ANAFRANIL 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Anafranil 25 mg Coated Tablets

Clomipramine Hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Anafranil 25 mg Coated Tablets are and what they are used for
2. What you need to know before taking Anafranil 25 mg Coated Tablets
3. How to take Anafranil 25 mg Coated Tablets
4. Possible side effects
5. Storage of Anafranil 25 mg Coated Tablets
6. Package contents and further information

1. What Anafranil 25 mg Coated Tablets are and what they are used for

Anafranil belongs to the group of medications called tricyclic antidepressants, which are used to treat depression and mood disorders.

In adults, Anafranil is used to treat depression and may also be used to treat obsessive-compulsive disorders, phobias, anxiety attacks, and narcolepsy syndrome.

In children, Anafranil is indicated for the treatment of obsessive-compulsive disorders and, in children over 5 years old, it may be used for bedwetting.

2. What you need to know before taking Anafranil 25 mg Coated Tablets

Do not take Anafranil:

• if you are allergic to clomipramine hydrochloride or any of the other components of this medication (listed in section 6).
• if you have had any unusual or allergic reactions to any other tricyclic antidepressant or any component of Anafranil 25 mg Coated Tablets.
• if you are taking any other type of medication for the treatment of depression. Inform your doctor.
• if you have recently had a heart attack or if you have any serious heart disease.

If the answer is YES to any of the above cases, Anafranil may not be suitable for you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Anafranil:

• if you have suicidal thoughts
• if you have epileptic seizures
• if you have heart rhythm disorders
• if you have schizophrenia or other mental problems.
• if you have glaucoma (high intraocular pressure)
• if you have liver or kidney disease
• if you have any blood disorders
• if you have difficulty urinating (e.g., due to prostate diseases)
• if you have hyperthyroidism
• if you suffer from frequent constipation
• if you have fainting spells

Your doctor will take this into account before and during treatment with Anafranil.

Before taking Anafranil, consult your doctor if any of the above circumstances have ever occurred to you.

Information for families and caregivers

You should monitor if the depressed patient shows signs of changes in behavior such as unusual anxiety, agitation, aggression, sleep disorders, irritability, aggression, overexcitement, or other unusual changes in behavior, worsening of depression, or suicidal thoughts. You should immediately inform the patient's doctor of any of these symptoms, especially if they are severe, appear suddenly, or were not part of the patient's previous symptoms. You should evaluate the appearance of these symptoms day by day, especially at the beginning of treatment with antidepressants and when the dose is increased or decreased, as these changes can be sudden.

Symptoms like those described may be associated with an increased risk of suicidal thoughts and behaviors and may indicate the need for strict monitoring and possible changes in medication.

Additional safety information

It is essential that your doctor monitors the treatment; performs a blood test and checks your blood pressure and heart function at the beginning of treatment and regularly throughout, to rule out the appearance of blood and liver or heart function alterations.

Anafranil may cause dry mouth, which can increase the risk of dental caries, meaning that in long-term treatments, regular dental checks should be performed. Before undergoing any surgery or dental procedure, inform your doctor or dentist that you are taking Anafranil.

Anafranil may cause dry eyes; patients who wear contact lenses and experience eye irritation should consult their doctor.

Anafranil may make the skin more sensitive to the sun. Do not take direct sun and protect yourself with protective clothing and sunglasses.

If you normally suffer from anxiety disorders, at the beginning of treatment with Anafranil, you may experience an increase in anxiety symptoms that usually disappear within 2 weeks after starting treatment.

Serotonin syndrome

Immediately contact your doctor if you suffer from high body temperature, involuntary rhythmic muscle contractions, agitation, convulsions, delirium, coma. These are signs and symptoms that may refer to serotonin syndrome.

Use in elderly patients (65 years or older)

Older patients usually require lower doses than other adult patients. Older patients may be more sensitive to side effects. Your doctor will provide you with special information about the necessary precautions, doses, and monitoring.

In patients over 50 years old, an increase in bone fractures has been observed.

Children and adolescents

The use of Anafranil is not recommended in children or adolescents unless specifically prescribed by a doctor. Your doctor will provide you with special information about the necessary precautions, doses, and monitoring.

Taking Anafranil with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, as it may be necessary to adjust the dose or interrupt some treatments. This warning is valid for medications acquired with and without a medical prescription, especially in the case of:

• daily consumption of alcohol or if you change your tobacco consumption
• inform your doctor that you are taking Anafranil if you need to receive anesthesia
• medications used to treat blood pressure and heart function
• other antidepressants, lithium, sedatives, tranquilizers, anticonvulsants (e.g., barbiturates), and antiepileptics (e.g., valproate)
• medications used as replacement therapy for opioid dependence (buprenorphine/opioids)
• medications for treating mental illnesses
• medications for preventing blood clots (anticoagulants)
• medications for asthma or allergies
• medications for Parkinson's disease
• thyroid medications
• medications for treating ulcers or acidity (e.g., cimetidine)
• medications used to treat fungal infections of the skin or nails (e.g., terbinafine)
• medications used to treat attention disorders (e.g., methylphenidate)
• medications for preventing conception (oral contraceptives or other estrogens)
• medications used to increase urine production (diuretics)
• medications for reducing cholesterol (e.g., colestyramine)
• some antibiotics such as rifampicin

The concomitant administration of antidepressants (MAO inhibitors, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants), or medications used as replacement therapy for opioid dependence (buprenorphine/opioids) with Anafranil may lead to serotonin syndrome, a potentially life-threatening disease.

Also, inform your doctor if you regularly consume grapefruit, grapefruit juice, or cranberry juice and St. John's Wort.

Taking Anafranil with food and alcohol

Anafranil can be taken with or without food.

Anafranil enhances the effect of alcoholic beverages.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Anafranil should only be administered to pregnant women if, in the doctor's judgment, the expected benefit to the mother is greater than any possible risk to the fetus. Your doctor will inform you about the benefits and possible risks of treatment during pregnancy.

Since the active ingredient of Anafranil passes into breast milk, breastfeeding should be discontinued during treatment with Anafranil.

No effects on reproductive function have been detected.

Driving and using machines

Anafranil may cause decreased attention, blurred vision, drowsiness, disorientation, etc. If this happens to you, you should not drive, operate machinery, and should avoid situations that require a special state of alertness. Alcohol consumption can enhance these effects.

Anafranil 25 mg Coated Tablets contain lactose and sucrose.

This medication contains lactose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Anafranil 25 mg Coated Tablets

Follow the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide the most suitable dose for your particular case.

Take your medication exactly as your doctor or pharmacist has indicated. Do not change the dose or interrupt treatment without first discussing it with your doctor.

The coated tablets should be taken whole with liquid. Anafranil can be administered with or without food.

For the treatment of depression, mood disorders, obsessive-compulsive disorders, and phobias, treatment is started with a dose of 25 mg twice a day and gradually increased to a daily dose between 100 mg and 150 mg.

For anxiety attacks and agoraphobia, treatment is started with 10 mg daily, and after a few days, the dose is slowly increased to 100 mg.

For narcolepsy syndrome, the recommended daily dose is between 25 and 75 mg.

For children who wet their beds (from 5 years old), the daily dose is between 20 and 50 mg, depending on the child's age.

Treatment with Anafranil should be carried out under the direction of your doctor. Do not take more doses, more frequently, or for longer than prescribed by your doctor. In some cases, your doctor may decide on treatment with injectable Anafranil.

If you take more Anafranil than you should

In case of overdose with Anafranil, inform your doctor or go immediately to the emergency department of the nearest hospital. The symptoms of overdose usually appear a few hours after ingestion and are: drowsiness, poor concentration, slow or rapid or irregular pulse, restlessness and agitation, loss of muscle coordination and muscle stiffness, breathing difficulties, convulsions, vomiting, and fever.

In cases of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Anafranil:

Do not take a double dose to make up for forgotten doses. If you forget a dose, take it as soon as you can, then return to your usual administration schedule. If it is almost time for the next dose, skip this dose and continue with your normal administration schedule. If you have any doubts, consult your doctor.

If you interrupt treatment with Anafranil

The diseases treated with Anafranil, such as depression, obsessive-compulsive syndromes, and chronic anxiety states, require long-term treatment.

Do not change or interrupt treatment without prior notice to your doctor, who may indicate a gradual reduction of the dose before completely stopping the medication. This is to prevent worsening of the general condition and reduce the risk of symptoms due to sudden withdrawal of the medication, such as headaches, nausea, vomiting, diarrhea, abdominal pain, insomnia, nervousness, anxiety, and general discomfort.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. They usually do not require medical attention and may occur during treatment while the body gets used to the medication.

