PATIENT INFORMATION LEAFLET

PHENOBARBITAL 30mg AND 60mg TABLETS Read all of this leaflet carefully before you start taking this medicine. o Keep this leaflet. You may need to read it again.

o If you have further questions, please ask your doctor or your pharmacist. o 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.

o If any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET

1.    What Phenobarbital is and what it is used for

2.    Before you take Phenobarbital

3.    How to take Phenobarbital

4.    Possible side effects

5.    How to store Phenobarbital

6.    Further information

1. WHAT PHENOBARBITAL IS AND WHAT IT IS USED FOR

Phenobarbital belongs to a group of medicines known as barbiturates.

Phenobarbital is used to treat epilepsy.

In an epileptic fit, excessive electrical activity builds up in the brain. Phenobarbital works by neutralising this excessive electrical activity.

2. BEFORE YOU TAKE PHENOBARBITAL Do NOT take Phenobarbital if you:

o are allergic (hypersensitive) to phenobarbital, other barbiturates or any of the other ingredients in this medicine (see section 6)

o suffer from a rare condition called porphyria (disorder of the red blood pigment haemoglobin that is passed down through families) o have long-term kidney or liver problems o severe breathing difficulty

Take special care with Phenobarbital

A small number of people being treated with anti-epileptics such as Phenobarbital have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately.

Tell your doctor or pharmacist of any medical problems you may have, or have previously had, especially if: o the person taking these tablets is elderly, young, debilitated or suffering from senile dementia o you have a history of drug abuse or alcoholism o you have kidney or liver problems o you have breathing difficulties o you suffer from severe or long term pain

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. It is especially important for your doctor to know if you are already being treated with any of the following medicines:

o Anticoagulants, medicines used to thin the blood (e.g. warfarin)

o Medicines to treat mental illness (e.g. chlorpromazipine, haloperidol, thioridazine, aripiprazole and clonazepam)

o Medicines to treat infections (antibiotics):

o Chloramphenicol, used to treat eye and ear infections o Doxycycline, used to treat infections caused by a wide range of bacteria o Griseofulvin, used to treat fungal infections of the skin

o Metronidazole, used to treat infections of the urinary, genital and digestive system o Rifampicin, a drug used to treat tuberculosis o Telithromycin, used to treat community acquired pneumonia o Itraconazole, posaconazole, voriconazole - used to treat fungal infections

o Systemic steroids, including oral contraceptives (medicine used to prevent pregnancy) - may lead to failure of medication

o Ciclosporin or tacrolimus used in organ and tissue transplants

o Other medicines used to treat epilepsy (e.g. phenytoin, lamotrigine, carbamazepine, sodium valproate, oxcarbazepine, tiagabine, primadone, zonisamide, vigabatrin and ethosuximide) o Medicines used to treat depression (e.g. mianserin, paroxetine)

o Medicines used to treat heart trouble (e.g. nifedipine, felodipine, verapamil, nimodipine, isradipine, diltiazem, metoprolol, timolol and propranolol)

o Medicines used to help your breathing (e.g. theophylline, montelukast) o Levothyroxine and liothyronine, used to treat disorders of the thyroid gland o The herbal remedy St John’s wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take St John’s wort, consult your doctor before stopping the St John’s wort preparation.

o Antiviral medicines used in the treatment of HIV (e.g. abacavir, amprenavir, darunavir, nelfinavir, indinavir, saquinavir and lopinavir)

o Medicines used to treat heart problems (e.g. disopyramide, quinidine, eplerenone and digitoxin)

o High doses of folic acid o Irinotecan or etopside (to treat some cancers) o Toremifene, used to treat breast cancer o Gestrinone, used for the treatment of endometriosis

o Tibolone, used for hormone replacement therapy in post-menopausal women o Tropisetron and aprepitant, used to treat nausea and vomiting following chemotherapy o Methadone, used for severe pain and drug addiction

o Memantine, used to treat dementia (condition causing gradual loss of brain function) o Methylphenidate, to treat attention deficit disorder (syndrome characterised by learning and behavioural problems)

o Sodium oxybate, to treat narcolepsy (sleep disorder causing recurrent episodes of sleep occurring throughout the day)

o Vitamin D (requirements may be increased) o Steroids such as hydrocortisone or prednisolone

Using Phenobarbital with food and drink

Do not drink alcohol while taking this medicine without first talking to your doctor.

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant you should speak to your doctor before taking Phenobarbital. If you become pregnant while taking Phenobarbital your doctor will decide if you should continue taking this medicine or whether another would be more suitable during pregnancy. Do not stop taking phenobarbital until you have seen your doctor, as it is important to control fits.

