Patient Information Leaflet

Citronil, 10 mg, film-coated tablets
Citronil, 20 mg, film-coated tablets
Citronil, 40 mg, film-coated tablets
citalopramum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Citronil is and what it is used for

Citalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing the concentration of serotonin.
Citronil is indicated for:

treatment of depression
prevention of relapse of depressive episodes
treatment of panic disorder with or without agoraphobia
treatment of obsessive-compulsive disorder.

2. Important information before taking Citronil

When not to take Citronil

if the patient is allergic to citalopram or any of the other ingredients of this medicine (listed in section 6)
if the patient is taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs). MAO inhibitors include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson's disease), moklobemide (used in the treatment of depression), and linezolid (an antibiotic).
if the patient has a congenital abnormal heart rhythm or has previously experienced an episode of abnormal heart rhythm (diagnosed by ECG – a test used to assess heart function)
if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Citronil and other medicines").

Even after stopping MAO inhibitors, a 2-week waiting period must elapse before starting
treatment with Citronil.
After discontinuing Citronil, a 1-week interval must pass before starting any
MAO inhibitor.
Warnings and precautions
Before starting treatment with Citronil, discuss this with your doctor or pharmacist.

if the patient has episodes of mania or hypomania
if the patient has severe liver or kidney function disorders
if the patient has an increased risk of bleeding or if the patient is pregnant (see section on pregnancy)
if the patient has diabetes. Treatment with Citronil may interfere with glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
if the patient has epilepsy. Treatment with Citronil should be discontinued if seizures occur or their frequency increases (see also section 4)
if the patient has low sodium levels in the blood
if the patient has undergone electroconvulsive therapy
if the patient has psychosis. Use of this medicine in patients with psychosis with depressive episodes may worsen psychotic symptoms.
if the patient currently has or has previously had angle-closure glaucoma
if the patient currently has or has a history of heart disease or has had a heart attack
if the patient has a slow resting heart rate and/or may experience loss of body salts due to severe diarrhoea or vomiting (with nausea) or due to the use of diuretics (water tablets)
if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.

Note!
In some patients with bipolar affective disorder, a manic phase may occur. This is characterised by unusual and rapidly changing thoughts, unjustified feelings of happiness, and excessive physical activity. If such symptoms occur, consult a doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still (akathisia) may also occur. If such symptoms appear, contact a doctor immediately.
Medicines such as Citronil (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Citronil should not usually be used to treat children and adolescents under 18 years of age. In patients under 18 years of age treated with medicines from this group, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviours, and expressions of anger). Nevertheless, a doctor may prescribe Citronil to patients under 18 years of age if they determine it is in their best interest. If Citronil has been prescribed to a patient under 18 years of age and there are any doubts, consult the doctor again. Inform the doctor immediately if any of the above-mentioned adverse effects occur or worsen in a patient under 18 years of age taking Citronil. The long-term impact of this medicine on growth, maturation, cognitive development, and behavioural development in children and adolescents under 18 years of age has not yet been established.
Suicidal thoughts, worsening depression, or anxiety disorders
Individuals with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to take effect.
The likelihood of such thoughts is higher if:

the patient has previously had suicidal thoughts or self-harm tendencies;
the patient is a young adult under 25 years of age. Clinical studies have shown an increased risk of suicidal thoughts and self-harm ideation in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

If the patient experiences thoughts of self-harm or suicidal thoughts, contact a doctor immediately or go to hospital.
Informing family members or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask family or friends to inform them if they notice worsening depression or anxiety or concerning behavioural changes.
Citronil and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. The effect of the medicine may be reduced if taken simultaneously with certain other medicines.
In particular, inform the doctor if the patient is taking the following medicines:

non-selective monoamine oxidase inhibitors (MAO inhibitors) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting Citronil. After stopping Citronil, wait 7 days before taking any of these medicines.
reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moklobemide (used in the treatment of depression)
the antibiotic linezolid
lithium (used in the prevention and treatment of bipolar affective disorder) and tryptophan
imipramine and desipramine (used in the treatment of depression)
irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects.
metoprolol (used in hypertension and heart diseases). Dose adjustment may be necessary.
sumatriptan and similar medicines (used in migraine treatment) and tramadol and similar medicines (opioids, used for severe pain). These medicines increase the risk of adverse effects.
cimetidine, lansoprazole, and omeprazole (used in peptic ulcer disease), fluconazole (used in fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase citalopram blood levels.
medicines increasing the risk of bleeding, e.g. anticoagulants (medicines preventing blood clotting, e.g. ticlopidine and dipyridamole), non-steroidal anti-inflammatory drugs (anti-inflammatory and pain-relieving medicines), and salicylic acid derivatives (e.g. acetylsalicylic acid). Concurrent use may lead to bleeding from the skin and mucous membranes.
herbal medicines containing St. John's wort (Hypericum perforatum). Concurrent use may increase the risk of adverse effects.
mefloquine (used in malaria treatment) and bupropion (used in depression treatment and to aid smoking cessation), due to possible risk of lowering the seizure threshold
neuroleptics (medicines used in schizophrenia, psychosis) due to possible risk of lowering the seizure threshold, and antidepressants
medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disturbances.

Do not take Citronil simultaneously with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, certain antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatment, mainly halofantrine), and certain antihistamines (astemizole, mizolastine).
If you have any further doubts, consult your doctor.
Citronil with food, drink, and alcohol
Take the tablet with liquid, during or independent of meals.
Swallow the tablet with half a glass of water.
Alcohol consumption is not recommended during treatment with Citronil.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Avoid abrupt discontinuation of treatment during pregnancy.
Pregnancy
When taking Citronil during the last 3 months of pregnancy, be aware that the newborn may experience the following symptoms: breathing difficulties, skin blueness (cyanosis), seizures, temperature changes, feeding difficulties, vomiting, low blood glucose, muscle stiffness or floppiness, increased reflexes, tremors, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur, contact a doctor immediately.
The patient must ensure that the midwife and/or doctor know she is taking Citronil. Medicines such as Citronil, when taken during pregnancy, particularly during the last three months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and cyanosis in infants. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur in the newborn, contact the midwife and/or doctor immediately.
Taking Citronil towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Citronil, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
Citalopram passes into breast milk during breastfeeding. There is a risk of effects on the breastfed infant. Therefore, Citronil should not be used during breastfeeding unless otherwise advised by a doctor.
Effect on fertility
Animal studies have shown that citalopram reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
Citalopram may impair the ability to concentrate. If in doubt whether the medicine affects concentration and reaction speed, avoid driving and operating machinery or performing tasks requiring special caution.
Citronil contains lactose
Citronil tablets contain lactose monohydrate: 10 mg tablet – approximately 23 mg, 20 mg tablet – approximately 46 mg, 40 mg tablet – approximately 91 mg. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Citronil

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
ask your doctor or pharmacist.
As with other medicines of this type, Citronil does not relieve symptoms immediately. Improvement
is usually seen after several weeks of treatment. Do not change the dose without
first consulting your doctor.
You should continue taking Citronil for as long as your doctor recommends. If you stop
treatment too early, symptoms may return. Therefore, it is recommended to continue treatment for at least
6 months after regaining a good sense of well-being. The condition may persist for a long time,
and if treatment is stopped too early, symptoms may recur.
In patients with recurrent depression, treatment may last several years to prevent relapses.
If you feel the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.

Recommended dose for adults:
Depression
The usual dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of
40 mg once daily.
Panic disorder
The initial dose is usually 10 mg once daily for the first week. Then, the dose
may be increased to 20–30 mg once daily. Your doctor may increase the dose up to
a maximum of 40 mg once daily.
Obsessive-compulsive disorder
The initial dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg
once daily. The first effects of treatment usually appear after 2–4 weeks, with further improvement
occurring during continued treatment.

Preventive treatment
The duration of preventive treatment depends on the individual patient's condition, but usually lasts
several years. Discontinuation of treatment should be done cautiously to avoid possible
relapse of the illness.

Elderly patients (over 65 years of age):
In elderly patients, the initial dose should be reduced to half the recommended dose, e.g. 10 to 20 mg per day.
Elderly patients usually should not take a dose higher than 20 mg per day.

Special patient groups
Patients with liver disease should not take a dose higher than 20 mg per day.

Use in children and adolescents
Citronil should not be used in children and adolescents under 18 years of age. For additional information, see section 2.

Taking more Citronil than recommended
If you take more Citronil than recommended, or if a child accidentally takes the medicine, contact your doctor,
go to a hospital or a poison control center, and bring the medicine packaging with you.
Symptoms of overdose include life-threatening irregular heartbeat, seizures, changes in heart rhythm, drowsiness,
coma, vomiting, tremor, low or high blood pressure, nausea, serotonin syndrome (see section 4), agitation,
dizziness, dilated pupils, excessive sweating, skin cyanosis, and hyperventilation.

If you miss a dose of Citronil
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to bed,
you should take the missed dose immediately. Take the next dose the following day. If you remember about the missed
dose during the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping Citronil
Do not stop taking this medicine unless your doctor tells you to. Talk to your doctor if you wish to stop treatment.
After ending therapy, it is generally recommended to gradually reduce the dose of citalopram over several weeks.
When stopping citalopram, especially abruptly, withdrawal symptoms may occur. This is typical after discontinuation of citalopram treatment.
The risk of such symptoms is higher if citalopram has been taken for a long time or in high doses, or if the dose was reduced too quickly.
In most cases, these symptoms are mild and resolve spontaneously within two weeks. If severe withdrawal symptoms occur after stopping
citalopram, contact your doctor. Your doctor may recommend resuming tablets and tapering them more slowly.
Withdrawal symptoms include: dizziness (unsteadiness or loss of balance), prickling or tingling sensations, burning sensations and (less commonly) electric shock-like sensations, also in the head,
sleep disturbances (intense dreams, nightmares, insomnia), anxiety, headache, nausea,
sweating (including night sweats), restlessness or agitation, tremor, feeling confused or disoriented,
feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, palpitations (strong heartbeat).

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following serious adverse reactions have been reported in some patients. If any of the
symptoms listed below occur, stop taking Citronil immediately and contact your doctor without delay:
Unknown ( frequency cannot be estimated from the available data ):

high fever, agitation, confusion, muscle twitching, and sudden violent muscle contractions; these may be symptoms of a rare condition called serotonin syndrome
swelling of the skin, tongue, lips or face, difficulty breathing or swallowing (allergic reactions), sudden swelling of the skin or mucous membranes (angioedema)
gastrointestinal bleeding
rapid, irregular heartbeat and fainting, which may be symptoms of a life-threatening condition called Torsade de Pointes
thoughts about suicide or death.

Rare ( may occur in no more than 1 in 1,000 people ):

feeling tired, disorientation, muscle tremors; these may be symptoms of a rare condition called hyponatraemia (low sodium levels in the blood)
if seizures occur or increase in frequency.

Other adverse reactions
The adverse reactions listed below are usually mild and generally resolve within a few days of
treatment.
If adverse reactions are particularly troublesome and persist for longer than a few days, consult your
doctor.
Very common ( may occur in more than 1 in 10 people ):

drowsiness
insomnia
excessive sweating
dry mouth
nausea.

Common ( may occur in no more than 1 in 10 people ):

decreased appetite
restlessness
reduced sexual drive
anxiety
sexual dysfunction (reduced sexual drive and sexual performance)
painful menstruation
nervousness
confusion
unusual dreams
tremor
paraesthesia (tingling and prickling sensations)
dizziness
attention disturbances
tinnitus
yawning
diarrhoea
vomiting
constipation
itching
muscle or joint pain
impotence, ejaculation disorders
orgasm disorders or anorgasmia in women
fatigue
tingling and prickling sensations
weight loss.

Uncommon ( may occur in no more than 1 in 100 people ):

subcutaneous bleeding
increased appetite
aggression
depersonalisation
hallucinations
mania
fainting
dilated pupils
increased heart rate
decreased heart rate
rash, urticaria
alopecia
photosensitivity
difficulty urinating
heavy menstrual bleeding
swelling of hands or feet
weight gain.

Rare ( may occur in no more than 1 in 1,000 people ):

movement disorders
taste disturbances
unusual bleeding
hepatitis
fever.

Unknown ( frequency cannot be estimated from the available data ):

abnormally low platelet count (thrombocytopenia), which increases the risk of bleeding and bruising
hypersensitivity reactions
inappropriate antidiuretic hormone secretion
increased blood levels of prolactin hormone
low potassium levels in the blood (hypokalaemia), which may cause muscle weakness, tremor or irregular heartbeat
panic attacks
teeth grinding
restlessness
seizures
unusual movements or muscle stiffness
involuntary muscle movements (akathisia)
visual disturbances
QT interval prolongation on ECG
irregular heartbeat (ventricular arrhythmias)
dizziness upon changing position from sitting or lying to standing, due to low blood pressure (orthostatic hypotension)
nosebleeds
abnormal liver function test results
bleeding, including skin and mucous membrane bleeding (petechiae)
milk secretion in men and in women who are not pregnant or breastfeeding (galactorrhoea)
irregular menstrual bleeding
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in section “Pregnancy, breastfeeding and fertility” in section 2.
painful penile erection (in men). An increased risk of bone fractures has been observed in patients taking medicines of this type.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301,
Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Citronil

There are no special storage requirements for this medicine.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Citronil contains

The active substance is 10 mg, 20 mg or 40 mg of citalopram as citalopram hydrobromide.
The other components of the tablet core are: monohydrate lactose, microcrystalline cellulose, maize starch, sodium croscarmellose, copovidone, magnesium stearate.
The coating components are: hypromellose 6 cP, macrogol 400, titanium dioxide (E 171).

What Citronil looks like and contents of the pack

10 mg tablets: white, biconvex, round, film-coated tablets marked with "A" on one side and "05" on the other side.
20 mg tablets: white, biconvex, capsule-shaped, film-coated tablets marked with "A" on one side and "06" on the other side (the dividing groove is located between 0 and 6). The tablet can be divided into equal doses.
40 mg tablets: white, biconvex, capsule-shaped, film-coated tablets marked with "A" on one side and "07" on the other side (the dividing groove is located between 0 and 7). The tablet can be divided into equal doses.

Packaging:
PVC/PVDC/Aluminium foil blisters in cardboard boxes:
28 tablets (2x 14 tablets) and 98 tablets (7x 14 tablets).
HDPE bottle container:
Citronil 10 mg, film-coated tablets: 30, 100 and 1000 tablets.
Citronil 20 mg, film-coated tablets: 30, 56, 100, 250 and 1000 tablets.
Citronil 40 mg, film-coated tablets: 30, 56, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation
Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic, Denmark, Finland, Hungary, Norway, Sweden: Citalopram Orion
Poland: Citronil