CARBOLITHIUM 150 mg Hard Capsule

Зміст інструкції

1. Carbolithium 150 mg hard capsules, 300 mg hard capsules
   1. What is Carbolithium and what is it used for
   2. What you need to know before taking Carbolithium
   3. How to take Carbolithium
   4. Possible side effects
   5. How to store Carbolithium
   6. Contents of the pack and other information

Carbolithium 150 mg hard capsules, 300 mg hard capsules

lithium carbonate

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Carbolithium and what is it used for

Carbolithium contains lithium carbonate,a substance belonging to a group of medicines called
antipsychotics, used in the prevention and treatment of some mental disorders (manic and
hypomanic forms) characterized by states of excitement alternating with states of depression or chronic depressive psychosis,
typical of manic-depressive psychosis.
Carbolithium is also used in the treatment of a form of headache that is extremely painful,
called Cluster Headache, in patients who do not respond to other therapy.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Carbolithium

Do not take Carbolithium

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from heart disease;
• if your kidney function is impaired (kidney damage);
• if you are severely debilitated;
• if your sodium levels in the blood are low;
• if you are taking medicines called diuretics, which help the body lose excess water in the form of urine;
• during pregnancy;
• if you are breastfeeding.

Warnings and precautions
Consult your doctor, pharmacist or nurse before taking Carbolithium.
Therapy with Carbolithium must always be started with the lowest doses, which may subsequently
be modified based on the level of lithium in your blood (lithiemia).
The doctor will, in fact, regularly check the lithiemia and your state of health after each increase in
dose and will subject you to constant checks throughout the duration of therapy.
This is particularly important:

• in case of relapses;
• if you should experience serious adverse effects;
• in the presence of other diseases (including urinary tract infections);
• if you alternate phases of excitement (manic) with phases of lowered mood (depressive);
• if you have started taking new medicines;
• if your daily diet has changed;
• in case of conditions or treatments that may cause an alteration of fluids or electrolyte balance, such as, for example, diuretic therapy.

Before starting therapy with Carbolithium your doctor will check:

• the functionality of your heart; Carbolithium must, in fact, be administered with caution if you suffer from cardiovascular diseases or have a family history of a rare heart anomaly (prolongation of the QT interval);
• the functionality of your kidneys; since during therapy with Carbolithium gradual or sudden changes in kidney function may occur, which may require a modification of the dose. Furthermore, therapy with lithium should not be started in patients with kidney damage (see also section “Do not take Carbolithium”). Patients with severe kidney damage treated with lithium for more than 10 years may be at risk of developing a benign or malignant kidney tumor (microcysts, oncocytoma or renal collecting duct carcinoma; see also section “Possible side effects”);
• the functionality of the thyroid; if you suffer from thyroid disorders your doctor will assess whether to prescribe you Carbolithium or not based on your condition. In particular, if you suffer from hypothyroidism (poorly functioning thyroid), the doctor will subject you to checks both during the initial phase of therapy and during maintenance.

If you are a woman of childbearing potential, before starting therapy with this medicine you must undergo a pregnancy
test to rule out pregnancy, as lithium carbonate can cause harm to the fetus (see
section “Pregnancy”).
During therapy with Carbolithium, the doctor will subject you to regular checks to verify:

• the functionality of the kidneys and thyroid (every 6 - 12 months);
• the blood count (the ratio between the various elements of the blood).

Furthermore, pay particular attention and inform your doctor:

• if you suffer from Addison's disease (a disease of the adrenal glands) or other conditions characterized by low levels of sodium in the blood;
• if you are severely debilitated (see also section “Do not take Carbolithium”);
• if you are in a state of dehydration caused by excessive sweating, diarrhea or vomiting as your tolerance to lithium may decrease; in these cases patients should be warned to increase their intake of mineral salts and fluids. If an infection with fever is added to this, the doctor will advise you whether to temporarily reduce the dose or interrupt the treatment;
• if you have a disease called Brugada syndrome (an inherited syndrome that affects the heart) or if one of your family members has had Brugada syndrome, cardiac arrest or died suddenly;
• if you suffer from cystic fibrosis, as this may result in a decrease in the elimination of lithium from your body;
• if you suffer from a disease characterized by muscle weakness (myasthenia gravis);
• if you need to start electroconvulsive therapy; in this case, discontinue Carbolithium at least one week before and resume it a few days after the end of electroconvulsive therapy;
• if you need to undergo surgery; in this case, discontinue Carbolithium at least 24 hours before the operation, as anesthesia combined with reduced elimination of lithium may cause an accumulation of the latter, and resume it as soon as possible after the operation;
• if you are planning or have already undergone weight loss surgery, as a lower dose of lithium may be required. The doctor will monitor the level of lithium in the blood and adjust the dose accordingly.

Stop treatment and consult your doctor immediatelyif you experience:
diarrhea, nausea, vomiting, abdominal pain, drowsiness, loss of muscle coordination,
sedation, tremors, muscle weakness, feeling cold, dry mouth, slowing of speech
and involuntary, rhythmic, oscillating eye movements; these may be symptoms of toxicity due to
lithium (see also section “Possible side effects”). Inform a friend or family member who is
starting treatment with Carbolithium, so that they can help you recognize the above
symptoms, for which it is necessary to stop treatment and consult a doctor immediately.
Never stop treatment abruptly but gradually reduce the doses, over a few
weeks, always under strict medical supervision. The doctor will inform you of the risk of a possible
relapse in case of abrupt interruption of treatment with Carbolithium.

Children and adolescents
The use of Carbolithium in children and adolescents under 12 years of age is not recommended.

Other medicines and Carbolithium
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Taking Carbolithium together with the following medicines must be avoided:

• clozapine, haloperidol, phenothiazines and sulpiride(other antipsychotic drugs) - used for the treatment of mental disorders - as brain damage (neurotoxicity) and adverse effects such as muscle stiffness and movements, lack of facial expression, restlessness, slowness or blocking of movements, slowing of reflexes (extrapyramidal side effects) may occur;
• diclofenac, ibuprofen, indometacin, menefamic acid, naproxen, ketorolac, piroxicam( non-steroidal anti-inflammatory drugs - NSAIDs) and COX2 selective inhibitors- used for pain, fever and inflammation - as this may reduce the elimination of lithium with a consequent increase in the risk of toxicity;
• amiodarone- a medicine used for the treatment of arrhythmias - as alterations in your heartbeat (ventricular arrhythmias) may occur;
• indapamide- a medicine used for the treatment of high blood pressure - as this may increase the toxicity of lithium as a result of reduced elimination of the latter at the level of the kidneys.

Furthermore, pay particular attention and inform your doctor if you are taking any of the following medicines:

• sertindoleand thioridazine(other antipsychotic drugs) -used for the treatment of schizophrenia and other mental disorders -as this may cause an alteration of your heartbeat (ventricular arrhythmias);
• haloperidol(another antipsychotic drug) -used for the treatment of psychoses; this association may be particularly dangerous as it may lead to symptoms such as weakness, lethargy, fever, tremors, convulsions, confusion, extrapyramidal symptoms, increased white blood cells in the blood (encephalopathic syndrome);
• venlafaxine -used in the treatment of depression - as this may cause an increase in the effects of lithium;
• tricyclic antidepressants -used in the treatment of depression - as these may increase the toxic effects of lithium;
• selective serotonin reuptake inhibitors -used for the treatment of depression - as this may result in an increase in the toxic effects of lithium and symptoms such as diarrhea, confusion, tremors, agitation and serotonin syndrome (a potentially life-threatening condition, the symptoms of which may include alterations in mental status, increased body temperature and hyperactivity of the nervous and neuromuscular systems);
• methyldopa -used for the treatment of high blood pressure (hypertension) - as this may cause an increase in the toxic effects of lithium;
• phenytoin, phenobarbital and carbamazepine -used for the treatment of epilepsy - as these may cause brain damage (neurotoxicity);
• ACE inhibitorsand angiotensin receptor antagonists -used for the treatment of high blood pressure
• as this may reduce the elimination of lithium with a consequent increase in the risk of toxicity;
• osmotic, loopand thiazide diureticssuch as acetazolamide, amiloride, triamterene, furosemide,bumetanide and ethacrynic acidas they may cause an increase in the elimination of lithium;
• verapamiland diltiazemand other calcium antagonists -used for the treatment of high blood pressure - as this may cause brain damage (neurotoxicity) with symptoms such as lack of coordination of movements, tremors, nausea, vomiting, diarrhea and hearing disorders (tinnitus);
• corticosteroids -used for the treatment of inflammation, fever and other disorders - as this may cause fluid retention with a consequent increase in lithium levels in the blood;
• metoclopramide -used to counter nausea and vomiting - as this may cause extrapyramidal symptoms;
• metronidazole -an antibiotic - as this may cause an increase in lithium levels in the blood;
• aminophyllineand mannitol -respectively used for the treatment of asthma and in renal insufficiency and other diseases - as this may cause a decrease in lithium levels in the blood;
• neuromuscular blocking agents -used to induce neuromuscular relaxation - as lithium may prolong their action;
• empagliflozin- used to treat diabetes or heart failure - and dapagliflozin- used to treat diabetes or heart failure or chronic kidney disease - as they may decrease the amount of lithium in the body reducing its effect;
• topiramate(used to treat epilepsy or migraine).

A combined therapy with chlorpromazine- used in the treatment of psychoses, acetazolamide- used for the
treatment of high blood pressure and other substances such as xanthines, ureaand sodium

bicarbonatecan reduce lithium levels in the blood by increasing their elimination with urine.

Carbolithium with drinks and alcohol
Avoid taking alcohol, or other medicines that contain alcohol during treatment with this
medicine, as this may increase the level of lithium in the blood with a consequent
increase in the risk of toxicity.
Excessive consumption of coffee may decrease the concentration of lithium in the blood reducing its
effect.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Carbolithium if you are pregnant, suspect you are pregnant or are planning to become pregnant,
as lithium can cause harm to the fetus (see section 2 “Do not take Carbolithium”).
A few days after delivery, it is advisable, always under strict medical supervision, to resume therapy
at low doses for the increased risk of manic episodes and relapses in the postpartum period,
carefully avoiding breastfeeding.
Breastfeeding
Do not take Carbolithium if you are breastfeeding (see section 2 “Do not take Carbolithium”).
Fertility
Women of childbearing potential must have a test before starting therapy with Carbolithium to rule out
a possible pregnancy. Women of childbearing potential who are already on lithium salts and are
planning a pregnancy should discontinue therapy by gradually reducing the dose, under
strict medical supervision, to avoid the occurrence of relapses (see section “Warnings and
precautions”).

Driving and using machines
Carbolithium may impair your ability to drive and operate machinery.

Carbolithium 150 mg contains lactose:if you have been diagnosed with an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Carbolithium

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is 300 mg from 2 to 6 times a day, administered at regular intervals. Your doctor
will start therapy with low doses of the drug, and then adjust the dose based on the level of lithium
in the blood (lithiemia).
In children and adolescents aged between 12 and 18 years, the doctor will prescribe a
short-term treatment that can only be continued after ascertaining an evident response to the
therapy.
The use of Carbolithium in children and adolescents under 12 years of age is not recommended.

If you take more Carbolithium than you should
In case of ingestion/accidental intake of an excessive dose of this medicine, consult
immediately your doctor or go immediately to the nearest hospital.
If you take more Carbolithium than you should, apathy and restlessness may occur
which may be confused with the mental state already caused by depression.
Overdosage can also lead to a condition known as extrapyramidal syndrome, i.e. a
set of symptoms including tremors, muscle rigidity due to increased muscle tone,
slowness and difficulty in movements.
In case of severe poisoning, the main signs are associated with the heart, with alterations of some
tests (ECG) and the nervous system, with dizziness, impaired state of consciousness,
increased reflexes (hyperreflexia) and awake coma.

If you forget to take Carbolithium
Do not take a double dose to make up for a missed dose.

If you stop taking Carbolithium
Do not stop treatment with Carbolithium suddenly or without first agreeing
with your doctor as a possible relapse may occur (see paragraph “Warnings and
precautions”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop treatment and consult your doctor immediatelyif you experience:
diarrhea, nausea, vomiting, abdominal pain, drowsiness, muscle weakness, incoordination of
movements, sedation, dry mouth, feeling of cold, slowed speech and involuntary, oscillating, rhythmic eye movements (nystagmus).
If the level of intoxication should increase, an exacerbation of
reflexes (hyperreflexia), dizziness, ringing in the ears (tinnitus), blurred
vision and excessive urine production (polyuria) may also appear. In very severe cases, toxicity may involve
various organs leading to generalized seizures, acute circulatory failure, stupor, coma and
death.
Within 24 hours of the first dose of lithium, the following may occur:
an increase in the elimination of certain substances normally present in the blood (sodium, potassium and
mineralocorticoids) through the urine. Subsequently, an excessive accumulation of fluids may occur
at the level of the legs (pretibial edema). These symptoms tend to disappear within a few
days.
In the first few days of therapy, the following symptoms may occur, which tend to disappear with the
continuation of treatment: tremors in the hands, increased urine production, moderate thirst and
general malaise. If they should persist, it would be wise to discuss with your doctor the
suspension of therapy.
Possible side effects include:

