Citalopram Normon 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citalopram Normon 30 mg film-coated tablets EFG

Citalopram (hydrobromide)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Citalopram Normon is and what it is used for

Citalopram is an antidepressant medicine that belongs to a group of medicines called "selective serotonin reuptake inhibitors".

Citalopram Normon is indicated for:

• Treatment of depression and prevention of relapse.
• Treatment of panic disorder with or without agoraphobia.
• Treatment of obsessive-compulsive disorder.

2. What you need to know before taking Citalopram Normon

Do not take Citalopram Normon

• If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with other antidepressant medicines of the monoamine oxidase inhibitors (MAOIs) group, or if you have been treated with such medicines within the last two weeks.
• If you have been born with a heart rhythm disorder or have ever experienced episodes of such a condition (this can be detected by an electrocardiogram, a test used to assess heart function).
• If you are taking medicines for a disease that affects your heart rhythm.
• If you are taking medicines that may affect your heart rhythm.

Also refer to the section “Other medicines and Citalopram Normon” below.

Warnings and precautions

• If you have hepatic impairment or severe renal impairment.
• If you have experienced manic episodes.
• If you have or have a history of epilepsy. If seizures occur or seizure frequency increases, treatment with citalopram should be discontinued.
• If you have diabetes, as you may require adjustment of your insulin or oral antidiabetic dosage.
• If you have a bleeding disorder or are being treated with medicines affecting blood coagulation, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you have or have had heart problems or recently suffered a heart attack.
• If your heart beats slowly at rest (known as bradycardia) and/or you suspect your body may be losing salts, for example due to severe diarrhea and vomiting over several days or due to diuretic use (medicines for increasing urine production).
• If you have noticed rapid or irregular heartbeats, or have experienced fainting or dizziness when standing up from a sitting or lying position. These symptoms may indicate a heart rhythm disorder.
• Suicidal thoughts and worsening of depression or anxiety disorder. If you are depressed and/or suffer from an anxiety disorder, you may occasionally experience thoughts of self-harm or suicide. These may increase when starting antidepressants, as all such medicines require time to become effective—usually about two weeks, although in some cases it may take longer.

You may be more likely to have such thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with an antidepressant.

If at any time you experience thoughts of self-harm or suicide, contact your doctor immediately or go directly to a hospital.

It may be helpful for you to inform a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them whether they have noticed any worsening of your depression or anxiety disorder, or if they are concerned about changes in your behaviour.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Some medicines in the class to which Citalopram Normon belongs (known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

When stopping treatment, withdrawal symptoms are common, particularly if discontinuation is abrupt (see section “Possible side effects”).

Children and adolescents

Citalopram Normon should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, oppositional behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram Normon to patients under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Citalopram Normon to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above worsen or become complicated while a patient under 18 years of age is taking Citalopram Normon. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development with Citalopram Normon in this age group have not yet been fully established.

Other medicines and Citalopram Normon

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

Concomitant administration of citalopram with non-selective or selective B monoamine oxidase inhibitors (MAOIs) (such as selegiline, an antiparkinsonian medicine) is contraindicated, as is administration within two weeks after stopping such treatment. Concomitant administration of citalopram with selective A MAOIs (such as moclobemide, an antidepressant medicine) is not recommended. Concomitant use of citalopram with MAOIs carries a risk of serotonin syndrome (see section “Possible side effects”).

Precautions should be taken if citalopram is administered together with any of the following medicines:

• Carbamazepine (antiepileptic medicine): increased blood levels of carbamazepine may occur, and a reduction in carbamazepine dosage may be necessary.
• Lithium (medicine used to treat bipolar disorder): increased risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), and other medicines affecting blood coagulation: increased risk of bleeding.
• Imipramine (antidepressant medicine): increased blood levels of imipramine’s metabolite.
• Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke): may increase citalopram blood levels.
• Metoprolol (antihypertensive, antianginal, and antiarrhythmic medicine).
• Herbal preparations containing St. John’s wort: adverse effects may occur more frequently.

Do not take Citalopram Normon if you are taking medicines for a pre-existing condition affecting your heart rhythm or if you are taking medicines that may themselves affect your heart rhythm. Examples include class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any doubts about this, consult your doctor.

Taking Citalopram Normon with food, drinks and alcohol

It is advisable to avoid alcohol consumption while taking this medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Ensure that your midwife and/or doctor knows that you are taking Citalopram Normon. Medicines such as Citalopram Normon, when taken during pregnancy—particularly during the last three months—may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this occurs with your baby, contact your midwife and/or doctor immediately.

If you take Citalopram Normon late in 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 be aware that you are taking Citalopram Normon so they can advise you appropriately.

Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed to date.

Driving and using machines

During treatment with citalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this treatment affects you.

Citalopram Normon contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Citalopram Normon

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will tell you how long your treatment with Citalopram Normon should last. Do not stop treatment early or abruptly, as this could worsen your condition. You should continue taking your medicine even if you do not notice improvement, as it may take several weeks for the medicine to start working.

Citalopram Normon are tablets for oral administration. The tablets can be taken at any time of day, regardless of meals, and should be taken as a single dose. They must be swallowed with sufficient liquid (a glass of water) and must not be chewed.

What dose should you take?

Adults:

Depression: the usual dose is 20 mg daily. If deemed necessary, your doctor may increase this dose up to a maximum of 40 mg daily.

Panic disorder: the initial dose is 10 mg daily for the first week before increasing to 20–30 mg daily. If deemed necessary, your doctor may increase this dose up to a maximum of 40 mg daily.

Obsessive-compulsive disorder (OCD): the initial dose is 20 mg daily. If deemed necessary, your doctor may increase this dose up to a maximum of 40 mg daily.

Elderly patients (over 65 years of age): treatment should be initiated at half the recommended dose, for example 10–20 mg daily. In general, elderly patients should not take more than 20 mg daily.

Use in children and adolescents

The safety and efficacy of Citalopram Normon have not been established in children and adolescents under 18 years of age, and therefore its use is not recommended in this population group.

Patients with special risks

Patients with liver disease should not take more than 20 mg daily. The use of citalopram is not recommended in patients with severe renal impairment.

If you think that the effect of Citalopram Normon is too strong or too weak, tell your doctor or pharmacist.

If you take more Citalopram Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

The most frequent symptoms in case of overdose are: nausea, vomiting, sweating, drowsiness, bluish discoloration of the skin, tremors, seizures, loss of consciousness, and palpitations.

If you forget to take Citalopram Normon

Do not take a double dose to make up for forgotten doses. Take your dose as soon as you remember, and the following day resume your regular schedule at the usual time.

If you stop taking Citalopram Normon

If treatment with Citalopram Normon is stopped abruptly, some withdrawal-related disturbances may occur, such as dizziness, nausea, sweating, sensory disturbances, sleep disturbances, headache, agitation or anxiety, and tingling sensations in the hands or feet. The risk of withdrawal reactions depends on several factors, including duration of treatment, dose used, and rate of dose reduction. Generally, these symptoms are mild or moderate; however, in some patients they may be severe. Usually, these symptoms are self-limiting and resolve within two weeks, although in some patients they may last longer.

Your doctor will advise you on how to gradually discontinue treatment with Citalopram Normon.

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

4. Possible adverse effects

Like all medicines, Citalopram Normon may produce adverse effects, although not everyone experiences them.

The adverse effects are generally mild or moderate in intensity. They usually occur during the first week, or even during the first two weeks of treatment, and then disappear as the condition improves.

If you notice any of the following symptoms, stop taking Citalopram Normon and contact your doctor immediately:

• Rapid or irregular heartbeat or feeling faint, as these could be symptoms of a serious heart problem known as torsade de pointes.

The following adverse effects have been reported:

Nervous and psychiatric disorders: restlessness, somnolence, weakness, headache, dizziness, sleep disturbances, memory loss, suicidal ideation, and serotonin syndrome characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex response, involuntary movements, chills, tachycardia, and tremor; psychomotor agitation/acathisia (characterized by inner restlessness and an urge to move, frequently associated with difficulty sitting still or remaining at rest; this is more likely to occur during the first weeks of treatment).

Gastrointestinal disorders: nausea, vomiting, diarrhea, constipation, dry mouth.

Skin disorders: rash, itching, increased sweating.

Visual disorders: visual disturbances.

Metabolic disorders: weight loss or weight gain.

Cardiovascular disorders: tachycardia, dizziness upon standing due to a drop in blood pressure, slowed heart rate in some patients.

Reproductive system and breast disorders: sexual desire disorders.

Renal and urinary disorders: urinary disturbances.

Rarely, cases of bleeding in the skin and mucous membranes have been observed, such as skin hemorrhages, vaginal bleeding, and gastrointestinal bleeding.

Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage). See "Pregnancy, breastfeeding and fertility" in section 2 for more information. (Frequency not known).

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Citalopram Normon

Keep this medicine out of sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citalopram Normon

The active substance is citalopram (hydrobromide). Each film-coated tablet contains 30 mg of citalopram.

The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, titanium dioxide (E-171), hypromellose, talc and macrogol 6000.

Appearance of the product and contents of the pack

Citalopram Normon 30 mg are film-coated tablets. The film-coated tablets are white or almost white, elongated, biconvex and scored on one side. They are available in packs of 28 or 56 film-coated tablets in a PVC/aluminum blister pack.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: August 2021

“Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es”