Fenemal may cause a severe allergic reaction. Stop taking Fenemal and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
restless muscle movements in your eyes, tongue, jaw, or neck;
slow heartbeat, shallow breathing;
feeling light-headed, fainting;
a fever or a sore throat;
sores in your mouth;
easy bruising or bleeding; or
broken blood vessels under your skin.
Less serious side effects may include:
drowsiness or dizziness;
problems with memory or concentration;
excitement, irritability, aggression, or confusion (especially in children or older adults);
loss of balance or coordination;
nausea, constipation;
headache; or
"hangover" effect (drowsiness the day after a dose).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Fenemal in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients.
More than 1 in 100 patients:
The most common adverse reaction estimated to occur at a rate of 1 to 3 patients per 100 is:
Nervous system: Somnolence.
Less than 1 in 100 patients:
Adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are:
Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic Fenemal use.
DRUG ABUSE AND DEPENDENCE
Fenemal may be habit forming:
Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of Fenemal. As tolerance to Fenemal 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 Fenemal include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints.
Symptoms of Fenemal 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 Fenemal withdrawal can be severe and may cause death. Minor withdrawal symptoms may appear 8 to 12 hours after the last dose of Fenemal. 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 Fenemal abuse and dependence include alcoholics and opiate abusers, as well as other sedative- hypnotic and amphetamine abusers.
Drug dependence on Fenemal 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 Fenemal 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 Fenemal dependence consists of cautious and gradual withdrawal of the drug. One method involves substituting a 30 mg dose of Fenemal for each 100 to 200 mg dose that the patient has been taking. The total daily amount of Fenemal 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 Fenemal may be administered IM in addition to the oral dose. After stabilization on Fenemal, 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 Fenemal may be given a lower dose of Fenemal at 3 to 10 mg/kg/day. After withdrawal symptoms (hyperactivity, disturbed sleep, tremors, hyperreflexia) are relieved, the dosage of Fenemal should be gradually decreased and completely withdrawn over a 2-week period.
What is the most important information I should know about Fenemal?
Fenemal elixir may cause dizziness, drowsiness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Fenemal elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fenemal elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Use Fenemal elixir with caution in the ELDERLY; they may be more sensitive to its effects.
Fenemal elixir should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Fenemal elixir. To prevent pregnancy, use an extra form of birth control (eg, condoms).
PREGNANCY and BREAST-FEEDING: Fenemal elixir has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fenemal elixir while you are pregnant. Fenemal elixir is found in breast milk. If you are or will be breast-feeding while you use Fenemal elixir, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high doses, Fenemal elixir may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Fenemal elixir stops working well. Do not take more than prescribed.
Some people who use Fenemal elixir for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Fenemal elixir suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, nausea, sleeplessness, and body aches.
Fenemal contraindications
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Do not use Fenemal if you are pregnant. It could harm the unborn baby. Fenemal may also cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy.
Fenemal can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking Fenemal.
Fenemal may cause a severe allergic reaction. Stop taking Fenemal and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Do not stop using Fenemal without first talking to your doctor, even if you feel better. You may have increased seizures if you stop using Fenemal suddenly. You will need to use less and less before you stop the medication completely.
Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Fenemal and talk with your doctor about another treatment for your sleep disorder.
Fenemal may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
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References
DTP/NCI. "phenobarbital: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "Phenobarbital: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Fenemal are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Fenemal. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
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