Andepin

Package Leaflet: Information for the Patient

Andepin, 20 mg, Hard Capsules

Fluoxetine

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Table of Contents of the Leaflet

• 1. What is Andepin and What is it Used For
• 2. Important Information Before Taking Andepin
• 3. How to Take Andepin
• 4. Possible Side Effects
• 5. How to Store Andepin
• 6. Contents of the Pack and Other Information

1. What is Andepin and What is it Used For

Andepin contains fluoxetine, which is an antidepressant. The mechanism of action of fluoxetine is based on the inhibition of serotonin reuptake by neurons of the central nervous system.
After oral administration, fluoxetine is well absorbed from the gastrointestinal tract. The maximum concentration in blood plasma is reached 6 to 8 hours after a single oral dose.
In the body, it undergoes metabolism, with one of the active metabolites being a demethylated derivative - norfluoxetine.
The effect of fluoxetine usually occurs after a few weeks of taking the medication.
The therapeutic concentration of the medication is maintained for several weeks after the end of treatment.
Indications for the use of Andepin:

• depressive disorders;
• obsessive-compulsive disorder;
• bulimia (psychic gluttony).

2. Important Information Before Taking Andepin

When Not to Take Andepin:

This medication should not be taken if the patient is allergic to fluoxetine or any of its other ingredients (listed in section 6).
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Andepin should not be taken simultaneously with monoamine oxidase inhibitors (MAO), either selective (e.g., selegiline) or reversible, known as RIMA (e.g., moclobemide), as it may cause symptoms similar to those of serotonin syndrome.
As a result of the interaction between fluoxetine and MAO inhibitors, symptoms such as:
hyperthermia (elevated body temperature), stiffness, autonomic nervous system disorders, myoclonus (sudden, short-term muscle contractions), coordination disorders, emotional instability, which includes: irritability, confusion (disorientation with anxiety and fear) and extreme agitation leading to delirium (hallucinations) or coma may occur. Therefore, fluoxetine cannot be taken with MAO inhibitors and at least 14 days after stopping their administration. The period after stopping fluoxetine and starting MAO inhibitors should be at least 5 weeks (in the case of long-term use of fluoxetine or administration of high doses of the medication, a longer than 5-week break should be maintained before taking MAO inhibitors).

Warnings and Precautions

Before starting Andepin, consult your doctor or pharmacist.
Particular caution should be exercised when taking Andepin:

• if a rash or other allergic reactions occur (e.g., itching, swelling of the lips or face, shortness of breath), discontinue the medication and contact your doctor immediately;
• if epilepsy or seizure disorders have been diagnosed; if a seizure occurs or the frequency of seizures increases, contact your doctor immediately, as it may be necessary to discontinue fluoxetine;
• if manic episodes have occurred in the past; in the event of a manic episode, contact your doctor immediately, as it may be necessary to discontinue fluoxetine;
• if diabetes has been diagnosed; it may be necessary to adjust the dose of insulin or other antidiabetic medications;
• if liver function disorders have been diagnosed (it may be necessary to adjust the dose of the medication);
• if heart disease has been diagnosed;
• if the patient is taking diuretics, especially in the elderly;
• if the patient is undergoing electroconvulsive therapy;
• if bleeding or bruising has occurred in the past or if unusual bleeding occurs;
• if medications that affect blood clotting are being taken concurrently;
• if fever, stiffness, or muscle tremors occur, or if there is a change in the state of consciousness, such as disorientation, irritability, and extreme agitation; serotonin syndrome or malignant neuroleptic syndrome may occur. Although this syndrome is rare, it may be necessary to discontinue fluoxetine;
• if suicidal thoughts or self-harm occur.

In patients with depression or anxiety disorders, suicidal thoughts or self-harm may sometimes occur. This condition may worsen when the patient first starts taking antidepressants and may persist until the medication starts to work, which usually happens after two weeks of treatment, although sometimes later.
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Such thoughts are more common in patients who:

• have had suicidal thoughts or self-harm in the past,
• are young adults. The risk of suicidal behavior in people under 25 with mental disorders treated with antidepressants is higher. If a patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or the nearest hospital. It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to provide information if they notice that the depression or anxiety has worsened, or if they are concerned about the patient's behavior. If disturbing changes in behavior occur, the doctor should be notified immediately or the patient should go to the nearest hospital.

Other Medications and Andepin

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Interactions may occur when taking MAO inhibitors (used to treat depression) (see "When Not to Take Andepin").
It has been observed that fluoxetine may increase the concentration in the blood of certain medications that act on the central nervous system, such as: carbamazepine, haloperidol, clozapine, diazepam, alprazolam, lithium, phenytoin, and tricyclic antidepressants. An increase in the effect of fluoxetine has been noted when tryptophan is administered concurrently.
Taking medications such as flecainide or encainide (medications used for heart conditions), vinblastine, carbamazepine (antiepileptic medications), and tricyclic antidepressants (e.g., imipramine, desipramine, and amitriptyline) concurrently with fluoxetine or up to the fifth week after its discontinuation may require a reduction in the dose of these medications.
Similarly, as with other medications, when fluoxetine is administered concurrently with warfarin or other anticoagulant medications, caution should be exercised.
There have been rare reports of seizures in patients undergoing concurrent therapy with fluoxetine and electroconvulsive therapy. Therefore, caution should be exercised when using both treatment methods concurrently.
Like most selective serotonin reuptake inhibitors, fluoxetine should not be administered concurrently with herbal preparations containing St. John's Wort (Hypericum perforatum), as this may lead to an increase in adverse effects.

Andepin with Food, Drink, and Alcohol

Andepin can be taken before, during, or after a meal.
Do not drink alcohol during treatment.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medication.
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Driving and Operating Machinery

Although fluoxetine has not been shown to affect psychomotor abilities in healthy volunteers, you should avoid driving and operating machinery in traffic until you are sure that your behavior and reflexes have not deteriorated.

Andepin Contains Lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medication.

The Medication Contains Tartrazine (E 104)

The medication may cause allergic reactions.

3. How to Take Andepin

This medication should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
In depressive disorders, the recommended dose is 1 capsule (20 mg) per day.
In obsessive-compulsive disorder, the recommended dose is 1 to 3 capsules (20 mg to 60 mg) per day. The initial dose should be 1 capsule per day, and after several weeks of treatment, the doctor may increase the dose to 3 capsules per day.
In bulimia, the recommended dose is 3 capsules (60 mg) per day.
Do not exceed the dose of 4 capsules (80 mg) per day.
In elderly patients, the dose should be increased with caution by the doctor. Generally, the daily dose should not exceed 40 mg. The maximum dose is 60 mg per day.
In patients with liver failure, the recommended daily doses should be lower or the intervals between doses should be longer.
In patients with renal failure and those undergoing dialysis, the recommended daily doses should also be lower or the intervals between doses should be longer (the concentration of fluoxetine and its metabolites in the blood is similar to that in healthy individuals).

Method of Administration

The medication is taken orally.
Swallow the capsules with a sufficient amount of liquid, e.g., a glass of water.
The medication should be taken at regular intervals.
If you feel that the effect of the medication is too strong or too weak, contact your doctor.

Use in Children

Andepin is not recommended for children.

Taking a Higher Dose of Andepin Than Recommended

In the event of taking a higher dose than recommended, go to the emergency room or the outpatient clinic of the nearest hospital or contact your doctor. If possible, take the packaging of Andepin with you. Symptoms of overdose include: nausea, vomiting, seizures, heart problems, agitation to coma. In the event of an overdose, monitoring of vital functions and symptomatic treatment is recommended. Activated charcoal with sorbitol should be administered.
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Missing a Dose of Andepin

Continue taking the medication as directed by your doctor. Do not take a double dose to make up for a missed dose.

Stopping Andepin

Do not stop taking Andepin without consulting your doctor, even if you feel better.
Make sure you always have enough medication to continue treatment.
After stopping treatment, withdrawal symptoms may occur, such as: dizziness, restlessness, fatigue or weakness, headache, sleep disturbances (nightmares, insomnia), paresthesia (tingling, prickling), nausea or vomiting. Most of these are mild and resolve on their own within a few weeks. If you experience any symptoms after stopping treatment, contact your doctor.
In the event of discontinuing Andepin, the doctor will recommend a gradual reduction in dose over a period of 1 to 2 weeks, which will reduce the risk of withdrawal symptoms.
If you have any further questions about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Andepin can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, inform your doctor immediately:

• if a rash or allergic reactions occur in the form of itching, swelling of the lips or tongue, wheezing, or shortness of breath, discontinue the medication and contact your doctor immediately;
• if you experience restlessness and a feeling of being unable to sit or stand still (this may be a sign of akathisia), increasing the dose of Andepin may worsen your condition. In this case, contact your doctor;
• if redness of the skin occurs, followed by blisters and peeling of the skin, inform your doctor immediately. This phenomenon is very rare.

