Li-Liquid 1018mg/5ml Oral Syrup
Tell your doctor if you get any of these side effects:
■ shaking of your hands
■ passing more water (urine) than normal or feeling thirsty
■ loss of appetite with a strange taste in your mouth, feeling sick (nausea) or being sick (vomiting), diarrhoea, a dry mouth or producing too much saliva, stomach pain and swelling of the stomach lining
■ increase in weight, water retention and swelling (particularly the feet and ankles)
■ feeling dizzy, feeling very tired, feeling less alert or dazed, forgetful
■ severe headache, blurred vision and rapid uncontrollable eye movements
■ numbness, tingling and colour change (white, blue then red) in your fingers and toes when exposed to the cold
■ hair loss, acne, skin rash, psoriasis or worsening of psoriasis and leg ulcers
■ sexual problems.
A change in blood tests may occur, particularly high white blood cell counts, high blood sugar levels, and high magnesium or calcium levels. Your doctor will notice this when you have your blood tests.
Lithium taken for a long time can cause kidney damage. This can usually be avoided if your kidney function is tested regularly by your doctor. Drinking plenty of fluids while taking this medicine will also help avoid kidney damage.
Frequency unknown: Benign/malignant kidney tumours (microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
■ Keep out of the sight and reach of children
■ Store above 4°C and keep out of direct sunlight
■ Do not use after the expiry date which is stated on the label and carton. (exp: month, year)
■ The expiry date refers to the last day of that month
■ Do not use Li-Liquid if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist
■ Medicines should not be disposed of via wastewater or household waste. Take back to the pharmacy 6 months after you first open it. These measures will help to protect the environment.
What Li-Liquid contains
■ The active ingredient is lithium citrate. Each 5ml contains 1018mg of lithium citrate. This is the same as 400mg lithium carbonate
■ The other ingredients are citric acid (E330), saccharin sodium, sorbitol solution (E420), syrup liquid glucose, propylene glycol (E1520), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), colouring E110, cherry favour (containing ethanol and propylene glycol) and purified water.
What Li-Liquid looks like and contents of the pack
A bright orange syrup with an odour of cherry.
It comes in a brown glass bottle holding 150ml of syrup.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK.
This leaflet was last revised in 04/2015
P0796
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Li-Liquid is and what it is used for 4. Possible side effects
2. What you need to know before you take Li-Liquid 5. How to store Li-Liquid
3. How to take Li-Liquid 6. Contents of the pack and other information
The name of your medicine is Li-Liquid 1018mg/5ml Oral Syrup (referred to as Li-Liquid in this leaflet). It contains lithium citrate. This belongs to a group of medicines called 'anti-manics'.
Lithium acts on the brain to calm your moods and emotions.
Lithium can be used to:
■ treat mania (over-excitability and exaggerated emotions) and hypomania (a milder form of mania)
■ treat bipolar depression. This is a condition where you have large mood swings from low mood and feelings of sadness (depression), to feeling excited and overactive. Lithium will be given when other antidepressant drugs have not worked
■ prevent mood problems that happen a lot
■ control aggressive feelings or if you have been intentionally harming yourself.
Do not take Li-Liquid and tell your doctor if:
■ you are allergic (hypersensitive) to lithium or any other ingredients in this liquid (listed in section 6). The signs of allergic reaction can include a rash, itching or shortness of breath
■ you have kidney problems or heart disease
■ you have thyroid problems that are not being treated. The signs of these include tiredness, feeling weak, muscle weakness, cramps, feeling cold, a slow heart rate, dry and flaky skin, hair loss, a deep husky voice or weight gain
■ you are on a low sodium diet or have low body sodium levels, including being dehydrated
■ you have Addison's disease. This is where your adrenal glands are not working properly. The signs of this are weakness, tiredness, weight loss and low blood pressure
■ you are pregnant, think you are pregnant or breast-feeding.
Children must not take this medicine.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Li-Liquid.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if:
■ you currently have an infection
■ you feel sick, have been sick, or have diarrhoea.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Li-Liquid.
Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma).
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Having operations and tests
■ if you are going into hospital for an operation under general anaesthetic, tell the nurse or doctor that you are taking lithium
■ it is important to have blood tests before and whilst taking Li-Liquid. These show that you are taking the right dose. They also check whether your heart, thyroid and kidneys are working properly (see Section 3).
Other medicines and Li-Liquid:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because lithium can affect the way some other medicines work. Also some medicines can affect the way lithium works.
Tell your doctor if you are taking any of these medicines
■ medicines used to treat infections, such as metronidazole or tetracyclines
■ non-steroidal anti-inflammatory (NSAID) medicines including Cox-II inhibitors, such as indometacin, diclofenac, ibuprofen or aspirin
■ medicines to treat high blood pressure or heart problems, such as:
- ACE inhibitors such as enalapril
- calcium channel blockers such as diltiazem or verapamil
- medicines to treat heart rhythm problems such as quinidine, procainamide amiodarone and sotalol
- angiotensin II antagonists such as losartan to lower blood pressure
- methyldopa
- diuretics (water tablets). These also help the body get rid of excess water
■ medicines for schizophrenia or other mental problems, such as haloperidol, fupentixol, risperidone, diazepam, thioridazine, fuphenazine, chlorpromazine and clozapine
■ medicines to treat depression, such as fuvoxamine, fluoxetine or amitriptyline
■ steroids
■ medicines that contain sodium bicarbonate, such as treatments for acid indigestion
■ medicines to treat gout such as allopurinol
■ urea. This is given to people who have had a head injury or to lower pressure in the eye (glaucoma)
■ medicines to treat epilepsy, such as phenytoin and carbamazepine
■ theophylline or aminophylline, used in the treatment of asthma.
