Patient Medication Information: uses, side effects, how to take - PMS-Phenobarbital
What are pms-PHENOBARBITAL and pms-PHENOBARBITAL ELIXIR used for?
pms-PHENOBARBITAL and pms-PHENOBARBITAL ELIXIR are used as:
- a sedative, for the relief of anxiety, tension and apprehension (nervousness)
- a hypnotic, for the short-term management of insomnia (sleeplessness)
- an anticonvulsant, for the long-term treatment of generalized seizures
- as prevention and treatment of febrile seizures (seizures that are seen with high body temperature)
- for the prevention and treatment of hyperbilirubinemia (a condition in which there is too much bilirubin in the blood) in newborns, and in patients with bile build up in the liver.
How do pms-PHENOBARBITAL and pms-PHENOBARBITAL ELIXIR work?
It is not completely known how phenobarbital works.
Are the ingredients in pms-PHENOBARBITAL?
Medicinal ingredients:
pms-PHENOBARBITAL contain:
- Each 15 mg tablet: 15 mg phenobarbital
- Each 30 mg tablet: 30 mg phenobarbital
- Each 60 mg tablet: 60 mg phenobarbital
- Each 100 mg tablet: 100 mg phenobarbital
Non-medicinal ingredients:
pms-PHENOBARBITAL:
- Each 15 mg and 30 mg tablet contains the following non-medicinal ingredients: gelatin, lactose monohydrate, maize starch, microcrystalline cellulose and stearic acid.
- Each 60 mg and 100 mg tablet contains the following non-medicinal ingredients: gelatin, lactose monohydrate, maize starch, microcrystalline cellulose, silicon dioxide and stearic acid.
What are the ingredients in pms-PHENOBARBITAL ELIXIR?
Medicinal ingredients:
pms-PHENOBARBITAL ELIXIR contains:
- Each 1 mL of elixir: 5 mg phenobarbital
Non-medicinal ingredients:
pms-PHENOBARBITAL ELIXIR:
- The elixir contains the following non-medicinal ingredients: alcohol, anise oil, artificial lemon flavour, FD&C Red No. 2, glycerin, methylparaben, natural and artificial orange flavour, propylparaben, purified water, sodium chloride, sodium cyclamate, and sucrose.
pms-PHENOBARBITAL and pms-PHENOBARBITAL ELIXIR come in the following dosage forms:
pms-PHENOBARBITAL is available in 4 dosage strengths containing 15 mg, 30 mg, 60 mg, or 100 mg phenobarbital.
pms-PHENOBARBITAL ELIXIR is available as a clear red liquid containing 5 mg / mL phenobarbital.
Do not use pms-PHENOBARBITAL and pms-PHENOBARBITAL ELIXIR if you or your child:
- is allergic to the active ingredient, phenobarbital, or any of the other ingredients, or to barbituric acid derivatives
have the following symptom or problems:
- Porphyria (a genetic disorder that can cause nervous system, blood, and skin problems).
- Lung problems or severe respiratory depression
- Liver or kidney problems
- Pauses in breathing during sleep
- Suicidal thoughts
Alcohol addiction
- Drug addiction
- Have uncontrolled pain
To help avoid side effects and ensure proper use, talk to your healthcare professional about any health conditions or problems you or your child may have BEFORE taking pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR, including if you or your child:
- Have ever had a rash or unusual reaction while taking phenobarbital or any other anti-epileptic drug.
- Drink alcohol. Drinking alcohol with Phenobarbital products may make you less alert and may make any feelings of anger, confusion or sadness worse.
Are pregnant or planning to become pregnant. You must only take pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR during pregnancy if your doctor tells you to.
If you become pregnant while taking pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR, talk to your healthcare provider about registering with
- the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.
- Are nursing or plan to nurse your baby. Nursing while you are taking pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR is not recommended.
Are taking birth control pills
- Phenobarbital may make hormonal birth control such as “the pill” less effective.
