Cital

Package Leaflet: Information for the User

Cital, 20 mg, Film-Coated Tablets

Citalopram

Read All of This Leaflet Carefully Before You Start Taking This Medicine.

• You should keep 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet

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

1. What Cital is and what it is used for

How Cital works

Cital belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain. Disturbances in serotonin levels can cause depression and related disorders.

What Cital is used for

Cital contains citalopram and is used to treat depression and prevent depression from coming back. Cital is also used to treat anxiety disorders with panic attacks, with or without agoraphobia.

2. Important information before taking Cital

When not to take Cital:

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs), including selegiline (used for Parkinson's disease). Do not take Cital if you have taken MAOIs in the last 14 days.
• if you have a heart condition or have recently had a heart attack.
• if you have a tendency to bleed easily or have a history of bleeding disorders.

If you stop taking MAOIs, wait 2 weeks before starting Cital. If you stop taking the MAOI, moklobemide, wait 1 day before starting Cital. After stopping Cital, wait 1 week (7 days) before taking any MAOIs.

Warnings and precautions

Before taking Cital, tell your doctor if you have any other medical conditions or if you are taking any other medicines. Your doctor will consider this information when deciding whether to prescribe Cital.

• tell your doctor if you have a history of mania or panic attacks.
• tell your doctor if you have liver or kidney disease.
• tell your doctor if you have diabetes.
• tell your doctor if you have epilepsy.
• tell your doctor if you have a history of bleeding disorders.
• tell your doctor if you have low sodium levels in your blood.
• tell your doctor if you are receiving electroconvulsive therapy.
• tell your doctor if you have a history of heart disease or have recently had a heart attack.
• tell your doctor if you have a slow heart rate or low blood pressure.
• tell your doctor if you have a history of irregular heartbeat or have fainted.
• tell your doctor if you have a history of eye problems, such as glaucoma.
• tell your doctor if you have a history of bleeding disorders or if you are pregnant or breastfeeding.
• tell your doctor if you are taking buprenorphine for pain relief.

SSRIs like Cital may cause sexual dysfunction (see section 4). In some cases, this has continued after stopping treatment.

Caution

In patients with bipolar disorder, mania may occur. If you experience any of these symptoms, contact your doctor immediately.

Suicidal thoughts and worsening of depression or anxiety disorders

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm may occur. This risk is higher in young adults (under 25 years old) and in patients who have not taken antidepressants before.

• if you have a history of suicidal thoughts or self-harm.
• if you are a young adult (under 25 years old).

If you experience any of these symptoms, contact your doctor or go to the nearest hospital immediately.

Children and adolescents under 18 years old

Cital should not be used in children and adolescents under 18 years old. If your doctor has prescribed Cital for a child under 18, consult your doctor if you have any concerns.

Additional disease information

As with other medicines used to treat depression and anxiety disorders, improvement may not occur immediately. You may need to take Cital for several weeks before you start to feel better.

Interactions with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, including those you have bought without a prescription. Some medicines can interact with Cital and cause serious side effects.

• monoamine oxidase inhibitors (MAOIs), such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine.
• reversible inhibitors of monoamine oxidase A (RIMAs), such as moclobemide.
• the antibiotic linezolid.
• lithium (used to treat bipolar disorder) and tryptophan.
• imipramine and desipramine (used to treat depression).
• irreversible monoamine oxidase inhibitors type B (MAO-B), such as selegiline.

Cital with food, drink, and alcohol

Cital can be taken with or without food. It is recommended to avoid drinking alcohol while taking Cital.

Pregnancy, breastfeeding, and fertility

Do not take Cital if you are pregnant or breastfeeding unless your doctor advises you to. If you are pregnant or breastfeeding, consult your doctor before taking Cital.

Driving and using machines

Cital may cause dizziness or drowsiness. Do not drive or operate machinery until you know how Cital affects you.

Cital contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking Cital.

3. How to take Cital

Always take Cital exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist.

