Citalopram Sun

Patient Information Leaflet

Citalopram SUN 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

citalopram bromide
Generic medicine
Read this leaflet carefully before taking this medicine because it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse; see section 4.

Contents of this leaflet:

1. What Citalopram SUN is and what it is used for
2. What you need to know before taking Citalopram SUN
3. How to take Citalopram SUN
4. Possible side effects
5. How to store Citalopram SUN
6. Contents of the pack and other information

1. What Citalopram SUN is and what it is used for

How Citalopram SUN works
Citalopram SUN is a Selective Serotonin Reuptake Inhibitor (SSRI) and
belongs to a class of medicines called antidepressants. These medicines help correct certain chemical imbalances in the brain that cause the symptoms of depression.

What Citalopram SUN is used for
Citalopram SUN contains citalopram and is used to treat depression and, once you feel better, to help prevent the return of symptoms. Citalopram SUN is also used for long-term treatment to prevent the recurrence of new episodes of depression, if you suffer from recurrent depression.

Citalopram SUN is also effective in relieving symptoms if you are prone to panic attacks with or without agoraphobia (for example, fear of leaving home, entering shops, or public places).

2. What you should know before taking Citalopram SUN

Do not take Citalopram SUN:
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• If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include rash, itching, swelling of the face, lips, or hands/feet, and difficulty breathing.
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs) or have stopped taking them within the last two weeks. Treatment must not be started until at least two weeks have passed since stopping an irreversible MAO-inhibitor, or until the time specified by your doctor after stopping a reversible MAO-inhibitor (e.g. moclobemide). Your doctor will advise you on how to start taking Citalopram SUN after stopping MAO-inhibitors. At least one week must pass after stopping Citalopram SUN before starting treatment with an MAO-inhibitor.
• If you are taking medicines such as linezolid (an antibiotic) and/or pimozide (used to treat mental disorders).
• If you were born with, or have had an episode of, a heart rhythm disorder (identified by ECG, a test used to assess heart function).
• If you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm. See also section “Citalopram SUN and other medicines”.

Warnings and precautions
Medicines such as Citalopram SUN, the so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These may increase when you first start treatment with antidepressants, as these medicines need time to become effective, usually about two weeks but sometimes longer.
You are more likely to have such thoughts if:

• You have previously had thoughts of suicide or self-harm.
• You are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults under 25 years of age with psychiatric conditions treated with an antidepressant.

If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately.
It may be helpful to inform a relative or friend that you are depressed or have anxiety disorders, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behaviour.
Inform your doctor, pharmacist, or nurse before taking Citalopram SUN if you have or have ever had:

• Epilepsy (seizures or fits).
• Kidney and/or liver problems. Your doctor may reduce your tablet dose if your kidneys and/or liver are not functioning properly.

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• Low levels of sodium in the blood, which may cause tiredness, confusion, muscle twitching, seizures, and coma. These effects are more likely to occur in elderly patients. However, blood sodium levels return to normal once you stop taking this medicine.
• You have undergone electroconvulsive therapy.
• Mania (feelings of euphoria or emotional excitement).
• A severe mental condition in which the person loses touch with reality and is unable to think or judge clearly.
• Diabetes (adjustment of insulin and/or oral antidiabetic medicines may be needed).
• Closed-angle glaucoma or a history of glaucoma.
• A history of bleeding or episodes of stomach or intestinal bleeding and/or if you are taking medicines that may affect blood clotting or increase the tendency to bleed, such as:
  o NSAIDs (e.g. aspirin, ibuprofen, and diclofenac)
  o Ticlopidine, dipyridamole (medicines known to affect blood platelets)
  o Atypical antipsychotics (e.g. clozapine), phenothiazines (e.g. chlorpromazine, thioridazine), tricyclic antidepressants (e.g. imipramine, desipramine) (see section “Citalopram SUN and other medicines”).
• If you suffer or have suffered from heart problems or have recently had a heart attack.
• If you have a slow resting heart rate and/or if you know you have salt deficiencies due to severe and prolonged diarrhoea or vomiting, or if you are using diuretics.
• If, when standing up, you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness, which could indicate a heart rhythm disorder.

