LITHIUM 250 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Lithium carbonicum GSK, 250 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Lithium carbonicum GSK and what is it used for
   1. Indications for use:
4. Important information before taking Lithium carbonicum GSK
   1. When not to take Lithium carbonicum GSK
   2. Warnings and precautions
   3. Effect on the kidneys
   4. Lithium carbonicum GSK and other medicines
   5. Lithium carbonicum GSK with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
   8. Lithium carbonicum GSK contains lactose
5. How to take Lithium carbonicum GSK
   1. Recommended dose:
   2. Use in children
   3. Taking a higher dose of Lithium carbonicum GSK than recommended
   4. Symptoms of acute poisoning:
   5. Missing a dose of Lithium carbonicum GSK
   6. Stopping treatment with Lithium carbonicum GSK
   7. Planned discontinuation of lithium
   8. Discontinuation of treatment due to toxicity
6. Possible side effects
   1. Severe side effects
   2. Other side effects
   3. In the initial treatment period, the following side effects occur relatively frequently and usually subside during continued treatment:
   4. Reporting side effects
7. How to store Lithium carbonicum GSK
8. Contents of the packaging and other information
   1. What Lithium carbonicum GSK contains
   2. What Lithium carbonicum GSK looks like and what the pack contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Lithium carbonicum GSK, 250 mg, tablets

Lithium carbonate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Lithium carbonicum GSK and what is it used for
• 2. Important information before taking Lithium carbonicum GSK
• 3. How to take Lithium carbonicum GSK
• 4. Possible side effects
• 5. How to store Lithium carbonicum GSK
• 6. Contents of the packaging and other information

1. What is Lithium carbonicum GSK and what is it used for

Lithium carbonicum GSK contains the active substance lithium carbonate. The medicine has a stabilizing effect on mood - depression and manic states.

Indications for use:

• treatment of a manic episode in bipolar affective disorders,
• prevention of relapse of bipolar affective disorders or reduction of the severity and frequency of subsequent manic episodes in patients with a history of manic states,
• prevention of depressive episodes in recurrent depressive disorders.

2. Important information before taking Lithium carbonicum GSK

When not to take Lithium carbonicum GSK

The medicine should not be taken:

• if the patient is allergic to lithium carbonate or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe kidney failure,
• if the patient has recently had a heart attack,
• if the patient has organic brain damage,
• if the patient has leukemia,
• if the patient is pregnant or breastfeeding (see section: Pregnancy and breastfeeding).

Warnings and precautions

Before starting treatment with Lithium carbonicum GSK, the patient should discuss it with their doctor if:

• the patient has Brugada syndrome (a hereditary condition that affects heart function) or if anyone in their family has had Brugada syndrome, cardiac arrest, or sudden death,
• the patient has severe kidney failure,
• the patient is or will be treated with electroconvulsive therapy,
• the patient has cardiovascular disease,
• the patient has untreated hypothyroidism,
• the patient has uncontrolled sodium levels due to dehydration or a low-sodium diet (restriction of salt intake in food),
• the patient has Addison's disease (chronic adrenal insufficiency caused by insufficient production of hormones in the adrenal cortex),
• the patient is taking medications for type 2 diabetes (see: Lithium carbonicum GSK and other medicines),
• the patient has elevated calcium levels in the blood.

The above conditions increase the risk of side effects (listed in section 4).
The patient should consult their doctor or pharmacist if:

• the patient plans to undergo or has undergone obesity treatment surgery, as it may be necessary to administer a lower dose of lithium. The doctor will monitor the patient's blood lithium levels and adjust the dose accordingly.

Elevated calcium levels in the blood
Treatment with Lithium carbonicum GSK may cause elevated calcium levels in the blood.
Before starting treatment and during treatment, the doctor may order a blood test to check calcium levels.
Lithium should be used with caution in patients with:

• Parkinson's disease,
• disorders of sinus node and atrioventricular conduction (heart rhythm disorders),
• epilepsy,
• psoriasis,
• congenital myasthenia gravis (a disease characterized by excessive muscle weakness),
• diabetes,
• schizophrenia.

Before starting treatment, the doctor will order tests to check thyroid, kidney, and heart function (ECG), as well as sodium and glucose levels in the blood.

