Patient Medication Information: uses, side effects, how to take - Piportil L4
ABOUT THIS MEDICATION
What the medication is used for:
Piportil L4 is used in adults to treat symptoms of chronic schizophrenias without agitation.
What it does:
Piportil L4 helps reduce and control the symptoms of schizophrenia.
When it should not be used:
Do not use Piportil L4 if you:
Are allergic to Piportil L4 to phenothiazines
(a type of antipsychotic) or to any of the ingredients in the product (see the section “What the non-medicinal ingredients are”)
Have a sudden blood circulation failure or
are in an altered state of consciousness or coma, especially if these were caused by alcohol or drugs
- Suffer from severe depression
- Have liver disease
- Have a blood disorder
- Have kidney problems
Have pheochromocytoma (a tumour of the
adrenal gland)
- Have severe heart or blood vessel disorders
- Have or have had brain damage
Are taking high doses of drugs that cause
you to sleep
Piportil L4 is not indicated for use in children or in elderly patients with dementia (mental decline).
What the medicinal ingredient is:
Pipotiazine palmitate
What the nonmedicinal ingredients are:
Sesame oil
What dosage forms it comes in:
Formulations for injection in the muscle
- 25 mg/mL
- 50 mg/mL
WARNINGS AND PRECAUTIONS
At the beginning of treatment, Piportil L4 may cause some people to become drowsy or less alert. You should not drive a car, operate machinery or participate in activities requiring alertness until you are sure Piportil L4 does not affect you.
You should use extra care not to be exposed to extreme heat or some type of insecticides. Check with your doctor or pharmacist.
Patients over 55 years of age are at greater risk to develop adverse effects.
If you experience severe constipation and you are elderly, please consult your doctor as soon as possible.
Muscular, neurologic, cardiac, vascular, eye, skin or respiratory problems and hyperglycaemia may occur in some patients taking Piportil L4 (see the section “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”).
Effects on Newborns:
In some cases, babies born to a mother taking Piportil
L4 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.
Before using Piportil L4, tell your doctor if you:
- Have heart or blood vessel disease
Have a history of cerebrovascular disease
including strokes or transient ischemic attacks (mini-strokes)
- Have constipation or intestinal blockage
Have or have had a brain tumour or brain
damage
Have or have had seizure disorders (e.g.
epilepsy or have members of your family with seizure disorders)
- Have or have had breast cancer
Plan to have surgery (or a procedure
requiring anaesthetics)
- Are or are planning to become pregnant
- Are breast feeding
Occasional liver and blood function tests should be done while you are taking Piportil L4, and kidney function tests should be done if you are taking it long-term.
INTERACTIONS WITH THIS MEDICATION
Piportil L4 can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on Piportil L4 therapy.
Before using any prescription, over-the-counter medicines or herbal products, check with your doctor or your pharmacist.
Piportil L4 can add to the effects of other drugs that cause drowsiness. Some examples of drugs that can cause drowsiness are:
- Drugs for allergies
- Drugs for sleep
- Drugs for pain
- Drugs for seizure
- Drugs for depression
- Drugs for mental illness
Piportil L4 may cause a false reading of some types of pregnancy tests. For further information, please consult your doctor or your pharmacist.
PROPER USE OF THIS MEDICATION
Usual dose:
Piportil L4 is given by an injection in the muscle.
- Your doctor has decided the best dose for you based on your individual situation and needs.
An initial dose of 50 mg to 100 mg may be given. Your doctor may decide to start your treatment with lower doses, particularly if you are over 50 years old. If needed, your doctor may increase your dose usually by 25 mg every 2 or 3 weeks.
Based on your response, your doctor will determine your dose and the interval between the injections.
You may experience side effects if the drug is stopped suddenly. Contact your physician before stopping your drug.
Overdose:
The signs if you have received too much Piportil L4 may include, spasm, muscle stiffness, tremor, impairment of voluntary movement, weakness, drowsiness and low blood pressure.
If you have received too much Piportil L4, immediately see your doctor or go to your nearest hospital emergency department or contact your Regional Poison Centre.
SIDE EFFECTS AND WHAT TO DO
ABOUT THEM
Piportil L4, like any medication, may cause some side effects. Discuss with your doctor if you do experience side effects.
Reactions at the site of injection are seldom seen.
Side effects include:
- Appetite change, constipation, dryness of the mouth, increase thirst, nasal congestion, nausea, urinary incontinence, sweating, vomiting, weight change.
▪
- Agitation, anxiety, bizarre dreams, dizziness, excitement, restlessness.
- Changes in libido, increase of the breast size in men, impotence, lactation, menstrual irregularities,
peripheral oedema (swelling
- of the legs, ankles, and feet)
- Your skin may be more sensitive to sunlight.
Side effects that might need a reduction in your dose are:
Drowsiness, fatigue, insomnia, sad mood, sleep disturbances.
Your doctor should check your body weight before starting Piportil L4 and continue to monitor it for as long as you are being treated.
Your doctor should take blood tests before starting Piportil L4. 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.
This is not a complete list of side effects. For any unexpected effects while taking Piportil L4, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15 to 30o C). Protect from exposure to light.
Keep in a safe place out of the reach of children.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||||
| HAPPEN ANDWHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency assistance | |||
| Only if severe | In all cases | ||||
| Common | |||||
| Muscle stiffness, body spasm, impairment of voluntary movement, upward eye rolling, exaggeration of reflexes or drooling | x | ||||
| Uncommon | |||||
| Allergic reaction such as skin rash, redness or itching | x | ||||
| Respiratory infection, fever, flu-like symptoms, coughing, difficult or fast breathing | x | ||||
| Soreness of the mouth, gums or throat, abdominal pain or jaundice | x | ||||
| Rapid or irregular heart beat, low or high blood pressure | x | ||||
| Blurred vision, or other eye disorder | x | ||||
| Increased sweating confusion, reduced consciousness | x | ||||
| Muscle twitching or abnormal movement of the face or tongue | x | ||||
| Pain, swelling , redness or warmth in arms or legs, chest pain, anxiety, coughing up blood | x | x | |||
| Hyperglycaemia (too much sugar in the blood) with symptoms such as increased thirst, decreased appetite, nausea or vomiting | x | ||||
| Long-lasting (greater than 4 hours in duration) and painful erection of the penis | x | ||||
| New or worsening constipation | x | ||||
MORE INFORMATION
Your physician, nurse and pharmacist are always your best source of information about your condition and treatment. If you have additional questions or concerns, be sure to ask them.
This document plus the full product monograph is available at www.sanofi-aventis.ca or upon request to the sponsor, sanofi-aventis Canada Inc., 2150 St Elzear Blvd. West , Laval , Quebec H7L 4A8, at: 1-800-265-7927
Last revised: October 31, 2011
REPORTING SUSPECTED 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 0701 E Ottawa, ON 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.