CIPRAMIL 20 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Cipramil, 20 mg, coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Cipramil and what is it used for
   1. How Cipramil works
   2. When Cipramil is used
4. Important information before taking Cipramil
   1. When not to take Cipramil
   2. Warnings and precautions
   3. Caution
   4. Suicidal thoughts and worsening of depression or anxiety disorders
   5. Children and adolescents under 18 years of age
   6. Additional disease-related information
   7. Cipramil with other medicines
   8. Cipramil with food, drink, and alcohol
   9. Pregnancy, breastfeeding, and fertility
   10. Driving and using machines
   11. Important information about some of the ingredients of Cipramil
5. How to take Cipramil
   1. Method of administration
   2. Duration of treatment
   3. Taking a higher dose of Cipramil than recommended
   4. Missing a dose of Cipramil
   5. Stopping treatment with Cipramil
6. Possible side effects
   1. Reporting side effects
7. How to store Cipramil
8. Contents of the packaging and other information
   1. What Cipramil contains
   2. What Cipramil looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Lundbeck Poland Sp. z o.o.

Leaflet accompanying the packaging: information for the user

Cipramil, 20 mg, coated tablets

Citalopram

You should carefully read the contents of the leaflet before using 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 to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Cipramil and what is it used for

How Cipramil works

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

When Cipramil is used

Cipramil contains citalopram and is used to treat depression and to prevent depression from recurring.
Cipramil is also used to treat anxiety disorders with panic attacks, with or without agoraphobia (e.g., fear of leaving home, fear of crowds and public places).

2. Important information before taking Cipramil

When not to take Cipramil

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6);
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs). MAOIs include phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if you have a congenital heart defect or if you have had an abnormal heart rhythm (visible on an ECG, a test that evaluates heart function);
• if you are taking medicines used to treat irregular heartbeats or medicines that may affect the heart rhythm (see "Cipramil with other medicines").

If you have stopped taking MAOIs:
you should wait 2 weeks before starting to take Cipramil.
If you have stopped taking moclobemide, you should wait 1 day before starting to take Cipramil.
After stopping Cipramil, you should wait 1 week (7 days) before taking any MAOIs.

Warnings and precautions

Before starting to take Cipramil, you should discuss it with your doctor. You should tell your doctor if you have any other conditions or diseases, as your doctor should take this information into account.
Especially, you should inform your doctor:

• if you have had episodes of mania or panic attacks;
• if you have liver or kidney problems. Your doctor may need to adjust the dose;
• if you have diabetes. Taking Cipramil may affect your blood sugar levels. You may need to adjust your insulin dose and/or oral hypoglycemic medications;
• if you have epilepsy. If you have seizures or an increased frequency of seizures, you should stop taking Cipramil (see also section 4 "Possible side effects");
• if you have an increased tendency to bleed or if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you have low sodium levels in your blood;
• if you are undergoing electroconvulsive therapy;
• if you have had heart problems or if you have recently had a heart attack;
• if you have a low resting heart rate and/or low levels of electrolytes due to prolonged, severe diarrhea, vomiting, or use of diuretic medicines;
• if you have a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate an abnormal heart rhythm; if you have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

You should consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Caution

In some patients with bipolar affective disorder, a manic phase may occur.
This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should consult your 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, you should immediately inform your doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm thoughts may sometimes occur. These thoughts may worsen after starting to take antidepressant medicines, as these medicines may take some time to start working – usually after two weeks, or even later.
A greater tendency to such thoughts may occur:

• in patients who have had suicidal thoughts or self-harm thoughts before.
• in young adults. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with mental illness who were treated with antidepressant medicines.

If you experience any thoughts of self-harm or suicide, you should immediatelycontact your doctor or go to the nearest hospital.
It may be helpful to inform your relatives or friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may ask them to keep an eye on you and inform you if your depression or anxiety worsens or if you experience any worrying changes in your behavior.

Children and adolescents under 18 years of age

Cipramil should not be used in children and adolescents under 18 years of age. It should also be noted that in patients under 18 years of age who take medicines of this class, there is an increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). Nevertheless, your doctor may prescribe Cipramil to patients under 18 years of age if he/she considers it to be in their best interest. If your doctor has prescribed Cipramil to a patient under 18 years of age, and you have any doubts, you should consult your doctor. If any of the above symptoms worsen in patients under 18 years of age who take Cipramil, you should inform your doctor. Additionally, there is currently no data on the long-term safety of Cipramil in this age group regarding growth, maturation, and cognitive and behavioral development.

Additional disease-related information

As with other medicines used to treat depression or related disorders, improvement does not occur immediately. You may not feel better until several weeks after starting to take Cipramil. In the treatment of anxiety disorders with panic attacks, improvement is usually observed after 2-4 weeks. In the initial treatment period, some patients may experience worsening of anxiety, which subsides during treatment. It is therefore very important that you follow your doctor's instructions carefully and do not stop treatment or change the dose without consulting your doctor.
Sometimes, symptoms of depression or anxiety disorders with panic attacks include suicidal thoughts or self-harm thoughts. It is possible that these symptoms may persist or worsen until the full antidepressant effect of the medicine occurs. The occurrence of these symptoms is more likely in young adult patients, i.e., under 25 years of age, who have not taken antidepressant medicines before.
Sometimes, the patient may not be aware of the above symptoms, and it may be helpful to ask someone from their acquaintances or family to help observe any changes in the patient's behavior.
If you experience any worrying thoughts or feelings or if any of the above symptoms occur during treatment, you should immediately consult your doctor or go to the nearest hospital.

Cipramil with other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may interact with other medicines, which can sometimes cause serious side effects.
You should inform your doctor if you are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take Cipramil. After stopping Cipramil, you 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);
• irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used to treat Parkinson's disease); these medicines increase the risk of side effects. The dose of selegiline should not exceed 10 mg per day;
• metoprolol (used to treat high blood pressure and/or heart disease) - the concentration of metoprolol in the blood increases, but no signs of increased effect or side effects of metoprolol have been observed;
• 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; if unusual symptoms occur during combined use of these medicines, you should consult your doctor;
• cimetidine, lansoprazole, and omeprazole (medicines used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of heart attack). These medicines may cause increased levels of citalopram in the blood;
• medicines with known effects on platelet function (e.g., some antipsychotic medicines, tricyclic antidepressants, acetylsalicylic acid (found in painkillers), nonsteroidal anti-inflammatory medicines (used to treat arthritis) - a slight increase in the risk of bleeding;
• St. John's Wort (Hypericum perforatum) (a herbal medicine used to treat depression) - taken together with Cipramil, it may increase the risk of side effects;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (given for severe pain) due to the possible risk of lowering the seizure threshold;
• antipsychotic medicines (used to treat schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold, as well as antidepressant medicines;
• medicines that lower potassium or magnesium levels in the blood (increasing the risk of life-threatening heart rhythm disorders).
• You should not take Cipramil together with medicines used to treat irregular heartbeats or medicines that may affect the heart rhythm, such as:
• anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), certain antihistamines (astemizole, mizolastine).

Cipramil with food, drink, and alcohol

Cipramil can be taken with or without food (see section 3 "How to take Cipramil").
It has been shown that Cipramil does not interact with alcohol. However, it is recommended that you do not drink alcohol during treatment with Cipramil.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine.
Cipramil should not be used during pregnancy, and women taking Cipramil should not breastfeed, unless the risks and benefits of treatment have been discussed with the doctor.
Patients taking Cipramil in the last 3 months of pregnancy and up to delivery should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, you should immediately consult your doctor.
You should inform your doctor and/or midwife about taking Cipramil. Taking medicines like Cipramil during pregnancy, especially in the last three months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue skin. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, you should immediately consult your doctor and/or midwife.
Taking Cipramil at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Cipramil, you should inform your doctor or midwife so that they can provide you with appropriate advice.
Animal studies have shown that citalopram reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Cipramil usually does not cause drowsiness; however, if you experience dizziness or drowsiness after starting to take Cipramil, you should not drive or operate machinery until these symptoms have subsided.

