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Generic Name: Phenobarbitone (fee-noe-BAR-bih-tal) Rx only.
Brand Name: CROPRAM

      For more information, please see Full Prescribing Information.

PHENOBARBITONE 15mg / 30 mg / 60 mg & 100 mg (FOR EXPORT)
30 pills
Also known as: Phenobarbitone Actavis, Phenobarbitone - Kimia farma, Phenobarbitol, Phenobarbitone tablets USP, Primidone, Barbit, Phenobarbitone Bristol Labs, Servira
Active Ingredient:
Each tablet contains:
Phenobarbitone 100 mg , Excipients Q.S.
Inactive Ingredients:
Phenobarbitone 100 mg:
Starch, Talk, Croscarmellose sodium, Lactose, Carboxymethylcellulose sodium, Microcrystalline cellulose, Magnesium stearate, Acacia, Aerosil 200, Methyl paraben sodium.
Pharmacological Group:
Barbiturates group.
Therapeutic Activity:
Acts as a sedative and hypnotic in short-term treatment of insomnia.
Side effects:
Rash, erythema multiforme, lumps in the armpits or groin area; fever, swelling of the face, lips, throat and tongue, pilling and swelling of the skin; swallowing and/or breathing difficulties; altered numbers and type of blood cells; bone diseases including softening, osteopenia and osteoporosis; restlessness, confusion, unusual excitement, depression, memory impairment, hallucinations; hyperactivity, behavioral disturbances in children, jerky movements, jerky eye movements, lethargy, drowsiness; low blood pressure; changes in urination, inflammation of the liver, jaundice; Stevens-Johnson Syndrome.
Should be stored in dark dry place below 25°C.
Taj Pharmaceutical Industries Ltd., India.

Phenobarbitone is used for:
Treating and preventing seizures, and treating sleep disorders.
It may also be used for other conditions as determined by your doctor. Phenobarbitone is a barbiturate. It works by depressing the central nervous system or brain. In low doses, it causes mild sedation. As the dose increases, it can cause sleep and even coma. As it causes the brain to relax, it also decreases seizure activity. Phenobarbitone is a barbiturate, nonselective central nervous system depressant which is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.

Phenobarbital Tablets - epilepsy-seizures-examination








Do NOT use Phenobarbitone if:
you are allergic to any ingredient in Phenobarbitone
you have a history of the blood disorder porphyria
you are taking methoxyflurane, sodium oxybate (GHB), or voriconazole
you consume alcohol
you have liver problems or lung disease with breathing problems

Contact your doctor or health care provider right away if any of these apply to you.
Before using Phenobarbitone:

Some medical conditions may interact with Phenobarbitone. Tell your doctor or pharmacist if
you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary
if you have allergies to medicines, foods, or other substances
if you have depression, pain, breathing problems, suicidal tendencies, or are in shock
if you have a history of substance abuse or dependence

Some MEDICINES MAY INTERACT with Phenobarbitone. Tell your health care provider if you are taking any other medicines, especially any of the following:

Ethanol , MAO inhibitors (eg, phenelzine), quinine, sodium oxybate (GHB), stiripentol, or valproic acid because side effects such as increased sedation and difficulty breathing may occur
Ethanol, methoxyflurane, orsodium oxybate because the risk of their side effects may be increased by PhenobarbitoneAnticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin, doxycycline, estrogens (eg, estradiol), imatinib, metronidazole, steroidal contraceptives (eg, birth control pills), theophylline, or voriconazole because their effectiveness may be decreased by Phenobarbitone.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Phenobarbitone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Why is this medication prescribed?

Phenobarbitone, a barbiturate, is used to control epilepsy (seizures) and as a sedative to relieve anxiety. It is also used for short-term treatment of insomnia to help you fall asleep.This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How to use Phenobarbitone:

Use Phenobarbitone as directed by your doctor. Check the label on the medicine for exact dosing instructions. Take Phenobarbitone by mouth with or without food.Do not suddenly stop taking Phenobarbitone or change the dose without checking with your doctor. If you miss a dose of Phenobarbitone, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.