Effect on the kidneys

Lithium increases sodium and water excretion by the kidneys, so during treatment, the patient should consume an adequate amount of sodium and water to avoid dehydration (see section: Lithium carbonicum GSK with food and drink).
If the patient is on a low-sodium diet, they should inform their doctor before taking this medicine.
If diarrhea or excessive sweating occurs (e.g., due to viral infections), the patient should contact their doctor immediately. In such cases, the doctor may reduce the dose or interrupt treatment for the duration of these disorders.
The patient should remember that fluid loss from the body can be increased by:

• drinking large amounts of caffeine-containing beverages, such as coffee, tea, and cola (which increases urine production),
• intensive physical exercise, staying in a room with high temperature (which increases sweating).

Long-term use of Lithium carbonicum GSK may cause severe kidney function disorders. If the patient produces more urine than usual, they should inform their doctor.
In some patients with severe kidney function disorders, long-term use of Lithium carbonicum GSK may cause kidney changes, including kidney cancer (see section 4).
If the patient plans to take any other medicine, they should consult their doctor (see section: Lithium carbonicum GSK and other medicines).
In elderly patients (over 65 years), the doctor may reduce the dose of Lithium carbonicum GSK.
In patients with depression or bipolar affective disorders, a worsening of the clinical condition may occur. They may experience suicidal thoughts and behaviors, regardless of whether they are taking antidepressants or not. If such symptoms occur, the patient should contact their doctor immediately.

Lithium carbonicum GSK and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Medicines that increase lithium levels in the blood and may cause lithium poisoning:

• metronidazole(a medicine used to treat infections caused by certain bacteria and protozoa),
• non-steroidal anti-inflammatory drugs(pain-relieving and anti-inflammatory medicines, e.g., indomethacin, ketoprofen), including selective cyclooxygenase-2 inhibitors (e.g., celecoxib),
• medicines used to treat high blood pressure:angiotensin-converting enzyme inhibitors (e.g., ramipril), angiotensin II receptor antagonists (e.g., losartan, valsartan),
• diuretics(medicines that increase urine production, especially thiazide and amiloride).

Medicines that decrease lithium levels in the blood:

• urea,
• xanthines(caffeine, medicines used to treat asthma, e.g., aminophylline, theophylline, and others),
• alkalizing agents(medicines used, e.g., to treat metabolic acidosis, such as sodium bicarbonate),
• medicines for type 2 diabetes(such as empagliflozin, dapagliflozin, and other gliflozins known as SGLT2 inhibitors),
• diuretics(e.g., carbonic anhydrase inhibitors).

The patient should inform their doctor or pharmacist about taking:

• topiramate(used to treat epilepsy or migraines).

Certain medicines taken with lithium may have toxic effects on the nervous system, causing:
mild motor impairment, muscle tremors, hypertension (increased muscle tone), involuntary muscle contractions, hyperreflexia (increased reflexes), speech disorders, confusion, drowsiness, and nystagmus (eye movements). If such symptoms occur, treatment should be stopped immediately.
In very rare cases, concurrent use of lithium and neuroleptics may cause psychiatric and neurological symptoms (delirium, seizures, or increased frequency of extrapyramidal symptoms - muscle stiffness, reduced facial expressions, slow movement, restlessness, involuntary muscle contractions, and involuntary movements). These symptoms may be similar to or identical to those of malignant neuroleptic syndrome. In some cases, irreversible brain damage may occur.
Medicines that have toxic effects on the nervous system when used with lithium:

• neuroleptics(antipsychotic medicines),
• carbamazepine(a medicine used to treat epilepsy),
• methyldopa(a medicine used to treat high blood pressure),
• selective serotonin reuptake inhibitors(medicines used to treat depression)
• may enhance the toxic effects of lithium, leading to serotonin syndrome, characterized by symptoms such as tremors, dizziness, agitation, confusion, diarrhea,
• calcium channel blockers(medicines used, e.g., to treat high blood pressure),

Lithium carbonicum GSK may enhance and prolong the effect of muscle relaxants
(medicines used before surgery). If the patient is to undergo surgery under anesthesia, they should inform their doctor that they are taking lithium.
Lithium enhances the effect of large doses of iodine(a medicine used to treat thyroid disorders).
Lithium may inhibit the effect of amfetamine derivatives(e.g., medicines used to treat ADHD and weight loss).
Lithium carbonicum GSK may affect laboratory blood test results,causing increased glucose, parathyroid hormone, and calcium levels.
In rare cases, Lithium carbonicum GSK may trigger congenital myasthenia gravis (a disease characterized by excessive muscle weakness).

