PHENOBARBITAL PIL:0048490415-02 180 X 297MM 4	43/15 12:09 PM Page 1
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Patient information leaflet

PHENOBARBITAL PHARMVIT 30MG & 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, pharmacist or nurse.

•    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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Phenobarbital is and what it is used for

2.    What you need to know before you take Phenobarbital

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 is and what it is used for

Phenobarbital belongs to a group of drugs known as barbiturates. Phenobarbital is used to treat all forms of epilepsy except absence seizures. In an epileptic fit excessive electrical activity builds up in the brain. Phenobarbital works by neutralising this excessive electrical activity.

2. What you need to know before you take Phenobarbital

DO NOT TAKE these tablets if you:

•    have previously suffered an allergic reaction to a medicine containing Phenobarbital or other barbiturates

•    are allergic to any of the other ingredients in this medicine (see section 6)

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

•    have long-term kidney or liver problems

•    have difficulty breathing

Warnings and precautions

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

•    are young, run down, senile

•    have a history of drug abuse or alcoholism

•    have kidney or liver problems

•    have breathing difficulties

•    have severe or long-term pain

If you develop a rash or the following skin symptoms, seek immediate advice from a doctor and tell him or her that you are taking this medicine:

•    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 ulcer 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 rashes 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 use of Phenobarbital tablets you must not be restarted on Phenobarbital tablets at anytime.

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.

Other medicines and Phenobarbital

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially:

•    anticoagulants, medicines used to thin the blood (e.g. warfarin)

•    chloramphenicol, an antibiotic used to treat eye and ear infections

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

•    griseofulvin, a drug used to treat fungal infections of the skin

•    systemic steroids including oral contraceptives (talk to your doctor about the best method of contraception for you) or tibolone (hormone replacement treatment)

•    ciclosporin or tacrolimus, which are used in organ and tissue transplants

•    other medicines used to treat epilepsy, e.g. oxcarbazepine, primidone, phenytoin, lamotrigine, carbamazepine, sodium valproate, tiagabine, zonisamide, ethosuxamide and vigabatrin

•    phenylbutazone, which is used to treat a painful condition of the spine

•    rifampicin, a drug used to treat tuberculosis

•    phenothiazines, chlorpromazine, thioridazine, haloperidol, aripiprazole and clonazepam which are used to treat psychiatric disorders

•    mianserin, paroxetine, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants or the herbal remedy St John’s wort (all used to treat depression), should not be taken at the same time as this medicine. If you already take St John’s wort (Hypericum perforatum), consult your doctor before stopping the St John’s wort preparation

•    medicine used to treat heart trouble or high blood pressure, e.g. nifedipine, felodipine, isradipine, verapamil and nimodipine, diltiazem, metoprolol, timolol and propranolol

•    digitoxin or eplerenone, disopyramide, quinidine (to treat certain heart conditions)

•    thyroxine and levothyroxine, which is used to treat a disorder of the thyroid gland

•    steroid such as hydrocortisone or prednisolone

•    folic acid or vitamin D (supplements)

•    tormifene, gestronone, irinotecan or etoposide (to treat some cancer)

•    methadone (used in severe pain or drug addiction)

•    montelukast or theophylline (to treat asthma)

•    tropisetron and aprepitant (to treat nausea and vomiting)

•    sodium oxybate (to treat narcolepsy)

•    methylphenidate (to treat Attention Deficit Hyperactivity Disorder)

•    memantine (to treat dementia)

Do not drink alcohol while taking this medicine without

asking 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 whilst 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 your 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.

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.

As with all women, adequate supplements of folic acid should be taken before conception and during pregnancy.

As Phenobarbital is released into breast milk this may make your baby sleepy and therefore breast feeding is not advisable.

Driving and using machines

If you feel drowsy after taking this medicine, DO NOT drive or operate machinery until this effect has worn off.

Phenobarbital tablets contain lactose and colour sunset yellow (E110)

If you have been told by your doctor that you have an intolerance to some sugars, contact them before taking this medicine, as it contains lactose.

The colour sunset yellow (E110) in the 60 mg tablets may cause allergic-type reactions including asthma.

