CITALOPRAM 40 MG / ML ORAL DROPS SOLUTION - patient leaflet, side effects, dosage

2. what you need to know before you take citalopram oral drops

Do not take Citalopram Oral Drops:

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6). Consult your doctor if you think you might be
• At the same time as taking medication known as monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used for the treatment of depression), selegiline (used in the treatment of Parkinson’s di­sease) and linezolid (an antibiotic). Even if you have finished taking one of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine you will need to wait 2 weeks before you start taking Citalopram Oral Drops. One day must elapse after you have finished taking moclobemide. After stopping Citalopram Oral Drops you must allow 1 week before taking any MAOI
• 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 (see Other medicines and Citalopram Oral Drops).

Warnings and precautions

Talk to your doctor or pharmacist if you have any medical problems, especially if you have:

• Liver disease.
• Kidney disease.
• Diabetes (you may need an adjustment of your antidiabetic therapy).
• Epilepsy or a history of seizures or fits.
• A bleeding disorder or have ever suffered from bleeding in the stomach or intestine or if you are pregnant (see ‘Pregnancy’).
• Mania or panic disorder.
• Low blood levels of sodium.
• ECT (electroconvulsive therapy).
• Suffered or suffer from heart problems or have recently had a heart attack.
• 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).
• Experienced a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate.
• If you have or have previously had eye problems, such as certain kinds of glaucoma (increased pressure in the eye).

The use of Buprenorphine together with Citalopram Oral Drops can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Citalopram Oral Drops”).

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Please note:

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. Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

Medicines like Citalopram Oral Drops (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

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 Oral Drops 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.

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 Oral Drops 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 Oral Drops for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Citalopram Oral Drops 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 Oral Drops. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Citalopram Oral Drops in this age group have not yet been demonstrated.

Other medicines and Citalopram Oral Drops

Medicines may affect the action of other medicines and this can sometimes cause serious adverse reactions.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes other medicines for depression (see Do not take Citalopram Oral Drops).

• The herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Citalopram Oral Drops.
• Monoamine oxidase inhibitors (MAOIs). These should not be taken at the same time as Citalopram Oral Drops (see Do not take Citalopram Oral Drops).

Tell your doctor if you are taking any of the following medicines:

• Linezolid (an antibiotic).
• Sumatriptan (used to treat migraine) or tramadol (a pain killer). If you feel unwell when using these medicines with Citalopram Oral Drops you should see your doctor.
• Lithium (used to prevent and treat mania) and tryptophan (an antidepressant).
• Pimozide (a neuroleptic). This should not be taken at the same time as Citalopram Oral Drops.
• Imipramine and desipramine (used to treat depression).
• Medicines containing selegiline (used to treat Parkinson’s di­sease).
• Cimetidine, lansoprazole, omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of citalopram.
• Mefloquine (used to treat malaria).
• Bupropion (used to treat depression).
• Medicines known to affect the blood platelets (e.g. anticoagulant drugs used to treat or prevent blood clots; aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and diclofenac used as painkillers; and some antipsychotic drugs and tricyclic antidepressants).
• Metoprolol, a beta blocker used to treat migraine, some heart conditions and high blood pressure. The effects of either drug could be increased, decreased or altered.
• Neuroleptics (used in the treatment of schizophrenia).

Buprenorphine/o­pioids may interact with Citalopram Oral drops and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

DO NOT TAKE Citalopram Oral Drops if you take drugs 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. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants , certain antimicrobial agents (e.g.

sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine) , certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.

Citalopram Oral Drops with food, drink and alcohol

Citalopram Oral Drops can be taken with or without food (see section 3 “How to take Citalopram Oral Drops”).

As with all antidepressants, it is sensible to avoid drinking alcohol whilst receiving treatment although Citalopram Oral Drops has not been shown to increase the effects of alcohol.

Pregnancy, breast-feeding and fertility

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant, think you might be pregnant, or are trying to become pregnant, tell your doctor. Do not take Citalopram Oral Drops if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

Make sure your midwife and/or doctor knows you are on Citalopram Oral Drops. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Oral Drops may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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 Oral Drops 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, 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.

If you take Citalopram Oral Drops 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 Oral Drops so they can advise you.

Breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are breast-feeding, ask your doctor for advice. You should not breast-feed your baby when taking Citalopram Oral Drops because small amounts of the medicine can pass into the breast milk.

Fertility

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

Citalopram does not usually affect the ability to carry out normal daily activities.

However, if you feel dizzy or sleepy when you start to take this medicine, you should be careful when driving, operating machinery or performing jobs that need you to be alert until these effects wear off.

Citalopram Oral Drops contains methyl parahydroxyben­zoate, propyl parahydroxybenzoate and ethanol

• methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) -these may cause allergic reactions (possibly delayed).
• This medicine contains 76 mg of alcohol (ethanol 96%) in each ml which is equivalent to 9.0 % v/v. The amount in 1 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

3. how to take citalopram oral drops

How much to take

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure:

To take your drops, unscrew the bottle cap then carefully tip the bottle up until the drops start to come out.

Count the required number of drops into your drink, stir it and then drink all of it

immediately

Do not leave your drink where someone else may drink it as your medicine could harm them.

The recommended dose is:

Adults – depression

• the recommended dose is 16mg (8 drops)/(0.4ml) per day
• this may be increased by your doctor to a maximum of 32mg (16drops)/(0.8ml) per day.

Adults – panic attacks

• the recommended starting dose is 8mg (4 drops)/(0.2ml) per day for the first week before increasing the dose to between 16–24mg (8–12 drops)/(0.4 –0.6 ml) per day
• the dose may be increased by your doctor to a maximum of 32mg (16 drops)/ (0.8ml) per day.

Elderly

• the recommended starting dose should be decreased to half the recommended dose, e.g. 8–16mg per day
• elderly patients should not usually receive more than 16mg (8 drops)/(0.4ml) per day.

Use in children and adolescents

• Citalopram Oral Drops should not be used for children and adolescents under 18 years of age.

Patients with special risks

Patients with liver complaints should not receive more than 16 mg (8 drops) per day.

If you have previously taken Citalopram tablets, you will find that the dose of your medicine in mg given as drops is a bit lower than that of tablets. This is because your body more easily absorbs the drops than the tablets, so you do not need as many mg to have the same effect.

The doses of tablets correspond to doses of drops as follows:

Tablets Drops

10 mg 8 mg (4 drops)

20 mg 16 mg (8 drops)

30 mg 24 mg (12 drops)

40 mg 32 mg (16 drops)

How and when to take Citalopram Oral Drops

The drops are for oral use and can be taken in a drink of water, or orange or apple juice.

Citalopram Oral Drops is taken every day as one dose at any time of the day.

Duration of treatment

Like other medicines for depression and panic disorder these drops may take a few weeks before you feel any improvement.. Continue to take Citalopram Oral Drops 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 drops 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 do not feel any better, tell your doctor.

If you take more Citalopram Oral Drops than you should

If you think that you or anyone else may have taken too many Citalopram Oral drops, contact a doctor or your nearest hospital casualty department immediately and take your Citalopram Oral Drops with you. Do this even if there are no signs of discomfort or poisoning. Take the Citalopram Oral Drops bottle with you if you go to a doctor or hospital. Some of the signs of an overdosage could be life-threatening.

Symptoms of overdosage may include:

• irregular heart beat
• seizures
• changes in heart rhythm
• feeling sick (nausea)
• vomiting
• sweating
• drowsiness
• unconsciousness
• fast heart beats
• tremor
• changes in blood pressure
• serotonin syndrome (see Section 4)
• agitation
• dizziness
• enlarged eye pupils
• bluish skin
• breathing too quickly.

If you forget to take Citalopram Oral Drops

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram Oral Drops

Stopping this medicine quickly may cause symptoms such as dizziness, nausea and numbness or tingling in hands or feet, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling or being sick, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). These are usually non-serious and disappear within a few days. When you have completed your course of treatment, the dose of Citalopram Oral Drops is usually reduced gradually over a couple of weeks.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Several of the effects listed below can also be symptoms of your illness and may disappear as you start to get better.

Serious side effects

Stop taking Citalopram Oral Drops and seek medical advice immediately if you have any of the following symptoms:

• difficulty breathing
• Swelling of the face, lips, tongue or throat that causes difficulty in swallowing or breathing
• severe itching of the skin (with raised lumps)
• fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.

If you notice any of the following you should contact your doctor immediately as your dose may need to be reduced or stopped:

• You start having fits for the first time or fits that you have suffered from in the past before become more frequent
• Your behaviour changes because you feel elated or over excited
• You experience high fever, agitation, confusion, and trembling or abrupt contractions of muscles. These may be signs of a rare condition called serotonin syndrome
• Tiredness, confusion and twitching of your muscles. These may be signs of a low blood level of sodium (hyponatraemia)
• Yellowing of the skin or whites of the eyes. These may be signs of hepatitis.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

Other possible side effects during treatment

The following side effects are often mild and usually disappear after a few days’ treatment.

Very common: may affect more than 1 in 10 people

• Sleepiness
• Difficulty in sleeping
• Headache
• Changes in your sleeping pattern
• Loss of body strength, weakness
• Increased sweating
• Dry mouth (a dry mouth increases the risk of tooth decay, so be sure to clean your teeth more often than usual)
• Feeling sick (nausea).

Common: may affect up to 1 in 10 people

• Lack of appetite
• Agitation
• Decreased sex drive
• Anxiety
• Nervousness
• Confusion
• Abnormal dreams
• Reduced emotions, indifference (apathy)
• Tremor
• Tingling or numbness in the hands or feet
• Dizziness
• Problems concentrating
• Migraine
• Loss of memory (amnesia)
• Ringing in the ears (tinnitus)
• Palpitations
• Yawning
• Blocked or runny nose (rhinitis)
• Diarrhoea
• Vomiting
• Constipation
• Stomach pain
• Flatulence (wind)
• Increase in saliva (drooling)
• Itching
• Pain in muscles and joints
• For men, problems with ejaculation and erection
• For women, failing to reach an orgasm
• Tiredness
• Prickling of the skin
• Loss of weight.

Uncommon: may affect up to 1 in 100 people

• Bruising easily
• Increased appetite
• Aggression
• Hallucinations
• Mania
• Fainting
• Large pupils (the dark centre of the eye)
• Fast heart beat
• Slow heart beat
• Nettle rash
• Loss of hair
• Rash
• Sensitivity to sunlight
• Difficulties urinating
• Excessive menstrual bleeding
• Swelling of the arms or legs
• Increased weight.

Rare: may affect up to 1 in 1,000 people

• Increased sex drive
• Convulsions
• Involuntary movements
• Taste disturbances
• Bleeding
• Coughing
• Feeling unwell (malaise).

Not known: frequency cannot be estimated from available data

• Thoughts of harming or killing themselves, see also section 2. “What you need to know before you take Citalopram Oral Drops”
• An increase in bleeding or bruising caused by a decrease in blood platelets (thrombocytopenia)
• Rash (hypersensitivity)
• Low potassium levels in the blood (hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythms
• Panic attack
• Grinding teeth
• Restlessness
• Unusual muscle movements or stiffness
• Involuntary movements of the muscles (akathisia)
• Low blood pressure
• Nosebleed
• Bleeding disorders including skin and mucosal bleeding (ecchymosis)
• Sudden swelling of skin or mucosa
• In men, painful erections
• Flow of breast milk in men or in women who are not breast-feeding (galactorrhoea)
• Irregular menstrual periods
• Abnormal liver function tests
• An increased risk of bone fractures has been observed in patients taking this type of medicines
• Abnormal heart rhythm
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy in section 2 for more information.

SSRIs can, very rarely, increase the risk of bleeding, including stomach or intestinal bleeding.

Let your doctor know if you vomit blood or develop black or blood stained stools. Also let your doctor know if you continue to have other symptoms associated with your depression. This might include hallucinations, anxiety, mania or confusion.

Any side effects that do occur will usually disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side effects while taking Citalopram Oral Drops, please tell your doctor.

If you have any other symptoms that you do not understand, tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at

Website: 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. Z7\

5. how to store citalopram oral drops                                 xlz”

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 bottle label after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Once opened do not keep your drops for more than 16 weeks.

Once diluted drink your medicine immediately.

Do not use this medicine if you notice any damage to the bottle dropper or any visible signs of deterioration in your medicine. Return it to your pharmacist.

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. /TX

6. contents of the pack and other information                           vjx”

What Citalopram Oral Drops contain

• the active substance is citalopram. Each 1ml of Citalopram Oral Drops contains 40mg of citalopram (as hydrochloride).
• the other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ethanol (96 per cent), hydroxyethylce­llulose and water (see section 2, What you need to know before you take Citalopram Oral Drops).

What Citalopram Oral Drops look like and contents of the pack

Citalopram Oral Drops are a colourless to yellowish clear solution in an amber glass bottle fitted with a dropper device and screw cap.

Each bottle of Citalopram Oral Drops contains 15ml of solution. There are 20 drops in each ml.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer

Help S.A., Pedini, loannina – GR 45500, Greece

This leaflet was last revised in February 2021.

LF-121672–01