Patient Medication Information: uses, side effects, how to take - Lithmax
Serious warnings and precautions box
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What LITHMAX is used for:
LITHMAX used to:
treat manic episodes in adults who have a condition called manic-depressive disorder (also known as bipolar disorder). Signs of a manic episode include:
- feeling invincible or an all-powerful inflated self-esteem,
- having racing thoughts, easily losing train of thought,
- overreacting to what you see or hear,
- speeding-up your activities,
- talking very quickly, too loudly, or more than usual,
- needing less sleep,
- having poor judgment,
- severe irritability.
- prevent or reduce further mood swings, either up (mania) or down (depression) in adults with manic-depressive disorders (bipolar disorder).
How LITHMAX works:
LITHMAX belongs to a group of medicines called antimanic agents. It works by stabilising the chemicals in your brain that affect your mood.
The ingredients in LITHMAX are:
Medicinal ingredients: Lithium carbonate.
Non-medicinal ingredients: Hydroxypropyl methylcellulose and magnesium stearate.
LITHMAX comes in the following dosage form:
Sustained-Release Tablets: 300 mg.
Do not use LITHMAX if:
- you are allergic to lithium carbonate, any of the ingredients in LITHMAX or any part of the container (see The ingredients in LITHMAX are).
- you have or have had severe brain damage.
- you have or have had kidney problems
- you have or have had heart problems, an abnormal heart beat or heart disease.
- you have a condition that causes severe weakness or frailty.
- you are severely dehydrated.
- have been told you have low levels of salt (sodium) in your blood or are on a diet low in salt (sodium).
- you are taking medicines called diuretics that increase urine production.
- you are under 12 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LITHMAX. Talk about any health conditions or problems you may have, including if you:
- have impaired renal function.
- have or have had thyroid or parathyroid problems.
- have been told that you have high levels of calcium in your blood.
- suffer from excessive vomiting, diarrhea, or sweating.
- are pregnant, think you might be pregnant or planning to become pregnant.
- are breastfeeding.
- are 65 years of age or older.
Other warnings you should know about:
LITHMAX may cause serious side effects such as:
- Encephalopathic syndrome (a brain disorder): Cases of encephalopathic syndrome have been seen in patients taking lithium with a medicine called haloperidol (antipsychotic medicine used to treat mental and emotional disorders). This condition can lead to permanent brain damage. Your healthcare professional will monitor you if you are taking LITHMAX with any antipsychotic medicines.
- Thyroid problems: The thyroid is a butterfly-shaped gland located at the front of your neck. LITHMAX can cause an enlarged thyroid (also known as goiter). Tell your healthcare professional if you notice your thyroid getting bigger while taking LITHMAX. They may prescribe treatment with small doses of thyroid hormones to help stop further growth or shrink your thyroid. If you have taken LITHMAX for a long time, the enlarged thyroid may disappear on its own after you stop taking LITHMAX.
- Hypercalcemia (high blood calcium): Taking LITHMAX for a long time may cause high levels of calcium in the blood. This can also be accompanied with a hormone disorder called hyperparathyroidism. This is a condition where your parathyroid glands (located behind your thyroid gland), create too much parathyroid hormone in the blood. This could lead to other medical problems.
- Kidney problems: LITHMAX may cause frequent urination and other kidney problems that may affect how the kidneys work. This may occur in patients taking LITHMAX for a long time.
- Serious skin reactions: LITHMAX may cause a condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). This is a serious condition where you experience a skin rash that spreads to large areas of your body. You may also experience a fever, swelling of the face, inflammation of major organs like your kidneys or liver and swollen lymph nodes (small organs in your body that are part of your immune system and contain white blood cells to help fight infections).
See the Serious side effects and what to do about them table for more information on these and other serious side effects
Driving and using machines: Be careful about driving, operating machines, or doing activities that require you to be alert. LITHMAX may impair your mental and physical abilities. If you experience this while using LITHMAX, you should not drive or operate machines.
Diet and hydration: LITHMAX may decrease salt (sodium) levels in your body. Therefore, it is important to have a consistent and normal diet consuming enough salt and water.
- Do not make any sudden changes to your diet or salt (sodium) intake. Talk to your healthcare professional before making any changes.
- If you are exercising for a long period of time or have been suffering from excessive vomiting, sweating or diarrhea, drink plenty of fluids.
- Low salt levels and dehydration may affect the amount of lithium in your blood. This could lead to toxic levels of lithium in your blood.
- If you experience conditions that could lead to low salt levels in your blood and/or dehydration (for example, sweating, diarrhea, infections, fevers, etc.) you may have to stop taking LITHMAX. Talk to your healthcare professional if you experience these conditions.
Pregnancy and birth control:
- LITHMAX should not be used by women who are pregnant or could be come pregnant.
- Tell your healthcare professional right away if you become pregnant or think you might be pregnant while taking LITHMAX. They will discuss the treatment and risks with you and decide if you should continue taking LITHMAX.
- Women who are able to get pregnant should have a pregnancy test done before starting treatment with LITHMAX and should avoid becoming pregnant during treatment.
- You should use birth control while taking LITHMAX whether you are male or female.
Breast-feeding
- LITHMAX can pass into breast milk and harm your child. LITHMAX should not bet used while breast-feeding. Your healthcare professional will decide if treatment with LITHMAX outweighs the risk in these cases.
Adults (65 years of age or older):
- You may be more likely to experience a side effect, called lithium toxicity (a serious, life-threatening condition where there is too much lithium in your body), while taking LITHMAX. This can happen even at doses prescribed for you. Your healthcare professional may start you with a lower dose of LITHMAX and see how you respond to it.
Check-ups and testing: Your healthcare professional may do check-ups and tests before you start LITHMAX and during your treatment. These tests may include:
blood tests to monitor:
- the amount of lithium in your blood
- the health of your kidneys, thyroid and parathyroid glands
- the electrolyte levels (sodium and calcium) in your blood
urine tests to monitor:
- your hydration level
- the health of your kidneys
- electrocardiogram (ECG) tests to monitor the health of your heart.
- body weight checks to monitor any weight gain.
- mental status checks to monitor your mental health.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LITHMAX:
medicines used to treat high blood pressure or other heart problems such as:
- thiazide diuretics, (also known as “water pills”) like furosemide.
- Angiotensin Converting Enzyme (ACE) inhibitors (e.g., benazepril, captopril, enalapril or lisinopril).
- calcium channel blockers (e.g., verapamil, diltiazem, amlodipine, felodipine, nifedipine).
- a beta blocker like propranolol.
- methyldopa.
- medicines used to treat asthma and other lung diseases like aminophylline or theophylline.
- medicines used to treat fits or seizures like carbamazepine or phenytoin.
- medicines used to treat serious mental and emotional disorders, including schizophrenia and other psychotic disorders. These include:
- haloperidol
- phenothiazines (like as prochlorperazine, chlorpromazine, thioridazine, perphenazine, fluphenazine).
- medicines used in anaesthesia (preventing the feeling of pain during medical procedures) called neuromuscular blocking agents.
- medicines called non-steroidal anti-inflammatory agents (NSAIDs) that are used to relieve pain and reduce inflammation like indomethacin, ibuprofen, naproxen, diclofenac and celecoxib.
- tetracyclines (used to treat infections).
- diets that are low in salt (sodium).
- mazindol (used to supress appetite).
- urea (used to treat low levels of salt (sodium) in the blood).
- sodium bicarbonate (used to reduce stomach acid and treat heartburn).
diazepam (used to treat anxiety, alcohol withdrawal and seizures).
- potassium iodide (used to treat an overactive thyroid and to protect the thyroid gland from the effects of radiation).
- medicines used to treat depression, like selective serotonin reuptake inhibitors (SSRI) (such as fluvoxamine, fluoxetine, citalopram and sertraline) or tricyclic antidepressants.
- medicines used to cause short-term paralysis during surgery (like succinylcholine and pancuronium).
How to take LITHMAX:
- Take LITHMAX exactly as your healthcare professional has told you.
- Swallow the whole tablet or half-tablet (if broken in half).
- Do NOT chew or crush the tablets.
- Do NOT take more LITHMAX than you are told by your healthcare professional. This may cause you serious harm or even death.
Usual dose:
- Your healthcare professional will tell you how much and how often to take LITHMAX. How much you take will depend on your condition.
- During your treatment, your healthcare professional will check if LITHMAX is working for you and if it is causing you any unwanted side effects.
- They may change how much LITHMAX you take depending on the amount of lithium in your blood and how your respond to LITHMAX.
- After a manic episode (usually within a week), your healthcare professional may rapidly decrease how much LITHMAX you take. This is to avoid unwanted side effects.
Overdose:
Signs of an overdose with LITHMAX may include:
- feeling sluggish,
- drowsiness
- lack of energy,
- shaking, or muscle or twitching,
- loss of appetite, vomiting,
- diarrhea.
If you experience these symptoms, STOP taking LITHMAX immediately and talk to your healthcare professional.
| If you think you, or a person you are caring for, have taken too much LITHMAX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed Dose:
If you miss a dose, skip the missed dose and take your next dose at the usual time.
Possible side effects from using LITHMAX:
These are not all the possible side effects you may have when taking LITHMAX. If you experience any side effects not listed here, tell your healthcare professional.
- nausea
- vomiting
- diarrhea
- dry mouth
- stomach pain
- loss of appetite
- tiredness, weakness
- blind spots in your eyesight
- weight changes
- repeated jerking movements of the arms and legs on one or both sides of the body, sometimes with numbness or tingling.
- headache
- worsening of a condition called organic brain syndrome. This is a condition that affects your brain and impacts you’re your mental abilities like memory, thinking, attention and perception.
- metallic taste in your mouth
- feeling thirsty or dehydrated
- vertigo (feeling like you are spinning)
- painful discoloration of fingers and toes, cold hands, and feet
- problems with kidney function, bones and skin
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Gastrointestinal disorders: Nausea, abdominal pain, vomiting, diarrhea, anorexia (eating disorder that causes very low body weight and obsession about weight and what you eat) | √ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Nervous system disorders: Reduced awareness of the environment, muscle weakness, sleepiness, a dazed feeling (unable to think clearly), hand tremor | √ | ||
| General disorders: Abnormally increased thirst and polyuria (larger than usual urine volumes), fatigue, vertigo | √ | ||
| RARE | |||
| Hyperthyroidism (high thyroid hormone): anxiety or nervousness, weight loss, frequent and loose bowel movements, breathlessness, feeling hot and possibly feelings of having rapid, fluttering or pounding heart, feeling shakey, increased appetite, excessive sweating, vision changes, menstrual changes. | √ | ||
| UNKNOWN | |||
| Blood and lymphatic system disorders: elevated white blood cell count | √ | ||
| Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat | √ | ||
| Endocrine disorders: Thyroid problem and the condition known as Euthyroid goiter (enlarged thyroid gland), hypothyroidism (including myxedema): lower T3 and T4 levels and elevated TSH, weight loss or weight gain | √ | ||
| Eye Disorders: Blurred vision, visual field defect (blind spot, partial loss of vision) | √ | ||
| Gastrointestinal disorders: Dry mouth, loss of appetite, metallic taste, vomiting | √ | ||
| General disorders: Loss of full control of body movement, lethargy, fatigue | √ | ||
| Metabolism and nutrition disorders: Loss of appetite, dehydration | √ | ||
| Enlargement of the thyroid gland (with or without hypothyroidism): elevated level of the sugar glucose in the blood | √ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Musculoskeletal and connective tissue disorders: Muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), swelling of ankles or wrists | √ | ||
| Nervous system disorders: tremor, muscle hyperirritability (fasciculation, twitching, especially of facial muscles and clonic movements of the limbs), hypertonicity, ataxia, choreoathetotic movement, hyperactive deep tendon reflexes, extrapyramidal symptoms including acute dystonia and parkinsonism, general muscle weakness, urinary and fecal incontinence, slurred speech, blackout spells, seizures, cranial nerve involvement, psychomotor retardation, somnolence, dizziness, toxic confusional states, restlessness, stupor, coma, tinnitus, hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes, myasthenic syndromes | √ | ||
| Psychiatric disorder: Slurred speech, state of being drowsy, slowing down or inhibition of mental and physical activity, state of near-unconsciousness or insensibility, tendency to sleep, confusion | √ | ||
| Renal and urinary disorders: Increased albumin in urine, decreased or increased urination (resembling diabetes insipidus), glucose in urine. | √ | ||
| Skin and subcutaneous tissue disorders: Drying and thinning of hair, loss of sensation of skin, acne, inflammation of hair follicles in skin, abnormally dry skin, alopecia and red, itchy scaly patches, most commonly on the knees, elbows, trunk and scalp, pruritis, cutaneous ulcers | √ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Drug reaction with eosinophilia and systemic symptoms (DRESS) (serious skin reaction that may affect one or more organs): fever, severe rash, peeling skin, swelling of the face or legs, swollen lymph glands, flu-like feeling, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feel thirsty, urinating less often, less urine or dark urine. | √ | ||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | √ | ||
| Peripheral circulatory collapse (the body is unable to circulate blood to the organs): low blood pressure, rapid heart rate, pale cool clammy skin, rapid breathing, confused or altered mental status, weakness or dizziness, loss of consciousness.This is very serious and can lead to death. | √ | ||
| Encephalopathic syndrome (a rare neurological disorder): feeling weak, extreme sleepiness, fever, trembling, confusion, inability to sit still, involuntary muscle contraction or facial movements, shaking, or stiff muscles, can lead to permanent brain damage. | √ | ||
| Hypercalcemia (high blood calcium): constipation, weight loss, nausea, vomiting, abdominal pain, loss of appetite. Can be accompanied with body aches, sleepiness or difficulty sleeping, bone pain, memory loss, poor concentration, depression, or headache. | √ | ||
| Lithium toxicity (lithium overdose): upset stomach, diarrhea, vomiting, feeling thirsty, lack of coordination, muscle control or energy, shaking, muscle weakness, sleepiness, ringing in the ears, blurry vision, confusion, feeling disoriented, muscle twitching, lack of reflexes, | √ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| involuntary eye movements (side to-side, up and down, or circular motion of the eyes), seizures, coma, death. | |||
| Thyroid problems: enlarged thyroid gland, weight changes, tiredness, anxiety or nervousness, hair loss, muscle weakness, feeling cold, dry skin, constipation or frequent and loose bowel movements, shortness of breath, puffy face, heavier than normal or irregular menstrual periods, feeling hot and possibly feelings of having rapid, fluttering or pounding heart. | √ | ||
| Pseudotumor cerebri (increased pressure in the skull): severe headache, ringing in the ears, blurred vision, double vision or brief periods of blindness. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
Store LITHMAX tablets between 15°C to 30°C.
Keep out of reach and sight of children.
If you want more information about LITHMAX:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.aapharma.ca/en/), or by calling 1-877-998-9097.