PHENOBARBITAL TABLETS BP 60MG

Active substance: PHENOBARBITAL

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Phenobarbital 30mg and 60mg
tablets
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.

Index
1 What Phenobarbital tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Phenobarbital tablets are and what they
are used for

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).

2 Before you take

Do not take Phenobarbital tablets and tell your doctor if you have:
• an allergy (hypersensitivity) to phenobarbital, other barbiturates
or any of the other ingredients (see section 6)
• porphyria (a genetic or inherited disorder of the red blood
pigment haemoglobin)
• severe breathing difficulties
• severe kidney or liver disease.

If you develop a rash or the following skin symptoms,
seek immediate advice from a doctor and tell 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 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 tablets you
must not be re-started on Phenobarbital tablets at any time.

Check with 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 alcoholism
• have kidney or liver problems
• have breathing difficulties
• have severe or long term pain.
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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. Especially:
• disopyramide and quinidine (to treat irregular heartbeats)
• chloramphenicol, doxycycline, metronidazole, rifampicin,
telithromycin, griseofluvin, 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 illness)
• felodipine, verapamil, diltiazem, nimodipine, nifedipine,
metoprolol, timolol and propranolol (to treat high blood
pressure)
• digitoxin or eplerenone (to treat certain heart conditions)
• 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 addiction)
• 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 disorder)
• sodium oxybate (to treat narcolepsy).

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Pregnancy and breast-feeding

• Metabolism and nutrition: bone softening and bone disease.
There have been reports of bone disorders including osteopenia and
osteoporosis (thinning of the bone) 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 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 water.
• 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 rash 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 (see section 2).

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.

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.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact
your doctor before taking this medicine, as it contains a type of sugar
called lactose.

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.

If you notice any side effects, they get worse, or if you notice any not
listed, please tell your doctor or pharmacist.

5 How to store

3 How to take

Keep out of the reach and sight of children.
Stored below 25°C in a dry place.
Do not use Phenobarbital tablets after the expiry date stated on the
label/carton/bottle. 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.

Always take Phenobarbital tablets exactly as your doctor has told you. If
you are not sure, check with your doctor or pharmacist.
You are advised not to drink alcohol, check with your doctor if you have
any questions.
Swallow the tablets with water at the same time each day.
Doses:
• Adults: 60mg-180mg at night.
• Children: 5mg-8mg per kg of bodyweight a day.
• Elderly: your doctor may prescribe a lower dose.

6 Further information

What Phenobarbital tablets contain

• The active substance (the ingredient that makes the tablet work) is
phenobarbital. Each tablet contains either 30mg or 60mg of the active
substance.
• The other ingredients are lactose, magnesium stearate, maize starch.

If you take more than you should

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.

What Phenobarbital tablets look like and contents
of the pack
Phenobarbital tablets are white, uncoated tablets.
Pack sizes are 28

If you forget to take the tablets

Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK

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.

Date of last revision: April 2012

If you stop taking the tablets

If you stop taking the tablets you may develop withdrawal effects such as
sleeplessness, anxiety, tremor, dizziness, feeling sick, fits and delirium.

If you would like a
leaflet with larger
text, please contact
01271 311257.

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 swallowing.
• 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.

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AAAD6657 50661173



Actavis, Barnstaple, EX32 8NS, UK



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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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