Lithium carbonate Nova Argentia

Package leaflet: information for the patient

LITHIUM CARBONATE NOVA ARGENTIA 300 mg tablets

Read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What LITHIUM CARBONATE NOVA ARGENTIA is and what it is used for
2. What you need to know before taking LITHIUM CARBONATE NOVA ARGENTIA
3. How to take LITHIUM CARBONATE NOVA ARGENTIA
4. Possible side effects
5. How to store LITHIUM CARBONATE NOVA ARGENTIA
6. Contents of the pack and other information

1. What LITIO CARBONATO NOVA ARGENTIA is and what it is used for

LITIO CARBONATO NOVA ARGENTIA contains the active substance lithium carbonate, which belongs to a class of medicines called antipsychotics that act on the central nervous system as mood stabilizers.
This medicine is used to prevent and control:

• episodes of excitement in manic and hypomanic states (mental disorders characterized by more or less severe agitation, socially inappropriate behavior, disorganized and aimless behavior, excessive energy, urgent sexual desire, hyperactivity, irritability, anger, aggressiveness, loss of contact with reality, and impaired thinking and judgment);
• depressive states (mood disorder characterized by frequent and intense feelings of dissatisfaction and sadness, bad mood, and negative thoughts) and chronic depressive psychosis (characterized by slowed activity, apathy, feelings of guilt and self-punishment) in manic-depressive psychoses (mental disorders characterized by alternating episodes of depression and mania). It is also used to treat cluster headache (a specific type of headache characterized by severe stabbing pain and symptoms such as tearing, nasal congestion or runny nose, facial sweating, affecting one side of the head), but only in patients who do not respond to other therapies, due to the toxicity of lithium carbonate.

2. What you should know before taking LITIO CARBONATO NOVA ARGENTIA

Do not take LITIO CARBONATO NOVA ARGENTIA

• if you are allergic to lithium carbonate or to any of the other ingredients of this medicine (listed in section 6);
• if you have heart problems;
• if you have severe kidney problems (renal failure);
• if you are very weak (severe debilitation);
• if you have abnormally low levels of sodium in your body;
• if you are being treated with medicines that increase urine output (diuretics);
• if you are pregnant, think you may be pregnant, or are breastfeeding (see section on Pregnancy and breastfeeding);
• if the person taking this medicine is under 12 years of age, unless otherwise advised by a doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking LITIO CARBONATO NOVA ARGENTIA.
Due to their toxicity, lithium salts should not be prescribed unless blood levels can be monitored.
Treatment will begin with low doses of the medicine, which your doctor will adjust based on the amount of lithium in your blood (serum lithium concentration) (see section How to use LITIO CARBONATO NOVA ARGENTIA). It will be necessary to monitor blood lithium levels at the beginning of treatment and after each dose increase.
Inform your doctor if you have other medical conditions (including urinary tract infections), episodes of mania and depression, if you are taking new medicines, or if you are changing your diet, particularly with regard to salt and fluid intake.
If you wish to switch from one lithium formulation to another, consult your doctor, who will carefully monitor your health status and take the same precautions as at the start of treatment, since the amount of medicine absorbed by the body may vary significantly between different formulations.
Before starting lithium therapy, your doctor will assess the function of your heart, kidneys, and thyroid gland. These checks will be repeated periodically throughout treatment, every 6–12 months (unless otherwise directed by your doctor). If gradual or sudden changes in kidney function occur—even within normal limits—your doctor will re-evaluate your treatment. Additionally, during lithium therapy, you will need periodic blood tests (haematological monitoring).
Please note that if you have been taking lithium for more than 10 years and have severe kidney problems (severe renal failure), small fluid-filled spherical formations (microcysts) or tumours (oncocytoma and collecting duct renal carcinoma) may develop in the kidneys (see section “Possible side effects”).
Exercise particular caution when using lithium and inform your doctor:

• if you have reduced thyroid function (hypothyroidism), a condition in which the thyroid gland produces insufficient hormones; your doctor will closely monitor you before and during treatment; if hypothyroidism develops during treatment, your doctor will prescribe thyroid hormone replacement therapy;
• if you have heart disease or if you or a family member has a heart rhythm disorder known as “QT interval prolongation”;
• if you have Addison’s disease, a condition characterized by severely reduced hormone production by the adrenal glands;
• if you have low sodium levels in your blood, as this increases lithium toxicity;
• if you are dehydrated due to excessive sweating, diarrhoea, or vomiting, as this may reduce tolerance to the medicine. In such cases, increase your intake of fluids and salt and inform your doctor. If, in addition to these symptoms, you develop an infection with fever, your doctor may reduce or interrupt your treatment;
• if you have a hereditary genetic disease that disrupts water and salt exchange in cells of certain organs, leading to thick, sticky mucus that impairs organ function, particularly in the lungs and digestive system (cystic fibrosis);
• if you have severe muscle weakness (myasthenia gravis);
• if treatment needs to be discontinued, as abrupt interruption may increase the risk of relapse (see section “If you stop taking LITIO CARBONATO NOVA ARGENTIA”);
• if you are scheduled for surgery, as lithium may enhance the effects of medicines used to block muscle function during anaesthesia (neuromuscular blocking agents).
• Due to the potential teratogenicity of the drug, women of childbearing potential are advised to perform a pregnancy test before starting treatment.

Your doctor will inform both you and your family members that you must contact your doctor immediately and stop treatment if any of the following early signs of lithium toxicity occur: diarrhoea, nausea, vomiting, abdominal pain, drowsiness, loss of muscle coordination, sedation, tremors affecting the hands and head (fine tremors), muscle weakness, and feeling cold.
Stop taking lithium at least one week before starting electroconvulsive therapy (ECT) and resume treatment several days after ECT is completed.
Additionally, discontinue lithium therapy 24 hours before major surgery, as reduced lithium excretion associated with anaesthesia may lead to lithium accumulation. Lithium therapy should be resumed as soon as possible after surgery.

Children
This medicine must not be used in children under 12 years of age.

Other medicines and LITIO CARBONATO NOVA ARGENTIA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Avoid taking LITIO CARBONATO NOVA ARGENTIA together with the following medicines:

• medicines used to treat mental disorders (antipsychotics) such as clozapine, haloperidol, phenothiazines, sulpiride, sertindole, thioridazine, and chlorpromazine;
• medicines used to treat depression (antidepressants) such as venlafaxine, tricyclic antidepressants, and selective serotonin reuptake inhibitors (SSRIs);
• medicines used to treat high blood pressure such as methyldopa and acetazolamide;
• medicines for epilepsy such as phenytoin, phenobarbital, and carbamazepine;
• medicines used to treat heart conditions and high blood pressure such as ACE inhibitors, angiotensin receptor blockers, and calcium channel blockers like verapamil and diltiazem;
• medicines used to treat heart rhythm disorders (amiodarone);
• non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation such as diclofenac, ibuprofen, indomethacin, mefenamic acid, naproxen, ketorolac, nimesulide, piroxicam, and selective COX-2 inhibitors;
• medicines used to treat inflammation and allergies (corticosteroids);
• medicines that increase urine output, used to treat high blood pressure (diuretics), including indapamide, acetazolamide, amiloride, triamterene, furosemide, bumetanide, and ethacrynic acid. If you are taking these medicines, consult your doctor, as lithium dosage adjustments may be necessary;
• medicines used to relieve nausea (metoclopramide);
• medicines used to treat infections (antibiotics) such as metronidazole;
• aminophylline and other xanthines, medicines that dilate the bronchi and ease breathing;
• mannitol, which promotes intestinal evacuation;
• products containing urea;
• alkalinizing agents such as sodium bicarbonate;
• medicines used during surgery to block muscle function (neuromuscular blocking agents).

These medicines may reduce the amount of lithium in your body, which means it may not work as effectively:

• empagliflozin (used to treat diabetes or heart failure)
• dapagliflozin (used to treat diabetes, heart failure, or chronic kidney disease)

LITIO CARBONATO NOVA ARGENTIA with drinks and alcohol
Do not consume alcohol during treatment with this medicine, as it may increase lithium levels in the blood.
Do not drink excessive amounts of coffee during treatment with this medicine, as it may decrease lithium levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant or suspect you may be pregnant, as it may harm the unborn baby.
Do not take this medicine if you are breastfeeding, as lithium passes into breast milk and may cause harm to the infant.
Due to the potential teratogenicity of lithium, perform a pregnancy test before starting treatment with this medicine.
If you are already on lithium therapy and plan to become pregnant, discontinue treatment gradually under close medical supervision to avoid relapse (see section “If you stop taking LITIO CARBONATO NOVA ARGENTIA”).
Resume treatment a few days after delivery, always under strict medical supervision, starting with low doses to prevent manic episodes and relapses. Avoid breastfeeding.

Driving and using machines
Lithium may impair mental or physical abilities and therefore may affect your ability to drive or operate machinery.
If you perform activities requiring alertness and quick reflexes, take these effects into account.

LITIO CARBONATO NOVA ARGENTIA contains lactose
LITIO CARBONATO NOVA ARGENTIA contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

LITIO CARBONATO NOVA ARGENTIA contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take LITHIUM CARBONATE NOVA ARGENTIA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Treatment should always be started with low doses of the medicine, which your doctor will adjust over time
depending on your health condition, your response to therapy, and the amount of lithium in your blood
(lithaemia).
The recommended dose for adults and adolescents is 300 mg (1 tablet) 2 to 6 times daily,
administered at regular intervals.
Maximum doses should be used in the initial treatment of severe conditions, minimum doses for preventive
maintenance therapy.
Four to eight days after starting treatment, you must undergo blood tests to measure the amount of lithium in
your blood (lithaemia), taken 10–12 hours after the last dose. Your doctor will adjust your dose to maintain an
optimal blood lithium level (0.4–1 mEq/litre). Repeat these tests weekly for the following four
weeks, until your dosage is stable, and then every three months thereafter.
For the treatment of acute mania, blood lithium levels should be maintained within the range of 0.8–1
mEq/litre, whereas for preventive therapy, levels of 0.6–0.75 mEq/litre are generally sufficient, although
lower concentrations (0.4–0.6 mEq/litre) may be adequate. Your doctor will adjust the dosage based on
your blood lithium levels.
Use in adolescents
In adolescents aged 12–18 years, treatment should be administered under strict medical supervision and for
the shortest possible duration.
If you take more LITHIUM CARBONATE NOVA ARGENTIA than you should
In case of accidental overdose of LITHIUM CARBONATE NOVA ARGENTIA,
contact your doctor immediately or go to the nearest hospital for urgent measurement of lithium levels in
the blood.
Early signs of lithium toxicity include: reduced or absent response to everyday situations and events (apathy);
restlessness, which may be confused with the depressive disorder itself.
In cases of severe toxicity, main symptoms include: irregular heartbeat; dizziness; altered consciousness;
increased reflexes; a state of wakefulness without awareness of oneself or the surrounding environment (vigilant coma).
The appearance of these symptoms requires immediate discontinuation of treatment and administration of
appropriate supportive therapies.
If you forget to take LITHIUM CARBONATE NOVA ARGENTIA
Do not take a double dose to make up for the missed dose. Inform your doctor.
If you stop taking LITHIUM CARBONATE NOVA ARGENTIA
If you need to discontinue treatment with this medicine, consult your doctor, who will gradually reduce the
dose over several weeks.
Do not stop taking this medicine abruptly, as this may lead to relapse.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The onset and severity of side effects are generally determined by the amount of lithium in the blood, the individual patient’s sensitivity to lithium, and age. Some patients may have blood lithium levels considered toxic without showing any signs of toxicity; others, on the contrary, may develop toxicity at therapeutic doses.
At the beginning of treatment, some side effects may occur which usually disappear with continued treatment or with a temporary reduction in dose. If they persist, treatment must be discontinued.
The following side effects may occur:

• mild hand tremors;
• excessive urine production and increased frequency of urination (polyuria);
• moderate thirst;
• general malaise.

Within the 24 hours following the first administration of lithium, the following adverse effects may occur:

• increased excretion of sodium, potassium, and mineralocorticoids in the urine; subsequently, potassium excretion normalizes, while sodium retention may occur, leading to swelling of the lower limbs (pretibial edema). These side effects usually disappear within a few days;
• kidney problems with increased urine output and reduced ability of the kidneys to reabsorb fluids, potentially leading to a condition called diabetes insipidus.

The first signs of lithium intoxication occurring at low blood levels are:

• diarrhea, nausea, vomiting, abdominal pain;
• drowsiness, sedation;
• muscle weakness and problems with movement coordination (motor incoordination);
• dry mouth;
• feeling cold;
• slowed speech;
• involuntary and rapid eye movements (nystagmus).

At higher lithium blood levels, the above effects may worsen and the following may occur:

• exaggerated reflexes (hyperreflexia);
• loss of muscle coordination (ataxia);
• dizziness and hearing disturbances such as ringing in the ears (tinnitus);
• blurred vision;
• excessive urine production and increased frequency of urination (polyuria).

At very high lithium blood levels, very serious effects may occur, such as:

• seizures;
• circulatory disturbances;
• psychiatric disturbances such as stupor;
• coma and death.

During treatment, in addition to the above, the following adverse effects have been reported:

• epileptic seizures, either as typical attacks characterized by loss of consciousness, muscle rigidity, convulsions, and collapse, or as absence seizures, i.e. sudden lapses of consciousness;
• speech difficulties, delays in development and acquisition of motor, cognitive, and communication skills (psychomotor retardation);
• dizziness, vertigo, confusion;
• involuntary loss of urine and feces (incontinence);
• drowsiness, fatigue, deep sleep often impossible to overcome, with complete muscle relaxation and lack of response to external stimuli (lethargy);
• restlessness, mental slowing with detachment from reality (stupor), coma;
• tremors, muscle hyperirritability (muscle contractions, clonic movements of the legs);
• loss of muscle coordination (ataxia), jerky movements (choreoathetoid movements), tendon reflex hyperexcitability, dry mouth;
• heart and circulatory problems, such as low blood pressure (hypotension), sudden loss of blood circulation (peripheral circulatory collapse), conditions and symptoms due to the heart’s inability to pump sufficient blood to meet the body’s needs (circulatory failure);
• changes in heart rhythm such as QT interval prolongation, disturbances in heartbeat rhythm (cardiac and ventricular arrhythmias) such as torsades de pointes, ventricular tachycardia, ventricular fibrillation, and cardiac arrest;
• sudden death;
• excessive urine production and increased frequency of urination (polyuria), increased levels of protein (albuminuria) or sugar (glucosuria) in the urine;
• reduced urine output (oliguria);
• severe kidney problems with structural changes in the kidneys (glomerular and interstitial fibrosis, nephron atrophy);
• swelling (thyroid goiter) and/or reduced thyroid function (hypothyroidism), which may cause accumulation of a dense mucous substance in the skin and subcutaneous tissue (myxedema);
• rare cases of increased thyroid function (hyperthyroidism);
• loss of appetite (anorexia), nausea, vomiting, and diarrhea;
• reduced number of white blood cells (leukopenia);
• changes in blood cells;
• visual disturbances (including scotomas);
• dryness, thinning, and hair loss (alopecia);
• loss of skin sensitivity (cutaneous anesthesia);
• skin inflammations (chronic folliculitis), worsening of psoriasis;
• excessive fluid loss from the body (dehydration) and weight loss;
• changes in heart and brain parameters measured by electrocardiogram (ECG) and electroencephalogram (EEG).

Frequency not known (frequency cannot be estimated from available data)

• small fluid-filled spherical formations (microcysts) or tumors (oncocytoma and renal collecting duct carcinoma) in the kidneys, especially in patients taking lithium for more than 10 years and suffering from severe kidney problems (severe renal failure);
• skin or mucosal rash (drug-induced lichenoid reaction).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store LITHIUM CARBONATE NOVA ARGENTIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Expires”.
The expiry date refers to the last day of that month.
Keep the container tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What LITIO CARBONATO NOVA ARGENTIA contains

• The active substance is lithium carbonate. Each tablet contains 300 mg of lithium carbonate.
• The other components are: maize starch, lactose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate.

Description of the appearance of LITIO CARBONATO NOVA ARGENTIA and contents of the pack
Pack containing 50 tablets.
Marketing Authorization Holder
Industria Farmaceutica NOVA ARGENTIA S.r.l. – Via Carlo Porta, 49 – Gorgonzola, Milan.
Manufacturer
Industria Farmaceutica Nova Argentia S.r.l. – Via Giovanni Pascoli, 1 – Gorgonzola, Milan.