PHENOBARBITAL TABLETS BP 15MG

Active substance: PHENOBARBITAL

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PHENOBARBITAL 15 mg,
30 mg AND 60 mg TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Pharma code 166

Read all of this leaflet carefully before you
start taking this medicine.
• 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 symptoms are the same as yours.
• 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.
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

• The name of your medicine is Phenobarbital
15 mg, 30 mg or 60 mg Tablets.
Phenobarbital is a barbiturate (sedative),
anticonvulsant drug which is used in the
management of epilepsy to reduce the
number and severity of fits.
• Phenobarbital is used:
• to treat all forms of epilepsy except absence
seizures (also known as petit mal in children).

2

BEFORE YOU TAKE PHENOBARBITAL

Do NOT take Phenobarbital if you:
• are allergic (hypersensitive) to Phenobarbital
or any of the other ingredients of this medicine
• are allergic to, or have ever had a specific
individual reaction on taking barbiturates
(sedatives)
• have problems with your kidneys or your liver
• have any problems with your breathing
• suffer from porphyria (a deficiency of specific
enzymes within the body, causing an increase
of substances called porphyrins).
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, immediately
contact your doctor.
• Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use
of phenobarbital, 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,
seek immediate advice from a doctor and
tell him that you are taking this medicine.
Tell your doctor before you start to take this
medicine if you:
• see another doctor or go into hospital, let him
or the staff know what medicines you are taking
• have a history of drug abuse or alcoholism
• have problems with your lungs, liver or kidneys
• are young, elderly or senile
• have severe or long term pain
• are pregnant, planning to become pregnant
or breast-feeding.

Taking other medicines
Do NOT take Phenobarbital in combination with
• the herbal remedy St John’s Wort
(Hypericum perforatum). If you already take
St John’s Wort, talk to your doctor before
stopping the St John’s Wort preparation.
Talk to your doctor if you are taking any of the
following:
• anticoagulants, such as warfarin (used to
stop the blood clotting)
• digitoxin, eplerenone (used to treat some
heart conditions), disopyramide or quinidine
(used to treat an abnormal heartbeat)
• drugs used to treat heart problems such as
metoprolol, timolol and propranolol; calcium
channel blockers, such as felodipine,
isradipine, nicardipine, diltiazem, verapamil,
nimodipine or nifedipine
• medicines used to treat infections, such as
chloramphenicol, telithromycin, itraconazole,
posaconazole, voriconazole, griseofulvin,
doxycycline, metronidazole, rifampicin,
indinavir, lopinavir, nelfinavir or saquinavir
• corticosteroids, such as hydrocortisone,
cortisone or prednisolone
• ciclosporin (an immunosuppressant used
following an organ transplant)
• tropisetron and aprepitant (used to stop you
feeling and being sick following chemotherapy),
irinotecan (used to treat cancer), toremifene
(used to treat breast cancer)
• tibolone (used to treat osteoporosis), or
gestrinone (used to treat endometriosis)
• liothyronine or levothyroxine (used to treat
an under-active thyroid gland)
• phenytoin, sodium valproate, clonazepam,
carbamazepine, vigabatrin tiagabine,
ethosuximide, oxcarbazepine or lamotrigine
(used to treat epilepsy)
• theophylline (used to treat asthma, bronchitis
and emphysema), montelukast (used to
prevent asthma)
• the non-steroidal anti-inflammatory drug
phenylbutazone (used to treat spondylitis)
• oral contraceptives (the Pill)
• drugs to treat depression, such as mianserin,
paroxetine, amitriptyline, moclobemide or
dosulepin
• any drugs to treat a mental health problem,
such as chlorpromazine, aripiprazole,
thioridazine or haloperidol
• methadone (used as a painkiller); memantine
(to treat dementia)
• methylphenidate to treat attention deficit
disorder
• vitamin D or folic acid, your doctor may
advise you to change your daily dose.
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription.
Taking Phenobarbital with food and drink
Do not take alcohol whilst taking these tablets as
it may interfere with the action of Phenobarbital.
Pregnancy and breast-feeding
Ask your doctor for advice before taking any
medicine if you are pregnant, planning to
become pregnant. 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.
This medicine may harm your baby. Ask your
doctor for advice if you intend to and before
you breast-feed.
Driving and using machines
Phenobarbital may impair the mental and/or
physical abilities required to drive or operate
machinery. If affected do not drive or operate
machinery.
Important information about some of the
ingredients of Phenobarbital
Patients who are intolerant to lactose should

