Patient Medication Information: uses, side effects, how to take - Largactil 25
ABOUT THIS MEDICATION
What the medication is used for:
Largactil® is used:
To treat symptoms of schizophrenias, psychoses, behavioural
disorders or confusion in the elderly
- To control nausea, vomiting or persistent hiccup
Largactil® is also used:
In conditions associated with emotional stress ③ In the treatment of withdrawal symptoms of addicts and
alcoholics.
Before a surgery to reduce anxiety, to reduce the need for
drugs relieving pain, to control nausea and vomiting or to prevent and treat shock following the surgery.
Ask your doctor if you have any questions about why Largactil® has been prescribed to you.
What it does:
Largactil® helps to:
reduce and control psychotic symptoms and induce sleep
which can control various states of emotional tension, agitation, hyperactivity and confusion.
- control nausea and vomiting.
- intensify the effects of drugs that relieve pain.
When it should not be used:
Do not use Largactil® if you:
Are allergic to Largactil®, to phenothiazines (a type of
antipsychotic) or to any of the ingredients in the product (see the section “What the non-medicinal ingredients are”) ③ Are in an altered state of consciousness or coma, especially if
this is caused by alcohol or drugs
- Have a blood disorders
- Have liver disease
What the medicinal ingredient is:
chlorpromazine hydrochloride
What the non-medicinal ingredients are:
Liquid of 25 mg/5 mL: alcohol, ascorbic acid, citric acid, ethyl vanillin, glycerin, peach flavor, purified water, sodium benzoate and sucrose.
Liquid of 100 mg/5 mL: alcohol, artificial fruit flavor, citric acid, D&C Yellow No. 10, ethyl vanillin, glycerin, purified water, sodium benzoate and sucrose.
Oral drops: alcohol, artificial and natural custard flavor, caramel, citric acid, glycerin, purified water, sucrose and terpeneless orange oil.
Suppositories: hydrogenated vegetable glycerides.
What dosage forms it comes in:
- Liquid 25 mg/5 mL
- Liquid 100 mg/5 mL
- Oral drops 40 mg/mL
- Suppositories 100 mg
WARNINGS AND PRECAUTIONS
At the beginning of treatment, Largactil® may cause some people to become drowsy or less alert. You should not drive a car, operate machinery or participate in activities requiring total alertness until you are sure Largactil® does not affect you.
Tardive dyskinesia, neuroleptic malignant syndrome and cardiac disorders may occur in some patients taking Largactil® (See the section “SIDE EFFECTS AND WHAT TO DO ABOUT THEM”).
Before using Largactil®, tell your doctor if you:
- Have heart or blood vessel disease
- Have constipation or intestinal blockage
- Suffer from an enlarged prostate (Benign prostatic hypertrophy)
Suffer from an increase pressure within the eyes (glaucoma) ③ Have or have had seizure disorders (e.g. epilepsy) ③ Plan to have surgery (or a procedure requiring anaesthetics) ③ Are or are planning to become pregnant
- Are breast-feeding
If you experience severe constipation and you are elderly, please consult your doctor as soon as possible.
During long-term therapy, liver and blood tests should be done at regular intervals.
INTERACTIONS WITH THIS MEDICATION
Largactil® can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on Largactil® therapy.
Before using any prescription, over-the-counter medicines or herbal products, check with your doctor or your pharmacist.
Largactil® can add to the effects of other drugs that cause drowsiness. Some examples of drugs that cause drowsiness are:
- Drugs for allergies
- Drugs for sleep
- Drugs for pain
- Drugs for seizure
- Drugs for depression
- Drugs for mental illness
Largactil® may cause a false pregnancy test result. Please check with your doctor if this happens.
PROPER USE OF THIS MEDICATION
Usual dose:
Your doctor has decided the best dose for you based on your individual situation and needs. It is important to take Largactil® the way your doctor told you. Your doctor may increase or decrease your dose depending on your response.
You may experience side effects if the drug is stopped suddenly. Contact your physician before stopping your drug.