Side effects from Phenobarbitone may occur and include:

excitement (especially in children)
upset stomach


Phenobarbitone, a long-acting barbiturate, is a central nervous system depressant. In ordinary doses, the drug acts as a sedative and anticonvulsant. Its onset of action occurs within 30 minutes, and the duration of action ranges from 5 to 6 hours. It is detoxified in the liver.

Phenobarbitone is indicated for use as a sedative or anticonvulsant.

Phenobarbitone is contraindicated in patients who are hypersensitive to barbiturates. In such patients, severe hepatic damage can occur from ordinary doses and is usually associated with dermatitis and involvement of parenchymatous organs. A personal or familial history of acute intermittent porphyria represents one of the few absolute contraindications to the use of barbiturates. Phenobarbitone is also contraindicated in patients with marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. It should not be administered to persons with known previous addiction to the sedative/hypnotic group, since ordinary doses may be ineffectual and may contribute to further addiction.


Barbiturates induce liver microsomal enzyme activity. This accelerates the biotransformation of various drugs and is probably part of the mechanism of the tolerance encountered with barbiturates. Phenobarbitone, therefore, should be used with caution in patients with decreased liver function. This drug should also be administered cautiously to patients with a history of drug dependence or abuse (see DRUG ABUSE AND DEPENDENCE ).

Oral Sedative Dose, Adults – 30 to 120 mg daily in 2 or 3 divided doses. Children – 6 mg/kg     of body weight daily in 3 divided doses.
Oral Hypnotic Dose, Adults – 100 to 320 mg.
Oral Anticonvulsant Dose, Adults – 50 to 100 mg 2 or 3 times daily.
Children – 15 to 50 mg 2 or 3 times daily.
Phenobarbitone Tablets USP 15 mg: White, round, unscored, compressed tablet imprinted     “West-   ward 445”.
Bottles of 1000 tablets.
Phenobarbitone Tablets USP 30 mg: White, round, scored, compressed tablet imprinted     “West-     ward 450”.
Bottles of 1000 tablets.
Bottles of 5000 tablets.
Phenobarbitone Tablets USP 60 mg: White, round, unscored, compressed tablet imprinted     “WW-   455”.
Bottles of 100 tablets. Bottles of 1000 tablets.
Phenobarbitone Tablets USP 100 mg: White, round, scored, compressed tablet imprinted     “WW-   458”.
Bottles of 100 tablets. Bottles of 1000 tablets.
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and    moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure

Phenobarbitone may be habit forming:
Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of Phenobarbitone. As tolerance to Phenobarbitone develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxicating dosage and fatal dosage becomes smaller.

Symptoms of acute intoxication with Phenobarbitone include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints.

Symptoms of Phenobarbitone dependence are similar to those of chronic alcoholism. If an individual appears to be intoxicated with alcohol to a degree that is radically disproportionate to the amount of alcohol in his or her blood, the use of barbiturates should be suspected. The lethal dose of a barbiturate is far less if alcohol is also ingested. The symptoms of Phenobarbitone withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of Phenobarbitone. These symptoms usually appear in the following order: anxiety, muscle twitching, tremor of hands and fingers, progressive weakness, dizziness, distortion in visual perception, nausea, vomiting, insomnia, and orthostatic hypotension. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of this drug. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Individuals susceptible to Phenobarbitone abuse and dependence include alcoholics and opiate abusers, as well as other sedative- hypnotic and amphetamine abusers.