Taking Li-Liquid with food and drink
It is important that you drink plenty of fluids whilst taking this medicine particularly in very hot weather or if your workplace is very hot.
Pregnancy and Breast-feeding:
■ talk to your doctor before taking this medicine if you are pregnant or planning to become pregnant. You should not use this medicine during the first three months of pregnancy unless your doctor feels it is absolutely necessary
■ you should make sure that you use adequate contraception whilst taking lithium
■ if you are planning to become pregnant, talk to your doctor about stopping the medicine
■ do not take this medicine if you are breastfeeding.
Driving and using machines:
This medicine may slow down your reactions or make you feel drowsy. If this happens to you, you should not drive or use any tools or machines.
Li-Liquid contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, glucose, sorbitol, ethanol and sunset yellow:
■ Methyl and propyl hydroxybenzoates (E218 and E216). These may cause an allergic reaction. This allergy may happen some time after starting the medicine
■ Glucose and sorbitol (E420). If your doctor has told you that you cannot tolerate some sugars, see your doctor before taking this medicine. It contains 1.7g of glucose in each 5ml. When taken according to dosage recommendations, the maximum dose supplies up to 10.2g of glucose. This should be taken into account in patients with diabetes mellitus and may be harmful to teeth
■ Ethanol (alcohol). This product contains a small amount of alcohol, less than 100mg per dose.
■ Sunset Yellow (E110). This may cause an allergic reaction and is more common in those who are allergic to aspirin.
■ if you feel that the effect of your medicine is too strong or too weak, do not change the dose yourself, but talk to your doctor or pharmacist
■ your doctor will check your blood levels while you are taking this medicine. These tests will be done just before you are due to take Li-Liquid and not less than 12 hours after your last dose. It is important that you do not miss these tests. The tests will be:
- 4 to 5 days after you have started your treatment
- then every week until your lithium levels are at a constant level in your blood
- once the levels are stable, you will have this test every 3 months.
Thoughts of harming or killing yourself
If you have a mood disorder, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting Li-Liquid or changing your dose of Li-Liquid. Like other medicines of this kind, Li-Liquid may not relieve your symptoms straight away. If you have thoughts of harming or killing yourself or worsening of your symptoms at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative, close friend or carer that you have a mood disorder, and ask them to read this leaflet. You might ask them to tell you if they think your mood disorder is getting worse, or if they are worried about changes in your behaviour.
Adults
The usual dose for adults is:
■ when first taking lithium, one to three 5ml spoonsful. This will be split into two doses, one in the morning and one in the evening.
■ your doctor will then change your dose according to your blood levels.
Children
Children must not take this medicine.
Older people
If you are an older person you may be more sensitive to the medicine. This means you have more of a chance of getting some of the side effects listed in section 4. Your doctor will start you on a lower dose.
If you take more Li-Liquid than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken.
If you forget to take Li-Liquid
Do not take a double dose (two doses at the same time) to make up for forgotten doses. Skip the missed dose then go on as before.
If you stop taking Li-Liquid
Keep taking Li-Liquid until your doctor tells you to stop. Do not stop taking your medicine suddenly.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, lithium can cause side effects, although not everybody gets them.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
■ this medicine contains 1018mg of lithium citrate in each 5ml. This is the same as 400mg lithium carbonate
■ take this medicine by mouth P0796
Stop taking the medicine and contact your doctor or hospital casualty department straight away if you get:
■ an allergic reaction to Li-Liquid such as skin rash, faking skin, boils or sore lips and mouth, sudden wheezing, fluttering or tightness of the chest or collapse
■ high blood pressure, swollen hands and feet and swelling around the eyes, more infections than usual. These could be signs of a kidney problem called 'nephrotic syndrome'
■ a speech disorder, confusion, impaired consciousness or loss of consciousness
■ loss of appetite, diarrhoea, vomiting, muscle weakness, difficulty in co-ordinating movements, drowsiness, tiredness, dizziness, ringing in your ears, blurred vision, slurred speech, muscle twitching and shaking or fits. The amount of lithium in your blood may be too high.
If any of the above applies to you, stop taking this medicine and contact your doctor or hospital casualty department
straight away. This is especially important if you are an older person.
Tell your doctor as soon as possible if you get any of the following:
■ changes in heart rate. The most common is a slow heart beat and low blood pressure
■ change in thyroid function. This may show as underactive (feeling very tired and slow, sweaty, shaky and unable to tolerate heat) or overactive (bone pain or tenderness, tiredness and vomiting). You may also notice a swelling in the neck.
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