Frimaind

Italy
Brand name Frimaind
Form tablets, film-coated
Active substance / Dosage
CITALOPRAM
Prescription type Prescription only
ATC code
N06AB04
Registration number 036143
Manufacturer S.F. GROUP S.R.L.

Table of Contents

PACKAGE LEAFLET: INFORMATION FOR THE USER

FRIMAIND 20 mg film-coated tablets, 40 mg film-coated tablets

Citalopram hydrobromide
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FRIMAIND is and what it is used for

FRIMAIND belongs to a group of medicines called Selective Serotonin Reuptake Inhibitors (SSRIs), also known as antidepressants.
FRIMAIND is used for the treatment of:

  • Depression (endogenous depressive syndromes) and prevention of relapses;
  • Anxiety disorders with panic attacks (panic attacks, including those caused by agoraphobia, which is the fear of open spaces).

2. What you should know before taking FRIMAIND

Do not take FRIMAIND:

  • if you are allergic to citalopram or any of the excipients of this medicine (listed in section 6);
  • if you are under 18 years of age;
  • if you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs). If you need to start treatment with an MAOI, wait at least 7 days after stopping FRIMAIND;
  • if you are taking a reversible MAOI (RIMA), take FRIMAIND only after stopping the RIMA for the time indicated in the RIMA’s package leaflet;
  • if you are taking irreversible MAOIs, including selegiline used to treat Parkinson’s disease, at doses exceeding 10 mg daily. In this case, wait at least 14 days after stopping the MAOI before taking FRIMAIND;
  • if you are taking an antibiotic called linezolid;
  • if you are taking pimozide (used to treat mental illnesses);
  • if you have a heart rhythm disorder (prolonged QT interval or congenital long QT syndrome), or if you are taking medicines that may cause such disorders. See also section “Other medicines and FRIMAIND”.

Warnings and precautions
Talk to your doctor or pharmacist before taking FRIMAIND:

  • if you have diabetes, as your doctor may need to adjust your insulin dose or other blood sugar-lowering medicines;
  • if you have epilepsy, as your doctor will monitor you more closely. Treatment with FRIMAIND should be stopped if you experience a seizure or an increase in seizure frequency (see section 4);
  • if you are undergoing electroconvulsive therapy (ECT);
  • if you have bipolar disorder (manic-depressive illness), as rapid and unusual changes in thinking, physical hyperactivity, and excitement may occur during treatment with FRIMAIND. In such cases, discontinue treatment;
  • if you have eye problems such as certain types of glaucoma;
  • if you have previously had bleeding problems, or if you are taking medicines that affect blood clotting or increase the risk of bleeding (see section “Other medicines and FRIMAIND”), or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
  • if you are taking medicines containing buprenorphine. Using these medicines together with FRIMAIND may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and FRIMAIND”);
  • if you are elderly or have liver problems or severe kidney problems, as your doctor may need to adjust your dose;
  • if you are taking St. John’s Wort (Hypericum perforatum) products;
  • if you have low sodium levels in your blood. FRIMAIND may reduce blood sodium levels, causing weakness, confusion, or painful muscle stiffness. Inform your doctor if you experience these symptoms (see section 4);
  • if you have an abnormal heart rhythm or low levels of salts (potassium, magnesium) in your blood. In such cases, your doctor will correct these imbalances before starting treatment;
  • if you have or have had heart problems (bradycardia, uncompensated heart failure) or have recently had a heart attack (acute myocardial infarction);
  • if you suffer from psychosis with depression.

Medicines such as FRIMAIND (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.
If you begin to experience agitation, confusion, tremor, or sudden muscle contractions, you may be experiencing a rare condition called serotonin syndrome. Contact your doctor immediately. Do not stop FRIMAIND abruptly, as you may experience withdrawal symptoms (see section 3).
Suicidal thoughts and worsening of depression or anxiety disorders
If you are depressed and/or suffer from anxiety disorders, you may occasionally have self-harming or suicidal thoughts. These symptoms are more common during the first few weeks or immediately after starting treatment. For this reason, your doctor should monitor you closely, especially at the beginning of treatment or when your dose is changed.
You may be more likely to have such thoughts:

  • If you have previously had suicidal or self-harming thoughts.
  • If you are a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age.
  • If you have suicidal or self-harming thoughts at any time, contact your doctor or go immediately to hospital. You can get help by confiding in close family members or friends that you are depressed or suffering from anxiety, and by asking them to read this leaflet. You may ask them to

tell you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Children and adolescents
FRIMAIND must not normally be taken by children and adolescents under 18 years of age. In patients under 18, a higher frequency of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger) has been observed.
Nevertheless, your doctor may prescribe FRIMAIND to patients under 18 years of age if they consider it strictly necessary. If your doctor has prescribed FRIMAIND to a patient under 18 and you wish to obtain further information, contact your doctor again. You must inform your doctor if any of the above symptoms appear or worsen during FRIMAIND treatment in a patient under 18 years of age.
In addition, the long-term safety effects of FRIMAIND on growth, maturation, and cognitive and behavioural development have not yet been established in this age group.
Other medicines and FRIMAIND
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, inform your doctor if you are taking or have taken any of the following medicines.
Do not take FRIMAIND if you are taking:

  • medicines for depression called monoamine oxidase inhibitors (MAOIs), e.g. selegiline, moclobemide, as serious, potentially fatal side effects may occur, including serotonin syndrome (see section “Do not take FRIMAIND”);
  • buspirone, used to treat anxiety disorders;
  • linezolid (an antibiotic);
  • medicines for heart rhythm disorders or that may affect heart rhythm, such as class IA and III antiarrhythmics;
  • antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol);
  • tricyclic antidepressants, some antimicrobial agents (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine);
  • antimalarial treatments, particularly halofantrine;
  • certain antihistamines (astemizole, mizolastine). If you have any further doubts, contact your doctor.

Do not take this medicine together with sumatriptan and similar medicines used to treat headache (migraine), or with tramadol, used to treat pain, as this may increase the risk of adverse effects.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

  • Lithium and tryptophan (used to treat mental illnesses);
  • products containing St. John’s Wort (Hypericum perforatum), used for depression;
  • medicines used to thin the blood (anticoagulants) or medicines that may affect platelet function such as dipyridamole, ticlopidine, and acetylsalicylic acid;
  • medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs);
  • medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine, and haloperidol;
  • medicines used for depression (tricyclic antidepressants – desipramine, clomipramine, nortriptyline);
  • medicines that reduce potassium or magnesium levels in the blood;
  • medicines that may cause seizures such as:
    • some medicines used to treat depression (bupropion, tricyclic antidepressants, and selective serotonin reuptake inhibitors - SSRIs);
    • neuroleptics (phenothiazines, thioxanthenes, and butyrophenones) used to treat certain mental disorders;
    • tramadol, used to treat severe pain;
    • mefloquine, used to treat malaria;
  • flecainide, propafenone, used to treat heart rhythm disorders;
  • metoprolol, used to treat heart problems and high blood pressure;
  • cimetidine, lansoprazole, omeprazole, esomeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of FRIMAIND;
  • Medicines containing buprenorphine. These medicines may interact with FRIMAIND and cause symptoms such as involuntary rhythmic muscle contractions, including those controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience such symptoms.

FRIMAIND with food and alcohol
You must not drink alcohol while taking this medicine.
No effects of food on the absorption and other pharmacokinetic properties of citalopram have been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take FRIMAIND if you are pregnant or planning a pregnancy, unless your doctor considers it absolutely necessary.
If you take this medicine during pregnancy, avoid stopping treatment abruptly (see section “If you stop taking FRIMAIND”).
If you are taking FRIMAIND during the last months of pregnancy, inform your doctor, as your baby may experience certain symptoms at birth. These symptoms usually begin within the first 24 hours after birth. They include breathing difficulties, apnea, bluish skin colour (cyanosis), seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar (hypoglycaemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances.
If your baby has any of these symptoms at birth, contact your doctor immediately for advice.
Ensure that your midwife and/or doctor knows that you are taking citalopram.
Medicines such as FRIMAIND, when taken during pregnancy, especially towards the end of pregnancy, 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 bluish. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take FRIMAIND near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking FRIMAIND so they can advise you accordingly.
Breastfeeding
FRIMAIND passes into breast milk in small amounts. If you are taking citalopram, inform your doctor before starting breastfeeding.
Fertility
Citalopram has been shown in animal studies to affect sperm quality. This effect reverses upon discontinuation of treatment (see section “Possible side effects”).
Driving and using machines
This medicine may affect your ability to drive or operate machinery, as it may impair your judgment and reaction time in dangerous situations. Therefore, exercise caution before driving or operating machinery.
Excipients with known effects
FRIMAIND tablets contain:

  • Lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine;
  • Sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take FRIMAIND

Always take FRIMAIND exactly as directed by your doctor. If you have any doubts, you must consult your
doctor or pharmacist.
Dosage
Adults
Depression
The recommended dose is 20 mg per day. Your doctor may increase the dose up to a maximum of 40 mg per day.
Panic disorder
The initial dose for the first week is 10 mg per day; thereafter, the dose may be increased to 20 mg per day. Your doctor may increase the dose up to a maximum of 40 mg per day.
For panic disorders, treatment is long-term. Maintenance of clinical response has been demonstrated during prolonged treatment (1 year).
In cases of insomnia or severe restlessness, additional treatment with sedatives is recommended during the acute phase.
When deciding to discontinue treatment, doses should be gradually reduced to minimize withdrawal symptoms.
Elderly patients (over 65 years of age)
The initial dose should be halved compared to the recommended dose, e.g., 10–20 mg per day. Elderly patients should normally not receive more than 20 mg per day.
Patients with particular risk factors
Patients with liver problems should not receive more than 20 mg per day.
Patients with kidney problems should follow the minimum recommended dosage.
Use in children and adolescents under 18 years of age
FRIMAIND must not be given to children and adolescents under 18 years of age (see section “Warnings and precautions”).
If you take more FRIMAIND than you should
Contact your doctor or the nearest Emergency Department immediately. Bring the container and any remaining tablets with you. Symptoms of overdose may include drowsiness, coma, seizures, nausea or vomiting, and changes in heart rhythm.
If you forget to take FRIMAIND
Do not take a double dose to make up for the missed tablet.
If you stop taking FRIMAIND
Do not stop treatment with your medicine abruptly, as you may experience withdrawal symptoms. If you need to discontinue treatment, your doctor will gradually reduce your dose over a period of at least 1 or 2 weeks.
Withdrawal symptoms
When stopping FRIMAIND treatment, you may experience withdrawal symptoms. This is more likely if you stop treatment suddenly.
Some patients have experienced the following adverse effects within the first days after discontinuation of treatment:

  • Dizziness
  • Sensory disturbances (e.g., tingling or numbness in hands and feet, electric shock-like sensations)
  • Sleep disturbances (e.g., difficulty sleeping or abnormal dreams)
  • Agitation or anxiety
  • Nausea, vomiting
  • Tremor
  • Confusion
  • Sweating
  • Headache
  • Diarrhea
  • Palpitations
  • Emotional instability, irritability
  • Visual disturbances
    Usually, these symptoms are mild to moderate and generally resolve within a couple of weeks. However, in some patients, they may be more severe or last longer. If you need to discontinue treatment with your medicine, your doctor will gradually reduce your dose over a period of at least 1 or 2 weeks. If you experience severe withdrawal symptoms when stopping FRIMAIND, inform your doctor. If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Side effects are more likely to occur during the first two weeks of treatment.

If you experience any of the following symptoms while taking this medicine, or if you have thoughts of harming yourself or of suicide, contact your doctor immediately and stop taking FRIMAIND.

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

  • A seizure (convulsions), or, if you are epileptic, an increase in the number of seizures.
  • Feeling weak and confused with stiff, sore muscles. These symptoms may indicate that citalopram has reduced the sodium level in your blood.
  • Yellowing of the skin or whites of the eyes. These are signs of liver dysfunction/hepatitis.

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

  • A severe allergic reaction causing swelling of the face and throat, chest tightness, difficulty breathing or swallowing.
  • High fever, feeling agitated or confused, tremor, sudden muscle spasms. These symptoms may be signs of a rare condition called serotonin syndrome.
  • Rapid or irregular heartbeat, feeling faint. These may be symptoms of a life-threatening condition known as Torsade de Pointes.
  • Restlessness or difficulty sitting still. These effects are more likely during the first weeks of treatment.

Suicidal thoughts and worsening of depression or anxiety disorders
Thoughts of suicide or self-harm may occur or worsen during the first weeks of antidepressant treatment, until the antidepressant effect begins. Inform your doctor immediately if you experience any distressing thoughts or feelings.
Patients who are prone to panic attacks may experience a temporary increase in anxiety after starting treatment. This usually resolves within the first two weeks (see also section 2, "Suicidal thoughts and worsening of depression or anxiety disorders").
Contact your doctor immediately if any of the following effects occur.
The following side effects may occur:

Very common (may affect more than 1 in 10 people):

  • Drowsiness or difficulty sleeping;
  • Headache;
  • Nausea;
  • Dry mouth;
  • Increased sweating.

