Anafranil 25 mg solution for injection and infusion

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Anafranil 25 mg injection solution and for infusion

Clomipramine hydrochloride

Read the entire leaflet carefully before you start using this medicine, as 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 others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Anafranil 25 mg injection solution and for infusion is and what it is used for
2. What you need to know before using Anafranil 25 mg injection solution and for infusion
3. How to use Anafranil 25 mg injection solution and for infusion
4. Possible adverse effects
5. How to store Anafranil 25 mg injection solution and for infusion
6. Contents of the pack and other information

1. What Anafranil 25 mg injectable and infusion solution is and what it is used for

Anafranil belongs to a group of medicines known as 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 starting to use Anafranil 25 mg injection solution for infusion

Do not use Anafranil:

• if you are allergic to clomipramine hydrochloride or to any of the other components of this medicine (listed in section 6).
• if you have experienced any unusual or allergic reaction to another tricyclic antidepressant.
• if you are taking any other type of medication for the treatment of depression. Inform your doctor.
• if you have recently suffered a heart attack or if you have a serious heart condition.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 disorders,
• if you have difficulty urinating (e.g., due to prostate problems),
• if you have hyperthyroidism,
• if you have frequent constipation,
• if you experience fainting.

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

Before using 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. 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 assess the emergence 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 suddenly.

Symptoms such as these 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 monitors your blood pressure and heart function, both at the beginning of treatment and regularly throughout, 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 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 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 by intramuscular or intravenous route is not recommended in children and adolescents.

Use of Anafranil with other medicines

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

• daily alcohol consumption or changes in tobacco use
• inform 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 substitution treatment for opioid dependence (buprenorphine/opioids)
• medications for mental illnesses
• medications used to prevent blood clots (anticoagulants)
• medications for asthma or allergies
• medications for Parkinson’s disease
• thyroid medications
• medications for ulcers or acid reflux (e.g., cimetidine)
• medications used to treat fungal infections of the skin or nails (e.g., terbinafine)
• medications used for attention disorders (e.g., methylphenidate)
• medications used to prevent pregnancy (oral contraceptives or other estrogens)
• medications used to increase urine production (called diuretics)
• certain antibiotics such as rifampicin

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

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 potential risk to the fetus. Your doctor will inform you about the benefits and possible risks associated with treatment during pregnancy.

Since the active substance in 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 enhance these effects.

3. How to use Anafranil 25 mg injection solution and infusion solution

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

The recommended initial dose is 1–2 ampoules per day, which may be gradually increased.

Once improvement has occurred, and at the physician's discretion, injections may be replaced with tablets:

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

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

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

Treatment with Anafranil must be carried out under the supervision of your doctor. Note that you must not administer higher doses, more frequently, or for longer than prescribed by your doctor.

How to use Anafranil

1. Breakable ampoule. Break line located below the black dot.
2. Place your thumb above the black dot and snap the ampoule by bending backward.

If you use more Anafranil than you should

In case of overdose with Anafranil, inform your doctor or go immediately to the nearest hospital emergency department. Symptoms of overdose usually appear within a few hours and include: drowsiness, poor concentration, slow or rapid or irregular pulse, restlessness and agitation, loss of muscle coordination and muscle rigidity, 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 use Anafranil

Do not take a double dose to make up for forgotten doses. If you miss a dose, have it administered 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 schedule. If you have any doubts about this, consult your doctor.

If you stop using Anafranil

The conditions treated by Anafranil, such as depression, obsessive-compulsive disorders, 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 such as headache, nausea, vomiting, diarrhea, insomnia, nervousness, and anxiety. 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 can 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 eye 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 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 and less than 1 out of every 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, severe muscle tension, taste disturbances, memory loss, difficulty concentrating, 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 out of every 1,000 and less than 1 out of every 100 patients treated)

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

• Rare (occur in less than 1 out of every 10,000 patients treated)

Neuroleptic malignant syndrome, urinary retention, disturbances in the heart's conduction system, liver inflammation, small hemorrhages under the skin, edema, allergic reaction at the injection site, hair loss, high fever, severe allergic reactions, disturbances in antidiuretic hormone secretion, changes in immune system cell counts, increased eye pressure, 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 sudden discontinuation or dose reduction: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, restlessness, and anxiety.

If you are on long-term treatment with Anafranil, visit your doctor regularly to monitor for any adverse reactions not described here.

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 injection solution and for infusion

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

Do not store above 30 °C.

Keep in the original packaging to protect from light.

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

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers 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: glycerol and water for injections.

Appearance of the medicinal product and contents of the pack

Anafranil 25 mg solution for injection and infusion is supplied in 2 ml glass ampoules. Each pack contains 6 ampoules and hospital packs of 100 ampoules are also available.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Alfasigma S.p.A.

Via Ragazzi del '99, n.5

40133 Bologna, ITALY

Manufacturer:

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 review 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/