10 mg, 20 mg, 40 mg film-coated tablet

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse. 
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Citalopram Orion is and what it is used for 
2. What you need to know before you take Citalopram Orion 
3. How to take Citalopram Orion 
4. Possible side effects 
5. How to store Citalopram Orion 
6. Contents of the pack and other information 

What Citalopram Orion is and what it is used for

Citalopram is a so-called serotonin reuptake inhibitor ( SSRI ) that increases the level of serotonin in the brain. Serotonin is a transmitter substance in the central nervous system. Disorders of the serotonin system in the brain have been observed in e.g. depression and anxiety.

Citalopram Orion is used for 

  • depression and prevention of recurrence of depression
  • panic disorder with or without market fear¶

Citalopram contained in Citalopram Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before you use Citalopram Orion

Do not use Citalopram Orion

  • if you are being treated with MAOIs at the same time (such as selegiline for Parkinson’s disease or moclobemide for depression) (see section Other medicines and Citalopram Orion).
  • if you are being treated with linezolid at the same time and your blood pressure is not closely monitored (see section “Other medicines and Citalopram Orion”)
  • if you are being treated with pimozide at the same time (see section “Other medicines and Citalopram Orion”).
  • if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
  • if you have congenital or have had an abnormal heart rhythm (as seen on ECG, a test to see how the heart works)
  • if you are taking medicines for heart rhythm problems or that may affect your heart rhythm. See also section Other medicines and Citalopram Orion.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Citalopram Orion.

  • if you have severe liver or kidney disease
  • if you have diabetes (see also section “Other medicines and Citalopram Orion”)
  • if you have epilepsy. Treatment with Citalopram Orion should be discontinued if you experience seizures or if the seizures occur at more frequent intervals. (See also section 4)
  • if you have previously suffered from mania or hypomania (See also section 4)
  • if you have an increased tendency to bleed due to illness or other medicines, e.g. anticoagulants (substances that prevent the blood from clotting), anti-inflammatory painkillers and salicylates (eg acetylsalicylic acid ) or if you have experienced bleeding disorders in the past
  • if you are receiving electric shock treatment
  • if you have narrow-angle glaucoma or have had glaucoma before.
  • if you have or have had heart problems or have recently had a heart attack
  • if you have a slow heart rhythm at rest and/or if you know that you may have anemia due to prolonged severe diarrhea and vomiting or the use of diuretics ( diuretics )
  • if you experience rapid or irregular heartbeat, fainting, collapse or dizziness when standing up. This may indicate an abnormal function of the heart rhythm

Drugs such as Citalopram Orion (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Children and adolescents under 18 years of age 
Citalopram Orion should not normally be used in the treatment of children and adolescents under 18 years of age. Despite this, doctors may prescribe CitalopramOrion to patients under 18 years of age if the doctor deems it appropriate.

If you are under 18 years of age and want to discuss why you have been prescribed Citalopram Orion, consult your doctor again.

The risk of side effects such as suicide attempts, suicidal thoughts, hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when treated with this type of drug. If you notice any of these symptoms or they get worse, tell your doctor straight away.

The long-term effects on growth, maturation and cognitive and behavioral development with the use of Citalopram Orion have not yet been established in children and adolescents below 18 years of age.

If you start to feel worse and have thoughts of harming yourself

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

-If you have previously had thoughts of harming yourself or committing suicide,

-If you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Note!

Like other medicines of this type (for depression and related diseases), CitalopramOrion does not provide immediate symptom relief, but it may take a few weeks before you start to feel better. In the treatment of the panic disorder, it usually takes 2-4 weeks before improvement is seen. At the beginning of treatment, some patients may experience a temporary increase in anxiety that disappears during continued treatment. Therefore, it is very important that you carefully follow your doctor’s prescription and do not stop treatment or change the dose without first consulting your doctor.

Some patients with manic-depressive illness may go into a manic phase. This is characterized by unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity. Contact your doctor if you experience these symptoms.

Symptoms such as restlessness and difficulty sitting or standing still can also occur during the first weeks of treatment. Contact your doctor immediately if you experience these symptoms.

You may be unaware of the above symptoms, and therefore it may be beneficial to ask a friend or relative to observe any signs of changes in your behavior.

Contact your doctor immediately or contact the nearest hospital if you have painful thoughts or experiences, or if you experience any of the above symptoms during treatment.

Other medicines and Citalopram Orion 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not use Citalopram Orion with:

  • so-called monoamine oxidase inhibitors ( MAOIs ) (eg selegiline for Parkinson’s disease or moclobemide for depression or linezolid which is an antibiotic ) or two weeks after stopping them. After stopping taking Citalopram Orion, you must wait 7 days before taking any of these medicines.
  • medicines for heart rhythm problems or medicines that can affect the heart rhythm, e.g. antiarrhythmics of Class IA and III (a drug for irregular cardiac activity).
  • antipsychotics (eg phenazine derivatives, pimozide, haloperidol ), tricyclic antidepressants ( antidepressants )
  • certain antimicrobial drugs (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial drugs especially halofantrine)
  • some antihistamines (astemizole, mizolastine).

