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PRIMIDONE ENNOGEN 250MG TABLETS

Active substance(s): PRIMIDONE / PRIMIDONE / PRIMIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Primidone Ennogen 250mg Tablets
Your medicine is known by the above name, but will be referred to as Primidone
Ennogen throughout this leaflet.
This medicine is available in another strength (50mg).
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.
In this leaflet:
1. What Primidone Ennogen is and what
it is used for
2. Before you use Primidone Ennogen

3. How to use Primidone Ennogen
4. Possible side effects
5. How to store Primidone Ennogen
6. Further information

1. WHAT PRIMIDONE ENNOGEN IS AND WHAT IT IS USED FOR
Primidone Ennogen contains primidone as the active ingredient; this belongs to a group
of medicines used to treat seizures.
Primidone Ennogen is used for the treatment of certain types of epilepsy, seizures (fits)
or shaking attacks (essential tremor).

2. BEFORE YOU USE PRIMIDONE ENNOGEN
Do not take Primidone Ennogen if you:
• are allergic (hypersensitive) to primidone, a substance called phenobarbitone, or
to any of the other ingredients of Primidone Ennogen (these are listed in Section 6:
Further information).
• have porphyria (a rare inherited disorder of metabolism) or anyone in your family has it.

Take special care with Primidone Ennogen 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)
If you go into hospital, tell the medical staff that you are taking Primidone Ennogen.
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.

Taking other medicines
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 Ennogen works, or Primidone Ennogen 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
Primidone Ennogen may increase the toxic effect on the liver of an overdose of paracetamol.

Taking Primidone Ennogen with food and drink
Alcohol can react with Primidone Ennogen. 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 Ennogen 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 Ennogen has the potential to harm your
unborn child.
Pregnant women can have reduced folic acid in their blood whilst taking Primidone
Ennogen. In addition, the new born child may develop withdrawal symptoms if the
mother has taken Primidone Ennogen 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 Ennogen may cause your
baby to be very sleepy.

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

3. HOW TO USE PRIMIDONE ENNOGEN
Always take Primidone Ennogen 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 Ennogen is normally taken twice a day. Try to take your tablets at the same
time each day.

Epilepsy
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:
Age group
Adults and children over 9 years
Children 6 to 9 years
Children 2 to 5 years
Children up to 2 years

Daily dose (milligrams)
750 to 1500
750 to 1000
500 to 750
250 to 500

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

Shaking attacks (essential tremor)
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 take more Primidone Ennogen than you should
If you take more than your normal dose, contact your doctor or nearest hospital.

If you forget to take Primidone Ennogen
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 Ennogen
Do not stop taking your Primidone Ennogen, even if you are feeling well, unless your doctor
tells you to. You may have become dependent on Primidone Ennogen, and therefore you
could get a withdrawal reaction if you stop treatment too quickly. Primidone Ennogen
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 Ennogen can cause side effects, although not everybody gets them.
When first taking Primidone Ennogen, 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

Uncommon side effects

(affecting fewer than 1 in every 10 people)

(affecting fewer than 1 in every 100 people)

• disturbances of vision
• dizziness
• jerky movements
• rolling of the eyes

• 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.
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.

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 ENNOGEN
Keep out of the sight and reach of children
Do not store above 25ºC.
Do not use Primidone Ennogen after the expiry date which is stated on the carton label.
The expiry date refers to the last day of that month.
If your tablets show signs of deterioration or discolouration, 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.

6. FURTHER INFORMATION
What Primidone Ennogen contains
Each tablet contains 250mg primidone.
Each tablet also contains carboxymethylcellulose calcium, gelatin, magnesium stearate,
povidone and stearic acid.
What Primidone Ennogen looks like and the contents of the pack
Each white, uncoated tablet has a breakline on one side, plain on the reverse.
Primidone Ennogen are available in blister packs of 30 tablets.
Who manufactured your medicine
Manufactured by Laboratorio Farmaceutico SIT srl – Via Cavour, 70 – 27035 Mede (PV) Italy.
Procured from within the EU and repackaged by Product Licence Holder Ennogen Healthcare
Limited, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent DA1 5BS.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 01322 629220 to obtain the leaflet in
a format suitable for you.
PL: 40739/0021
Leaflet date: 23 March 2017

POM
Ref: PrimE250I/v1

PACKAGE LEAFLET: INFORMATION FOR THE USER
Primidone Ennogen 250mg Tablets
Your medicine is known by the above name, but will be referred to as Primidone
Ennogen throughout this leaflet.
This medicine is available in another strength (50mg).
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.
In this leaflet:
1. What Primidone Ennogen is and what
it is used for
2. Before you use Primidone Ennogen

3. How to use Primidone Ennogen
4. Possible side effects
5. How to store Primidone Ennogen
6. Further information

1. WHAT PRIMIDONE ENNOGEN IS AND WHAT IT IS USED FOR
Primidone Ennogen contains primidone as the active ingredient; this belongs to a group
of medicines used to treat seizures.
Primidone Ennogen is used for the treatment of certain types of epilepsy, seizures (fits)
or shaking attacks (essential tremor).

2. BEFORE YOU USE PRIMIDONE ENNOGEN
Do not take Primidone Ennogen if you:
• are allergic (hypersensitive) to primidone, a substance called phenobarbitone, or
to any of the other ingredients of Primidone Ennogen (these are listed in Section 6:
Further information).
• have porphyria (a rare inherited disorder of metabolism) or anyone in your family has it.

Take special care with Primidone Ennogen 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)
If you go into hospital, tell the medical staff that you are taking Primidone Ennogen.
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.

Taking other medicines
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 Ennogen works, or Primidone Ennogen 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
Primidone Ennogen may increase the toxic effect on the liver of an overdose of paracetamol.

Taking Primidone Ennogen with food and drink
Alcohol can react with Primidone Ennogen. 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 Ennogen 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 Ennogen has the potential to harm your
unborn child.
Pregnant women can have reduced folic acid in their blood whilst taking Primidone
Ennogen. In addition, the new born child may develop withdrawal symptoms if the
mother has taken Primidone Ennogen 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 Ennogen may cause your
baby to be very sleepy.

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

3. HOW TO USE PRIMIDONE ENNOGEN
Always take Primidone Ennogen 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 Ennogen is normally taken twice a day. Try to take your tablets at the same
time each day.

Epilepsy
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:
Age group
Adults and children over 9 years
Children 6 to 9 years
Children 2 to 5 years
Children up to 2 years

Daily dose (milligrams)
750 to 1500
750 to 1000
500 to 750
250 to 500

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

Shaking attacks (essential tremor)
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 take more Primidone Ennogen than you should
If you take more than your normal dose, contact your doctor or nearest hospital.

If you forget to take Primidone Ennogen
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 Ennogen
Do not stop taking your Primidone Ennogen, even if you are feeling well, unless your doctor
tells you to. You may have become dependent on Primidone Ennogen, and therefore you
could get a withdrawal reaction if you stop treatment too quickly. Primidone Ennogen
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 Ennogen can cause side effects, although not everybody gets them.
When first taking Primidone Ennogen, 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

Uncommon side effects

(affecting fewer than 1 in every 10 people)

(affecting fewer than 1 in every 100 people)

• disturbances of vision
• dizziness
• jerky movements
• rolling of the eyes

• 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.
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.

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 ENNOGEN
Keep out of the sight and reach of children
Do not store above 25ºC.
Do not use Primidone Ennogen after the expiry date which is stated on the carton label.
The expiry date refers to the last day of that month.
If your tablets show signs of deterioration or discolouration, 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.

6. FURTHER INFORMATION
What Primidone Ennogen contains
Each tablet contains 250mg primidone.
Each tablet also contains carboxymethylcellulose calcium, gelatin, magnesium stearate,
povidone and stearic acid.
What Primidone Ennogen looks like and the contents of the pack
Each white, uncoated tablet has a breakline on one side, plain on the reverse.
Primidone Ennogen are available in blister packs of 30 tablets.
Who manufactured your medicine
Manufactured by Laboratorio Farmaceutico SIT srl – Via Cavour, 70 – 27035 Mede (PV) Italy.
Procured from within the EU by Product Licence Holder Ennogen Healthcare Limited, Unit G4
Riverside Industrial Estate, Riverside Way, Dartford, Kent, DA1 5BS.
Repackaged by Prodlekpol Sp. z.o.o, ul. Matuszewska 14, 03-876 Warsaw, Poland.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 01322 629220 to obtain the leaflet in
a format suitable for you.
PL: 40739/0021
Leaflet date: 23 March 2017

POM
Ref: Prim/D/v1

PACKAGE LEAFLET: INFORMATION FOR THE USER
Primidone Serb® 250mg Tablets
Your medicine is known by the above name, but will be referred to as Primidone Serb
throughout this leaflet.
This medicine is available in another strength (50mg).
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.
In this leaflet:
1. What Primidone Serb is and what
it is used for
2. Before you use Primidone Serb

3. How to use Primidone Serb
4. Possible side effects
5. How to store Primidone Serb
6. Further information

1. WHAT PRIMIDONE SERB IS AND WHAT IT IS USED FOR
Primidone Serb contains primidone as the active ingredient; this belongs to a group of
medicines used to treat seizures.
Primidone Serb is used for the treatment of certain types of epilepsy, seizures (fits) or
shaking attacks (essential tremor).

2. BEFORE YOU USE PRIMIDONE SERB
Do not take Primidone Serb if you:
• are allergic (hypersensitive) to primidone, a substance called phenobarbitone, or
to any of the other ingredients of Primidone Serb (these are listed in Section 6:
Further information).
• have porphyria (a rare inherited disorder of metabolism) or anyone in your family has it.

Take special care with Primidone Serb 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)
If you go into hospital, tell the medical staff that you are taking Primidone Serb.
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.

Taking other medicines
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 Serb works, or Primidone Serb 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
Primidone Serb may increase the toxic effect on the liver of an overdose of paracetamol.

Taking Primidone Serb with food and drink
Alcohol can react with Primidone Serb. 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 Serb 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 Serb has the potential to harm your
unborn child.
Pregnant women can have reduced folic acid in their blood whilst taking Primidone
Serb. In addition, the new born child may develop withdrawal symptoms if the mother
has taken Primidone Serb 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 Serb may cause your baby
to be very sleepy.

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

3. HOW TO USE PRIMIDONE SERB
Always take Primidone Serb 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 Serb is normally taken twice a day. Try to take your tablets at the same time
each day.

Epilepsy
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:
Age group
Adults and children over 9 years
Children 6 to 9 years
Children 2 to 5 years
Children up to 2 years

Daily dose (milligrams)
750 to 1500
750 to 1000
500 to 750
250 to 500

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

Shaking attacks (essential tremor)
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 take more Primidone Serb than you should
If you take more than your normal dose, contact your doctor or nearest hospital.

If you forget to take Primidone Serb
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 Serb
Do not stop taking your Primidone Serb, even if you are feeling well, unless your doctor tells
you to. You may have become dependent on Primidone Serb, and therefore you could get
a withdrawal reaction if you stop treatment too quickly. Primidone Serb 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 Serb can cause side effects, although not everybody gets them.
When first taking Primidone Serb, 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

Uncommon side effects

(affecting fewer than 1 in every 10 people)

(affecting fewer than 1 in every 100 people)

• disturbances of vision
• dizziness
• jerky movements
• rolling of the eyes

• 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.
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.

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 SERB
Keep out of the sight and reach of children
Do not store above 25ºC.
Do not use Primidone Serb after the expiry date which is stated on the carton label. The
expiry date refers to the last day of that month.
If your tablets show signs of deterioration or discolouration, 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.

6. FURTHER INFORMATION
What Primidone Serb contains
Each tablet contains 250mg primidone.
Each tablet also contains carboxymethylcellulose calcium, gelatin, magnesium stearate,
povidone and stearic acid.
What Primidone Serb looks like and the contents of the pack
Each white, uncoated tablet has a breakline on one side, plain on the reverse.
Primidone Serb are available in blister packs of 30 tablets.
Who manufactured your medicine
Manufactured by Laboratorio Farmaceutico SIT srl – Via Cavour, 70 – 27035 Mede (PV) Italy.
Procured from within the EU and repackaged by Product Licence Holder Ennogen Healthcare
Limited, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent DA1 5BS.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 01322 629220 to obtain the leaflet in
a format suitable for you.
POM
PL: 40739/0021
Leaflet date: 23 March 2017
Ref: Prim250I/v1
SERB is a registered trademark

PACKAGE LEAFLET: INFORMATION FOR THE USER
Mysoline* 250 mg Tablets
(primidone)
Your medicine is known by the above name, but will be referred to as Mysoline
throughout this leaflet.
This medicine is available in another strength (50mg).
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.
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

1. WHAT MYSOLINE IS AND WHAT IT IS USED FOR
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).

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

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)
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.

Taking other medicines
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.

Taking Mysoline with food and drink
Alcohol can react with Mysoline. 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 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.

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

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.

Epilepsy
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:
Age group
Adults and children over 9 years
Children 6 to 9 years
Children 2 to 5 years
Children up to 2 years

Daily dose (milligrams)
750 to 1500
750 to 1000
500 to 750
250 to 500

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

Shaking attacks (essential tremor)
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 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.
Common side effects

Uncommon side effects

(affecting fewer than 1 in every 10 people)

(affecting fewer than 1 in every 100 people)

• disturbances of vision
• dizziness
• jerky movements
• rolling of the eyes

• 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.
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.

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.
Do not use Mysoline after the expiry date which is stated on the carton label. The expiry
date refers to the last day of that month.
If your tablets show signs of deterioration or discolouration, 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.

6. FURTHER INFORMATION
What Mysoline contains
Each tablet contains 250mg primidone.
Each tablet also contains carboxymethylcellulose calcium, gelatin, magnesium stearate,
povidone and stearic acid.
What Mysoline looks like and the contents of the pack
Each white, uncoated tablet has a breakline on one side, plain on the reverse.
Mysoline are available in blister packs of 30 tablets.
Who manufactured your medicine
Manufactured by Laboratorio Farmaceutico SIT srl – Via Cavour, 70 – 27035 Mede (PV) Italy.
Procured from within the EU and repackaged by Product Licence Holder Ennogen Healthcare
Limited, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent DA1 5BS.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 01322 629220 to obtain the leaflet in
a format suitable for you.
PL: 40739/0021

POM

*Mysoline is a registered trademark in Italy of ASTRAZENECA UK LTD
Leaflet date: 23 March 2017

Ref: Mys250I/v3

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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