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 has told you. The pharmacist’s label should tell you how much to take and how often. Check with your doctor if you are not sure. Swallow the tablets with a glass of water at the same time each day.

The usual doses are:

Adults - The usual dose is 60 to 180 mg 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 5 to 8 mg per kg of bodyweight per day.

Elderly - Your doctor may prescribe a lower dose.

If you take more tablets than you should

If you or anyone else has swallowed a lot of the tablets all together contact your nearest hospital casualty department or doctor immediately. Signs of an overdose include drowsiness, speech problems, jerky movements, and jerky eye movements, loss of inhibition, reduced reflex response, low body temperature, low blood pressure and breathing problems.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, but do not take two doses together. Then go on as before.

If you stop taking the tablets

Do not stop taking the tablets suddenly, if you stop taking the tablets you may develop withdrawal effects such as sleeplessness, anxiety, tremor, dizziness, feeling sick, fits and delirium.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Serious effects: tell your doctor straight away if the

following happens:

•    allergic reaction: skin eruptions, fever, swelling of face, lips, tongue or throat, or difficulties in breathing or swallowing

•    blood: reduced numbers and types of blood cells and platelets (anaemia). If you notice pale skin, weakness or breathlessness, increased bruising, nosebleeds, sore throats or infections, you should tell your doctor who may want to perform a blood test

•    liver: inflammation of liver (hepatitis), reduced flow of bile from the gall bladder (cholestasis), yellowing of your skin or the whites of your eyes

•    skin: rashes, erythema multiforme (circular, irregular red patches), lumps in the armpits or groin area. Potentially life threatening skin rashes (Stevens-Johnson syndrome -severe skin rashes with flushing, fever, blisters or ulcers and toxic epidermal necrolysis - severe rash involving reddening, peeling and swelling of the skin that resembles severe burns) have been reported very rarely

The following side effects are usually mild and may disappear with continued treatment. If they are severe or last longer than a few days you should tell your doctor.

•    nervous system: hyperactivity, behavioural disturbances in children, unsteady walking, jerky eye movement, visual disorders, lack of energy, drowsiness

•    metabolism and nutrition: bone softening and bone disease (rickets). There have been reports of bone disorders including osteopenia (thinning of the bones) and osteoporosis (loss of bone mass) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids

•    mental health: restlessness and confusion in elderly, unusual excitement, depression, hallucination (sensing things that are not real), memory problems, difficulty in concentrating, changes in behaviour

•    heart: low blood pressure

•    lungs: difficulty breathing

•    kidneys: changes in the amount or need to pass water

•    anticonvulsant hypersensitivity syndrome characterised by fever, rash, swollen lymph nodes and other multi-organ failure

Reporting of side effects

If you 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 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 tablets

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

•    Do not use this medicine after the expiry date stated on the label after ‘EXP’. The expiry date refers to the last day of that month.

•    Do not store above 25°C.

•    Keep the container tightly closed.

•    Store in the original container.

•    The tablets are sensitive to moisture and light.

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.

What Phenobarbital tablets contain

The active ingredient is 30mg or 60mg of Phenobarbital.

The other ingredients are maize starch, lactose monohydrate, sodium lauryl sulphate, sodium starch glycollate, magnesium stearate and stearic acid. The 60 mg tablets contain the colour sunset yellow E110.

See end of section 2 for further information on lactose and colour sunset yellow (E110).

What Phenobarbital tablets look like and contents of the pack

•    Phenobarbital 30mg tablets are white, circular tablets embossed PV on one side and P over 30 on the other.

•    Phenobarbital 60mg tablets are pale orange, circular tablets embossed PV on one side and P over 60 on the other.

•    Phenobarbital tablets are available in pack sizes of 28 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Pharmvit Ltd, 177 Bilton Road, Perivale,

Greenford, Middlesex UB6 7HQ.

Telephone: 0208 997 5444 Fax:    0208 997 5433

To request a copy of this leaflet in large print or audio format or additional copies, please contact the licence holder at the address (or telephone, fax) above.

PL 4556/0048 & PL 4556/0049

Reference: 0048490415/02 Date leaflet last revised: April 2015