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

  • Weight loss;
  • Decreased appetite;
  • Abnormal dreams;
  • Anxiety, confusion;
  • Decreased sex drive;
  • Agitation, nervousness;
  • Abnormal orgasm in women;
  • Tingling sensations;
  • Tremor;
  • Dizziness;
  • Difficulty concentrating;
  • Ringing in the ears;
  • Fatigue, yawning, vomiting;
  • Constipation or diarrhoea;
  • Itching;
  • Muscle pain, joint pain;
  • Impaired sexual function in men (impotence, ejaculation disorders, failure to ejaculate).

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

  • Increased appetite;
  • Weight gain;
  • Aggressiveness;
  • Depersonalization;
  • Hallucinations;
  • A feeling of excitement leading to unusual behaviour (mania);
  • Fainting (syncope);
  • Dilated pupils (mydriasis);
  • Slow heartbeat (bradycardia);
  • Fast heartbeat (tachycardia);
  • Skin sensitivity to light;
  • Hives (urticaria);
  • Skin rash;
  • Hair loss;
  • Reddish spots on the skin (purpura);
  • Difficulty urinating;
  • Heavy and prolonged menstrual periods (menorrhagia);
  • Swelling due to fluid retention in the body (oedema).

Rare (may affect up to 1 in 1000 people):

  • Changes in taste;
  • Involuntary contractions, spasms, and other movement disorders (dyskinesia);
  • Bleeding;
  • Fever.

Frequency not known (frequency cannot be estimated from the available data):

  • Reduced number of platelets in the blood;
  • Inappropriate production of antidiuretic hormone (ADH), which regulates urine production;
  • Low levels of potassium in the blood (hypokalaemia), which may cause muscle weakness, cramps, or abnormal heart rhythm;
  • Panic attacks;
  • Teeth grinding (bruxism);
  • Restlessness;
  • Suicidal ideation, suicidal behaviour;
  • Seizures;
  • Extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity, and motor restlessness, or an urge or need to move to relieve an unpleasant sensation (akathisia);
  • Movement disorders;
  • Vision problems;
  • Heart rhythm disorders (prolongation of the QT interval, ventricular arrhythmias, including Torsade de Pointes), especially in women with low blood potassium levels or those who already have heart conditions;
  • Sudden drop in blood pressure when standing up (orthostatic hypotension);
  • Nosebleeds;
  • Gastrointestinal and rectal bleeding;
  • Abnormal results in liver function tests;
  • Bruising;
  • Angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty breathing and swallowing);
  • Persistent painful erection;
  • Abnormal milk secretion from the breasts in men;
  • Irregular menstrual periods in women (metrorrhagia);
  • Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, "Pregnancy, breastfeeding and fertility" for further information. An increased risk of bone fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FRIMAIND

Keep this medicine out of the sight and reach of children.
Do not use FRIMAIND after the expiry date which is stated on the carton or container after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FRIMAIND contains
FRIMAIND 20 mg Film-coated tablets

  • The active substance is citalopram. Each tablet contains: 24.98 mg of citalopram hydrobromide equivalent to 20 mg of citalopram. The other components are: maize starch, monohydrate lactose, microcrystalline cellulose, vinylpyrrolidone vinylacetate copolymer, glycerin, sodium croscarmellose, magnesium stearate. Coating film: titanium dioxide, hypromellose, polyethylene glycol 400.

FRIMAIND 40 mg Film-coated tablets

  • The active substance is citalopram. Each tablet contains: 49.96 mg of citalopram hydrobromide equivalent to 40 mg of citalopram. The other components are: maize starch, monohydrate lactose, microcrystalline cellulose, vinylpyrrolidone vinylacetate copolymer, glycerin, sodium croscarmellose, magnesium stearate. Coating film: titanium dioxide, hypromellose, polyethylene glycol 400.

Description of the appearance of FRIMAIND and contents of the pack
Film-coated tablet.
FRIMAIND 20 mg Film-coated tablets
Your medicine is a 20 mg film-coated tablet, available in packs of 28 tablets.
FRIMAIND 40 mg Film-coated tablets
Your medicine is a 40 mg film-coated tablet, available in packs of 14 tablets.

