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PHENOBARBITAL TEVA 15 MG TABLETS

Active substance(s): PHENOBARBITAL

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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.

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
IN THIS LEAFLET:
nifedipine
• medicines used to treat infections, such as
1. What Phenobarbital is and what it is used for
chloramphenicol, telithromycin, itraconazole,
2. Before you take Phenobarbital
posaconazole, voriconazole, griseofulvin,
3. How to take Phenobarbital
doxycycline, metronidazole, rifampicin,
4. Possible side effects
indinavir, lopinavir, nelfinavir or saquinavir
5. How to store Phenobarbital
• corticosteroids, such as hydrocortisone,
6. Further information
cortisone or prednisolone
WHAT PHENOBARBITAL IS AND WHAT IT • ciclosporin (an immunosuppressant used
following an organ transplant)
IS USED FOR
• tropisetron and aprepitant (used to stop you
• The name of your medicine is Phenobarbital
feeling and being sick following chemotherapy),
Teva 15 mg, 30 mg or 60 mg Tablets.
irinotecan (used to treat cancer), toremifene
Phenobarbital is a barbiturate (sedative),
(used to treat breast cancer)
anticonvulsant drug which is used in the
• tibolone (used to treat osteoporosis), or
management of epilepsy to reduce the number
gestrinone (used to treat endometriosis)
and severity of fits.
• liothyronine or levothyroxine (used to treat an
under-active thyroid gland)
• Phenobarbital is used:
• phenytoin, sodium valproate, clonazepam,
• to treat all forms of epilepsy except absence
carbamazepine, vigabatrin tiagabine,
seizures (also known as petit mal in
ethosuximide, oxcarbazepine or lamotrigine
children).
(used to treat epilepsy)
• theophylline (used to treat asthma, bronchitis
BEFORE YOU TAKE PHENOBARBITAL
and emphysema), montelukast (used to prevent
asthma)
Do NOT take Phenobarbital if you:
• the non-steroidal anti-inflammatory drug
• are allergic (hypersensitive) to Phenobarbital or
phenylbutazone (used to treat spondylitis)
any of the other ingredients of this medicine
• oral contraceptives (the Pill)
• are allergic to, or have ever had a specific
• drugs to treat depression, such as mianserin,
individual reaction on taking barbiturates
paroxetine, amitriptyline, moclobemide or
(sedatives)
dosulepin
• have problems with your kidneys or your liver
• any drugs to treat a mental health problem,
• have any problems with your breathing
such as chlorpromazine, aripiprazole,
• suffer from porphyria (a deficiency of specific
thioridazine or haloperidol
enzymes within the body, causing an increase
• methadone (used as a painkiller); memantine
of substances called porphyrins).
(to treat dementia)
• methylphenidate to treat attention deficit disorder
Take special care with Phenobarbital
• vitamin D or folic acid, your doctor may advise
you to change your daily dose.
A small number of people being treated with
anti-epileptics such as Phenobarbital have had
Please tell your doctor or pharmacist if you are
thoughts of harming or killing themselves. If at
taking or have recently taken any other
any time you have these thoughts, immediately
medicines, including medicines obtained without
contact your doctor.
a prescription.
• Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
Taking Phenobarbital with food and drink
necrolysis) have been reported with the use of Do not take alcohol whilst taking these tablets as
it may interfere with the action of Phenobarbital.
phenobarbital, appearing initially as reddish
target-like spots or circular patches often with
Pregnancy and breast-feeding
central blisters on the trunk
Ask your doctor for advice before taking any
• Additional signs to look for include ulcers in
medicine if you are pregnant, planning to become
the mouth, throat, nose, genitals and
pregnant. Your doctor should discuss the possible
conjunctivitis (red and swollen eyes)
effects of Phenobarbital tablets on the unborn
• These potentially life-threatening skin rashes
child and the risks and benefits of treatment
are often accompanied by flu-like symptoms.
The rash may progress to widespread blistering should be considered carefully.
• Check with your doctor before taking folic acid
or peeling of the skin.
supplements as they interact with Phenobarbital
• The highest risk for occurrence of serious skin
tablets, your doctor may need to adjust your dose.
reactions is within the first weeks of treatment

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

PHENOBARBITAL TEVA 15 mg,
30 mg AND 60 mg TABLETS

1

Pharma code 643

2

• 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.

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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.

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PAGE 2: REAR FACE (OUTSIDE OF REEL)

• jaundice (a yellowing of the skin and whites of
Tests
the eyes)
If you see another doctor or go into hospital or
• softening and weakening of the bones
need a blood or urine test, let them know what
medicines you are taking as Phenobarbital tablets • a severe skin reaction may occur, which may
cause scaly, itchy skin, or red, itchy spots, loss
may interfere with the results.
of hair and nails
• there have been reports of bone disorders
HOW TO TAKE PHENOBARBITAL
including osteopenia and osteoporosis
(thinning of the bone) and fractures. Check with
Always take Phenobarbital exactly as your doctor
your doctor or pharmacist if you are on
has told you. You should check with your doctor or
long-term antiepileptic medication, have a
pharmacist if you are not sure.
history of osteoporosis, or take steroids.
The tablets should be swallowed preferably with
• Bending contracture of the fingers into the
a glass of water.
palm of the hand.

Stiffness
and pain in shoulder joint.
The usual dose is:
• Pain in joints.
Adults: 60-180 mg to be taken at night.
• Pain and curvature during erection.
• potential life-threatening skin rashes
Children
(Stevens-Johnson syndrome, toxic epidermal
The doctor will calculate the appropriate dose of
necrolysis) have been reported (see section 2)
Phenobarbital for your child based on the child’s
very rarely.
body weight.

3

Elderly
Your doctor will monitor you and may reduce
your dose if necessary.

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

If you take more Phenobarbital than you should

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.

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.

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

If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
plain on reverse.
casualty department at your nearest hospital:
• Phenobarbital is available in pack sizes of 7, 10,
• an allergic reaction (swelling of the lips, face or
14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120,
neck leading to severe difficulty in breathing;
150, 160, 168 and 1000 tablets. In addition, the
skin rash or hives)
15 mg and 30 mg tablets are available in pack
• a syndrome called antiepilectic hypersensitivity
sizes of 5000 tablets, and the 60 mg tablets
syndrome. Symptoms of this include fever,
in pack sizes of 500 tablets. See outer
rash, yellowing of the eyes and skin (hepatitis),
packaging or the pharmacy label for contents
and swollen glands.
i.e. the number of tablets.
These are very serious but rare side effects. You
Not all pack sizes may be marketed.
may need urgent medical attention or
hospitalisation.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
The following side effects have been reported:
responsible for manufacture: TEVA UK Limited,
• drowsiness, lethargy and depression
Eastbourne, BN22 9AG.
• problems with memory and general perception
in the elderly
This leaflet was last revised: May 2017
• lack of co-ordination and clumsiness
PL 00289/5133R, PL 00289/5134R, PL 00289/5136R
• 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
83634-ZD
• hyperactivity and behavioural problems in
EAS1078a
children
160 x 323
• hepatitis (inflammation of the liver)

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+ Expand Transcript

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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