Citalopram Mylan Generics Italia: detailed information

Package leaflet: Information for the patient

Citalopram Mylan Generics Italia 40 mg/ml oral drops, solution

citalopram hydrochloride
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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Citalopram Mylan Generics Italia contains the active substance citalopram hydrochloride, belonging
to a class of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs), which
work by regulating mood.
This medicine is indicated for the treatment of the following disorders:

depression (endogenous depressive syndromes)
prevention of relapse and recurrent depressive episodes
panic attacks (anxiety disorders with panic attacks), including those caused by fear of open spaces (agoraphobia).

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

Do not take Citalopram Mylan Generics Italia if:

you are allergic to citalopram hydrochloride or any of the other ingredients of this medicine (listed in section 6)
the person taking the medicine is a child or adolescent under 18 years of age

you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs)
you are taking selegiline (an irreversible MAOI), used to treat Parkinson’s disease. In this case, take Citalopram Mylan Generics Italia at least 14 days after stopping treatment with that medicine. If you need to start therapy with an MAOI, wait at least 7 days after stopping treatment with Citalopram Mylan Generics Italia
you are using linezolid, a medicine used to treat infections
you suffer from a heart rhythm disorder (prolonged QT interval or congenital long QT syndrome) or are taking medicines that may cause these disorders
you are taking pimozide, used to treat certain mental disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Mylan Generics Italia.
Take this medicine with caution and inform your doctor in the following cases:

if you are elderly or suffer from kidney or liver problems. In these cases, your doctor will adjust the dose of the medicine (see section 3)
if you suffer from panic attacks, as you may experience severe anxiety at the beginning of treatment (paradoxical anxiety)
if you have low levels of sodium in the blood
if you suffer from bipolar disorder (manic-depressive illness), as rapid and unusual changes in thinking, physical hyperactivity, and excitement may occur during treatment with Citalopram Mylan Generics Italia. In this case, stop treatment
if you suffer from epilepsy
if you suffer from diabetes
if you have a coagulation disorder and are at risk of bleeding (haemorrhage), and if you are taking medicines that worsen these conditions (see section “Other medicines and Citalopram Mylan Generics Italia”) or if you are pregnant, see section “Pregnancy, breastfeeding and fertility”
if you are undergoing electroconvulsive therapy (electroshock)
if you are taking products containing St. John’s wort ( Hypericum perforatum )
if you suffer or have suffered from heart problems (bradycardia, uncompensated heart failure) or have recently had a heart attack (acute myocardial infarction)
if you have low levels of potassium or magnesium in the blood. In such cases, your doctor will correct these imbalances before starting treatment with this medicine
if you or someone in your family has an eye condition (narrow-angle glaucoma)
if you are taking medicines containing buprenorphine. Taking medicines together with Citalopram Mylan Generics Italia may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and Citalopram Mylan Generics Italia”).

Suicidal thoughts and worsening of your depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially if you suffer from other mental disorders (psychiatric conditions), you may have thoughts of harming yourself or of suicide. For this reason, your doctor should monitor you closely, particularly at the beginning of treatment or when the dose is increased, if you have previously experienced such symptoms, or if you are young (under 25 years of age). Inform your doctor immediately if you experience these symptoms or if someone caring for you notices changes in your behaviour.
It may be helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder, 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 any changes in your behaviour.
Within the first few weeks of treatment, you may experience restlessness, distress, or a need to move frequently accompanied by an inability to sit still or remain motionless. If you experience these symptoms, contact your doctor immediately.
Stop treatment with this medicine immediately and inform your doctor if you experience agitation, tremor, involuntary muscle contractions, or increased body temperature (fever above 38°C) (these may be symptoms of a condition characterised by excessive accumulation of serotonin in your body, called serotonin syndrome) (see “Other medicines and Citalopram Mylan Generics Italia”).
Medicines such as Citalopram Mylan Generics Italia (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 been observed to persist after discontinuation of treatment.
Children and adolescents
This medicine is normally contraindicated in children and adolescents under 18 years of age. However, your doctor may prescribe Citalopram Mylan Generics Italia to patients under 18 years of age if they consider it the best option for them. In such cases, you must inform your doctor if symptoms such as suicide attempts, suicidal ideation, or hostility appear or worsen during treatment with Citalopram Mylan Generics Italia in a patient under 18 years of age.
Other medicines and Citalopram Mylan Generics Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine if you are taking the following medicines:

medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), as serious, potentially fatal adverse effects may occur, including serotonin syndrome, such as moclobemide (see sections “Warnings and precautions” and “Possible side effects”)
buspirone, used to treat anxiety disorders
linezolid, an antibiotic
class IA and III antiarrhythmics, medicines used for heart rhythm disorders
phenothiazine antipsychotics, pimozide and haloperidol, used to treat mental disorders
tricyclic antidepressants, used to treat depression
antimicrobials such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, used to treat infections
antimalarials such as halofantrine, used to treat malaria
antihistamines such as astemizole and mizolastine, used to treat allergies.

Do not take this medicine together with sumatriptan and similar medicines, used to treat headache (migraine), and tramadol or medicines containing buprenorphine used to treat pain. These medicines may interact with Citalopram Mylan Generics Italia and symptoms such as involuntary and rhythmic muscle contractions, including those controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C may occur. Contact your doctor if you experience such symptoms (see “Warnings and precautions”).
Take this medicine with caution and inform your doctor if you are taking the following medicines:

selegiline, a medicine used to treat Parkinson’s disease
lithium and tryptophan, used to treat certain mental disorders
products containing St. John’s wort ( Hypericum perforatum ), used for depression
medicines used to thin the blood (anticoagulants) such as dipyridamole and ticlopidine
medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid
medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine and haloperidol
medicines used for depression (tricyclic antidepressants)
medicines that reduce potassium or magnesium levels in the blood
medicines that may cause seizures such as:
certain medicines used to treat depression (bupropion, desipramine, imipramine, clomipramine and nortriptyline, and serotonin reuptake inhibitors - SSRIs)
neuroleptics (phenothiazines, thioxanthenes and butyrophenones) used to treat certain mental disorders
tramadol, used to treat severe pain
mefloquine, used to treat malaria.
cimetidine, omeprazole, esomeprazole, lansoprazole used to treat stomach problems, 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
flecainide, propafenone, used to treat heart rhythm disorders
metoprolol, used to treat heart problems and high blood pressure.

Citalopram Mylan Generics Italia and alcohol
Do not drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless absolutely necessary, as it may cause serious problems in your baby.
If you have taken this medicine during the later stages of pregnancy, your baby may experience breathing difficulties, apnoea, bluish skin colour (cyanosis), seizures, body temperature changes, feeding difficulties, vomiting, low blood sugar levels (hypoglycaemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances.
When taken during pregnancy, particularly during the last three months, medicines such as Citalopram Mylan Generics Italia 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 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 have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Citalopram Mylan Generics so they can advise you on what to do.
If you take this medicine during pregnancy, avoid abruptly stopping treatment (see section “If you stop taking Citalopram Mylan Generics Italia”).
Breastfeeding
If you are breastfeeding, take this medicine with caution because citalopram passes into breast milk.
Fertility
This medicine may cause fertility problems in men. The effect disappears upon discontinuation of treatment (see section “Possible side effects”).
Driving and using machines
This medicine may affect your ability to drive vehicles or operate machinery because it may reduce your ability to judge and react in dangerous situations. Therefore, be cautious before driving or operating machinery.
Citalopram Mylan Generics Italia contains alcohol and propylene glycol
This medicine contains 38.39 mg of alcohol (ethanol) per 0.4 ml (8 drops), equivalent to 2.40 mg/mg. The amount in 0.4 ml (8 drops) of this medicine is equivalent to less than 0.8 ml of beer or 0.32 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains approximately 716.16 mg of propylene glycol per maximum daily dose, equivalent to 22.38 mg/mg.

3. How to take Citalopram Mylan Generics Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the drops once daily, after mixing them with some water, orange juice, or apple juice.
Do not stop treatment with Citalopram Mylan Generics Italia abruptly to avoid withdrawal symptoms (see section “If you stop taking Citalopram Mylan Generics Italia”).
Your doctor will adjust the dose according to your needs. Do not change the dose without consulting your doctor (see section “If you stop taking Citalopram Mylan Generics Italia”).

Treatment of depression: the recommended dose is 16 mg (8 drops) daily as a single dose. Your doctor may increase the dose up to a maximum of 32 mg (16 drops) daily, depending on your response to treatment. The effect of the medicine usually appears within 2–4 weeks after starting treatment, which should be continued for at least 4–6 months to manage symptoms of bipolar disorder. If you suffer from recurrent unipolar depression, maintenance treatment should be continued for longer periods to prevent relapse.
Treatment of panic attacks (panic disorder): the recommended initial dose is 8 mg (4 drops) daily for the first week of treatment. Afterwards, your doctor may increase the dose to 16 mg (8 drops) daily, up to a maximum of 32 mg (16 drops) daily depending on your response to treatment. If you suffer from anxiety and experience panic attacks, treatment should be prolonged (1 year). If you have insomnia or are highly agitated, your doctor may prescribe sedative medicines.

Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose to 8–16 mg (4–8 drops) daily.
The maximum recommended dose is 16 mg daily.
Use in patients with liver problems (hepatic impairment)
If you have mild to moderate liver problems, the recommended initial dose is 8 mg (4 drops) daily for the first 2 weeks. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) daily, depending on your response to treatment.
If you have severe liver problems, your doctor may decide to further reduce the dose.
Use in patients with kidney problems (renal impairment)
If you have kidney problems, your doctor will prescribe the lowest recommended dose.
Use in patients with impaired drug metabolism (poor metabolizers of CYP2C19)
If you have impaired drug metabolism (poor metabolizer of CYP2C19), the recommended initial dose is 8 mg (4 drops) daily for the first two weeks of treatment. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) daily, depending on your response to treatment.

If you take more Citalopram Mylan Generics Italia than you should
If you (or someone else) have taken an excessive dose of Citalopram Mylan Generics Italia, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (prolongation of QT interval, torsades de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever, tremors, muscle contractions, and anxiety), agitation, reduced heart rate (bradycardia), dizziness, electrical conduction block in the heart, changes in heart activity (prolongation of QRS interval), high blood pressure (hypertension), pupil dilation (mydriasis), stupor (state of unresponsiveness), sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis), fatigue, weakness, sedation.

If you forget to take Citalopram Mylan Generics Italia
Do not take a double dose to make up for the missed dose.

If you stop taking Citalopram Mylan Generics Italia
Do not stop treatment with Citalopram Mylan Generics Italia suddenly or without first discussing it with your doctor.
When stopping treatment with this medicine, the following withdrawal symptoms may occur:

dizziness, sensory disturbances such as tingling sensations in arms and legs (paraesthesiae)
sleep disturbances such as difficulty falling asleep (insomnia) and vivid dreams
agitation, anxiety, tremors, confusion
nausea, vomiting, diarrhoea
sweating, headache
increased awareness of heartbeats (palpitations)
emotional instability, irritability
visual disturbances.

These symptoms, which are usually mild to moderate in intensity, typically appear within the first few days after stopping treatment and usually resolve on their own within 2 weeks, although sometimes they may be severe and last for a long time (2–3 months or more).
Discontinuation of treatment should be carried out under medical supervision, with doses gradually reduced over weeks or months.

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.
Side effects occur mainly during the first or second week of treatment and then gradually disappear.
If while taking this medicine you feel like harming yourself or have thoughts of suicide, contact your doctor immediately and stop taking the medicine.

The following side effects may occur:

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

drowsiness, difficulty sleeping (insomnia), headache (cephalalgia)
dry mouth, nausea
excessive sweating (hyperhidrosis).

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

decreased appetite, weight loss
restlessness, reduced sexual desire, anxiety, nervousness, confusion, abnormal orgasm in women, unusual dreams
tremor, tingling sensations in arms and legs (paraesthesia), dizziness, attention disturbances
perception of ringing in the ears (tinnitus)
yawning
diarrhoea, vomiting, constipation
itching
pain in muscles (myalgia) and joints (arthralgia)
sexual dysfunction in men (impotence, ejaculation disorders, failure to ejaculate)
fatigue.

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

increased appetite, weight gain
aggression, feeling detached from oneself (depersonalization/derealization), hallucinations, mania
temporary loss of consciousness (syncope)
dilation of the pupil (mydriasis)
reduced/increased heart rate (bradycardia/tachycardia)
urticaria, skin rash, hair loss (alopecia), development of red skin spots and bleeding (purpura), skin reactions due to exposure to sunlight (photosensitivity reaction)
difficulty urinating (urinary retention)
prolonged and heavy menstrual periods in women (menorrhagia)
swelling due to fluid accumulation (oedema).

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

reduced sodium levels in the blood (hyponatraemia)
seizures (generalized tonic-clonic seizures), involuntary movements (dyskinesia), altered taste
bleeding (haemorrhage)
inflammation of the liver (hepatitis)
fever.

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

reduced number of platelets in the blood (thrombocytopenia)
allergic reactions, even severe (hypersensitivity, anaphylactic reaction)
inappropriate production of antidiuretic hormone (ADH) which regulates urine production
reduced potassium levels in the blood (hypokalaemia)
panic attacks, restlessness
teeth grinding (bruxism)
suicidal thoughts (suicidal ideation), suicidal behaviour
seizures
serotonin syndrome
extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and contractions, feeling of restlessness and inability to remain still even for a very short time (akathisia), movement disorders
visual disturbances
disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias, including torsade de pointes), particularly in women with low potassium levels in the blood or who already suffer from heart disorders
sensation of dizziness when standing up quickly due to low blood pressure (orthostatic hypotension)
nosebleeds (epistaxis)
bleeding in the stools (gastrointestinal or rectal haemorrhage)
abnormal liver function laboratory tests
bruising (ecchymosis), swelling of face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema)
irregular menstrual periods in women (metrorrhagia)
prolonged and painful erection (priapism), sudden production of milk from the mammary gland in men
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section "Pregnancy, breastfeeding and fertility" for further information.

An increased risk of fractures has been reported following the use of Citalopram Mylan Generics Italia together with other antidepressant medicines known as tricyclic antidepressants (TCA).

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 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.

5. How to store Citalopram Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
The product should be used within 4 months of first opening the bottle. Any excess product must be discarded.
Do not dispose of any medicine 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 Italia contains

The active substance is citalopram hydrochloride. 1 ml (20 drops) of solution contains 44.48 mg of citalopram hydrochloride (equivalent to 40 mg of citalopram).
The other components are: ethanol 96% and propylene glycol.

Description of the appearance of Citalopram Mylan Generics Italia and contents of the pack
Carton box containing a 15 ml glass bottle of solution with a dropper cap.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano.
Manufacturers
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe 1, 29016 Cortemaggiore (PC)
ABC Farmaceutici S.p.A., Via Cantone Moretti 29, Località San Bernardo, 10090 Ivrea (TO)