LITIO 300 mg Tabletka

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1. LITIO CARBONATO NOVA ARGENTIA 300 mg tablets
   1. What is LITIO CARBONATO NOVA ARGENTIA and what it is used for
   2. What you need to know before taking LITIO CARBONATO NOVA ARGENTIA
2. lithium present in the blood (lithiemia) (see the section How to use LITIO CARBONATO NOVA
   1. How to take LITIO CARBONATO NOVA ARGENTIA
   2. Possible side effects
   3. How to store LITIO CARBONATO NOVA ARGENTIA
   4. Contents of the pack and other information

LITIO CARBONATO NOVA ARGENTIA 300 mg tablets

Read this 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

LITIO CARBONATO NOVA ARGENTIA contains the active ingredient 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:

• states of excitement in manic and hypomanic forms (mental disorders characterized by more or less severe excitement, inappropriate social behaviors, disorganized and inconclusive behaviors, excessive energy, compelling sexual desire, hyperactivity, irritability, anger, aggression, loss of contact with reality and the ability to think and judge clearly);
• states of depression (a mood disorder characterized by frequent and intense states of dissatisfaction and sadness, bad mood and negative thoughts) and chronic depressive psychosis (characterized by slowing down, apathy, feelings of guilt and self-punishment) of manic-depressive psychoses (mental disorders characterized by moments of depressed mood that alternate with moments of exaltation). It is also used to treat cluster headache (a particular headache characterized by stabbing pain and symptoms such as tearing, nasal congestion or runny nose, facial sweating, which affects only one side of the head), but only in subjects who do not respond to other therapies, due to the toxicity of lithium carbonate.

2. What you need to 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 a severe kidney problem (renal insufficiency);
• if you are very weak (severe state of debilitation);
• if you have an increased reduction of sodium in the body;
• if you are taking medicines that increase urine output (diuretics);
• if you are pregnant or think you may be pregnant and if you are breastfeeding (see section Pregnancy and breastfeeding);
• if the person who needs to take this medicine is less than 12 years of age, unless otherwise advised by your doctor.

Warnings and precautions
Consult your doctor or pharmacist before taking LITIO CARBONATO NOVA ARGENTIA
Lithium salts, due to their toxicity, should not be prescribed unless it is possible to monitor the
amount in the blood.
Therapy will begin with low doses of the medicine which your doctor will then adjust based on the amount of

lithium present in the blood (lithiemia) (see the section How to use LITIO CARBONATO NOVA

ARGENTIA). It will be necessary to check the amount of lithium in the blood at the beginning of treatment and after each
dose increase.
Inform your doctor if you suffer from other illnesses (including urinary tract infections), alternating states of
excitement (manic phases) and depression (depressive phases), if you are taking new medications and if you are
changing your diet with modifications in the intake of salts and fluids.
If you want to replace one preparation of the medicine with another, consult your doctor, who will carefully monitor
your health conditions and take the same precautions as for the start of treatment, because the amount of medicine that
the body absorbs varies greatly in different preparations.
Before starting therapy with lithium salts, your doctor will check the functionality of your heart, kidneys and
thyroid. You will be subjected to these checks periodically during the course of therapy, every 6-12 months
(unless otherwise indicated by your doctor). If gradual or sudden changes in kidney function occur, even if within
normal limits, your doctor will re-evaluate the treatment. In addition, during therapy with lithium, you must undergo
periodic blood tests (blood count).
Keep in mind that if you have been taking lithium for more than 10 years and suffer from serious kidney problems (severe
renal insufficiency), small spherical formations filled with fluid (microcysts) or tumors (oncocytoma and renal cell
carcinoma of the collecting ducts) may develop in the kidneys (See section “Possible undesirable effects”).
Pay particular attention to the use of lithium and inform your doctor:

