Citalopram Normon 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citalopram Normon 20 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 group known as monoamine oxidase inhibitors (MAOIs), or if you have been treated with such medicines within the last two weeks.
• If you have a congenital heart rhythm disorder or have ever experienced episodes of such a disorder (this is detected by electrocardiogram, a test used to assess heart function).
• If you are taking medicines for a condition 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 the frequency of seizures 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 prolonged diarrhoea and vomiting or use of diuretics (medicines that increase 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 thoughts may increase when starting antidepressants, as all such medicines require time to take effect, usually about two weeks, although in some cases it may take longer.

You are 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 or go immediately to a hospital.

It may be helpful for you to inform a family member 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 notice your depression or anxiety worsening, 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 same class as Citalopram Normon (known as SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

When stopping treatment, withdrawal symptoms are common, particularly if treatment is stopped abruptly (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, confrontation behaviour and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram Normon for 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 for a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms mentioned above worsen or complications arise while patients under 18 years of age are taking Citalopram Normon. In addition, the long-term effects on safety, as well as on growth, maturation and cognitive and behavioural development of Citalopram Normon in this age group have not yet been established.

Other medicines and Citalopram Normon

Inform your doctor or pharmacist if you are currently using, have recently used or might need to use 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 following discontinuation of MAOI treatment. Concomitant administration of citalopram with selective A MAOIs (such as moclobemide, an antidepressant medicine) is not recommended. The combined 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 (an antiepileptic medicine): blood levels of carbamazepine may increase, possibly requiring a reduction in carbamazepine dosage.
• Lithium (a 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 (an antidepressant medicine): increased blood levels of imipramine metabolite.
• Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant) and ticlopidine (used to reduce the risk of stroke): may increase blood levels of citalopram.
• Metoprolol (an antihypertensive, antianginal and antiarrhythmic medicine).
• Preparations containing St. John’s wort (Hypericum perforatum): adverse effects may occur more frequently.

Do not take Citalopram Normon if you are taking medicines for a condition that affects 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 or 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 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 in your baby, contact your midwife and/or doctor immediately.

If you take Citalopram Normon in late 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 citalopram 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 your doctor 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 use 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 determine the duration of your treatment with Citalopram Normon. Do not stop treatment prematurely or abruptly, as this could worsen your condition. You should continue taking your medicine even if you do not notice improvement, since 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 feel that the effect of Citalopram Normon is too strong or too weak, inform 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 telephone number: 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 missed doses. Take your dose as soon as you remember, and then take your next dose at the usual time the following day.

If you stop taking Citalopram Normon

If treatment with Citalopram Normon is stopped abruptly, withdrawal symptoms 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 the duration of treatment, the dose used, and the rate of dose reduction. These symptoms are usually mild or moderate, although in some patients they may be severe. Generally, 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 cause adverse effects, although not everyone experiences them.

The adverse effects are generally mild or moderate in intensity. They usually occur during the first, or even the first two, weeks of treatment and subsequently 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 signs of a serious heart problem known as torsade de pointes.

The following adverse effects have been reported:

Neuropsychiatric disorders: restlessness, drowsiness, weakness, headaches, 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 accompanied by 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.

Excessive 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Punto Sigre collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers 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 20 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 20 mg are film-coated tablets. The film-coated tablets are white or almost white, round, biconvex, and scored on one side. They are available in packs of 14, 28 or 56 film-coated tablets in PVC/aluminum blister packs, and 500 tablets (hospital pack) in PVC/aluminum blister packs.

Only certain 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 review of this leaflet: August 2021

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