Marketing Authorization Holder
S.F. Group Srl – Via Tiburtina, 1143 - 00156 Roma – Italy

Manufacturer
20 mg film-coated tablets
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)
40 mg film-coated tablets
Special Product’s Line S.p.A.
Via Campobello, 15 – 00071 Pomezia (Rome) – Italy

PATIENT INFORMATION LEAFLET

FRIMAIND 40 mg/ml oral drops, solution

Citalopram hydrochloride
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

  • Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What FRIMAIND is and what it is used for

FRIMAIND contains the active substance citalopram hydrochloride, which belongs to a class of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs), which work by regulating mood.
This medicinal product is indicated for the treatment of the following disorders:

  • depression (endogenous depressive syndromes)
  • prevention of relapses and recurrent episodes of depression
  • anxiety disorders with panic attacks with or without agoraphobia (fear of open spaces).

2. What you should know before taking FRIMAIND

Do not take FRIMAIND if:

  • you are allergic to citalopram hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
  • the person taking the medicine is a child or adolescent under 18 years of age;
  • you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs). If you need to start treatment with an MAOI, wait at least 7 days after stopping treatment with FRIMAIND;
  • you are taking a reversible MAOI (RIMA); take FRIMAIND only after stopping the RIMA treatment for the time indicated in the package leaflet of that medicine;
  • you are taking irreversible MAOIs, including selegiline used to treat Parkinson’s disease, at doses exceeding 10 mg per day. In this case, wait at least 14 days after stopping the medicine before taking FRIMAIND;
  • you are using linezolid, a medicine used to treat infections;
  • you suffer from a heart rhythm disorder (prolonged QT interval or congenital long QT syndrome) or are taking medicines that may cause these conditions;
  • you are taking pimozide, used to treat certain mental disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking FRIMAIND.
Take this medicine with caution and inform your doctor in the following cases:

  • if you are elderly or suffer from kidney or liver problems. In these cases, your doctor will adjust the dose of the medicine (see section 3 “How to take FRIMAIND”);
  • if you suffer from panic attacks, as you may experience severe anxiety at the beginning of treatment (paradoxical anxiety);
  • if you have low sodium levels in the blood (hyponatremia), particularly if you are an elderly woman;
  • if you suffer from bipolar disorder, as rapid and unusual changes in thinking, physical hyperactivity, and excitement may occur during treatment with FRIMAIND. In this case, stop treatment;
  • if you suffer from epilepsy, as your doctor will monitor you more closely. Treatment with FRIMAIND must be stopped if you have a seizure or experience more frequent seizures than usual (see section 4);
  • if you suffer from diabetes, as your doctor may need to adjust the dose of insulin or other medicines used to lower your blood sugar levels;
  • if you have a blood clotting disorder and are at risk of bleeding (haemorrhage), and if you are taking medicines that worsen these problems (see section “Other medicines and FRIMAIND”) or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
  • if you are taking medicines containing buprenorphine. Using these medicines together with FRIMAIND may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and FRIMAIND”);
  • if you are undergoing electroconvulsive therapy (ECT);
  • if you are taking St. John’s Wort (Hypericum perforatum) products;
  • if you suffer or have suffered from heart problems (bradycardia, uncompensated heart failure) or have recently had a heart attack (acute myocardial infarction);
  • if you have low levels of potassium or magnesium in the blood. In such cases, your doctor will correct these imbalances before starting treatment with this medicine;
  • if you or someone in your family has a condition of the eye (closed-angle glaucoma);
  • if you suffer from psychosis with depression.

Medicines such as FRIMAIND (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially if you suffer from other mental disorders (psychiatric conditions), you may have thoughts of harming yourself or of suicide. For this reason, your doctor must monitor you closely, particularly at the beginning of treatment or when the dose is changed, if you have previously experienced such conditions, or if you are young (under 25 years of age). Inform your doctor immediately if you experience these symptoms or if someone caring for you notices changes in your behaviour.
It may be helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behaviour.
Within the first few weeks of treatment, you may experience restlessness, agitation, or an urge to move frequently accompanied by an inability to sit still or remain motionless. If you experience these symptoms, contact your doctor immediately.
Stop treatment with this medicine immediately and inform your doctor if you experience agitation, tremor, involuntary muscle contractions, or increased body temperature.
These may be symptoms of a condition called serotonin syndrome.

Children and adolescents
This medicine is normally contraindicated in children and adolescents under 18 years of age.
However, your doctor may prescribe FRIMAIND to patients under 18 years of age if they consider it the best treatment option. In such cases, inform your doctor if symptoms such as suicide attempts, suicidal ideation, or hostility appear or worsen during treatment with FRIMAIND in a patient under 18 years of age.

Other medicines and FRIMAIND
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking or have taken any of the following medicines.
Do not take FRIMAIND if you are taking the following medicines:

  • medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), as serious, even fatal, adverse effects may occur, including serotonin syndrome, such as moclobemide, or selegiline used to treat Parkinson’s disease (see sections “Warnings and precautions” and “Possible side effects”);
  • buspirone, used to treat anxiety disorders;
  • linezolid, an antibiotic;
  • class IA and III antiarrhythmics, medicines used for heart rhythm disorders;
  • phenothiazine antipsychotics, pimozide, and haloperidol, used to treat mental disorders;
  • tricyclic antidepressants, used to treat depression;
  • antimicrobial agents such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, used to treat infections;
  • antimalarials such as halofantrine, used to treat malaria;
  • antihistamines such as astemizole and mizolastine, used to treat allergies.

Do not take this medicine together with sumatriptan and similar medicines used to treat headache (migraine), or tramadol, used to treat pain, as this increases the risk of adverse effects.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

  • lithium and tryptophan, used to treat certain mental disorders;
  • products containing St. John’s Wort (Hypericum perforatum), used for depression;
  • medicines used to thin the blood (anticoagulants) or drugs that may affect platelet function such as dipyridamole, ticlopidine, and acetylsalicylic acid;
  • medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs);
  • medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine, and haloperidol;
  • medicines used for depression (tricyclic antidepressants – desipramine, clomipramine, nortriptyline);
  • medicines that reduce potassium or magnesium levels in the blood;
  • medicines that may provoke seizures such as:
    • certain medicines used to treat depression (bupropion, tricyclic antidepressants, and serotonin reuptake inhibitors - SSRIs);
    • neuroleptics (phenothiazines, thioxanthenes, and butyrophenones) used to treat certain mental disorders;
    • tramadol, used to treat severe pain;
    • mefloquine, used to treat malaria.
  • cimetidine, lansoprazole, omeprazole, esomeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of citalopram;
  • flecainide, propafenone, used to treat heart rhythm disorders;
  • metoprolol, used to treat heart problems and high blood pressure;
  • medicines containing buprenorphine. These medicines may interact with FRIMAIND and may cause symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience such symptoms.

FRIMAIND with food and alcohol
You must not drink alcohol during treatment with this medicine.
No effects of food on the absorption and other pharmacokinetic properties of citalopram have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take FRIMAIND during pregnancy unless absolutely necessary, as it may cause serious problems in your baby.
If you take this medicine during pregnancy, avoid abruptly stopping treatment (see section “If you stop taking FRIMAIND”).
If you have taken this medicine during the last stages of pregnancy, your baby may experience breathing difficulties, apnoea, bluish skin colour (cyanosis), seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar levels (hypoglycaemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances. These symptoms usually appear within the first 24 hours after the baby’s birth.
WHEN TAKEN DURING PREGNANCY, ESPECIALLY TOWARDS THE END, MEDICINES LIKE FRIMAIND 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 BLUISH. IF THIS HAPPENS TO YOUR BABY, CONTACT YOUR MIDWIFE AND/OR DOCTOR IMMEDIATELY.
If you take FRIMAIND near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking FRIMAIND so they can advise you on what to do.

Breastfeeding
FRIMAIND passes into breast milk in small amounts. If you are taking citalopram, inform your doctor before starting breastfeeding.

Fertility
Citalopram has been shown in animal studies to affect sperm quality. This effect disappears upon discontinuation of treatment (see section “Possible side effects”).

Driving and using machines
This medicine may impair your ability to drive or operate machinery, as it may reduce your judgment and reactivity in dangerous situations. Therefore, exercise caution before driving or operating machinery.

Important information about certain excipients
FRIMAIND oral drops, solution contains ethanol (ethyl alcohol) and sodium.

  • This medicine contains 74 mg of alcohol (ethanol) per ml, equivalent to 74 mg/ml (7.4% w/v). The amount in 1 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine.
    The small amount of alcohol in this medicine will not produce significant effects.

  • This medicine contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate: may cause allergic reactions (including delayed reactions).

3. How to take FRIMAIND

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take the drops once daily, after mixing them with a small amount of water, orange juice, or apple juice.
Do not stop treatment with FRIMAIND abruptly to avoid withdrawal symptoms (see section “If you stop taking FRIMAIND”).
Your doctor will adjust the dose according to your needs. Do not change the dose without consulting your doctor (see section “If you stop taking FRIMAIND”).

  • Treatment of depression: The recommended dose is 16 mg (8 drops) per day as a single dose. Your doctor may increase the dose up to a maximum of 32 mg (16 drops) per day, depending on your response to treatment. The effect of the medicine usually appears within 2–4 weeks after starting treatment, which should generally continue for 4–6 months for symptoms of bipolar disorder. If you suffer from recurrent unipolar depression, long-term maintenance treatment may be necessary to prevent relapse.
  • Treatment of anxiety disorders with panic attacks: The recommended initial dose is 8 mg (4 drops) per day for the first week of treatment. Afterwards, your doctor may increase the dose to 16 mg (8 drops) per day, up to a maximum of 32 mg (16 drops) per day, depending on your response to treatment. If you suffer from anxiety with panic attacks, treatment should be long-term (1 year). If you have insomnia or are very restless, your doctor may prescribe sedative medicines.

Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose by half, for example, from 8 mg (4 drops) up to 16 mg (8 drops) per day.
The maximum recommended dose is 16 mg per day.
Use in patients with liver problems (hepatic impairment)
If you have mild or moderate liver problems, the recommended initial dose is 8 mg (4 drops) per day for the first 2 weeks. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) per day, depending on your response to treatment.
If you have severe liver problems, your doctor will pay particular attention to dosing.
Use in patients with kidney problems (renal impairment)
If you have kidney problems, your doctor will prescribe the lowest recommended dose.
Use in patients with impaired drug metabolism (poor metabolizers of CYP2C19)
If you have impaired drug metabolism (poor metabolizer of CYP2C19), the recommended initial dose is 8 mg (4 drops) per day for the first two weeks of treatment.
Thereafter, your doctor may increase the dose up to a maximum of 16 mg (8 drops) per day, depending on your response to treatment.

If you take more FRIMAIND than you should
If you (or someone else) have taken an excessive dose of FRIMAIND, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (prolongation of QT interval, torsades de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (characterized by symptoms such as high fever, tremors, muscle contractions, and anxiety), agitation, reduced heart rate (bradycardia), dizziness, conduction block in the heart, changes in heart activity (prolongation of QRS complex), high blood pressure (hypertension), pupil dilation (mydriasis), stupor (state of unresponsiveness), sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis).

If you forget to take FRIMAIND
Do not take a double dose to make up for a forgotten dose.

If you stop taking FRIMAIND
Do not stop treatment with FRIMAIND suddenly or without first discussing it with your doctor.
When stopping treatment with this medicine, the following withdrawal symptoms may occur:

  • dizziness, sensory disturbances such as tingling sensations (paraesthesiae);
  • sleep disturbances such as difficulty falling asleep (insomnia) and vivid dreams;
  • agitation, anxiety, tremors, confusion;
  • nausea, vomiting, diarrhoea;
  • sweating, headache;
  • increased awareness of heartbeats (palpitations);
  • emotional instability, irritability;
  • visual disturbances.

These symptoms are usually mild to moderate in intensity and typically appear within the first few days after stopping treatment. They generally resolve on their own within 2 weeks, although they may occasionally be severe and last for a long time (2–3 months or more). Discontinuation of treatment should be carried out under medical supervision, with doses gradually reduced over weeks or months.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects occur mainly during the first or second week of treatment and usually diminish thereafter.
If you experience any of the following symptoms while taking this medicine, if you feel like harming yourself or have thoughts of suicide, contact your doctor immediately and stop taking FRIMAIND.

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

  • A seizure (convulsion), or, if you are epileptic, an increase in the number of seizures.
  • If you feel weak and confused with stiff, sore muscles. These symptoms may indicate that citalopram has reduced the amount of sodium in your blood.
  • If you notice yellowing of the skin or whites of the eyes, these may be signs of impaired liver function/hepatitis.

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

  • A severe allergic reaction causing swelling of the face and throat, chest tightness, difficulty breathing or swallowing.
  • High fever, feeling agitated or confused, tremor, sudden muscle spasms. These symptoms may indicate a rare condition called serotonin syndrome.
  • Rapid or irregular heartbeat, feeling faint—these may be symptoms of a life-threatening condition known as Torsade de Pointes.
  • Restlessness or difficulty sitting still. These effects are more likely during the first weeks of treatment.

