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PHENOBARBITAL ACTAVIS 15MG TABLETS

Active substance(s): PHENOBARBITAL

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PATIENT INFORMATION LEAFLET

Phenobarbital Actavis
15mg 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 only.
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

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
The active ingredient in this medicine is Phenobarbital. This is the new
name for Phenobarbitone. The ingredient itself has not changed.

1 W
 hat 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 W
 hat you need to know before you take
Phenobarbital Tablets
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)
•p
 orphyria (a genetic or inherited disorder of the red blood pigment
haemoglobin)
• s evere 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 them that
you are taking this medicine:

•p
 otentially 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.

Warnings and precautions

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 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.

Other medicines and Phenobarbital tablets

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. 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
John’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)
• s teroids 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)
•o
 ral contraceptives (talk to your doctor about the best method of
contraception for you) or tibolone (female hormone)
• l evothyroxine (thyroid hormone)
• montelukast or theophylline (to treat asthma)
• tropisetron and aprepitant (to treat nausea and vomiting)
•m
 emantine (to treat dementia)
•m
 ethylphenidate (to treat attention deficit disorder)
• s odium oxybate (to treat narcolepsy).

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148x210 Leaflet Reel Fed Profile (BST)

Phenobarbital Actavis 15mg 28 Tablets PIL - UK
item no: AAAI0301

dimensions: 148 x 210 (Reel Fed)

print proof no: 5

pharmacode:

origination date: 15.06.15

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 30.06.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

Non Printing Colours
1.
2.
3.

Phenobarbital Tablets
15mg x 28’s (UK)
JDE No.:

50844295

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 2771
Date Sent:
29/01/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Pregnancy and breast-feeding

This medicinal product contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

•M
 etabolism 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.
•M
 ental health: restlessness and confusion in the elderly, unusual
excitement, depression, memory impairment, hallucinations.
•N
 ervous system: hyperactivity, behavioural disturbances in children,
jerky movements, jerky eye movements, drowsiness, lethargy.
•H
 eart: low blood pressure.
• L ungs: difficulty breathing.
• L iver: inflammation of the liver (hepatitis), damaged bile system
(cholestasis). Seen as yellowing of skin and whites of eyes.
•K
 idneys: changes in the amount or need to pass water.
• S kin: 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).

Tests

Reporting of side effects

If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking Phenobarbital tablets.
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.

Phenobarbital Tablets contain lactose

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 How to take Phenobarbital Tablets
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.
•C
 hildren: 5mg-8mg per kg of bodyweight a day.
• E lderly: your doctor may prescribe a lower dose.

If you take more Phenobarbital Tablets 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.

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 the tablets

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

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:
•A
 llergic reaction: skin rash, fever, swelling of the face, lips, tongue or
throat, or difficulty breathing or swallowing.
•B
 lood: 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.

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 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 Tablets
Keep out of the sight and reach of children.
Stored below 25°C. Keep the blister in the outer carton in order to protect
from light.
Do not use Phenobarbital tablets after the expiry date stated on the carton.
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 Contents of the pack and other information
What Phenobarbital tablets contain

• The active substance (the ingredient that makes the tablet
work) is phenobarbital. Each tablet contains 15mg of the
active substance.
• The other ingredients are lactose, starch, talc and stearic acid.

What Phenobarbital tablets look like and contents
of the pack
Phenobarbital tablets are white tablets.
Pack size is 28
Marketing Authorisation Holder:
Actavis Group PTC ehf.,
Reykjavíkurvegi 76-78,
220 Hafnarfjörður,
Iceland
Manufacturer:
Actavis
Barnstaple
EX32 8NS
UK
This leaflet was last revised in June 2015.

Continued top of next column
50844295 AAAI0301

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Phenobarbital Actavis 15mg 28 Tablets PIL - UK
item no: AAAI0301

dimensions: 148 x 210 (Reel Fed)

print proof no: 5

pharmacode:

origination date: 15.06.15

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 30.06.15

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date: n/a

Non Printing Colours
1.
2.
3.

Phenobarbital Tablets
15mg x 28’s (UK)
JDE No.:

50844295

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 2771
Date Sent:
29/01/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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