During the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may occur. If you develop these symptoms, inform your doctor immediately. A dose adjustment may be needed.
Some patients with bipolar disorder may enter a manic phase. This phase is characterised by unusual and rapid thought changes, inappropriate happiness, and physical hyperactivity. If these symptoms occur, contact your doctor.
In rare cases, during treatment with Citalopram SUN, certain serotonergic effects may develop, including serotonin syndrome or a condition similar to neuroleptic malignant syndrome, especially if taken together with other serotonergic and/or neuroleptic medicines. Since these syndromes may lead to life-threatening conditions, treatment with Citalopram SUN must be stopped immediately if these symptoms occur, and symptomatic supportive treatment should be initiated. These syndromes are characterised by a number of symptoms occurring simultaneously, such as motor restlessness, confusion, sweating, hallucinations, increased reflexes, muscle rigidity, shivering, increased heart rate, and tremor (see also section “Possible side effects”). Rhabdomyolysis (temporary paralysis or muscle weakness) may occur rarely.
Important information about the illness
As with other medicines used to treat depression or related conditions, improvement does not occur immediately. Several weeks may pass after starting treatment with Citalopram SUN before you feel any improvement. At the beginning of treatment, some patients may experience increased anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow your doctor’s instructions exactly and do not stop treatment or change your dose without first consulting your doctor.
Children and adolescents
Citalopram SUN is generally not recommended for use in children and adolescents under 18 years of age. You should also be aware that patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram SUN to patients under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Citalopram SUN to a patient under 18 years of age and you would like more information, contact your doctor. You must inform your doctor if any of the above symptoms appear or worsen during treatment with Citalopram SUN in patients under 18 years of age.
Furthermore, the long-term safety effects of Citalopram SUN on growth, maturation, and cognitive and behavioural development in this patient group have not yet been established.
Taking Citalopram SUN with food, drinks, and alcohol
Citalopram SUN should be taken as a single daily dose. Citalopram SUN may be taken at any time of day, with or without food.
You must not drink alcohol while taking Citalopram SUN.
Citalopram SUN and other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Some medicines may cause problems if taken together with this medicine.
Special caution is needed if you are taking the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, or tranylcypromine.
• Reversible selective monoamine oxidase inhibitors containing moclobemide (used to treat depression).
• Irreversible monoamine oxidase inhibitors containing selegiline (used to treat Parkinson’s disease). These increase the risk of adverse effects.
• Lithium (used to treat bipolar disorders) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine), dextromethorphan (used to relieve cough), and tramadol (used for severe pain). These increase the risk of adverse effects.
• St. John’s wort (Hypericum perforatum), a herbal remedy used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (used for pain relief or to thin the blood, also known as anticoagulants).
• Ticlopidine, dipyridamole (medicines that affect blood platelets).
• Medicines for mental disorders, such as atypical antipsychotics (e.g. clozapine, risperidone, olanzapine, quetiapine) or phenothiazines (e.g. chlorpromazine, trifluoperazine), or antidepressants (e.g. imipramine, clomipramine, desipramine). Taking citalopram with these medicines may increase the risk of bleeding.
• Medicines that reduce blood potassium and magnesium levels.

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• Metoprolol, a beta-blocker used to treat migraine, certain heart conditions, and high blood pressure. The effect of each medicine may be increased, decreased, or altered.
• Neuroleptics (used to treat schizophrenia).
• Carbamazepine (used to treat epileptic seizures).
• Cimetidine, lansoprazole, and omeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of citalopram.
• Mefloquine (used to treat malaria).
• Bupropion (used to treat depression).

DO NOT TAKE Citalopram SUN if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), or certain antihistamines (e.g. astemizole, mizolastine).
If you have further questions, consult your doctor.
Fertility, pregnancy, and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether treatment with Citalopram SUN is truly necessary or whether an alternative treatment is possible for you.
Do not stop treatment with Citalopram SUN suddenly because of pregnancy or for other reasons.
Ensure that your midwife and/or doctor are aware that you are being treated with Citalopram SUN. When taken during pregnancy, particularly in the last three months, medicines such as Citalopram SUN may increase the risk of a serious condition in newborns called Persistent Pulmonary Hypertension of the Newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after the baby’s birth. If this happens to your baby, contact your midwife and/or doctor immediately.
Additionally, if you take Citalopram SUN during the last three months of pregnancy and up to delivery, you should know that the following symptoms may occur in the newborn: seizures, feeling too hot or too cold, difficulty breathing, bluish or purplish skin or mucous membranes, feeding difficulties, vomiting, low blood sugar, rigid or floppy muscles, hyperactive reflexes, tremor, nervousness, irritability, lethargy, continuous crying, drowsiness, or difficulty falling asleep. If the newborn shows any of these symptoms, contact your midwife and/or doctor immediately.
It is known that citalopram passes into breast milk. The effects on the breastfed infant have not been established. If treatment with citalopram is considered necessary, discontinuation of breastfeeding should be considered.
Animal studies have shown that citalopram reduces sperm quality. In theory, this does not affect fertility, but the impact on human fertility has not yet been studied.
Ask your doctor or pharmacist for advice before taking any medicine.
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Driving and using machines
This medicine may cause side effects (such as dizziness, drowsiness, confusion, and vision problems) that may affect your ability to concentrate or your reaction speed. If any of these side effects occur, you must not drive, operate tools or machinery, or perform any other activity requiring attention and concentration.
Citalopram SUN contains lactose monohydrate
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Citalopram SUN

Take this medicine exactly as directed by your doctor or
pharmacist. If you are in doubt, consult your doctor or pharmacist.
How much medicine to take
It is important to always take the tablets exactly as directed by your doctor.
Your prescription will indicate how many to take and for how long. If you are unsure,
consult your doctor or pharmacist.
Adults
Depression
The usual dose is 20 mg daily. Your doctor may increase the dose up to a
maximum of 40 mg daily.
Panic disorders
The initial dose is 10 mg daily for the first week of treatment, before increasing the
dose to 20–30 mg daily. Your doctor may increase the dose up to a maximum of 40 mg daily.
Elderly patients (aged over 65 years)
The initial dose should be halved compared to the recommended dose, for example 10–20 mg daily. Elderly patients should normally not take more than 20 mg daily.
Children and adolescents (under 18 years of age)
Citalopram SUN must not be given to children and adolescents. For further information,
please refer to section 2 “What you need to know before taking Citalopram SUN”.
Patients with particular risk factors
Patients with liver problems must not take more than 20 mg daily.
How and when to take Citalopram SUN
Citalopram SUN is taken as a single daily dose. Citalopram SUN
can be taken at any time of day, before, during or after meals. Swallow the
tablets with a glass of water. Do not chew them (they have a bitter taste).
The score line is not intended for breaking the tablet.
Duration of treatment
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As with all tablets for depression and panic disorders, it may take several weeks before you notice improvement with these tablets. Continue taking Citalopram SUN even if it takes time before you feel any improvement in your condition.
The duration of treatment is individual, usually at least 6 months. Continue taking the tablets for as long as your doctor has advised. Do not stop taking them even if you start to feel better, unless your doctor tells you to do so. The underlying illness may persist for a long time, and if you stop treatment too early, symptoms may return.
Patients suffering from recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.
Never change the dose of this medicine without first consulting your doctor.
If you feel that the effect of Citalopram SUN is too strong or too weak, discuss this with your doctor or pharmacist.
If you take more Citalopram SUN than you should
Never take more tablets than your doctor has recommended. If you take too many
tablets or accidentally swallow some, consult your doctor or the nearest hospital immediately.
Show them the tablet packaging. Symptoms that typically occur following an overdose (overdose) are: dizziness, drowsiness, sweating, high fever, bluish or purplish skin and mucous membranes, serotonin syndrome, feeling unwell (nausea or vomiting), dilated pupils, rapid and deep breathing, abnormal heartbeat, irregular heart rhythm, high or low blood pressure, heart attack, uncontrolled muscle spasms of the eyes, tremor or trembling of the head, neck and body, agitation, anxiety and coma.
If you forget to take Citalopram SUN
If you forget to take a dose of this medicine, simply continue with the next
dose as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Citalopram SUN
Do not stop treatment with this medicine unless your doctor tells you to do so, even if you feel better.
If you stop treatment suddenly after taking this medicine for a long time, withdrawal symptoms may occur such as dizziness, diarrhoea, numbness and tingling, sweating, headache, rapid or irregular heartbeat, emotional instability, irritability, agitation or anxiety, sleep disturbances including difficulty falling asleep and/or vivid dreams, tremor or trembling, confusion, visual disturbances, nausea and vomiting. Generally, these symptoms are not severe and disappear within a few days. Citalopram treatment should be discontinued gradually over a period of 1–2 weeks.
If withdrawal symptoms occur when stopping treatment, your doctor may decide on a slower discontinuation.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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Like all medicines, Citalopram SUN may cause side effects, although not everyone experiences them.
Side effects are more noticeable during the first two weeks of treatment and usually decrease as your depression improves.
If you experience any of the following symptoms, you must stop taking Citalopram SUN and contact your doctor immediately:

• Allergic reactions
• Angioedema such as: swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties.
• Serotonin syndrome (symptoms: physical agitation, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, increased heart rate and tremor).
• Fast or irregular heartbeat, feeling faint – these may be symptoms of a life-threatening condition known as Torsades de Pointes.

Very common (affects more than 1 in 10 people):

• Trouble sleeping, drowsiness
• Headache, dizziness
• Palpitations or increased heart rate
• Feeling unwell (nausea), dry mouth
• Increased sweating
• Vision disturbances
• Fatigue.

Common (affects less than 1 in 10 but more than 1 in 100 people):

• Agitation, anxiety, nervousness
• Sleep disturbances (excessive drowsiness, abnormal dreams), reduced concentration, abnormal dreams, memory loss, anxiety, decreased sexual desire, abnormal orgasm (in women), decreased appetite, feeling of complete dissatisfaction and confusion.
• Headache and paraesthesia (tingling or itching sensation on the skin)
• Tremor
• Changes in blood pressure (increase or decrease)
• Indigestion, vomiting, constipation, diarrhoea (loose stools), stomach pain, increased flatulence and salivation
• Difficulty urinating, excessive urination
• Muscle or joint pain
• Weight loss
• Nasal inflammation and sinusitis
• Ejaculation failure in men, impotence; in some female patients, painful menstrual flow has been observed
• Localized or general skin itching
• Vision disturbances
• Tinnitus
• Tiredness, yawning.

Uncommon (affects less than 1 in 100 but more than 1 in 1,000 people):

• Aggressiveness; seeing or hearing things that are not there (hallucinations); feeling excited, hyperactive and disinhibited behaviour (mania); depersonalization; feeling extremely happy and increased sexual desire
• Increased appetite and weight gain

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• Abnormal heartbeat
• Fainting
• Dilated pupils
• Skin rash, hives, hair loss, unusual bleeding or bruising
• Difficulty urinating
• Heavy menstrual cycles
• Cough
• Sweating of hands, ankles or feet
• Increased skin sensitivity to light
• Allergic reactions, general feeling of malaise.

Rare (affects less than 1 in 1,000 but more than 1 in 10,000 people):

• Unusual bleeding, particularly of the skin and mucous membranes, gastrointestinal bleeding, vaginal bleeding
• Fatigue, confusion and muscle spasms – these may be symptoms of low sodium levels in the blood
• Altered taste
• Seizures, uncontrolled spasms, involuntary movements or contractions
• Liver disorders, characterized by yellowing of the skin and whites of the eyes, pale stools, dark urine, etc.
• Fever or high fever.

Very rare (affects less than 1 in 10,000 people, including isolated cases):

• Fast heartbeat
• Increased prolactin levels.

Not known (frequency cannot be estimated from available data):

• Bleeding or bruising more easily than usual
• Excessive secretion of antidiuretic hormone, resulting in weakness, tiredness or confusion
• Low potassium levels in the blood
• Panic attacks, teeth grinding, restlessness, suicidal thoughts, suicidal behaviour
• Abnormal involuntary movements (extrapyramidal disorders)
• Restlessness and difficulty standing still, movement disorders
• Feeling faint or dizzy when standing due to a drop in blood pressure
• Nosebleeds
• Abnormal liver function test results
• Persistent and painful erection of the penis occurring without sexual stimulation
• Abnormal milk production from the breasts in men and women.

Bone fractures have been reported in female patients aged 50 years and older.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store Citalopram SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister.
The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Citalopram SUN contains
The active substance is citalopram bromide.
Each 10 mg tablet contains 12.5 mg of citalopram bromide, equivalent to 10 mg of citalopram.
Each 20 mg tablet contains 25 mg of citalopram bromide, equivalent to 20 mg of citalopram.
Each 40 mg tablet contains 50 mg of citalopram bromide, equivalent to 40 mg of citalopram.
The other components are: monohydrate lactose, microcrystalline cellulose, maize starch, copovidone, sodium croscarmellose and magnesium stearate.
Tablet coating: Opadry white 20H-58983: hypromellose, titanium dioxide (E171), propylene glycol, hydroxypropylcellulose and talc.

Description of the appearance of Citalopram SUN and package contents
White to off-white, round, biconvex, film-coated tablets.

• 10 mg tablets, engraved with "10" on one side and smooth on the other side.
• 20 mg tablets, engraved with "20" on one side and a score line on the other side.
• 40 mg tablets, engraved with "40" on one side and a score line on the other side.

Citalopram SUN tablets are available in blister packs in pack sizes of 1, 14, 20, 28, 30, 50, 56, 98, 100 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH Hoofddorp, The Netherlands

Batch release
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH, Hoofddorp
The Netherlands
Terapia S.A.
124 Fabricii Str.
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400632 Cluj-Napoca - Romania

This medicinal product is authorized in the European Economic Area member states under the following names:
United Kingdom: Citalopram 10 mg Film-coated tablets
Citalopram 20 mg Film-coated tablets
Citalopram 40 mg Film-coated tablets
Italy: Citalopram SUN 10 mg film-coated tablets
Citalopram SUN 20 mg film-coated tablets
Citalopram SUN 40 mg film-coated tablets
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