Pram

Patient Information Leaflet: Pram 20 mg, film-coated tablets

Pram, 20 mg, film-coated tablets

Citalopram
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Pram and what is it used for

Citalopram, the active substance of Pram, is a 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 to restore the normal serotonin level in the brain.

Pram is used:

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

2. Important information before taking Pram

When not to take Pram

• if you are allergic to citalopram or any of the other ingredients of this medicine
• if you are taking other antidepressants, called monoamine oxidase inhibitors (MAOIs). These include phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, and moclobemide. When changing from one medicine to another, an appropriate time interval should be allowed. The change should only be made under medical supervision.
• if you are taking linezolid (an antibiotic) and it is not possible to monitor your blood pressure or ECG.
• if you have congenital heart rhythm disorders or have experienced such disorders (as shown by an ECG, which is used to assess heart function).
• if you are taking medicines for heart rhythm disorders or that may affect heart rhythm (e.g. the antipsychotic pimozide). See also the section below: Pram and other medicines.

Warnings and precautions

Before starting treatment with Pram, discuss it with your doctor or pharmacist.
Be particularly careful when taking Pram:

• if you have a skin rash or other allergic reactions. Inform your doctor immediately if you experience any symptoms. The doctor will decide whether to continue treatment.
• if you have had seizures or have a history of seizures, inform your doctor before starting treatment. If seizures occur for the first time or if their frequency increases, contact your doctor immediately, who will decide whether to continue or discontinue treatment.
• if you have had severe mood swings in the past, inform your doctor before starting treatment. If you experience excessive excitement, inform your doctor immediately. The doctor will decide whether to continue or discontinue treatment.
• if you have anxiety disorders. At the beginning of treatment, symptoms may worsen. This effect usually decreases after about two weeks. Inform your doctor if anxiety worsens.
• if you have liver function disorders. In case of liver failure, the doctor will decide whether to adjust the dose and may order laboratory tests.
• if you have diabetes. Medicines like Pram may affect blood sugar levels. The doctor will decide whether to adjust the dose of insulin or other antidiabetic medicines.
• if you have had heart problems in the past or have recently had a heart attack.
• if you have low resting heart rate and (or) low sodium levels in the body due to prolonged severe diarrhea and vomiting or the use of diuretics.
• if you experience rapid or irregular heartbeat, fainting, falls, or dizziness when standing up, which may indicate heart rhythm disorders.
• if you have had bleeding disorders in the pastor if you are pregnant (see "Pregnancy"), as bleeding may occur when taking Pram. Therefore, caution is advised when taking medicines that affect platelet function and (or) increase the risk of bleeding. This applies in particular to certain medicines used in psychiatric disorders (known as atypical neuroleptics, such as clozapine and phenothiazine), certain medicines used in the treatment of depression (tricyclic antidepressants), and medicines used in the treatment of pain and inflammation (acetylsalicylic acid and other non-steroidal anti-inflammatory drugs).
• if you are undergoing electroconvulsive therapy, as prolonged seizures may occur when taking Pram.
• if you experience fatigue, confusion, and muscle cramps, which may be a sign of low sodium levels in the body (hyponatremia).
• if you have eye problems, such as glaucoma with closed-angle glaucoma or a history of glaucoma (including increased intraocular pressure).
• if you have kidney disease.

Serotonin syndrome:Caution is advised when citalopram is used concomitantly with other serotonergic medicines, such as sumatriptan or other triptans, tramadol, buprenorphine, and tryptophan (see section 4).
Medicines like Pram (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.
It is possible that during the first few weeks of taking Pram, the patient may not feel an improvement. If symptoms worsen, consult your doctor (see section "Duration of treatment").
Suicidal thoughts(including suicide attempts) may persist or worsen during the early treatment period. In such cases, consult your doctor.
In case of sudden discontinuationof Pram, withdrawal symptomsmay occur (see section 4 Possible side effects). Therefore, never stop taking Pram without consulting your doctor.
If you want to stop taking Pram, consult your doctor first (see also section 3 Stopping Pram).
Perform all liver function tests, sodium levels, and blood testsas recommended by your doctor.

Children and adolescents

Pram should not be used in children and adolescents under 18 years of age. It should also be noted that patients under 18 years of age taking medicines from this group are at increased risk of side effects, such as suicide attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, the doctor may prescribe Pram to patients under 18 years of age if they consider it to be in their best interest.
If the doctor has prescribed Pram to a patient under 18 years of age and any doubts arise, consult the attending doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Pram, inform the attending doctor.
There is currently no data on the long-term safety of Pram in this age group, regarding growth, maturation, and cognitive and behavioral development.

Pram and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Citalopram and other concomitantly used medicines may interact with each other and affect the occurrence of side effects. This applies in particular to:

• buspirone (an anxiolytic),
• migraine medicines, such as sumatriptan and other triptans,
• antidepressants, such as other selective serotonin reuptake inhibitors, selective reversible MAO-A inhibitors, including moclobemide, selegiline (do not use at a dose higher than 10 mg per day with citalopram), tricyclic antidepressants (e.g. desipramine, clomipramine, and nortriptyline), lithium, tryptophan, and herbal preparations containing St. John's Wort (Hypericum perforatum),
• analgesics, such as tramadol,
• medicines used in hypertension or heart failure, such as metoprolol, flecainide, propafenone,
• cimetidine, lansoprazole, and omeprazole (medicines used in the treatment of stomach ulcers), fluconazole (a medicine used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of heart attack). These medicines may increase the level of citalopram in the blood,
• anticoagulants,
• medicines that affect platelet function, such as dipyridamole and ticlopidine,
• analgesic and anti-inflammatory medicines, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs,
• medicines that may increase the risk of bleeding, such as antipsychotic medicines, phenothiazine derivatives, thioxanthenes, butyrophenones, bupropion, risperidone, thioridazine, and haloperidol,
• the antimalarial medicine mefloquine,
• buprenorphine (used in the treatment of chronic moderate to severe pain), as the risk of serotonin syndrome may increase, a potentially life-threatening condition (see also section 4 Possible side effects).

DO NOTtake Pram if you are taking medicines that regulate heart rhythm or medicines that may affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenously administered erythromycin, pentamidine),
antimalarial medicines (especially halofantrine), and certain antihistamines (astemizole, mizolastine).
Do not take Pram earlier than 14 days after stopping the use of so-called reversible MAOIs.
Do not start taking an MAOI inhibitor for 7 days after discontinuing Pram.
In case of doubts about taking any of the above-mentioned medicines, consult your doctor or pharmacist.

Taking Pram with food, drinks, and alcohol

Pram can be taken with or without food (see section 3 How to take Pram).
Avoid consuming alcohol while taking Pram.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Inform your doctor and (or) midwife about taking Pram.Taking medicines like Pram during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn. This condition is characterized by rapid breathing and cyanosis. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, contact your doctor and (or) midwife immediately.
It is known that taking SSRI medicines during the third trimester of pregnancy may cause withdrawal symptoms in the newborn (see also section 4 Possible side effects).
Pregnant women may take Pram only if the doctor considers it absolutely necessary.
Taking Pram at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if there is a history of bleeding disorders. If you are taking Pram, inform your doctor or midwife so that they can provide you with appropriate advice.

Breastfeeding

The active substance of Pram passes into breast milk in small amounts. Therefore, do not take Pram during breastfeeding, unless the doctor considers the treatment to be absolutely necessary after careful consideration of the benefits and risks.

Fertility

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

Driving and using machines

As with all medicines that affect psychomotor function, judgment, and reaction, psychomotor function, judgment, and reaction may be impaired. Therefore, do not drive vehicles or operate machines until you are sure how Pram affects you.

3. How to take Pram

Always take this medicine exactly as your doctor has told you.If you are not sure, consult your doctor or pharmacist.

Recommended dose

Adults
Depression
Usually, 20 mg per day is used.
The doctor may increase the dose to a maximum of 40 mg per day.
Panic disorder
The initial dose is 10 mg per day for the first week and then increased to 20 mg per day. The doctor may increase the dose to a maximum of 40 mg per day.
Obsessive-compulsive disorder
The initial dose is 20 mg per day. The dose may be increased to a maximum of 40 mg per day.

Taking Pram in elderly patients (over 65 years of age)

The recommended initial dose should be reduced to half of the recommended dose for adults, i.e. 10-20 mg per day. Elderly patients should not receive more than 20 mg per day.

Taking Pram in children and adolescents

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

Taking Pram in patients with kidney function disorders

There is no need to reduce the dose in patients with mild or moderate kidney impairment.
There is no information on the use of the product in patients with severe kidney function disorders (creatinine clearance below 30 ml/min).

Taking Pram in patients with liver function disorders

In patients with mild to moderate liver function disorders, the recommended initial dose is 10 mg for the first two weeks of treatment. Depending on the patient's response to treatment, the dose may be increased to a maximum of 20 mg per day. In patients with severe liver impairment, caution is advised.

Taking Pram in patients with low CYP enzyme activity

In some patients, the metabolism of certain medicines is slower than in others. These metabolic processes involve enzymes of the cytochrome P450 system.
In patients with low CYP2C19 enzyme activity, the recommended initial dose is 10 mg per day for the first two weeks. Depending on the response to treatment and tolerance, the dose may be increased to a maximum of 20 mg per day.

Method of administration

Pram is taken in a single dose once a day.
Pram can be taken at any time of the day, with or without food.
Swallow the tablet with water.
The tablet can be divided into two equal doses.

Duration of treatment

As with other medicines used in depression and anxiety disorders, improvement is usually achieved after a few weeks.
Therefore, continue taking Pram, even if it takes some time for the improvement to occur.
Do not change the dose without consulting your doctor.
The duration of treatment is different for each 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 discontinued too early, symptoms may recur.
In patients with recurrent depression, maintenance treatment may last for several years to prevent new depressive episodes.

Taking a higher dose of Pram than recommended

Symptoms of overdose include fatigue, weakness, drowsiness, dizziness, nausea, and vomiting, inability to move, and breathing difficulties.
If you experience any of these symptoms, seek immediate medical attention.

Missing 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 want to stop taking Pram or if you think the effect of Pram is too weak or too strong.
Even if you do not feel better, do not change the dose or stop treatment without consulting your doctor.
In case of doubts about taking Pram, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pram can cause side effects, although not everybody gets them.
Rarelyand especially in combination with other medicines that act similarly, Pram may cause side effects called serotonin syndrome: high fever, muscle stiffness, muscle spasms, rapid changes in blood pressure and breathing, and changes in mental status, including confusion, irritability, and agitation, as well as delirium and drowsiness. This can lead to life-threatening events. If these symptoms occur, immediate medical attention is required. The doctor will decide on the necessary treatment (see also section Warnings and precautions).
In case of any of the following symptoms, stop taking Pram and contact your doctor: rapid or irregular heartbeat, fainting, which may be a sign of life-threatening torsades de pointes.

• Very common(may affect more than 1 in 10 people):
• drowsiness, insomnia
• headache
• dry mouth, nausea
• increased sweating

Frequent(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
• tremors (involuntary movements), tingling and numbness, dizziness, attention disorders
• ringing in the ears
• yawning
• diarrhea, vomiting, constipation
• flatulence
• muscle pain, joint pain
• impotence, ejaculation disorders

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

• increased appetite, weight gain
• aggression, hallucinations, mania, depersonalization
• transient loss of consciousness
• pupil dilation
• bradycardia, tachycardia (slow heart rate, rapid heart rate)
• skin rash (hives, rash, urticaria), hair loss, increased sensitivity to sunlight
• urination disorders
• prolonged menstruation in women
• edema

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

• low sodium levels in the blood (hyponatremia)
• seizures, movement disorders, taste disorders
• bleeding
• liver inflammation
• fever

Frequency not known(cannot be estimated from the available data):

• decreased platelet count (thrombocytopenia) leading to increased risk of bleeding
• allergic reactions
• increased antidiuretic hormone secretion, which may cause water and electrolyte balance disorders
• low potassium levels in the blood (hypokalemia) that may cause muscle weakness, cramps, or heart rhythm disorders
• panic attacks, anxiety, suicidal thoughts, suicidal behavior, teeth grinding (bruxism)
• seizures, serotonin syndrome, movement disorders, anxiety
• vision disorders
• irregular heartbeat
• sudden drop in blood pressure
• nosebleeds
• gastrointestinal bleeding
• abnormal liver function tests
• menstrual bleeding in women, prolonged erection (priapism), and milk secretion in men
• severe postpartum hemorrhage, see additional information in the "Pregnancy" subsection in section 2.

Side effects such as increased sweating, dry mouth, insomnia, drowsiness, diarrhea, nausea, and fatigue are dose-dependent.

Withdrawal symptoms

It has not been established whether taking Pram can lead to dependence. However, after stopping treatment, withdrawal symptoms may occur. These include dizziness, tingling of the extremities, nausea, and panic attacks. Usually, these symptoms are mild and resolve on their own after a short time.

Fractures

In patients taking medicines of this type, an increased risk of fractures has been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
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 helps to gather more information on the safety of the medicine.

5. How to store Pram

Keep this medicine out of the sight and reach of children.
There are no special storage precautions.
Do not use this medicine after the expiry date stated on the carton.The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste.Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pram contains

The active substance of Pram is citalopram. Each film-coated tablet contains 20 mg of citalopram in the form of citalopram hydrobromide.
The other ingredients are: mannitol, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. The coating contains: hypromellose, titanium dioxide (E 171), macrogol 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 authorization holder and manufacturer

G.L. Pharma GmbH
Schloβplatz 1
A-8502 Lannach
Austria
To obtain more detailed information, contact the local representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet:

Information for healthcare professionals:

Overdose
Information on citalopram overdose is limited, and most cases of overdose involve concomitant overdose of other medicines and (or) alcohol. There are reports of deaths after citalopram overdose, but most fatal cases involved concomitant use of several medicines.
Symptoms
After citalopram overdose, the following symptoms have been observed: seizures, tachycardia, drowsiness, QT prolongation, dizziness, vomiting, tremors, hypotension, cardiac arrest, and serotonin syndrome, agitation, and hallucinations.
Procedure in case of overdose
There is no specific antidote for citalopram. Symptomatic and supportive treatment should be used.
Consider administering activated charcoal, an osmotic laxative (e.g. sodium sulfate), and gastric lavage. In case of impaired consciousness, intubation should be performed. ECG and vital function monitoring are recommended.
ECG monitoring is recommended in case of overdose in patients with congestive heart failure and (or) bradycardia, as well as in patients taking concomitantly medicines that prolong the QT interval or in patients with impaired metabolism, e.g. liver impairment.