Lithionit 42 mg (6 mmol) Prolonged Release Lithium Sulfate Tablet
What Lithionite Is And What It Is Used For
Lithionite contains the active substance lithium and has a preventive effect against both manic (abnormal agitation) and depressive (pronounced depression) phases in patients with bipolar disorder. In hospitals, Lithionite can also be given in acute manic conditions. The full effect is then reached within about 1 week. The mechanism of action of lithium is not fully understood.
What You Need To Know Before Taking Lithionite
Do Not Take Lithionite
- If you have severe kidney problems.
- If you have cardiovascular disease.
- If you have severely disturbed the salt and fluid balance.
- If you are allergic to lithium sulfate or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
Talk to your doctor or pharmacist before taking Lithionite:
- If you have heart problems ( ECG changes).
- If you have high blood pressure.
- If you have myasthenia gravis (severe muscle weakness).
- If you have epilepsy or other seizures.
- If you have mild to moderate kidney problems.
- If you have any kind of brain damage.
- If you are on a low-salt diet or dieting diet.
- If you drink large amounts of coffee or tea.
- If you are elderly, especially if you are being treated with diuretics, ACE inhibitors, or anti-inflammatory drugs ( NSAIDs ).
Always consult a doctor or clinic for extra check-ups at the following times:
in diseases with fever and sweating (for example influenza ), in long-term diarrhea or vomiting, and in connection with dieting or if troublesome side effects occur.
Dietary habits, especially the salt in the food, must not be significantly changed after your Lithionit dosering has been adjusted using blood tests. The lithium content in the blood changes when you change the salt intake. Large amounts of coffee or tea can also affect the effect. Therefore, consult a physician in case of high consumption of coffee or tea.
Treatment with lithium can lead to hypothyroidism (lack of thyroid hormone). Your doctor may therefore want to check the function of your thyroid gland regularly.
Treatment with lithium can lead to hyperparathyroidism (overactive parathyroid glands). Your doctor may therefore want to check the calcium level in your blood regularly.
Patients with kidney problems: The doctor should monitor the level of lithium in the blood and adjust the dose accordingly. You should not take Lithionite if you have severe kidney failure (see section 2 “Do not take Lithionite”).
Kidney tumors: Patients with severe renal impairment who have received lithium for more than 10 years may be at risk of developing a benign or malignant kidney tumor (microcysts, oncocytoma, and kidney cell cancer).
Other Drugs And Lithionite
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The effect of the treatment can be affected if Lithionite is taken with certain other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Non-steroidal anti-inflammatory drugs ( NSAIDs ), e.g. indomethacin, diclofenac, meloxicam, ibuprofen, dexibuprofen, and naproxen (painkillers and anti-inflammatory drugs)
- COX-2 inhibitors, e.g. celecoxib, rofecoxib, parecoxib, and etoricoxib (analgesics and anti-inflammatory drugs)
- ACE inhibitors, e.g. enalapril and lisinopril (antihypertensive drugs)
- Angiotensin II receptor antagonist s, e.g. losartan (antihypertensive drug)
- Aciclovir (antiviral medicine)
- Neuroleptics, e.g. haloperidol and thioridazine (antipsychotic drugs)
- Selective serotonin reuptake inhibitors ( SSRIs ), e.g. fluoxetine and fluvoxamine (antidepressants)
- Venlafaxine (an antidepressant)
- Sibutramine (weight loss medicine)
- Sumatriptan (anti-migraine medicine )
- Calcitonin (the drug that regulates calcium metabolism)
- Metronidazole (drug against anaerobic bacteria and parasites)
- Thiazides and loop diuretics ( diuretics )
- L-methyldopa (antihypertensive drug)
- Carbamazepine (drugs against epilepsy )
- Muscle relaxants
- Xanthine derivatives, e.g. theophylline (a drug that dilates the trachea) and caffeine
Pregnancy, Breastfeeding And Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is a risk of fetal harm. Do not use Lithionit during pregnancy except on certain prescribed by a doctor.
The following symptoms may occur in newborns of mothers who have Lithionite uses during the last trimester (the last three months of pregnancy):
- Tremors
- Muscle stiffness and/or weakness
- Drowsiness
- Anxiety
- Difficulty breathing
- Difficulty eating
If your child has any of these symptoms, you may need to consult a doctor.
Breast-feeding
Lithium passes into breast milk and there is a risk that the baby will be affected. Breast-feeding should therefore be avoided during treatment with Lithionite.
Children
Lithium should not be given to children.
Driving And Using Machines
During treatment with Lithionite, the ability to concentrate and react may be impaired. You should therefore know how the treatment affects you before performing anything that requires sharpened attention (for example, driving a car or performing precision work).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How To Take Lithionite
Lithionite uses
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Lithionit dosering one is determined by the doctor who adjusts it individually for you. Dose one can vary quite a bit from one patient to another. Dose one is determined after repeated determination of the lithium concentration in the blood. This requires regular blood tests, usually every 2-3 months throughout the treatment period.
- The usual dosage for preventive treatment:
- Initially 1 tablet morning and evening. After one week of treatment, the concentration of lithium in the blood is measured. Based on this value, the doctor determines the continued dosage.
- The usual dosage in the treatment of manic conditions:
- Initially, 2 tablets 4 times daily for a few days, then the dose is adjusted based on the blood test value.
- Never change the dosage without consulting your doctor. Take the tablets at fixed times according to your doctor’s prescription.
- The tablets should be swallowed whole. To reduce the risk of side effects in the gastrointestinal tract, Lithionite can be taken with a meal.
Possible Lithionite Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common Lithionite side effects (may affect more than 1 user in 10):
- Renal diabetes insipidus (simultaneous increase in thirst and urine output)
- Weight gain (avoid high-calorie drinks)
- Trembling hand
Common (may affect up to 1 in 10 people):
- Increased amount of urine
- Increased thirst
- Fluid retention (edema)
- Feeling tired in arms and legs
- Diarrhea
- Nausea and stomach pain (especially during the first weeks)
- Acne-like rash
- ECG changes
- Effect on thyroid function, e.g. goiter
- Impaired ability to concentrate and react
- Reversible leukocytosis (temporary increase in white blood cells )
Uncommon (may affect up to 1 in 100 people):
- Muscle weakness
- Transient Parkinson’s-like symptoms
- Psoriasis or worsening psoriasis
- ECG -förändringar of severe type
- Headache
Has been reported (occurs in an unknown number of users):
- Fatigue (especially during the first weeks)
- Dry mouth
- Hyperparathyroidism (overproduction of parathyroid hormone)
- Malignant neuroleptic syndrome (mainly in combination with neuroleptics ), a severe condition with symptoms such as
- High fever
- Excessive sweating
- Decreased level of consciousness
- Stiff muscles
- Benign or malignant kidney tumors (with long-term treatment)
- Impaired renal function (with long-term treatment) including renal failure
- Rash on the skin or mucous membranes (lichenoid drug reaction)
- Hair loss
Many side effects occur at the beginning of treatment, such as
- Thirst
- Diarrhea
- Fatigue
- Trembling
They often disappear on their own after a while or can be remedied. If they become too troublesome, consult a doctor. Some patients also experience transient muscle fatigue. Stomach problems can be alleviated by taking the tablets with meals.
Weight gain is not uncommon and it is therefore important to pay attention to calorie intake and to watch out for calorie-rich drinks. Thyroid, parathyroid and renal function should be checked by regular sampling.
See also section “If you have taken too much Lithionite”.
How To Store Lithionite
- 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 blister, label, or carton after EXP or EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is anhydrous lithium sulfate equivalent to 42 mg (6 mmol) lithium.
- The other ingredients are polyacrylate, hypromellose, and magnesium stearate.
What The Medicine Looks Like And Contents Of The Pack
- Lithionite 42 mg prolonged-release tablets are white, round prolonged-release tablets
- Blister Pack: 100 and 250 prolonged-release tablets
- Glass jar: 500 prolonged-release tablets are
- Not all pack sizes may be marketed