Adults:

Treatment of depression

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

Treatment of anxiety disorders with panic attacks

The starting dose is 10 mg per day for the first week, then increased 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 old):

The starting dose should be reduced to half the recommended dose, e.g., 10-20 mg per day. Do not take more than 20 mg per day if you are an elderly patient.

Patients with liver disease:

Do not take more than 20 mg per day if you have liver disease.

How to take Cital

Take Cital once a day, at any time of day, with or without food. Swallow the tablet with water.

Duration of treatment

As with other medicines used to treat depression and anxiety disorders, improvement may not occur immediately. You may need to take Cital for several weeks before you start to feel better.

What to do if you take more Cital than you should

If you think you have taken too many Cital tablets, contact your doctor or go to the nearest hospital immediately. Take the pack with you.

What to do if you forget to take Cital

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.

What to do if you stop taking Cital

Do not stop taking Cital without talking to your doctor first. If you stop taking Cital, your doctor will gradually reduce your dose over a few weeks.

4. Possible side effects

Like all medicines, Cital can cause side effects, although not everybody gets them. If you experience any of the following side effects, stop taking Cital and contact your doctor immediately:

• high fever, agitation, confusion, trembling, and sudden muscle contractions - these may be symptoms of a condition called serotonin syndrome.
• swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction).
• unusual bleeding or bruising.

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

• low sodium levels in the blood, which may cause tiredness, confusion, and muscle twitching.
• fast or irregular heartbeat, fainting - these may be symptoms of a condition called torsades de pointes.

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

• drowsiness
• headache
• difficulty sleeping
• increased sweating
• dry mouth
• nausea

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

• reduced appetite
• agitation
• reduced sex drive
• anxiety
• confusion
• abnormal dreams
• tremors
• tingling or numbness in the hands or feet
• dizziness
• problems with attention
• ringing in the ears (tinnitus)
• yawning
• diarrhea
• vomiting
• constipation
• itching
• muscle and joint pain
• erectile dysfunction
• delayed ejaculation
• fatigue
• tingling sensation in the skin
• weight loss

Rare side effects (may affect up to 1 in 1000 people)

• seizures
• involuntary movements
• taste disturbances
• bleeding
• liver inflammation
• fever

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

• suicidal thoughts and behaviors (see also section 2)
• reduced platelet count, which may increase the risk of bleeding and bruising.
• allergic reactions (hypersensitivity), including anaphylaxis.
• increased urine production.
• low potassium levels in the blood, which may cause muscle weakness, muscle twitching, or irregular heartbeat.
• panic attacks.
• teeth grinding.
• anxiety.
• abnormal movements or stiffness.
• restlessness (akathisia) - a state of agitation and compulsive need to move.
• seizures.
• serotonin syndrome.
• vision disturbances.
• low blood pressure.
• nosebleeds.
• bleeding, including bruising and bleeding in the skin and mucous membranes.
• sudden swelling of the skin or mucous membranes.
• painful erection.
• galactorrhea (milk production) in men and women who are not breastfeeding.
• abnormal menstrual bleeding.
• abnormal liver function tests.
• increased risk of bone fractures.
• irregular heartbeat.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the regulatory agency in your country.

5. How to store Cital

Keep Cital out of the sight and reach of children. Store in a cool, dry place, below 25°C. Do not use Cital after the expiry date stated on the pack.

6. Contents of the pack and other information

What Cital contains

• The active substance is citalopram (as citalopram hydrobromide). Each film-coated tablet contains 20 mg of citalopram (as citalopram hydrobromide).
• The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, glycerol 85%, crospovidone, sodium carmellose, magnesium stearate, and hypromellose.

What Cital looks like and contents of the pack

Cital 20 mg film-coated tablets are white, round, and biconvex, with a score line on one side. They are available in packs of 30 or 60 tablets.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764 Langenfeld, Germany

Manufacturer

Glenmark Pharmaceuticals s.r.o., Fibichova 143, 566 17 Vysoké Mýto, Czech Republic

For further information, contact the marketing authorization holder

Neuraxpharm Polska Sp. z o.o., ul. Domaniewska 37, 02-672 Warszawa, Poland

Date of last revision of the package leaflet