Citalopram Mylan Generics: detailed information

Patient Information Leaflet

Citalopram Mylan Generics 20 mg Film-coated Tablets

Citalopram
Generic medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may be harmful to them.
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Citalopram Mylan Generics is and what it is used for
What you need to know before taking Citalopram Mylan Generics
How to take Citalopram Mylan Generics
Possible side effects
How to store Citalopram Mylan Generics
Contents of the pack and other information

1. What Citalopram Mylan Generics is and what it is used for

Citalopram Mylan Generics belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs), also known as antidepressants. These medicines act on the serotonin system in the brain by increasing levels of a substance called serotonin. Imbalances in the serotonin system are considered an important factor in the development of depression and related disorders.

Citalopram Mylan Generics is used to treat:

Depression (major depressive episodes)
Panic disorders (panic attacks), including those caused by agoraphobia, which is the fear of leaving home, entering shops, or going to public places.

2. What you need to know before taking Citalopram Mylan Generics

Do not take Citalopram Mylan Generics:

if you are allergic to citalopram or any of the excipients of this medicine (listed in section 6).
if you are taking medicines called monoamine oxidase inhibitors (MAOIs), for example:
moclobemide (an antidepressant),
linezolid (an antibiotic medicine), unless you are under strict medical supervision with blood pressure monitoring.
irreversible MAO inhibitors (other antidepressants) within the past two weeks, or if you have taken a reversible MAO inhibitor (RIMA) within the time period specified in the RIMA patient leaflet (see "Taking other medicines").
selegiline (a medicine for Parkinson’s disease) at daily doses of 10 mg per day (see "Taking other medicines"). After stopping Citalopram Mylan Generics, you must wait at least 7 days before starting any MAO inhibitor (see "Taking other medicines").
if you are taking pimozide (used to treat mental illnesses)
if you are taking sumatriptan (a 5-HT agonist) used to treat migraine, or similar medicines (see section “Other medicines and Citalopram Mylan Generics”).
if you were born with or have experienced an episode of cardiac arrhythmia (identified by ECG; a test performed to assess heart function).
if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm. Also refer to section “Other medicines and Citalopram Mylan Generics”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Mylan Generics:

if you have diabetes, as your doctor may need to adjust your insulin dose or that of other medicines used to lower your blood sugar levels
if you suffer from epilepsy, as your doctor will monitor you more closely. Treatment with Citalopram Mylan Generics should be stopped if you have a seizure or experience more seizures than usual (see section 4)
if you are undergoing electroconvulsive therapy
if you are experiencing manic episodes characterized by hyperactive behavior or thoughts. If you are in a manic phase, contact your doctor immediately
if you have previously suffered from mental illnesses, as your psychotic symptoms may worsen
if you have or have had eye problems such as certain types of glaucoma
if you have previously had bleeding problems or are taking medicines that affect blood clotting or increase the risk of bleeding (see section “Other medicines and Citalopram Mylan Generics”), or if you are pregnant (see “Pregnancy”)
if you have liver or kidney problems, as your doctor may need to adjust your dose. Your doctor should monitor liver function. Caution and careful dosing are advised in cases of severe liver or kidney impairment.
if you have an abnormal heart rhythm or low levels of salts (potassium, magnesium) in your blood. Your doctor may prescribe treatment to correct these symptoms before starting citalopram therapy
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 diarrhea or vomiting (feeling unwell) or are using diuretics (medicines to increase urination)

During treatment
Talk to your doctor or pharmacist:

if you start to feel agitation, confusion, body temperature above 38°C, and notice tremors or sudden muscle contractions, including muscles controlling eye movements, exaggerated reflexes, increased muscle contraction, hallucinations, coma, excessive sweating, you may be experiencing a rare condition called serotonin syndrome, inform your doctor immediately.
Do not stop treatment with Citalopram Mylan Generics abruptly, as you may experience withdrawal syndrome (see section 3)
if you experience symptoms such as restlessness, agitation, or difficulty staying still during the first few weeks of treatment. Your doctor may adjust your dose
if you experience increased anxiety at the beginning of treatment
if you have a rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an abnormality in heart rhythm
Citalopram Mylan Generics may reduce sodium levels in the blood, making you feel weak, confused, or have painful, stiff muscles. Inform your doctor if you experience these symptoms. Medicines like Citalopram Mylan Generics (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Children and adolescents under 18 years of age
Citalopram Mylan Generics should not normally be taken by children and adolescents under 18 years of age. When taking this class of medicines, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger).
Nevertheless, your doctor may prescribe Citalopram Mylan Generics to patients under 18 years of age if they consider it strictly necessary. If your doctor has prescribed Citalopram Mylan Generics to a patient under 18 years of age and you wish to obtain further information, please contact your doctor again. You must inform your doctor if any of the above symptoms appear or worsen during treatment with Citalopram Mylan Generics in a patient under 18 years of age.
Furthermore, the long-term safety effects of Citalopram Mylan Generics on growth, maturation, and cognitive and behavioral development have not yet been established in this age group.

Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have self-harming or suicidal thoughts.
These symptoms may increase when starting antidepressants, as all these medicines require time to take effect, usually about two weeks or even longer.
You may be more prone to such thoughts:

If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If you have suicidal or self-harming thoughts at any time, contact your doctor or go immediately to hospital. You can seek support by confiding in close family members or friends that you are depressed or suffering from anxiety disorders, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Other medicines and Citalopram Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Do not use Citalopram Mylan Generics if:

you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, e.g., class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol, risperidone), tricyclic antidepressants (e.g., imipramine, desipramine, clomipramine, nortriptyline), certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this, discuss them with your doctor.
you are taking sumatriptan and similar medicines used to treat migraine
you are taking opioids (e.g., buprenorphine) used to treat pain
you are taking linezolid (an antibiotic) (see section “Do not take Citalopram Mylan Generics”)
you are taking medicines for Parkinson’s disease or depression called monoamine oxidase inhibitors (MAOIs), e.g., selegiline (more than 10 mg per day) or moclobemide (see section “Do not take Citalopram Mylan Generics”). Citalopram Mylan Generics must not be administered until 14 days after discontinuation of an irreversible MAO inhibitor. If you stop treatment with Citalopram Mylan Generics, you must wait 7 days before starting any MAOI medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

tryptophan and oxitriptan (used for depression) and tramadol (for severe pain), as these medicines may increase the risk of adverse effects.
other antidepressants, e.g., fluvoxamine
lithium (for treatment of mental illnesses)
medicines used to treat gastric ulcers, e.g., cimetidine, omeprazole, esomeprazole, lansoprazole
fluconazole (used to treat fungal infections)
medicines used to thin the blood (anticoagulants), e.g., warfarin, acetylsalicylic acid (aspirin)
medicines used to prevent blood clotting, e.g., ticlopidine, dipyridamole
any medicine that may reduce potassium or magnesium levels in the blood, as these conditions increase the risk of potentially life-threatening cardiac arrhythmias (QT interval prolongation, torsades de pointes)
metoprolol (e.g., for heart conditions), propafenone or flecainide (for irregular heartbeat). Increased blood levels of these medicines have been reported or are possible, and dose adjustment may be necessary.
bupropion (to help you stop smoking) or mefloquine (for prevention and treatment of malaria), as there is a risk of a possible lowering of the seizure threshold.
a herbal remedy, St. John’s wort (Hypericum perforatum),
medicines called non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen.

Citalopram Mylan Generics and alcohol
It is recommended not to drink alcohol while being treated with this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Citalopram Mylan Generics is not recommended if you are pregnant or planning a pregnancy, unless your doctor considers it absolutely necessary. There are insufficient data on the use of Citalopram Mylan Generics in pregnant women.
Do not stop treatment with Citalopram Mylan Generics abruptly during pregnancy. If you are taking Citalopram Mylan Generics during the last three months of pregnancy, inform your doctor, as your baby may experience certain symptoms at birth. These symptoms usually begin within the first 24 hours after birth. They include difficulty sleeping or feeding, breathing problems, cyanosis, unstable body temperature, feeling unwell, constant crying, stiff or floppy muscles, lethargy, tremors, drowsiness, irritability, low blood sugar, agitation, or seizures. If your baby shows any of these symptoms at birth, contact your doctor immediately; they will know how to advise you.
Ensure that your midwife and/or doctor are aware that you are taking citalopram.
When taken during pregnancy, especially during the last three months, medicines like Citalopram Mylan Generics may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually occur within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you take Citalopram Mylan Generics near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders. Inform your doctor or midwife that you are taking Citalopram Mylan Generics so they can advise you on what to do.

Breastfeeding
Citalopram Mylan Generics passes into breast milk in small amounts. There is a risk of effects on the infant. If you are taking citalopram, inform your doctor before starting breastfeeding. Your doctor may ask you to stop breastfeeding if treatment with this medicine is considered necessary for you.

Fertility
Citalopram has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Citalopram Mylan Generics may reduce your ability to perform tasks requiring precision or high attention. Do not drive or operate tools or machinery until you know how this medicine affects you. If in doubt, consult your doctor.

Citalopram Mylan Generics contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before starting to take this medicine.

