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PHENOBARBITAL TEVA 15 MG TABLETS

Active substance(s): PHENOBARBITAL

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TEVA UK Ref:

231-30-83634-ZC LEA PHENOBARBITAL TAB ALL STR TUK

Version:

5

03 June 2015

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.
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

Pharma code 166

• The name of your medicine is Phenobarbital
Teva 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.

REG0048758

Version 4.6

Approved

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.

Top of page cut-off to middle of registration mark: 44 mm.

PHENOBARBITAL TEVA 15 mg,
30 mg AND 60 mg TABLETS

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 note
that Phenobarbital tablets contain a small amount
of lactose. If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this medicinal
product.

Page 1 of 3

TEVA UK Ref:

231-30-83634-ZC LEA PHENOBARBITAL TAB ALL STR TUK

Version:

5

03 June 2015

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• hepatitis (inflammation of the liver)
• jaundice (a yellowing of the skin and whites of
the eyes)
• softening and weakening of the bones
• a severe skin reaction may occur, which may
cause scaly, itchy skin, or red, itchy spots, loss
of hair and nails
HOW TO TAKE PHENOBARBITAL
• there have been reports of bone disorders
including osteopenia and osteoporosis
Always take Phenobarbital exactly as your doctor
(thinning of the bone) and fractures. Check with
has told you. You should check with your doctor or
your doctor or pharmacist if you are on
pharmacist if you are not sure.
long-term antiepileptic medication, have a
The tablets should be swallowed preferably with
history of osteoporosis, or take steroids.
a glass of water.
• potential life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
The usual dose is:
necrolysis) have been reported (see section 2)
very rarely.
Adults: 60-180 mg to be taken at night.
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

Children
The doctor will calculate the appropriate dose of
Phenobarbital for your child based on the child’s
body weight.
Elderly
Your doctor will monitor you and may reduce
your dose if necessary.
If you take more Phenobarbital than you should

If you (or someone else) swallow a lot of the

tablets all together or if you think a child has
swallowed any of the tablets contact your nearest
hospital casualty department or your doctor
immediately.
An overdose is likely to cause drowsiness, jerky
eye movements, speech problems, lack of muscle
control during movement or when swallowing,
heart problems and/or attack, breathing problems,
low blood pressure, low body temperature and
coma.
Please take this leaflet, any remaining tablets and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Phenobarbital
If you forget to take a tablet, take one as soon 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.
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.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Phenobarbital can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash or hives)
• a syndrome called antiepilectic hypersensitivity
syndrome. Symptoms of this include fever,
rash, yellowing of the eyes and skin (hepatitis),
and swollen glands.
These are very serious but rare side effects. You
may need urgent medical attention or
hospitalisation.
The following side effects have been reported:
• drowsiness, lethargy and depression
• problems with memory and general perception
in the elderly
• lack of co-ordination and clumsiness
• involuntary movements of your eyes
• problems with your breathing, low blood
pressure
• anaemia, a reduction in red blood cells
characterised by headaches, weight loss and a
sore mouth and tongue
• restlessness, confusion and excitability
• hyperactivity and behavioural problems in
children

REG0048758

Version 4.6

Approved

If used for extended periods, Phenobarbital can
become addictive. If you have any concerns about
this, you should discuss them with your doctor.
Reporting of 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

Keep out of the reach and sight of children.
These tablets should be stored in the package or
container supplied, do not transfer them to
another container. Do not use Phenobarbital after
the expiry date that is stated on the outer
packaging. The expiry date refers to the last day of
that month. 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 Teva 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 Teva 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.
• Phenobarbital 30 mg are white biconvex tablets
marked “APS” over “0311” on one side and
plain on reverse.
• Phenobarbital 60 mg are white biconvex tablets
marked “APS” over “0312” on one side and

plain on reverse.

• Phenobarbital is available in pack sizes of 7, 10,
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120,
150, 160, 168 and 1000 tablets. In addition, the
15 mg and 30 mg tablets are available in pack

sizes of 5000 tablets, and the 60 mg tablets
in pack sizes of 500 tablets. See outer
packaging or the pharmacy label for contents
i.e. the number of tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: June 2015
PL 00289/5133R, PL 00289/5134R, PL 00289/5136R

83634-ZC
160 x 323

Page 2 of 3

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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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