Anafranil 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Anafranil 25 mg coated tablets

Clomipramine hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the 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. How to store Anafranil 25 mg coated tablets
6. Contents of the pack and other information

1. What Anafranil 25 mg coated tablets is and what it is used for

Anafranil belongs to a group of medicines 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 for the treatment of obsessive-compulsive disorders, phobias, panic attacks, and narcolepsy syndrome.

In children, Anafranil is indicated for the treatment of obsessive-compulsive disorders, and may be used only in children aged 5 years and older who experience 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 to any of the other ingredients of this medicine (listed in section 6).
• if you have experienced any unusual reaction or allergic reaction to any other tricyclic antidepressant or to 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 suffer from any severe heart disease.

If you answered YES to any of the above conditions, Anafranil is probably not 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 disorders.
• if you have glaucoma (increased intraocular pressure)
• if you have liver or kidney disease
• if you have any blood disorder
• if you have difficulty urinating (e.g., due to prostate conditions)
• if you have hyperthyroidism
• if you frequently suffer from constipation
• if you experience fainting

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

Before taking Anafranil, consult your doctor if any of the above conditions have ever occurred in your medical history.

Information for families and caregivers

You should monitor whether a depressed patient shows signs of behavioral changes such as unusual anxiety, agitation, aggressiveness, sleep disturbances, irritability, overexcitement, or other unusual changes in behavior, worsening of depression, or suicidal thoughts. You must immediately inform the patient's doctor of any of these symptoms, especially if they are severe, appear suddenly, or were not previously part of the patient's symptoms. You should assess the appearance of these symptoms on a daily basis, particularly at the beginning of antidepressant treatment and when the dose is increased or decreased, as these changes may occur abruptly.

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

Additional safety information

It is important that your doctor monitors your treatment, performs blood tests, and checks your blood pressure and heart function at the beginning of treatment and regularly throughout treatment, to rule out any blood abnormalities or liver or heart dysfunction.

Anafranil may cause dry mouth, which can increase the risk of dental caries. This means that regular dental check-ups should be performed during long-term treatment. Before undergoing any type of 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 your skin more sensitive to sunlight. Avoid direct sun exposure 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, which usually disappear within 2 weeks after starting treatment.

Serotonin syndrome

Contact your doctor immediately if you experience high body temperature, involuntary rhythmic muscle contractions, agitation, seizures, delirium, or coma. These are signs and symptoms that may indicate serotonin syndrome.

Use in elderly patients (65 years or older)

Elderly patients usually require lower doses than other adult patients. Elderly patients may be more sensitive to adverse effects. Your doctor will provide you with specific information regarding necessary precautions, dosage, and monitoring.

An increased risk of bone fractures has been observed in patients over 50 years of age.

Children and adolescents

The use of Anafranil is not recommended in children and adolescents unless specifically prescribed by a doctor. Your doctor will provide you with specific information regarding necessary precautions, dosage, and monitoring.

Taking Anafranil with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as it may be necessary to adjust the dose or discontinue one of the treatments. This warning applies to both prescription and over-the-counter medicines, and especially in the case of:

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

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

Also inform your doctor if you regularly consume grapefruit, grapefruit juice, cranberries, or St. John's wort.

Taking Anafranil with food and alcohol

Anafranil can be taken with or without food.

Anafranil enhances the effects of alcoholic beverages.

Pregnancy, breastfeeding, and fertility

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

Anafranil should only be administered to pregnant women if, in the doctor’s judgment, the expected benefit to the mother outweighs any possible risk to the fetus. Your doctor will inform you about the benefits and possible risks associated with 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 reduced attention, blurred vision, drowsiness, disorientation, etc. If you experience any of these effects, you should not drive, operate machinery, or engage in activities requiring special alertness. Alcohol consumption may intensify these effects.

Anafranil 25 mg coated tablets contain lactose and sucrose.

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

3. How to take Anafranil 25 mg coated tablets

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again. Your doctor will determine the most appropriate dose for your particular case.

Take your medicine exactly as prescribed by your doctor or pharmacist. Do not change the dose or stop treatment without first discussing it with your doctor.