3. How to take Citalopram Mylan Generics

Always take this medicine exactly as instructed by your doctor. If you have any doubts, you must
consult your doctor or pharmacist.
Dosage
Adults
Depression
The recommended dose is 20 mg per day. Three or four weeks after starting treatment, your
doctor may review the dosage and decrease or increase the dose of the medicine. This may be
increased up to a maximum of 40 mg per day.
Panic disorder
The recommended initial dose for the first week is 10 mg per day; thereafter, the dose may be increased to 20 mg per day. The dose may be gradually increased by your doctor
up to a maximum of 40 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose is 10 mg per day.
Elderly patients should normally not receive more than 20 mg per day.
Patients with particular risk factors
The recommended initial dose for patients with liver problems is 10 mg per day for the first 2
weeks, after which it may be increased up to a maximum of 20 mg per day.
Use in children and adolescents under 18 years of age
Citalopram Mylan Generics should normally not be given to children and adolescents under
18 years of age (see section “Warnings and precautions”).
Method of administration

Swallow the tablets with a glass of water.
Try to take the tablets at the same time each day, with or without food, either in the morning or in the evening.
Citalopram Mylan Generics 20 mg may be divided into equal parts.

Duration of treatment
Like other medicines for depression and panic disorder, these tablets may take several weeks before you notice improvement. Continue taking Citalopram Mylan Generics even if it takes some time before you feel better.
The duration of treatment is individual and usually lasts at least 6 months. Continue taking the tablets for the entire duration prescribed by your doctor. Do not stop taking them even if you start to feel better, unless your doctor has told you otherwise. The underlying illness may persist for a long time, and if treatment is stopped too early, symptoms may return. Never change the dose of this medicine without first discussing it with your doctor.
If you take more Citalopram Mylan Generics than you should
Contact your doctor or the nearest Emergency Department immediately. Bring the container and any remaining tablets with you. Symptoms of overdose may include drowsiness, dizziness, increase or decrease in blood pressure, dilated pupils, coma, seizures or tremors, agitation, loss of consciousness, sweating, bluish discoloration of the skin, increased respiratory rate, fever, changes in mental status, restlessness, inability to sit still or stand still, muscle weakness, nausea or vomiting, and changes in heart rate or heart rhythm (which may be observed in tests such as ECG).
If you forget to take Citalopram Mylan Generics
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for the forgotten dose.
If you stop taking Citalopram Mylan Generics
Do not stop treatment with this medicine abruptly, as you may experience withdrawal symptoms (see section 4 “Withdrawal symptoms”). If you need to stop taking this medicine, your doctor will gradually reduce your dose over a period of at least 1 or 2 weeks.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is more likely that very common side effects will occur during the first two weeks of treatment.

If you experience any of the following symptoms, you must contact your doctor immediately:

Common (may affect up to 1 in 10 people)

inability to urinate

Uncommon (may affect up to 1 in 100 people)

feeling of excitement that may lead to unusual behaviour (mania)
a seizure (fit), or if you have epilepsy, you may notice an increase in the number of seizures occurring

Rare (may affect up to 1 in 1,000 people)

nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine (hepatitis)
heavy bleeding or bleeding from the intestine or rectum
high fever, feeling agitated or confused, tremor, sudden muscle spasms. These symptoms may be signs of a rare condition called serotonin syndrome
restlessness or difficulty sitting still or staying still. These effects are more likely during the first weeks of treatment. Inform your doctor immediately if you notice these symptoms
excessive production of a hormone causing fluid retention, leading to weakness, tiredness or confusion

Frequency not known (cannot be estimated from the available data)

a severe allergic reaction causing swelling of the face and throat, tightness in the chest, difficulty breathing or swallowing
fast and irregular heartbeat, changes in heart rhythm that may appear on an electrocardiogram as QT interval prolongation, fainting – these could be symptoms of a life-threatening condition known as Torsades de Pointes

Suicidal thoughts and worsening of depression or anxiety disorders

Suicidal thoughts or self-harming thoughts may occur or worsen during the first weeks of treatment for depression, until the antidepressant effect begins. Inform your doctor immediately if you have any distressing thoughts or experiences. Patients who are prone to panic attacks may in fact experience a temporary period of increased anxiety after starting treatment. This usually resolves within the first two weeks (see also section 2 “Suicidal thoughts and worsening of depression or anxiety disorders”).

Other side effects:

Very common (may affect more than 1 in 10 people):

drowsiness
sleep problems
difficulty sleeping
headache
dizziness
feeling of agitation
feeling nervous
tremor
rapid or irregular heartbeat or pounding in the chest (palpitations)
constipation
nausea
dry mouth
increased sweating
feeling weak

Common (may affect up to 1 in 10 people):

Weight loss, loss of appetite
Memory loss
Difficulty concentrating
Abnormal dreams
Feeling anxious
Feeling confused
Decreased sexual desire
Lack of emotions
Migraine
Itching or tingling
Dizziness
Difficulty paying attention
Taste disturbances
Vision problems
Dilated pupils which may also lead to visual disturbances due to increased eye pressure
Ringing in the ears (tinnitus)
Fast heartbeat
Feeling faint or dizzy when standing
Itchy, runny nose
Indigestion, stomach ache, discomfort
Vomiting
Flatulence
Increased salivation
Diarrhoea
Irritated skin
Muscle pain, joint pain
Impaired sexual function in men (such as impotence, ejaculation problems)
Absence of orgasm or abnormal orgasm in women
Tiredness
Yawning

