Wednesday, October 5, 2016

Camcolit 250






CAMCOLIT 250mg film coated tablets



Lithium carbonate



Read all of this leaflet carefully before you start taking this medicine


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What CAMCOLIT is and what it is used for

  • 2. Before you take CAMCOLIT

  • 3. How to take CAMCOLIT

  • 4. Possible side effects

  • 5. How to store CAMCOLIT

  • 6. Further information




What CAMCOLIT is and what it is used for


CAMCOLIT 250mg tablets contain lithium carbonate, which is used to treat and prevent mania or manic depressive illness and recurrent depression. It is sometimes used to treat other behavioural disorders.




Before you take CAMCOLIT



Do not take CAMCOLIT if you:


  • are hypersensitive (allergic) to lithium or to any of the other ingredients

  • have severe kidney disease

  • have hypothyroidism (low thyroid hormones) that is difficult to treat

  • have problems with the rhythm of your heart

  • have low sodium levels

  • are breast-feeding



Whilst you are taking CAMCOLIT


Before you start taking CAMCOLIT and while you are taking it, your doctor should check on your:


  • Kidneys and urine

  • Thyroid

  • Heart

It is important that you tell your doctor if you notice any side-effects or are ill whilst you are taking CAMCOLIT. These could be early signs that your doctor should give you another check-up. Elderly patients should take particular care about this.


Possible side-effects are described later in this leaflet.


Other situations where you may need your blood monitoring more often are:


  • If there is a change in your dose or you change brands of lithium tablets.

  • You have an infection or other existing disease/disorder.

  • Large changes in the amount of fluid you drink or sodium (salt) you consume.

  • Taking other medicines.



Taking other medicines


You should tell your doctor if you are taking any of the following:


These medicines may increase the amount of lithium in your body making you more likely to have side effects:


  • Any medicine which may cause kidney problems.

  • Antibiotics called tetracyclines, metronidazole, co-trimoxazole, trimethoprim.

  • Non-steroidal anti-inflammatory drugs (e.g. diclofenac or ibuprofen) including COX-II inhibitors such as celecoxib. These are used for rheumatism and for other pains. You can also get pain killers of this type without a prescription so check with your pharmacist before you buy them.

  • A group of medicines for your heart or blood pressure called ACE inhibitors such as ramipril or lisinopril, or angiotensin II receptor antagonists such as losartan or irbesartan.

  • Diuretics (water tablets)

These medicines may decrease the amount of lithium in your body meaning it will not work as well:


  • Theophylline (for asthma), or caffeine

  • Anything containing sodium bicarbonate

  • A special group of diuretics (water tablets) called carbonic anhydrase inhibitors

These medicines may cause other side effects when taken with CAMCOLIT:


  • Medicines used to treat schizophrenia such as olanzapine or clozapine

  • Carbamazepine, phenytoin or clonazepam used for epilepsy

  • Methyldopa used for the treatment of high blood pressure

  • Anti-depressants called selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or paroxetine, or tricyclics e.g. amitriptyline or tetracyclics

  • Calcium channel blockers for angina, high blood pressure or other heart problems such as amlodipine or diltiazem

  • Muscle relaxants used in anaesthesia

Some medicines when taken with CAMCOLIT can cause serious heart rhythm disorders. These include:


  • Quinidine, procainamide, disopyramide, amiodarone and sotalol all for heart rhythm disorders

  • Arsenic trioxide for the treatment of leukaemia

  • Erythromycin for the treatment of an infection given into a vein

  • Haloperidol, sertindole and thioridazine for schizophrenia and other behavioural disorders

  • Terfenadine, an antihistamine

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.




Taking CAMCOLIT with food and drink


It does not matter if you take CAMCOLIT with or without food but if you want to go on any sort of diet talk to you doctor first. Any large changes in how much water you drink or how much sodium (salt) is in your diet may mean you need your blood monitoring more often.




Pregnancy and breast-feeding



Do not take CAMCOLIT if you are pregnant or plan to become pregnant unless otherwise recommended by your doctor. Do not take CAMCOLIT whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.




Driving and using machines


As CAMCOLIT may cause dizziness or other nervous disorders, your ability to drive or use machines may be impaired





How to take CAMCOLIT


Always take CAMCOLIT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


  • CAMCOLIT 250mg tablets are usually taken twice a day.

  • The exact number of tablets you need every day depends on the level of lithium in your blood.

  • Your doctor will give you a blood test to tell you how many tablets to take and when to take them. Your doctor will repeat the blood test regularly whilst you are taking CAMCOLIT.


Try to take your tablets at the same times every day.




If you take more CAMCOLIT than you should, contact a doctor or the nearest hospital immediately.





Signs of taking too much CAMCOLIT include, sickness, diarrhoea, blurred vision, passing a lot of water, light-headedness, muscle weakness or drowsiness. In extreme cases unconsciousness, coma, fits, heart rhythm problems (slow or irregular heartbeat) and kidney failure can occur.



Tell your family about lithium side effects so they know what to look for too.





If you forget to take your tablets, take them as soon as you remember. If you forget for more than 6 hours, just take the next dose when it is due. Tell your doctor if you miss a few doses.



If you have any further questions on the use of this product, ask your doctor pharmacist.




Camcolit 250 Side Effects


Like all medicines, CAMCOLIT can cause side effects, although not everybody gets them.



Contact your doctor immediately if you notice any changes in heart rate, for example a slower, faster or irregular hear beat.



Other side effects include:


  • Heart rhythm problems including a fast or irregular heartbeat.

  • Thyroid problems.

  • Sickness, feeling sick, diarrhoea, upset stomach, dry mouth or too much saliva.

  • Oedema (usually seen as swelling caused by too much fluid).

  • Weight gain, loss of appetite or too much calcium, magnesium or sugar in the blood.

  • Hand tremor, vertigo, dazed feeling, not being able to think clearly, fits, changes of the sense of taste, shaky movements, slurred speech, dizziness, rapid eye movements, unconsciousness, coma and myasthenia gravis (a long term disease characterised by abnormal tiredness and muscle weakness).

  • Kidney problems which may not be reversible. Symptoms may include passing a lot of urine or feeling thirsty.

  • Skin problems including worsening of psoriasis, hairloss, acne, soreness around the hair-root, itching and rashes.

  • Low blood pressure or Raynaud’s phenomena where fingers/toes are cold and numb.

It is important to have the right level of lithium in the blood. If it is too high, then you are more likely to get a side-effect.



Tell your family about lithium side effects so they know what to look for too.



If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How To Store Camcolit


Keep all medicines out of the reach and sight of children


Do not store above 25°C. Keep the container tightly closed.


Do not use CAMCOLIT after the expiry date which is printed or embossed on the bottle label as month/year. The expiry date refers to the last day of the month.




Further Information



What CAMCOLIT contains


The active substance is lithium carbonate. Each tablet contains 250 mg lithium carbonate.


The other ingredients are maize starch, magnesium stearate, pregelatinised maize starch, hypromellose and macrogol 400.




What CAMCOLIT looks like and contents of the pack


Each bottle contains 100 or 1000 white tablets.




Marketing Authorisation Holder and Manufacturer


The Marketing Authorisation Holder is



Norgine Ltd

Moorhall Road

Harefield

Middlesex

UB9 6NS

UK


It is made by



Norgine Ltd

Hengoed

Mid Glamorgan

CF82 8SJ

UK



UK Marketing Authorisation Number: PL 00322/5900R



The leaflet was last approved in February 2009





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