• if you suffer from reduced thyroid function, the gland that produces hormones (hypothyroidism), your doctor will subject you to careful checks before and during therapy; if hypothyroidism occurs during treatment, your doctor will prescribe replacement therapy with thyroid hormones;
• if you suffer from heart disease or if you or someone in your family suffers from a heart rhythm disturbance called “prolongation of the QT interval”;
• if you suffer from Addison's disease, an illness characterized by a severe decrease in hormone production by the adrenal gland;
• if you have reduced sodium levels in the blood, because it increases the toxicity of lithium;
• if you are dehydrated due to excessive sweating, diarrhea or vomiting, because it may decrease tolerance to the medicine. In these cases, increase your intake of salts and fluids and inform your doctor. If, together with these disorders, an infection with an increase in body temperature also occurs, your doctor may reduce or interrupt the treatment;
• if you suffer from a hereditary genetic disease that alters the exchange of water and salts at the cellular level of some organs with production of thick and viscous mucus that compromises the functionality of the affected organs, in particular the lungs and the digestive system (cystic fibrosis);
• if you suffer from severe muscle weakness (myasthenia gravis);
• if the treatment must be stopped as abrupt discontinuation may give a risk of relapse (see the section If you stop treatment with LITIO CARBONATO NOVA ARGENTIA);
• if you have to undergo surgery, as lithium increases the effects of medicines used to block muscles during surgery (neuromuscular blockers).
• Given the potential teratogenicity of the drug, it is recommended that women of childbearing potential perform a pregnancy test before starting treatment.

The doctor will inform both you and your family that it is necessary to immediately inform the doctor and
suspend treatment if the following symptoms of early medicine toxicity occur: diarrhea,
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 with lithium a few days after its completion.
Also, stop lithium therapy 24 hours before major surgeries, because the decrease in
lithium excretion associated with anesthesia can lead to an accumulation of lithium. Lithium therapy should
be re-established as soon as possible after surgery.

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

Other medicines and LITIO CARBONATO NOVA ARGENTIA
Inform your doctor or pharmacist if you are taking, have recently taken or may take any
other medicine.
Avoid the concurrent use of LITIO CARBONATO NOVA ARGENTIA with the following medicines:

• medicines used for mental illnesses (antipsychotics) such as clozapine, haloperidol, phenothiazines, sulpiride, sertindole and thioridazine, chlorpromazine;
• medicines used for the treatment of depression (antidepressants) such as venlafaxine, tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs);
• medicines used for the treatment of high blood pressure such as methyldopa and acetazolamide;
• medicines for epilepsy such as phenytoin, phenobarbital and carbamazepine;
• medicines used for the treatment of heart problems and high blood pressure such as ACE inhibitors, angiotensin receptor antagonists and calcium channel blockers such as verapamil and diltiazem;
• medicines used for the treatment of heart rhythm disturbances (amiodarone);
• non-steroidal anti-inflammatory drugs, used to relieve pain and inflammation such as diclofenac, ibuprofen, indometacin, menefamic acid, naproxen, ketorolac, nimesulide, piroxicam and COX2 selective inhibitors;
• medicines used for the treatment of inflammation and allergies (corticosteroids);
• medicines that promote the elimination of urine, used to treat high blood pressure (diuretics), including indapamide, acetazolamide, amiloride, triamterene, furosemide, bumetanide and ethacrylic acid. If you are taking these medicines, consult your doctor because it may be necessary to adjust the dosage of lithium;
• medicines used to relieve the sensation of vomiting (metoclopramide);
• medicines used for infections (antibiotics) such as metronidazole;
• aminophylline and other xanthines, medicines that dilate the bronchi and facilitate breathing;
• mannitol, which promotes and favors intestinal evacuation;
• urea-containing products;
• alkalizing agents such as sodium bicarbonate;
• medicines used during surgery to block muscles (neuromuscular blockers).