Adults - In general medicine and psychiatry
Oral route: The average dose is 30 to 75 mg a day (mild cases) or 75 to 100 mg a day (more severe cases). The daily dose is divided into smaller doses during the day. Your doctor may decrease or increase your dose if needed.
Rectal route: 1 to 3 suppositories daily.
Adults - In surgery and anesthesia
Oral route: doses of 25 to 50 mg are administered 2 to 3 hours before anesthesia and every 4 to 6 hours after surgery.
Children
Oral route: Dose is based on body weight.
Overdose:
If you have taken too much Largactil®, immediately see your doctor or go to your nearest hospital emergency department. Show the doctor your bottle or box of Largactil®. Do this even if there are
no signs of discomfort or poisoning. The signs if you have taken too much Largactil® may include agitation, hyperactivity, confusion, drowsiness and coma.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Largactil®, like any medication, may cause some side effects. Discuss with your doctor if you do experience side effects.
Side effect include:
- Drowsiness frequently occurs at the beginning of treatment but gradually disappear with time or with a reduction of the dose. If this effect persists, discuss this with your doctor.
- Blurred vision, changes in libido, coloration of the skin or the cornea (transparent portion of the outer covering of the eyes), constipation, dryness of the mouth, enlargement of the breast in male, nasal congestion, nausea, sleepiness, weight gain.
- Your skin may be more sensitive to sunlight
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
Symptom / effect See text below for more details | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| Only if severe | In all cases | ||||
| Common | Hypotensiona) | √ | |||
| Uncommon | Allergic Reactions Blood disordersb) Cardiac disordersa) Extrapyramidal reactionsc) Liver disordersb) Lung disordersb) Neuroleptic malignant syndromed) Tardive dyskinesiae) | √ √ √ √ √ √ √ | √ | ||
- a) Cardiac disorders: At the start of treatment, some people may have low blood pressure and feel dizzy, especially when getting up from a lying or sitting position, particularly when high doses are used. Uncommonly, Largactil® may cause the heartbeat to
become faster or irregular. Check with your doctor immediately if you experience any of these side effects.
- b) Blood, liver and lung disorders have been associated with this class of drug. It is important that you tell your doctor at once about any unexplained symptom you might experience. Examples of this are soreness of the mouth, gums or throat or any symptoms of upper respiratory infection, unexplained fever, itching, flu-like symptoms, coughing, abdominal pain or jaundice.
- c) Extrapyramidal reactions are rare and usually appear only after long-term therapy at high doses. The signs and symptoms of extrapyramidal reactions include tremor, muscle stiffness, body spasm, impairment of voluntary movement, upward eye rolling, exaggeration of reflexes or drooling. Tell your doctor immediately if you experience any of these side effects. Your medication might have to be reduced.
- d) Neuroleptic malignant syndrome. Another possible serious unwanted effect is the neuroleptic malignant syndrome. Signs and symptoms of the neuroleptic malignant syndrome include severe muscle stiffness, increased sweating, fever, fast or irregular heartbeat, high or low blood pressure, difficult or fast breathing and confusion. If any of the above side effects occur, consult your doctor immediately.
- e) Tardive dyskinesia may occur in some patients on long-term therapy or after they stop using Largactil®. Signs of tardive dyskinesia include muscle twitching or uncontrolled movements of the mouth, tongue, face or jaw. In some patients, this side effect may not go away after they stop using Largactil®. Tell your doctor immediately if you experience any muscle twitching or abnormal body movements.
Other very rare side effects include:
painful erection or systemic lupus erythematosis (an
autoimmune disease: the immune system turns against parts of the body it is designed to protect. This leads to inflammation and damage to various body tissues).
This is not a complete list of side effects. For any unexpected effects while taking Largactil®, contact your doctor or pharmacist.
HOW TO STORE IT
Largactil® oral drops, liquid and suppositories should be protected from exposure to light.
Largactil® suppositories should be stored in a cool place.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
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 upon request to the sponsor, sanofi-aventis Canada Inc., 2150 St Elzear Blvd. West, Laval, Quebec H7L 4A8, at:
1-800-265-7927