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ARTWORK INFORMATION:

V.

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.

In this leaflet:    I.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 PRIMIDONE Tablets

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.

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 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. 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, 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 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, 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.

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.

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:

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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

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•    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.

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. gov.uk/yellowcard. 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

Manufacturer:

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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Auden Mckenzie

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