These medicines can reduce the amount of lithium in the body, which means that it will not work
as well:

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

LITIO CARBONATO NOVA ARGENTIA with drinks and alcohol
Do not drink alcohol during therapy with this medicine because it can cause an increase in lithium levels
in the blood.
Do not drink too much coffee during therapy with this medicine because it can cause a decrease in
lithium levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant, confirmed or suspected, because it can cause harm to
the fetus.
Do not take this medicine if you are breastfeeding, as lithium passes into breast milk and can cause
problems for the baby.
Given the potential toxicity of lithium to the fetus (teratogenicity), perform a pregnancy test before starting
therapy with this medicine.
If you are already taking lithium and intend to become pregnant, stop therapy by gradually decreasing the dose,
under strict medical supervision, to avoid the onset of relapses (see the
section “If you stop treatment with LITIO CARBONATO NOVA ARGENTIA”)
Resume therapy after a few days after delivery, always under strict medical supervision, at low doses to
avoid manic and relapse episodes. Carefully avoid breastfeeding.

Driving and using machines
Lithium can alter mental or physical ability and therefore alters the ability to drive vehicles or use
machinery.
If you are performing activities that require quick reflexes, you should consider these effects.

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

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

3. How to take LITIO CARBONATO NOVA ARGENTIA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
It is always necessary to start therapy with low doses of the medicine that the doctor will adjust from time to time
depending on your health conditions, your response to therapy and the amount of lithium in the blood
(lithiemia).
The recommended dose for adults and adolescents is 300 mg (1 tablet) 2 to 6 times a day,
administered at regular intervals.
Maximum doses should be used in the treatment of severe forms, the minimum in maintenance
preventive therapy.
After 4-8 days from the start of therapy, you will need to undergo tests to measure the amount of lithium in
the blood (lithiemia) 10-12 hours after the last dose and the doctor will adjust the dose to maintain a
good amount of lithium in the blood (0.4-1 mEq/liter). Repeat these tests every week for another four
weeks, until the dosage is stable, and then every three months.
For the treatment of acute mania it is necessary to maintain the amount of lithium in the blood in the range 0.8-1
mEq/liter, while in preventive therapy generally 0.6 – 0.75 mEq/liter are sufficient but
lower concentrations (0.4-0.6 mEq/liter) may be sufficient. The doctor will adjust the dosage in
based on the amounts of lithium in the blood.

Use in adolescents
In adolescents between 12-18 years of age, treatment must occur under strict medical supervision and for the
shortest possible time.

If you take more LITIO CARBONATO NOVA ARGENTIA than you should
In case of accidental ingestion of an excessive dose of LITIO CARBONATO NOVA ARGENTIA
immediately notify your doctor or go to the nearest hospital to urgently determine the amount of lithium levels in the blood.
The first signs of intoxication are: decreased or absence of reaction to situations and events of
everyday life (apathy); restlessness that can be confused with the depressive illness itself.
In case of severe intoxication, the main signs are: alteration of the heartbeat; dizziness; alteration
of consciousness; increased reflexes; state of wakefulness without awareness
neither of oneself nor of the surrounding environment (vigilant coma).
The appearance of these symptoms requires immediate interruption of treatment and administration of
appropriate supportive therapies.

If you forget to take LITIO CARBONATO NOVA ARGENTIA
Do not take a double dose to make up for the missed dose and inform your doctor.

If you stop taking LITIO CARBONATO NOVA ARGENTIA
If you need to stop treatment with this medicine, consult your doctor who will gradually reduce the dose
over a few weeks.
Do not suddenly stop taking this medicine, as relapses may occur.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The onset and severity of side effects are generally determined by the amount of lithium in the
blood and by the varying degree of sensitivity to lithium and the patient's age. Some patients may have
lithium levels in the blood considered toxic and not show any signs of toxicity; others, conversely,
may develop toxicity at the doses used in therapy.
At the beginning of therapy, some side effects may occur which then disappear with the continuation
of treatment or with a temporary reduction of the drug dose. If they persist it is necessary
to discontinue treatment.
The following side effects may occur:

• mild tremors in the hands;
• increased urine production and increased frequency of urination (polyuria);
• moderate feeling of thirst;
• general malaise.