In some patients, the following have occurred:

• several symptoms at the same time (so-called serotonin syndrome), including unexplained fever with rapid breathing or heart rate, excessive sweating, stiffness or muscle tremors, disorientation, extreme agitation or drowsiness (rarely);
• feeling of weakness, drowsiness, or disorientation - mainly in elderly patients and patients (in the elderly) taking diuretics;
• prolonged and painful erection;
• irritability and extreme agitation.

Inform your doctor or pharmacist if you experience any of the following symptoms, especially if they persist for a longer period or are particularly troublesome.
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The frequency of possible side effects listed below is defined as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• unknown: (frequency cannot be estimated from available data).

Very Common:(occurring in more than 1 in 10 people)
insomnia; headaches; diarrhea; nausea; fatigue
Common:(occurring in 1 to 10 people in 100)
loss of appetite, weight loss; nervousness, anxiety; restlessness, concentration disorders; tension; decreased libido or sexual problems (including difficulties in maintaining an erection); sleep disturbances, unusual dreams, fatigue or drowsiness; dizziness; change in taste; uncontrolled movements, tremors; blurred vision; sensation of rapid and irregular heartbeat; sudden flushing of the skin of the face; yawning; indigestion, vomiting; dry mouth; rash, urticaria, itching; excessive sweating; joint pain; frequent urination; unexplained vaginal bleeding; feeling of trembling or chills
Uncommon:(occurring in 1 to 10 people in 1,000)
feeling of detachment from oneself; strange thinking; abnormal mood; orgasm disorders; teeth grinding; involuntary muscle movements or balance and coordination disorders; pupil dilation; low blood pressure; shortness of breath; difficulty swallowing; hair loss; increased tendency to bruise; cold sweat; difficulty urinating; feeling of heat or cold
Rare:(occurring in 1 to 10 people in 10,000)
low sodium levels in the blood; unusual, strange behavior; hallucinations; excitement; panic attacks; seizures; vasculitis; sudden swelling of tissues around the neck, face, mouth, and (or) throat; pain in the esophagus when eating and drinking; hypersensitivity to light; galactorrhea
Very Rare:(occurring in less than 1 in 10,000 people)
decreased platelet count, which increases the risk of bleeding or bruising
Unknown:(frequency cannot be estimated from available data)
suicidal thoughts or self-harm; memory disorders; lung disease; liver inflammation, abnormal liver function test results; muscle pain; difficulty urinating; confusion, disorientation; stuttering; nosebleeds; ringing in the ears; unexplained bruising or bleeding
Bone Fractures- an increased risk of bone fractures has been observed in patients taking this type of medication.
Most of the listed side effects usually resolve during treatment.

Reporting Side Effects

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If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone number, and fax of the Department}
e-mail: adr@urpl.gov.pl.
Reporting side effects will help gather more information on the safety of the medication.

5. How to Store Andepin

Store the medication in a place that is out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton after the words "Expiry Date".
The expiry date stated is the last day of the specified month.
Store at a temperature below 25°C.
Store in the original packaging to protect from light.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Andepin Contains

• The active substance of the medication is fluoxetine (Fluoxetinum)
• Other excipients are:
• lactose anhydrous, cornstarch, talc, magnesium stearate.
• The composition of the capsule shell is: gelatin, tartrazine (E 104), indigo carmine (E 132), titanium dioxide (E 171).

What Andepin Looks Like and What the Pack Contains

Andepin is a hard capsule with a green-white color.
Packaging:
Blister packs of aluminum/PVC in a cardboard box.
30 capsules (3 blister packs of 10 capsules each)
A polypropylene container in a cardboard box.
30 capsules (1 container of 30 capsules)
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Marketing Authorization Holder and Manufacturer

Pharmaceutical-Chemical Enterprise "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
phone: 61 879-20-81
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Poland
Pharmaceutical-Chemical Enterprise "Synteza" Ltd.
ul. Św. Michała 67/71
61-005 Poznań
phone: 61 879-20-81

Date of the Last Update of the Leaflet:

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