10 mg, 20 mg, 40 mg film-coated tablets 
citalopram

Read all of this leaflet carefully before you start using 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 or pharmacist.
  • 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 or pharmacist. This also applies to any side effects mentioned in this information. See section 4.

In this leaflet: 
1. What Citalopram Bluefish is and what it is used for 
2. What you need to know before you use Citalopram Bluefish 
3. How to use Citalopram Bluefish 
4. Possible side effects 
5. How to store Citalopram Bluefish 
6. Contents of the pack and other information 

What Citalopram Bluefish is and what it is used for

Citalopram Bluefish belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ). Everyone has a substance called serotonin in the brain. It is not entirely clear how citalopram works but it can help by correcting the serotonin system in the brain.

Citalopram Bluefish is used to treat severe depression.

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

What you need to know before you use Citalopram Bluefish

Do not use Citalopram Bluefish

  • if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
  • if you are being treated at the same time or have just finished treatment with a so-called MAO inhibitor (monoamine oxidase inhibitor, another type of antidepressant), such as selegiline or moclobemide. You should talk to your doctor before using Citalopram Bluefish. Citalopram Bluefish must not be used at the same time as an MAOI, or if you have completed treatment with a so-called irreversible MAOI within the last two weeks. After stopping treatment with a so-called reversible MAO inhibitor such as selegiline (used to treat Parkinson’s disease) you must wait to start treatment with citalopram for as long as indicated on the package leaflet of the reversible MAOI. After stopping treatment with Citalopram Bluefish, you must wait at least 7 days before starting treatment with MAOIs.
  • if you are taking linezolid (a medicine used to treat bacterial infections) unless you are being cared for by a doctor and your blood pressure is being closely monitored.
  • if you are taking pimozide (a medicine used to treat certain psychiatric conditions).
  • if you have congenital or had an abnormal heart rhythm (as seen on the 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 section 2 “Other medicines and Citalopram Bluefish”).

If any of these apply to you, tell your doctor before taking Citalopram Bluefish.

Warnings and cautions

Talk to your doctor or pharmacist before taking Citalopram Bluefish

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.
  • Be especially careful if you experience symptoms of akathisia that are an inner feeling of restlessness and anxiety, such as an inability to sit or stand still ( psychomotor anxiety), often accompanied by experienced anguish. This is likely to occur within the first few weeks of treatment. Increasing the dose of CitalopramBluefish may aggravate these feelings (see section 4, “Possible side effects”).

Tell your doctor if any of the following conditions apply to you. They can affect what treatment you should receive. Tell your doctor:

  • if you are taking other medicines (see “Other medicines and CitalopramBluefish”).
  • if you have diabetes, your doctor may need to adjust the dosage of one of the insulins or other medications used to lower your blood sugar.
  • if you have epilepsy or have had a seizure before or suffer from seizures during treatment with Citalopram Bluefish. Your doctor may decide to stop treatment with Citalopram Bluefish if you have a seizure.
  • if you are receiving electroconvulsive therapy (ECT).
  • if you suffer from periods of mania/hypomania (overactivity in terms of behavior or thoughts). Your doctor may decide to stop treatment with Citalopram Bluefish if you are entering a manic phase.
  • if you have had bleeding disorders or bleed easily or if you are taking medicines that may increase the tendency to bleed (see section “Other medicines and Citalopram Bluefish”).
  • if you are susceptible to certain heart diseases (prolongation of the so-called QT interval in the ECG ) or if you have a suspected congenital long QT syndrome or if you have low levels of potassium or magnesium in your blood.
  • if you suffer from other psychiatric conditions ( psychosis ).
  • if you suffer from liver or kidney problems. Your doctor may need to reduce the dose of Citalopram Bluefish.
  • if you have or have had heart problems or have recently had a heart attack.
  • if you have a slow heartbeat at rest and/or if you know you may be salt deficient 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.

Tell your doctor immediately if any of the following symptoms develop during treatment with Citalopram Bluefish, as you may then have something called serotonin syndrome. The symptoms are as follows: you feel restless, shaky, have sudden muscle movements, and fever. If this happens, your doctor will immediately stop taking Citalopram Bluefish.

Citalopram Bluefish can in rare cases, mainly in elderly patients, cause decreased sodium levels in the blood and a disturbed secretion of a hormone in the brain that regulates the water balance in the body (syndrome of insufficient antidiuretic hormone secretion, SIADH). Tell your doctor if you start to feel nauseous and sick with weak muscles or confused while you are being treated with Citalopram Bluefish.

Medicines such as Citalopram Bluefish ( SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Withdrawal symptoms are seen with discontinuation of treatment

Withdrawal symptoms are common when treatment is stopped, especially if treatment with Citalopram Bluefish is stopped abruptly. The risk of withdrawal symptoms may be due to several factors including the duration of treatment and the dosage and how quickly someone is stepped down. Dizziness, disturbed sensation (including sensation and feeling of electric shock), sleep disturbances (including insomnia and intense dreams), anxiety or worrying, nausea and/or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations and irritability, irritability visual disturbances have been reported. In general, the symptoms are mild to moderate but can be severe in some patients. They usually occur within the first few days after stopping treatment, but there have been very few reports of such symptoms in patients who have accidentally skipped a dose. In general, the symptoms are limited to a certain time and disappear on their own within two weeks, although they may be prolonged in some people (2-3 months or more). Therefore, when treatment is stopped, Citalopram Bluefish should be phased out over a period of several weeks or months according to your needs.

If unbearable symptoms occur after a reduction of dose one when treatment is to be discontinued, reconsideration of the previously prescribed dose must be considered. Thereafter, your doctor may continue to reduce the dose one, but at a slower rate.

Children and young people

Citalopram should not normally be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when treated with drugs of this type. Despite this, citalopram can be prescribed by a doctor to patients under 18 years of age if the doctor deems it appropriate. If you are under 18 years of age and you want to discuss why you have been given this medicine, consult your doctor. If any of the above symptoms occur in patients under 18 years of age or worsen with the use of citalopram, tell your doctor. There are no data on the long-term effects of citalopram on growth, maturation and cognitive function, and behavioral development within this age group.

Other medicines and Citalopram Bluefish

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

If you are taking or have recently taken any of the medicines listed below and you have not already discussed them with your doctor, contact your doctor again and ask what to do. Dose one may need to be changed or you may need to get another medicine.

  • monoamine oxidase inhibitors , linezolid and pimozide (see “Do not use Citalopram Bluefish”).
  • medicines called triptans, such as sumatriptan (used to treat migraines )
  • tramadol (medicin som används för att behandla svår smärta)
  • antikoagulanter, dipyridamol och tiklopidin (blodförtunnande mediciner)
  • acetylsalicylsyra, icke steroida antiiflammatoriska läkemedel (NSAID) såsom i ibuprofen (mediciner som används för att behandla svår smärta)
  • neuroleptika (fenotiaziner [t.ex. tiorudazin], tioxanter, butyrofenoner [t.ex. haloperidol]), atypiska antipsykotika, t.ex. risperidon (mediciner som används för att behandla vissa psykiatriska tillstånd).
  • tricykliska antidepressiva (mediciner som används för att behandla depression)
  • naturläkemedel som innehåller johannesört (Hypericum perforatum)
  • cimetidin, omeprazol, esomeprazol, lansoprazol (mediciner som används för att minska magsyraproduktionen)
  • flukonazol (används för behandling av svampinfektioner)
  • tryptofan, oxitriptan (läkemedel med serotonerga effekter)
  • litium (medicin som används för att behandla mani)
  • imipramin, desipramin, klomipramin, nortriptylin (mediciner som används för att behandla depression)
  • fluvoxamin (medicin som används för att behandla depression och tvångssyndrom)
  • meflokin (medicin som används för att behandla malaria)
  • bupropion (medicin som används för att behandla depression och som stöd vid rökavvänjning)
  • flekainid, propafenon (mediciner som används för att behandla oregelbunden hjärtrytm)
  • metoprolol (mediciner som används för att behandla hjärtbesvär)
  • läkemedel som kan förändra EKG (ge oregelbunden hjärtrytm) eller kan orsaka låga nivåer av kalium eller magnesium i blodet. Fråga din läkare eller apotekspersonalen om den medicin/de mediciner du tar/använder samtidigt med Citalopram Bluefish ingår i denna grupp.

Ta inte Citalopram Bluefish om du tar läkemedel för problem med hjärtrytmen eller läkemedel som kan påverka hjärtrytmen, t.ex. antiarytmika av klass IA och III (läkemedel mot oregelbunden hjärtaktivitet), antipsykotika (t.ex. fentiazinderivat, pimozid, haloperidol), tricykliska antidepressiva (läkemedel mot depression), vissa antimikrobiella läkemedel (t.ex. sparfloxacin, moxifloxacin, erytromycin IV, pentamidin, läkemedel mot malaria särskilt halofantrin), vissa antihistaminer (astemizol, mizolastin). Om du har ytterligare frågor om detta bör du tala med din läkare.

Citalopram Bluefish med mat, dryck och alkohol

Det rekommenderas att inte dricka alkohol under behandling med CitalopramBluefish.

Citalopram Bluefish kan tas med eller utan föda.

Graviditet, amning och fertilitet

Om du är gravid eller ammar, tror att du kan vara gravid eller planerar att skaffa barn, rådfråga läkare eller apotekspersonal innan du använder detta läkemedel.

Graviditet

Data tyder på att användning av citalopram under graviditet inte leder till problem för fostret. Därför kan citalopram användas om du är gravid eller planerar att bli gravid med hänsyn till följande;

Du bör inte avbryta behandlingen med Citalopram Bluefish plötsligt. Om du tar Citalopram Bluefish under graviditetens tre sista månader ska du informera din läkare eftersom ditt barn kan ha vissa symtom när det är fött. Dessa symtom kommer vanligen under de första 24 timmarna efter att barnet har fötts. De består av oförmåga att sova och äta ordentligt, problem med andningen, blåaktig hud eller att barnet är för varmt eller för kallt, mår illa, gråter mycket, har stela eller slappa muskler, slöhet, darrningar, nervositet eller kramper. Om ditt barn har några av dessa symtom när det är fött ska du genast kontakta din läkare som kan ge dig råd.

Tala om för din barnmorska eller läkare att du använder Citalopram Bluefish. När läkemedel såsom Citalopram Bluefish används under graviditet, särskilt under de tre sista månaderna, kan de öka risken för ett allvarligt tillstånd kallat persistentpulmonell hypertension hos den nyfödde (PPHN). Detta tillstånd gör att barnet andas snabbare och ser blåfärgat ut. Symtomen uppkommer vanligtvis inom 24 timmar från det att barnet är fött. Om detta drabbar ditt barn, kontakta barnmorska eller läkare omedelbart.

Amning

Citalopram passerar över i bröstmjölk i små mängder. Det finns risk för att barnet påverkas. Om du tar Citalopram Bluefish ska du tala med din läkare innan du börjar amma.

Fertility

I djurstudier har det visat sig att citalopram minskar kvaliteten på sperma. I teorin skulle detta kunna påverka fertiliteten, men någon sådan nedsättande effekt av citalopram på fertilitet har ännu ej påvisats hos människa.

Körförmåga och användning av maskiner

Citalopram Bluefish har mindre eller måttliga effekter på förmågan att köra bil och använda maskiner. Läkemedel som påverkar det centrala nervsystemet kan emellertid nedsätta förmågan att bedöma och att reagera på oförutsedda situationer. Kör inte eller använd maskiner förrän du vet hur Citalopram Bluefish påverkar dig. Diskutera med läkare eller apotekspersonal om du är osäker.

Du är själv ansvarig för att bedöma om du är i kondition att framföra motorfordon eller utföra arbeten som kräver skärpt uppmärksamhet. En av faktorerna som kan påverka din förmåga i dessa avseenden är användning av läkemedel på grund av deras effekter och/eller biverkningar.

Beskrivning av dessa effekter och biverkningar finns i andra avsnitt. Läs därför all information

i denna bipacksedel för vägledning. Diskutera med din läkare eller apotekspersonal om du är

osäker.

Citalopram Bluefish innehåller laktos

Citalopram Bluefish innehåller laktos. Om du inte tål vissa sockerarter, bör du kontakta din läkare innan du tar denna medicin.

Citalopram Bluefish innehåller natrium

Citalopram Bluefish innehåller mindre än 1 mmol (23 mg) natrium per 10 mg, 20 mg och 40 mg, d.v.s. är näst intill “natriumfritt”.

3. Hur du använder Citalopram Bluefish

Använd alltid detta läkemedel enligt läkarens anvisningar. Rådfråga läkare eller apotekspersonal om du är osäker.

Dosering

Rekommenderad dos är:

Vuxna

Depression

Vanlig dos är 20 mg per dag. Din läkare kan öka dosen till högst 40 mg per dag.

Äldre patienter (över 65 år):

Startdosen bör sänkas till hälften av den rekommenderade dosen, dvs 10-20 mg per dag. Äldre patienter bör vanligtvis inte ta mer än 20 mg per dag.

Patienter med särskilda riskfaktorer

Patienter som har problem med levern bör inte ta mer än 20 mg per dag.

Citalopram Bluefish bör tas en gång dagligen, antingen på morgonen eller på kvällen. Tabletterna kan tas med eller utan mat men bör sväljas med lite vatten eller annan vätska.

Citalopram Bluefish börjar inte verka direkt, effekten kan i regel förväntas först efter 2-4 veckor. Behandlingen bör fortsätta tills du har varit symtomfri i 4-6 månader.

Att avbryta behandling

Citalopram Bluefish bör trappas ner långsamt för att minska risken för utsättningsreaktioner. Din läkare kommer att gradvis trappa ner din dos över en period om minst 1-2 veckor (se ”Varningar och försiktighet).

The following symptoms may occur: drowsiness, coma, inability to move the body ( dizziness ), cramps, increased heart rate, increased sweating, nausea, vomiting, blue discoloration of the lips, tongue, skin, and mucous membranes (caused by lack of oxygen in the blood) and faster breathing.

Serotonin syndrome may also occur (symptoms see “Warnings and precautions”).

If you forget to take Citalopram Bluefish

If you forget to take a dose, take it as soon as possible and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram Bluefish

Do not stop taking Citalopram Bluefish until your doctor tells you to. CitalopramBluefish should be discontinued slowly and it is recommended that the dose be gradually reduced over a period of at least 1-2 weeks. It is important that you follow your doctor’s prescriptions. Discontinuation of treatment with Citalopram Bluefish, especially if it occurs suddenly, may result in withdrawal symptoms (see “Warnings and Precautions”). Talk to your doctor if such withdrawal symptoms occur after you stop taking Citalopram Bluefish.

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

4. Possible side effects

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

The side effects observed with Citalopram Bluefish are generally mild and transient. They are most prominent during the first weeks of treatment and subside as the depressive state improves.

If you experience any of the following side effects , stop taking Citalopram Bluefish and contact your doctor immediately:

  • suicidal thoughts and suicidal behavior
  • movement disorders (extrapyramidal symptoms)
  • restlessness and inability to stand or sit still ( akathisia )
  • severe allergic reactions (for symptoms: see below under the frequency “Has been reported”)
  • swelling of the skin and mucous membranes due to fluid retention and angioedema (for symptoms: see below under the frequency “Has been reported”)
  • rapid irregular heartbeat, fainting which may be a symptom of a life-threatening condition called torsades de pointes

The side effects that have been reported with citalopram are described below and are frequently reported.

The following classification is used to indicate how often side effects have been reported:

Very common may occur in more than 1 in 10 users
Usual may affect up to 1 in 10 users
Less common may affect up to 1 in 100 users
Rare can occur in up to 1 in 1000 users
Has been reported occurs in an unknown number of users

Very common

  • drowsiness, insomnia
  • headache
  • nausea, dry mouth, increased sweating

Usual

  • tremors, dizziness
  • decreased appetite, weight loss, anorexia
  • agitation, anxiety, nervousness, confusion
  • anxiety, confusion, indifference
  • decreased sex drive ( libido )
  • creeps, tingling, or numbness in the skin ( paresthesia )
  • impaired concentration
  • ringing in the ears ( tinnitus )
  • diarrhea, vomiting, stomach upset (acid regurgitation, heartburn), abdominal pain, flatulence, increased salivation
  • muscle pain ( myalgia ), joint pain ( arthralgia )
  • itching, rash
  • fatigue, yawning
  • the inability for women to have an orgasm, menstrual pain, problems with ejaculation and erection
  • abnormal dreams, memory loss, indifference

Less common

  • slow heartbeat
  • fast heartbeat
  • increased appetite or weight gain
  • aggression, a feeling of being cut off from oneself (depersonalization), hallucinations, mania (elation with rushing thoughts and actions), euphoria(optimistic, happy, prosperous), increased sexual desire
  • fainting or fainting
  • dilated pupils are
  • hives ( urticaria )
  • rash
  • hair loss
  • small red, swollen and itchy skin areas ( hives )
  • photosensitive skin
  • difficulty urinating
  • unusually heavy or long periods
  • edema (fluid retention)

Rare

  • bleeding (eg vaginal bleeding, gastrointestinal bleeding, bleeding from the skin or mucous membranes)
  • seizures, involuntary movements
  • taste changes
  • inflammation of the liver
  • fever
  • lower-sodium levels than normal in the blood

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

  • decreased platelet count ( thrombocytopenia )
  • abnormal rhythm or rate of heartbeat ( arrhythmia )
  • swelling ( angioedema ) of the skin or mucous membranes of the body
  • a sudden, severe allergic reaction ( anaphylactic reaction ) is characterized by a sharp drop in blood pressure, itchy rash, swelling of the lips, tongue or throat, and difficulty breathing
  • allergy (hypersensitivity)
  • a condition called SIADH (syndrome of inappropriate secretion of antidiuretic hormone ) especially in the elderly
  • low levels of potassium in the blood
  • panic attacks, gnashing of teeth (bruxism), restlessness
  • suicidal ideation or behavior
  • seizures (convulsions)
  • serotonin syndrome (symptoms such as high fever, tremors, muscle twitching, and anxiety)
  • extrapyramidal symptoms (eg involuntary movements, tremors, muscle stiffness, and muscle contractions)
  • the feeling of restlessness and not being able to sit still ( akathisia )
  • movement disorders
  • visual disturbances
  • heart problems called QT prolongation (irregular heartbeat recognizable on ECG )
  • dizziness when getting up quickly is caused by low blood pressure ( orthostatic hypotension )
  • nosebleeds
  • blood in the stool (bleeding in the gastrointestinal tract or rectal bleeding)
  • abnormal liver function values
  • bruises ( Eskimos )
  • milk secretion from the breasts in men ( galactorrhea )
  • painful prolonged erection (priapism)
  • irregular periods ( metrorrhagia )
  • an increased risk of bone fractures has been seen in patients taking this type of drug

Cases of suicidal ideation and suicidal behavior have been reported during treatment with citalopram or immediately after stopping treatment.

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

Withdrawal symptoms are seen with discontinuation of treatment

See “Warnings and Cautions”

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Citalopram Bluefish

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 expiration date is the last day of the specified month.

No special storage instructions.

Medicines 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 .

Citalopram Bluefish 10 mg, 20 mg, and 40 mg film-coated tablets contain citalopram hydrobromide equivalent to 10 mg, 20 mg, and 40 mg citalopram, respectively, per tablet.

Other ingredients are

Tablet core

Kopovidon

croscarmellose sodium (E468)

glycerol (E471)

lactose monohydrate

magnesium stearate (E470b)

corn starch

microcrystalline cellulose (E460)

Film coating

hypromellose (E464)

microcrystalline cellulose (E460)

polyoxyethylene stearate (E431)

titanium dioxide (E171)

What the medicine looks like and the contents of the pack

Citalopram Bluefish 10 mg and 20 mg film-coated tablets packaged in PVC / PVDC / aluminum blisters available in pack sizes of 14, 20, 28, 30, 50, or 100 tablets per carton.

Citalopram Bluefish 40 mg film-coated tablets packaged in PVC / PVDC / aluminum blisters available in pack sizes of 20, 28, 30, 50, or 100 tablets per carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

PO Box 49013

100 28 Stockholm

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm


This medicinal product is authorized under the European Economic Area under the names :

Member State Name of the medicine
Austria Citalopram Bluefish 10 mg Film TabletCitalopram Bluefish 20 Mg Film TabletsCitalopram Bluefish 40 mg Film Tablet
Ireland Citalopram Bluefish 10 mg Film-Coated TabletsCitalopram Bluefish 20 mg Film-Coated TabletsCitalopram Bluefish 40 mg Film-Coated Tablets
Iceland Citalopram Bluefish 10 mg film-coated tablets Citalopram Bluefish 20 mg film-coated tablets citalopram Bluefish 40 mg film-coated tablets
France Citalopram Bluefish 20 mg compressed tablets

Muhammad Nadeem

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