LITHICARB

LITHICARB

Active ingredient(s): Lithium carbonate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Lithicarb. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about Lithicarb.

Where to find information in this leaflet:

1. Why am I using Lithicarb?
2. What should I know before I use Lithicarb?
3. What if I am taking other medicines?
4. How do I use Lithicarb?
5. What should I know while using Lithicarb?
6. Are there any side effects?
7. Product details

1. Why am I using Lithicarb?

Lithicarb contains the active ingredient lithium carbonate. Lithicarb is a powerful mood stabiliser, however the exact way that lithium works to stabilize a person’s mood is not known. It helps you have more control over your emotions and helps you cope better.

Lithicarb is used to both treat and prevent episodes of a condition called manic-depressive or bipolar disorder, in which there are sustained mood swings either up (manic) or down (depressive).

It is also used in the treatment of schizo-affective illness and chronic schizophrenia.

Your doctor, however, may have prescribed Lithicarb for another purpose.

2. What should I know before I use Lithicarb?

Warnings

Do not use Lithicarb if:

• You are allergic to lithium carbonate, or any of the ingredients listed at the end of this leaflet.
• Some symptoms of an allergic reaction include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips or tongue or other parts of the body, rash, itching or hives on the skin.
• Always check the ingredients to make sure you can use this medicine.
• You have or have had severe heart or kidney disease, low activity of the adrenal gland (e.g. Addison’s disease), an underactive thyroid gland or low levels of sodium in your body (e.g. if you are dehydrated or on a low salt diet)
• It is after the expiry date printed on the pack. The packaging is torn or shows signs of tampering.

Check with your doctor if you:

Have any of the following medical conditions

• Conditions for which you take diuretics (fluid tablets)
• Vomiting or diarrhoea
• Two infections occurring at the same time
• Brugada syndrome or someone in your family has Brugada syndrome (a genetic disease that affects the heart.

Do not take diuretics (water pills) medication that increases urination without first consulting your doctor.

Take any medicines for any other condition.

A medical examination and some laboratory tests are usually performed before you begin therapy with Lithicarb. They are usually repeated at regular intervals while you continue to take this medicine.

If you have not told your doctor about any of the above, tell them before you start taking Lithicarb. During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take Lithicarb if you are pregnant, plan to become pregnant or are breastfeeding unless you and your doctor have discussed the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start taking Lithicarb.

Use in Children

Do not give Lithicarb to children.

This medicine is not recommended for children as there is no specific information about such use.

Use in Elderly

Elderly patients may be more sensitive to the effects or side effects of this medicine. If you are elderly you need to watch carefully for signs of side effects or lithium toxicity. Elderly patients may require a lower dosage than younger patients.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Lithicarb interacts with many other medicines. This can cause a change in the blood levels of either the lithium or of the other medicine, increasing the chance of side effects or lithium toxicity.

Lithium toxicity may occur if the level of lithium in your blood becomes too high. If you are taking a medication which interacts with Lithicarb your blood lithium levels will need to be monitored closely.

Some medicines in common use that may interfere with Lithicarb include:

• Medicines for removal of fluid (diuretics)
• Some medicines for high blood pressure and other heart drug (e.g. captopril, enalapril, calcium channel blockers, methyldopa, Atacand and Cozaar)
• Some types of tranquillisers (e.g. diazepam)
• Some medicines for depression (e.g. fluoxetine, imipramine)
• Some medicines for arthritis or pain (e.g. indomethacin, piroxicam, celecoxib)
• Appetite suppressants
• Some medicines for epilepsy (e.g. carbamazepine and phenytoin)
• Medicines for epilepsy (e.g. carbamazepine and phenytoin)
• Medicines used to treat respiratory illness (e.g. theophylline)
• Medicines that change the acidity of the urine (e.g. sodium bicarbonate)
• Medicines used to treat certain mental health conditions (e.g. haloperidol)
• Ziprasidone, which can interact with lithium to affect the heart
• Medicines containing steroids (e.g. prednisolone)
• Medicines used to treat glaucoma (e.g. acetazolamide)
• Medicines used to treat skin disorders (e.g. urea)
• Some antibiotics (e.g. metronidazole).

These medicines may be affected by Lithicarb or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Lithicarb.

If you have not told your doctor about any of these things, tell them before you take Lithicarb.

4. How do I use Lithicarb?

How much to take / use

• Your doctor will tell you how much Lithicarb to take.
• Follow the instructions provided and use Lithicarb until your doctor tells you to stop.
• The dose required to reach an effective level in the blood varies between individuals. For this reason the dose needs to be adjusted to suit you.
• In the early stages of your treatment your doctor will arrange several blood tests to establish your blood level of lithium and the dose of Lithicarb that is correct for you. You will need to have regular blood tests to monitor your blood lithium level.
• Your body’s requirements of lithium may change and it may be necessary for your doctor to change the amount of Lithicarb taken to effectively control your mood swings.

When to take / use Lithicarb

• Lithicarb should be taken with a meal or snack to prevent stomach upset.
• In order for Lithicarb to work properly, spread out the recommended dose evenly throughout the day. This will help keep the amount of lithium in your blood constant.
• Do not miss any doses and do not stop taking the medicine even if you feel better.
• Missing doses may make your symptoms worse.

How long to take it

• Continue taking Lithicarb for as long as your doctor tells you.
• Lithicarb is not a cure. To control mood swings you may need to take it for a long period of time. Only after several months or even years can you and your doctor decide whether taking it is still necessary.
• To maximise its effectiveness it is important that you take the prescribed dose of Lithicarb regularly.

