ANAFRANIL 75 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Anafranil 75 mg prolonged-release tablets

Clomipramine hydrochloride

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Anafranil 75 mg prolonged-release tablets are and what they are used for.
2. What you need to know before you take Anafranil 75 mg prolonged-release tablets.
3. How to take Anafranil 75 mg prolonged-release tablets.
4. Possible side effects.
5. Storing Anafranil 75 mg prolonged-release tablets.
6. Contents of the pack and other information.

1. What Anafranil 75 mg prolonged-release tablets are and what they are used for

Anafranil belongs to a group of medicines called tricyclic antidepressants, used to treat depression and mood disorders.

In adults, Anafranil can be used to treat depression, obsessive-compulsive disorders, phobias, panic attacks, and narcolepsy syndrome.

2. What you need to know before you take Anafranil 75 mg prolonged-release tablets

Do not take Anafranil:

• if you are allergic to clomipramine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have had any unusual or allergic reaction to any other tricyclic antidepressant.
• 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 suffer from any serious heart disease.

If the answer is YES to any of the above, 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 disorder,
• 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 disturbances, 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, which means 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 cause the skin to be 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 experience 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 (65 years or older)

Older patients usually need lower doses than the rest of adult patients. Older patients may be more sensitive to adverse effects. Your doctor will provide you with special information about the necessary precautions, doses, and follow-up.

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 follow-up.

Taking Anafranil with other medicines

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

• daily consumption of alcohol or if you change your tobacco consumption
• inform that you are taking Anafranil in case you need 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 treatment for opioid dependence (buprenorphine/opioids)
• medicines for treating mental illnesses
• medicines for preventing blood clots (anticoagulants)
• medicines for asthma or allergies
• medicines for Parkinson's disease
• thyroid medicines
• medicines for treating ulcers or acidity (e.g., cimetidine)
• medicines used for treating fungal infections of the skin or nails (e.g., terbinafine)
• medicines used for attention disorders (e.g., methylphenidate)
• medicines for preventing conception (oral contraceptives and other estrogens)
• medicines used to increase urine production (diuretics)
• medicines for reducing cholesterol (e.g., cholestyramine)
• certain 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 medicines used as replacement treatment for opioid dependence (buprenorphine/opioids) with Anafranil may lead to serotonin syndrome, a potentially fatal disease.

Also, inform your doctor if you regularly consume grapefruit, grapefruit juice, or cranberry 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 medicine.

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 of 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, do not drive, operate machinery, and avoid situations that require a special state of alertness. Alcohol consumption may enhance these effects.

Anafranil 75 mg prolonged-release tablets contain castor oil.

This medicine may cause stomach upset and diarrhea because it contains castor oil.

3. How to take Anafranil 75 mg prolonged-release tablets

Follow exactly the administration instructions of this medicine 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 medicine exactly as your doctor or pharmacist has indicated. Do not change the dose or interrupt treatment without talking to your doctor first.

The prolonged-release tablets should be taken whole, although they can be broken in half to allow for dose adjustment to individual needs, but always without chewing, with liquid.

Anafranil can be administered with or without food.

For the treatment of depression, mood disorders, obsessive-compulsive disorders, and phobias, the recommended daily dose is between 100 mg and 150 mg.

For panic attacks and agoraphobia, treatment starts 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.

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 fast 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 Toxicological 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 stop taking 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 would be 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, and anxiety.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. They usually do not require medical attention and may occur during treatment while the body gets used to the medicine.

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 really exist, yellowing of the skin and eyes, skin reactions (itching or redness), frequent infections with 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 with Parkinson's disease), anxiety, agitation, sleep disturbances, 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 transaminases 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, changes in the immune system cell count, increased eye pressure, changes in heart conduction, changes in antidiuretic hormone secretion, changes in the electroencephalogram.

• Frequency not known

Increased blood prolactin levels, 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 of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this 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 help provide more information on the safety of this medicine.

5. Storing Anafranil 75 mg prolonged-release tablets

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

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is 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 should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Anafranil Composition

• The active ingredient is clomipramine hydrochloride.
• The other components (excipients) are: anhydrous colloidal silica, calcium hydrogen phosphate, calcium stearate, dispersed acrylic polymers, hypromellose, red iron oxide (E 172), hydrogenated ricin oil, talc, and titanium dioxide (E 171).

Product Appearance and Packaging Content

Anafranil 75 mg are prolonged-release tablets. Each package contains 28 or 500 tablets (clinical package).

Only some package 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

O

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 Leaflet: 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/