Package leaflet: Information for the patient

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

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Pram is and what it is used for
Important information before taking Pram
How to take Pram
Possible side effects
How to store Pram
Contents of the package and other information

1. What Pram is and what it is used for

Citalopram, the active substance in Pram, is a so-called selective serotonin reuptake inhibitor (SSRI). Depression and anxiety are associated with a deficiency of substances that transmit information in the brain (including serotonin). Citalopram helps restore normal serotonin levels in the brain.
Pram is used:

in the treatment of mood disorders and depressive disorders
in the treatment of panic disorder
in the treatment of anxiety disorders
in the treatment of obsessive-compulsive disorders

2. Important information before using Pram

When not to use Pram

if the patient is allergic to citalopram or any of the other ingredients of the medicine listed in section 6;
if the patient is currently taking other antidepressant medicines called monoamine oxidase inhibitors (MAOIs). MAOIs include: phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, and moclobemide. When switching from one medicine to another, an appropriate interval must be observed. Such a switch may only be made under medical supervision;
if the patient is taking linezolid (an antibiotic) and close monitoring of their condition and blood pressure cannot be ensured;
if the patient has a congenital heart rhythm disorder or has previously experienced such a disorder (as shown on an ECG, a test used to assess heart function);
if the patient is taking medicines used for heart rhythm disorders or medicines that may affect heart rhythm (e.g. the antipsychotic medicine pimozide). See also the section below: Pram and other medicines.

Warnings and precautions
Before starting treatment with Pram, discuss this with your doctor or pharmacist.
Special caution is required when using Pram:

if the patient develops skin rash or other allergic reactions. Inform the doctor immediately upon onset of symptoms. The doctor will decide whether treatment may continue.
if the patient has had or previously experienced seizures, inform the doctor before starting treatment. If seizures occur for the first time or if their frequency increases, contact the doctor immediately. The doctor will decide whether to continue or discontinue treatment.
if the patient has previously experienced serious mood swings, inform the doctor before starting treatment. If the patient experiences excessive excitement for several days, inform the doctor immediately. The doctor will decide whether to continue or discontinue treatment.
if the patient has anxiety disorders. At the beginning of treatment, symptoms may worsen. This effect usually diminishes after approximately two weeks. Inform the doctor if anxiety symptoms intensify.
if the patient has liver function disorders. In case of liver impairment, the doctor will decide whether dose adjustments are necessary and may order laboratory tests.
if the patient has diabetes. Medicines such as Pram may affect blood sugar levels. The doctor will decide whether adjustment of insulin or other antidiabetic medication dosage is required.
if the patient has previously or recently experienced heart disorders or has recently suffered a heart attack.
if the patient has low resting heart rate and/or salt deficiency due to prolonged severe diarrhoea and vomiting or use of diuretic medicines.
if the patient experiences rapid or irregular heartbeat, fainting, falls, or dizziness upon standing, which may indicate heart rhythm disorders.
if the patient has previously experienced bleeding disorders or if the patient is pregnant (see "Pregnancy"), as bleeding may occur during treatment with Pram. Therefore, caution is advised when using Pram concomitantly with medicines affecting platelet function and/or increasing bleeding risk. This particularly applies to certain medicines used in psychiatric disorders (known as atypical antipsychotics, such as clozapine and phenothiazines), certain antidepressants (tricyclic antidepressants), and medicines used for pain and inflammation (acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs).
if the patient is undergoing electroconvulsive therapy, prolonged seizures may occur during treatment with Pram.
if the patient experiences fatigue, confusion, and muscle spasms, which may indicate low sodium levels in the body (hyponatremia).
if the patient has eye problems, such as closed-angle glaucoma or a history of glaucoma (including increased intraocular pressure).
if the patient has kidney diseases.

Serotonin syndrome: Caution is advised if citalopram is used concomitantly with other serotonergic medicines, such as sumatriptan or other triptans, tramadol, buprenorphine, and tryptophan (see section 4).
Medicines such as Pram (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
It is possible that during the first weeks of treatment with Pram, the patient may not feel improvement. If symptoms worsen, consult a doctor (see section Duration of treatment).
Suicidal thoughts (including suicide attempts) may persist or even intensify during the early phase of treatment. In such cases, consult a doctor.
If Pram is abruptly discontinued, so-called withdrawal symptoms may occur (see section 4 Possible side effects). For this reason, Pram should never be discontinued independently without medical advice.
If the patient wishes to discontinue Pram, they should first consult their doctor (see also section 3 Discontinuing Pram).
All liver function tests, sodium levels, and blood tests recommended by the doctor should be performed.

Children and adolescents
Pram must not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age taking medicines from this group are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and anger). Nevertheless, a doctor may prescribe Pram to patients under 18 years of age if they determine it to be in their best interest. If Pram has been prescribed to a patient under 18 years of age and any concerns arise, contact the treating doctor. If any of the above symptoms develop or worsen in patients under 18 years of age taking Pram, inform the treating doctor immediately. Furthermore, there are currently no long-term safety data available regarding the use of Pram in this age group, particularly concerning growth, maturation, cognitive development, and behavioral development.

Pram and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Citalopram and other concomitantly used medicines may interact with each other, affecting their actions and increasing the risk of adverse effects. This particularly applies to the following medicines:

buspirone (an anti-anxiety medicine),
migraine treatments such as sumatriptan and other triptans,
antidepressants, including other selective serotonin reuptake inhibitors, selective reversible MAO-A inhibitors (including moclobemide), selegiline (do not use in doses exceeding 10 mg per day together with citalopram), tricyclic antidepressants (e.g. desipramine, clomipramine, and nortriptyline), lithium, tryptophan, and herbal preparations containing St. John's wort (Hypericum perforatum),
painkillers such as tramadol,
medicines used for hypertension or heart failure, such as metoprolol, flecainide, and propafenone,
cimetidine, lanziprazole, and omeprazole (medicines used to treat peptic ulcer disease), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of heart attack). These medicines may increase citalopram blood levels,
anticoagulants,
medicines affecting platelet function, such as dipyridamole and ticlopidine,
pain and anti-inflammatory medicines, such as acetylsalicylic acid and other so-called nonsteroidal anti-inflammatory drugs (NSAIDs),
medicines that may increase bleeding risk, such as antipsychotics, phenothiazine derivatives, thioxanthenes, butyrophenones, bupropion, risperidone, thioridazine, and haloperidol,
the antimalarial medicine mefloquine,
buprenorphine (used to treat moderate to severe chronic pain), as this increases the risk of serotonin syndrome, a potentially life-threatening condition (see also section 4 Possible side effects).

Pram must NOT be used 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 (especially halofantrine), and certain antihistamines (astemizole, mizolastine).
Pram must not be administered earlier than 14 days after discontinuation of so-called reversible MAO inhibitors.
Do not start an MAOI within seven days after discontinuing Pram.
If in doubt whether the patient is taking any of the mentioned medicines, consult a doctor or pharmacist.

Taking Pram with food, drink, and alcohol
Pram may be taken during meals or independently of meals (see section 3 How to take Pram).
Alcohol consumption should be avoided during treatment with Pram.

Pregnancy, breastfeeding, and effects on fertility

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

Pregnancy
Inform the doctor and/or midwife about the use of Pram. Taking medicines such as Pram 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). This condition manifests as rapid breathing and cyanosis (bluish skin). Symptoms typically appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
It is known that using SSRIs during the third trimester of pregnancy may cause withdrawal symptoms in the newborn (see also section 4 Possible side effects).
Therefore, pregnant women may take Pram only if the doctor considers it absolutely necessary.
Taking Pram towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, particularly if the patient has a history of coagulation disorders. If the patient is taking Pram, she should inform her doctor or midwife so appropriate advice can be provided.

Breastfeeding
The active substance in Pram passes into human milk in small amounts. Therefore, Pram should not be used during breastfeeding unless the doctor considers treatment absolutely necessary after carefully weighing the benefits against potential risks.

Fertility
Animal studies have shown that citalopram affects sperm quality. This may theoretically affect fertility; however, no effect on human fertility has been observed to date.

Driving and operating machinery
As with all medicines affecting psychomotor performance, the ability to judge and react may be impaired. Therefore, do not drive or operate machinery until the patient is certain how they react to Pram.

3. How to use Pram

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose
Adults
Depression
The usual dose is 20 mg once daily.
Your doctor may increase the dose up to a maximum of 40 mg once daily.

Panic disorder with or without agoraphobia
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 once daily.

Obsessive-compulsive disorder
The initial dose is 20 mg once daily. The dose may be increased up to a maximum of 40 mg once daily.

Use of Pram in elderly patients (over 65 years of age)
The recommended initial dose should be reduced by half compared to the adult dose, i.e. 10–20 mg once daily. Elderly patients should not receive more than 20 mg once daily.

Use in children and adolescents
Pram must not be used in children and adolescents under 18 years of age.

Use in patients with renal impairment
Dose adjustment is not necessary in patients with mild or moderate renal impairment. There is no information available on the use of this product in patients with severe renal impairment (creatinine clearance below 30 ml/min).

Use in patients with hepatic impairment
In patients with mild to moderate hepatic impairment, the recommended initial dose for the first two weeks of treatment is 10 mg once daily. Depending on the patient's response to treatment, the dose may be increased up to a maximum of 20 mg once daily. Special caution is required in patients with severe hepatic impairment.

Use in patients with low CYP enzyme activity
In some patients, metabolism of certain drugs is slower than in others. These metabolic processes involve cytochrome P450 enzymes.

In patients with low CYP2C19 enzyme activity, the recommended initial dose is 10 mg once daily for the first two weeks. Depending on treatment response and tolerability, the dose may be increased up to a maximum of 20 mg once daily.

Method of administration
Pram should be taken as a single dose once daily.
Pram may be taken at any time of day, with or without food.
Swallow the tablet with water.
The tablet may be divided into two equal doses.

Duration of treatment
As with other medicines used in depression and panic disorder, improvement may take several weeks.
Therefore, continue taking Pram even if it takes some time before you feel better.
Do not change the dosage 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 condition improves.
The illness 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 Pram than prescribed
Symptoms of overdose include fatigue, weakness, drowsiness, tremor, nausea and vomiting, inability to move, and difficulty breathing.
If any of these symptoms occur, seek immediate medical attention at a hospital.

If you miss a dose of Pram
If you forget to take a dose of Pram, take it as soon as possible.
Do not take a double dose to make up for the missed dose.

Stopping Pram
Never stop taking Pram without consulting your doctor.
Consult your doctor if you wish to stop taking Pram or if you think the effect of the medicine is too weak or too strong.
Even if there is no improvement in symptoms, do not change the dosage or stop treatment without consulting your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not in everyone.
Rarely, and particularly in combination with other medicines acting in a similar way, Pram may
cause the following adverse reactions known as serotonin syndrome: high fever,
muscle rigidity, muscle spasms, rapid fluctuations in heart rate and breathing, and changes in mental state including confusion, agitation, restlessness, delirium and coma. This may lead to life-threatening events. If these symptoms occur, immediate medical assistance is required. The physician will decide on the necessary treatment (see also section Warnings and precautions).
If any of the following symptoms occur, the use of the medicine must be discontinued immediately and
medical advice sought: rapid, irregular heartbeat, fainting, which may be a sign of life-threatening torsade de pointes.
The following adverse reactions may occur:
Very common (may affect more than 1 in 10 people):

drowsiness, insomnia
headache
dryness of the oral mucosa, nausea
increased sweating

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

decreased appetite, weight loss
excessive excitement or nervousness, unusual dreams, anxiety, confusion, decreased libido, orgasm disorders in women
tremor (involuntary movements), tingling and numbness of the skin, dizziness, attention disturbances
tinnitus (ringing in the ears)
yawning
diarrhoea, vomiting, constipation
itching
muscle pain, joint pain
impotence, ejaculation disorders
fatigue

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

increased appetite, weight gain
aggression, hallucinations, mania, depersonalisation
transient loss of consciousness
dilatation of pupils
bradycardia, tachycardia (slow heartbeat, fast heartbeat)
skin rash (urticaria, rash, purpura), hair loss, photosensitivity
difficulty in urination
prolonged menstruation in women
oedema (swelling)

Rare (may affect up to 1 in 1000 people):

low sodium concentration in serum (hyponatraemia)
seizures, movement disorders, taste disturbances
bleeding
hepatitis (liver inflammation)
fever

Frequency unknown (cannot be estimated from available data):

decreased platelet count (thrombocytopenia) leading to increased risk of bleeding
hypersensitivity reactions (allergy)
increased secretion of antidiuretic hormone, which may cause disturbances in water balance and electrolyte equilibrium
low potassium level in blood (hypokalaemia) which may cause muscle weakness, cramps or cardiac rhythm disturbances
panic attacks, anxiety, suicidal thoughts, suicidal behaviour, teeth grinding (bruxism)
seizures, serotonin syndrome, movement disorders, restlessness
visual disturbances
irregular heartbeat
sudden drop in blood pressure
nosebleeds
gastrointestinal bleeding
abnormal liver function tests
intermenstrual bleeding in women, prolonged erection (priapism) and galactorrhoea in men
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy in section 2.

Adverse reactions such as increased sweating, dryness of the oral mucosa, insomnia,
drowsiness, diarrhoea, nausea and fatigue are dose-dependent.
Withdrawal symptoms
It has not yet been established whether the use of Pram may lead to dependence. However, after
discontinuation of treatment, withdrawal symptoms may occur. These include dizziness, tingling in the
upper and lower limbs, nausea and panic attacks. These symptoms are usually mild and resolve
within a short time.
Bone fractures
An increased risk of bone fractures has been observed in patients taking medicines of this type.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
By reporting adverse reactions, you help provide more information on the safety of this medicine.

5. How to store Pram medicine

Keep the medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Pram contains
The active substance is citalopram. Each film-coated tablet contains 20 mg of citalopram in the form of
citalopram hydrobromide.
The other ingredients are: mannitol, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Tablet coating composition: hypromellose, titanium dioxide (E 171), polyethylene glycol 6000.

What Pram looks like and contents of the pack
White, round, biconvex film-coated tablets with a score line on both sides and a diameter of 8 mm.
The pack contains 28 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schloßplatz 1
A-8502 Lannach
Austria

For further information, please contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Sienna 75 Street; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Information for healthcare professionals:

Toxicity
Information regarding citalopram overdose is limited, and many cases involve concomitant overdose of other medicinal products and/or alcohol. Fatalities following citalopram overdose have been reported; however, most fatal cases occurred after overdose with multiple concurrently administered medicinal products.

Symptoms
The following symptoms have been observed following citalopram overdose: seizures, tachycardia, somnolence, QT interval prolongation, coma, vomiting, tremor, hypotension, cardiac arrest, nausea, serotonin syndrome, agitation, bradycardia, dizziness, left bundle branch block, wide QRS complex, hypertension, mydriasis, torsade de pointes, stupor, sweating, cyanosis, hyperventilation, and ventricular and supraventricular arrhythmias.

Management of overdose
There is no specific antidote for citalopram. Symptomatic and supportive treatment should be administered.
Administration of activated charcoal, an osmotic purgative (e.g. sodium sulfate), and gastric lavage should be considered. Endotracheal intubation should be performed if consciousness is impaired. ECG and vital function monitoring are recommended.

ECG monitoring is recommended in cases of overdose in patients with congestive heart failure and/or bradyarrhythmia, in patients concurrently using medicinal products that prolong the QT interval, or in patients with impaired metabolism, e.g. hepatic insufficiency.