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PACKAGE LEAFLET: INFORMATION FOR THE USER Phenobarbital Bristol Labs 15mg Tablets Phenobarbital Bristol Labs 30mg Tablets Phenobarbital Bristol Labs 60mg 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. 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.

What is in this leaflet:

1.    What Phenobarbital tablets are and what they are used for

2.    What you need to know before you take Phenobarbital tablets

3.    How to take Phenobarbital tablets

4.    Possible side effects

5.    How to store Phenobarbital tablets

6.    Contents of the pack and other information

1. What Phenobarbital tablets are and _what they are used for_

The name of your medicine is Phenobarbital 15mg or 30mg or 60mg tablets. The active substance is Phenobarbital.

Phenobarbital tablets belong to a group of medicines called barbiturates. These medicines reduce brain activity which would otherwise cause fits or seizures in epilepsy, except absence seizures (day dreaming).

2. What you need to know before you take _Phenobarbital tablets_

Do not take Phenobarbital tablets and tell your

doctor:

•    If you have an allergy (hypersensitivity) to phenobarbital, other barbiturates or any of the other ingredients (listed in section 6)

•    If you suffer from porphyria (a genetic or inherited disorder of the red blood pigment haemoglobin)

•    If you have severe breathing difficulties

•    If you have severe kidney or liver disease.

•    Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenobarbital tablets, 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 with the use of phenobarbital, you must not be re-started on Phenobarbital at any time.

•    If you develop a rash or these skin symptoms, stop taking Phenobarbital tablets, seek urgent advice from a doctor and tell him that you are taking this medicine.

Warnings and precautions

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, immediately contact your doctor.

Talk to your doctor or pharmacist before taking phenobarbital tablets if you:

•    or the person taking these tablets are young, run down, senile or have a history of drug abuse or alcoholism

•    have kidney or liver problems

•    have breathing difficulties

•    have severe or long term pain.

Other medicines and Phenobarbital tablets

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Especially:

•    disopyramide and quinidine (to treat irregular heartbeats)

•    chloramphenicol, doxycycline, metronidazole, rifampicin, telithromycin, griseofulvin, itraconazole, posaconazole, voriconazole, abacavir, amprenavir, lopinavir, indinavir, darunavir, nelfinavir and saquinavir (to treat infections)

•    medicines used to thin the blood such as warfarin

•    mianserin, paroxetine, MAOI or tricyclic antidepressants or St Johns's wort (Hypericum perforatum) a herbal remedy (to treat depression)

•    oxcarbazepine, primidone, phenytoin, sodium valproate, carbamazepine, lamotrigine, tiagabine, zonisamide, ethosuxamide and vigabatrin (to treat epilepsy)

•    chlorpromazine, thioridazine, haloperidol, aripiprazole and clonazepam (to treat mental illness)

•    isradipine, felodipine, verapamil, diltiazem, nimodipine, nifedipine, metoprolol, timolol and propranolol (to treat high blood pressure)

•    digitoxin or eplerenone (to treat certain heart conditions)

•    ciclosporin or tacrolimus (to prevent organ transplant rejection)

•    steroids such as hydrocortisone or prednisolone

•    folic acid or vitamin D (supplements)

•    toremifene, gestrinone, irinotecan or etoposide (to treat some cancers)

•    methadone (used in severe pain or drug addiction)

•    oral contraceptives (talk to your doctor about the best method of contraception for you) or tibolone (female hormone)

•    levothyroxine (thyroid hormone)

•    montelukast or theophylline (to treat asthma)

•    tropisetron and aprepitant (to treat nausea and vomiting)

•    memantine (to treat dementia)

•    methylphenidate (to treat attention deficit disorder)

•    sodium oxybate (to treat narcolepsy).

Pregnancy, breast-feeding and fertility

Pregnancy

•    Your doctor should discuss the possible effects of Phenobarbital tablets on the unborn child and the risks and benefits of treatment should be considered carefully.

•    Check with your doctor before taking folic acid supplements as they interact with Phenobarbital tablets, your doctor may need to adjust your dose.

Breast-feeding

•    If you are taking Phenobarbital tablets, do not

breastfeed, as the medicine will pass into the breast milk and may harm the baby.    s

Phenobarbital with food and drink and alcohol I

•    You are advised not to drink alcohol whilst

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taking these tablets as it may interfere with the action of Phenobarbital.

Driving and using machines

•    Phenobarbital tablets may make you feel less alert than normal. Make sure you are not affected before driving or operating machinery.

Phenobarbital tablets contains Lactose

•    If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

Tests

•    If you see another doctor or go into hospital or need

a blood or urine test, let them know what medicines you are taking as Phenobarbital tablets may interfere with the results._

|    3. How to take Phenobarbital Tablets |

•    Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    The tablets should be swallowed with a drink of water at the same time each day.

The usual dose is:

Adults and children over 12 years

•    60mg to 180mg daily taken at night.

Children under 12 years

•    Your doctor will calculate the appropriate dose based on the child's body weight

Elderly

•    Your doctor may prescribe a lower dose.

If you take more of Phenobarbital tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include

drowsiness, speech problems,jerky movements,jerky eye movements, loss of inhibition, reduced reflex response, low body temperature, low blood pressure and breathing problems.

If you forget to take Phenobarbital tablets Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. If you stop taking Phenobarbital tablets If you stop taking the tablets you may develop withdrawal effects such as sleeplessness, anxiety, tremor, dizziness, feeling sick, fits and delirium.

|    4. Possible Side Effects    |

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

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    Allergic reaction: skin rash, fever, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

•    Blood: 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.

•    Metabolism and nutrition: bone softening and bone disease.

There have been reports of decreased bone mineral density, osteopenia, osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term anti-epileptic medication, have a history of osteoporosis, or take steroids.

•    Mental health: restlessness and confusion in the elderly, unusual excitement, depression, memory impairment, hallucinations.

•    Nervous system: hyperactivity, behavioural disturbances in children,jerky movements, jerky eye

movements, drowsiness, lethargy.

•    Heart: low blood pressure.

•    Lungs: difficulty breathing.

•    Liver: inflammation of the liver (hepatitis), damaged bile system (cholestasis). Seen as yellowing of skin and whites of eyes.

•    Kidneys: changes in the amount or need to pass water.

•    Skin: rashes, erythema multiforme (circular, irregular red patches), lumps in the armpit or groin.

very rare: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2) Reporting of side effects Ifyou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safely of this medicine.

| 5. How to store Phenobarbital tablets |

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package.

•    Do not use this medicine after the expiry date (EXP.) which is stated on the carton. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other

_information_

What Phenobarbital tablets contain

•    The active substance is Phenobarbital.

•    The other ingredients are pregelatinised maize starch, lactose, maize starch, stearic acid, purified water.

What Phenobarbital tablets look like and contents of the pack

•    Phenobarbital 15mg, 30mg and 60mg tablets are smooth unmottled tablets showing no evidence of chipping or capping; free from specks and extraneous matter; odorless.

•    Phenobarbital 15mg Tablets are available in pack of 28 tablets.

•    Phenobarbital 30mg Tablets are available in pack of 28 tablets.

•    Phenobarbital 60mg Tablets are available in pack of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Name and address:    Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Phenobarbital Bristol Labs 15mg Tablets,

PL 17907/0175

Phenobarbital Bristol Labs 30mg Tablets,

PL 17907/0176

Phenobarbital Bristol Labs 60mg Tablets,

PL 17907/0177

This leaflet was last revised in October 2014 To request a copy of this leaflet in Braille, large print or audio format, please contact the license holder at the address (or telephone, fax, email) above. |

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