Drug dependence on Phenobarbitone arises from repeated administration of the barbiturate or an agent with barbiturate- like effect on a continuous basis, generally in amounts exceeding therapeutic dose levels. The characteristics of drug dependence on Phenobarbitone include: (a) a strong desire or need to continue taking the drug, (b) a tendency to increase the dose, (c) a psychic dependence on the effects of the drug related to subjective and individual appreciation of those effects, and (d) a physical dependence on the effects of the drug requiring its presence for maintenance of homeostasis and resulting in a definite, characteristic, and self-limited abstinence syndrome when the drug is withdrawn.

Treatment of Phenobarbitone dependence consists of cautious and gradual withdrawal of the drug. One method involves substituting a 30 mg dose of Phenobarbitone for each 100 to 200 mg dose that the patient has been taking. The total daily amount of Phenobarbitone is then administered in 3 to 4 divided doses, not to exceed 600 mg daily. Should signs of withdrawal occur on the first day of treatment, a loading dose of 100 to 200 mg of Phenobarbitone may be administered IM in addition to the oral dose. After stabilization on Phenobarbitone, the total daily dose is decreased by 30 mg a day as long as withdrawal is proceeding smoothly. A modification of this regimen involves initiating treatment at the patient's regular dosage level and decreasing the daily dosage by 10 percent if tolerated by the patient.

Infants physically dependent on Phenobarbitone may be given a lower dose of Phenobarbitone at 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of Phenobarbitone should be gradually decreased and completely withdrawn over a 2-week period.

Most reports of clinically significant drug interactions occurring with the barbiturates have involved Phenobarbitone.

1. Anticoagulants: Phenobarbitone lowers the plasma levels of dicumarol (name previously used: bishydorxycoumarin) and causes a decrease in anticoagulant activity as measured by the prothrombin time. Phenobarbitone can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., warfarin, acenocournarol, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if Phenobarbitone is added to or withdrawn from their dosage regimen.

2. Corticosteroids: Phenobarbitone appears to enhance the metabolism of exogenous corticosteroids probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if Phenobarbitone is added to or withdrawn from their dosage regimen.

3. Griseofulvin: Phenobarbitone appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs.

4. Doxycycline: Phenobarbitone has been shown to shorten the half- life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued. This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If Phenobarbitone and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.

5. Phenytoin, sodium valproate, valproic acid: The effect of Phenobarbitone on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while others report no effect. Because the effect of Phenobarbitone on the metabolism of phenytoin is not predictable, phenytoin and Phenobarbitone blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid appear to decrease Phenobarbitone metabolism; therefore, Phenobarbitone blood levels should be monitored and appropriate dosage adjustments made as indicated.

6. Central nervous system depressants: The concomitant use of other central nervous system depressants including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects.

7. Monoamine oxidase inhibitors (MAOIs): MAOIs prolong the effects of Phenobarbitone probably because metabolism of the Phenobarbitone is inhibited.

8. Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of Phenobarbitone may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (e.g., Phenobarbitone) who became pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking Phenobarbitone.

1. Habit forming: Phenobarbitone may be habit forming. Tolerance, psychological and physical dependence may occur with continued use. (See ADVERSE REACTIONS: Drug Abuse and Dependence). To minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in the dependent person may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Phenobarbitone should be withdrawn gradually. (See ADVERSE REACTIONS: Drug Abuse and Dependence.)

2. Acute or chronic pain: Caution should be exercised when Phenobarbitone is administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked. However, the use of Phenobarbitone as a sedative in the postoperative surgical period and as an adjunct to cancer chemotherapy is well established.

3. Use in pregnancy: Phenobarbitone can cause fetal damage when administered to a pregnant woman. Retrospective case-controlled studies have suggested a connection between the maternal consumption of Phenobarbitone and higher than expected incidence of fetal abnormalities. Following oral administration, Phenobarbitone readily crosses the placental barrier and is distributed throughout fetal tissues with highest concentrations found in the placenta, fetal liver, and brain.

Withdrawal symptoms occur in infants born to mothers who receive Phenobarbitone throughout the last trimester of pregnancy. (See ADVERSE REACTIONS: Drug Abuse and Dependence.) If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

4. Synergistic effects: The concomitant use of alcohol or other CNS depressants may produce additive CNS depressant effects.

Phenobarbitone may be habit forming. Tolerance and psychological and physical dependence may occur with continuing use. (See ADVERSE REACTIONS: Drug Abuse and Dependence.) Phenobarbitone should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or a history of drug abuse. Elderly or debilitated patients may react to Phenobarbitone with marked excitement, depression, and confusion. In some persons, Phenobarbitone repeatedly produces excitement rather than depression.

In patients with hepatic damage, Phenobarbitone should be administered with caution and initially reduced doses. Phenobarbitone should not be administered to patients showing the premonitory signs of hepatic coma.

Laboratory Tests
Prolonged therapy with Phenobarbitone should be accompanied by periodic laboratory evaluation of organ systems, including hematopoietic, renal, and hepatic systems (See General - above and ADVERSE REACTIONS.)

Human-data: A retrospective study of 84 children with brain tumors matched to 73 normal controls and 78 cancer controls (malignant disease other than brain tumors) suggested an association between exposure to barbiturates prenatally and an increased incidence of brain tumors.

Teratogenic effects: Pregnancy Category D. (See WARNINGS Use in Pregnancy.)

Nonteratogenic effects: Reports of infants suffering from long- term Phenobarbitone exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days. (See ADVERSE REACTIONS: Drug Abuse and Dependence.)

Labor and Delivery
Hypnotic doses of Phenobarbitone do not appear to significantly impair uterine activity during labor. Full anesthetic doses of Phenobarbitone decrease the force and frequency of uterine contractions. Administration of sedative-hypnotic Phenobarbitone to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of Phenobarbitone. If Phenobarbitone is used during labor and delivery, resuscitation equipment should be available.

Data are currently not available to evaluate the effect of Phenobarbitone on the later growth, development, and functional maturation of the child.

Nursing Mothers
Caution should be exercised when Phenobarbitone is administered to a nursing woman since small amounts of Phenobarbitone are excreted in the milk.


Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited,  medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.
SCHEDULE IV CONTROLLED SUBSTANCES : Controlled Substances Import and Export Act
"Placement on schedules; findings required Schedule IV substances are those that have the following findings:The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III. The drug or other substance has a currently accepted medical use in treatment in the United StatesAbuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.Control measures are similar to Schedule III. Prescriptions for Schedule IV drugs may be refilled up to five times within a six-month period. A prescription for controlled substances in Schedules III, IV, and V issued by a practitioner, may be communicated either orally, in writing, or by facsimile to the pharmacist, and may be refilled if so authorized on the prescription or by call-in. DRUGS IN THIS SCHEDULE INCLUDE:Benzodiazepines, such as ALPRAZOLAM (Xanax), chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam (Valium), and Lorazepam (Ativan), as well as:temazepam (Restoril) (note that some states require specially coded prescriptions for temazepam) flunitrazepam (Rohypnol) (note that flunitrazepam is not used medically in the United States). The benzodiazepine-like Z-drugs: zolpidem (Ambien), zopiclone (Imovane), eszopiclone (Lunesta), and zaleplon (Sonata) (zopiclone is not commercially available in the U.S.) Chloral hydrate, a sedative-hypnotic, Long-acting barbiturates such as phenobarbitalSome partial agonist opioid analgesics, such as pentazocine (Talwin) The stimulant-like drug modafinil (sold in the U.S. as Provigil) as well as its (R)-enantiomer armodafinil (sold in the U.S. as Nuvigil)
Difenoxin, an antidiarrheal drug, such as when combined with atropine (Motofen) (difenoxin is 2–3 times more potent than diphenoxylate, the active ingredient in Lomotil, which is in Schedule V)
Tramadol (Ultram) / Carisoprodol (Soma) has become a Schedule IV medication as of 11 January 2012.
Section 1000 [951 note] Short Title
This title may be cited as the "Controlled Substances Import and Export Act.'' EXPORT IS SUBJECTED TO NOC (Narcotic Drugs Import and Export Act) INDIA.
Export/ Import
The import of - (i) opium, concentrate of poppy straw, and (ii) morphine, codeine, thebaine, and their salts is prohibited save by the Government Opium Factory under the provision of Rule 54 of the NDPS Rules, 1985. The import into and export out of India of any narcotic drugs or psychotropic substances specified in Schedule I  is prohibited under the provision of Rule 53 of the NDPS Rules, 1985. The export of any narcotic drugs or psychotropic substances or preparations containing any of such narcotic drugs or psychotropic substances specified in Schedule II  shall be prohibited to the countries or to the region of such country specified therein under the provision of Rule 53-A of the NDPS Rules, 1985.The manufacture of psychotropic substances specified in Schedule III  can be allowed for export purpose only under the provision of Rule 65(1) of the NDPS Rules, 1985. The import of psychotropic substances specified in Schedule III may be allowed for test/ analysis purpose as well as for re-export purpose. The export out of / import into India of a select number of Precursor Chemicals  is exercised by the Narcotics Commissioner in accordance with Directorate General of Foreign Trade (DGFT) notification  and Administrative Control.
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Phenobarbitone (and Phenobarbitone sodium) is manufactured and supplied in various forms: in tablets of 15, 30, 60 and 100 mg (though not all are available in all countries: for example, in Australia only the 30-mg tablets are available); in an oral elixir (commonly 3 mg/ml in strength); and in a form for injection (as Phenobarbitone sodium - usually 200 mg/ml). The injectable form is used principally to control status epilepticus, while the oral forms are used for prophylactic and maintenance therapy. The dose range for epilepsy is 60–320 mg/day; its very long active half-life means for some patients, doses do not have to be taken every day, particularly once the dose has been stabilised over a period of several weeks or months, and seizures are effectively controlled. It is occasionally still used as a sedative/hypnotic in anxious or agitated patients who may be intolerant of or do not have access to benzodiazepines, neuroleptics and other, newer drugs. For this purpose, Phenobarbitone has a lower dose range - around 30–120 mg/day, but this practice is uncommon in developed countries

Phenobarbitone is a barbiturate, nonselective central nervous system depressant which is primarily used as a sedative hypnotic and also as an anticonvulsant in subhypnotic doses.

Phenobarbitone Tablets and Elixir are administered orally and are contained in DEA Schedule IV. Barbiturates are substituted pyrimidine derivatives in which the basic structure common to these drugs is barbituric acid, a substance which has no central nervous system (CNS) activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring.
Chemically Designated: 5-Ethyl -5-phenylbarbituric acid
Molecular Formula: C12H12N2O3
Molecular Weight: 232.24

Inactive Ingredients
Oral Tablets - corn starch, lactose (monohydrate), magnesium stearate and sodium starch glycolate

Suggested doses of Phenobarbitone for specific indications are as follows:

a. Pediatric Oral Dosage (as recommended by the American Academy of Pediatrics):

Preoperative: 1 to 3 mg/kg.

b. Adult Oral Dosage:
1. Daytime sedative: 30 to 120 mg daily in 2 to 3 divided doses.
2. Bedtime hypnotic: 100 to 320 mg.
3. Anticonvulsant: 50 to 100 mg 2 to 3 times daily.

Dosages of Phenobarbitone must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical.

Anticonvulsant use: A therapeutic anticonvulsant level of Phenobarbitone in serum is 10 to 25 µg/mL. To achieve the blood levels considered therapeutic in children, higher per-kilogram dosages are generally necessary for Phenobarbitone and most other anticonvulsants. In children and infants, Phenobarbitone at loading dose of 15 to 20 mg/kg produces blood levels of about 20 µg/mL shortly after administration.

