Prospect: information for the user

Fluvoxamine Sandoz 50 mg film-coated tablets EFG

Fluvoxamine Sandoz 100 mg film-coated tablets EFG

Fluvoxamine maleate

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

1.What is Fluvoxamine Sandoz and for what it is used

2.What you need to know before starting to take Fluvoxamine Sandoz

3How to take Fluvoxamine Sandoz

4Possible adverse effects

5.Storage of Fluvoxamine Sandoz

6.Contents of the package and additional information

Fluvoxamina Sandoz belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Fluvoxamina Sandoz contains a substance called fluvoxamine. This is an antidepressant.

It is used for the treatment of depression (major depressive disorder).

Fluvoxamina Sandoz may also treat individuals who suffer from obsessive-compulsive disorder (OCD).

Do not take Fluvoxamina Sandoz if:

If any of the above circumstances apply to you, do not take fluvoxamine and consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Fluvoxamina Sandoz if:

• You have had a heart attack recently,
• You are pregnant, or think you may be,
• You have epilepsy,
• You have a history of bleeding problems or if you take regularly medicines that increase the risk of bleeding, such as analgesics, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”),
• You have diabetes,
• You are undergoing electroconvulsive therapy (ECT),
• You have a history of having had mania (feeling of euphoria or overexcitement),
• You have liver or kidney insufficiency,
• You have high eye pressure (glaucoma),
• You are under 18 years old (see also section 3),
• You are taking medicines containing buprenorphine or buprenorphine/naloxone, as these products taken in combination with fluvoxamine may cause serotonin syndrome, a potentially fatal condition (for symptoms, see section 4, "Possible side effects") and also "Other medicines and Fluvoxamina Sandoz".

If any of the above circumstances apply to you, your doctor will tell you if it is safe to start with fluvoxamine.

Medicines like Fluvoxamina Sandoz (called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms have continued after stopping treatment.

In some cases, agitation ideas, cannot sit or stay still (akathisia) may occur in the first weeks of fluvoxamine treatment until the antidepressant effect is produced.

Inform your doctor immediately if you have these symptoms. It may be helpful to adjust the dose.

Severe skin reactions have been reported when using fluvoxamine. Stop taking fluvoxamine and contact a doctor immediately if you develop a rash or ulcers in the mucous membranes. Severe rashes may include skin rashes that start on the hands, feet, arms, or legs, usually on both sides of the body and evolving in concentric circles that resemble erythema (erythema multiforme), generalised rashes with blisters and skin peeling, which occur mainly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), extensive skin peeling (more than 30% of the body surface - toxic epidermal necrolysis).

Thoughts of suicide and worsening of your anxiety or depression:

If you are depressed and/or experiencing anxiety, you may experience thoughts of self-harm or suicide. This may increase when starting antidepressant treatment, as these medicines take time to work, usually two weeks, but sometimes longer.

You may think like this:

• If you have had thoughts of suicide or self-harm before,
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults under 25 years with psychiatric disorders treated with an antidepressant.

If you have thoughts of self-harm or suicide, inform your doctor immediately or go directly to a hospital.

It may be very helpful to tell a family member or friend that you are depressed or have anxiety, and ask them to read the leaflet.

You can ask them for their opinion on whether you are getting worse with your depression or anxiety, or if they are concerned about the changes in your behaviour.

Inform your doctor immediately if you have thoughts or experiences that cause you distress.

Children and adolescents under 18 years old

Children and adolescents under 18 years old should not take this medicine, unless they are being treated for obsessive-compulsive disorder (OCD). This is because fluvoxamine is not used to treat depression in people under 18 years old.

When taking this type of medicine, patients under 18 years old have a higher risk of side effects such as suicidal thoughts, suicidal attempts, and hostility, such as aggression, confrontational behaviour, and irritability.

If your doctor has prescribed fluvoxamine to a patient under 18 years old and wants to discuss this decision, go back to your doctor. If a patient under 18 years old is taking fluvoxamine, inform your doctor if any of the symptoms mentioned above worsen or if you have complications.

There is no information on the long-term safety of fluvoxamine in patients under 18 years old regarding growth, maturation, and intellectual and behavioural development.

Other medicines and Fluvoxamina Sandoz

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

• Do not start taking St. John's Wort if you have been prescribed fluvoxamine, as it may increase the risk of side effects. If you are already taking St. John's Wort when starting fluvoxamine treatment, stop taking St. John's Wort and consult your doctor at your next visit.
• If you have been taking a medicine to treat depression or anxiety in the last two weeks or have schizophrenia, consult your doctor or pharmacist.

Your doctor or pharmacist should know if you are taking other medicines to treat depression or related conditions that contain:

• Benzodiazepines,
• Tricyclic antidepressants,
• Neuroleptics or antipsychotics,
• Lithium,
• Tryptophan,
• MAOIs such as moclobemide,
• Pimozide,
• SSRIs such as citalopram.

Your doctor will tell you if it is safe for you to start treatment with fluvoxamine.

