LITIO 300 mg Tabletka

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1. LITIO CARBONATO L.F.M. 300 mg tablets
   1. What is LITIO CARBONATO L.F.M. and what it is used for
   2. What you need to know before taking LITIO CARBONATO L.F.M.
   3. How to take LITIO CARBONATO L.F.M.
   4. Possible side effects
   5. How to store LITIO CARBONATO L.F.M.
   6. Contents of the pack and other information

LITIO CARBONATO L.F.M. 300 mg tablets

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is LITIO CARBONATO L.F.M. and what it is used for

LITIO CARBONATO L.F.M. 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);
manic-depressive psychosis (mental disorders characterized by moments of depressed mood
alternating with moments of exaltation).
It is also used to treat cluster headache (a particular headache characterized by
lancinating pain and symptoms such as tearing, nasal congestion or runny nose, facial sweating, which affect 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 L.F.M.

Do not take LITIO CARBONATO L.F.M.
if you are allergic to the active ingredient or 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 is going to take this medicine is less than 12 years old, unless otherwise advised
by your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking LITIO CARBONATO L.F.M..
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 section “How to use LITIO
CARBONATO L.F.M.”).
Tell your doctor if you suffer from other diseases (including urinary tract infections), alternating states of
excitement (manic phases) and depression (depressive phases), if you are taking new
medicines and if you are changing your diet with changes 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 the different
preparations.
Before starting therapy with lithium salts, your doctor will check the function 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 will have to undergo periodic blood tests
(blood count).
Keep in mind that if you have been taking lithium for more than 10 years and have severe 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 at the
level of the kidneys (See section “Possible side effects”).
Pay particular attention to the use of lithium and tell 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 an alteration of
the heartbeat called “prolongation of the QT interval”;
if you suffer from Addison's disease, a disease characterized by a severe decrease in the
production of hormones by the adrenal gland;
if you have a reduced amount of sodium in your blood, because it increases the toxicity of lithium;
if you are dehydrated due to excessive sweating, diarrhea or vomiting, because it may decrease the
tolerance to the medicine. In these cases, increase your intake of salts and fluids and inform your
doctor. If these disorders are accompanied by an infection with an increase in
body temperature, your doctor may reduce or stop treatment;
if you suffer from a hereditary genetic disease that alters the exchange of water and salts at the level of the
cells of some organs with the production of thick and viscous mucus that compromises the functionality
of the affected organs, in particular lung and intestine (cystic fibrosis);
if you suffer from severe muscle weakness (myasthenia gravis);
if you decide to stop treatment abruptly, because there could be a risk of
relapse (see section “If you stop taking LITIO CARBONATO L.F.M.”).
if you are going to undergo surgery, as lithium increases the effects of medicines
used to block muscles during surgery (neuromuscular blocking agents).
The doctor will inform both you and your family that you need to inform him immediately and
suspend treatment if you experience the following symptoms of early medicine toxicity:
diarrhea, nausea, vomiting, abdominal pain, drowsiness, loss of muscle coordination,
sedation, tremors affecting the hands and head (fine tremors), muscle weakness and
feeling of 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 surgery, because the
decrease in lithium excretion associated with anesthesia can lead to an accumulation of lithium. The
lithium therapy should be resumed as soon as possible after the operation.

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

Other medicines and LITIO CARBONATO L.F.M.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Avoid the simultaneous use of LITIO CARBONATO L.F.M. with the following medicines:
medicines used for mental illnesses (antipsychotics) such as clozapine, haloperidol, phenothiazines,
sulpiride, sertindole and thioridazine, 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 problems and high blood pressure such as
ACE inhibitors, angiotensin receptor antagonists and calcium antagonists such as verapamil and
diltiazem;
medicines used to treat heart rhythm disorders (amiodarone);
non-steroidal anti-inflammatory drugs, used to relieve pain and inflammation such as
diclofenac, ibuprofen, indometacin, mefenamic acid, naproxen, ketorolac, nimesulide,
piroxicam and COX2 selective inhibitors;
medicines used to treat inflammation and allergies (corticosteroids);
medicines that promote urine output, 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 modify 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;
products containing urea;
alkalinizing agents such as sodium bicarbonate;
medicines used during surgery to block muscles (neuromuscular
blocking agents).
These medicines can reduce the amount of lithium in the body and therefore lithium may not work
well:
empagliflozin (used to treat diabetes or heart failure)
dapagliflozin (used to treat diabetes or heart failure or chronic kidney disease)

LITIO CARBONATO L.F.M. 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 a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant, confirmed or suspected, as it may 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
gradually reducing the dose, under strict medical supervision, to avoid relapse (see section “If you stop taking LITIO CARBONATO L.F.M.”).
A few days after delivery, resume therapy, always under strict medical supervision, at low
doses to avoid manic and relapse episodes. Carefully avoid breastfeeding.
In newborns of mothers who have taken LITIO CARBONATO L.F.M. as an antipsychotic, in the
last three months of pregnancy, the following symptoms have been observed: tremor, rigidity and/or weakness
to the muscles, drowsiness, agitation, breathing problems and difficulty in taking food. If the
your baby shows any of these symptoms, contact your doctor immediately.

Driving and operating machinery
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 prompt reflexes, you must consider these effects.
LITIO CARBONATO L.F.M. contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is
essentially ‘sodium-free’

3. How to take LITIO CARBONATO L.F.M.

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult 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 condition and the amount of lithium in the blood (lithiemia).
The recommended dose for adults and adolescents is 300 mg (1 tablet) from 2 to 6 times a day,
administered at regular intervals.
Maximum doses should be used in the treatment of attacks of severe forms, the minimum in the
preventive maintenance 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 intake and the doctor will adjust the dose for
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 constant, 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 of 0.8-1 mEq/liter, while in preventive therapy generally 0.6-0.75 mEq/liter are sufficient.
The doctor will adjust the dosage based on the amount of lithium in the blood.

Use in adolescents
In adolescents between 12-18 years, treatment must occur under strict medical supervision and
for as short a time as possible.

If you take more LITIO CARBONATO L.F.M. than you should
In case of accidental ingestion of an excessive dose of LITIO CARBONATO L.F.M., immediately warn
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: decrease or absence of reaction to situations and
everyday events (apathy); restlessness that can be mistaken for the depressive disease
itself.
In case of severe intoxication, the main signs are: alteration of the heartbeat; dizziness;
alteration of consciousness; increased reflexes; state of wakefulness during which
there is no awareness of oneself or the surrounding environment (vigilant coma).

If you forget to take LITIO CARBONATO L.F.M.
Do not take a double dose to compensate for the forgotten dose and inform your doctor.

If you stop taking LITIO CARBONATO L.F.M.
If you have 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The onset and severity of side effects are generally determined by the amount of
lithium in the blood and 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 present 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, treatment should be discontinued.
The following side effects may occur:

• mild tremors of 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 disease 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 coordination of movements (motor incoordination);
• dry mouth;
• feeling of cold;
• slowed speech;
• involuntary and rapid eye movements (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 can occur such as:
• convulsions;
• circulatory disturbances;
• 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 absence, 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, deep sleep, often invincible, with complete muscle relaxation and disappearance of response to external stimuli (lethargy);
• restlessness, a state of slowing down of mental activities with detachment from reality (stupor), coma;
• tremors, muscle hyperirritability (contractions, clonic leg movements);
• loss of muscle coordination (ataxia), jerky movements (choreoathetosis), hyperreflexia of tendon reflexes, dry mouth;
• heart and circulatory problems, such as low blood pressure (hypotension), sudden loss of blood circulation (collapse of peripheral circulation), 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 rhythm of the heartbeat (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 amount 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 (myxedema);
• 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 (transient scotomas);
• dryness, thinning and loss of hair (alopecia);
• loss of skin sensitivity (cutaneous anesthesia);
• skin inflammations (chronic folliculitis and psoriasis);
• - excessive loss of fluids from the body (dehydration) and weight loss;
• variations in heart and brain parameters measured with electrocardiogram (ECG) and electroencephalogram (EEG). Frequency not known (the frequency cannot be estimated from the 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).
• skin or mucous membrane rash (drug lichenoid reaction);

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can contribute to providing more information about
the safety of this medicine.

5. How to store LITIO CARBONATO L.F.M.

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 “Exp.”.
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 CARBONATOL.F.M.contains

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

Description of the appearance of LITIO CARBONATO L.F.M. and contents of the pack
Pack of 50 tablets in blisters.

Marketing Authorisation Holder and Manufacturer
Laboratorio Farmacologico Milanese S.r.l., Via Monterosso 273, 21042 – Caronno Pertusella
(VA).