Nozinan (Methotrimeprazine)

Usual dose:

Your doctor has decided the best dose for you based on your individual situation and needs. It is important to take NOZINAN 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.

For Adults:

• NOZINAN is given as an injection into the muscle.

For Children: the dose is based on the body weight:

• NOZINAN may be given as an injection into the muscle.
• NOZINAN may also be given as an injection in the vein. The NOZINAN injection formulation is to be diluted with a glucose solution and injected slowly into a vein.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you have taken too much NOZINAN, immediately see your doctor, contact your regional Poison Control Centre or go to your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. The signs if you have taken too much NOZINAN may include drowsiness, spasm, shaking, seizure, low blood pressure, difficult breathing and coma.

NOZINAN, like any medication, may cause some side effects. Discuss with your doctor if you do experience side effects.

Side effects include:

• Drowsiness may appear early in treatment but usually disappears during the first weeks. If this effect persists, discuss this with your doctor. Your medication might have to be reduced.
• Dryness of the mouth.
• In older patients, constipation and difficulty in urinating.

Less common side effects include:

• Weight gain has been occasionally reported in patients during long-term treatment with high doses.
• Your skin may be more sensitive to sunlight.

Your doctor should check your body weight before starting NOZINAN and continue to monitor it for as long as you are being treated.

Your doctor should take blood tests before starting NOZINAN. They will monitor blood sugar, and the number of infection fighting white blood cells. Should symptoms such as sore throat or fever appear, consult your doctor. 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.

During the first few days of treatment, NOZINAN 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 NOZINAN does not affect you.

Muscular, neurologic, vascular, cardiac disorders, and hyperglycaemia may occur in some patients taking NOZINAN.

Effects on Newborns: In some cases, babies born to a mother taking NOZINAN 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.

Effects on fertility: NOZINAN may affect the fertility in both men and women.

Before using NOZINAN, tell your doctor if you:

• Have heart or blood vessel disease
• If you have a history of cerebrovascular disease including strokes or transient ischemic attacks (mini-strokes)
• Suffer from an enlarged prostate (Benign Prostatic Hyperplasia)
• Suffer from an increased pressure within the eyes (glaucoma)
• Have or have had seizure disorders (e.g. epilepsy)
• Plan to have surgery (or a procedure requiring anaesthetics)
• Are pregnant or are planning to become pregnant
• Are breast-feeding
• Are taking any other medicines (prescriptions or over the counter medicines).

If you are given NOZINAN and that you may be exposed to extreme heat or if you perform activities which may increase your body temperature (for example exercising vigorously or work in hot, sunny places) or if you are dehydrated, consult your doctor regarding special cares.

If you experience severe constipation and you are elderly, please consult your doctor as soon as possible.

During long-term therapy, periodic liver function tests should be done.

The combination of NOZINAN with some medicines can increase the quantity of the other medicine in your body and therefore the risk of having side effects. Before using any prescription, over-the-counter medicines or herbal products, check with your doctor or your pharmacist.

Drug-Drug Interactions: NOZINAN may increase the drowsiness effect of the following drugs:

• allergy pills
• sleeping pills
• pain killers
• medications for seizure
• anti-depressant pills
• medications for mental illness

Drug-Lifestyle Interactions:

• NOZINAN can add to the effects of alcohol. You should avoid consuming alcoholic beverages while on NOZINAN therapy

NOZINAN may cause a false reading of some types of pregnancy tests. For further information, please consult your doctor or your pharmacist.