line on
one side and is plain on the other
Primidone Tablets are available as blister packs of 30, 90 or 120
tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Wembley,
HA0 1DX.



nausea and vomiting

Manufacturer



headache

This product is manufactured by Laboratorio Farmaceutico SIT
(Specialita Igienico-Terapeutiche srl), Via Cavour, 70, Mede, Italy.

 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, StevensJohnson 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.
If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

POM

PL No: 19488/0728

Leaflet revision date: 4 March 2014
S728 LEAFLET Primidone 20140304

+ Expand Transcript

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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