Uncommon (may affect up to 1 in 100 people):

Increased appetite
Weight gain
Euphoria
Increased sexual desire
Aggressiveness
Depersonalisation
Hallucinations
Fainting
Movement disorders
Slow heartbeat
Cough
Abnormal results in liver function tests
Skin sensitivity to light
Hives
Rash
Hair loss
Reddish spots on the skin
Heavy menstrual periods
General feeling of being unwell
Swelling due to excessive fluid in the body

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

Uncontrollable muscle contractions, tics or body distortions and other movement disorders
Fever
Decreased levels of sodium in the blood
Bruising

Very rare (may affect up to 1 in 10,000 people):

Abnormal milk secretion from the breast

Frequency not known (frequency cannot be estimated from the available data)

Reduction in the number of platelets in the blood, increasing the risk of bleeding or bruising
Low levels of potassium in the blood, which may cause muscle weakness, cramps or abnormal heart rhythm
Panic attacks
Teeth grinding (during sleep)
Nosebleeds
Prolonged painful erection
Irregular vaginal bleeding
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, “Pregnancy,” for further information

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Withdrawal symptoms

When you stop taking Citalopram Mylan Generics, you may experience withdrawal symptoms. This is more likely if you stop treatment suddenly.

Some patients have experienced the following side effects within the first few days after stopping treatment:

Dizziness
Sensory disturbances (e.g. tingling or numbness in hands and feet, electric shock sensations)
Sleep disturbances (e.g. difficulty sleeping or abnormal dreams)
Agitation or anxiety
Feeling unwell
Tremor
Dizziness
Confusion
Sweating
Headache
Diarrhoea
Palpitations
Emotional instability, irritability
Vision disturbances

These symptoms are usually mild to moderate and generally resolve within a couple of weeks. However, in some patients they may be more severe or last longer.

If you need to stop treatment with your medicine, your doctor will gradually reduce your dose over a period of at least 1 or 2 weeks. If you experience severe withdrawal symptoms when stopping Citalopram Mylan Generics, inform your doctor. They may advise you to restart treatment and then stop more gradually.

Reporting of side effects

If you experience any side effects, 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use Citalopram Mylan Generics after the expiry date which is stated on the carton/labelling or on the blister after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Mylan Generics contains
The active substance is citalopram. Each tablet contains 20 mg of citalopram (as citalopram
hydrobromide).
The other components are: monohydrate lactose (see section 2 “Citalopram contains lactose”),
maize starch, microcrystalline cellulose, povidone, crospovidone, magnesium stearate. The coating
also contains titanium dioxide (E171), macrogol, hypromellose and monohydrate lactose.
Description of the appearance of Citalopram Mylan Generics and package contents
The tablets are white, oval, film-coated tablets marked with “CM” and a break line “20” on one side and “G” on the other side. The tablets can be divided into two equal parts.
Citalopram Mylan Generics 20 mg film-coated tablets are available in blisters containing 10, 12, 14, 20,
28, 30, 49, 50, 56, 60, 98, 100 and 500 tablets, calendar pack containing 28 tablets, and in plastic bottles containing 12, 14, 20, 28, 50, 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Manufacturer
Mc Dermott Laboratories T/A Gerard Laboratories LTD
35/36 Baldoyle, Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Limited
Station Close
Potters bar
Hertfordshire
EN6 1TL
United Kingdom
Mylan Hungary Kft.,
H-2900, Komarom
Mylan utca 1,
Hungary
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Austria Citalopram 20 mg ‘Arcana’ filmtabletten
Belgium Citalopram Mylan 20 mg, filmomhulde tabletten
Germany Citalopram dura 20 mg filmtabletten
Ireland Ciprager 20 mg film coated tablets
Italy Citalopram Mylan Generics 20 mg compresse rivestite con film
Luxembourg Citalopram Mylan 20 mg
United Kingdom (Northern Ireland) Citalopram 20 mg film coated tablets

Package leaflet: Information for the patient

Citalopram Mylan Generics 40 mg film-coated tablets

Citalopram
Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
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 could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Citalopram Mylan Generics is and what it is used for
What you need to know before taking Citalopram Mylan Generics
How to take Citalopram Mylan Generics
Possible side effects
How to store Citalopram Mylan Generics
Contents of the pack and other information

1. What Citalopram Mylan Generics is and what it is used for

Depression (major depressive episodes)
Panic disorders (panic attacks), including those caused by agoraphobia, which is the fear of leaving home, entering shops or being in public places.

