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Active substance(s): PRIMIDONE

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Primidone Auden 50 mg & 250 mg Tablets


PL 17507/0251 & 250

ITEM / SIZE: Generic package leaflet / 147 mm (h) x 250 mm (w) [flat]


ITERATION: Version 4; 22/04/2015



Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
In this leaflet:

1. What PRIMIDONE is and what it is used for
2. What you need to know before you take PRIMIDONE Tablets
3. How to take PRIMIDONE Tablets
4. Possible side effects
5. How to store PRIMIDONE Tablets
6. Contents of the pack and other information

1. What PRIMIDONE is and what it is used for
Primidone Tablets 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. What you need to know before you take
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
• Have porphyria (a rare inherited disorder of metabolism)
or anyone in your family has it.
Special Precautions
Check with your doctor or pharmacist before taking your
medicine if any of the following applies to you:
• Have ever had problems with your breathing, kidneys or
• 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. If you are not sure if any
of the above applies to you, talk to your doctor or
pharmacist before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including medicines
obtained without a prescription. Taking some medicines
together can be harmful.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines:
• 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,
• Antiviral medicines (such as nelfinavir)
• Asthma medicines (such as theophylline, montelukast)

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• Hormone containing medicines (such as the oral
contraceptive pill)
• Medicines used to treat high blood pressure or heart
conditions (such as betablockers, digitoxin, losartan,
nimodipine, quinidine)
• Cyclosporin (used to prevent rejection of an organ
transplant and also for other diseases of the body’s
immune system)
• Medicines used to treat mental health problems or
depression (such as cloazepine, lamotrigine, mianserin,
tricyclic antidepressants)
• Steroid-containing medicines
• Medicines used to treat cancer (such as cyclophosphamide,
• 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
Primidone may increase the toxic effect on the liver of an
overdose of paracetamol.
If you are unsure of the types of medicines you are taking,
ask your doctor or pharmacist.
Taking PRIMIDONE with food and drink
Alcohol can react with Primidone. Ask your doctor for
advice if you want to drink alcohol.
Pregnancy and breast feeding
Ask your doctor for advice before taking any medicine.
The use of Primidone in pregnancy is associated with an
increased risk of abnormalities in babies. Therefore, you
must tell your doctor if you are pregnant, or trying to
become pregnant because Primidone has the potential to
harm your unborn child.
Pregnant women can have reduced folic acid in their blood
whilst taking Primidone. In addition, the new born child may
develop withdrawal symptoms if the mother has taken
Primidone in the late stages of pregnancy. Blood clotting
problems have occurred occasionally in children born to
women who were previously taking anticonvulsant drugs.
Tell your doctor if you are breast-feeding because Primidone
may cause your baby to be very sleepy.
Driving and using machines
Primidone can make you feel sleepy. If so, do not drive or
operate machinery.
Important information about some of the
ingredients of PRIMIDONE
This product contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, please
contact your doctor before taking this medicinal product.

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3. How to take PRIMIDONE Tablets
Always take this medicine exactly as your doctor or
pharmacist has told you.You should check with them 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.
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
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):
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:
Do not take more tablets than stated on the label of your
medicine. If you take too many tablets you should seek
medical attention immediately, either by calling your doctor,
or going to the nearest casualty department. Always take the
labelled medicine container with you, even if there are no
tablets left.
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 your medicine:
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 have side effects, although
not everybody gets them.
When first taking Primidone, drowsiness and lack of energy
may occur; these usually pass.
Common side effects (affecting fewer than 1 in every
10 people)
• Disturbances of vision
• Dizziness
• Jerky movements
• Rolling of the eyes
Uncommon side effects (affecting fewer than 1 in every
100 people)
• Nausea and vomiting
• Headache
• Skin rash
Rare side effects (affecting fewer than 1 in every
1000 people)
• Joint or bone pain
• Changes in mood or behaviour

• S evere 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
 evelopment 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
 aised levels of enzymes in your liver
Do not be alarmed by this list of possible events.You may
not have any of them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet.You can also report side effects directly via the
United Kingdom Yellow Card Scheme, Website: www.mhra. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store PRIMIDONE Tablets
Keep out of the sight and reach of children.
Do not use Primidone Tablets after the expiry date on the
carton and blister as [EXP XX/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. Contents of the pack and other information
What PRIMIDONE contains:
Each tablet contains either 50 mg or 250 mg of primidone
as the active ingredient.
The tablets also contain lactose monohydrate,
microcrystalline cellulose, sodium starch glycolate (type A),
povidone K 30, sodium laury sulfate, colloidal anhydrous
silica, stearic acid and magnesium stearate.
What PRIMIDONE looks like and contents of
the pack:
Primidone Auden 50 mg Tablets are white to off white,
circular uncoated tablets, diameter 6 mm with ‘PR’
embossed on one side of the break line and ‘50’ on the
other side of the break line.
Primidone Auden 250 mg Tablets are white to off white,
circular uncoated tablets, diameter 11.5 mm with ‘PR’
embossed on one side of the break line and ‘250’ on the
other side of the break line.
Primidone Auden tablets are available in boxes of 100 tablets.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House,
Bury Street Ruislip, Middlesex, HA4 7TL, UK
Tiofarma, Benjamin Franklinstraat 9,
3261 LW Oud-Beijereland, Netherlands
This leaflet was last revised in January 2015.

For information in large print,
on tape, on CD or in Braille,
phone +44 (0)1895 627 420.


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22/04/2015 10:05

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Source: Medicines and Healthcare Products Regulatory Agency

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