The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 14894/0163 , PL 14894/0164 , PL 14894/0165.
Citalopram 10mg, 20mg and 40mg Film-coated Tablets
Please read all of this leaflet before you start to take your medicine as it contains important information about Citalopram
If you have any concerns about how you feel, or about this medication, it is important that you talk to your doctor - even if you feel anxious or worried about doing so.
You may find it helpful to tell a friend or relative that you are depressed, and that you have been prescribed this medication; it might be useful to show them this leaflet.
Keep this leaflet. You may need to read it again.
If you have more questions, ask your doctor or pharmacist.
Leaflet date March 2021
Citalopram 10 mg Film-coated Tablets
Citalopram 20 mg Film-coated Tablets
Citalopram 40 mg Film-coated Tablets
1. What Citalopram Tablets are and what are they used for
2. What you need to know before you take Citalopram Tablets
3. How to take Citalopram Tablets
4. Possible side effects
5. How to store Citalopram Tablets
6. Contents of the pack and other information
How does Citalopram work?
Citalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants. These medicines help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness.
What is Citalopram used for?
Citalopram contains citalopram and is used for the treatment of depression and, when you feel better, to help prevent these symptoms recurring. Citalopram is also used for long-term treatment to prevent the occurrence of new episodes of depression if you have recurrent depression.
Citalopram is also beneficial in relieving symptoms if you tend to suffer from panic attacks with or without agoraphobia (e.g. fear of leaving the house, entering shops, or fear of public places).
Also refer to the section “Other medicines and Citalopram” below.
Medicines like Citalopram (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
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:
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.
Talk to your doctor, pharmacist or nurse before taking Citalopram Tablets, if you have, or ever had
Symptoms such as restlessness, for example, you cannot sit or stand still, can occur during the first weeks of treatment. Tell your doctor immediately if you experience these symptoms. Then a dosage adjustment may be helpful.
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
In some rare instances, during treatment with Citalopram Tablets, certain concurrent serotonergic effects serotonin syndrome or a condition resembling malignant neuroleptic syndrome may develop, in particular when taken along with other serotonergic and/or neuroleptic substances. As these syndromes may possibly lead to life-threatening conditions, treatment with Citalopram Tablets should be stopped whenever they occur, and a supportive symptomatic treatment should be initiated. These syndromes are characterised by a number of symptoms occurring simultaneously, such as motor restlessness, confusion, sweating, hallucinations, increased reflexes, stiffness in muscle, shaking chills, increased heart rate, and trembling (see also “Possible side effects”). Rhabdomyolysis (temporary paralysis or weakness of muscles) can occur rarely.
Special information relating to your disease
As with other medicines used to treat depression or related diseases, the improvement is not 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 will disappear during 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.
Citalopram Tablets 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 Tablets for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Citalopram Tablets 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 Tablets.
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.
Citalopram Tablets are to be taken as a single daily dose. Citalopram Tablets can be taken any time of the day with or without food.
Do not drink alcohol while you are taking Citalopram Tablets.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can cause problems if you take them with this medicine.
Care is needed if you are taking the following medicines:
DO NOT TAKE Citalopram Tablets 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 derivatives, 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.
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. Your doctor will have to decide whether treatment with Citalopram Tablets is clearly necessary or whether an alternative treatment is possible for you.
You should not stop treatment with Citalopram Tablets abruptly due to pregnancy or other reasons.
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.
Also, if you take Citalopram 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: fits, being too hot or cold, breathing difficulties, blue or purple coloration of the skin or mucous membranes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, overactive reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or sleeping difficulties. If your newborn baby gets any of these symptoms please contact your midwife and/or doctor immediately.
Citalopram is known to be found in breast milk. Its effects on children taking breast milk have not been established. If treatment with citalopram is considered necessary, discontinuation of breast feeding should be considered.
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.
If you take Citalopram near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Citalopram so they can advise you.
Ask your doctor or pharmacist for advice before taking any medicine.
This medicine may cause side-effects (such as feeling dizzy, sleepy, confused and having problems with eyesight) that affect how well you concentrate and how quickly you can react. If you get these side-effects, do not drive or use machines or anything else where you need to be alert and concentrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
It is important to take your tablets as instructed by your doctor.
