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PRIMIDONE LANDMARK PHARMA 250MG TABLETS

Active substance(s): PRIMIDONE / PRIMIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Primidone Serb 250mg Tablets
(primidone)
Your medicine is available using the name Primidone Serb 250mg
Tablets but will be referred to as Primidone throughout this leaflet.
Primidone Tablets are also available as 50mg strength.

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.
2.
3.
4.
5.
6.

What Primidone is and what it is used for
Before you use Primidone
How to use Primidone
Possible side effects
How to store Primidone
Further information

1. What Primidone is and what it is used for
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).

2. Before you use Primidone
Do not take Primidone if you:




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.

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).
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.

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 works, or Primidone may affect the way other
medicines work.

Tell your doctor if you are breast-feeding because Primidone may
cause your baby to be very sleepy.

Driving and using machines

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

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

3. How to use Primidone

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

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.

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.
Page 1 of 2

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.

Epilepsy

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:
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)

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

5. How to store Primidone

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

Keep out of the sight and reach of children.

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 anti-epileptic
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

Do not use Primidone after the expiry date (Exp) printed on the
carton and blister labels. The expiry date refers to the last day of
that month.
Do not store above 25°C.
If your doctor decides to stop the treatment, return any leftover
medicine to the pharmacist. Only keep it if your doctor tells you
to.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return 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 contains

The active substance is primidone.
Each tablet contains 250mg of primidone.

(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.

The other ingredients are: carmellose calcium, gelatin,
magnesium stearate, povidone and stearic acid.

Do not be alarmed by this list of possible events.
You may not have any of them.

PL No: 21828/0553

Reporting of side effects

What Primidone looks like and contents of the pack
Primidone are white, round tablets with a break line on one side
and plain on the reverse.
Primidone is available in packs of 90 tablets.

Manufacturer:

Manufactured by: Laboratorio Farmaceutico SIT s.r.l.,
Via Cavour 70, 27035 Mede (PV), Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX
POM

Leaflet revision and issue date (Ref): 04.05.17

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.

Page 2 of 2

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: Primidone
Serb 250mg Tablets
Reference No: 21828/0553

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mysoline® 250mg Tablets
(primidone)
Your medicine is available using the name Mysoline 250mg
Tablets but will be referred to as Mysoline throughout this leaflet.
Mysoline Tablets are also available as 50mg strength.

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.
2.
3.
4.
5.
6.

What Mysoline is and what it is used for
Before you use Primidone
How to use Primidone
Possible side effects
How to store Primidone
Further information

1. What Mysoline is and what it is used for
Mysoline contains Mysoline 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
Primidone.


A small number of people being treated with anti-epileptics such
as Mysoline 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.

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.

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

3. How to use Mysoline

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

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.

Taking Mysoline 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 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 Primidone. 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.
Page 1 of 2

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

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 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. 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

5. How to store Mysoline

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

Keep out of the sight and reach of children.

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 anti-epileptic
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

Do not use Mysoline after the expiry date (Exp) printed on the
carton and blister labels. The expiry date refers to the last day of
that month.
Do not store above 25°C.
If your doctor decides to stop the treatment, return any leftover
medicine to the pharmacist. Only keep it if your doctor tells you
to.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return 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 contains

The active substance is primidone.
Each tablet contains 250mg of primidone.

(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.

The other ingredients are: carmellose calcium, gelatin,
magnesium stearate, povidone and stearic acid.

Do not be alarmed by this list of possible events.
You may not have any of them.

PL No: 21828/0553

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.

What Mysoline looks like and contents of the pack
Mysoline are white, round tablets with a break line on one side
and plain on the reverse.
Mysoline is available in packs of 90 tablets.

Manufacturer:

Manufactured by: Laboratorio Farmaceutico SIT s.r.l.,
Via Cavour 70, 27035 Mede (PV), Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX
POM

Leaflet revision and issue date (Ref): 04.05.17
Mysoline® is a registered trademark of SERB.

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

Page 2 of 2

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: Mysoline
250mg Tablets
Reference No: 21828/0553

PACKAGE LEAFLET: INFORMATION FOR THE USER

Primidone Landmark Pharma 250mg Tablets
(primidone)
Your medicine is available using the name Primidone Landmark
Pharma 250mg Tablets but will be referred to as Primidone
throughout this leaflet.
Primidone Tablets are also available as 50mg strength.

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.
2.
3.
4.
5.
6.

What Primidone is and what it is used for
Before you use Primidone
How to use Primidone
Possible side effects
How to store Primidone
Further information

1. What Primidone is and what it is used for
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).

2. Before you use Primidone
Do not take Primidone if you:




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.

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).
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.

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 works, or Primidone may affect the way other
medicines work.

Tell your doctor if you are breast-feeding because Primidone may
cause your baby to be very sleepy.

Driving and using machines

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

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

3. How to use Primidone

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

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.

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.
Page 1 of 2

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.

Epilepsy

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:
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)

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

5. How to store Primidone

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

Keep out of the sight and reach of children.

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 anti-epileptic
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

Do not use Primidone after the expiry date (Exp) printed on the
carton and blister labels. The expiry date refers to the last day of
that month.
Do not store above 25°C.
If your doctor decides to stop the treatment, return any leftover
medicine to the pharmacist. Only keep it if your doctor tells you
to.
If your medicine appears to be discoloured or shows any other
signs of deterioration, please return 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 contains

The active substance is primidone.
Each tablet contains 250mg of primidone.

(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.

The other ingredients are: carmellose calcium, gelatin,
magnesium stearate, povidone and stearic acid.

Do not be alarmed by this list of possible events.
You may not have any of them.

PL No: 21828/0553

Reporting of side effects

What Primidone looks like and contents of the pack
Primidone are white, round tablets with a break line on one side
and plain on the reverse.
Primidone is available in packs of 90 tablets.

Manufacturer:

Manufactured by: Laboratorio Farmaceutico SIT s.r.l.,
Via Cavour 70, 27035 Mede (PV), Italy.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX
POM

Leaflet revision and issue date (Ref): 04.05.17

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.

Page 2 of 2

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call +44 (0) 1302 365000
(Regulatory)
Please be ready to give the
following information:
Product name: Primidone
Landmark Pharma 250mg
Tablets
Reference No: 21828/0553

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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