Citalopram 10mg Film-Coated Tablets
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Package leaflet: Information for the user
Citalopram 10 mg film-coated tablets Citalopram 20 mg film-coated tablets Citalopram 40 mg film-coated tablets
(Citalopram)
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 symptoms are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.This included any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Citalopram is and what it is used for
2. What you need to know before you take Citalopram
3. How to take Citalopram
4. Possible side effects
5. How to store Citalopram
6. Contents of the pack and other information
1. What Citalopram is and what it is used for
Citalopram belong to the group of medicines known as antidepressants which work by relieving the symptoms of depressed mood.
Citalopram is used to treat the symptoms of depression and, when you are feeling better, to help prevent these symptoms recurring. Citalopram is also beneficial in relieving symptoms in patients prone to panic attacks.
Treatment for depression is usually continued for at least six months, and for panic disorder for at least three months.
2. What you need to know before you take Citalopram Do not take Citalopram
• If you are allergic to Citalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking antidepressant medicines of the type called monoamino oxidase inhibitors (MAOIs). MAOIs typically prescribed are phenelzine, isocarboxazid, tranylcypromine, selegiline, linezolid or moclobemide. Even if you have finished taking the MAOI medicine you will need to wait 2 weeks before starting your Citalopram. You must wait at least one day between stopping the reversible monoamine oxidase inhibitor (RIMA) moclobemide and starting Citalopram. If your doctor asks you to take an MAOI you will be asked to stop taking your Citalopram at least seven days before starting the MAOI.
• If you are simultaneously taking the antipsychotic medicine pimozide (see " Other medicines and Citalopram ")
• If you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning)
• If you take medicines for heart rhythm problems or that may affect the heart's rhythm. Also refer to the section “Other medicines and Citalopram” below.
Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram.
• If you have episodes of mania or panic disorder
• If you have a decreased level of sodium in the blood
• If you have diabetes (you may need an adjustment of your antidiabetic therapy)
• If you have epilepsy or a history of seizures or fits
• If you are receiving electroconvulsive treatment
• if you have a heart problem or liver complaint
• if you have a bleeding disorder; also let your doctor know if you have a stomach ulcer or have had any bleeding in the stomach or intestine in the past.
• If you experience restlessness and/or a need to move often (akathisia)
• If you suffer or have suffered from heart problems or have recently had a heart attack
• If you have a low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
• If you experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate
The herbal remedy St John's Wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John's Wort preparation stop taking the St. John's Wort and mention it to your doctor at your next visit.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
- If you have previously had thoughts about killing or harming yourself.
- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Children and adolescents
Citalopram should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe citalopram for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Citalopram for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Citalopram. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram in this age group have not yet been demonstrated.
Other medicines and Citalopram Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking
• Drugs to control fits (anti convulsants) or if your fits have increased whilst taking citalopram
• Lithium or tryptophan medication (prescribed for people with depression or for people prone to attacks of mania)
• Medicines to thin your blood (anti coagulants) and aspirin
• Pain relief medicines called Non steroidal anti inflammatory drugs (NSAIDs) such as Ibuprofen
• Serotonergic drugs, such as a medicine used to relieve pain, called tramadol and a migraine medicine called Sumatriptan can be taken with Citalopram. However, if you feel unwell after taking tramadol or sumatriptan do not take these again. Continue to take your Citalopram and tell your doctor.
• Cimetidine, when used in high doses (used to treat stomach ulcers); blood levels of citalopram may be increased.
• Metoprolol (used for high blood pressure and/or heart disease); the blood levels of metoprolol are increased.
DO NOT TAKE Citalopram if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, e.g. such as Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derviatives, pimozide, haloperidol), tricyclic antidepressants , certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Citalopram with food, drink and alcohol
Do not consume alcohol during treatment with Citalopram. Citalopram can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Citalopram if you are pregnant or breast-feeding unless you and your doctor have discussed the risk and benefits involved. If you take this group of medicines (antidepressants) during the last 3 months of your pregnancy and until the date of birth you should be aware that the following effects may be seen in your newborn: trouble with breathing, stiff or loose muscles, jitteriness, a bluish skin or being too hot or cold. If your newborn baby gets any of these symptoms please contact your doctor.