Important information about some of the ingredients of Cipramil

Cipramil contains lactose. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Cipramil

This medicine should always be taken exactly as instructed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Adults
Treatment of depression
Usually, 20 mg is taken per day. Your doctor may increase the dose to a maximum of 40 mg per day.
Treatment of anxiety disorders with panic attacks
The initial dose is 10 mg per day for the first week, and then it is increased to 20 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day.
Use of Cipramil in elderly patients (over 65 years of age)
The initial dose should be reduced to half of the recommended dose, e.g., 10-20 mg per day.
In elderly patients, the dose should not exceed 20 mg per day.
Use of Cipramil in special patient groups
In patients with liver disease, the dose should not exceed 20 mg per day.
Caution is recommended in patients with severe renal impairment (creatinine clearance below 30 mL/min).
Use of Cipramil in children and adolescents (under 18 years of age)
Cipramil should not be used in children and adolescents under 18 years of age. Additional information is also provided in section 2 "Important information before taking Cipramil".

Method of administration

Cipramil is taken in a single dose once a day.
Cipramil can be taken at any time of day, with or without food.
The tablet should be swallowed with water. Do not chew (the tablets have a bitter taste).

Duration of treatment

As with other medicines used to treat depression and anxiety disorders with panic attacks, improvement is usually observed after a few weeks. You should therefore continue to take Cipramil, even if it takes some time before you feel better. You should not change the dose without consulting your doctor.
The duration of treatment varies from patient to patient, and therapy usually lasts at least 6 months.
Treatment should be continued for as long as your doctor recommends, even if you feel better. The disease may persist for a long time, and if treatment is stopped too early, symptoms may return.
In patients with recurring depression, maintenance treatment may last for several years to prevent new depressive episodes.

Taking a higher dose of Cipramil than recommended

If you suspect that you have taken too many Cipramil tablets, you should immediately consult your doctor or go to the emergency department of the nearest hospital, even if you do not feel any discomfort or symptoms of poisoning. You should take the packaging of Cipramil with you.
Some of the symptoms of overdose may be life-threatening: irregular heartbeat, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremors, low blood pressure, high blood pressure, nausea, serotonin syndrome (see section 4), agitation, dizziness, dilated pupils, increased sweating, blue skin, hyperventilation.

Missing a dose of Cipramil

You should not take a double dose to make up for a missed dose. If you have forgotten to take a dose and remember before bedtime, you should take the missed dose immediately. You should take the next dose the next day. If you remember that you have missed a dose at night or the next day, you should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Cipramil

You should not stop taking Cipramil unless your doctor advises you to do so. When you stop treatment, your doctor will usually recommend that you gradually reduce the dose of Cipramil over a period of several weeks.
Sudden stopping of Cipramil may cause mild and temporary withdrawal symptoms, such as dizziness, tingling, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea, vomiting, sweating, psychomotor agitation or excitement, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), visual disturbances, or palpitations (heart pounding).
Therefore, when stopping treatment, it is recommended that you gradually reduce the dose of Cipramil over a few weeks, rather than stopping the medicine abruptly.
If you have any further doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cipramil can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of the disease and will subside as you feel better.
Some patients have reported the following serious side effects.

• high fever, agitation, confusion, tremors, and muscle stiffness - these may be symptoms of a rare disorder called serotonin syndrome, reported during the use of antidepressant medicines.
• sudden swelling of the skin and mucous membranes, swelling of the tongue, lips, or face, and difficulty breathing or swallowing (allergic reaction) or dizziness.
• unusual bleeding, including bleeding from the gastrointestinal tract.
• suicidal thoughts and behaviors, see also section "Warnings and precautions".
• allergic reactions (rash).

Rare but serious side effects(may occur in less than 1 in 100 people)
If you experience any of the following symptoms, you should stop taking Cipramil and immediately consult your doctor:

• hyponatremia: low sodium levels in the blood, which may cause fatigue, confusion, and muscle tremors;
• rapid or irregular heartbeat.

The following side effects are usually mild and disappear after a few days of treatment (except for the serious side effects listed above).
If the side effects are particularly troublesome and last longer than a few days, you should inform your doctor.
Very common (may occur in more than 1 in 10 people):

• drowsiness,
• headache,
• difficulty sleeping,
• increased sweating,
• dry mouth (dry mouth increases the risk of tooth decay. Therefore, you should brush your teeth more often than usual),
• nausea.

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

• decreased appetite,
• agitation,
• decreased sexual desire,
• anxiety,
• restlessness,
• confusion (disorientation),
• unusual dreams,
• tremors,
• tingling or numbness in hands or feet,
• dizziness,
• disturbances of attention,
• ringing in the ears (tinnitus),
• yawning,
• diarrhea,
• vomiting,
• constipation,
• itching,
• muscle and joint pain,
• in men - problems with ejaculation and erection,
• in women - inhibited orgasm,
• fatigue,
• tingling sensation in the skin (sensory disturbances)
• weight loss.

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

• bleeding under the skin (easy bruising),
• increased appetite,
• aggression,
• depersonalization (loss of sense of one's own personality),
• hallucinations,
• mania,
• fainting,
• dilated pupils,
• rapid heartbeat,
• slow heartbeat,
• hives,
• hair loss,
• rash,
• urticaria,
• sensitivity to light,
• heavy menstrual bleeding,
• swelling of hands or feet,
• weight gain,
• difficulty urinating, reduced urination

Rare (may occur in less than 1 in 1000 people):

• seizures,
• involuntary movements,
• disturbances of taste,
• bleeding,
• hepatitis
• fever.

Side effects with unknown frequency (cannot be estimated from available data):

• suicidal thoughts and behaviors, see also section "Warnings and precautions",
• decreased platelet count, which may increase the risk of bleeding and the formation of blood spots on the skin,
• allergic reactions (rash),
• severe allergic reactions, which may cause difficulty breathing or dizziness,
• hypokalemia: abnormally low potassium levels in the blood, which may cause muscle weakness, muscle tremors, or abnormal heart rhythm,
• panic attacks,
• grinding of teeth,
• restlessness,
• abnormal movements or muscle stiffness,
• akathisia - psychomotor restlessness - a state of restlessness accompanied by a need to move,
• seizures,
• serotonin syndrome,
• visual disturbances,
• fainting, which may be a sign of a life-threatening condition called torsades de pointes,
• low blood pressure,
• nosebleeds,
• bleeding, including bleeding into the skin and mucous membranes,
• sudden swelling of the skin or mucous membranes,
• painful erection of the penis,
• increased prolactin levels in the blood,
• galactorrhea in men and in women who are not breastfeeding,
• abnormal menstrual bleeding, metrorrhagia,
• abnormal liver function test results,
• patients taking medicines of this class have been observed to have an increased risk of fractures,
• abnormal heart rhythm,
• severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to:
Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C,
02-222 Warsaw
Phone: +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 Cipramil

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Cipramil contains

The active substance is citalopram (in the form of citalopram hydrobromide).
The coated tablets contain 20 mg of citalopram (in the form of citalopram hydrobromide).
The medicine also contains: cornstarch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerol 85%, croscarmellose sodium, magnesium stearate;
The coating contains: hypromellose, macrogol 400, and the colorant: titanium dioxide (E 171).

What Cipramil looks like and contents of the pack

Cipramil is available in the form of 20 mg coated tablets.
The tablets are packaged in aluminum/PVC/PVdC blisters containing 28 tablets (2 blisters of 14 coated tablets) or 56 tablets (4 blisters of 14 coated tablets).
The blisters with tablets are packaged in cardboard boxes.
Not all pack sizes may be marketed.
Description of the tablets
20 mg coated tablets:
White, oval, coated tablets with a dividing line, marked with the letters "C" and "N" symmetrically on either side of the dividing line. The tablets can be divided into equal doses.

Marketing authorization holder and manufacturer

• H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark For more information, you should contact the representative of the marketing authorization holder.

Poland

Lundbeck Poland Sp. z o.o.

Marszałkowska Street 142
00-061 Warsaw
Phone: +48 22 626 93 00
Date of last revision of the leaflet: