PRIMBITAL 50 MG TABLETS - patient leaflet, side effects, dosage

PACKAGE LEAFLET

PRIMBITAL 50 MG & 250 MG TABLETS

(Primidone)

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:

• 1. What primidone is and what it is used for

• 2. What you need to know before you take primidone

• 3. How to take primidone

• 4. Possible side effects

• 5. How to store primidone

• 6. Contents of the pack and other information

1. what primidone is and what it is used for

Primidone belongs to a group of medicines used to treat seizures.

Primidone is used for the treatment of certain types of epilepsy and seizures (fits)

2. what you need to know before you take primidone 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.

Special warnings & precautions of use

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis or DRESS syndrome) have been reported with the use of primidone, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes).

These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome, or toxic epidermal necrolysis or DRESS syndrome with the use of primidone or any other medicine containing phenobarbital, you must not be restarted on these medicines at any time.

If you develop a rash or these skin symptoms, stop using primidone and seek immediate advice from a doctor and tell him that you are 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

If taken during pregnancy, primidone can cause serious birth defects and can affect the way in which the child develops as it grows. Birth defects which have been reported in studies include cleft lip (split in the top lip) and cleft palate (split in the roof of the mouth) and heart abnormalities. Other birth defects have also been reported, such as malformation of the penis (hypospadias), smaller than normal head size, facial, nail and finger abnormalities. If you take primidone during pregnancy you have a higher risk than other women of having a child with birth defects that require medical treatment. In the general population, the baseline risk of major malformations is 2–3%. This risk is increased by about 3 times in women taking phenobarbital.

Babies born to mothers using primidone during pregnancy may also be at increased risk of being smaller than expected.

Neurodevelopmental disorders (delays in development due to disorders in brain development) have been reported among children exposed to primidone during pregnancy. Studies on the risk of neurodevelopmental disorders remain contradictory.

Primidone should not be used during pregnancy unless nothing else works for you.

Talk to your doctor immediately if you are pregnant. Your doctor should discuss the possible effects of primidone tablets on the unborn child and the risks and benefits of treatment should be considered carefully. Do not stop taking primidone until you have discussed this with your doctor, as stopping the medication abruptly may increase the risk of developing seizures, which may have harmful effects on you and the unborn child.

If you have taken primidone during the last third of the pregnancy, appropriate monitoring should be conducted to detect potential disorders in the newborn, such as seizures, excessive crying, muscle weakness, sucking disorders.

Woman of child-bearing potential/Con­traception

If you are a woman of childbearing age you should use effective contraception during treatment with primidone and for two months after treatment. Primidone may affect how hormonal contraceptives, such as the contraceptive pill, work and make them less effective at preventing pregnancy. Talk to your doctor, who will discuss with you the most suitable type of contraception to use while you are taking primidone.

If you are a woman of childbearing age and are planning a pregnancy, talk to your doctor before you stop contraception and before you become pregnant about switching to other suitable treatments in order to avoid exposing the unborn baby to primidone.

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 Primbital Tablets

This medicine 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.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take primidone

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:

Elderly / Patients with low physical strength:

Lower doses may be prescribed.

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 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 primidonel, drowsiness and lack of energy may occur; these usually pass.

Common (may affect up to 1 in 10 people)

• Disturbances of vision
• Dizziness
• Jerky movements
• Rolling of the eyes

Uncommon (may affect up to 1 in 100 people)

• Nausea and vomiting
• Headache
• Skin rash

Rare (may affect up to 1 in 1,000 people)

• Joint or bone pain
• Changes in mood or behaviour
• 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

Very rare (may affect up to 1 in 10,000 people)

• Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2)

Not known (frequency cannot be estimated from the available data)

• Potentially life-threatening skin rashes (drug reaction with eosinophilia and systemic symptoms) have been reported (see section 2).

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 Yellow Card Scheme website at: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 use Primbital 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 informationeach 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 Primbital Tablets look like and contents of the pack:

Primbital 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.

Primbital 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.

Primbital tablets are available in boxes of 100 tablets.

Marketing authorisation holder:

TEVA UK Limited,

Eastbourne,

BN22 9AG,

UK

Manufacturer:

Tiofarma

Benjamin Franklinstraat 9

3261 LW Oud-Beijereland

Netherlands

This leaflet was last revised in August 2021.

PL 00289/2326

PL 00289/2327