If you have any further questions on the use of this product, ask your doctor.

Combination therapy with certain drugs may affect the effect of Citalopram Orion by either increasing or decreasing the effect. Therefore, tell your doctor if you are using:

  • so-called SSRIs for depression (ie selective serotonin reuptake inhibitors such as fluoxetine, sertraline, and fluvoxamine) or tricyclic antidepressants (eg amitriptyline)
  • certain antidepressant drugs, which are also used in smoking cessation (bupropion) 
  • certain sedatives (buspirone)
  • certain medicines for migraines (sumatriptan and other triptans)
  • some painkillers (tramadol) 
  • drugs that increase the risk of bleeding, e.g. drugs that inhibit the ability of the blood to clot as anticoagulants, anti-inflammatory painkillers (eg acetylsalicylic acid ), dipyridamole, and ticlopidine
  • an herbal medicine containing St. John’s wort ( Hypericum perforatum )
  • certain medicines for high blood pressure or cardiovascular disease ( metoprolol )
  • medicines for stomach ulcers (cimetidine, lansoprazole, omeprazole, esomeprazole)
  • drugs for the treatment of fungal infections ( fluconazole )
  • some medicines for psychosis such as lithium, tryptophan, and desipramine
  • certain medicines for the prevention and treatment of malaria (mefloquine).

If you have diabetes, you should carefully monitor your blood sugar and the effect of insulin. Contact your doctor if you notice any change (see also section Warnings and precautions).

Citalopram Orion with food, drink, and alcohol

Alcohol consumption is not recommended during treatment with Citalopram Orion.

The tablet is taken with liquid, with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

When using Citalopram Orion during the last 3 months of pregnancy, the following symptoms may occur in the newborn: difficulty breathing, blue discoloration of the skin, cramps, difficulty regulating body temperature, difficulty breastfeeding, vomiting, low blood sugar, tense or slack muscles, jerkiness, tremors, irritability, lethargy, persistent crying, drowsiness and difficulty sleeping. Contact a doctor immediately if the newborn has any of these symptoms.

Tell your midwife or doctor that you are taking Citalopram Orion. When drugs such as Citalopram Orion are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

Breast-feeding

Citalopram passes into breast milk during breast-feeding.

Fertility

In animal studies, citalopram has been shown to reduce sperm quality. In theory, this could affect fertility, but no such degrading effect of citalopram on fertility has yet been demonstrated in humans.

Driving and using machines

Citalopram Orion may impair the ability to react and concentrate on some people. Therefore, avoid driving motor vehicles, using machines, or doing other precision work before you are sure that the medicine does not affect your performance.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Citalopram Orion contains lactose

The tablets contain lactose monohydrate 23 mg (10 mg tablet), 46 mg (20 mg tablet) and 91 mg (40 mg tablet). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other ingredients

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Citalopram Orion

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Depression: 
Adults:

The usual dose is 20 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day

Panic disorder: 
Adults: The 
the starting dose is 10 mg per day for the first week. Thereafter, the dose is increased one to 20-30 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day.

Elderly patients (over 65 years of age): The starting dose should be reduced to half the recommended dose, ie 10-20 mg per day. Elderly patients should usually not take more than 20 mg per day.

Patients with special risk factors

Patients who have liver problems should not take more than 20 mg per day.

The treatment should last for at least 6 months after symptom relief, as it is possible that the symptoms may otherwise return.

If you have the impression that the effect of Citalopram Orion is too strong or too weak, talk to your doctor or pharmacist.

If you forget to use Citalopram Orion

Take the next dose as usual. Do not take a double dose to make up for a forgotten dose. Remember to bring enough medicine with you on your vacation or trips.

If you stop using Citalopram Orion

Do not stop taking citalopram unless your doctor tells you to. Talk to your doctor if you wish to end treatment. Do not end the treatment abruptly.

Usually, your doctor will advise you to slowly reduce your dose for a few weeks. When you stop taking Citalopram Orion, and especially if it happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Citalopram Orion is stopped. The risk is higher if Citalopram Orion has been used for a long time or in higher doses, or if dose one is reduced too quickly. In most cases, these symptoms are mild and usually resolve within two weeks. Contact your doctor if you experience severe withdrawal symptoms after stopping treatment. He or she may ask you to start taking the tablets again, and then put them out more slowly.

Withdrawal symptoms include Dizziness (feeling unsteady or unbalanced), and crawling, burning sensation, and (less commonly) feeling of electric shock, including in the head, difficulty sleeping (with vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, nausea, sweating (including night sweats), restlessness and elation, tremors, confusion and disorientation, emotional outbursts or irritability, diarrhea, visual disturbances, palpitations.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Stop taking Citalopram Orion and contact your doctor immediately if you experience any of the following symptoms:

  • High fever, restlessness confusion, tremors, and muscle twitching, can be signs of a rare condition called serotonergic syndrome
  • Swelling of the skin, tongue, lips, or face, difficulty breathing, or difficulty swallowing ( allergic reaction )
  • Unusual bleeding, including bleeding in the gastrointestinal tract.
  • Mania. 

