PHENOBARBITONE

Parent or patient Information Leaflet

Dr. C. P. Ravi Kumar

Consultant Paediatric Neurologist
MRCPCH, CCT in Paediatrics (U.K.)
Fellow in Paediatric Epilepsy &
Neurology (London)

Brand names :
Tablet & Syrup : Gardenal

Phenobarbitone is one of the OLDEST medicines used in epilepsy to control several different seizures or convulsions (fits), it is effective, and time tested for various types of seizures. Its main disadvantage is sedating effect, and the side effect profile on long term use.

This drug is still the first line drug in controlling seizures during emergency, especially in newborn baby. For long-term use, it is being replaced by newer drugs with better side effect profile.

Why is Phenobarbitone important for my child’s treatment?

It is important that your child takes Phenobarbitone regularly so that they have no Seizures or fewer seizures.

Do not stop giving Phenobarbitone suddenly, as your child may have more seizures.

What is Phenobarbitone available as?

Phenobarbitone is available in the preparation of Liquid medicine, Tablets in the market.

“Generic Vs Branded Drugs”

When should I give Phenobarbitone?

Usually at bedtime to minimise the sedating side effect, rarely it may be advised to be used Twice a day, morning and evening. Ideally, 10-12 hours apart.

For example, anytime between 7 to 8 am and right after 12 hours between 7 to 8 pm. You can adjust the time slot according to your schedule.

It should ideally be given at the same time every day to establish a routine as it minimizes the chances of missing a dose.

What if I miss a dose?

Tablets & liquids: The child can be given the missed dose, if you remember to give it within a lapse of 6 hours. If you fail to give the missed dose within 6 hours, then might as well leave it. It is advisable to wait until the time of next routine dose.

Never give a double dose of Phenobarbitone.

If your child vomits out the content within 30 minutes of taking the medicine dosage then you can give the dose again; but if your child vomits after 30 minutes of taking the dose, then just leave it be and do not give it again.

How much of the drug should be given?

Your doctor will work out and prescribe the accurate amount of Phenobarbitone (the dose) for your child.

When you first start giving Phenobarbitone to your child, you are supposed to give them a small amount and then increase the dose little by little over a course of few days or weeks. This will help your child’s to get use to the medicine. Your doctor will clarify what steps to take.

It is mandatory to follow the instructions given by your doctor about the dosage of medication.

Ultimately, when your child is free of seizures or convulsions (fits) and has no obvious side effects, you will know that the dosage is just correct.

How should I give the medicine ? “Giving Medicines”

Tablets: A whole tablet must be swallowed with a glass of water, juice or milk. You may give it by crushing and mixing it in water/ juice or small serving of yogurt / Curd.

Liquid or syrup: Use an oral syringe or a medicine spoon to measure the adequate amount. You can easily get these from any pharmacy nearby.

Do not use a kitchen teaspoon as it will not give the accurate amount of the drug.

Could this medication have any side effects on my child? Side effects

Although medicines are given to make children feel better, sometimes, they may cause some unwanted side effects.

Side-effects that you must do something about

Most common side effects include being unusually sleepy or change in behaviour leading to restlessness and agitation.

It can also affect concentration.

Phenobarbitone if used for years, it can have a negative effect on cognition. It is important to note, children with epilepsy may have other issues with cognitive function, in such cases it is difficult to attribute the impact of medicine on cognition.

Liver disease: If your child’s health deteriorates and falls sick every few hours, suffers from stomachache, skin and eyes are pale yellow in color, feels lethargic and sleepy or increased number of seizures take them to your doctor straight away.

Occasionally, Phenobarbitone causes a reduction in the blood platelets, which help the blood to clot after cuts. However, this rarely causes a matter of concern, but if your child does develop unexplained bruising or bleeding, you should contact your doctor who will arrange a blood test.

If your child starts developing skin Rash, Stop Medications right there and SEEK IMMEDIATE MEDICAL ADVICE from your DOCTOR

Sometimes your child may experience other side-effects that are not listed above. If you notice any abnormalities with your child’s body or behavior, do not hesitate and immediately contact your doctor.

Despite this long list of side effects, Phenobarbitone is a very effective anti-epileptic (anticonvulsant) medicine and has very little effect on the child’s alertness levels, behaviour and learning abilities.

Can other common medicines be given at the same time as Phenobarbitone?

Medications like ibuprofen, paracetamol, antibiotics or any of the other over the counter medicines can be given when necessary, except the ones your doctor has prohibited you from.

Consult with your doctor before giving any other medicines to your child. This includes herbal or complementary medicines.

Some other medicines used to treat epilepsy may affect how well Phenobarbitone works or may cause side effects. If your child is experiencing more fits or seizures, or any other side effects after using other medications, talk to your doctor immediately.

Phenobarbitone and pregnancy

Phenobarbitone has significant impact on fetus, hence it is advised not to use this drug during pregnancy.

The oral contraceptive pill MAY BE LESS EFFECTIVE in women or girls who are taking Phenobarbitone. Alternate contraceptive means should be considered.

Where should I keep the medication?

Keep the medicine in a cupboard, secured away from heat and direct sunlight. It is not a must to keep the medicine in the refrigerator though.

Make sure the medicine is out of your child’s reach.

Store the medication in the same box it was packed in.

For more information please to the manufacturer’s information leaflet.

References :

1. IAP Drug Formulary Web Update 2020(3) Edition 58, https://www.iapdrugformulary.com/Home
2. Consumer Medicines Information (CMI), https://www.tga.gov.au/consumer-medicines-information-cmi
3. British National Formulary for Children (BNFC), https://www.nice.org.uk/bnfc
4. Food and Drug Administration, USA https://www.fda.gov