During the twenty-four hours following the first administration of lithium, the following
side effects may occur:

• increased elimination of sodium, potassium and mineralocorticoids in the urine; subsequently, the elimination of potassium normalizes and sodium retention may occur, with the appearance of swelling of the lower limbs (pretibial edema). These side effects normally disappear within a few days;
• kidney problems with an increase in the amount of urine produced and a decrease in the kidney's ability to reabsorb fluids, with the possible onset of a condition called diabetes insipidus. The first signs of lithium intoxication that occur at low levels in the blood are:
• diarrhea, nausea, vomiting, abdominal pain;
• drowsiness, sedation;
• muscle weakness and problems with movement coordination (motor incoordination);
• dry mouth;
• feeling of cold;
• slowed speech;
• involuntary and rapid eye movement (nystagmus). At higher levels of lithium in the blood, the previous 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;
• increased urine production and increased frequency of urination (polyuria). At very high levels of lithium in the blood, very serious effects may occur such as:
• convulsions;
• circulatory disorders;
• psychiatric disorders such as stupor;
• coma and death.

During therapy, other side effects have been reported in addition to the previous ones:

• epileptic seizures, both as true attacks, characterized by loss of consciousness, stiffening, muscle jerks and falling to the ground, and as absences, i.e. sudden suspensions of consciousness;
• difficulty with speech, delays in the development and acquisition of motor, cognitive and communicative skills (psychomotor delays);
• dizziness, lightheadedness (vertigo), confusion;
• involuntary loss of urine and feces (incontinence);
• drowsiness, fatigue, a deep state of sleep, often irresistible, with complete muscle relaxation and disappearance of response to external stimuli (lethargy);
• restlessness, a state of slowing down of mental activity with detachment from reality (stupor), coma;
• tremors, muscle hyperirritability (contractions, clonic leg movements);
• loss of muscle coordination (ataxia), jerky movements (choreoathetotic), hyperreflexia of tendon reflexes, 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 enough blood to meet the body's needs (heart failure);
• alteration of the heartbeat such as prolongation of the QT interval, alteration of the heart rate (cardiac and ventricular arrhythmias) such as torsade de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest;
• sudden death;
• increased urine production and increased frequency of urination (polyuria) and increased amounts of protein (albuminuria) or sugar (glycosuria) in the urine;
• decreased urine production (oliguria);
• serious problems with alteration of the shape of the kidneys (glomerular and interstitial fibrosis, nephron atrophy);
• swelling (goiter) and/or decreased thyroid function (hypothyroidism) which can cause the accumulation of a dense mucous substance in the skin and subcutaneous tissue (mixedema);
• rare cases of increased thyroid function (hyperthyroidism);
• loss of appetite (anorexia), nausea, vomiting and diarrhea;
• reduction in the number of white blood cells (leukopenia);
• alterations of blood cells;
• visual disturbances (including scotomas);
• dryness, thinning and loss of hair (alopecia);
• loss of skin sensitivity (skin anesthesia);
• skin inflammation (chronic folliculitis), exacerbation of psoriasis;
• excessive fluid loss from the body (dehydration) and weight loss;
• changes in heart and brain parameters measured with electrocardiogram (ECG) and electroencephalogram (EEG).

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

• small spherical formations filled with fluid (microcysts) or tumors (oncocytoma and renal cell carcinoma of the collecting ducts) at the level of the kidneys, especially if you have been taking lithium for more than 10 years and have severe kidney problems (severe renal failure).
• Eruption of the skin or mucous membranes (lichenoid drug reaction).

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

5. How to store LITIO CARBONATO NOVA ARGENTIA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LITIO CARBONATO NOVA ARGENTIA contains

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

Description of the appearance of LITIO CARBONATO NOVA ARGENTIA and contents of the pack
Pack of 50 tablets.

Marketing Authorisation 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.