2. What you should know before taking Citalopram Mylan Generics

Do not take Citalopram Mylan Generics:

if you are allergic to citalopram or to any of the excipients of this medicine (listed in section 6).
if you are taking medicines called monoamine oxidase inhibitors (MAOIs), for example:
moclobemide (an antidepressant),
linezolid (an antibiotic medicine), unless you are under close supervision with blood pressure monitoring.
irreversible MAO inhibitors (other antidepressants) within the last two weeks or if you have taken a reversible MAO inhibitor (RIMA) within the time specified in the RIMA patient leaflet (see "Taking other medicines").
selegiline (a medicine for Parkinson's disease) at daily doses of 10 mg per day (see "Taking other medicines"). After stopping Citalopram Mylan Generics, you must wait at least 7 days before starting any MAOI inhibitor (see "Taking other medicines").
if you are taking pimozide (for the treatment of mental illnesses)
if you are taking sumatriptan (5-HT agonist) used to treat migraine, or similar medicines (see section "Other medicines and Citalopram Mylan Generics").
if you have been born with or have had an episode of heart rhythm disorder (identified by an ECG; a test performed to assess how the heart functions)
if you are taking medicines for heart rhythm problems or that may affect your heart rhythm. Also refer to the section "Other medicines and Citalopram Mylan Generics".

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Mylan Generics:

if you have diabetes, as your doctor may need to adjust the dose of insulin or other medicines used to lower your blood sugar levels
if you suffer from epilepsy, as your doctor will monitor you more closely. Treatment with Citalopram Mylan Generics should be stopped if you have a seizure or experience more seizures than usual (see section 4)
if you are receiving electroconvulsive therapy if you suffer from manic episodes characterized by hyperactive behavior or thoughts. If you are in a manic phase, contact your doctor immediately
if you have previously suffered from mental illnesses, as your psychotic symptoms may worsen
if you have or have had eye problems such as certain types of glaucoma
if you have previously had bleeding problems or if you are taking medicines that affect blood clotting or increase the risk of bleeding (see section "Other medicines and Citalopram Mylan Generics") or if you are pregnant (see "Pregnancy")
if you have liver or kidney problems, as your doctor may need to adjust your dose. Your doctor should monitor liver function. Caution and careful administration are advised in cases of severe liver or kidney impairment.
if you have an abnormal heart rhythm or low levels of salts (potassium, magnesium) in your blood. Your doctor may prescribe treatment to correct these symptoms before starting citalopram therapy
if you suffer or have suffered from heart problems or 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 diarrhea or vomiting (feeling unwell) or use diuretics (medicines to increase urination)

During treatment
Talk to your doctor or pharmacist

if you start experiencing agitation, confusion, body temperature above 38°C, tremors, and sudden muscle contractions, including muscles controlling eye movements, heightened reflexes, increased muscle contraction, hallucinations, coma, excessive sweating, you may be suffering from a rare condition called serotonin syndrome, inform your doctor immediately.
Do not stop treatment with Citalopram Mylan Generics abruptly, as you may experience withdrawal symptoms (see section 3)
if you experience symptoms such as restlessness, agitation, or difficulty staying still during the first weeks of treatment. Your doctor may adjust your dose
if you experience increased anxiety at the beginning of treatment
if you have a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate a heart rhythm disorder
Citalopram Mylan Generics may reduce sodium levels in the blood, making you feel weak, confused, or experience painful, stiff muscles. Inform your doctor if you experience these symptoms.

Medicines like Citalopram Mylan Generics (so-called SSRIs/SNRIs) may cause symptoms of
sexual dysfunction (see section 4). In some cases, these symptoms persist after
discontinuation of treatment.
Children and adolescents under 18 years of age
Citalopram Mylan Generics must not normally be taken by children and adolescents under
18 years of age. When taking this class of medicines, patients under 18 years of age
have an increased risk of adverse effects such as suicide attempts, suicidal thoughts,
and hostility (mainly aggression, oppositional behavior, and anger).
Nevertheless, your doctor may prescribe Citalopram Mylan Generics to patients under
18 years of age if they consider it strictly necessary. If your doctor has prescribed Citalopram Mylan
Generics to a patient under 18 years of age and you wish to obtain further information, contact your
doctor again. You must inform your doctor if any of the above symptoms appear or worsen during
treatment with Citalopram Mylan Generics in a patient under 18 years of age.
Furthermore, the long-term safety effects of Citalopram Mylan Generics on growth,
maturation, and cognitive and behavioral development have not yet been established
in this age group.
Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may sometimes have self-harming or suicidal thoughts.
These symptoms may increase when starting antidepressants, as all these medicines take time to work, usually about two weeks or even longer.
You may be more prone to such thoughts:

If you have previously had suicidal or self-harming thoughts.
If you are a young adult. Clinical studies have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If you have suicidal or self-harming thoughts at any time, contact your doctor or go immediately to hospital. You can get help by confiding in close family members or friends that you are depressed or suffer from anxiety disorders and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behavior.

Other medicines and Citalopram Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not use Citalopram Mylan Generics if:

you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, e.g., class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol, risperidone), tricyclic antidepressants (e.g., imipramine, desipramine, clomipramine, nortriptyline), some antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), some antihistamines (astemizole, mizolastine). If you have any further questions about this, discuss them with your doctor.
you are taking sumatriptan and similar medicines used to treat migraine
you are taking opioids (e.g., buprenorphine) used to treat pain.
you are taking linezolid (an antibiotic) (see section "Do not take Citalopram Mylan Generics")
you are taking medicines for Parkinson's disease or depression called monoamine oxidase inhibitors (MAOIs), e.g., selegiline (more than 10 mg per day) or moclobemide (see section "Do not take Citalopram Mylan Generics"). Citalopram Mylan Generics must not be administered until 14 days after discontinuation of an irreversible MAO inhibitor. If you stop treatment with Citalopram Mylan Generics, you must wait 7 days before starting any MAOI medicine.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
of the following medicines:

tryptophan and oxitriptan (used for depression) and tramadol (for the treatment of severe pain), as these medicines may increase the risk of adverse effects.
other antidepressants, e.g., fluvoxamine
lithium (for the treatment of mental illnesses)
medicines used to treat gastric ulcers, e.g., cimetidine, omeprazole, esomeprazole, lansoprazole
fluconazole (used to treat fungal infections)
medicines used to thin the blood (anticoagulants), e.g., warfarin, acetylsalicylic acid (aspirin)
medicines used to prevent blood clotting, e.g., ticlopidine, dipyridamole
any medicine that may reduce potassium or magnesium levels in the blood, as these conditions increase the risk of potentially life-threatening heart rhythm disturbances (QT interval prolongation, torsades de pointes)
metoprolol (e.g., for heart conditions), propafenone or flecainide (for treating irregular heartbeat). An increased blood level of these medicines has been reported or may be possible, and dose adjustment may be necessary. bupropion (to help you stop smoking) or mefloquine (for prevention and treatment of malaria) as there is a risk of a possible lowering of the seizure threshold.
a herbal remedy, St. John's wort ( Hypericum perforatum ),
medicines called non-steroidal anti-inflammatory drugs (NSAIDs), e.g., ibuprofen.

Citalopram Mylan Generics and alcohol
It is recommended not to drink alcohol while being treated with this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor
or pharmacist for advice before taking this medicine.
Pregnancy
Citalopram Mylan Generics is not recommended if you are pregnant or planning a
pregnancy, unless your doctor considers it absolutely necessary. There are insufficient data
on the use of Citalopram Mylan Generics in pregnant women.
Do not stop treatment with Citalopram Mylan Generics abruptly during
pregnancy. If you are taking Citalopram Mylan Generics during the last 3 months of pregnancy, inform your
doctor, as your baby may experience certain symptoms at birth. These symptoms usually
begin within the first 24 hours after the baby's birth. They include difficulty
falling asleep or feeding problems, breathing difficulties, cyanosis, unstable body temperature, feeling unwell, constant crying, stiff or floppy muscles, lethargy, tremors, drowsiness,
irritability, low blood sugar, agitation, or seizures. If your baby has any of these symptoms at birth, contact your doctor immediately; they will be able to advise you.
Ensure that your midwife and/or doctor know that you are taking citalopram.
When taken during pregnancy, especially during the last 3 months, medicines
such as Citalopram Mylan Generics may increase the risk of a serious condition in newborns
called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours
after the baby's birth. If this occurs in your baby, you must contact your midwife
and/or doctor immediately.
If you take Citalopram Mylan Generics close to the end of pregnancy, there may be an
increased risk of heavy vaginal bleeding shortly after delivery, especially if you suffer from
bleeding disorders. Inform your treating doctor or midwife that you are taking Citalopram
Mylan Generics so they can advise you on what to do.
Breastfeeding
Citalopram Mylan Generics passes into breast milk in small amounts. There is a risk of an effect on
the baby. If you are taking citalopram, inform your doctor before starting breastfeeding. The doctor
may ask you to stop breastfeeding if treatment with this medicine is considered necessary for you.
Fertility
Citalopram, in animal studies, has been shown to reduce sperm quality. In theory, this could
affect fertility, but the impact on human fertility has not yet been observed.
Driving and using machines
Citalopram Mylan Generics may reduce your ability to perform tasks requiring
precision or high concentration. Do not drive or operate tools or machinery until you
know how this medicine affects you. If in doubt, consult your doctor.
Citalopram Mylan Generics contains lactose.
If your doctor has told you that you have an intolerance to certain sugars, contact your doctor
before starting to take this medicine.

3. How to take Citalopram Mylan Generics

Always take this medicine exactly as instructed by your doctor. If you have any doubts, you should
consult your doctor or pharmacist.
Dosage
Adults
Depression
The recommended dose is 20 mg once daily. Three or four weeks after starting treatment, your
doctor may review the dosage and decrease or increase the dose of the medicine. This may be
increased up to a maximum of 40 mg per day.
Panic disorder
The recommended initial dose for the first week is 10 mg per day; thereafter, the dose may be increased to 20 mg per day. The dose may be gradually increased by your doctor up to a maximum of 40 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose is 10 mg per day.
Elderly patients should normally not receive more than 20 mg per day.
Patients with particular risk factors
The recommended initial dose for patients with liver problems is 10 mg per day for the first 2
weeks, after which it may be increased up to a maximum of 20 mg per day.
Use in children and adolescents under 18 years of age
Citalopram Mylan Generics should normally not be given to children and adolescents under
18 years of age (See section “Warnings and precautions”).
Method of administration

Swallow the tablets with a glass of water.
Try to take the tablets at the same time each day, with or without food, either in the morning or in the evening.
Citalopram Mylan Generics 40 mg tablets may be divided into equal parts.
For doses not achievable with this strength, other dosage forms of this medicine are available.

Duration of treatment
Like other medicines for depression and panic disorder, these tablets may take several weeks before
you notice improvement. Continue taking Citalopram Mylan Generics even if it takes some time
before you feel better. The duration of treatment is individual, usually at least 6 months. Continue taking the tablets for as long as prescribed by your doctor. Do not stop taking them even if you start to feel better, unless your doctor has told you to do so. The underlying illness may persist for a long time, and if you stop treatment too early, symptoms may return. Never change the dose of this medicine without first discussing it with your doctor.
If you take more Citalopram Mylan Generics than you should
Contact your doctor or the nearest Emergency Department immediately. Bring the container and any remaining tablets with you. Symptoms of overdose may include drowsiness, dizziness, increased or decreased blood pressure, dilated pupils, coma, seizures or tremors, agitation, loss of consciousness, sweating, bluish discoloration of the skin, increased respiratory rate, fever, changes in mental status, restlessness, inability to sit still or stand still, muscle weakness, nausea or vomiting, and changes in heart rate or heart rhythm (which may be observed through tests such as ECG).
If you forget to take Citalopram Mylan Generics
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and 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 Mylan Generics
Do not stop treatment with this medicine abruptly, as you may experience withdrawal symptoms (See section 4 “Withdrawal symptoms”). If you need to discontinue treatment with this medicine, your doctor will gradually reduce your dose over a period of at least 1 or 2 weeks.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is more likely that very common side effects will occur during the first two weeks of treatment.

If you experience any of the following symptoms, you must contact your doctor immediately:

Common (may affect up to 1 in 10 people)

inability to urinate

Uncommon (may affect up to 1 in 100 people)

feeling of excitement that may lead to unusual behaviour (mania)
a seizure (fit), or if you have epilepsy, you may notice an increase in the number of seizures occurring

Rare (may affect up to 1 in 1,000 people)

nausea, vomiting, loss of appetite, general feeling of being unwell, fever, itching, yellowing of the skin and eyes, pale stools, dark urine (hepatitis)
heavy bleeding or bleeding from the bowel or rectum
high fever, feeling agitated or confused, tremor, sudden muscle spasms. These symptoms may be signs of a rare condition called serotonin syndrome
restlessness or difficulty sitting still or staying still. These effects are more likely during the first weeks of treatment. Inform your doctor immediately if you notice these symptoms
excessive production of a hormone causing fluid retention, resulting in weakness, tiredness or confusion

Frequency not known (cannot be estimated from the available data)

a severe allergic reaction causing swelling of the face and throat, tightness in the chest, difficulty breathing or swallowing
fast and irregular heartbeat, changes in heart rhythm that may be seen on an electrocardiogram as QT interval prolongation, fainting, which could be symptoms of a life-threatening condition known as Torsades de pointes

Suicidal thoughts and worsening of depression or anxiety disorders
Suicidal thoughts or self-harming thoughts may occur or worsen during the first weeks of depression treatment, until the antidepressant effect begins. Inform your doctor immediately if you have any distressing thoughts or experiences. Patients who are prone to panic attacks may in fact experience a temporary period of increased anxiety after starting treatment. This usually resolves within the first two weeks (see also section 2 “Suicidal thoughts and worsening of depression or anxiety disorders”).