• alterations in heart rate such as cardiac arrhythmias, ventricular arrhythmia (e.g. torsade de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest);
• unmasking and/or worsening of Brugada syndrome (an inherited syndrome affecting the heart) (frequency not known);
• low blood pressure (hypotension);
• collapse of circulation (peripheral circulatory failure);
• circulatory failure;
• increased thyroid function (hyperthyroidism);
• onset of diabetes insipidus (due to the loss of the kidney's ability to concentrate urine);
• loss of consciousness (petit mal epilepsy);
• seizure;
• speech disorder (dysarthria);
• extrapyramidal disorder (see paragraph 3 “If you take more Carbolithium than you should”);
• dizziness;
• vertigo;
• urinary incontinence and anal incontinence;
• drowsiness;
• fatigue;
• lethargy;
• psychomotor retardation;
• confusional state;
• restlessness;
• stupor;
• coma;
• tremor;
• involuntary muscle contractions and repetitive movements of the leg muscles (tonic-clonic movements);
• difficulty or lack of coordination of muscle movements (ataxia);
• very fast or slow movements (choreoathetosis);
• hyperreflexia of deep tendon reflexes;
• dry mouth;
• heart disorders (prolonged QT interval on the electrocardiogram);
• cases of sudden death (due to lithium toxicity);
• elevated levels of albumin or glucose in the urine (albuminuria, glucosuria);
• decreased or increased urine production (oliguria, polyuria);
• changes in the functional units of the kidney (nephrons);
• benign/malignant kidney tumors (microcysts, oncocytoma or renal collecting duct carcinoma (in long-term therapy);
• thyroid abnormalities: enlargement of the thyroid gland (goiter) and/or decreased thyroid function (hypothyroidism, including myxedema);
• hyperparathyroidism (a condition in which the parathyroid glands produce an excessive amount of parathyroid hormone, which increases calcium levels in the blood - frequency not known), benign tumor (non-cancerous) of the parathyroid gland (parathyroid adenoma - frequency not known); enlargement of one or more parathyroid glands (parathyroid hyperplasia - frequency not known);
• eating disorder leading to refusal of food (decreased appetite);
• nausea;
• vomiting;
• diarrhea;
• abdominal pain;
• severe decrease in white blood cells in the blood associated with an acute increase in lithium concentration in the blood (lithiemia);
• changes at the blood level, in case of long-term therapies with lithium;
• transient visual impairment (visual field defect);
• visual impairment;
• thinning and thinning of hair;
• hair loss (alopecia);
• loss of sensitivity at the skin level (cutaneous anesthesia);
• inflammation of the hair follicles (chronic folliculitis);
• worsening of psoriasis;
• skin or mucous membrane rash (drug-induced lichenoid reaction);
• widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome) - (frequency not known). Stop using Carbolithium if you develop these symptoms and contact your doctor or seek immediate medical attention;
• dehydration;
• weight loss;
• increased calcium levels in the blood (hypercalcemia);
• muscle weakness;
• changes in some heart and brain tests (ECG and EEG);
• sexual dysfunction;
• excessive levels of calcium in the blood (very common frequency).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 on the safety of
this medicine.

5. How to store Carbolithium

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date that is reported on the pack after “Exp.”. The expiry
date refers to the last day of that month.
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 Carbolithium 150 mg hard capsules contain:

• The active ingredient is lithium carbonate. Each capsule contains 150 mg of lithium carbonate.
• The other ingredients are magnesium stearate, gelatin, titanium dioxide, indigotine (E 132), lactose monohydrate, corn starch, methylcellulose.

What Carbolithium 300 mg hard capsules contain:

• The active ingredient is lithium carbonate. Each capsule contains 300 mg of lithium carbonate.
• The other ingredients are magnesium stearate, gelatin, titanium dioxide, indigotine (E 132), methylcellulose.

Description of the appearance of Carbolithium and pack contents
Carbolithium is presented in a pack containing 50 capsules in blisters.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Laboratorio Farmaceutico SIT S.r.l., Via Cavour, 70 - 27035 Mede (PV)

Manufacturer
ITC Production S.r.l. - Via Pontina KM 29 - 00071 Pomezia (RM)