The label will tell you how many to take and how often. If it does not, or you are not sure, ask your doctor or pharmacist.
The usual dose is 20 mg per day. This may be increased by your doctor to a maximum of 40 mg per day.
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.
Older 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. Older patients should not usually receive more than 20 mg per day.
Children and adolescents (< 18 years)
Citalopram should not be given to children and adolescents. For further information, please see section 2 what you need to know before you take Citalopram.
Patients with liver complaints should not receive more than 20 mg per day.
Citalopram is taken every day as a single daily dose. Citalopram can be taken any time of the day with or without food. Swallow the tablets with a drink of water. Do not chew them (they have a bitter taste).
The score line is not intended for breaking the tablet.
Like other medicines for depression and panic disorder these tablets may take a few weeks before you feel any improvement. Continue to take Citalopram even if it takes some time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue to take the 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. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return.
Patients who have recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to your doctor first.
If you have the impression that the effect of Citalopram Tablets is too strong or too weak, talk to your doctor or pharmacist.
Never take more tablets than your doctor recommends. If you have taken too many tablets, or if someone accidentally swallows some, contact your doctor or the nearest hospital for advice. Show them the pack of tablets. The most likely signs of taking too many tablets (overdose) are: feeling dizzy or drowsy, sweating, very high fever, bluish or purplish tinge to the skin and mucous membranes, serotonin syndrome, feeling or being sick (nausea or vomiting), dilated pupils, rapid or deep breathing, having abnormal heartbeats, abnormal heart rhythm, high or low blood pressure, heart attack, uncontrollable muscle spasms affecting the eyes, head, neck and body, shaking or tremors, fits, feeling agitated or anxious and coma.
If you forget to take your dose of this medicine, simply carry on with the next dose as usual. Do not take a double dose to make up for a forgotten dose.
Do not stop taking this medicine until your doctor tells you to, even if you feel better.
If you stop suddenly after taking this medicine for a long time you can experience withdrawal effects, symptoms such as dizziness, diarrhoea, numbness and tingling, sweating, headache, fast or irregular heartbeats, emotional instability, irritability, agitation or anxiety, sleep disturbances including inability to sleep and/or intense dream, shaking or tremor, confusion, visual disturbances, nausea and vomiting may occur. These symptoms are generally non-serious and disappear within a few days. Citalopram should always be stopped gradually over 1-2 weeks period.
If you get withdrawal effects when you are coming off your tablets your doctor may decide that you should come off them more slowly.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side-effects, although not everybody gets them.
They are most prominent during the first one or two weeks of treatment and usually decrease as your depression improves.
Very common: (more than 1 in 10 patients treated)
Common: (less than 1 in 10 but more than 1 in 100 patients treated)
Uncommon: (less than 1 in 100 but more than 1 in 1000 patients treated)
Rare: (less than 1 in 1000 but more than 1 in 10000 patients treated)
Very rare: (less than 1 in 10000 patients treated, including isolated reports)
Bone fractures have been reported in patients aged 50 years and older.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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 carton and blister strip.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 protect the environment.
The active substance is Citalopram hydrobromide.
Each 10 mg film-coated tablet contains 12.5 mg citalopram hydrobromide equivalent to 10 mg citalopram.
Each 20 mg film-coated tablet contains 25 mg citalopram hydrobromide equivalent to 20 mg citalopram.
Each 40 mg film-coated tablet contains 50 mg citalopram hydrobromide equivalent to 40 mg citalopram.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, copovidone, croscarmellose sodium and magnesium stearate. The ingredients of the film-coating material, Opadry White 20H 58983 comprise of hypromellose, titanium dioxide (E171), propylene glycol, hydroxypropyl cellulose and talc.
Citalopram Tablets are white to off-white, circular biconvex film-coated tablets.
Citalopram Tablets are available as blister strips in pack sizes of 1, 14, 20, 28, 30, 50, 56, 98, 100 or 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in March 2021.
Var. 27 PRAC EMA/PRAC/513083/2020