What to Expect:

• When you start taking Lithicarb your mood swings should become less frequent, less severe and less prolonged.
• Sometimes it must be taken for one to several weeks before you begin to feel better. However, it may take six to twelve months before the full benefits of lithium therapy become apparent. To maximise its effectiveness it is important that you take the prescribed dose of Lithicarb regularly.

If you forget to use Lithicarb

Lithicarb should be used regularly at the same time each day. If you miss your dose at the usual time and it is

• More than two hours before your next dose is due: Take it straight away, then continue as you normally would.
• Less than two hours to your next dose: Skip the dose you have missed but be sure to take the next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much Lithicarb

If you think that you or anyone else have used too much Lithicarb, you may need urgent medical attention.

Symptoms of overdose include vomiting, nausea, abdominal pain, anorexia, occasionally mild diarrhoea, giddiness, tremor, ataxia, slurring speech, myoclonus, twitching, asthenia, depression and renal symptoms. In serious cases, fits (convulsions) and coma may occur.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Lithicarb?

Things you should do

When you first start taking Lithicarb, you may require two or more blood tests a week. Once your lithium levels are stable, you should need tests about 4 times a year to check that your blood lithium level is stable. If your Lithicarb dose is changed or if you have signs of lithium toxicity you may need more frequent blood tests.

The blood test must be done twelve hours after a dose, before you have taken your morning tablets. Take Lithicarb exactly as your doctor has prescribed.

Tell your doctor if you are taking medicines to treat epilepsy or seizures (e.g. carbamazepine and phenytoin). This is because when it is taken with Lithicarb, it may cause a rare serious brain condition called encephalopathic syndrome. The symptoms include weakness, lethargy, fever, confusion and shaking. Monitor closely for these symptoms and visit your doctor immediately if you experience these.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Lithicarb.

Tell your doctor immediately if you become pregnant while taking Lithicarb.

Tell all doctors, dentists and pharmacists who are treating you, that you are taking Lithicarb.

Lithicarb should always be taken with care and under your doctor’s supervision because serious side effects may occur if the level of lithium in your blood becomes too high (lithium toxicity). This can happen if you are taking too much lithium or if there are major changes to your normal health or lifestyle.

There are a number of things you can do during therapy with Lithicarb to help prevent lithium toxicity, such as:

• maintain a normal diet with adequate salt and fluid
• consult your doctor before you make any dietary changes
• avoid reducing your salt intake
• avoid heavy exercise which may lead to excessive sweating and water loss
• take extra care in hot weather by limiting exposure to the heat. Drink plenty of fluids to avoid becoming dehydrated.
• watch for signs of lithium toxicity if you have an infection or have symptoms such as fever, vomiting or diarrhoea
• watch for signs of lithium toxicity if your regular dose of Lithicarb is increased or changed or if you start taking another medication

If you are not aware of the signs of lithium toxicity you should ask your doctor.

You and your family should be able to recognise the signs of lithium toxicity and know what to do if they occur.

Things you should not do

Do not give this medicine to anyone else, even if they have the same condition as you.

Do not stop taking Lithicarb suddenly unless advised by your doctor.

If you stop taking it suddenly your mood swings may return. If you want to stop taking Lithicarb, your doctor will tell you how to do it gradually over several weeks or months.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Lithicarb affects you.

This medicine may cause drowsiness, poor co-ordination and blurred vision in some patients, especially when you first start to take it. Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous.

Drinking alcohol

Be careful when drinking alcohol while you are taking Lithicarb.

If you drink alcohol while you are taking it side effects such as drowsiness may become worse.

Looking after your medicine

Keep Lithicarb tablets in a cool dry place where the temperature stays below 30°C.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If your doctor advises you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Stomach upset with mild nausea (feeling sick) and diarrhoea Feeling dazed, dizzy or lightheaded Muscle weakness Fine tremor of the hands Fluid retention Thirst Passing more urine than usual Unusual tiredness or weakness Loss of appetite Vomiting Increased saliva Stomach pain Stomach problems with pain, nausea, vomiting, vomiting blood and blood in the bowel motions Constipation Slurred speech Slightly altered taste Dry mouth Headache Impotence Rash Worsening of skin diseases such as acne or psoriasis Numbness, tingling and colour change in fingers and toes when exposed to cold.

These are the common side effects. Most will improve or resolve with time. Speak to your doctor if you have any of these less serious side effects and they worry you.

When Lithicarb is taken for long periods of time the following side effects can occur:

• Thyroid changes (goitre)
• Weight gain
• Mild forgetfulness
• Hair thinning

Your doctor may suggest some dietary or lifestyle changes to help reduce these effects.

Serious side effects

Serious side effects	What to do
Irregular heartbeat Excessive thirst Passing large amounts of urine Severe stomach cramps or pain Vomiting or diarrhoea Severe drowsiness or dizziness Ringing in the ears Confusion Staggering and slurred speech Severe tremor Increased muscle twitches or weakness Blurred vision or agitation Swelling of the face, mouth lips, tongue or throat which may cause difficulty in breathing or swallowing.	These are possible signs of high levels of lithium in the blood (lithium toxicity). You may need urgent medical attention or hospitalisation

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Lithicarb contains

Active ingredient (main ingredient)	Each tablet contains 250mg lithium carbonate
Other ingredients (inactive ingredients)	starch – maize dextrin lactose macrogol 6000 sodium starch glycollate A talc – purified sodium lauryl sulphate magnesium stearate hypromellose
Potential allergens	Lactose

Do not take this medicine if you are allergic to any of these ingredients.

Lithicarb tablets do not contain sucrose, tartrazine or any other azo dyes.

What Lithicarb looks like

Lithicarb are white to off-white oval-shaped bevel edged film coated tablets, with breakline on one side and plain on the other.

The tablets are available in bottles of 200.

Who distributes Lithicarb

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

AUST R 49625

This leaflet was prepared in October 2022.