Rare but serious side effects are  (may affect up to 1 in 1000 people):

If you experience any of the following symptoms, stop taking Citalopram Orion and see a doctor immediately:

  • Vomiting and nausea and muscle twitching and confusion; may be signs of a rare condition called hyponatremia (low blood sodium). Hyponatremia may develop when antidepressant drugs of this type ( SSRIs ) are used especially in elderly female patients.
  • Rapid, irregular heartbeat, fainting which may be a symptom of a life-threatening condition called Torsade de Pointes
  • Thoughts of suicide or death
  • If you get cramps or if the cramps come at more frequent intervals.

Other side effects ar

The following side effects are usually mild and disappear with continued treatment. Contact your doctor if they are severe or last longer than a couple of days.

Very common  (may affect more than 1 user in 10) :

  • increased sweating
  • fatigue and unusual lethargy
  • insomnia
  • headache
  • visual disturbances (difficulty reading the fine print)
  • increased or irregular heartbeat
  • nausea
  • dry mouth
  • impotence.

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

  • weight loss
  • loss of appetite
  • difficulty sleeping
  • concentration disorders
  • dream disorders
  • memory slots
  • anxiety
  • sexual disorders (decreased sexual desire or ability, impotence, in men problems with delayed ejaculation, for women abnormal or difficulty in achieving orgasm)
  • painful menstruation
  • indignation
  • nervousness
  • apathy
  • confusion
  • migraine
  • shaking
  • ant crawls
  • dizziness
  • disturbances of attention
  • tinnitus
  • blood pressure rise or fall
  • nasal congestion and inflammation of the sinuses
  • diarrhea
  • constipation
  • acid reflux
  • vomiting
  • abdominal pain
  • gas voltages and increased saliva secretion
  • itching
  • muscle or joint pain
  • difficulty urinating or increased production of urine
  • fatigue
  • yawning.

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

  • increased appetite
  • weight gain
  • aggression
  • personality change
  • hallucinations
  • exhilaration
  • increased sexual desire
  • fainting
  • enlarged pupil er
  • slowed heart rhythm
  • increased heart rate
  • cough
  • hepatic impairment (increased enzyme activity)
  • allergic reactions (eg skin redness)
  • hair loss
  • increased sensitivity to sunlight
  • reduced urine output
  • heavy menstruation
  • swelling of arms and legs
  • general malaise.

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

  • musculoskeletal disorders
  • taste changes
  • unusual bleeding
  • mild liver disease
  • fever.

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

  • cardiac arrhythmias
  • milk secretion from the breasts.

Has been reported ( occurs in an unknown number of users ):

  • abnormally low levels of platelets ( thrombocytopenia )
  • inappropriate secretion of antidiuretic hormone
  • low potassium levels in the blood ( hypokalaemia ), which can cause muscle weakness, twitching, or abnormal heart rhythm
  • panic attack
  • gnashing of teeth
  • restlessness
  • cramps
  • unusual muscle movements or stiffness
  • involuntary muscle movements ( akathisia )
  • visual disturbances
  • prolongation of QT interval et observed with ECG
  • heart rhythm disorders
  • dizziness when getting up from sitting or lying down due to low blood pressure ( orthostatic hypotension )
  • nosebleeds
  • abnormal liver function values
  • sudden swelling of the skin or mucous membranes
  • bleeding disorders including cutaneous and mucosal bleeding ( ecchymosis )
  • irregular menstruation
  • painful erection er (in men).

An increased risk of bone fractures has been seen in patients taking this type of drug.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

SE-751 03 Uppsala

Website: www.lakemedelsverket.se

5. How to store Citalopram Orion

No special storage instructions. 
Keep this medicine out of the sight and reach of children. 
Do not use this medicine after the expiry date (EXP) on the carton. 
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is citalopram hydrobromide. Each tablet contains citalopram hydrobromide equivalent to 10 mg, 20 mg, and 40 mg citalopram, respectively.
  • The other ingredients in the tablet core are corn starch, lactose monohydrate, copovidone, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
  • The other ingredients in the film coating are hypromellose, macrogol, and titanium dioxide (E171).

What the medicine looks like and the contents of the pack

10 mg tablet: white, biconvex, round, film-coated, marked A on one side and 05 on the other side. 
20 mg tablet: white, biconvex, capsule-shaped film-coated tablet, marked A on one side and 06 on the other side (break score between 0 and 6). The tablet can be divided into two equal doses. 
40 mg tablet: white, biconvex, capsule-shaped film-coated tablet, marked A on one side and 07 on the other side (break score between 0 and 7). The tablet can be divided into two equal doses.

PVC / PVDC aluminum blister

28 tablets (2x 14 tablets) and 98 tablets (7x 14 tablets).

HDPE plastic jar:

Citalopram Orion 10 mg film-coated tablets: 30, 100 and 1000 tablets

Citalopram Orion 20 mg film-coated tablets: 30, 56, 100, 250 and 1000 tablets

Citalopram Orion 40 mg film-coated tablets: 30, 56, 100 and 500 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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