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Phenobarbital Sodium Injection Bp 60mg/Ml

PACKAGE LEAFLET: INFORMATION FORTHE USER


Phenobarbital Sodium Injection 15mg/ml, 30mg/ml, 60mg/ml or 200mg/ml


Phenobarbital Sodium

(Referred to as Phenobarbital Injection in this leaflet)


Read all of this leaflet carefully before you are given this

medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please askyour 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What Phenobarbital Injection is and what it is used for

2.    Before Phenobarbital Injection is given

3.    Plow Phenobarbital Injection will be given t. Possible side effects

5. Howto store Phenobarbital Injection 5. Further information

1.    What Phenobarbital Injection is and what it is used for

Phenobarbital belongs to a group of drugs known as oarbiturates. Barbiturates have antiepileptic properties which mean they help prevent some types of epileptic seizures. They also have hypnotic properties which mean they can make you feel sleepy.

Phenobarbital Injection is used in the treatment of most types of epilepsy except absence seizures (petit mal).

2.    Before Phenobarbital Injection is given

You should not be given Phenobarbital Injection if:

•    You are allergic (hypersensitive) to any barbiturates or any of the ingredients of this medicine (see section 6)

•    You suffer from acute intermittent porphyria (a type of blood disorder)

•    You suffer from severe breathing difficulties (respiratory depression)

•    You suffer from liver or kidney problems

f your problem is not severe your doctor may decide to give you the medicine with caution. Talk to your doctor, they will advise you on your particular situation.

Take special care with Phenobarbital Injection if:

•    You have an alcohol or drug problem

•    You are pregnant, planning to become pregnant or are breast-feeding

•    You are young, elderly or in poor health

f any of the above applies to you, please tell your doctor.

A small number of people being treated with anti-epileptics such as Phenobarbital Injection have had thoughts of harming or killing themselves. If at any time you have these thoughts, mmediately contact your doctor.

Using other medicines:

3lease tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a orescription.

3lease tell your doctor if you are taking any of the following medicines which may interact with Phenobarbital Injection:

•    Any calcium channel blockers (drugs that affect the way calcium passes into certain muscle cells) e.g. diltiazem, felodipine, verapamil, nimodipine, nifedipine

•    Coumarin anticoagulants (drugs that reduce the clotting of blood e.g. warfarin)

•    Chloramphenicol, doxycycline, metronidazole, voriconozole, telithromycin (antibiotics)

•    Cyclosporin (a drug used to suppress the body's immune system)

•    Digitoxin, quinidine, disopryamide (drugs used to treat certain heart disorders)

•    Griseofulvin (a drug used to treat certain fungal infections)

•    Phenylbutazone (an anti-inflammatory drug)

•    Rifampicin (used in the treatment of TB)

•    Systemic steroids including oral contraceptives (birth control), possibly leading to contraceptive failure

•    Theophylline (used to treat asthma)

•    Thyroxine (used to treat an under active thyroid)

•    Protease inhibitors indinavir, lopinavir, nelfinavir and saquinavir (drugs used to treat HIV)

•    Memantine (a drug used to treat Alzheimer's disease)

•    Toremifene (an anti-oestrogen used to treat certain types of breast tumour following the menopause)

•    Tropisetron (an anti-sickness drug)

•    Folic acid or folinic acid

•    Vitamin D

•    Montelukast (a drug used to treat breathing difficulties)

•    Alcohol and strong painkillers (e.g. aspirin, paracetamol)

•    Tricyclic antidepressants (e.g. amitriptyline)

•    Antiepileptic drugs (e.g. other barbiturates, carbamazepine, lamotrigine, phenytoin and sodium valproate)

•    Phenothiazines (mood modifiers e.g. chlorpromazine, fluphenazine and pericyazine)

•    Tranquillisers (e.g. diazepam)

•    Antipsychotic drugs (e.g. haloperidol)

•    St John's wort (Hypericum perforatum) for depression If you are in any doubt please tell your doctor of any medication you are taking.

Using Phenobarbital Injection with food and drink:

You are advised NOT to drink alcohol with this medicine.

Pregnancy and breast-feeding

This medicine should not be given to you if you are pregnant, trying to become pregnant or are breast-feeding, unless your doctor has specifically recommended it.

Askyour doctor or pharmacist for advice before taking any medicine.

Driving and using machinery:

This medicine may make you feel sleepy. If so, do not drive a car or operate machinery.

3. How Phenobarbital Injection will be given

This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you require.

Adults

•    50 - 200mg as a single dose

•    The injection can be administered into a muscle, under the skin or, into a vein following dilution with water

•    Repeated, if necessary after 6 hours

Children

•    Use with caution

•    3 - 5mg per kg body weight as a single dose into the muscle Your doctor will advise you on the duration of your therapy.

If you are given too much Phenobarbital Injection:

fyou experience any of the following, tell your doctor immediately:

•    feeling sleepy

•    feeling faint

•    feeling extremely cold

•    your breathing becoming very shallow

If you are at all concerned that you have been given too much of this medicine please tell your doctor.

If you missed a dose of Phenobarbital Injection:

This is not applicable because your doctor will administer this medicine.

If treatment with Phenobarbital Injection is stopped:

Stopping treatment with this medicine may result in the return of, and increase in, seizures.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Continued overleaf

4.    Possible side effects

_ike all medicines Phenobarbital Injection can cause side effects, although not everybody gets them.

This injection may cause:

•    Breathing difficulty

•    Confusion

•    Loss of control of intentional movements

•    Drowsiness

•    Depression

•    Blood disorders

•    Memory impairment

•    Rapid involuntary movements of the eye (Nystagmus)

•    Skin reactions (though these are rare)

•    Sluggishness

•    Excitement and irritability

•    Allergic skin reactions

•    Shaky movements and unsteady walk (ataxia)

•    Inflammation of the liver (hepatitis)

•    Softening of bones

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bones) 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 any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

5.    How to store Phenobarbital Injection

<eep out of the reach and sight of children.

Phenobarbital Injection should be kept in the outer carton in order to protect from light. Do not store above 25°C.

Do not use Phenobarbital Injection after the expiry date which is stated on the ampoule label.The expiry date refers to the ast day of that month. The doctor or nurse will check that the oroduct has not passed this date.

Medicines should not be disposed of via wastewater or oousehold waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to orotect the environment.


6. Further Information

What Phenobarbital Injection contains

The active ingredient is Phenobarbital Sodium.

Phenobarbital Injection is a sterile solution.

Each 15mg/ml ampoule contains 15mg of Phenobarbital Sodium

Each 30mg/ml ampoule contains 30mg of Phenobarbital Sodium

Each 60mg/ml ampoule contains 60mg of Phenobarbital Sodium

Each 200mg/ml ampoule contains 200mg of Phenobarbital Sodium

The other ingredients are Propylene Glycol, Disodium Edetate and Water for Injections.

What Phenobarbital Injection looks like and contents of the pack:

Each ampoule contains 1 ml of Phenobarbital Injection.

The medicine is supplied to your pharmacist or doctor in packs of 10 clear glass ampoules.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals, Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom.

Product Licence Number:

Phenobarbital Injection 15mg/ml PL 01883/6161; Phenobarbital Injection 30mg/ml PL 01883/6188; Phenobarbital Injection 60mg/ml PL 01883/6189; Phenobarbital Injection 200mg/ml PL 01883/6190; HK45682

This leaflet was last revised in: November 2012


Martindale iii Pharmaceuticals fVi

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom