10 mg, 20 mg, 30 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 information, 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.

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

What Citalopram Orifarm is and what it is used for

Citalopram Orifarm belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors, SSRIs. This type of medicine helps to normalize serotonin levels in the brain. Disorders of the serotonin system in the brain are considered an important factor in the development of depression and related diseases

Citalopram Orifarm is used to treat:

  • Actually depression
  • Panic disorder with or without agoraphobia
  • Obsessive-compulsive disorder
  • Prevention of relapses or new occasions of depression

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

What you need to know before you use Citalopram Orifarm

Do not use Citalopram Orifarm

  • 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 with medicines that contain MAO inhibitors , e.g. selegiline or moclobemide. The MAO inhibitor selegiline can be used in combination with citalopram in daily doses not exceeding 10 mg selegiline daily.
  • if you have recently taken MAOIs. Depending on the type of MAOI you have taken, you may need to wait up to 14 days after stopping MAOIs before you can start taking Citalopram (see also “Taking other medicines”). If you stop taking Citalopram Orifarm and want to start taking MAOIs, you must wait at least 7 days.
  • if you are being treated at the same time with medicines containing linezolid (an antibiotic )
  • if you are taking pimozide (for mental illness)
  • if you have congenital or have 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 Orifarm”).

Warnings and cautions

Children and young people

Citalopram Orifarm 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 taking drugs of this type. Nevertheless, Citalopram Orifarm 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 want to discuss why you were given this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse.

The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.

Treatment of elderly patients and patients with hepatic and renal impairment

Treatment should be done with caution and possibly with lower doses (See section 3 “How to use Citalopram Orifarm”).

Suicidal ideation and worsening depression or anxiety

If you are depressed and/or have anxiety, you can sometimes have thoughts of harming yourself or committing suicide. These thoughts may worsen when you first start taking antidepressants, as it always takes time for these medicines to start working, usually around two weeks, but sometimes longer.

You may be more inclined to think like this

  • if you have previously had thoughts of suicide or self-harm
  • if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under the age of 25 with mental conditions treated with an antidepressant drug.

If you ever have thoughts of harming yourself or suicidal thoughts, contact your doctor immediately or see a hospital.

It may be helpful to tell a relative or close friend that you are depressed or anxious and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

When treating panic disorder, the attacks may get worse in the beginning, but then improve again during the continued treatment.

When treating psychotic patients with depressive periods, the psychotic periods may worsen.

Insomnia and agitation may occur at the beginning of treatment. It may be necessary to adjust the dose one.

Talk to your doctor, pharmacist, or nurse before taking Citalopram Orifarm:

  • if you have unstable epilepsy . Patients with controlled epilepsy should be closely monitored and treatment should be discontinued if the number of seizures increases
  • if you have severe renal impairment
  • if you are also taking herbal medicines containing St. John’s wort, see “Citalopram Orifarm and other medicines”
  • if you are diabetic, your insulin/tablet treatment may need to be adjusted
  • 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. Contact a doctor for an ECG test
  • if you have low potassium or magnesium levels in your blood (hypokalaemia/hypomagnesemia). This can increase the risk of heart rhythm disorders.
  • in concomitant treatment with electroconvulsive therapy (ECT)
  • if you are in a manic phase (overactive behavior or thoughts) contact your doctor. In this case, treatment should be discontinued.
  • if you have or have ever had bleeding disorders or if you are taking medicines that affect the coagulation of the blood or increase the risk of bleeding, as the use of Citalopram Orifarm may increase the risk of bleeding, or if you are pregnant (see “Pregnancy” 2 )
  • if you have or have had eye problems such as increased pressure in the eye ( glaucoma ) and especially so-called narrow-angle glaucoma. Citalopram may have an effect on pupil size resulting in dilation of pupil one ( mydriasis ). This effect leads to a decrease in the angle of the eye which results in an increase in the pressure of the eye

Pregnancy 2

If you take Citalopram Orifarm at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should tell you to take Citalopram Orifarm so that they can advise you on this.

Rare cases of serotonergic syndrome have been reported. This is a combination of the following symptoms: agitation, tremors, muscle cramps, and fever. Contact your doctor if you experience any of these symptoms.

During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may occur. Tell your doctor immediately if you experience these symptoms. He or she can then adjust your dose. 

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

Withdrawal symptoms may occur when treatment is stopped; see “Possible side effects” and “If you stop using Citalopram Orifarm”.

Other medicines and Citalopram Orifarm

The treatment effect may be affected if this medicine is taken at the same time as certain other medicines.

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

Do not take Citalopram Orifarm if you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm, e.g. antiarrhythmics of Class IA and III (drug for irregular cardiac activity), antipsychotics (such as phenothiazines, pimozide, haloperidol ), tricyclic antidepressants (depression), certain antimicrobial drugs (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial drugs, especially halofantrine), certain antihistamines(astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.

Concomitant use of MAOIs including moclobemide or selegiline can cause serious side effects, including serotonergic syndrome; see “Warnings and Cautions”. Citalopram Orifarm can be used in combination with selegiline if the dose does not exceed 10 mg/day.

After taking irreversible MAOIs (such as phenelzine, isocarboxazid, tranylcypromine), you must wait at least 14 days before taking Citalopram Orifarm. After taking reversible MAOIs (eg moclobemide) you must wait as long as indicated in the information for this medicine. Conversely, you must wait at least 7 days after stopping taking Citalopram Orifarm before you can start taking MAOIs. Consult your doctor. (See also “Do not take Citalopram Orifarm”).

Use caution when taking at the same time

  • bupropion, tricyclic antidepressants, desipramine, clomipramine, and the herbal medicine St. John’s wort (Hypericum perforatum)
  • drugs for mental illness, e.g. lithium, risperidone, chlorpromazine, thioridazine, chlorprotixen, haloperidol, and buspirone.
  • painkillers, tramadol
  • other drugs with serotonergic effects such as oxitriptan or tryptophan
  • painkillers and anti-inflammatory drugs, non-steroidal anti-inflammatory drugs ( NSAIDs ) e.g. ibuprofen, ketoprofen, and diclofenac.
  • drugs that prevent blood clots, anticoagulants e.g. warfarin, acetylsalicylic acid, dipyridamole, ticlopidine
  • anti-malarial drugs, e.g. mefloquine
  • medicines for stomach ulcers, omeprazole, lansoprazole, cimetidine
  • fluconazole (used to treat fungal infections)
  • heart failure drug, metoprolol
  • drugs for irregular heartbeat, e.g. propafenone and flecainide.
  • drugs that lower potassium / magnesium levels in the blood
  • anti-migraine drugs, e.g. sumatriptan and other triptans

Do not take citalopram if you are taking:

  • pimozide (for mental illness)
  • linezolid (an antibiotic )

Citalopram Orifarm with food, drink, and alcohol

The tablets can be taken with or without concomitant food intake. Take with half a glass of water.

You should not combine Citalopram Orifarm with alcohol.

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

Data from pregnant women treated with Citalopram Orifarm indicate that there is no increased risk of malformations. Citalopram Orifarm should be used during pregnancy only if clearly needed.

Citalopram Orifarm treatment should not be stopped abruptly during pregnancy. If you are taking Citalopram Orifarm during the last 3 months of your pregnancy, tell your doctor because your baby may have some symptoms at birth. These symptoms usually begin in the first 24 hours after the baby is born. They include difficulty sleeping or eating properly, difficulty breathing, bluish skin or difficulty regulating body temperature, vomiting, persistent crying, tense or slack muscles, lethargy, tremors, tremors, or seizures. If your baby has any of these symptoms at birth, contact your doctor immediately for advice.

Tell your midwife and/or doctor that you are being treated with Citalopram Orifarm. When medicines like Citalopram Orifarm are taken during pregnancy, especially during the last 3 months, they may increase the risk of a serious condition in the baby called persistent pulmonary hypertension in newborns (PPHN). This makes the baby breathe faster and has a bluish color. These symptoms usually begin in the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

Breast-feeding

Citalopram passes into breast milk. There is a risk that a breastfed baby may be affected. Therefore, do not use Citalopram Orifarm during breast-feeding unless specifically prescribed by a doctor.

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 Orifarm may impair the ability to react in some people, which you should keep in mind at times when increased attention is required, such as when driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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 Orifarm contains lactose

Citalopram Orifarm contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Citalopram Orifarm

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

Citalopram Orifarm is taken once daily, at any time of the day, with or without food.

The tablets should be swallowed with half a glass of water.

Use for children :

Treatment for children is not recommended as efficacy and safety have not been studied.

Adults:

Depression :

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

Panic disorder :

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. The treatment is long-lasting.

Obsessive-compulsive disorder :

The starting dose is 20 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day. The effect can be seen after 2-4 weeks and further improvement is seen during continued treatment.

Preventive treatment :

In preventive treatment, the treatment time is individual, often years. When treatment is stopped, this should be done under close supervision to avoid recurrence.

Elderly (over 65 years):

The starting dose should be reduced to half the recommended dose, ie 10-20 mg per day. Elderly patients should not usually take more than 20 mg per day.

Renal impairment :

For patients with renal impairment, your doctor may prescribe a lower dose than the ones listed above.

Hepatic impairment :

If you have impaired liver function, the dose must be adjusted. Follow your doctor’s instructions.

The recommended starting dose is 10 mg daily. Patients who have liver problems should not take more than 20 mg per day.

Do not stop treatment without consulting your doctor. If you have to stop taking Citalopram Orifarm, reduce the dose slowly.

Processing time :

After starting treatment with Citalopram Orifarm, it may take 2-3 weeks before you notice any improvement. Treatment should last for at least three, usually six months after improvement. If an improvement does not occur after one month, the doctor should be consulted.

Symptoms:

Morbid drowsiness, coma, severe lethargy/apathy, seizures, high heart rate, increased sweating, nausea, vomiting, bluish discoloration of the skin and mucous membranes, rapid, heavy breathing, and in rare cases altered heart rhythm.

If you forget to use Citalopram Orifarm

Take your next dose as usual. Do not take a double dose to make up for a forgotten dose .

If you stop using Citalopram Orifarm

Do not stop taking Citalopram Orifarm until your doctor tells you to. Usually, your doctor will advise you to slowly reduce your dose for a few weeks. When you stop treatment with Citalopram Orifarm, and especially if this happens quickly, there is a risk of so-called withdrawal symptoms (see further in the section: “Discontinuation symptoms at the end of treatment”).

Withdrawal symptoms at the end of treatment :

So-called withdrawal symptoms are common when treatment with CitalopramOrifarm is stopped. The risk is increased if Citalopram Orifarm has been used for a longer period of time or in higher doses, or if the dose has been reduced too quickly. In most cases, these symptoms are transient within two weeks. Contact a doctor if you experience severe withdrawal symptoms after stopping treatment. Your doctor may ask you to start taking the tablets again, then discontinue them more slowly.

If you experience withdrawal symptoms, this does not mean that you are addicted or will not be able to stop taking Citalopram Orifarm.

Common withdrawal symptoms: dizziness (feeling of instability, balance difficulties), sensory disturbances such as ant crawling, burning sensation, sleep disturbances (with vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache.

Uncommon withdrawal symptoms: nausea, sweating (including night sweats), agitation, tremor (shaking), confusion (feeling confused or disoriented), emotional instability, visual disturbances, palpitations, diarrhea, irritability.

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.

Many side effects occur only at the beginning of treatment and usually disappear during continued treatment.

The side effects of Citalopram Orifarm are often mild and temporary.

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

  • Rapid, irregular heartbeat, fainting which may be a symptom of a life-threatening condition called Torsade de Pointes (has been reported (occurs in an unknown number of users)).
  • High fever, anxiety, confusion, and sudden muscle contractions: may be signs of a condition called serotonergic syndrome (reported (occurs in an unknown number of users)).
  • If you experience swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing ( allergic reaction ) (reported (occurs in an unknown number of users)).
  • Uncommon bleeding, including bleeding in the gastrointestinal tract and in the skin and mucous membranes (has been reported (occurs in an unknown number of users)).
  • Thoughts of suicide and self-harm (reported (occurs in an unknown number of users)).

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

  • Drowsiness, insomnia
  • Dry mouth, nausea
  • Increased sweating
  • headache

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

  • Decreased appetite, weight loss
  • Agitation, decreased sex drive, anxiety, nervousness, confusion, abnormal orgasm in women, abnormal dreams
  • Shaking ( tremor ), stinging sensation ( paresthesia ), dizziness, attention problems
  • Tinnitus
  • Yawn
  • Diarrhea, vomiting, constipation
  • Itching
  • Muscle and joint pain
  • Impotence, ejaculation disorders, inability to ejaculate
  • Fatigue (exhaustion)

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

  • Increased appetite, weight gain
  • Aggression, abnormal self-perception (depersonalization), hallucinations, mania
  • Fainting
  • Dilated pupil is
  • Slow heartbeat, fast heartbeat
  • Hives ( urticaria ), hair loss, rash, redness of the skin, increased sensitivity to light.
  • Urinary retention
  • Abnormally heavy menstruation ( menorrhagia )
  • Fluid retention in the body ( edema )

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

  • Low salt levels in the blood ( hyponatremia )
  • Epileptic seizures (generalized seizures), involuntary movements ( dyskinesia ), taste disturbances
  • Bleeding
  • Inflammation of the liver ( hepatitis )
  • Fever

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

  • Reduced number of red blood cells
  • Hypersensitivity
  • Headache, nausea, vomiting caused by fluid disturbances (SIADH)
  • Low potassium levels in the blood ( hypokalaemia )
  • Panic disorder, gnashing of teeth, restlessness,
  • Seizures, restlessness and movement disorders (extrapyramidal symptoms), inner feeling of restlessness, movement disorders
  • Visual disturbances
  • Cardiac Disorder ( QT Prolongation)
  • Low blood pressure when standing ( orthostatic hypotension )
  • Nasal blood
  • Bleeding in the stomach or intestines
  • Abnormal liver function tests
  • Bruising, swelling under the skin ( angioedema )
  • Irregular menstruation (women), painful persistent erection (priapism), secretion of milk from the breasts
  • Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy” 2 in section 2 for more information

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

Withdrawal symptoms

Discontinued citalopram treatment, especially when abrupt, often causes withdrawal symptoms. Dizziness, emotional disturbances, sleep disturbances, agitation, anxiety, nausea, vomiting, tremors, confusion, sweating, headaches, diarrhea, palpitations, emotional instability, irritability, and visual disturbances are the most common reactions. In general, these are mild to moderate and cease again, but in some cases they can be long-lasting. When treatment with Citalopram Orifarm is to be discontinued, it is recommended that the dose be reduced gradually.

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 Orifarm

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 carton after EXP. date / EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

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 hydrobromide. Each tablet contains citalopram hydrobromide equivalent to 10 mg, 20 mg 30 mg, and 40 mg citalopram, respectively.
  • The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, corn starch, glycerol, copovidone, magnesium stearate. 
    Sepifilm: Hypromellose, microcrystalline cellulose, macrogol stearate, titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Citalopram Orifarm 10 mg is a white, round, flat film-coated tablet with beveled edges.

Citalopram Orifarm 20 mg is a white, oval, biconvex film-coated tablet with a notch on one side.

Citalopram Orifarm 30 mg is a white, oval, biconvex film-coated tablet with a notch on one side.

Citalopram Orifarm 40 mg is a white, oval, biconvex film-coated tablet with a notch on one side.

Blister pack: 1, 10, 14, 20, 28, 30, 49, 50, 56, 60, 98, 100, 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orifarm Generics A / S,

Energivej 15,

5260 Odense S,

Denmark 

Manufacturer

Orifarm Generics A / S 
Energivej 15

5260 Odense S 
Danmark


Or


[Atlantic Pharma Producoes Pharmaceuticals, SA 
Ruada Tapada GrandeNo.2.

Abrunheira, 2710-089 Sintra

Portugal] 

Or /


[Polpharma Pharmaceutical Works SA

83-200 Starogard Gdański

19, Pelplińska Street

Poland]

Local representative

Orifarm Generics AB

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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