- Use other forms of safe and effective birth control when taking pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR.
- You need to use the other forms of birth control until the end of your menstrual cycle after stopping treatment.
- Have used or abused drugs in the past.
Have any of the following diseases or conditions:
- Suffer from seizures that spread to the whole brain
- Heart problems
- Have kidney or liver problems. Your doctor may need to adjust your dose
- Hypothyroidism (a condition in which your body has low thyroid hormone)
- Myasthenia Gravis (a chronic disease that causes severe muscle weakness)
- Central nervous system depression
- Low blood pressure
- Severe anemia (low red blood cell count)
- Hemorrhagic shock (shock due to bleeding)
- Asthma (wheeze or gasp for air due to spasm of the airway)
- Diabetes mellitus
- Hyperkinesis tendencies (abnormally heightened, sometimes uncontrollable muscle movement)
Other warnings you should know about:
- If you use Phenobarbital products regularly for a long time, it may cause mental and physical dependence.
- Sudden removal of this drug may cause unwanted side effects. Your doctor should stop your drug slowly and carefully.
- Ask your doctor about signs and symptoms of life-threatening skin reactions that have been reported with the use of phenobarbital, including Stevens-Johnson syndrome (SJS, a skin reaction with rash and blisters), Toxic Epidermal Necrolysis (TEN, skin rash often with blisters, lesions and lifting skin) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS, a skin reaction with itchy rash and fever). Closely monitor for skin reactions. Most often SJS, TEN and DRESS happen in the first few weeks of treatment. If symptoms or signs of SJS, TEN or DRESS are present, phenobarbital treatment should be stopped, and you should seek urgent medical treatment. The best results in managing SJS, TEN and DRESS come from early detection and stopping the drug treatment right away (see table of Serious Side Effects and What to do About Them, below).
DURING treatment with pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR, tell your doctor if you or your child develops:
- Thoughts of suicide or self-harm
- Abnormal vision (blurry or double vision)
Driving and using machines:
Before doing tasks that require special attention, wait until you know how you respond to pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR. Being dizzy or drowsy can occur. Be careful to avoid accidental injury or falls.
Tell your healthcare professional about all the medicines you or your child are taking, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR:
- Birth control pills
- Other anti-seizure drugs including phenytoin, valproic acid, carbamazepine.
- Oral coumarin anticoagulants
- Antidepressants, MAO Inhibitors (e.g. isocarboxazid, moclobemide, or linezolid etc.)
- Antidepressants (e.g. clomipramine, imipramine, or nortriptyline, amitriptyline)
- Central Nervous System depressants, including alcohol, benzodiazepines
- Corticosteroids (e.g. beclomethasone, fluticasone furoate etc.)
- Griseofulvin (an antifungal drug)
- Digitoxin
- Doxycycline (an antibiotic)
- Ketamine
- Anesthetics
- To a lesser extent: acetaminophen, estrogens, digitalis, digitoxin, cyclophosphamide, doxycycline, quinidine, and vitamin D.
How to take pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR:
Usual dose:
pms-PHENOBARBITAL are given by mouth.
When used as a sedative:
Adults (18 years and over): 15 to 30 mg, 2 or 3 times a day.
Children (under 18 years): 2 mg/kg body weight 3 times a day.
When used as a hypnotic:
Adults (18 years and over): 100 to 200 mg at bedtime.
When used as an anticonvulsant:
Adults (18 years and over): 50 to 100 mg, 2 or 3 times a day
Children (under 18 years): 15 to 50 mg, 2 or 3 times a day
pms-PHENOBARBITAL ELIXIR is given by mouth.
When used as a sedative:
Adults (18 years and over): 4 to 8 mL, 2 or 3 times a day.
Lower doses are required in elderly people and very weak patients in order to prevent a very strong drug effect.
- Do not stop taking pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR without talking to your doctor if you are using it to control seizures. Stopping pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR suddenly can cause serious problems, including seizures that will not stop. Your doctor will tell you if and when you or your child can stop taking this medicine.
- When given for minor seizures, the risk of stopping medication prior to or during pregnancy should be weighed against the risk of birth defects in the particular case and with the particular family history.
Overdose:
| If you think you, or a person you are caring for, have taken too much pms-PHENOBARBITAL and pms-PHENOBARBITAL ELIXIR, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Missed Dose:
If you forget to take one dose, you should never make up for the missing dose by doubling the dose next time. Instead, you should simply continue with the following dose when it is due.
What are possible side effects from using pms-PHENOBARBITAL or pms-PHENOBARBITAL
ELIXIR?
These are not all the possible side effects you may feel when taking pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR. If you or your child experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
The most common side effects associated with the use of pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR are:
- Sleepiness/drowsiness, feeling tired/fatigue
- Headache, dizziness along with the feeling of a spinning movement
- Nausea/ vomiting
- Broken sleep
- Depression
- Diarrhea, constipation
- Unusual or unexpected feeling of joy, happiness, excitement and confusion
- Hypotension (low blood pressure)
- Hyperactivity in children
- "Hangover" confusion especially in the elderly (drowsiness the day after a dose)
Other possible side effects associated with the use of pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR:
- Increase/worsening of pre-existing pain
- Epigastric pain (pain in the upper abdomen)
Serious Side Effects and What to do About Them
| Serious Side Effects and What to do About Them | ||||
|---|---|---|---|---|
| Symptom / effect | Talk to your Healthcare Professional | Stop taking drug and get immediate medical help | ||
| Symptom / effect | Talk to your Healthcare Professional | Stop taking drug and get immediate medical help | ||
| Only if Severe | In all Cases | |||
| Only if Severe | In all Cases | |||
| Common | Low sodium level in blood (symptoms like lack of energy, confusion, muscular twitching or convulsions) | X | ||
| Nervous system problems (symptoms like dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, blurred vision, double vision, etc.) | X | |||
| Allergies (symptoms like fever, rash and swollen lymph nodes, and may be associated with symptoms involving other organs, e.g., liver) | X | |||
| Uncommon | Liver problems (symptoms like yellowing of your skin or the whites of your eyes, nausea or vomiting, loss of appetite, stomach pain, dark [brownish] urine etc.) | X | ||
| Thoughts of suicide or self-harm | X | |||
| Respiratory depression (shallow, slow, weak breathing) | X | |||
| Thinning of the bone, bone softening, bone disease, or fractures (In situations where healthy people would not normally break a bone you may have sudden pain in any location and especially in the wrist, spine or hip. This may be a fracture.) | X | |||
| Altered numbers and types of blood cells, symptoms like unexplained tiredness, weakness, shortness of breath, and sometimes, feeling like you are going to pass out and increased bruising, nosebleeds, sore throats, or infections) | X You should tell your doctors who may want to perform a blood test | |||
| Rare | Severe allergic reactions (symptoms like swelling of face, eyes, lips, or tongue, trouble swallowing or breathing, skin rash) | X | ||
A rare, serious disorder in which your skin reacts severely to a medication (Stevens-Johnson syndrome [SJS] or Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]). If symptoms or signs of SJS or DRESS (e.g. skin rash often with blisters or lesions) are present, phenobarbital treatment should be stopped right away. | X | |||
Severe skin reaction where the upper surface of your skin detaches like a patient who has suffered burns (Toxic Epidermal Necrolysis [TEN]). If symptoms or signs of TEN (e.g. skin rash often with blisters or lesions and lifting skin) are present, phenobarbital treatment should be stopped right away. | X | |||
If you or your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at room temperature (15°C to 30°C).
Keep out of reach and sight of children.
If you want more information about pms-PHENOBARBITAL or pms-PHENOBARBITAL ELIXIR:
- Talk to your healthcare professional
- Find the full Prescribing Information that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.pharmascience.com; or by calling, at 1-888-550-6060.