Lithium carbonicum GSK with food and drink

• During treatment, the patient should consume a constant amount of sodium and water (2.5 to 3 liters per day) and avoid changing their salt intake (see section: Warnings and precautions).
• If the patient plans to follow a diet, they should consult their doctor.
• Antacids (containing aluminum or magnesium hydroxide) do not affect lithium absorption and can be taken concurrently.
• Drinking larger amounts of coffee may decrease lithium levels in the blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Lithium carbonicum GSK should not be taken during pregnancy, especially during the first trimester.
The medicine should not be taken during breastfeeding, as it passes into breast milk and may cause poisoning in the child.

Driving and operating machinery

Lithium may cause drowsiness, dizziness, or hallucinations, which may affect the ability to drive and operate machinery.
If such symptoms occur, the patient should not drive or operate machinery.

Lithium carbonicum GSK contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Lithium carbonicum GSK

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor.

Recommended dose:

The dose is determined individually by the doctor for each patient (based on blood lithium levels and clinical improvement).
The daily dose is usually 0.5 to 1.25 g of lithium carbonate, administered in divided doses.
The daily dose should be increased gradually.
During the initial treatment period, blood lithium levels should be monitored at least once a week. The recommended blood lithium level is between 0.5 and 0.8 mmol/l (to prevent relapse of affective disorders). After achieving the desired level, monitoring can be done less frequently, every month or every 2 months; during remission, every 2 to 3 months.
In acute conditions (manic states), a dose of 1.5 to 2.0 g per day is used (blood lithium levels should be between 0.6 and 1.2 mmol/l). After the acute phase subsides, the dose should be reduced immediately.
The daily dose should be divided into at least 3 parts.
The medicine can be taken independently of meals.

Use in children

Do not use in children under 12 years of age.

Taking a higher dose of Lithium carbonicum GSK than recommended

In case of taking a higher dose than recommended, the patient should contact their doctor immediately.
Any lithium overdose should be considered potentially life-threatening. In patients treated with lithium for a long time, even a small overdose can lead to severe toxicity, as the body's tissues are already saturated with lithium.

Symptoms of acute poisoning:

• persistent vomiting, diarrhea,
• motor impairment, seizures,
• coma,
• often cardiac arrhythmias and shock, which can be life-threatening.

During long-term treatment, symptoms of poisoning usually develop gradually. The cause may be irregular medication use, electrolyte disturbances, increased sodium loss due to diuretic use, or excessive sweating.
At levels of 1.5 - 2 mmol/l (12 hours after the last dose), the following symptoms may occur: diarrhea, coarse and fine tremors, muscle weakness, speech disorders, motor impairment.
At levels of 2 - 3 mmol/l, the following symptoms may occur: confusion, seizures, memory disorders, nystagmus, coma, and even death.
If the first symptoms of poisoning appear, the medicine should be stopped immediately, and the patient should contact their doctor.

Missing a dose of Lithium carbonicum GSK

In case of missing a dose, the patient should take the medicine as soon as possible. If the next dose is approaching, the missed dose should be skipped. The next dose should be taken at the usual time.
A double dose should not be taken to make up for the missed dose.

Stopping treatment with Lithium carbonicum GSK

Planned discontinuation of lithium

It is recommended to discontinue lithium gradually (over at least 2 weeks). Abrupt discontinuation of the medicine may cause a relapse of the disease that was being treated with lithium.

Discontinuation of treatment due to toxicity

Treatment should be stopped immediately if the first symptoms of poisoning appear, such as:

• cardiovascular disorders (e.g., QT/QTc interval prolongation visible on ECG),
• diarrhea, vomiting, dehydration,
• neurological disorders, such as: ataxia (difficulty maintaining balance, unsteady gait), tremors, hypertension (increased muscle tone), involuntary muscle contractions, hyperreflexia (increased reflexes), speech disorders, confusion, drowsiness, and nystagmus (eye movements).

In case of any further doubts about the use of this medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The occurrence and severity of side effects depend on the patient's sensitivity and blood lithium levels.

Severe side effects

The patient should stop taking the medicine and contact their doctor or seek medical attention immediately if they experience the following side effects with unknown frequency (frequency cannot be determined based on available data ):

• Widespread rash, high body temperature, increased liver enzyme activity, blood abnormalities (eosinophilia), lymph node enlargement, and involvement of other body organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or hypersensitivity syndrome).
• Diarrhea, vomiting, mild motor impairment (coordination disorders), dizziness, muscle tremors, and muscle weakness, speech disorders, confusion (disorders of consciousness, thought process, time, place, situation, or own person), drowsiness, and nystagmus (eye movements).

The patient should contact their doctor immediately if they experience the following side effects with unknown frequency (frequency cannot be determined based on available data ):

• In case of blood in the urine, appearance of any lumps or pain in the flank area while taking this medicine. In some patients with severe kidney function disorders, long-term use of Lithium carbonicum GSK may cause kidney changes, including kidney cancer.

