CIPRAMIL

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Cipramil (Prisdal)
20 mg, film-coated tablets
Citalopram
Cipramil and Prisdal are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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

1. What Cipramil is and what it is used for

How Cipramil works
Citalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines affect the serotonergic system in the brain by increasing the concentration of serotonin.
When is Cipramil used
Cipramil contains citalopram and is used for the treatment of depression and for the prevention of relapses in recurrent depressive disorders.
Cipramil is indicated for the treatment of panic disorder with or without agoraphobia (e.g. fear of leaving home, crowds, and public places).

2. Important information before using Cipramil

When not to use Cipramil

• if the patient is allergic to citalopram or any of the other ingredients of this medicine (listed in section 6);
• simultaneously with medicines known as monoamine oxidase inhibitors (MAOIs). Monoamine oxidase inhibitors (MAOIs) include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), and linezolid (an antibiotic);
• if the patient has congenital abnormal heart rhythm or has experienced an episode of abnormal heart rhythm (visible on ECG – a test assessing heart function);
• when taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section “Cipramil with other medicines”).

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If stopping MAO inhibitors: wait 2 weeks before
starting Cipramil.
After stopping moclobemide, wait 1 day before starting
treatment with Cipramil.
After stopping Cipramil, wait 1 week (7 days) before starting
any MAO inhibitors.
Warnings and precautions
Before starting treatment with Cipramil, discuss this with your doctor. Inform your doctor if the patient has any other disorders or medical conditions, as the doctor should take such information into account. Specifically, inform the doctor:

• if the patient has episodes of mania or panic attacks;
• if the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required;
• if the patient has diabetes. Treatment with Cipramil may affect blood glucose levels. Adjustment of insulin dose and (or) oral glucose-lowering medicines may be necessary;
• if the patient has epilepsy. If seizures occur or their frequency increases, treatment with Cipramil should be discontinued (see also section 4 “Possible side effects”);
• if the patient has an increased tendency to bleed or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”);
• if the patient has low sodium levels in the blood;
• if the patient is undergoing electroconvulsive therapy;
• if the patient has current or past heart problems or recently suffered a heart attack;
• if the patient has a slow resting heart rate and (or) reduced electrolyte levels due to prolonged, severe diarrhoea, vomiting, or use of diuretic medicines;
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm;
• if the patient has current or past eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

Consult your doctor, even if the above warnings relate to conditions that occurred
in the past.
Note
In some patients with bipolar affective disorder, a manic phase may occur. It is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, contact your doctor.
In the first weeks of treatment, symptoms such as restlessness or difficulty remaining still (akathisia) may also occur. If such symptoms appear, inform your doctor immediately.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and (or) anxiety disorders may sometimes experience thoughts of self-harm or suicidal ideation. These may worsen after starting antidepressant treatment, as such medicines take time to become effective – usually about two weeks or longer.
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The risk of such thoughts may be higher:

• in patients who previously experienced suicidal or self-harming thoughts.
• in young adults. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants.

If the patient experiences any thoughts of self-harm or suicide, contact a doctor immediately or go to the nearest hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or anxiety, or concerning changes in behaviour.
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 when taking medicines of this class, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviours, and expressions of anger). Nevertheless, a doctor may prescribe Cipramil to patients under 18 years of age if he or she considers it to be in their best interest. If a doctor has prescribed Cipramil to a patient under 18 years of age, contact the doctor in case of any doubts. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Cipramil, inform the doctor. Furthermore, there are currently no data on the long-term safety of Cipramil in this age group regarding growth, maturation, cognitive development, and behavioural development.
Additional information about the condition
As with other medicines used to treat depression or related disorders, improvement does not occur immediately. The patient may only notice improvement after several weeks of treatment with Cipramil. In the treatment of panic disorder, improvement is usually observed after 2–4 weeks. In the initial phase of treatment, anxiety may worsen in some patients, but it subsides during treatment. It is therefore very important that the patient follows the doctor’s instructions exactly and does not stop treatment or change the dose without consulting the doctor.
Sometimes, suicidal thoughts or thoughts of self-harm are part of depression or panic disorder. These symptoms may persist or worsen until the full antidepressant effect of the medicine becomes apparent. The occurrence of such symptoms is more likely in young adult patients, i.e. under 25 years of age, who have not previously taken antidepressants.
Sometimes the patient may not be aware of the symptoms described above, so it may be helpful to ask someone from family or friends to help monitor possible changes in the patient’s behaviour.
If the patient has distressing thoughts or experiences, or if any of the symptoms described above occur during treatment, the patient should contact a doctor or the nearest hospital immediately.
Cipramil with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the action of other medicines, which may sometimes lead to serious side effects.
Inform your doctor if the patient is taking any of the following medicines:
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• 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, wait 14 days before starting Cipramil. After stopping Cipramil, wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (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 side effects. The dose of selegiline must not exceed 10 mg per day;
• metoprolol (used in hypertension and (or) heart disease) – blood levels of metoprolol increase, but no symptoms of enhanced or adverse effects of metoprolol have been observed;
• sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used for severe pain). These increase the risk of side effects; if unusual symptoms occur during concomitant use of these medicines, contact the treating doctor;
• cimetidine, lansoprazole, and omeprazole (medicines used to treat peptic ulcer disease), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of heart attack). These medicines may increase blood levels of citalopram;
• medicines known to affect platelet function (e.g. some antipsychotics, tricyclic antidepressants, acetylsalicylic acid (found in painkillers), non-steroidal anti-inflammatory drugs (used for joint inflammation)) – slight increase in bleeding risk;
• St. John’s wort (Hypericum perforatum) (a herbal medicine used for 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 (used for severe pain) due to possible risk of lowering the seizure threshold;
• neuroleptics (medicines used to treat schizophrenia, psychosis) due to possible risk of lowering the seizure threshold, and antidepressants;
• medicines that reduce potassium or magnesium levels in the blood (increase the risk of life-threatening heart rhythm disturbances).
• Do not take Cipramil simultaneously with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as: class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials – particularly halofantrine), certain antihistamines (astemizole, mizolastine).

Cipramil with food, drink, and alcohol
Cipramil may be taken with or without food (see section 3 “How to take Cipramil”).
No interaction between Cipramil and alcohol has been demonstrated. However, alcohol consumption is not recommended during treatment with Cipramil.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
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Cipramil is generally not recommended for use during pregnancy, and women taking Cipramil should not breastfeed unless the risks and benefits of treatment have been discussed with a doctor.
Women who have taken Cipramil during the last three months of pregnancy and up to delivery should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, persistent crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform your doctor and (or) midwife about taking Cipramil. Taking medicines such as Cipramil during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It is characterised by rapid breathing and cyanosis. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact a doctor and (or) midwife immediately.
Taking Cipramil towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Cipramil, she should inform her doctor or midwife so they can provide appropriate advice.
Animal studies have shown that citalopram reduces sperm quality. This could theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
Cipramil generally does not cause drowsiness; however, if dizziness or drowsiness occurs after starting treatment with Cipramil, the patient should not drive or operate machinery until these symptoms subside.
Important information about some ingredients of Cipramil
Cipramil contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to take Cipramil

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Adults

Treatment of depression
The usual dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg per day.

Treatment of anxiety disorder with panic attacks
The initial dose is 10 mg once daily for the first week, then increased to 20 mg once daily. Your doctor may increase the dose up 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 by half of the recommended dose, e.g., 10–20 mg per day. In elderly patients, doses higher than 20 mg per day should not be used.

Use of Cipramil in special patient groups
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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 should be taken as a single daily dose.
Cipramil can be taken at any time of day, with or without food.
The tablet should be swallowed whole with water. Do not chew (tablets have a bitter taste).

Duration of treatment
As with other medicines used in the treatment of depression and anxiety disorder with panic attacks, improvement may take several weeks. Therefore, continue taking Cipramil even if it takes some time before you feel better. Do not change the dose without consulting your doctor.

The duration of treatment varies between individual patients; therapy usually lasts at least 6 months.

Treatment should be continued for as long as your doctor recommends, even if your mood improves. The condition may persist for a long time, and if treatment is stopped too early, symptoms may return.

In patients with recurrent depression, maintenance treatment may last several years to prevent new depressive episodes.

Taking more Cipramil than prescribed
If you suspect that an excessive amount of Cipramil tablets has been taken, seek immediate medical advice from your doctor or the nearest hospital emergency department, even if there are no symptoms or signs of poisoning. Bring the medicine packaging with you.

Some 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, excessive sweating, cyanosis (bluish skin), hyperventilation.

Missed dose of Cipramil
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, take the missed dose immediately. Take the next dose at the usual time 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 Cipramil
Do not stop taking Cipramil unless your doctor advises you to do so. When stopping treatment, your doctor will usually recommend gradually reducing the dose of Cipramil over several weeks.

Suddenly stopping Cipramil may cause mild and transient withdrawal symptoms such as: dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, insomnia), feeling anxious, headache, nausea, vomiting, sweating, psychomotor agitation or restlessness, tremors, feelings of disorientation, emotional instability or irritability, diarrhea (loose stools), visual disturbances, palpitations or increased heart activity (awareness of heartbeat).

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Therefore, when ending treatment, it is recommended to gradually reduce the dose of Cipramil over a few weeks rather than stopping abruptly.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects usually subside after a few weeks of treatment. It should be remembered that
some of these effects may also be symptoms of the underlying illness and will resolve as your condition improves.
Some patients have reported the following serious adverse effects.
If any of the symptoms listed below occur, stop taking Cipramil immediately and contact your doctor:

• high fever, agitation, confusion, muscle tremors and violent muscle spasms – these may be symptoms of a rare disorder called serotonin syndrome, reported during concomitant use of antidepressant medicines.
• sudden swelling of the skin, mucous membranes, tongue, lips or face, difficulty breathing or swallowing (allergic reaction) or dizziness.
• unusual bleeding, including gastrointestinal bleeding.
• suicidal thoughts and behaviour, see also section “Warnings and precautions”.
• hypersensitivity (rash).

Rare but serious adverse effects (may occur in not more than 1 in 1,000 people)
If any of the symptoms listed below occur, stop taking Cipramil and contact your doctor immediately:

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

The adverse effects listed below are usually mild and typically resolve after a few days of treatment (except for the serious adverse effects listed in the section above).
If adverse effects are particularly troublesome and persist for longer than a few days, inform your doctor.
Very common (may occur in more than 1 in 10 people):

• drowsiness,
• headache,
• difficulty falling asleep,
• increased sweating,
• dry mouth. (Dry mouth increases the risk of dental caries. Therefore, teeth should be brushed more frequently than usual.),
• nausea.

Common (may occur in not more than 1 in 10 people):

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

Uncommon (may occur in not more than 1 in 100 people):

• bleeding under the skin (easy bruising),
• increased appetite,
• aggression,
• depersonalisation (loss of sense of self),
• hallucinations,
• mania,
• fainting,
• dilated pupils,
• increased heart rate,
• decreased heart rate,
• urticaria,
• hair loss,
• rash,
• purpura,
• photosensitivity,
• heavy menstrual bleeding,
• swelling of hands or feet,
• weight gain,
• difficulty passing urine, reduced urination.

Rare (may occur in not more than 1 in 1,000 people):

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

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

• suicidal thoughts and behaviour, see also section “Warnings and precautions”,
• reduced platelet count, leading to increased risk of bleeding and development of purpura on the skin,
• hypersensitivity (rash),
• severe allergic reactions causing difficulty breathing or dizziness,
• hypokalaemia: abnormally low potassium levels in the blood, which may cause muscle weakness, muscle tremors or irregular heartbeat,
• panic attacks,
• teeth grinding,
• restlessness,
• unusual movements or muscle stiffness,
• akathisia – psychomotor agitation – a state of restlessness associated with an urge to move,
• convulsions,
• serotonin syndrome,
• visual disturbances,
• fainting, which may be a symptom of a life-threatening condition called torsade de pointes,
• low blood pressure,
• nosebleeds,
• bleeding, including purpura on the skin and mucous membranes,
• sudden swelling of the skin or mucous membranes,
• painful penile erection,
• increased prolactin levels in the blood,
• galactorrhoea in men and in women who are not breastfeeding,
• irregular menstrual bleeding, uterine haemorrhage,
• abnormal liver function test results,
• in patients taking medicines from this group, an increased risk of bone fractures has been observed,
• irregular heartbeat,
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and effect on fertility” in section 2.

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

5. How to store Cipramil

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the outer carton and
blister.
The expiry date refers to the last day of the stated month.
Medicines must 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. Package contents and other information

What Cipramil contains
The active substance is citalopram (in the form of citalopram hydrobromide).
The film-coated tablets contain 20 mg of citalopram (in the form of citalopram hydrobromide).
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Other ingredients: maize starch, lactose monohydrate, microcrystalline cellulose,
copovidone, glycerol 85%, sodium croscarmellose, magnesium stearate.
The coating contains: hypromellose, macrogol 400, and titanium dioxide (E 171).

What Cipramil looks like and contents of the pack
Cipramil is available as 20 mg film-coated tablets.
The tablets are packed in PVC/PVDC/Aluminium blisters containing 28 or 56 tablets.
The blisters are packed into cardboard boxes.

Description of the tablets
White, oval, film-coated tablets with a division line, marked with the letters “C” and “N” symmetrically on both sides of the line. The tablets can be divided into equal doses.

For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Spain, the country of export:
Lundbeck España, S.A., Av. Diagonal 605, 08028 Barcelona, Spain

Manufacturer:
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation number in Spain, the country of export: 682591.4
Parallel Import Licence number: 314/25
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