Make sure your midwife and/or doctor know you are on Citalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
Citalopram has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Do not drive or work any tools or machinery, if you feel dizzy or sleepy when you start to take this medicine until these effects wear off.
Citalopram contains Lactose.
Citalopram Tablets contain lactose. If you have been told by your doctor that you have an intolerance to lactose or some types of sugar, contact your doctor before taking this medicinal product.
3. How to take Citalopram
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets with a drink of water. Do not chew them.
Usually your doctor will prescribe between 20 and 40 mg per day, taken as a single dose either in the morning or in the evening.
The recommended dose is: Adults
Depression
The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of 40 mg per day.
Panic disorder
The starting dose is 10 mg per day for the first week before increasing the dose to 20-30 mg per day. The dose may be increased by your doctor to a maximum of 40 mg per day.
Elderly patients (above 65 years of age)
The starting dose should be decreased to half of the recommended dose, e.g. 10-20 mg per day.
Elderly patients should not usually receive more than 20 mg per day.
Citalopram should not be used in the treatment of children and adolescents under the age of 18 years (see “Warnings and precautions”)
Patients with special risks
Patients with liver complaints should not receive more than 20 mg per day.
It may take several days before you feel any benefit from these tablets. This is normal for this type of medicine. Continue to take your tablets for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. Never change the dose of your medicine without talking to your doctor first.
If you take more Citalopram than you should
Too many tablets at once can be dangerous. If you have accidentally taken too many tablets contact your doctor. If you are unable to contact your doctor, go to your local hospital casualty department at once.
If you forget to take Citalopram
If you forget to take your medicine, do not worry and take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Citalopram
Do not stop taking Citalopram on your own. Your doctor will advise you when to discontinue the treatment.
When you stop taking Citalopram, especially if it is abruptly, you may feel discontinuation or withdrawal symptoms. These are common when treatment with Citalopram is stopped. The risk is higher, when Citalopram has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking Citalopram, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.
Discontinuation symptoms such as dizziness (unsteady or off-balance), feeling like “pins and needles”, burning sensation and (less commonly) electric shock sensations (including in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), tingling, headache, feeling anxious, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
After taking your medicine - Special information relating to your disease
As with other medicines used to treat depression or related diseases, improvement may not be achieved immediately. After the start of Citalopram treatment it may take several weeks before you experience any improvement. In the beginning of the treatment certain patients may experience increased anxiety, which should disappear with continued treatment. Therefore, it is very important that you follow exactly your doctor's orders and do not stop the treatment or change the dose without consulting your doctor.
Patients who are prone to panic attacks may actually experience a temporary period of heightened anxiety after starting treatment. This generally resolves during the first 1-2 weeks.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happens, stop taking Citalopram and tell your doctor immediately or go to the casualty department at your nearest hospital:
Serotonin syndrome has been reported in patients treated with these types of antidepressants (SSRIs). Tell your doctor if you experience high fever, trembling, muscle twitches and anxiety, because these symptoms may indicate the development of this condition. Treatment with citalopram should be discontinued immediately.
You should see your doctor immediately if you experience allergic symptoms such as a swollen face, tongue and/or pharynx and/or difficulty to swallow or a sudden rash (like 'hives') together with difficulties in breathing.
These may be very serious side effects. If you have them, you may have had a serious allergic reaction to citalopram. You may need urgent medical attention or hospitalisation.
All of these very serious side effects are very rare.
The following side effects have been reported at the approximate frequencies shown:
Very common ( 1/10):
Common ( 1/100 to <1/10):
Uncommon ( 1/1,000 to <1/100):
Rare ( 1/10,000 to <1/1,000):
Very Rare ( <1/10,000):
Very common (>1/10):
• sleepiness
• difficulty sleeping
• feeling sick
• dry mouth
• increased sweating
Common (>1/100 to <1/10):
• reduction in weight
• problems with concentration
• abnormal dreaming
• emotional disturbances
• impairment of voluntary movement i.e. tremors
• lightheadedness (dizziness)
• ringing in ears
• anxiety
• decreased sex drive
• loss of appetite
• confusion
• pins and needles
• vomiting
• frequent and watery bowel movements (diarrhoea)
• irregular and infrequent or difficult evacuation of the bowels (constipation)
• muscle and joint pain
• tiredness
• inability of women to achieve orgasm
• impotence
• ejaculation failure
• rash and itching
• yawning
Uncommon (>1/1,000 to <1/100):
• Increased appetite
• weight gain
• aggressiveness
• depersonalization
• hallucination
• mania
• slowing of the heart beat
• light sensitivity of the skin
• fainting
• enlarged pupils
• fast heart beat
• nettle rash
• loss of hair
• rash
• skin and mucous bleeding
• difficulties urinating
• abnormally heavy or prolonged menstruation
• swelling of the arms or legs
Rare (>1/10,000 to <1/1,000):
• Increased body temperature
• bleeding (e.g. vaginal, gastrointestinal, skin and mucous bleeding)
• lower amount of blood sodium
• fits
• slowness of movement
• taste abnormalities
• liver disease (Hepatitis)
Very rare (<1/10,000):
• Blood disease characterized by an abnormally small number of platelets in the blood
• hypersensitivity (rash)
• serious allergic reaction which causes difficulty in breathing or dizziness
• abnormally low level of potassium in the circulating blood leading to weakness and heart abnormalities
• sudden attack of fear
• clenching or grinding the teeth
• restlessness
• thoughts of harming themselves or thoughts of killing themselves
• fits
• disturbances of muscular movement
• marked or incontrollable restlessness and fidgeting (akathisia)
• blurred vision
• hear rhythm problems
• lowering of blood pressure when suddenly standing up
• bleeding from the nose
• bleeding of stomach and intestine
• abnormal liver function test
• bruising
• serious allergic reaction which causes swelling of the face or throat
• vaginal bleeding at irregular intervals
• painful erection in males
• milky secretion from the male breasts
If you get any of the following symptoms you should stop taking Citalopram and see your doctor immediately:
• Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Since withdrawal reactions may occur when the treatment is stopped, it is advised to reduce the dose gradually at intervals of 1-2 weeks. Withdrawal reactions include: dizziness, pins and needles or numbness, headache, nausea and anxiety. Most of the withdrawal reactions are mild and self-limiting in nature. If treatment is being stopped, it is advised that the dose is gradually reduced over 1-2 week periods.
Some side effects may disappear after a few days.If they are troublesome or persistent, or if you develop any other unusual side-effects while taking Citalopram, please tell your doctor.
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 national reporting system listed in Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Citalopram Tablets
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Do not use Citalopram if you notice the visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Citalopram contains
- The active substance is Citalopram.
Each film-coated tablet contains 10 mg citalopram (as citalopram hydrobromide).
Each film-coated tablet contains 20 mg citalopram (as citalopram hydrobromide).
Each film-coated tablet contains 40 mg citalopram (as citalopram hydrobromide).
- The other ingredients are:
Core tablets:
Lactose monohydrate, Maize starch, Copovidone, Croscarmellose sodium, Cellulose
microcrystalline, Magnesium stearate
Film-coating:
Hypromellose, Macrogol 400, Titanium dioxide (E 171)
What Citalopram looks like and contents of the pack
Film-coated tablet.
Citalopram 10 mg film-coated tablets are white coloured, biconvex, round shaped film-coated tablets debossed with 'A' on one side and '05' on the other side.
Citalopram 20 mg film-coated tablets are white coloured, biconvex, capsule shaped film-coated tablets marked with 'A' on one side and with a score line in between '0' and '6' on the other side. The tablet can be divided into equal doses.
Citalopram 40 mg film-coated tablets are white coloured, biconvex, capsule shaped film-coated tablets marked with 'A' on one side and with a score line in between '0' and '7' on the other side. The tablet can be divided into equal doses.
A pack of Citalopram contains 10, 14, 20, 28, 30, 50, 56, 84, 98 and 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom.
Manufacturer
Milpharm Limited
Ares block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
or
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta