Citalopram Sandoz BV: detailed information

Package leaflet: Information for the user

Citalopram Sandoz BV 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Citalopram Sandoz BV is and what it is used for
What you need to know before taking Citalopram Sandoz BV
How to take Citalopram Sandoz BV
Possible side effects
How to store Citalopram Sandoz BV
Contents of the pack and other information

1. What Citalopram Sandoz BV is and what it is used for

Citalopram Sandoz BV belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
Citalopram Sandoz BV is used for the treatment of:

depressive illness (major depressive episodes)
panic disorder with or without agoraphobia (e.g. intense fear of leaving one's home, entering shops or attending public places)

2. What you should know before taking Citalopram Sandoz BV

Do not take Citalopram Sandoz BV

if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6)
if you are taking monoamine oxidase inhibitors (MAOIs),
for example the antidepressant moclobemide or
if you are being treated with the non-selective MAO inhibitor linezolid (an antibiotic), unless you are under close observation and blood pressure monitoring.
selegiline, an irreversible MAO inhibitor (a medicine used to treat Parkinson’s disease), may be used in combination with citalopram at daily selegiline doses not exceeding 10 mg (see “Other medicines and Citalopram Sandoz BV”)
if you have taken irreversible MAO inhibitors within the last two weeks or if you have taken a reversible MAO inhibitor (RIMA) within the period specified in the RIMA’s package leaflet (see “Other medicines and Citalopram Sandoz BV”)
if you are stopping treatment with citalopram and wish to start taking MAO inhibitors, you must wait at least 7 days (see “Other medicines and Citalopram Sandoz BV”).
if you were born with an abnormal heart rhythm or have a history of abnormal heart rhythm (identified by ECG, a test to check heart function)
if you are taking medicines for heart rhythm problems or that affect heart rhythm

See also the section below “Other medicines and Citalopram Sandoz BV”
Warnings and precautions
Talk to your doctor before taking Citalopram Sandoz BV.
Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may occasionally develop thoughts of harming yourself or of suicide.
These thoughts may increase at the beginning of treatment, as all these medicines require
some time to take effect, usually about two weeks but sometimes longer.
You may be more likely to develop such thoughts:

if you have previously had thoughts of suicide or self-harm
if you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants. If you experience thoughts of harming yourself or of suicide at any time, contact your doctor immediately or go to hospital.

You may wish to inform a friend or relative about your depression or anxiety disorder, and ask them to read this leaflet. You may also ask them to inform you if they believe your depression or anxiety is worsening, or if they are concerned about any changes in your behaviour.
Restlessness and inability to remain still
During the first weeks of treatment, you may experience symptoms such as restlessness or
inability to sit or remain still (akathisia). If you experience any of these symptoms, inform your
doctor immediately. A dosage adjustment may therefore be helpful.
Increased anxiety
In the treatment of panic disorder, it usually takes 2-4 weeks before improvement can be observed. At the beginning of treatment, some patients may experience increased anxiety, which, however, will disappear with continued therapy. For this reason, it is very important that you follow your doctor’s instructions exactly and do not stop treatment or change the dosage without first consulting your doctor.
Mania (hyperactive behaviour or thoughts)
If you notice that you are entering a manic phase, characterised by unusual and sudden changes in thoughts, abnormal elation and excessive physical activity, contact your doctor.
Withdrawal symptoms observed upon discontinuation of SSRI antidepressant treatment
When stopping treatment with Citalopram Sandoz BV, especially if this is done abruptly,
withdrawal symptoms may occur (see sections “How to take Citalopram Sandoz BV” and “Possible side effects”). These symptoms commonly occur upon stopping treatment. The risk is higher when Citalopram Sandoz BV has been used for a long time or at high doses, or when the dose is reduced too quickly. In most cases, symptoms are mild and resolve on their own within two weeks. However, in some patients they may be severe and persistent (2-3 months or longer).
If you experience severe withdrawal symptoms when stopping treatment with Citalopram Sandoz BV, contact your doctor, who may advise you to restart taking the tablets and to discontinue treatment more gradually.
Children and adolescents under 18 years of age
Antidepressants should not normally be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age, when taking this class of medicines, have a higher risk of experiencing side effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, oppositional behaviour and anger).
Nevertheless, your doctor may prescribe Citalopram Sandoz BV to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Citalopram Sandoz BV to a patient under 18 years of age and you require clarification, contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen in a patient under 18 years of age who is taking Citalopram Sandoz BV. Furthermore, the long-term effects on safety regarding growth, maturation and cognitive and behavioural development in this age group have not yet been established.
Consult your doctor if:

you start developing fever, muscle stiffness or tremor, and extreme agitation: you may be experiencing serotonin syndrome. Although rare, this syndrome can lead to potentially fatal conditions. Contact your doctor immediately; discontinuation of Citalopram Sandoz BV treatment may be necessary.
you are taking herbal remedies containing St. John’s wort ( Hypericum perforatum - see “Other medicines and Citalopram Sandoz BV”).
you are taking serotonergic medicines, such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan (see “Other medicines and Citalopram Sandoz BV”).
you are sensitive to changes in heart rhythm (QT interval prolongation), or if you have suspected congenital long QT syndrome, or if you suffer from low levels of potassium or magnesium in the blood (hypokalaemia/hypomagnesaemia).
you suffer or have suffered from heart problems or have recently had a heart attack
you have a low resting heart rate and/or know that you may have salt depletion due to prolonged severe diarrhoea and vomiting (being ill) or use of diuretics
you have a fast or irregular heartbeat, faint, collapse or dizziness when standing, which may indicate abnormal heart rhythm
you are at risk of low sodium levels in the blood (hyponatraemia), for example due to concomitant medicines or cirrhosis. Hyponatraemia associated with syndrome of inappropriate antidiuretic hormone secretion (SIADH) has been rarely reported during Citalopram Sandoz BV therapy, mainly in elderly patients.
you suffer from diabetes. An adjustment of the dose of your antidiabetic medicine may eventually be necessary.
you suffer from epilepsy. If a seizure occurs, treatment must be discontinued. Contact your doctor.
you suffer from bleeding disorders, for example gynaecological or gastric haemorrhages, or are taking medicines that affect blood coagulation and increase the risk of bleeding (see “Other medicines and Citalopram Sandoz BV”), since the use of Citalopram Sandoz BV may increase the risk of bleeding, or if you are pregnant (see section “Pregnancy”).
sleep difficulties or a state of excitement occur at the beginning of treatment; your doctor may adjust the dose.
you are undergoing electroconvulsive therapy.
you suffer from so-called psychotic depression with depressive episodes, as psychotic symptoms may intensify.
you have or have had panic disorders
you have eye problems, such as certain types of glaucoma

Medicines such as Citalopram Sandoz BV (the so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.
Other medicines and Citalopram Sandoz BV
DO NOT TAKE Citalopram Sandoz BV if you are taking medicines for heart rhythm problems or
medicines that may affect heart rhythm, for example class IA and III antiarrhythmics, antipsychotics
(e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have further doubts, contact your doctor.
Other medicines may affect or be affected by Citalopram Sandoz BV. Some of these medicines are listed below:

desipramine (used to treat depression). The blood level of desipramine may increase, and therefore a reduction in the dose of desipramine may be necessary.
metoprolol (used, for example, to treat heart conditions), flecainide and propafenone (used to treat irregular heartbeat), other medicines for treating depression (clomipramine, nortriptyline) or medicines used to treat psychosis (risperidone, thioridazine, haloperidol). Increased blood levels of these medicines have been reported or are possible.
Pimozide (an antipsychotic medicine). Concomitant treatment with citalopram and pimozide is contraindicated due to the effect of this combination on heart function.
medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders (QT interval prolongation, Torsades de pointes).
medicines that lower the seizure threshold, for example other antidepressants (SSRIs), antipsychotic medicines (e.g. butyrophenones, thioxanthenes), mefloquine, bupropion and tramadol (analgesic).

The following medicines may increase the serotonergic effects of Citalopram Sandoz BV and may therefore
cause an increase in side effects:

MAO inhibitors (used for depression or Parkinson’s disease, e.g. moclobemide and selegiline or linezolide, an antibiotic). Except for selegiline (at a dose not exceeding 10 mg per day), you must not use Citalopram Sandoz BV concomitantly with MAO inhibitors, as serious and even fatal reactions (serotonin syndrome) may occur. There must be a washout period between treatments (see section “Do not take Citalopram Sandoz BV”). Ask your doctor for advice.
oxitriptan and tryptophan (serotonin precursors)
lithium (used to treat mental disorders)
sumatriptan and other triptans (used for migraine)
opioids, such as tramadol and buprenorphine (for severe pain)
St. John’s wort ( Hypericum perforatum )
cimetidine (a medicine for the stomach) and other medicines for treating stomach ulcers, e.g. omeprazole, esomeprazole, lansoprazole, fluconazole (used to treat fungal infections), ticlopidine or fluvoxamine (another medicine for treating depression). Combination with citalopram may cause an increase in citalopram blood levels.

The following medicines may increase the risk of bleeding:

warfarin and other anticoagulant medicines
acetylsalicylic acid and other painkillers such as NSAIDs (non-steroidal anti-inflammatory drugs), for example ibuprofen
dipyridamole and ticlopidine (heart medicines)
phenothiazines and atypical antipsychotics (used to treat mental disorders)
tricyclic antidepressants (used to treat depression), for example imipramine.

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Citalopram Sandoz BV with food and drink
Food does not affect the effects of Citalopram Sandoz BV.
Concomitant alcohol intake is not recommended.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Citalopram Sandoz BV if you are pregnant or planning to become pregnant, unless you and your doctor have discussed the risks and benefits.
Do not stop treatment with Citalopram Sandoz BV abruptly during pregnancy.
Inform your doctor if you wish to discontinue or stop treatment.
Ensure that your midwife and/or doctor know that you are taking Citalopram Sandoz BV.
If taken during pregnancy, particularly during the last 3 months, medicines such as Citalopram Sandoz BV may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor.
If you are taking Citalopram Sandoz BV during the last trimester of pregnancy and up to delivery, your baby may experience serious side effects or withdrawal symptoms, such as breathing difficulties, bluish skin/lips, irregular breathing with pauses, temperature changes, seizures, lethargy, sleep difficulties, feeding difficulties, vomiting, low blood sugar levels, muscle stiffness or floppiness, abnormally increased reflexes, tremor, extreme nervousness or agitation, irritability, constant crying and drowsiness.
If your baby shows any of these symptoms immediately after birth, contact your midwife and/or doctor immediately, who will be able to advise you.
If you take Citalopram Sandoz near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Citalopram Sandoz so they can advise you on what to do.
Breastfeeding
Citalopram passes into breast milk in small amounts. As there is a risk that this medicine may affect the newborn, consult your doctor before breastfeeding if you are taking Citalopram Sandoz BV.
Fertility
Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not yet been observed.
Driving and using machines
Citalopram has a mild to moderate influence on the ability to drive and use machines.
Do not drive or operate machinery until you know how this medicine affects you. Citalopram usually does not impair the ability to perform normal daily activities. However, if you experience dizziness or drowsiness when starting this medicine, you should be cautious when driving, operating machinery or performing tasks requiring alertness until these effects subside.
If you are unsure, consult your doctor if you are unable to perform the above activities.
Citalopram Sandoz BV contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Citalopram Sandoz BV

Please note that it may take 2 to 4 weeks before you notice an improvement. Treatment should continue for 4–6 months after symptoms have disappeared. When it is time to stop treatment, the dose should be gradually reduced over a period of at least 1–2 weeks.

Citalopram Sandoz BV should be taken once daily, in the morning or in the evening. Drink a glass of water with the medicine; it may be taken with or without food.

Other strengths of this medicine are available for prescribed amounts not suitable for this dosage.

How much to take

Adults:

Depression:
The recommended dose is 20 mg daily. Your doctor may increase the dose up to a maximum of 40 mg daily.

Panic disorder:
The initial dose is 10 mg daily for the first few weeks, before increasing the dose to 20–30 mg once daily. The dose may be increased up to a maximum of 40 mg daily. Up to three months of treatment may be needed to achieve a full therapeutic response.

Elderly patients (over 65 years of age):

Depression and panic disorder:
The initial dose should be halved compared to the recommended dose, e.g. 10–20 mg daily. Elderly patients should generally not take more than 20 mg daily.

Use in children and adolescents under 18 years of age:
Citalopram Sandoz BV should normally not be used in children and adolescents under 18 years of age (see section 2 “Warnings and precautions”).

Hepatic impairment:
The usual initial dose is 10 mg once daily. Patients with liver disorders should not take more than 20 mg daily.

Renal impairment:
Dose adjustment may be necessary; follow your doctor’s instructions.

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

20 mg, 40 mg film-coated tablets:
Film-coated tablets may be divided into equal doses.

If you take more Citalopram Sandoz BV than you should
If you accidentally take more Citalopram Sandoz BV than indicated in this leaflet or prescribed by your doctor, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department. Some symptoms of overdose can be life-threatening.

Depending on the ingested dose, citalopram overdose may cause symptoms such as irregular heartbeat, seizures, changes in heart rhythm (faster or slower heartbeat), discomfort (nausea), vomiting, sweating, drowsiness, loss of consciousness, tremor, changes in blood pressure (which may increase or decrease), serotonin syndrome (see section 4), agitation, dizziness, dilated pupils, bluish skin, rapid breathing, cardiac arrest, coma.

If you forget to take Citalopram Sandoz BV
Do not take a double dose to make up for the missed dose.

If you stop taking Citalopram Sandoz BV
Treatment must not be stopped abruptly.

When stopping treatment with Citalopram Sandoz BV, the dose should be gradually reduced over a period of at least one to two weeks to reduce the risk of withdrawal symptoms.

If intolerable symptoms occur following dose reduction or discontinuation, your doctor may consider resuming the previously prescribed dose. Subsequently, your doctor may continue to reduce the dose, but at a slower rate.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment.
Many of the effects listed below may also be symptoms of the illness and may disappear as you start to feel better.
If you experience one or more of the side effects listed below, you must stop taking Citalopram Sandoz BV and contact your doctor or go to the emergency room immediately.

Common side effects (may affect up to 1 in 10 people)

severe heart rhythm disturbances with rapid, irregular pulse.

Uncommon side effects (may affect up to 1 in 100 people)

severe itching of the skin (with raised lumps).
difficulty breathing (dyspnoea).

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

nausea, muscle weakness, confusion, fatigue, and muscle spasms due to low sodium levels in the blood. In some patients, this may lead to a serious adverse reaction. Contact your doctor.
hepatitis, jaundice.
seizures, which you may have experienced in the past, may become more frequent.

Very rare side effects (may affect up to 1 in 10,000 people)

skin rash (urticaria) and swelling.

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

suicidal thoughts, suicidal behaviour. Cases of suicidal thoughts and behaviour have been reported during treatment with citalopram or immediately after stopping treatment (see "Warnings and precautions"). Contact your doctor or go to the emergency room.
high fever, chills, and sudden muscle contractions, confusion, pathological euphoria, and agitation.
reduction in platelet count, leading to an increased risk of bleeding and bruising.
unusual bleeding, including gastrointestinal bleeding (vomiting blood and/or black stools due to bleeding in the stomach and intestines) and uterine bleeding.
irregular, rapid heartbeat, fainting, which could be symptoms of a life-threatening condition known as torsade de pointes.
you begin having seizures for the first time.
cases involving swelling of the face, lips, and tongue, which may be life-threatening (angioedema).
sudden allergic reaction (within minutes or hours), e.g. skin rash, dizziness, and fainting (anaphylactic reaction).

The following side effects have also been reported:
Very common side effects (may affect more than 1 in 10 people)

increased sweating.
lethargy (need to sleep), drowsiness, weakness, and fragility.
sleep disturbances.
blurred vision (difficulty reading small print).
dry mouth, which may increase the risk of tooth decay – you should brush your teeth more frequently than usual while taking Citalopram Sandoz BV.
nausea.
headache.

Common side effects (may affect up to 1 in 10 people)

decreased appetite, weight loss.
restlessness, nervousness.
diarrhoea, constipation, vomiting, gastric disturbances (including acid reflux, heartburn), stomach ache, flatulence, increased salivation.
high blood pressure. Inform your doctor. High blood pressure must be treated. Very high blood pressure is serious.
low blood pressure.
dizziness.
fever.
tremors.
tingling, sensations of tingling or prickling on the skin.
fatigue, difficulty sleeping, abnormal dreams.
migraine, ringing in the ears (tinnitus).
runny nose, sinusitis, yawning.
difficulty urinating.
itching.
muscle pain, joint pain.
ejaculation problems, impotence (erectile dysfunction).
menstrual pain, difficulty reaching orgasm.
reduced libido.
anxiety, confusion, indifference.
difficulty concentrating, attention disturbances, abnormal dreams, memory loss.
excessive urine production (polyuria).

Uncommon side effects (may affect up to 1 in 100 people)

hallucinations. These may be severe. Contact your doctor or go to the emergency room.
fainting.
seizures.
palpitations.
movement disorders and involuntary movements.
dilated pupils.
difficulty urinating, possible urinary retention. This may be or become serious. Contact your doctor.
oedema (fluid retention), skin rash.
hair loss.
urticaria, itchy rash, rash, increased skin sensitivity to light (photosensitivity).
unusually heavy menstrual bleeding.
aggression (threatening behaviour, possibly violent), feeling of unreality or detachment from oneself.
pathological elevation of mood (mania).
elation (euphoria).
increased libido.
anorexia.
malaise.
weight gain, increased appetite.
slower heartbeat, increased heart rate.

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

involuntary movements.
haemorrhage.
taste disturbances.
restless legs.
cough.
inappropriate antidiuretic hormone secretion (SIADH).

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

weakness, reduced muscle strength, abnormal heart rhythm, and tremors due to low potassium levels in the blood (hypokalaemia). In some patients, this may develop into a serious adverse reaction. Contact your doctor.
nosebleeds.
blood spots under the skin.
irregular, heavy menstrual bleeding.
painful, prolonged erection. Inform your doctor or go to the emergency room as soon as possible.
panic attacks.
teeth grinding.
an increased risk of bone fractures has been observed in patients taking this type of medicine.
inability to stay still, excessive movement, cramps.
visual disturbances.
dizziness and possible fainting (likely only when standing up) due to low blood pressure.
milk secretion from the breasts.
inflammation of the pancreas.
elevated levels of prolactin in the blood.

In addition, Citalopram Sandoz BV may cause side effects that are usually not noticeable. These include changes in certain laboratory test results, such as liver values, which return to normal once treatment is stopped.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Sandoz BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Citalopram Sandoz BV contains

The active substance is citalopram. Citalopram Sandoz BV 20 mg film-coated tablets: Each film-coated tablet contains 20 mg of citalopram (as bromide).

Citalopram Sandoz BV 40 mg film-coated tablets
Each film-coated tablet contains 40 mg of citalopram (as bromide).

The other components are (tablet core): microcrystalline cellulose, glycerol 85%, magnesium stearate, maize starch, lactose monohydrate, copovidone, sodium starch glycolate (type A); (film coating): macrogol 6000, hypromellose, talc, titanium dioxide (E171).

Description of the appearance of Citalopram Sandoz BV and package contents
Citalopram Sandoz BV 20 mg film-coated tablets
White, elongated, biconvex film-coated tablets, with a break line on one side and engraved with C20.
Citalopram Sandoz BV 40 mg film-coated tablets
White, elongated, biconvex film-coated tablets, with a break line on one side and engraved with C40.
The film-coated tablets are packaged in PVDC/PVC/aluminium blisters or in HDPE bottles, and placed in a cardboard carton.
Pack sizes:
Citalopram Sandoz BV 20 mg film-coated tablets
Blister packs: 7, 10, 12, 14, 20, 28, 30, 40, 49, 49x1, 50, 50x1, 56, 98, 100, 100x1, 250 film-coated tablets
Bottles: 100, 105 and 250*: film-coated tablets.
Citalopram Sandoz BV 40 mg film-coated tablets
Blister packs: 7, 10, 14, 20, 28, 30, 40, 49, 49x1, 50, 56, 98, 100, 100x1 film-coated tablets
Bottles: 105 film-coated tablets.
* for dispensers and hospitals only
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturers

Marketing Authorization Holder
Sandoz BV – Hospitaaldreef 29, 1315 RC Almere (The Netherlands)
Local representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milano
Italy

Manufacturers responsible for batch release
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1, - 39179 Barleben – Germany
LEK S.A. - ul. Domaniewska 50 c - 02-672 Warszawa – Poland
Lek Pharmaceuticals d.d. - Verovškova 57 -1526 Ljubljana – Slovenia
Lek Pharmaceuticals d.d. - Trimlini 2D - 9220 Lendava - Slovenia

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Germany Citalopram HEXAL 10 mg Filmtabletten
Citalopram HEXAL 20 mg Filmtabletten
Citalopram HEXAL 30 mg Filmtabletten
Citalopram HEXAL 40 mg Filmtabletten
Ireland Citrol 10 mg Film-coated Tablets
Citrol 20 mg Film-coated Tablets
Citrol 30 mg Film-coated Tablets
Italy Citalopram Sandoz BV
Luxembourg Citalopram HEXAL 20 mg Filmtabletten
Norway Citalopram Sandoz 10 mg tabletter, filmdrasjerte
Citalopram Sandoz 20 mg tabletter, filmdrasjerte
Citalopram Sandoz 40 mg tabletter, filmdrasjerte
Sweden Citalopram Sandoz 10 mg filmdragerade tabletter
Citalopram Sandoz 20 mg filmdragerade tabletter
Citalopram Sandoz 30 mg filmdragerade tabletter
Citalopram Sandoz 40 mg filmdragerade tabletter
United Kingdom (Northern Ireland) Citalopram 10 mg Tablets