Other side effects:

Very common (may affect more than 1 in 10 people)

drowsiness
sleep problems
difficulty sleeping
headache
dizziness
feeling of agitation
feeling nervous
tremor
rapid or irregular heartbeat or pounding in the chest (palpitations)
constipation
nausea
dry mouth
increased sweating
feeling of weakness

Common (may affect up to 1 in 10 people)

Weight loss, loss of appetite
Memory loss
Difficulty concentrating
Abnormal dreams
Feeling anxious
Feeling confused
Decreased sex drive
Lack of emotions
Migraine
Itching or tingling
Dizziness
Difficulty paying attention
Taste disturbances
Vision problems
Dilated pupils which may also lead to visual disturbances due to increased eye pressure
Ringing in the ears (tinnitus)
Fast heartbeat
Feeling faint or dizzy when standing
Itchy, runny nose
Indigestion, stomach ache, discomfort
Vomiting
Flatulence
Increased salivation
Diarrhoea
Irritated skin
Muscle pain, joint pain
Impaired sexual function in men (such as impotence, ejaculation problems)
Absence of orgasm or abnormal orgasm in women
Tiredness
Yawning

Uncommon (may affect up to 1 in 100 people)

Increased appetite
Weight gain
Euphoria
Increased sex drive
Aggressiveness
Depersonalization
Hallucinations
Fainting
Movement disorders
Slow heartbeat
Cough
Abnormal results in liver function tests
Skin sensitivity to light
Hives
Rash
Hair loss
Reddish spots on the skin
Heavy menstrual periods
General feeling of being unwell
Swelling due to excessive fluid in the body

Rare (may affect up to 1 in 1,000 people)

Uncontrollable contractions, tics or twisting movements of the body and other movement disorders
Fever
Decreased levels of sodium in the blood
Bruising

Very rare (may affect up to 1 in 10,000 people)

Abnormal milk production from the breast

Frequency not known (frequency cannot be estimated from the available data)

Reduction in the number of platelets in the blood, increasing the risk of bleeding or bruising
Low levels of potassium in the blood which may cause muscle weakness, cramps or abnormal heart rhythm
Panic attacks
Teeth grinding (during sleep)
Nosebleeds
Prolonged painful erection
Irregular vaginal bleeding
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage) – see section 2 “Pregnancy” for further information

An increased risk of bone fractures has been observed in patients taking this type of medicine.

Withdrawal symptoms
When you stop taking Citalopram Mylan Generics, you may experience withdrawal symptoms. This is more likely if you stop treatment suddenly.
Some patients have experienced the following side effects within the first few days of stopping treatment:

Dizziness
Sensory disturbances (e.g. tingling or numbness in hands and feet, electric shock sensations)
Sleep disturbances (e.g. difficulty sleeping or abnormal dreams)
Agitation or anxiety
Feeling unwell
Tremor
Dizziness
Confusion
Sweating
Headache
Diarrhoea
Palpitations
Emotional instability, irritability
Vision disturbances

Usually these symptoms are mild to moderate and generally resolve within a couple of weeks. However, in some patients they may be more severe or last longer.
If you need to stop treatment with your medicine, your doctor will gradually reduce your dose over a period of at least 1 or 2 weeks. If you experience severe withdrawal symptoms when stopping Citalopram Mylan Generics, inform your doctor. They may advise you to restart treatment and then stop more gradually.

Reporting of side effects
If you experience any side effects, 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use Citalopram Mylan Generics after the expiry date stated on the carton/labelling or on the
blister after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Mylan Generics contains
The active substance is citalopram. Each tablet contains 40 mg of citalopram (as citalopram
bromide).
The other components are: monohydrate lactose (see section 2 “Citalopram contains lactose”),
maize starch, microcrystalline cellulose, povidone, crospovidone, magnesium stearate. The coating
also contains titanium dioxide (E171), macrogol, hypromellose and monohydrate lactose.
Description of the appearance of Citalopram Mylan Generics and the contents of the pack
The tablets are white, oval, film-coated tablets marked with “CM” and a break line “40” on one side and “G” on the other side. The tablets can be divided into two equal halves.
Citalopram Mylan Generics 40 mg film-coated tablets are available in blisters of 7, 10, 14, 20, 28,
30, 50, 56, 60, 84, 90, 98 and 100 tablets, calendar packs of 28 tablets, and plastic bottles containing
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Manufacturer
Mc Dermott Laboratories T/A Gerard Laboratories LTD
35/36 Baldoyle, Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
Mylan Hungary Kft.,
H-2900, Komarom
Mylan utca 1,
Hungary
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Belgium Citalopram Mylan 40 mg, filmomhulde tabletten
Germany Citalopram dura 40 mg filmtabletten
Ireland Ciprager 40 mg film coated tablet
Italy Citalopram Mylan Generics 40 mg film-coated tablets
Luxembourg Citalopram Mylan 40 mg
United Kingdom (Northern Ireland) Citalopram 40 mg film coated tablet