The coated tablets should be swallowed whole with liquid. Anafranil may be taken with or without food.

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

For panic attacks and agoraphobia, treatment starts at 10 mg daily, and after a few days the dose is slowly increased up to 100 mg.

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

For children with bedwetting (from age 5), the daily dose is between 20 and 50 mg, depending on the child's age.

Treatment with Anafranil must be carried out under the supervision of your doctor. Do not take more than the prescribed dose, more frequently, or for longer than your doctor has instructed. In some cases, your doctor may decide to use injectable Anafranil.

If you take more Anafranil than you should

In case of Anafranil overdose, inform your doctor immediately or go to the nearest hospital emergency department. Overdose symptoms usually appear within a few hours and include: drowsiness, poor concentration, slow, fast, or irregular pulse, restlessness and agitation, loss of muscle coordination and muscle stiffness, breathing difficulties, seizures, vomiting, and fever.

In cases of overdose or accidental ingestion, contact 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 a missed dose. If you forget a dose, take it as soon as possible, then return to your usual dosing schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. If you have any doubts, consult your doctor.

If you stop taking Anafranil

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

Do not change or stop treatment without first consulting your doctor, who may advise you to gradually reduce the dose before completely stopping the medication. This is to prevent worsening of your general condition and to reduce the risk of withdrawal symptoms due to abrupt discontinuation of the medicine, such as headache, nausea, vomiting, diarrhea, abdominal pain, insomnia, nervousness, anxiety, and general malaise.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. Usually, these do not require medical attention and may occur during treatment while the body adjusts to the medicine.

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

Some effects may be serious:

If any of the following adverse effects occur, consult your doctor as soon as possible, as they may require medical attention: seeing or hearing things that are not real, yellowing of the skin and eyes, skin reactions (itching or redness), frequent infections accompanied by fever and sore throat (due to decreased white blood cells), allergic reactions with or without cough and difficulty breathing, inability to coordinate movements, increased intraocular pressure, severe stomach pain, severe loss of appetite, sudden muscle contractions, muscle weakness and stiffness, muscle spasms, difficulty urinating, rapid heartbeat or palpitations, difficulty speaking, confusion and delirium, hallucinations, seizures.

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

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

Restlessness, dizziness, tremor, headache, involuntary muscle movements, somnolence, urinary disorders, nausea, dry mouth, constipation, increased appetite, increased sweating, fatigue, libido disorders, erectile dysfunction, blurred vision, weight gain.

• Common (occur in at least 1 in every 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 detached or as if being outside oneself, worsening of depression, insomnia, nightmares, delusions, language disorders, tingling sensation, marked muscle tension, taste disturbances, memory loss, loss of concentration, muscle weakness, hot flushes, tachycardia, palpitations, drop in blood pressure upon changing position, vomiting, abdominal discomfort, diarrhea, decreased appetite, skin allergic reactions, photosensitivity, pruritus, abnormal milk secretion from mammary glands, breast enlargement, yawning, tinnitus, pupil dilation, increased blood transaminases.

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

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

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

Neuroleptic malignant syndrome, urinary retention, liver inflammation, small hemorrhages under the skin, edema, hair loss, high fever, severe allergic reactions, changes in immune system cell counts, increased intraocular pressure, disturbances in the heart's conduction system, disturbances in antidiuretic hormone secretion, changes in electroencephalogram.

• Frequency not known:

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

The following symptoms have commonly occurred after abrupt discontinuation or dose reduction: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, restlessness, and anxiety.

If you take Anafranil for a prolonged period, visit your doctor regularly so they can monitor you and ensure that no unlisted adverse reactions occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Anafranil 25 mg coated tablets

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 the month indicated.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point located at pharmacies. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Anafranil

• The active substance 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 contents of the pack

Anafranil 25 mg are film-coated tablets packed in boxes containing 40 or 500 units (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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.

Via Pontina, Km 30.400

00071 Pomezia, ITALY

Local representative:

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona, Spain

Date of the most recent revision of this leaflet: August 2021

Other sources of information:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/