In status epilepticus, it is imperative to achieve therapeutic blood levels of Phenobarbitone as rapidly as possible. Because a barbiturate-induced depression may occur along with a postictal depression once the seizures are controlled, it is important, therefore, to use the minimal amount required, and to wait for the anticonvulsant effect to develop before administering a second dose.

Phenobarbitone has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention of febrile seizures influences the subsequent development of epilepsy.

Special patient population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to Phenobarbitone. Dosage should be reduced for patients with impaired renal function or hepatic disease.

(Phenobarbitone can make these types of contraceptive ineffective, or cause breakthrough bleeding. Women taking Phenobarbitone who need a contraceptive should be prescribed hormonal contraceptives that contain a total of at least 50 micrograms of oestrogen, or use non-hormonal methods of contraception, such as condoms. Discuss this with your doctor.)
oestrogens and progestogens in HRT (hormone replacement therapy)
protease inhibitors for HIV infection
tricyclic antidepressants, eg amitriptyline
vitamin D
voriconazole (should not be used in combination with Phenobarbitone)
warfarin and other coumarin anticoagulants

The following medicines may reduce the breakdown of Phenobarbitone by the liver. As this could increase the level of Phenobarbitone in your blood and may increase the risk of side effects, your doctor may need to decrease your Phenobarbitone dose if you are prescribed any of these:

sodium valproate.

The following medicines may increase the breakdown of Phenobarbitone by the liver. As this could decrease the level of Phenobarbitone in your blood and may make it less effective, your doctor may need to increase your Phenobarbitone dose if you are prescribed any of these:

folic acid
pyridoxine (large doses)
the herbal remedy St John's wort (Hypericum perforatum) - this should not be taken by people who are taking Phenobarbitone.

There may be an increased risk of bone softening due to lack of vitamin D (osteomalacia) if acetazolamide is used in combination with Phenobarbitone.



























































































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How does it work?

Phenobarbitone (previously known as phenobarbitone in the UK) belongs to a group of medicines called barbiturates. It is used to treat epilepsy and works by stabilising electrical activity in the brain.

The brain and nerves are made up of many nerve cells that communicate with each other through electrical signals. These signals must be carefully regulated for the brain and nerves to function properly. When abnormally rapid and repetitive electrical signals are released in the brain, the brain becomes over-stimulated and normal function is disturbed. This can result in fits or seizures.

Phenobarbitone prevents epileptic fits by preventing the excessive electrical activity in the brain. It is thought to achieve this by affecting certain neurotransmitters in the brain.

Neurotransmitters are chemicals that are stored in nerve cells and are involved in transmitting messages between the nerve cells. GABA is a neurotransmitter that acts as a natural 'nerve-calming' agent. It helps keep the nerve activity in the brain in balance. Glutamate is a neurotransmitter that acts as a natural 'nerve-exciting' agent. It is released when electrical signals build up in nerve cells and subsequently excites more nerve cells. It is thought to play a key role in causing epileptic seizures.

Phenobarbitone increases the activity of GABA and decreases the activity of glutamate in the brain. These actions help stabilise the electrical activity in the brain and prevent epileptic fits.

Phenobarbitone is available as tablets, elixir and injection. The injection is used to control repeated fitting, when consciousness is not regained between seizures. This condition is called status epilepticus.

What is it used for?

This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
You should not suddenly stop taking this medicine unless your doctor tells you otherwise, as suddenly stopping treatment is likely to make your seizures return. It may also result in withdrawal symptoms such as difficulty sleeping (insomnia), anxiety, tremor, dizziness, nausea and delirium.
Phenobarbitone decreases the blood levels of hormonal contraceptives that contain oestrogen and/or progesterone. This can make these types of contraceptive ineffective, or cause breakthrough bleeding. Women taking Phenobarbitone who need contraception should be prescribed hormonal contraceptives that contain a total of at least 50 micrograms of ethinylestradiol (oestrogen), or use non-hormonal methods of contraception, such as condoms. It is important for women who could get pregnant to discuss contraception and pregnancy with their doctor before starting treatment with this medicine.
This medicine may rarely cause problems with your blood cells. You should consult your doctor immediately if you experience any of the following symptoms, as these may signs of problems with your blood cells: unexplained bruising or bleeding, purple spots, sore throat, mouth ulcers, high temperature (fever), feeling tired or general illness. Your doctor may want you to have a blood test to check your blood cells.

Use with caution in

Elderly people.
Slow, shallow breathing (respiratory depression).
History of asthma.
Decreased kidney function.
Decreased liver function.
Diabetes mellitus.
History of drug or alcohol abuse.
People who are hyperactive.
People who are suffering from senility or dementia.
People who are run down, weak or debilitated.
People suffering from severe chronic pain.

Not to be used in

Allergy to barbiturate medicines.
Dangerously slow, shallow breathing (severe respiratory depression).
Hereditary blood disorders called porphyrias.
Severe kidney disease.
Severe liver disease.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

It is vital that women with epilepsy receive specialist advice before getting pregnant, so they are well informed of potential risks and benefits of continuing antiepileptic treatment. Pregnant women taking antiepileptic medicine have a higher risk of carrying a baby with developmental problems and malformations. However, if a woman with epilepsy stops treatment because she is pregnant, there is a risk of seizures that can harm both mother and baby. This risk may be higher than that from continuing the medication. It is important that all the risks and benefits of treatment are weighed up. Seek medical advice from your doctor.
Women who decide to try for a baby while taking Phenobarbitone should start taking folic acid daily as soon as contraception is stopped, as this may reduce the risk of neural tube defects such as spina bifida in the baby. Ask your doctor for advice on the dose to take - it may be recommended that you take 5mg daily.
This medicine passes into breast milk and may cause drowsiness in a nursing infant. The manufacturer recommends that women taking this medicine should avoid breastfeeding their infants and bottlefeed instead. Seek medical advice from your doctor.

Label warnings

This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.
Do not stop taking this medication except on your doctor's advice.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Disturbances in behaviour.
Unusual excitement.
Hyperactivity, particularly in children and elderly people.
Difficulty thinking.
Memory problems.
Seeing or hearing things that are not really there (hallucinations).
Slow, shallow breathing (respiratory depression).
Low blood pressure (hypotension).
Shaky movements and unsteady walk (ataxia).
Rapid involuntary movements of the eyes (nystagmus).
Disturbances in the normal numbers of blood cells in the blood.
Inflammation of the liver (hepatitis).
Softening of the bones (osteomalacia).
Allergic skin reactions.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?

Phenobarbitone can interact with many medicines and the dose of Phenobarbitone or the interacting medicine may need to be altered as a result. It is important to tell your doctor what medicines you are taking, including herbal medicines and non-prescription medicines, before you start Phenobarbitone. Likewise, once you are taking Phenobarbitone it is important to check with your doctor or pharmacist before you stop taking any existing medicines, or start taking any new medicines, including herbal medicines and those bought without a prescription.

There may be an increased risk of drowsiness if Phenobarbitone is taken in combination with any of the following, which can also cause drowsiness:

benzodiazepines, eg diazepam, temazepam
sedating antihistamines, eg chlorphenamine, promethazine, hydroxyzine
sleeping tablets, eg zopiclone
strong opioid painkillers, eg morphine, codeine (these may also increase the risk of breathing difficulties).

Phenobarbitone may may increase the breakdown of the following medicines by the liver. As this could decrease the level of these medicines in the blood and may make them less effective, your doctor may need to prescribe a larger than normal dose of these:

calcium channel blockers, eg felodipine, nifedipine, nimodipine, verapamil
corticosteroids such as dexamethasone, methylprednisolone, prednisolone
efavirenz (this may also affect the blood level of Phenobarbitone)
oestrogens and progestogens such as those in the contraceptive pill








































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