If taken during pregnancy (particularly in the first 3 months and the last 3 months), Phenobarbital may cause birth defects. It may also cause problems with bleeding in your baby when it is born. However, your doctor may decide that it is very important that you continue taking Phenobarbital. Your doctor will explain the risks to you.

Check with your doctor before taking folic acid supplements. Folic acid may interact with Phenobarbitol tablets, your doctor may need to adjust your dose.

As Phenobarbital is released into breast milk, this may harm the baby and therefore, breast-feeding is not advisable.

Driving and using machines

Phenobarbital may make you feel drowsy. Do not drive or operate machinery if you feel drowsy when you start to take this medicine.

Important information about some of the ingredients of Phenobarbital

Phenobarbital contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Phenobarbital 60mg Tablets contain the colour sunset yellow (E110). This may cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

Blood and urine tests

If you are having blood or urine tests tell the doctor or nurse that you are taking Phenobarbital Tablets as Phenobarbital may affect the results of these tests.

3. HOW TO TAKE PHENOBARBITAL

Swallow the tablets with a drink of water.

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

Adults

The usual dose is 60mg -180mg daily, taken at night.

Children

If this medicine is prescribed for a child make sure that the tablets are taken as stated on the pharmacist's label. The usual dose is 5mg-8mg per kg of bodyweight per day.

Elderly

Your doctor may prescribe a lower dose.

If you take more Phenobarbital than you should

The symptoms of an overdose may include drowsiness, difficulty breathing, low blood pressure, low body temperature (hypothermia), speech problems, jerky movements, jerky eye movements, loss of inhibition, reduced reflex response and coma.

If you or anyone else has swallowed a lot of the tablets all together contact your nearest hospital casualty department or doctor immediately.

If you forget to take Phenobarbital

If you forget to take a dose, take it as soon as you remember, then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Phenobarbital

Do not stop taking Phenobarbital unless your doctor tells you to. If you stop taking Phenobarbital suddenly or before your doctor tells you to, there is an increased risk of seizures. You may develop withdrawal effects such as sleeplessness, anxiety, tremor, dizziness, feeling sick, fits and delirium. Always speak to your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines Phenobarbital can cause side effects, although not everybody gets them.

If you experience any of the following contact your doctor IMMEDIATELY:

o Allergic reactions e.g. fever, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, skin rashes.

o A yellowing of your skin or the whites of your eyes, which may be signs of hepatitis (inflammation of the liver) or cholestasis (damaged bile system),

o potentially life-threatening skin rashes such as erythema multiforme (skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet), Sevens-Johnson syndrome (blistering or bleeding of the skin around the lips, eyes, mouth, throat, nose or genitals and conjunctivitis (red and swollen eyes). Rashes may progress to widespread blistering/peeling of the skin. Also flu-like symptoms and fever), toxic epidermal necrolysis (severe blistering rash, peeling of the skin, raw exposed skin. Feeling generally unwell, fever, chills and aching muscles). The highest risk of developing serious skin reactions occurs within the first two weeks of treatment

You must not be re-started on Phenobarbital tablets at any time if you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Phenobarbital tablets.

Tell your doctor as soon as possible if you have any of the following side effects:

o Restlessness, difficulty in concentrating in the elderly, unusual excitement, depression, memory impairment, hallucinations (seeing or hearing things that are not real). o Hyperactivity, changes in behaviour in children, jerky movements, jerky eye movements, drowsiness, lack of energy o Hypotension - low blood pressure o Difficulty breathing

o Changes in the amount or need to pass water

o Anaemia, altered numbers and types of blood cells. If you notice increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want to perform a blood test. o Bone softening and bone disease

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.If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting 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 at 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 PHENOBARBITAL

Do not use Phenobarbital after the expiry date stated on the pack. The expiry date refers to the last day of that month.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 25°C. Keep the container tightly closed. Store in the original container. 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 Phenobarbital contains

The active substance is phenobarbital.

The other ingredients are maize starch, lactose monohydrate, sodium lauryl suphate, sodium starch glycolate, magnesium stearate and stearic acid.

The 60mg tablets contain the colour sunset yellow E110.

What Phenobarbital looks like and the contents of the pack

Phenobarbital 30mg Tablets are white, circular tablets. Each tablet contains 30mg of phenobarbital, the active ingredient.

Phenobarbital 60mg Tablets are pale, orange, circular tablets. Each tablet contains 60mg of phenobarbital, the active ingredient.

The tablets are available in packs of 28 and 1,000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, WA8 0RP, UK.

PL 20395/0112 and PL 20395/0113 This leaflet was last revised in