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PRIMIDONE AUDEN 250 MG TABLETS

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Product
Artwork

Primidone Auden 50mg & 250mg Tablets

PIL Code

A1000397/1

Date started

PIL

Version

001

AW/V

13.02.2012

001/v4 (DS) 03.12.2013

MP-AUD/GH-DS

Author

Finished folded size: 250mm(h) x 147mm (w)

Notes

147mm

PATIENT INFORMATION LEAFLET

PRIMIDONE AUDEN 50 MG & 250 MG TABLETS
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 leaflet.

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.
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
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

• Severe skin reactions affecting large portions of your body
including redness, pain, ulcers, blisters, shedding the outer
layer of skin or involvement of lips or the lining of the mouth,
nostrils or ears (e.g. toxic epidermal necrolysis, StevensJohnson syndrome)
• A disease called lupus erythematosus which causes
inflammation of various parts of the body including the skin,
joints, lungs, kidneys, heart, and liver
• Development of Dupuytren’s contracture (a thickening of
fibrous tissue in the palm of the hand that causes one or
more fingers to draw back)
• Abnormalities of the blood cells; if you notice a pale
appearance of your skin, abnormal bleeding or tendency to
bruising, fever or sore throat please consult your doctor
• Raised levels of enzymes in your liver
Do not be alarmed by this list of possible events. You may not
have any of them.
If any of the above side effects are troublesome or last more
than a few days or if you notice any side effects not mentioned in
this leaflet, please inform your doctor or pharmacist.
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.

250mm

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
• Medicines used to treat high blood pressure or heart
1. What PRIMIDONE is and what it is
conditions (such as betablockers, digitoxin, losartan,
used for
nimodipine, quinidine)
Primidone Tablets belongs to a group of medicines used to treat
• Cyclosporin (used to prevent rejection of an organ
seizures.
transplant and also for other diseases of the body’s immune
system)
Primidone is used for the treatment of certain types of epilepsy,

Medicines
used to treat mental health problems or
seizures (fits) or shaking attacks (essential tremor).
depression (such as cloazepine, lamotrigine, mianserin,
2. What you need to know before you take
tricyclic antidepressants)
• Steroid-containing medicines
PRIMIDONE Tablets
• Medicines used to treat cancer (such as cyclophosphamide,
Do not take PRIMIDONE if you:
etoposide)
• Are allergic (hypersensitive) to primidone, a substance called
• Granisetron (used to treat severe nausea and vomiting)
phenobarbitone, or to any of the other ingredients of
• Medicines used during an anesthetic for surgery (such as
Primidone (these are listed in Section 6: Further information).
rocuronium, vecuronium)
• Have porphyria (a rare inherited disorder of metabolism) or
• Medicines containing morphine, or similar medicines called
anyone in your family has it.
opiates
Special Precautions
Primidone may increase the toxic effect on the liver of an
Check with your doctor or pharmacist before taking your
overdose of paracetamol.
medicine if any of the following applies to you:
• Have ever had problems with your breathing, kidneys or liver. If you are unsure of the types of medicines you are taking, ask
• Are pregnant or are trying to become pregnant (see beneath your doctor or pharmacist.
for further information)
Taking PRIMIDONE with food and drink
If you go into hospital, tell the medical staff that you are taking
Alcohol can react with Primidone. Ask your doctor for advice if
Primidone.
you want to drink alcohol.
A small number of people being treated with anti-epileptics such
as primidone have had thoughts of harming or killing themselves. Pregnancy and breast feeding
Ask your doctor for advice before taking any medicine.
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 The use of Primidone in pregnancy is associated with an
to your doctor or pharmacist before taking this medicine.
increased risk of abnormalities in babies. Therefore, you must tell
your doctor if you are pregnant, or trying to become pregnant
Taking other medicines
because Primidone has the potential to harm your unborn child.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
Pregnant women can have reduced folic acid in their blood whilst
prescription. Taking some medicines together can be harmful.
taking Primidone. In addition, the new born child may develop
withdrawal symptoms if the mother has taken Primidone in the
In particular, tell your doctor or pharmacist if you are taking any
late stages of pregnancy. Blood clotting problems have occurred
of the following medicines:
occasionally in children born to women who were previously
• Other medicines used to treat epilepsy and other types of
taking anticonvulsant drugs.
seizures (such as phenytoin, felbamate, sodium valproate,
carbamazepine, ethosuxamide, oxcarbazepine, tiagabine,
Tell your doctor if you are breast-feeding because Primidone
topiramate, zonisamide)
may cause your baby to be very sleepy.
• Anticoagulants to prevent blood clots (such as warfarin)
• Barbiturates (such as sleeping tablets)
Driving and using machines
• Methadone (used to treat severe pain, cough, or as a
Primidone can make you feel sleepy. If so, do not drive or
substitute for morphine addiction)
operate machinery.
• Herbal remedies containing St John’s Wort
• Antibiotics (such as chloramphenicol, metronidazole,
Important information about some of the ingredients of
doxycycline)
PRIMIDONE
• Antiviral medicines (such as nelfinavir)
This product contains lactose. If you have been told by your
• Asthma medicines (such as theophylline, montelukast)
doctor that you have an intolerance to some sugars, please
• Hormone containing medicines (such as the oral
contact your doctor before taking this medicinal product.
contraceptive pill)
In this leaflet

147mm

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 lauryl 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
Manufacturer:
Tiofarma, Benjamin Franklinstraat 9,
3261 LW Oud-Beijereland, Netherlands
This leaflet was last approved in November 2013.

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

A1000397/1

Auden Mckenzie

© Auden Mckenzie (Pharma Division) Ltd,
Mckenzie House, Bury Street,
Ruislip, Middlesex HA4 7TL.
Tel: 01895 627 420
info@audemmckenzie.com

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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