Citronil

Leaflet accompanying the packaging: information for the user

Citronil, 10 mg, coated tablets

Citronil, 20 mg, coated tablets

Citronil, 40 mg, coated tablets

citalopram

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Citronil and what is it used for
• 2. Important information before taking Citronil
• 3. How to take Citronil
• 4. Possible side effects
• 5. How to store Citronil
• 6. Contents of the packaging and other information

1. What is Citronil and what is it used for

Citalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRI). These medicines work on the serotonin system in the brain by increasing the levels of serotonin.

Indications for the use of Citronil include:

• treatment of depression
• prevention of recurrence 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 that belong to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used to treat Parkinson's disease), and moclobemide (used to treat depression)
• if the patient has congenital or a history of abnormal heart rhythm (diagnosed on the basis of an electrocardiogram - a test 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 if the patient has stopped taking MAOIs, they should wait 2 weeks before starting to take Citronil.

After stopping treatment with Citronil, the patient should wait 1 week before starting to take any MAOIs.

Warnings and precautions

Before starting treatment with Citronil, the patient should discuss it with their doctor or pharmacist.

• if the patient has episodes of mania or hypomania
• if the patient has severe liver or kidney problems, 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 affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• if the patient has epilepsy. Treatment with Citronil should be discontinued if the patient experiences seizures or an increased frequency of seizures (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. The use of Citronil in patients with psychosis and depressive episodes may worsen psychotic symptoms.
• if the patient currently has or has a history of 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 heart rate at rest and/or may have a loss of salts in the body due to severe diarrhea or vomiting (with nausea) or due to the use of diuretic medicines (water pills)
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may be symptoms of abnormal heart rhythm.

Warning!

In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If such symptoms occur, the patient should consult their doctor.

In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still (akathisia) may also occur. If such symptoms occur, the patient should immediately consult their doctor.

Medicines like Citronil (SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

Children and adolescents

Citronil should not normally be used in the treatment of children and adolescents under 18 years of age. In patients under 18 years of age treated with medicines of this group, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Citronil to patients under 18 years of age if they consider it to be in their best interest. If the doctor has prescribed this medicine to a patient under 18 years of age and there are any doubts, the patient should consult their doctor again. The patient should also inform their doctor if any of the above side effects occur or worsen in patients under 18 years of age taking Citronil.

Suicidal thoughts, worsening of depression or anxiety disorders

Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start to work after 2 weeks, sometimes later.

The occurrence of such thoughts is more likely if:

• the patient has had suicidal thoughts or self-harm in the past
• the patient is a young adult under 25 years of age. Clinical trials have shown an increased risk of suicidal thoughts and self-harm in young adults (under 25 years of age) with mental disorders treated with antidepressant medicines.

If the patient experiences thoughts of self-harm or suicidal thoughts, they should immediatelycontact their doctor or go to the hospital. It may be helpful to inform relatives or friendsabout depression or anxiety disorders and ask them to read this leaflet. The patient may ask their relatives or friends to inform them if they notice that depression or anxiety has worsened or if there are any worrying changes in behavior.

Citronil and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The effect of the medicine may be reduced if it is taken with certain other medicines.

In particular, the patient should tell their doctor if they are taking:

• non-selective monoamine oxidase inhibitors (MAOIs) 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 to take Citronil. After stopping treatment with Citronil, the patient should wait 7 days before taking any of these medicines.
• reversible, selective monoamine oxidase A inhibitors (MAO-A) containing moclobemide (used to treat depression)
• the antibiotic linezolid
• lithium (used to prevent and treat bipolar affective disorder) and tryptophan
• imipramine and desipramine (used to treat depression)
• non-reversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• metoprolol (used to treat high blood pressure and heart disease). The dose may need to be adjusted.
• sumatriptan and similar medicines (used to treat migraines) and tramadol and similar medicines (opioids, used to treat severe pain). These medicines increase the risk of side effects.
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in citalopram levels in the blood.
• medicines that increase the risk of bleeding, such as anticoagulant medicines (medicines that prevent blood clotting, e.g., ticlopidine and dipyridamole), non-steroidal anti-inflammatory medicines (anti-inflammatory medicines with analgesic effects and salicylate derivatives, e.g., acetylsalicylic acid). Concomitant use may lead to bleeding from the skin and mucous membranes.

The patient should not take Citronil at the same time as medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as:

anti-arrhythmic medicines of class IA and III, certain antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin administered intravenously, pentamidine, antimalarial treatment, mainly halofantrine), and certain antihistamine medicines (astemizole, mizolastine).

