FLUVOXAMINE EG

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluvoxamine EG 50 mg / 100 mg film-coated tablets

Generic medicine
Read all of this leaflet carefully before taking this medicine.
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 personally. Never give it to others. It may be harmful to other
people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Contents of this leaflet

1. What Fluvoxamine EG is and what it is used for
2. Before you take Fluvoxamine EG
3. How to take Fluvoxamine EG
4. Possible side effects
5. How to store Fluvoxamine EG
6. Further information

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

Fluvoxamine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs).
Fluvoxamine EG is used to treat:
Depression (major depressive episodes)
Obsessive-compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour; OCD). Obsessive-compulsive disorder (OCD) is an anxiety disorder.

2. Before taking Fluvoxamina EG

DO NOT take Fluvoxamina EG
if you are allergic (hypersensitive) to fluvoxamine or to any of the excipients in Fluvoxamina EG
(see section 6 “Other information” at the end of this leaflet).
if you are taking other medicines called monoamine oxidase inhibitors (MAO inhibitors), including
moclobemide (a medicine used to treat depression), or have taken them at any time within the previous
two weeks. Your doctor will advise you on how to start taking Fluvoxamina EG after stopping the MAO inhibitor.

Take special care with Fluvoxamina EG

Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may experience thoughts of harming yourself or suicide.
These effects may worsen when starting antidepressants, as all medicines of this type require time to take effect, usually about two weeks but sometimes longer.

You are more likely to have such thoughts:

• if you have previously had suicidal or self-harming thoughts.
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If at any time you experience thoughts of self-harm or suicide, seek immediate medical help
or go to hospital.
It may be helpful to inform a close friend or relative that you are depressed or suffering from anxiety disorders and ask them to read this leaflet. You may ask them whether they notice your depression or anxiety worsening, or if they observe any concerning changes in your behaviour.

Inform your doctor if you suffer from or have suffered from any medical condition, particularly the following:

Akathisia (inability to sit still) or psychomotor agitation (unpleasant inner restlessness associated with a constant need to move). You may develop an unpleasant or painful inner sensation of restlessness and a persistent urge to move. At the same time, you may be unable to sit or stand still. This is more likely to occur during the first weeks of treatment.

Reduced kidney or liver function. Your doctor may prescribe a lower dose of Fluvoxamina EG and monitor you closely.

if you have diabetes (when your blood sugar levels are too high). The dosage of your antidiabetic medicines may need adjustment. This is more likely to occur during the first weeks of treatment.

if you have had seizures (fits) due to epilepsy or other conditions. Treatment with Fluvoxamina EG may need to be discontinued if seizures occur or increase in frequency.

if you start experiencing symptoms such as fever, muscle stiffness, or involuntary muscle contractions, or changes in your mental state such as confusion, irritability, or extreme agitation; you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Although rare, these syndromes can lead to life-threatening conditions; seek immediate medical attention. Discontinuation of fluvoxamine treatment may be necessary.

Hyponatraemia (low sodium levels in the blood), which may cause symptoms such as nausea, vomiting, headache, and malaise (feeling unwell).

if you have a history of bleeding disorders or develop unusual bruising or bleeding.

if you are taking medicines that affect blood clotting (see section 3 “Taking Fluvoxamina EG with other medicines”).

if you have previously experienced mania. Symptoms include over-excitement, hyperactivity, excessive feelings of well-being and self-esteem, or agitation. If you experience a manic episode, contact your doctor immediately. Discontinuation of fluvoxamine treatment may be necessary.

if you are undergoing electroconvulsive therapy (ECT). Electroconvulsive therapy is used to treat depression. Consult your doctor.

if you have had a heart attack (acute myocardial infarction).

Children and adolescents
Fluvoxamina EG should generally not be used in children and adolescents under 18 years of age, except in patients who have had obsessive-compulsive disorder for more than 8 years.

You should also be aware that patients under 18 years of age taking this class of medicines have an increased risk of adverse effects, such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe Fluvoxamina EG to patients under 18 years of age if deemed strictly necessary. If your doctor has prescribed Fluvoxamina EG to a patient under 18 and you wish to obtain further information, please consult your doctor again. You should inform the doctor if any of the above symptoms appear or worsen during treatment with Fluvoxamina EG in patients under 18 years of age. Furthermore, the long-term safety effects of fluvoxamine on growth, maturation, and cognitive and behavioural development in this patient group have not yet been established.

Taking Fluvoxamina EG with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This includes herbal remedies, health foods, or supplements obtained without a prescription.

The following medicines may interact with or be affected by Fluvoxamina EG:

• Monoamine oxidase inhibitors (MAO inhibitors), medicines used to treat, for example, depression or Parkinson’s disease (see section 2: DO NOT take Fluvoxamina EG).
  You must not take these medicines at the same time as Fluvoxamina EG.

• Tricyclic antidepressants (to treat depression), e.g. clomipramine, imipramine, and amitriptyline.

• Neuroleptics (to treat mental disorders), e.g. clozapine and olanzapine.

Fluvoxamina EG may enhance the effect of certain medicines, possibly increasing the risk of adverse effects. These include:

• Tacrine (for the treatment of Alzheimer’s disease),
• Theophylline (for the treatment of asthma),
• Methadone (for treating drug dependence),
• Mexiletine (a heart medicine),
• Phenytoin, carbamazepine (for the treatment of epilepsy),
• Cyclosporine (to prevent rejection of transplanted organs),
• Warfarin (to prevent blood from clotting too easily),
• Thioridazine (for the treatment of mental disorders). Concomitant use of Fluvoxamina EG and thioridazine may cause cardiac toxicity.
• Propranolol (a medicine for high blood pressure).
• Medicines containing caffeine (such as stimulants or cold remedies).
• Ropinirole (a medicine for the treatment of Parkinson’s disease and restless legs syndrome).
• Terfenadine, astemizole (medicines for the treatment of hay fever) or cisapride (for the treatment of heartburn). Fluvoxamina EG must not be taken concurrently with some of these medicines due to possible effects on heart rhythm. A condition known as Torsades de Pointes may occur.
• Benzodiazepines such as triazolam, midazolam, alprazolam, and diazepam (anti-anxiety and/or sleeping medicines). The dose of these medicines may need to be reduced during treatment with Fluvoxamina EG.

The following medicines may enhance the effects of Fluvoxamina EG:

• other antidepressants such as other SSRIs,
• St. John’s wort,
• lithium,
• tryptophan (also used to treat sleep disorders),
• triptans (a group of medicines for the treatment of migraine).

Treatment with Fluvoxamina EG may increase the risk of bleeding when taken together with the following medicines:

• atypical antipsychotics and phenothiazines (medicines for mental disorders),
• painkillers and medicines for the treatment of arthritis (joint inflammation), e.g. acetylsalicylic acid and other anti-inflammatory medicines (NSAIDs).

Taking Fluvoxamina EG with food and drinks
Ask your doctor or pharmacist what you can eat and drink during treatment with Fluvoxamina EG.
You should avoid alcoholic beverages during treatment with Fluvoxamina EG.
A substance found in tea and coffee (caffeine) may have a stronger effect when taken during treatment with Fluvoxamina EG. This may cause tremors (shaking, especially in the hands), palpitations (sudden awareness of your heartbeat), nausea (feeling unwell), restlessness, and insomnia (difficulty sleeping). Drink less tea and coffee to avoid this.

Pregnancy, breast-feeding, and fertility

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine.

Pregnancy
Ensure that your midwife and/or doctor know that you are being treated with Fluvoxamina EG. Medicines such as Fluvoxamina EG, 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), causing the baby to breathe faster and appear bluish. 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 are pregnant and your doctor decides to treat you with Fluvoxamina EG during pregnancy, you will be closely monitored. It is possible that your baby may show symptoms known as withdrawal effects. These symptoms occur when fluvoxamine is administered to mothers during late pregnancy. See section 3 for more information on withdrawal reactions.

Breast-feeding
Small amounts of fluvoxamine may pass into breast milk. Do not use fluvoxamine if you are breast-feeding.

Fertility
In animal studies, fluvoxamine has shown a reduction in sperm quality. In theory, this could impair fertility, but no impact on human fertility has been observed so far.

Driving and using machines
Fluvoxamina EG has no effect on the ability to drive or operate machinery. However, some patients have experienced drowsiness while taking Fluvoxamina EG. If you experience these symptoms, do not drive or operate machinery.

3. How to take Fluvoxamina EG

Always take Fluvoxamina EG exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You must swallow the Fluvoxamina EG tablets whole, with water, without breaking, crushing, or chewing them.

Depression
In adults, the recommended initial dose is 50 or 100 mg as a single dose taken in the evening. The dose should be gradually increased until the effective dose is reached. The usual effective dose is 100 mg/day. The maximum daily dose for adults is 300 mg.
Doses exceeding 150 mg/day should be divided into 2 or 3 daily administrations.
You should continue treatment for at least 6 months after recovery from an episode of depression.
Fluvoxamina EG must not be administered to treat depression in individuals under 18 years of age.

Obsessive-Compulsive Disorder (OCD)
Adults
The usual initial dose of Fluvoxamina EG is 50 mg/day as a single dose, preferably taken in the evening. The dose should be gradually increased until the effective dose is reached. The maintenance dose usually ranges between 100 mg and 300 mg per day. The maximum daily dose for adults is 300 mg.
Doses exceeding 150 mg/day should be divided into 2 or 3 daily administrations.

Children over 8 years of age and adolescents
The initial dose of fluvoxamine for the treatment of OCD is 25 mg/day. This may be increased by 25 mg every 4–7 days until an effective dose is reached. The maximum dose must not exceed 200 mg/day.
Doses exceeding 50 mg/day should be divided into 2 daily administrations. If the two doses are not equal, take the larger dose at bedtime.

Elderly patients
If you are elderly, your doctor will increase the dose more gradually to determine the most effective dose for you.

Patients with impaired renal or hepatic function
If your kidney or liver function is impaired, you may be given a lower initial dose than indicated above. Your doctor will monitor you closely.

Please consult your doctor if you think the effect of Fluvoxamina EG is too strong or too weak.

If you take more Fluvoxamina EG than you should
If you take too many Fluvoxamina EG tablets, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: feeling unwell (nausea), illness (vomiting), loose stools (diarrhea), drowsiness (somnolence), dizziness, rapid heartbeat (tachycardia), slower than normal heartbeat (bradycardia), low blood pressure (hypotension), epileptic seizures (convulsions), and loss of consciousness (coma).

If you forget to take Fluvoxamina EG
Do not take a double dose to make up for a missed dose. Take the next dose at your usual time.
If you have missed several doses, consult your doctor.

If you stop taking Fluvoxamina EG
Do not stop treatment with Fluvoxamina EG unless your doctor tells you to do so.

Withdrawal reactions upon discontinuation of Fluvoxamina EG treatment
Withdrawal reactions often occur when stopping treatment with fluvoxamine. This generally applies to other medicines in this class (selective serotonin reuptake inhibitors).
Withdrawal reactions mostly occur when treatment is stopped abruptly (also refer to section 4 "Possible side effects"). The occurrence of a withdrawal reaction depends on several factors, for example:

• how long you have been taking Fluvoxamina EG,
• how much Fluvoxamina EG you have taken, and
• how quickly you reduced the dose of Fluvoxamina EG.

Symptoms of such a withdrawal reaction are usually mild to moderate, but may be severe in some patients. Typically, symptoms appear in the days immediately following discontinuation of treatment. They usually resolve spontaneously and disappear within 2 weeks. However, in some individuals, they may persist longer (2–3 months or more).

You must not stop treatment with Fluvoxamina EG abruptly. When stopping treatment, the dose of Fluvoxamina EG should be gradually reduced over several weeks or months to minimize the risk of withdrawal reactions (see also section 4 "Possible side effects").

If withdrawal symptoms occur during dose reduction of the tablets, your doctor may decide to taper the dose more gradually. If severe withdrawal symptoms occur after stopping fluvoxamine, contact your doctor. They may ask you to restart taking the tablets and then discontinue more slowly.

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

4. Possible adverse reactions

Like all medicines, Fluvoxamine EG can cause adverse reactions, although not everyone experiences them.
The assessment of adverse reactions is based on the following frequency data:

The following adverse reactions have been reported:
Common
sudden awareness of heartbeat (palpitations)/faster than normal heartbeat (tachycardia)
headache
dizziness
drowsiness (somnolence)
tremor, especially in the hands or limbs (tremor)
stomach ache (abdominal pain)
difficulty passing stools (constipation)
loose stools (diarrhea)
dry mouth
indigestion (dyspepsia)
sweating
loss of appetite (anorexia)
lack of energy and strength (asthenia)
feeling of general discomfort (malaise)
agitation
anxiety
difficulty sleeping (insomnia)
nervousness

Uncommon
uncontrolled muscle movements and instability (ataxia)
unusual physical and mental symptoms (extrapyramidal symptoms) such as: instability (tremors), inability to speak clearly (dysarthria), unpleasant inability to remain still/restlessness (akathisia), inability to move, rigidity (akinesia), abnormal movements especially of the lips, mouth and tongue;
abnormal posture (dystonia)
skin allergic reactions (cutaneous hypersensitivity reactions), including skin rash, itching (pruritus), swelling of lips and tongue (angioedema)
joint pain (arthralgia)
muscle pain (myalgia)
low blood pressure leading to dizziness or fainting when standing up suddenly (orthostatic hypotension)
delayed ejaculation
confusion
visual/sensory/auditory perception of things that are not really present (hallucinations)

Rare
epileptic seizures (convulsions)
unpleasant or painful restlessness with a need to move frequently, accompanied by inability to sit or stand still (psychomotor agitation/akathisia)
a series of adverse effects (serotonin syndrome or neuroleptic malignant syndrome); for symptoms, see section 2 “Watch out with Fluvoxamina EG”)
increased sensitivity to sunlight (photosensitivity)
syndrome of inappropriate antidiuretic hormone secretion [SIADH]/low sodium levels in the blood (hyponatremia)
bleeding (haemorrhage)
abnormal liver function
sudden or excessive production of breast milk, regardless of whether or not you are breastfeeding (galactorrhea)
mental excitement (mania)

Very rare
abnormal skin sensations, such as numbness, tingling (paresthesia)
changes in taste sensation when eating and drinking
inability to achieve orgasm (anorgasmia)

Frequency not known
weight gain or weight loss
feeling unwell (nausea), sometimes accompanied by malaise (vomiting)
bleeding
suicidal thoughts and behaviours. Cases of suicidal ideation and behaviour have been reported during treatment with fluvoxamine or immediately after treatment discontinuation (see section 2 “Watch out with Fluvoxamina EG”).

The following adverse reactions have additionally been observed in clinical studies in children and adolescents with OCD: sleep disturbances (insomnia), lack of strength and energy (asthenia), abnormally increased muscle activity (hyperkinesia), drowsiness (somnolence), indigestion (dyspepsia), agitation, a mood state characterised by persistent and generalised feelings of euphoria or irritability and related thoughts and behaviours (hypomania), epileptic seizures (convulsions).

Bone fractures
An increased risk of fractures has been observed in patients taking this type of medicine.

Withdrawal reactions upon discontinuation of Fluvoxamina EG treatment
Withdrawal reactions may frequently occur upon stopping treatment. After taking Fluvoxamina EG, these mostly consist of:
dizziness, sensory disturbances (including paresthesias, visual disturbances and sensations of “electric shocks”), sleep disturbances (such as insomnia and vivid dreams)
agitation or anxiety
irritability, confusion or emotional instability
nausea and/or vomiting, diarrhea
sweating
abnormal awareness of heartbeat (palpitations)
tremors and headache.

Generally, these symptoms are mild to moderate in intensity and resolve spontaneously. However, in some patients they may be severe and persist for a longer time. Therefore, it is recommended to gradually reduce the dose once treatment with Fluvoxamina EG is no longer needed.

If any of the adverse effects worsen, or if you notice any adverse effects not listed in this leaflet, please inform your doctor or pharmacist.

5. How to store Fluvoxamine EG

Keep Fluvoxamine EG out of the reach and sight of children.
Do not use Fluvoxamine EG after the expiry date stated on the pack. The expiry date refers to the last day of the month.
Do not store Fluvoxamine EG above 25°C.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What Fluvoxamina EG contains
The active substance is fluvoxamine maleate.
Each tablet of Fluvoxamina EG 50 mg contains 50 mg of fluvoxamine maleate.
Each tablet of Fluvoxamina EG 100 mg contains 100 mg of fluvoxamine maleate.

The excipients are:
Corn starch
Anhydrous colloidal silica
Pregelatinized starch
Sodium stearyl fumarate
Mannitol
Macrogol 6000
Talc
Titanium dioxide (E 171)
Hypromellose

Description of the appearance of Fluvoxamina EG tablets and packaging contents
Fluvoxamina EG 50 mg tablets are available as film-coated, round, biconvex tablets, white to almost white in colour, with a score line on both sides and marked "FLM 50".
Fluvoxamina EG 100 mg tablets are available as film-coated, round, biconvex tablets, white to almost white in colour, with a score line on both sides and marked "FLM 100".
The tablets are supplied in plastic and aluminum blisters. Pack sizes of 10, 15, 20, 28, 30, 50, 56, 60, 90, 100, 250, 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via D. Scarlatti, 31 – 20124 Milano, Italy

Manufacturers
STADA Arzneimittel AG, Stadastraße 2-18 - 61118 Bad Vilbel, Germany
SYNTHON B.V., Microweg 22 - 6545 CM Nijmegen, The Netherlands

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
BE: Fluvoxamine EG 100mg
LU: Fluvoxamine EG 100mg
DE: Fluvoxamin STADA 50mg/100mg Filmtabletten
FI: Fluvosol 50mg/100mg tabletti kalvopäällysteinen
IT: Fluvoxamina EG 50mg/100mg
NL: Fluvoxaminemaleaat CF 50mg/100mg

This patient information leaflet was last reviewed on