Package Insert: Information for the Patient

Anafranil 10 mg Coated Tablets

Clomipramine Hydrochloride

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 not listed in this package insert. See section 4.

1. What Anafranil 10 mg Coated Tablets are and for what they are used

2. What you need to know before starting to take Anafranil 10 mg Coated Tablets

3. How to take Anafranil 10 mg Coated Tablets

4. Possible adverse effects

5. Storage of Anafranil 10 mg Coated Tablets

6. Contents of the package and additional information

Anafranil belongs to a group of medicines called tricyclic antidepressants, medicines for treating 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 treating obsessive-compulsive disorders and is only used in children aged 5 years or older who experience bedwetting.

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 experienced any unusual or allergic reaction to any other tricyclic antidepressant or component of Anafranil 10 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, 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 seizures

- if you have heart rhythm disorders

- if you have schizophrenia or other mental health 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 disease)

- if you have hyperthyroidism

- if you experience 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 occurred at any time.

Information for families and caregivers

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

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

Additional safety information

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

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

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

Anafranil may cause skin to be more sensitive to the sun. Do not take direct sun and protect yourself with clothing and sun-protective glasses.

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 of starting treatment.

Serotonin syndrome

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

Use in the 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

Anafranil is not recommended for use 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 medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, as it may be necessary to adjust the dose or discontinue one of the treatments. This warning applies to medications purchased with and without a prescription and 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 high blood pressure and heart function
• other antidepressants, lithium, sedatives, tranquilizers, anticonvulsants (e.g. barbiturates) and antiepileptics (e.g. valproate)
• medications used as a substitute treatment for opioid dependence (buprenorphine/opioids)
• medications used to treat mental health disorders
• medications used to prevent blood clots (anticoagulants)
• medications used to treat asthma or allergies
• medications used to treat Parkinson's disease
• thyroid medications
• medications used to treat ulcers or acid reflux (e.g. cimetidine)
• medications used to treat fungal infections on the skin or nails (e.g. terbinafine)
• medications used to treat attention disorders (e.g. methylphenidate)
• medications used to prevent conception (oral contraceptives or other estrogens)
• medications used to increase urine production (diuretics)
• medications used to lower cholesterol (e.g. cholestyramine)
• 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 a substitute 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 aronia and St. John's Wort.

Taking Anafranil with food and alcohol

Anafranil can be taken with or without food.

Anafranil potentiates the effect of alcoholic beverages.

Pregnancy, breastfeeding, and fertility

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

Anafranil should only be administered to pregnant women if, in the doctor's opinion, the expected benefit for the mother outweighs any possible risk to the fetus. Your doctor will inform you of the benefits and possible risks associated with treatment during pregnancy.

Due to the active ingredient of Anafranil passing into breast milk, it is recommended to discontinue breastfeeding during treatment with Anafranil.

No effects have been detected on reproductive function.

Driving and operating machinery

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 may potentiate these effects.

Anafranil 10 mg coated tablets contain lactose and saccharose.

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

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

Take your medication exactly as your doctor or pharmacist has instructed. Do not change the dose or interrupt treatment without first consulting your doctor.

Swallow the coated tablets whole with liquid. Anafranil can be taken with or without food.

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

For anxiety attacks and agoraphobia, treatment begins with 10 mg per day, and after a few days the dose is gradually increased to 100 mg.

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

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

Anafranil treatment should be carried out under the guidance 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 to administer Anafranil injectable.

If you take more Anafranil than you should

In case of Anafranil overdose, inform your doctor or go immediately to the nearest hospital emergency service. Overdose symptoms usually appear a few hours later and include: drowsiness, poor concentration, slow or rapid or irregular pulse, restlessness and agitation, muscle coordination loss and muscle rigidity, respiratory difficulty, convulsions, vomiting, and fever.

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

If you forget to take Anafranil

Do not take a double dose to compensate for the missed doses. If you forget a dose, take it as soon as possible, then return to your regular administration schedule. If it almost coincides with the next dose, skip this dose and continue with your normal administration schedule. If you have any doubts, consult your doctor.

If you interrupt Anafranil treatment

Diseases treated by 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 in dose before completely stopping medication. This would be to prevent a 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience them. Normally, they do not require medical attention, and they may occur during treatment as the body gets used to the medicine.

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

Some side effects can be serious:

If any of the following side effects occur, consult your doctor as soon as possible, as they may require medical attention: seeing or hearing things that are not really there, 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 coughing and difficulty breathing, inability to coordinate movements, increased eye pressure, severe stomach pain, severe loss of appetite, sudden muscle contraction, muscle weakness and stiffness, muscle spasms, difficulty urinating, rapid heartbeat or palpitations, difficulty speaking, confusion, and delirium, hallucinations, convulsions.

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

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

Restlessness, dizziness, tremors, 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 in 100 and fewer 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 disconnected or out of body, worsening of depression, insomnia, nightmares, delirium, language disorders, numbness, severe muscle tension, taste disorders, memory loss, loss of concentration, muscle weakness, hot flashes, tachycardia, palpitations, low blood pressure upon changing position, vomiting, abdominal discomfort, diarrhea, decreased appetite, skin allergic reactions, light sensitivity, pruritus, abnormal milk secretion by mammary glands, breast enlargement, yawning, ear buzzing, pupil dilation, increased blood transaminases.

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

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

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

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

• Frequency not known

Increased blood prolactin levels, muscle fiber rupture (rhabdomyolysis), ejaculatory insufficiency 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 a sudden withdrawal or reduction in dose: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, nervousness, and anxiety.

If you take Anafranil for a long time, visit your doctor for regular checks to ensure that no adverse reactions are occurring.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears 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 observe that the packaging is damaged or shows signs of handling.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Anafranil

• The active ingredient is clomipramine hydrochloride.

• The other components (excipients) are: sucrose, lactose, gelatin, glycerol (E 422), magnesium stearate, cornstarch, talc, hypromellose, copovidone, titanium dioxide (E171), microcrystalline cellulose, yellow iron oxide (E 172), polyethylene glycol, and povidone.

Appearance of the product and content of the packaging

Anafranil 10 mg are coated tablets packaged in boxes of 50 units.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Alfasigma S.p.A

Via Ragazzi del ’99, n.5

40133 Bolonia. ITALIA

Responsible for manufacturing:

Pharmaloop, S.L.

C/ Bolivia, 15. Polígono Industrial Azque

28806 Alcalá de Henares. ESPAÑA

O

Alfasigma S.p.A.

Vía Pontina, Km 30,400

00071 Pomezia. ITALIA

Local representative:

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona. ESPAÑA

Last review date of this leaflet: August 2021

Other sources of information:

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/