Consult your doctor if any of these effects continue or are bothersome.

Some effects can be serious:

If you experience any of the following side effects, consult your doctor as soon as possible, as they may require medical attention: seeing or hearing things that do not exist, yellowing of the skin and eyes, skin reactions (itching or redness), frequent infections accompanied by fever and sore throat (due to a decrease in white blood cells), allergic reactions with or without cough and difficulty breathing, inability to coordinate movements, increased eye pressure, severe stomach pain, severe loss of appetite, sudden muscle contraction, weakness and muscle stiffness, muscle spasms, difficulty urinating, rapid or irregular heartbeat, difficulty speaking, confusion and delirium, hallucinations, convulsive attacks.

The reported side effects are detailed below according to the following frequencies:

• Very common (occurring in at least 1 in 10 patients treated)

Restlessness, dizziness, tremors, headaches, involuntary muscle movements, drowsiness, urination disorders, nausea, dry mouth, constipation, increased appetite, increased sweating, fatigue, libido disorders, erectile dysfunction, blurred vision, weight gain.

• Common (occurring in at least 1 in 100 and less than 1 in 10 patients treated)

Confusion, disorientation, hallucinations (particularly in elderly patients and/or those with Parkinson's disease), anxiety, agitation, sleep disorders, manic symptoms, aggression, feeling of disconnection or being outside oneself, worsening of depression, insomnia, nightmares, delirium, language disorders, sensation of tingling, severe muscle tension, taste disorders, memory loss, concentration loss, muscle weakness, hot flashes, rapid or irregular heartbeat, low blood pressure when changing position, vomiting, abdominal discomfort, diarrhea, decreased appetite, allergic skin reactions, hypersensitivity to light, itching, abnormal milk secretion from the mammary glands, breast enlargement, yawning, ringing in the ears, pupil dilation, increased liver enzymes in blood.

• Uncommon (occurring in at least 1 in 1,000 and less than 1 in 100 patients treated)

Activation of psychotic symptoms, convulsions, uncoordinated movements, increased blood pressure, arrhythmias.

• Very rare (occurring in less than 1 in 10,000 patients treated)

Malignant neuroleptic syndrome, urinary retention, liver inflammation, small bleeding under the skin, edema, hair loss, high fever, severe allergic reactions, modification of the immune system cell count, increased eye pressure, alterations in the heart conduction system, alterations in the secretion of antidiuretic hormone, changes in the electroencephalogram.

• Frequency not known:

Increased blood levels of prolactin, muscle fiber rupture (rhabdomyolysis), ejaculatory failure or delayed ejaculation, serotonin syndrome, movement disorders (extrapyramidal symptoms), increased risk of bone fractures in patients over 50 years old.

The following symptoms have occurred frequently after sudden withdrawal or dose reduction: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, nervousness, and anxiety.

If you take Anafranil for a long time, go to your doctor for regular check-ups to ensure that no unforeseen adverse reactions occur.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Anafranil 25 mg Coated Tablets

Keep this medication out of sight and reach of children.

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

No special storage conditions are required.

Do not use this medication if you notice that the packaging is damaged or shows signs of tampering.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Anafranil

• The active ingredient is clomipramine hydrochloride.
• The other components (excipients) are: sucrose, lactose, stearic acid, anhydrous colloidal silica, magnesium stearate, corn starch, glycerol (E 422), talc, hypromellose, copovidone, titanium dioxide (E 171), microcrystalline cellulose, yellow iron oxide (E 172), polyethylene glycol, and povidone.

Appearance of the Product and Packaging Contents

Anafranil 25 mg are film-coated tablets packaged in boxes of 40 or 500 units (clinical packaging).

Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Alfasigma S.p.A

Via Ragazzi del ’99, n.5

40133 Bologna, ITALY

Manufacturer:

Pharmaloop, S.L.

C/ Bolivia, 15. Polígono Industrial Azque

28806 Alcalá de Henares, SPAIN

Or

Alfasigma S.p.A.

Vía Pontina, Km 30,400

00071 Pomezia, ITALY

Local Representative:

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona, Spain

Date of the Last Revision of this Prospectus: August 2021

Other Sources of Information:

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