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Aspirin (acetylsalicylic acid) or similar medicines used to treat pain and inflammation (arthritis),
• Ciclosporin, used to reduce the activity of the immune system,
• Metadone, used to treat pain and withdrawal syndrome,
• Mexiletine, used to treat heart rhythm disorders,
• Phenytoin or carbamazepine, used to treat epilepsy,
• Propranolol, used to treat high blood pressure and heart disorders,
• Ropinirol, for Parkinson's disease,
• A “triptan”, used to treat migraines, such as sumatriptan,
• Terfenadine, used to treat allergies. Fluvoxamine should not be used with terfenadine,
• Sildenafil, used to treat erectile dysfunction,
• Theophylline, used to treat asthma and bronchitis,
• Tramadol, used to treat pain,
• Buprenorphine or buprenorphine/naloxone,
• Clopidogrel, warfarin, acenocoumarol, or any anticoagulant.

If you are taking or have taken recently any of the medicines listed above and have not informed your doctor, go back to your doctor and ask what you should do. You may need to change your dose or take a different medicine.

Taking Fluvoxamina Sandoz with food, drinks, and alcohol

• Do not take alcoholic beverages while taking this medicine. Alcohol may interact with fluvoxamine and cause drowsiness and instability.
• If you normally drink a lot of tea, coffee, or soft drinks with caffeine, you may experience symptoms such as shaky hands, discomfort, rapid heartbeat (palpitations), restlessness, and difficulty sleeping (insomnia). If you reduce the amount of caffeine you drink, these symptoms may disappear.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

There is limited experience with the use of fluvoxamine during pregnancy.Do not take fluvoxamine if you are pregnant unless your doctor considers it absolutely necessary. If you are currently taking fluvoxamine and are planning to become pregnant, please consult your doctor to decide whether it is necessary or appropriate to change your medication.

Make sure your midwife and/or doctor know that you are being treated with fluvoxamine. If you take it during pregnancy, especially in the last 3 months of pregnancy, medicines like fluvoxamine may increase the risk of a serious condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should inform your midwife and/or doctor immediately.

Do not stop treatment with fluvoxamine suddenly. If you have been taking fluvoxamine for the last 3 months of pregnancy, your baby may have other symptoms at birth in addition to difficulty breathing or blue skin, such as being unable to sleep or feed properly, being too hot or cold, feeling unwell, crying a lot, stiff or floppy muscles, lethargy, drowsiness, trembling, becoming nervous or having seizures.

If your baby has any of these symptoms at birth, consult your doctor immediately.

If you take Fluvoxamina Sandoz in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Fluvoxamina Sandoz to be able to advise you.

Breastfeeding

Fluvoxamine passes into breast milk. There is a risk that it may affect the baby. Therefore, discuss with your doctor whether you should stop breastfeeding or stop taking fluvoxamine.

Driving and using machines

You can drive and use machines while taking this treatment, as long as this medicine does not cause drowsiness.

Fluvoxamina Sandoz contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Usual initial dose for adults (18 years and older)

Treatment of depression

• Start with 50 or 100 mg daily, taken at night.

Treatment of obsessive-compulsive disorder

• Start with 50 mg daily, preferably taken at night.

If you do not start feeling better after two weeks, consult your doctor, who will advise you and decide if you need to increase your dose gradually.

The maximum recommended daily dose is 300 mg.

If your doctor tells you to take more than 150 mg a day,do not takeit all at once, consult your doctor when to take it.

Usual dose in children and adolescents with obsessive-compulsive disorder (8 years and older):

• Start with 25 mg (half a tablet) a day. Your doctor may increase the dose every 4-7 days by 25 mg as tolerated until an effective dose is reached.
• The maximum daily dose is 200 mg.

If your doctor tells you to take more than 50 mg a day, do not take it all at once, consult your doctor when to take it. If not divided into equal doses, the larger dose should be taken at night.

Children and adolescents under 18 yearsshould not takethis medication for depression. This medicationshould onlybe prescribed for children and adolescents with obsessive-compulsive disorder (OCD).

How to take Fluvoxamine Sandoz

Swallow the tablets with water.Do notchew the tablets.

You can break the tablets in half if your doctor has told you to do so.

When it takes effect

Fluvoxamine takes some time to take effect. Some patients do not feel better during the first 2 or 3 weeks of treatment.

Continue taking thetablets until your doctor tells you to stop. Although you may feel better, your doctor may advise you to continue taking the tablets for some time longer, at least six months, to ensure that the medication has worked completely.

Do notstop treatment with fluvoxamine abruptly. You may experiencewithdrawal symptomssuch as:

• agitation and anxiety,
• confusion,
• diarrhea,
• difficulty falling asleep/intense dreams,
• dizziness,
• emotional instability,
• headache,
• irritability,
• nausea and/or vomiting,
• palpitations (rapid heart rate),
• sensorial disturbances (such as electric shock sensation or visual disturbances),
• sweating,
• tremors.

Your doctor will help you reduce your dose gradually over weeks or months, which will help reduce the likelihood of experiencing withdrawal symptoms. Most patients find that these withdrawal symptoms from fluvoxamine are mild and will disappear on their own within two weeks, however, for some patients, these symptoms may be more severe or last longer.

If you experience withdrawal symptoms when stopping the tablets, your doctor will decide if you should stop them more slowly. If you experience severe withdrawal symptoms when stopping fluvoxamine, please inform your doctor, who will advise you to restart treatment and taper it off gradually (see section 4 “Possible side effects”).

If you experience any symptoms when stopping treatment,contactyour doctor.

If you take more Fluvoxamine Sandoz than you should

If you have taken more fluvoxamine than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. Bring the packaging of the medication with you.

The symptoms of overdose include, but are not limited to, nausea, vomiting, diarrhea, and a feeling of drowsiness or dizziness. Cardiac symptoms (slow or rapid heart rate, low blood pressure), liver complications, seizures (convulsions), and coma have been reported.

If you forgot to take Fluvoxamine Sandoz

If you forget to take a tablet, wait until the next dose. Do not take a double dose to compensate for the missed dose.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Side effects related to this type of medication

In some cases, you may experience or have an increase insuicidal thoughts or self-harmduring the first weeks of treatment with fluvoxamine, until the antidepressant effect occurs.

Inform your doctor immediatelyif you have anxious thoughts or experiences.

Ifyou have several symptoms at the same timeyou may have one of the rare conditions described below:

Stop taking fluvoxamineand consult your doctor immediately.

If you experience unusual bruises or purple rashes on your skin or if you vomit blood or have blood in your stool, contact your doctor.

Stopping fluvoxamine (especially when done abruptly) often leads to withdrawal symptoms (see section 3 withdrawal symptoms).

Occasionally, patientsexperience nauseawhen starting treatment with fluvoxamine, which begins to take effect. Although the sensation of nausea is unpleasant, it should pass over time if you continue taking the tablets as prescribed. This may occur a few weeks after starting treatment.

Side effects caused by fluvoxamine

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

• Anxiety,
• Restlessness,
• Constipation,
• Diarrhea,
• Difficulty falling asleep,
• Dizziness,
• Dry mouth,
• Increased heart rate,
• Sleepiness (lethargy),
• Uncomfortable feeling,
• Headache,
• Indigestion,
• Loss of appetite,
• Nervousness,
• Abdominal pain,
• Sweating,
• Tremors,
• Weakness (asthenia),
• Vomiting,

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

• Allergic reactions (including swelling of the face, lips or tongue, hives, itching),
• Confusion,
• Aggression
• Delayed ejaculation,
• Dizziness when standing up/rapidly getting up,
• Hallucinations,
• Lack of coordination,
• Muscle or joint pain.

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

• Seizures,
• Liver problems,
• Mania (feeling of euphoria or overexcitement),
• Sensitivity to sunlight,
• Unintended milk secretion.

Unknown frequency (cannot be estimated from available data):

Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation and fertility" in section 2 for more information.

Other reported adverse reactions:

-Acatisia (restlessness),

-Abnormal taste,

-Anorgasmia (inability to achieve orgasm),

-For female patients: menstrual disorders (menstruation),

-Urinary disorders (such as frequent urination during the day and/or night, sudden loss of bladder control during the day and/or night, or inability to urinate),

-Paresthesia (tingling or numbness),

-Glaucoma (increased eye pressure),

-Dilated pupils,

-Increased prolactin hormone (a hormone that supports milk production in a lactating mother),

-Weight changes.

A higher risk of bone fractures has been observed in patients taking this type of medication.

Adverse reactions related to treatment for obsessive-compulsive disorder (OCD), in children and adolescents, whose frequency is not established.

• Hypomania (feeling of euphoria and overexcitement),
• Agitation,
• Seizures,
• Difficulty falling asleep (insomnia),
• Lack of energy (asthenia),
• Hypervigilance (hyperkinesia),
• Sleepiness (somnolence),
• Indigestion.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C. Store in the original packaging.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Fluvoxamine Sandoz 50 mg

• The active ingredient is fluvoxamine (as maleate). Each film-coated tablet contains 50 mg of fluvoxamine (as maleate).

Composition of Fluvoxamine Sandoz 100 mg

• The active ingredient is fluvoxamine (as maleate). Each film-coated tablet contains 100 mg of fluvoxamine (as maleate).

The other components are:

• Tablet core: maize starch, mannitol (E 421), pregelatinized maize starch, anhydrous colloidal silica, sodium stearyl fumarate.
• Tablet coating: macrogol 6000, talc (E 553b), titanium dioxide (E 171), hypromellose (E 464).

Appearance of the product and contents of the package

Fluvoxamine Sandoz 50 mg:

They are white to off-white, round, biconvex, scored, and marked with “FLM 50” on one side.

Fluvoxamine Sandoz 100 mg:

They are white to off-white, round, biconvex, scored, and marked with “FLM 100” on one side.

This product is presented in ALU/PVC/PVDC blisters introduced in a cardboard box.

Package sizes:

10, 20, 30, 50, 60, 90, 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

Netherlands

or

Synthon Hispania, S.L.

Castello, 1

Poligono Las Salinas

08830 Sant Boi de Llobregat

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Fluvoxaminemaleaat Sandoz 50

Fluvoxaminemaleaat Sandoz 100

Last review date of thisleaflet:January 2024

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