Anafranil 75 mg prolonged-release tablets

Package leaflet: Information for the user

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, 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Anafranil 75 mg prolonged-release tablets are and what they are used for.
2. What you need to know before taking Anafranil 75 mg prolonged-release tablets.
3. How to take Anafranil 75 mg prolonged-release tablets.
4. Possible side effects.
5. How to store 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, which are used to treat depression and mood disorders.

In adults, Anafranil may be used for the treatment of depression, obsessive-compulsive disorders, phobias, panic attacks, and narcolepsy syndrome.

2. What you need to know before taking 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 previously experienced an unusual reaction or any allergic reaction to another tricyclic antidepressant;
• if you are taking any other type of medication for depression. Inform your doctor;
• if you have recently had a heart attack or if you suffer from a serious heart condition.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Anafranil:

• if you have suicidal thoughts;
• if you have 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 disorders;
• if you have difficulty urinating (e.g. due to prostate disease);
• 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 family members and caregivers

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

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 the development of blood abnormalities or impaired liver or heart function.

Anafranil may cause dry mouth, which can increase the risk of dental caries. Therefore, regular dental check-ups are recommended during long-term treatment. 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 increase skin sensitivity to sunlight. Avoid direct sun exposure and protect yourself with clothing and UV-protective 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 signs and symptoms 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, dosing, 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, dosing, 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 or anesthesiologist that you are taking Anafranil if you are to receive anesthesia;
• medicines used to treat high blood pressure and heart function;
• other antidepressants, lithium, sedatives, tranquilizers, anticonvulsants (e.g. barbiturates), and antiepileptics (e.g. valproate);
• medicines used as opioid replacement therapy in opioid dependence (buprenorphine/opioids);
• medicines used to treat mental illnesses;
• medicines used to prevent blood clots (anticoagulants);
• medicines for asthma or allergies;
• medicines for Parkinson’s disease;
• thyroid medications;
• medicines for ulcers or acid reflux (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 and other estrogens);
• medicines used to increase urine production (diuretics);
• medicines used to lower cholesterol (e.g. cholestyramine);
• certain antibiotics such as rifampicin.

Concomitant administration of antidepressants (MAO inhibitors, selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants), or medicines used as opioid dependence treatment (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, cranberry products, or St. John’s wort (Hypericum perforatum).

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, breastfeeding, think you may be pregnant, or are planning 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 potential risk to the fetus. Your doctor will inform you about the benefits and potential risks of treatment during pregnancy.

Since the active substance in Anafranil passes into breast milk, breastfeeding is not recommended during treatment with Anafranil.

No effects on reproductive function have been observed.

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 75 mg prolonged-release tablets contain castor oil.

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

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

Follow exactly the instructions given by your doctor for using this medicine. If in doubt, consult your doctor or pharmacist again. Your doctor will decide the most appropriate dose for your particular case.

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

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

Anafranil may be taken 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 at 10 mg daily, and after a few days the dose is gradually increased up to 100 mg.

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

Treatment with Anafranil should be carried out under your doctor's supervision. Do not take more medication, 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 Anafranil overdose, inform your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose 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 missed doses. If you forget a dose, take it as soon as possible, then return to your regular dosing schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. If you have any doubts about this, 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 your treatment without first informing 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 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 will experience them. Usually, they 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 eye pressure, severe stomach pain, marked 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 listed below according to the following frequencies:

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

Restlessness, dizziness, tremor, headache, involuntary muscle movements, drowsiness, 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 out of every 100 but less than 1 out of 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, light sensitivity, pruritus, abnormal milk secretion from mammary glands, breast enlargement, yawning, tinnitus, pupil dilation, increased blood transaminases.

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

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

• Very rare (occur in less than 1 out of 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 eye pressure, disturbances in the heart's conduction system, disturbances in antidiuretic hormone secretion, changes in electroencephalogram.

• Frequency not known

Increased blood levels of prolactin hormone, 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 long time, visit your doctor regularly for check-ups to 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 they are possible adverse effects 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 75 mg prolonged-release 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 a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This 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: anhydrous colloidal silica, calcium hydrogen phosphate, calcium stearate, acrylic polyesters dispersed, hypromellose, red iron oxide (E 172), hydrogenated castor oil, talc, and titanium dioxide (E 171).

Appearance of the product and contents of the pack

Anafranil 75 mg are prolonged-release tablets. Each pack contains 28 or 500 tablets (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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/