Other side effects

The patient should contact their doctor, pharmacist, or nurse if they experience the following side effects:

In the initial treatment period, the following side effects occur relatively frequently and usually subside during continued treatment:

• tremors,
• gastrointestinal disorders (nausea, vomiting, diarrhea, abdominal pain, salivation, dryness of the oral mucosa),
• polyuria (excretion of large amounts of urine),
• increased thirst,
• muscle weakness,
• fatigue.

Very common side effects (may occur in more than 1 in 10 people):

• endocrine disorders:hypercalcemia (elevated calcium levels in the blood).

Side effects with unknown frequency (frequency cannot be determined based on available data ):

• blood and lymphatic system disorders:leukocytosis (increased white blood cell count in the blood);
• endocrine disorders:goiter (enlargement of the thyroid gland), hypothyroidism, hyperthyroidism, hyperparathyroidism (when the parathyroid glands produce too much parathyroid hormone, which increases calcium levels in the blood), increased parathyroid gland size, parathyroid adenoma (a benign tumor);
• metabolic and nutritional disorders:hyperglycemia (elevated glucose levels in the blood), weight gain, anorexia (loss of appetite);
• psychiatric disorders:hallucinations (perception of non-existent objects or people), drowsiness, memory disorders;
• nervous system disorders:seizures, muscle tremors (fine and coarse), ataxia (difficulty maintaining balance, unsteady gait), choreoathetoid movements (uncoordinated movements of the limbs, independent of will), nerve conduction disorders, increased deep tendon reflexes, extrapyramidal symptoms (muscle stiffness, reduced facial expressions, slow movement, restlessness, involuntary muscle contractions, and involuntary movements), seizures, speech disorders, dizziness, nystagmus (eye movements), stupor (the patient is conscious but does not respond to external stimuli), coma, pseudotumor cerebri (a condition characterized by increased intracranial pressure), headaches, taste disorders, myasthenia gravis(muscle weakness - a disease characterized by excessive muscle weakness);
• eye disorders:vision disorders - blindness, blurred vision;
• heart disorders:arrhythmia, bradycardia (slow heart rate), disorders of sinus node function, peripheral edema, ECG changes, and (or) exacerbation of Brugada syndrome symptoms (a hereditary condition that affects heart function);
• vascular disorders:peripheral circulatory failure, hypotension (low blood pressure), Raynaud's phenomenon (intermittent constriction of blood vessels in the hands - the hands first become pale, then blue, and finally red due to increased blood flow);
• gastrointestinal disorders:nausea, vomiting, diarrhea, gastritis, salivation, dryness of the oral mucosa;
• skin and subcutaneous tissue disorders:hair loss, acne, folliculitis (inflammation of the hair follicles), pruritus (itching), exacerbation of psoriasis, rash, ulcers, excessive skin thickening, other skin hypersensitivity reactions, skin or mucous membrane eruptions (drug-related lichenoid reaction); musculoskeletal and connective tissue disorders:joint pain, muscle pain;
• kidney and urinary tract disorders:symptoms of nephrogenic diabetes insipidus, urinary incontinence, kidney damage (tubulointerstitial nephropathy) due to long-term treatment, kidney function disorders.
• reproductive system and breast disorders:impotence (erectile dysfunction), sexual disorders;
• general disorders and administration site conditions:edema.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Lithium carbonicum GSK

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C in the original packaging. Protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP.
The expiry date refers to the last day of the month.
The batch number of the medicine is stated on the carton and blister pack after: Lot.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Lithium carbonicum GSK contains

• The active substance of the medicine is lithium carbonate. Each tablet contains 250 mg of lithium carbonate.
• Other ingredients are: lactose monohydrate, potato starch, povidone K-30, talc, anhydrous colloidal silica, magnesium stearate.

What Lithium carbonicum GSK looks like and what the pack contains

The medicine is in the form of white to cream-colored, round tablets with the inscription "LC" on one side and a smooth surface on the other side of the tablet.
The tablets are packaged in a polyethylene (HDPE) container with a polyethylene child-resistant closure and a guarantee ring or a polypropylene child-resistant closure with an induction seal in a carton.
The packaging of the medicine is 60 tablets, along with the patient information leaflet, in a carton.

Marketing authorization holder

GSK PSC Poland sp. z o.o.
ul. Grunwaldzka 189,
60-322 Poznań

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
tel. +48 (22) 576-90-00

Date of last revision of the leaflet: