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PHENOBARBITAL THORNTON & ROSS 15MG/5ML ELIXIR

Active substance(s): PHENOBARBITAL

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25.01.2016

22822012

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 628971
Suf fix

CRN

12618

Reason for
Change

Addition of 28 day in use shelf life.

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Issued by
Date

MHRA/IMB
submission Yes
required

VERIFIED
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Data Matrix: 22822012

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and breast
feeding
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If you are pregnant or planning to become pregnant you should speak to your
ExistingComponent
liver disease. Leaflet
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print) beforeTimes
taking Phenobarbital. If you become pregnant whilst taking
Kidney disease.
Phenobarbital
your doctor will decide if you should continue taking this
Pack
Size
500ml
Severe shortage of breath.­­
medicine or whether another would be more suitable during your pregnancy.
Restricted
movement.
IG Code
22822012
Or are due to have a flu (influenza) vaccination.
297mm
x 210mm
Dimensions
Your doctor
may prescribe
additional
Vitamin D supplements especially if you

25.01.2016
Date

1

15mg/5ml Elixir

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Talk to your doctor or pharmacist if you have:

297mm x 210mm

Are allergic to barbiturates.
Are allergic to any ingredients listed in section 6.
Suffer from severe lack of breath.
Box disorder.
Have aMHRA
severeHeader
liver or kidney
Have porphyria – where chemicals in the body do not break down normally.
Colours Used
Phenobarbital Thornton & Ross
Product
Are a child
who is hyperactive.

Dimensions

Do not take the medicine if you:

Important

•• The herbal remedy St Johns Wort (hypericum perforatum) should not
be taken at the same time as this medicine. If you already take St John’s
Wort, talk to your doctor before stopping the St John’s Wort preparation.
•• Steroid medicines including oral contraceptives or emergency
contraceptives (morning after pill) – Using Phenobarbital may cause your
oral contraceptive to be less effective, and it may not prevent pregnancy. An
alternative contraceptive medicine may be more appropriate when taking
Phenobarbital. You should discuss this with your doctor before taking this
medicine.Fonts Used

22822012

If you are concerned that you are becoming addicted to this medicine, talk to
your doctor or pharmacist as soon as possible, but do not stop taking the
medicine unless the doctor tells you to as it is important to control your fits.

IG Code

Prolonged use may lead to dependence

500ml

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.
Phenobarbital Elixir contains a significant amount of alcohol. (See Important
information about some of the ingredients of this medicine).
You must avoid other sources of alcohol while using this medicine.
If you are alcoholic, or have a history of alcohol abuse there may be a more
appropriate medicine to treat your epilepsy. Tell your doctor or pharmacist if
this applies to you.
Take special care if you have liver disease or if this medicine is prescribed for a
baby or child.
If you have severe pain, Phenobarbital may not produce a calming action, and
may cause wakefulness, excitement and delirium, unless taken with a painkiller.
Young, elderly, depressed, feeble or weak people need to take special care
when using this medicine, as they can react differently to it. Talk to your doctor
about this if it applies to you, or if you have any concerns about your reaction to
the medicine.

Leaflet

Take special care with Phenobarbital

Pack Size

2. Before you use this medicine

Component

Phenobarbital Elixir is a barbiturate drug, taken by mouth to treat epilepsy. It
can be taken by adults and children.

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1. What the medicine is for

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What the medicine is for
Before you use this medicine
How to use this medicine
Possible side effects
Storing this medicine
Further information

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5.
6.

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In this leaflet

Phenobarbital Thornton & Ross
15mg/5ml Elixir

•• Phenobarbital Elixir is prescribed to treat epilepsy.
•• Take Phenobarbital Elixir regularly to get the most benefit. Do not stop
taking the medicine without talking to your doctor first. Stopping the
medicine abruptly can cause problems.
•• Phenobarbital can cause side effects, although most people do not have
serious problems - see section 4 for details. If you have fever, skin rashes or
skin yellowing, mouth ulcers, bruising or bleeding, see your doctor
immediately.
•• Some side effects may occur early on in treatment. These often disappear
after a few days as your body gets used to the drug.
•• Taking other medicines including other anti-epilepsy drugs may sometimes
cause problems, see section 2 for details. Check with your doctor before
taking any other medicines.
•• If you might become pregnant while taking Phenobarbital it is important
that you talk to your doctor about this.
Now read the rest of the leaflet before you use this medicine. It includes
other information which might be especially important for you.
Keep this leaflet. You may need to read it again.
If any of these side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

Tell your doctor if you are taking any of the following:

•• Alcohol.
•• Anticoagulants - which are used to thin the blood (e.g. warfarin).
•• Antibiotics (e.g. tetracyclines, cefotaxime, metronidazole, telithromycin,
chloramphenicol).
•• Anti-inflammatory medicines known as corticosteroids (e.g. prednisolone,
betamethasone).
•• Antihistamine medicines for allergies (e.g. chlorphenamine, promethazine).
•• Antismoking medicines (e.g. amfebutamone, bupropion).
•• Anti viral medicines for HIV (e.g. nelfinavir, indinavir, saquinavir, abacavir,
amprenavir, darunavir, fosamprenavir, lopinavir, etravirine, ritonavir,
tipranavir).
•• Medicines to treat arthritis or rheumatism (e.g. methotrexate).
•• Medicines used to help with asthma or breathing (e.g. theophylline,
montelukast).
•• Medicines to treat some cancers, leukaemia or Hodgkin’s disease (e.g.
doxorubicin, etoposide, ifosfamide, procarbazine, irinotecan, teniposide,
cyclophosphamide, gefitinib).
•• Ciclosporin or tacrolimus, used in organ and tissue transplants.
•• Medicines used to treat depression (e.g. MAOIs, imipramine, amyltriptyline
paroxetine, SSRIs, fluoxetine, mianserin, lithium).
•• Medicines to treat diabetes (e.g. chlorpropamide, tolbutamide).
•• Diuretic medicines to reduce water in the body (e.g. furosemide,
eplerenone, acetazolamide).
•• Other medicines to treat epilepsy (e.g. phenytoin, carbamazepine,
lamotrigine, sodium valproate, clonazepam, diazepam, tiagabine,
zonisamide, ethosuximide, oxcarbazepine, felbamate, stiripentol, vigabatrin,
primidone).
•• Folic acid used to treat anaemia.
•• Medicines used to treat fungal infections (e.g. grisefulvin, itraconazole,
posaconazole, voriconazole).
•• Flu (influenza) vaccine. Talk to your doctor before having a flu vaccination
if taking phenobarbital.
•• Medicines for heart problems, high blood pressure and angina
(e.g. propranolol, timolol, metoprolol, felodipine, isradipine,
dihydropyridines, diltiazem, verapamil, digitoxin, disopyramide, lidocaine,
propafenone, dronedarone, quinidine).
•• Hormones and related medicines (e.g. tibolone, gestrinone, toremifene).
•• Lofexidine - used to treat opioid overdose.
•• Medicines used to treat malaria (e.g. quinine).
•• Memantine - for Alzheimer’s disease.
•• Methadone, a medicine used to treat drug dependency.
•• Methylphenidate - for ADHD.
•• Medicines which prevent nausea and vomiting (e.g. topisetron, aprepitant).
•• Medicines for psychiatric disorders (e.g. chlorpromazine, haloperidol,
mesoridazine, thiodorazine, aripiprazole).
•• Painkillers, sedatives or anaesthetics (e.g. morphine, dextropropoxyphene,
pethidine, fenoprofen, paracetamol, diazepam, lidocaine).
•• Rifampicin, a drug used to treat tuberculosis.
•• Sodium oxybate - for serious daytime sleepiness.
•• Thyroxine, a drug which treats an under active thyroid.
•• Medicines to treat Vitamin B6 deficiency (e.g. pyridoxine).

Product
Title

Phenobarbital Thornton & Ross 15mg/5ml Elixir
Important things you need to know:

have been immobile for a long time, if you don’t get much sunlight or your diet
is low in vitamin D or calcium. If you think any of these apply to you talk to
your doctor.

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PATIENT INFORMATION LEAFLET

Important side effects to look out for – and what to do if you are
affected.
MHRA Header Box

What the medicine contains

The active substance is Phenobarbital 15mg per 5ml.
The other ingredients are anise oil, coriander oil, ethanol, glycerol (E422),
If you think you have any of these side effects, see a doctor immediately.
Colours Used orange oil terpeneless,
Fonts Used
Phenobarbital
Thornton & Ross
Productof harming
lemon oil terpeneless, tartrazine (E102), sunset yellow
•• Thoughts
or killing yourself.
Title
15mg/5ml Elixir
dye
(E110)
and
purifiedNeue
water.
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Process Black
•• Fever, skin rashes/eruptions or skin yellowing.
•• Skin
sores or mouthLeaflet
ulcers.
looks like
Component
Times
Keyline (Does notWhat
print) the medicine
The medicine is a deep yellow liquid.
•• Bruising or bleeding.
Pack Size
500ml
•• Shedding or peeling of the skin.
Marketing Authorisation Holder and Manufacturer
IG Code
Thornton and Ross Ltd., Huddersfield, HD7 5QH, England.
•• Swollen
glands. 22822012
Dimensions

297mm x 210mm

Proof No.

1

Date

This leaflet was last revised in
January 2016

25.01.2016

22822012

PCP Header Box
Operator

Approved by
Date

gill.kennedy

Artwork No 628971
Suf fix

CRN

12618

Reason for
Change

Addition of 28 day in use shelf life.

B

Issued by
Date

MHRA/IMB
submission Yes
required

25.01.2016

6. Further information

Stopping this medicine abruptly may cause severe withdrawal symptoms
including a return of your seizures. If you want to stop taking the medicine for
any reason you must talk about this with your doctor before stopping.

