Details for: NEULEPTIL
Company: ERFA CANADA 2012 INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 01926780 | NEULEPTIL | PERICIAZINE | 5 MG | CAPSULE | ORAL |
| 01926772 | NEULEPTIL | PERICIAZINE | 10 MG | CAPSULE | ORAL |
| 01926756 | NEULEPTIL | PERICIAZINE | 10 MG / ML | DROPS | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Neuleptil belongs to a group of medicines called “phenothiazines”. It is used to control prevailing hostility, impulsiveness and aggressiveness when used with other medicines.
What it does
Neuleptil is an antipsychotic medication which affects chemicals in the brain that allow communication between nerve cells (neurotransmitters). These chemicals are called dopamine and serotonin. Exactly how Neuleptil works is unknown. However, it seems to readjust the balance of dopamine and serotonin.
When it should not be used
You should not use Neuleptil if you have:
- An allergy to periciazine, to any of its ingredients or to phenothiazines
- A medical condition known as pheochromocytoma (a tumor of the adrenal gland)
- A severe heart or blood vessel disorder
- Severe kidney problems
- Had brain damage
- Liver disease
- A blood cell disorder such as anemia, low white blood cell counts, or low platelets
- Drowsiness, slow breathing, weak pulse
- Decreased alertness caused by taking certain medications or drinking alcohol
- You are going to receive anesthesia in the spine or for a region (such as an arm, leg or the lower part of your body)
What the medicinal ingredient is
Periciazine
What the non-medicinal ingredients are
Capsules: calcium phosphate, croscarmellose sodium, FD&C
Blue No 1, FD&C Red No 3, gelatin, magnesium stearate and
titanium oxide.
Oral drops: alcohol, ascorbic acid, caramel, glycerin,
peppermint oil, purified water, sucrose and tartaric acid.
What dosage form it comes in
Capsules: 5mg, 10mg, 20mg
oral drops:10 mg/ml.
Warnings and precautions
Serious Warnings and Precautions
Studies with various medicines of the group to which NEULEPTIL belongs, when used in the elderly patients with dementia, have been associated with an increased rate of death. NEULEPTIL is not indicated in elderly patients with dementia.
BEFORE you use Neuleptil talk to your doctor or pharmacist if:
- You have heart disease, glaucoma or prostatic hypertrophy
- You are addicted to alcohol. You should not take Neuleptil if you are under the effects of alcohol.
- You have risk factors for developing blood clots such as: a family history of blood clots, age over 65, smoking, obesity, recent major surgery (such as hip or knee replacement), immobility due to air travel or other reason, or take oral contraceptives (“The Pill”).
- You are pregnant. Neuleptil should not be used during pregnancy unless your doctor considers the benefits to you markedly outweigh the potential risks to the fetus
- You are taking barbiturates, painkillers, narcotics, antihistamines or other drugs that make you drowsy.
- You have any allergies to this drug or its ingredients
- You have or ever had a blackout or seizure
- You are breast feeding.
Effects on Newborns:
In some cases babies born to a mother taking Neuleptil during pregnancy have experienced symptoms that are severe and require the newborn to be hospitalized. Sometimes, the symptoms may resolve on their own. Be prepared to seek immediate emergency medical attention for your newborn if they have difficulty breathing, are overly sleepy, have muscle stiffness, or floppy muscles (like a rag doll), are shaking, or are having difficulty feeding.
People who take Neuleptil are cautioned:
- Against exposure to extreme heat
- That drugs such as Neuleptil increase the toxicity of certain types of insecticides ("organophosphorous" insecticides) including insecticides for agriculture (farming), treating animals (flea and tick control) and for treating pests around the house and garden. Be cautious if you must use these products while taking Neuleptil.
Interactions with this medication
Neuleptil can add to the effects of alcohol. You should avoid
consuming alcoholic beverages while on Neuleptil therapy.
Tell your doctor about all your prescription and over-thecounter
medications, vitamins, minerals, herbal products (such
as St. John’s Wort), and drugs prescribed by other doctors. Do
not start a new medication without telling your doctor.
Before using Neuleptil, tell your doctor if you regularly use
other medicines that make you sleepy (such as cold or allergy
medicine, narcotic pain medicine, sleeping pills, muscle
relaxants, and medicine for seizures, depression, or anxiety).
You should not take Neuleptil if you have drowsiness caused
by other medications.
Drugs that may interact with Neuleptil include:
anti-anxiety agents, antidepressants, muscle relaxants, antiseizure
medicine, high blood pressure medicine, cabergoline,
metrizamide, guanethidine, guanadrel, grepafloxacin,
sparfloxacin, lithium, cisapride, atropine-like drugs, narcotic
pain relievers (e.g., codeine), drugs used to aid sleep,
drowsiness-causing antihistamines (e.g., diphenhydramine),
other drugs that may make you drowsy.
Many cough-and-cold products contain ingredients that may
add a drowsiness effect. Before using cough-and-cold
medications, ask your doctor or pharmacist about the safe use
of those products. Do not start or stop any medicine without
doctor or pharmacist approval.
This list is not complete and there may be other drugs that can
interact with Neuleptil.
Proper use of this medication
Take this medication by mouth exactly as prescribed. During
the first few days your doctor may gradually increase your
dose to allow your body to adjust to the medication. Do not
take this more often or increase your dose without consulting
your doctor. Your condition will not improve any faster but
the risk of serious side effects will be increased. Do not stop
taking this drug suddenly without your doctor's approval.
Your doctor will decide which dose is best for you.
Usual dose
Usual initial doses are:
Adults: 5 to 20 mg in the morning and 10 to 40 mg in the
evening
Older adults: At first, 5 mg a day. Your doctor may increase
your dose if needed. However, the dose is not usually more
than 30 mg a day
Children 5 years of age and older: 2.5 to 10 mg taken in the
morning, and 5 to 30 mg taken in the evening.
Overdose
Overdose symptoms may include agitation, and confusion, drowsiness, dizziness, muscle stiffness or twitching, increased salivation, trouble swallowing, weakness, loss of balance or coordination, and fainting.
Missed Dose
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not double your dose to make up the missed dose.
Side effects and what to do about them
Like other medications, Neuleptil may cause some side effects.
These side effects may be minor and temporary. However,
some may be serious and need medical attention.
Side effects may include: sweating, urinary incontinence,
dizziness, drowsiness, dry mouth, nasal congestion, nausea
and vomiting, headache, menstrual changes, change in libido,
swelling of the breasts and milk production in both men and
women, weight changes and blurred vision.
If any of these affects you severely, tell your doctor.
Your doctor should check your body weight before starting
Neuleptil and continue to monitor it for as long as you are being
treated.
Your doctor should take blood tests before starting Neuleptil.
They will monitor blood sugar, and the number of infection
fighting white blood cells. Your doctor should continue to
monitor your blood for as long as you are being treated.
If you have high levels of prolactin (measured with a blood test)
and a condition called hypogonadism you may be at increased
risk of breaking a bone due to osteoporosis. This occurs in both
men and women.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and seek immediate emergency medical attention |
|---|---|---|---|
| Unknown | |||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
| Neuroleptic Malignant Syndrome: any group of symptoms which may include high fever, sweating, stiff muscles, fast heartbeat, fast breathing and feeling confused, drowsy or agitated | ✔ | ||
| Extrapyramidal Symptoms: muscle stiffness, body spasms, upward eye rolling, exaggeration of reflexes, drooling, difficulty moving how and when you want. | ✔ | ||
| Fast or irregular heartbeat | ✔ | ||
| Seizures or fits | ✔ | ||
| Long-lasting (greater than 4 hours in duration) and painful erection of penis | ✔ | ||
| Tardive Dyskinesia: uncontrollable movements or twitches of the body, face, eyes or tongue, stretching the neck and body | ✔ | ||
| Low Blood Pressure: feeling of Lightheadedness or fainting especially when getting up from a lying or sitting position | ✔ | ||
| High Blood Pressure: headaches, vision disorders, nausea and vomiting | ✔ | ||
| Decreased sweating | ✔ | ||
| Jaundice: yellow colour to skin and eyes, dark urine | ✔ | ||
| Respiratory Infection: fever, flu-like symptoms, coughing, difficult or fast breathing | ✔ | ||
| New or worsening constipation | ✔ | ||
| Akathisia: a feeling of restlessness, inability to remain motionless | ✔ | ||
| Vision Changes: blurred vision, glaucoma or other eye disorder | ✔ | ||
| Increased Blood Sugar: frequent urination, thirst and hunger | ✔ | ||
| Uncommon | |||
| Blood clots: swelling, pain and redness in an arm or leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations. | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Neuleptil, contact your doctor or pharmacist.
How to store
Store this medication at room temperature between 15 and 30 oC away from heat and light. Do not store in the bathroom. Keep this and all medications out of the reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at:
http://www.ECI2012.net
or by contacting the sponsor, Erfa Canada Inc. at:
1-800-922-3133
This leaflet was prepared by Erfa Canada 2012 Inc.
Last revised: December 19, 2012.