Citronil with food, drink, and alcohol

The tablet should be taken with a drink, during a meal or independently of it.

The tablet should be swallowed with half a glass of water.

It is not recommended to consume alcohol during treatment with Citronil.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

If the patient takes Citronil during the last 3 months of pregnancy, they should be aware that the newborn may experience:

breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, difficulties with feeding, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, trembling, restlessness, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur, the patient should immediately contact their doctor.

The patient must ensure that their midwife and/or doctor know that they are taking Citronil. Medicines like Citronil, when taken during pregnancy, especially during the last 3 months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension in the newborn (PPHN), which causes rapid breathing and blue discoloration in newborns. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur in the baby, the patient should immediately contact their midwife and/or doctor.

Taking Citronil at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Citronil, they should inform their doctor or midwife so that they can provide appropriate advice.

Breastfeeding

Citalopram passes into breast milk during breastfeeding. There is a risk of affecting the breastfed baby. Therefore, Citronil should not be used during breastfeeding, unless the doctor recommends otherwise.

Fertility

In animal studies, citalopram has been shown to reduce sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Citalopram may affect concentration. If the patient is unsure that the medicine does not affect their concentration and reaction speed, they should avoid driving vehicles and operating machines or performing tasks that require 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 some sugars, they should contact their doctor before taking the medicine.

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Citronil

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their 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. The patient should not change the dose without consulting their doctor first.

The patient should continue to take Citronil for as long as their doctor recommends. If the patient stops treatment too early, symptoms may return. It is recommended to continue treatment for at least 6 months after feeling better. The illness may persist for a longer period, and if treatment is stopped too early, symptoms may return.

In patients with recurrent depression, treatment may last for several years to prevent recurrence of the illness.

If the patient feels that the effect of the medicine is too strong or too weak, they should inform their doctor or pharmacist.

The recommended dose for adultsis:

Depression

The usual dose is 20 mg once daily. The doctor may increase the dose 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. The doctor may increase the dose to a maximum of 40 mg once daily.

Obsessive-compulsive disorder

The initial dose is 20 mg once daily. The doctor may increase the dose to a maximum of 40 mg once daily. The first effects of treatment usually appear after 2-4 weeks, and further improvement occurs during continued treatment.

Preventive treatment

The duration of preventive treatment depends on the individual patient's condition but usually lasts for several years. Stopping treatment should be done with caution to avoid possible recurrence of the illness.

Patient over 65 years of age:

In elderly patients, the initial dose should be reduced to half of the recommended dose, e.g., 10-20 mg per day. Elderly patients should not normally take a dose greater than 20 mg per day.

Special patient groups

Patients with liver disease should not take a dose greater 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 more information, see section 2.

Overdose of Citronil

In case of overdose of Citronil or accidental ingestion by a child, the patient should contact their doctor, go to the hospital, or a poison treatment center, taking the medicine packaging with them.

Symptoms of overdose include life-threatening irregular heartbeat, seizures, changes in heart rhythm, drowsiness, coma, vomiting, trembling, low or high blood pressure, nausea, serotonin syndrome (see section 4), excitement, dizziness, dilated pupils, increased sweating, blue discoloration of the skin, hyperventilation.

Missed dose of Citronil

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a dose and remembers before bedtime, they should take the missed dose immediately. The next dose should be taken the next day. If the patient remembers missing a dose at night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Citronil

The patient should not stop taking Citronil unless their doctor advises them to do so. The patient should talk to their doctor if they want to stop treatment.

After stopping treatment, it is usually recommended to gradually reduce the dose of citalopram over several weeks.

If the patient stops taking citalopram, especially suddenly, they may experience withdrawal symptoms. This is common after stopping treatment with citalopram. The risk of these symptoms is greater if citalopram has been taken for a long time or in high doses, or if the dose has been reduced too quickly. In most cases, these symptoms are mild and resolve on their own within two weeks. If the patient experiences severe withdrawal symptoms after stopping citalopram, they should contact their doctor. The doctor may recommend taking the tablets again and reducing the dose more slowly.

Withdrawal symptoms include:

dizziness (instability or loss of balance), sensation of pins and needles, sensation of burning, and (less commonly) sensation of electric shock, also in the head, sleep disturbances (intense dreams, nightmares, insomnia), anxiety, headaches, nausea, sweating (including night sweats), restlessness or excitement, trembling, feeling of confusion or disorientation, feeling of agitation or irritation, diarrhea (loose stools), vision disturbances, palpitations (strong heartbeat).

4. Possible side effects

Like all medicines, Citronil can cause side effects, although not everybody gets them.

Some patients have reported the following serious side effects. If the patient experiences any of the following symptoms, they should stop taking Citronil and immediately contact their doctor:

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

Rarely (may occur in less than 1 in 100 patients):

• feeling of fatigue, disorientation, trembling; these may be symptoms of a rare disorder called hyponatremia (low sodium levels in the blood)
• if the patient experiences seizures or an increased frequency of seizures.

Other side effects

The following side effects are usually mild and resolve on their own within a few days of treatment.

If the side effects are particularly troublesome and last longer than a few days, the patient should consult their doctor.

Very common (may occur in more than 1 in 10 patients):

• drowsiness
• insomnia
• increased sweating
• dry mouth
• nausea.

Common (may occur in less than 1 in 10 patients):

• decreased appetite
• excitement
• decreased sexual desire
• anxiety
• sexual dysfunction (decreased sexual desire and sexual ability)
• painful menstruation
• nervousness
• confusion
• unusual dreams
• trembling
• sensory disturbances (sensation of pins and needles)
• dizziness
• attention disturbances
• ringing in the ears
• yawning
• diarrhea
• vomiting
• constipation
• itching
• muscle or joint pain
• impotence, ejaculation disorder
• orgasm disorder or absence of orgasm in women
• fatigue
• sensation of pins and needles
• weight loss.

Uncommon (may occur in less than 1 in 100 patients):

• bleeding under the skin
• increased appetite
• aggression
• depersonalization
• hallucinations
• mania
• fainting
• dilated pupils
• rapid heartbeat
• slow heartbeat
• rash, hives
• hair loss
• increased sensitivity to sunlight
• difficulty urinating
• heavy menstrual bleeding
• swelling of the hands or feet
• weight gain.

Rare (may occur in less than 1 in 1,000 patients):

• 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
• allergic reactions
• inappropriate secretion of antidiuretic hormone
• increased levels of prolactin in the blood
• low potassium levels in the blood (hypokalemia), which may cause muscle weakness, trembling, or irregular heartbeat
• panic attacks
• grinding of teeth
• feeling of restlessness
• seizures
• unusual movements or muscle stiffness
• involuntary movements of the muscles (akathisia)
• vision disturbances
• prolonged QT interval on the electrocardiogram
• irregular heartbeat (ventricular arrhythmias)
• dizziness when standing up from a sitting or lying position due to low blood pressure (orthostatic hypotension)
• nosebleeds
• abnormal liver function test results
• bleeding, including bleeding from the skin and mucous membranes (ecchymoses)
• milk secretion in men and in women who are not pregnant or breastfeeding (galactorrhea)
• irregular menstrual bleeding
• severe postpartum hemorrhage (see additional information in section 2 "Pregnancy, breastfeeding, and fertility")
• painful erection of the penis (in men). An increased risk of bone fractures has been observed in patients taking medicines of this type.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Citronil

There are no special precautions for storing the medicine.

The medicine should be stored out of 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 stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Citronil contains

• The active substance of the medicine is 10 mg, 20 mg, or 40 mg of citalopram in the form of citalopram hydrobromide.
• Other ingredients of the tablet core are: lactose monohydrate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose, copovidone, magnesium stearate.
• Ingredients of the coating 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, coated tablets, marked with "A" on one side and "05" on the other side.
• 20 mg tablets: white, biconvex, capsule-shaped, coated tablets, marked with "A" on one side and "06" on the other side (a dividing line is between 0 and 6). The tablet can be divided into equal doses.
• 40 mg tablets: white, biconvex, capsule-shaped, coated tablets, marked with "A" on one side and "07" on the other side (a dividing line is between 0 and 7). The tablet can be divided into equal doses.

Packaging:

PVC/PVDC/Aluminum blisters in a cardboard box:

28 tablets (2 x 14 tablets) and 98 tablets (7 x 14 tablets).

HDPE bottle:

Citronil, 10 mg, coated tablets: 30, 100, and 1000 tablets.

Citronil, 20 mg, coated tablets: 30, 56, 100, 250, and 1000 tablets.

Citronil, 40 mg, coated tablets: 30, 56, 100, and 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o.o.

[email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Denmark, Finland, Hungary, Norway, Sweden: Citalopram Orion

Poland: Citronil

Date of last revision of the leaflet:03.2025