Oropram 20 mg coated tablets

Package leaflet: Information for the patient

Oropram 20 mg, coated tablets
Citalopramum
Please read this leaflet carefully before taking this medicine, because it
contains important information for the patient.

• 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Oropram 20 mg is and what it is used for
2. Important information before taking Oropram 20 mg
3. How to take Oropram 20 mg
4. Possible side effects
5. How to store Oropram 20 mg
6. Contents of the pack and other information

1. What Oropram 20 mg is and what it is used for

Oropram 20 mg belongs to a group of antidepressant medicines known as selective
serotonin reuptake inhibitors (SSRIs). These medicines are selective inhibitors
of serotonin reuptake in the brain and normalize the levels of neurotransmitters in the brain.
Disturbances in the brain's serotonin system are considered an important factor in the development
of depression and related disorders.
Oropram 20 mg is used in the treatment of depressive disorders and anxiety disorders
with panic attacks with or without agoraphobia (fear of public places).
Your doctor may recommend other uses. Follow your doctor's instructions.

2. Important information before using Oropram 20 mg tablets

When not to use Oropram 20 mg tablets:

• if the patient is allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is currently taking or has taken within the last two weeks a monoamine oxidase inhibitor (MAOI), a medicine used to treat depression. MAOIs include: selegiline, phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, and moclobemide. If the doctor switches treatment from Oropram 20 mg to an MAOI, at least 7 days should pass before starting the MAOI.

The doctor will advise on how to take Oropram 20 mg after stopping MAOIs (see "Other medicines and Oropram 20 mg").

• if the patient is taking a medicine containing linezolid (used to treat infections) (see "Other medicines and Oropram 20 mg")
• if the patient has congenital heart rhythm disorders or has previously experienced episodes of heart rhythm disturbances (visible on ECG – a test assessing heart function)
• if the patient is taking medicines that regulate heart rhythm or that may affect heart rhythm. See below, section "Other medicines and Oropram 20 mg".

Warnings and precautions
Use in children and adolescents under 18 years of age
Oropram 20 mg tablets should not be used in children and adolescents under 18 years of age.
When antidepressants are used, patients under 18 years of age are at increased risk of suicidal behaviour (including suicide attempts), suicidal thoughts, and hostility (particularly aggression, oppositional behaviour, and anger). Nevertheless, the prescribing physician may decide to prescribe Oropram 20 mg to patients under 18 years of age if they consider it to be in the patient's best interest. If Oropram 20 mg has been prescribed to a patient under 18 years of age and any concerns arise, please consult the doctor. If any of the above symptoms develop or worsen in patients under 18 years of age taking Oropram 20 mg, the prescribing doctor should be informed immediately. Additionally, there is a lack of safety data indicating how long-term use of Oropram 20 mg in children and adolescents may affect their growth, maturation, cognitive development, and behavioural development.

Oropram 20 mg should be used with caution:

• if the patient suffers from anxiety. Symptoms of anxiety may worsen at the beginning of treatment. These symptoms usually resolve within 2 weeks of starting treatment. The doctor may adjust the dose (see section 3 "How to take Oropram 20 mg tablets").
• if the patient has bipolar disorder. In some patients, a manic phase may occur, characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, contact the doctor.
• if the patient has diabetes (adjustment of antidiabetic treatment may be necessary).
• if the patient has epilepsy. If seizures occur or the frequency of convulsive seizures increases, the doctor will decide whether to discontinue the medicine.
• if the patient experiences restless movement, agitation, and/or an urge to move frequently, often accompanied by difficulty sitting or standing still. These symptoms occur more frequently during the first weeks of treatment.
• if the patient is taking medicines that bind to serotonin receptors in the body (serotonergic medicines), such as sumatriptan or other triptans, tramadol, buprenorphine, oxytriptan, and tryptophan. See section "Other medicines and Oropram 20 mg".
• if the patient is taking selective MAO-A inhibitors (monoamine oxidase inhibitors used to treat psychiatric disorders). See section "Do not use Oropram 20 mg" and "Other medicines and Oropram 20 mg".
• if the patient has low sodium levels in the blood (visible in blood tests). Symptoms may include fatigue, confusion, and muscle cramps. These types of medicines rarely cause low blood sodium, especially in elderly women. Sodium levels usually return to normal after stopping treatment.
• if the patient has previously experienced bleeding disorders or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility"). Caution is advised when using medicines that increase the risk of bleeding, such as acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) (pain-relieving medicines). See also "Other medicines and Oropram 20 mg".
• during concurrent electroconvulsive therapy.
• if the patient is taking medicines containing St. John's wort (Hypericum perforatum). Taking this together with Oropram 20 mg may increase the risk of adverse effects (see section "Other medicines and Oropram 20 mg").
• if the patient has severe kidney or liver disease. The doctor may recommend reducing the dose or discontinuing the medicine.
• if the patient has psychiatric disorders such as psychosis or depression.
• if the patient or their family has a history of heart diseases causing QT interval prolongation.
• if the patient has heart disease or has recently had a heart attack.
• if the patient has a low resting heart rate and/or knows they may have sodium deficiency due to prolonged diarrhoea, vomiting, or use of diuretics (water tablets).
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rhythm.
• if the patient has low blood potassium or magnesium levels (hypokalaemia/hypomagnesaemia).
• if the patient has or has previously had closed-angle glaucoma.
• when discontinuing the medicine, withdrawal symptoms may occur (see section 3, "Stopping Oropram 20 mg tablets").

Medicines such as Oropram 20 mg (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Suicidal thoughts, worsening of depression or anxiety disorders
If the patient suffers from depression or anxiety disorders, they may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of antidepressant treatment, as these medicines usually take about 2 weeks, sometimes longer, to start working.

The occurrence of suicidal thoughts, thoughts of self-harm, or suicide is more likely if:

• the patient has previously experienced thoughts of suicide or self-harm;
• the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders treated with antidepressants.

If the patient experiences thoughts of suicide or self-harm, they should contact their doctor immediately or go to 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 family or friends for help and ask them to inform them if they notice worsening depression or anxiety or concerning changes in behaviour.

Serotonin syndrome
In some patients, Oropram 20 mg may lead to the development of serotonin syndrome. Contact the doctor immediately if symptoms such as high fever, muscle tremors, chills, confusion, or agitation occur simultaneously, as they may indicate the development of this syndrome.

Other medicines and Oropram 20 mg
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Bear in mind that this may include medicines taken up to 14 days ago or those to be taken in the future.

Do not use Oropram 20 mg if the patient is taking medicines that regulate heart rhythm 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 medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (astemizole, mizolastine). In case of doubt, consult your doctor.

Exercise caution when taking Oropram 20 mg together with the following medicines:

• monoamine oxidase inhibitors (MAOIs, used to treat depression and Parkinson's disease), such as selegiline, phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, and moclobemide (see section above "Do not use Oropram 20 mg"). These medicines should not be taken simultaneously with Oropram 20 mg;
• medicines containing linezolid (used to treat infections). Do not take Oropram 20 mg together with linezolid (see section above "Do not use Oropram 20 mg");
• sumatriptan and other triptans (used to treat migraine);
• oxytriptan and tryptophan (used for sleep disorders and depression);
• tramadol (used to treat pain);
• medicines containing buprenorphine (used to treat severe pain and opioid dependence);
• medicines that may increase the risk of bleeding in the skin and mucous membranes when taken together with Oropram 20 mg, including anticoagulants (medicines affecting platelet function), e.g. warfarin, ticlopidine, and dipyridamole, painkillers such as NSAIDs, including ibuprofen, ketoprofen, diclofenac, and acetylsalicylic acid;
• neuroleptics (medicines used for other psychiatric disorders), e.g. thioxanthenes and butyrophenones;
• medicines used for peptic ulcer, omeprazole, lanzoprazole, cimetidine, esomeprazole;
• fluconazole (a medicine used to treat fungal infections);
• medicines used for depression, such as fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, bupropion, tricyclic antidepressants such as nortriptyline, desipramine, clomipramine, imipramine, desipramine, and herbal preparations containing St. John's wort (Hypericum perforatum);
• buspirone (used to treat anxiety disorders and depression);
• propafenone and flecainide (used for heart rhythm disorders);
• medicines used for psychiatric disorders (antipsychotics), e.g. lithium, risperidone, chlorpromazine, thioridazine, chlorprothixene, haloperidol;
• mefloquine (used for malaria);
• medicines that prolong the QT interval or medicines that reduce potassium and magnesium levels in the blood. Ask your doctor how to take these medicines;
• metoprolol (a medicine used for hypertension, cardiovascular diseases, and migraine prevention).

Oropram 20 mg with food, drink and alcohol
Oropram 20 mg tablets can be taken with or without food or drink. Avoid consuming alcohol.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Oropram 20 mg may be used during pregnancy only in clinically justified cases. Inform the doctor if the patient may be pregnant or suspects she may be pregnant. Do not use Oropram 20 mg if the patient is pregnant or planning a pregnancy unless otherwise advised by the doctor, who will consider the risks and benefits of using Oropram 20 mg. Do not stop taking the medicine abruptly. Inform the midwife and/or the doctor managing the pregnancy that the patient is taking Oropram 20 mg. Using the medicine during pregnancy, especially during the last three months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), characterised by breathing difficulties and bluish skin discoloration. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, contact the midwife and/or doctor immediately.

Inform the doctor if Oropram 20 mg is taken during the last three months of pregnancy; certain symptoms may occur in the newborn. These symptoms usually appear within 24 hours after birth and include: difficulty sleeping, feeding, or breathing, bluish skin, temperature fluctuations, vomiting, constant crying, muscle stiffness or floppiness, lethargy, tremors, irritability, or seizures. If such symptoms occur in the newborn, seek medical advice immediately.

Taking Oropram 20 mg near 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 Oropram 20 mg, she should inform her doctor or midwife so they can provide appropriate advice.

Breastfeeding
Citalopram passes into breast milk in small amounts. There is a risk of affecting the infant. If taking Oropram 20 mg, consult the doctor before starting breastfeeding.

Fertility
Animal studies have shown that citalopram reduces sperm quality. This may theoretically affect fertility, although no effect on human fertility has been observed so far.

Driving and operating machinery
Oropram 20 mg may affect the ability to drive and operate machinery. During treatment, do not drive or operate machinery.

3. How to use Oropram 20 mg tablets

Dosage
This medicine should always be taken as prescribed by your doctor. Different people have different needs. Based on an assessment of the patient's condition, the doctor will decide the dose and duration of treatment with this medicine. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults:
Depression
The recommended starting dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg once daily. Treatment should continue after symptoms have resolved for a period of 4 to 6 months.
Anxiety disorders with panic attacks
During the first week, the starting dose is 10 mg once daily, which may then be increased to 20–30 mg once daily. Your doctor may further increase the dose up to a maximum of 40 mg once daily.
Elderly patients (over 65 years of age):
The starting dose should be reduced by half, e.g. 10–20 mg once daily. Elderly patients should not take more than 20 mg once daily.
Use in children and adolescents:
Oropram 20 mg tablets are not recommended for use in children and adolescents under 18 years of age, as safety and efficacy have not been established.
Renal or hepatic impairment
Dose reduction is required. Follow your doctor's instructions.
Patients with impaired liver function should not take more than 20 mg once daily.
Oropram 20 mg tablets should be taken as a single daily dose, in the morning or evening, with or without food. Swallow the tablets with a glass of water.
Consult your doctor before changing or discontinuing treatment with Oropram 20 mg. See special warnings above.
Taking more Oropram 20 mg than recommended
Contact your doctor, emergency department, or pharmacist immediately if you have taken more Oropram 20 mg than recommended in this leaflet or prescribed by your doctor.
Symptoms of overdose may include:
drowsiness, loss of consciousness, seizures, rapid or slow heartbeat, dizziness, cardiac arrhythmias (e.g. QT interval prolongation), low blood pressure, high blood pressure, tremors, fainting, nausea, vomiting, profuse sweating, agitation, high fever, cardiac arrest, dilated pupils, changes in mental status, cyanosis (bluish skin discoloration due to lack of oxygen), hyperventilation. Symptoms of serotonin syndrome (see "Possible side effects") may occur, especially when other medicines are taken concomitantly.
Missed dose of Oropram 20 mg
If you miss a dose of Oropram 20 mg, take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping treatment with Oropram 20 mg
Do not stop taking Oropram 20 mg tablets suddenly, as this may cause symptoms such as dizziness, tingling sensations, sleep disturbances, irritability, tremors, feelings of disorientation, headache, nausea, nervousness, restlessness, or excessive sweating (and a possible return of suicidal thoughts in patients with a predisposition).
These symptoms usually resolve within two weeks, but may be more severe or prolonged, especially in patients receiving high doses of Oropram 20 mg.
If you plan to discontinue Oropram 20 mg, consult your doctor for advice, as the medicine must be tapered gradually and slowly over weeks or months. It is important that your doctor monitors you during this period.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will
experience them. When taking Oropram 20 mg, if any adverse reactions occur, they usually
occur during the first 8 to 14 days of treatment. Adverse reactions usually resolve again.
If any of the symptoms listed below occur, stop taking Oropram 20 mg immediately and
contact your doctor or go to the nearest hospital:

• Serotonin syndrome: inform your doctor if you experience high fever, muscle tremors, and sudden muscle spasms (tics), or a feeling of restlessness; these symptoms may indicate the development of a disease. Immediately discontinue use of Oropram 20 mg.
• Severe allergic reactions: contact your doctor immediately if you experience swelling of the face, tongue and/or throat and/or difficulty breathing or swallowing combined with breathing difficulties. These symptoms are very serious; their occurrence may indicate a severe allergic reaction to Oropram 20 mg. Immediate medical intervention or hospitalization may be necessary. These symptoms usually occur very rarely.
• Rapid or irregular heartbeat, fainting – these may be symptoms of a life-threatening condition called Torsades de Pointes.

You should see a doctor or go to the emergency department if suicidal thoughts or
behaviors occur during treatment with citalopram.
The following adverse reactions are usually mild and resolve within a few days of
treatment: nausea, diarrhoea, excessive sweating, dry mouth, feeling of fatigue, insomnia,
and drowsiness.
The following adverse reactions have been reported at the frequencies listed below:
Very common (may affect more than 1 in 10 people):

• palpitations
• headache
• nausea, dry mouth
• excessive sweating
• drowsiness, insomnia.

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

• tremor, dizziness
• decreased appetite, decreased body weight, weight loss
• restlessness, anxiety, nervousness, confusion
• reduced sexual desire (libido)
• tingling, pricking, or burning sensations of the skin
• difficulty concentrating
• ringing in the ears (tinnitus)
• increased blood pressure (hypertension)
• diarrhoea, vomiting, constipation, indigestion (dyspepsia), abdominal pain, bloating with passing wind
• increased salivation
• muscle pain, joint pain
• migraine
• rhinitis and sinusitis
• excessive urination
• itching
• feeling of fatigue, yawning
• anorgasmia in women, menstrual pain, impotence (in men), ejaculation disorders
• nightmares, memory loss (amnesia), lack of emotion and enthusiasm.

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

• slow heartbeat
• fast heartbeat
• increased appetite, weight gain
• aggression, depersonalization (loss of sense of self), hallucinations, mania (feelings of excessive excitement, hyperactivity, nervousness, and hyperarousal), euphoria (excessive state of optimism, cheerfulness, and well-being), increased sexual desire
• fainting
• dilated pupils
• cough
• urticaria
• rash
• hair loss
• redness of the skin or skin spots (purpura)
• photosensitivity (skin rash caused by exposure to sunlight)
• problems passing urine (urinary retention)
• menstrual bleeding (heavy periods)
• swelling (oedema).

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

• bleeding (e.g. from the vagina, gastrointestinal tract, skin, soft tissues)
• tonic-clonic seizures (grand mal seizures), involuntary movements (dyskinesias)
• taste disturbances
• hepatitis (liver inflammation)
• fever
• low sodium blood levels (hyponatremia).

Unknown (frequency cannot be estimated from available data):

• reduced number of blood platelets (thrombocytopenia)
• heart rhythm disorders (arrhythmia)
• swelling (angioedema) of the skin and internal organs (mucous membranes)
• sudden, severe allergic reactions (anaphylactic reaction) with accompanying rapid drop in blood pressure, itchy rash, swelling of lips, tongue and throat, and breathing difficulties
• allergy (hypersensitivity)
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), particularly in elderly people
• reduced potassium levels in blood
• panic attacks, teeth grinding (bruxism), feeling of restlessness
• suicidal thoughts and suicidal behaviour
• seizures
• serotonin syndrome (with symptoms such as high fever, tremor, unusual muscle movements and stiffness, feeling of restlessness)
• extrapyramidal disorders (e.g. involuntary muscle movements, tremor, stiffness, muscle spasms)
• feeling of restlessness and difficulty sitting still (akathisia)
• movement disorders
• visual disturbances
• heart conditions leading to QT interval prolongation (irregular heartbeat detectable on ECG)
• dizziness upon standing quickly due to low blood pressure (orthostatic hypotension)
• nosebleeds
• blood in stool (gastrointestinal or anal ulcers)
• abnormal liver function test results
• blood spots in the skin (bruising)
• galactorrhea in men
• painful erection (priapism)
• irregular menstruation
• severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effect on fertility" in section 2
• in patients taking medicines from the same group as Oropram 20 mg, an increased risk of bone fractures has been observed.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet,
inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse
Reactions of Medicinal Products, Medical Devices and Biocidal Products at the 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Oropram 20 mg tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following:
{Expiry date}. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to properly dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the package and other information

What Oropram 20 mg contains
The active substance is citalopram hydrobromide in an amount equivalent to 20 mg of citalopram.
Other components of the medicine are: mannitol (E 421), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E 171), polyethylene glycol 6000.

What Oropram 20 mg looks like and contents of the pack
Round, white, biconvex film-coated tablets with a score line on both sides and grooves on the sides of the tablet, with a diameter of 8 mm.
Pack sizes: 10, 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
+pharma arzneimittel gmbh
Hafnerstraße 211
A-8054 Graz
Austria

Manufacturers
Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211
A-8054 Graz, Austria
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning, Germany
Actavis Nordic A/S
Ørnegårdsvej 16
DK-2820 Gentofte, Denmark
Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000, Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600, Bulgaria

This medicinal product is authorised in the European Economic Area under the following names:
Citalopram +pharma – Czech Republic
Citalopram Actavis tablets – Estonia, Lithuania
Oropram 20 mg, film-coated tablets – Poland