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Active substance(s): PHENOBARBITAL

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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 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).

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2. What you need to know before you take
Phenobarbital tablets
Do not take Phenobarbital tablets and tell your
• 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 (StevensJohnson 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
Warnings and precautions
A small number of people being treated with
anti-epileptics such as Phenobarbital have had thoughts

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

• digitoxin or eplerenone (to treat certain heart
• 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
• 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
• sodium oxybate (to treat narcolepsy).
Pregnancy, breast-feeding and fertility
• 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.
• If you are taking Phenobarbital tablets, do not
breastfeed, as the medicine will pass into the breast
milk and may harm the baby.
Phenobarbital with food and drink and alcohol
• You are advised not to drink alcohol whilst


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24 mm

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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
• 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
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
• 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
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 theYellow Card Scheme at:
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
• Do not store above 250C. Store in the original
• 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
What Phenobarbital tablets contain
• The active substance is Phenobarbital.

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• The other ingredients are pregelatinised maize
starch, lactose, maize starch, stearic acid, purified
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
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside,
Northbridge Road,
Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom
0044 (0)1442 200922
0044 (0)1442 873717
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.
V5 31-10-14 D0

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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
• Your doctor may prescribe a lower dose.
If you take more of Phenobarbital tablets than you
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.


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
• 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.

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Further information

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