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PRIMIDONE PHARMARAM 250MG TABLETS

Active substance(s): PRIMIDONE / PRIMIDONE / PRIMIDONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Mysoline® 250 mg Tablets
Primidone Serb 250 mg Tablets
(primidone)
This product is available by any of the above names, but
will be referred to as Primidone in this leaflet.

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 is and what 4. Possible side effects
it is used for
5. How to store Primidone
2. Before you use Primidone
6. Further information
3. How to use Primidone
____________________________________________________
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.

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

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.

Always take Primidone exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

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)

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:

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.

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 than you should
If you take more than your normal dose, contact your doctor or
nearest hospital.
If you forget to take Primidone
If you miss a dose, take it as soon as you remember. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Primidone
Do not stop taking your Primidone, even if you are feeling well,
unless your doctor tells you to. You may have become dependent
on Primidone, and therefore you could get a withdrawal reaction
if you stop treatment too quickly. Primidone treatment should be
reduced gradually to prevent this.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
____________________________________________________
4. POSSIBLE SIDE EFFECTS
Like all medicines, Primidone can cause side effects, although not
everybody gets them.
When first taking Primidone, drowsiness and lack of energy may
occur; these usually pass.
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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme
(Website: www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of
this medicine.
____________________________________________________
5. HOW TO STORE PRIMIDONE
Keep out of the sight and reach of children
Do not store above 25°C.
Do not use Primidone after the expiry date which is stated on the
carton as {EXP MM/YYYY}. The expiry date refers to the last
day of that month.
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 250 mg of
primidone.
The other ingredients are povidone, gelatin, carmellose calcium,
magnesium stearate and stearic acid.
What Primidone looks like and contents of the pack
Primidone tablets are white uncoated tablets with a score line on
one side and plain on the other.
Primidone comes in containers of 30 tablets.
Procured from within the EU and repackaged by the Product
Licence Holder: Pharmaram Limited, Tom Bill Way, Ashby de
la Zouch, LE65 2UY, UK.
Manufacturer

Laboratorio Farmaceutico SIT Srl, Via Cavour, 70 – 27035
Mede (PV), Italy.
PL 33652/0079

Primidone Serb 250 mg Tablets

POM
Leaflet edit date: 21.09.2016

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.
P-PILPRIMSERB250MGX30 (IT) V1

PACKAGE LEAFLET: INFORMATION FOR THE USER

Mysoline® 250 mg Tablets
Primidone Pharmaram 250 mg Tablets
(primidone)
This product is available by any of the above names, but
will be referred to as Primidone in this leaflet.

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 is and what 4. Possible side effects
it is used for
5. How to store Primidone
2. Before you use Primidone
6. Further information
3. How to use Primidone
____________________________________________________
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.

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

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.

Always take Primidone exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.

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)

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:

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.

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 than you should
If you take more than your normal dose, contact your doctor or
nearest hospital.
If you forget to take Primidone
If you miss a dose, take it as soon as you remember. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Primidone
Do not stop taking your Primidone, even if you are feeling well,
unless your doctor tells you to. You may have become dependent
on Primidone, and therefore you could get a withdrawal reaction
if you stop treatment too quickly. Primidone treatment should be
reduced gradually to prevent this.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
____________________________________________________
4. POSSIBLE SIDE EFFECTS
Like all medicines, Primidone can cause side effects, although not
everybody gets them.
When first taking Primidone, drowsiness and lack of energy may
occur; these usually pass.
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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme
(Website: www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety of
this medicine.
____________________________________________________
5. HOW TO STORE PRIMIDONE
Keep out of the sight and reach of children
Do not store above 25°C.
Do not use Primidone after the expiry date which is stated on the
carton as {EXP MM/YYYY}. The expiry date refers to the last
day of that month.
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 250 mg of
primidone.
The other ingredients are povidone, gelatin, carmellose calcium,
magnesium stearate and stearic acid.
What Primidone looks like and contents of the pack
Primidone tablets are white uncoated tablets with a score line on
one side and plain on the other.
Primidone comes in containers of 30 tablets.
Procured from within the EU and repackaged by the Product
Licence Holder: Pharmaram Limited, Tom Bill Way, Ashby de
la Zouch, LE65 2UY, UK.
Manufacturer

Laboratorio Farmaceutico SIT Srl, Via Cavour, 70 – 27035
Mede (PV), Italy.
PL 33652/0079

Primidone Pharmaram 250 mg Tablets

POM
Leaflet edit date: 21.09.2016

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.
P-PILPRIMRAM250MGX30 (IT) V1

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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