PAGE 2: REAR FACE (OUTSIDE OF REEL)

note that Phenobarbital tablets contain a small • involuntary movements of your eyes
• problems with your breathing, low blood
amount of lactose. If you have been told by
pressure
your doctor that you have an intolerance to
some sugars, contact your doctor before taking • anaemia, a reduction in red blood cells
characterised by headaches, weight loss and
this medicinal product.
a sore mouth and tongue
Tests
• restlessness, confusion and excitability
If you see another doctor or go into hospital or • hyperactivity and behavioural problems in
need a blood or urine test, let them know what
children
medicines you are taking as Phenobarbital
• hepatitis (inflammation of the liver)
tablets may interfere with the results.
• jaundice (a yellowing of the skin and whites
of the eyes)
3 HOW TO TAKE PHENOBARBITAL
• softening and weakening of the bones
Always take Phenobarbital exactly as your
• a severe skin reaction may occur, which may
doctor has told you. You should check with
cause scaly, itchy skin, or red, itchy spots,
your doctor or pharmacist if you are not sure.
loss of hair and nails
• there have been reports of bone disorders
The tablets should be swallowed preferably
including osteopenia and osteoporosis
with a glass of water.
(thinning of the bone) and fractures. Check
with your doctor or pharmacist if you are on
The usual dose is:
long-term antiepileptic medication, have a
Adults: 60-180 mg to be taken at night.
history of osteoporosis, or take steroids
Children
• potential life-threatening skin rashes
The doctor will calculate the appropriate dose
(Stevens-Johnson syndrome, toxic epidermal
of Phenobarbital for your child based on the
necrolysis have been reported (see section 2)
child’s body weight.
very rarely.
Elderly
If used for extended periods, Phenobarbital can
Your doctor will monitor you and may reduce
become addictive. If you have any concerns about
your dose if necessary.
this, you should discuss them with your doctor.
If you take more Phenobarbital than you should
If any of the side effects get serious, or if you
If you (or someone else) swallow a lot of the
notice any side effects not listed in this leaflet,
tablets all together or if you think a child has
please tell your doctor or pharmacist.
swallowed any of the tablets contact your
nearest hospital casualty department or your
doctor immediately.
5 HOW TO STORE PHENOBARBITAL
An overdose is likely to cause drowsiness,
jerky eye movements, speech problems, lack of Keep out of the reach and sight of children.
These tablets should be stored in the package
muscle control during movement or when
or container supplied, do not transfer them to
swallowing, heart problems and/or attack,
another container. Do not use Phenobarbital
breathing problems, low blood pressure, low
after the expiry date that is stated on the outer
body temperature and coma.
packaging. The expiry date refers to the last
Please take this leaflet, any remaining tablets
day of that month.
and the container with you to the hospital or
Medicines should not be disposed of via
doctor so that they know which tablets were
wastewater or household waste. Ask your
consumed.
pharmacist how to dispose of medicines no
If you forget to take Phenobarbital
longer required. These measures will help to
If you forget to take a tablet, take one as soon
protect the environment.
as you remember, unless it is nearly time to
take the next one. Do not take a double dose to
make up for a forgotten dose.
6 FURTHER INFORMATION
If you stop taking Phenobarbital
Do not stop taking Phenobarbital suddenly. If
you suddenly stop taking this medicine, you
may experience side effects such as dizziness,
sleep disturbances or anxiety, headaches,
feeling sick, fits, delirium and shaking. If you
experience any of these side effects or any
other side effects whilst stopping taking
Phenobarbital, please speak to your doctor. If
your doctor decides to stop your tablets, the
dose will be gradually reduced.

What Phenobarbital tablets contain:
• The active ingredient is phenobarbital.
• The other ingredients are lactose
monohydrate, maize starch, sodium starch
glycolate (Type A), magnesium stearate
(E572), dextrin.

What Phenobarbital tablets look like and
contents of the pack:
• Phenobarbital 15 mg are white biconvex
tablets marked “APS” over “0310” on one
side and plain on reverse.
If you have any further questions on the use of
• Phenobarbital 30 mg are white biconvex
this product, ask your doctor or pharmacist.
tablets marked “APS” over “0311” on one
side and plain on reverse.
POSSIBLE SIDE EFFECTS
4
• Phenobarbital 60 mg are white biconvex
tablets marked “APS” over “0312” on one
Like all medicines, Phenobarbital can cause
side and plain on reverse.
side effects, although not everybody gets them.
If the following happens, stop taking the tablets • Phenobarbital is available in pack sizes of 7,
10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112,
and tell your doctor immediately or go to the
120, 150, 160, 168 and 1000 tablets. In
casualty department at your nearest hospital:
addition, the 15 mg and 30 mg tablets are
• an allergic reaction (swelling of the lips, face
available in pack sizes of 5000 tablets, and
or neck leading to severe difficulty in
the 60 mg tablets in pack sizes of 500 tablets.
breathing; skin rash or hives)
See outer packaging or the pharmacy label
• a syndrome called antiepilectic
for contents i.e. the number of tablets.
hypersensitivity syndrome. Symptoms of
Not all pack sizes may be marketed.
this include fever, rash, yellowing of the eyes
and skin (hepatitis), and swollen glands.
Marketing Authorisation Holder and
These are very serious but rare side effects.
Manufacturer
You may need urgent medical attention or
Marketing Authorisation holder and company
hospitalisation.
responsible for manufacture: TEVA UK Limited,
The following side effects have been reported: Eastbourne, BN22 9AG.
• drowsiness, lethargy and depression
This leaflet was last revised: April 2012
• problems with memory and general
PL 00289/5133R, PL00289/5134R,
perception in the elderly
PL00289/5136R
• lack of co-ordination and clumsiness

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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