297mm x 210mm

Like all medicines Phenobarbital Elixir can have side effects although these
don’t affect everyone.

Stopping this medicine

Dimensions

4. Possible side effects

Do not use the product after any expiry date which may appear on the label.
Keep out of the sight and reach of children.
Keep your medicine locked in a cupboard if possible.
Do not store the product above 25°C. Once opened use within 28 days.
Protect from light.
Medicines should not be disposed of via wastewater or household waste. Return
any unused medicine to your pharmacist. These measures will help protect the
environment.

Date

5. Storing this medicine

1

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.

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Reporting of side effects

22822012

The doctor will prescribe the correct dose for the child depending on their age
and weight.
As your treatment progresses, the doctor may want to vary the amount you take
each day, or when you take it. The doctor may want you to take all the medicine
at one go each day, or he may ask you to take the medicine in 2 or 3 portions
throughout the day.
Always follow the dose instructions given by your doctor carefully.
If you miss a dose take the next as soon as you remember. Do not take a double
dose. You can then carry on with the next dose at the correct time. Missing
doses may risk withdrawal symptoms.
If you take too much see a doctor immediately.

IG Code

Children

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The usual adult daily dose is between 20 and 65ml. The doctor will decide the
exact amount that you should take each day.

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Adults

500ml

Take this medicine by mouth.

Leaflet

Dose

Pack Size

This medicine has been prescribed for you personally. Do not pass it on to others
as it may harm them. Always take your medicine as prescribed by your doctor.

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3. How to take the medicine

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This medicine contains 38vol% of ethanol (alcohol), i.e. up to 20g per daily
dose, equivalent to 513ml beer or 214ml wine per day. Harmful for those
suffering from alcoholism. To be taken into account in pregnant or breast feeding
women, children and high risk groups, such as patients with liver disease or
epilepsy. This amount of alcohol may alter the effects of other medicines taken
at the same time. The amount of alcohol in this product may impair your ability
to drive or use machines. You must avoid other alcoholic drinks when taking this
medicine.
The product also contains a large proportion of glycerol. This may cause
headache, stomach upset and diarrhoea. It also contains tartrazine (E102) and
sunset yellow FCF (E110) colours, which may cause allergic reactions.

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Important information about some of the ingredients of this
medicine

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This product may cause drowsiness. The amount of alcohol may impair your
ability to drive or use machines.
If affected do not drive or operate machinery. Consult your doctor for further
information.

Headache.
Insomnia (sleeplessness).
Difficulty breathing.
Skin itching.
Sensitivity to light.
Seeing things.
Jerky eye movements.
Small mood changes.
Changes in behaviour including hyperactivity, irritability and aggression.
Dizziness.
Restlessness, feeling excited or agitated.
Children - may become irritable and hyperactive.
Reduced levels of folate, Vitamin K, phosphate or calcium in the blood.
Reduced thyroid hormones in the blood.
Anaemia or low white blood cells.
Problems with levels of Vitamin D in the body.
Problems with inflammation of tendons (e.g. Dupuytren’s contracture of the
hand, frozen shoulder, Ledderhose’s syndrome of the foot, Peyronie’s
disease of the penis).
Fibromas (non-cancerous growths).
Problems with bile and the liver (including inflammation).
Softening of the bones, rickets and general joint pain.
Low blood pressure.
Fits (Grand Mal convulsion).
Using this medicine for a long time may lead to dependence and withdrawal
problems when you stop taking it (see section 3).
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.
If you have any of these side effects or notice any other effects not mentioned
here, tell your doctor or pharmacist. They will advise you what to do.

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Driving and using machinery

Other side effects which may occur are:

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Phenobarbital Thornton & Ross
15mg/5ml Elixir

This product may be used by children. The doctor will take into account the
weight and the age of the child and prescribe the correct dose.

These side effects are usually mild and may disappear after a few days - if
they are severe or last for longer than a few days, tell your doctor.
•• Drowsiness.
•• Lack of energy.
•• Unsteady walking or jerky movements.
•• Memory problems, difficulty in concentrating, confusion.
•• Depression.

Product
Title

Use by children

Other possible side effects

MHRA Header Box

Do not stop taking Phenobarbital until you have seen your doctor as it is
important to control your fits. If taken during pregnancy (particularly during the
first 3 months and the last 3 months) Phenobarbital may cause birth defects. It
may also cause problems with bleeding in your baby when it is born. Use of
Phenobarbital during pregnancy may lead to drug dependence and sleepiness in
the newborn baby. However, your doctor may decide that it is very important
that you continue to take Phenobarbital. He or she will explain the risks to you.
Adequate supplements of folic acid should be taken before conception and
during pregnancy.
As Phenobarbital is released into breast milk this may make your baby sleepy or
get too little oxygen and therefore breast feeding is not advisable.

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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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