Suicidal thoughts and worsening of depression or anxiety disorders
Thoughts about suicide or self-harm may occur or worsen during the first weeks of antidepressant treatment, until the antidepressant effect begins to take effect. Inform your doctor immediately if you experience any distressing thoughts or symptoms.
Patients who are prone to panic attacks may experience a temporary increase in anxiety after starting treatment. This usually resolves within the first two weeks (see also section 2 “Suicidal thoughts and worsening of depression or anxiety disorders”).
Contact your doctor immediately if any of the following side effects occur.
The following side effects may occur:

Very common (may affect more than 1 in 10 people):

  • Drowsiness, difficulty sleeping (insomnia);
  • Headache;
  • Nausea;
  • Dry mouth;
  • Increased sweating.

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

  • Decreased appetite, weight loss;
  • Agitation, reduced sex drive, anxiety, nervousness, confusion, abnormal orgasm in women, unusual dreams;
  • Tremor, tingling sensations (paraesthesia), dizziness, attention disturbances;
  • Perception of ringing or buzzing sounds in the ear (tinnitus);
  • Yawning;
  • Diarrhoea, vomiting, constipation;
  • Itching;
  • Pain in muscles and joints;
  • Sexual dysfunction in men (impotence, ejaculation disorders, failure to ejaculate);
  • Fatigue.

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

  • Increased appetite, weight gain;
  • Aggression, feeling detached from oneself (depersonalization), hallucinations, mania;
  • Temporary loss of consciousness (syncope);
  • Pupil dilation (mydriasis);
  • Slowed/increased heart rate (bradycardia/tachycardia);
  • Hives, skin rash, hair loss (alopecia), development of red skin spots and bleeding (purpura), skin reactions caused by sun exposure (photosensitivity reaction);
  • Difficulty urinating (urinary retention);
  • Prolonged and heavy menstrual bleeding in women (menorrhagia);
  • Swelling due to fluid accumulation (oedema).

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

  • Involuntary movements (dyskinesia);
  • Taste disturbances;
  • Bleeding (haemorrhage);
  • Fever.

Frequency not known (cannot be estimated from the available data):

  • Decreased number of platelets in the blood;
  • Inappropriate production of antidiuretic hormone (ADH), which regulates urine production;
  • Reduced potassium levels in the blood;
  • Panic attacks, restlessness;
  • Teeth grinding (bruxism);
  • Suicidal thoughts (suicidal ideation), suicidal behaviour;
  • Seizures;
  • Extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and contractions, feeling restless and inability to remain still even for a very short time (akathisia), movement disorders;
  • Visual disturbances;
  • Heart rhythm disorders (prolongation of the QT interval, ventricular arrhythmias, including Torsade de Pointes), particularly in women with low potassium levels in the blood or in those who already have heart conditions;
  • Sudden drop in blood pressure when standing up (orthostatic hypotension);
  • Nosebleeds (epistaxis);
  • Bleeding with stools (gastrointestinal haemorrhage including rectal bleeding);
  • Abnormal liver function tests;
  • Bruising (ecchymosis), swelling of the face, lips, mouth, tongue or throat that may cause difficulty breathing and swallowing (angioedema);
  • Irregular menstrual bleeding in women (metrorrhagia);
  • Prolonged and painful erection (priapism), sudden milk production from the mammary gland in men;
  • Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, “Pregnancy, breastfeeding and fertility” for further information. An increased risk of fractures has been reported following the use of FRIMAIND together with other antidepressant medicines known as tricyclic antidepressants (TCA).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FRIMAIND

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
The product should be used within 4 months after first opening the bottle. Any excess product must be
discarded.
Store the medicine below 25°C and in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What FRIMAIND contains

  • The active substance is citalopram hydrochloride. 1 ml (20 drops) of solution contains 44.48 mg of citalopram hydrochloride (equivalent to 40 mg of citalopram).
  • The other components are: Methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, ethanol 96 percent, methylcellulose, purified water.

Description of the appearance of FRIMAIND and contents of the pack
Carton box containing a 15 ml glass bottle of solution with a dropper cap.
Marketing Authorization Holder
S.F. Group Srl – Via Tiburtina, 1143 – 00156 Rome - Italy
Manufacturers
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)