ANAFRANIL 75 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Anafranil SR 75, 75 mg, Prolonged-Release Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Anafranil SR 75 and what is it used for
4. Important information before taking Anafranil SR 75
   1. When not to take Anafranil SR 75
   2. Warnings and precautions
   3. Anafranil SR 75 and other medications
   4. Using Anafranil SR 75 in elderly patients
   5. Children and adolescents
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
5. How to take Anafranil SR 75
   1. Taking a higher dose of Anafranil SR 75 than recommended
   2. Missing a dose of Anafranil SR 75
   3. Discontinuing Anafranil SR 75
6. Possible side effects
   1. Seek medical help immediately if you experience any of the following side effects, as medical intervention may be necessary:
   2. Reporting side effects
7. How to store Anafranil SR 75
8. Contents of the pack and other information
   1. What Anafranil SR 75 contains
   2. What Anafranil SR 75 looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Anafranil SR 75, 75 mg, Prolonged-Release Tablets

Clomipramine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others.
• The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Anafranil SR 75 and what is it used for
• 2. Important information before taking Anafranil SR 75
• 3. How to take Anafranil SR 75
• 4. Possible side effects
• 5. How to store Anafranil SR 75
• 6. Contents of the pack and other information

1. What is Anafranil SR 75 and what is it used for

Anafranil SR 75 is a prolonged-release tablet containing clomipramine hydrochloride, which belongs to the group of tricyclic antidepressants.
Anafranil SR 75 is used to treat depressive states of various causes and symptoms, such as endogenous, reactive, neurotic, organic, masked, and involutional forms of depression; depression associated with schizophrenia and personality disorders; depressive syndromes associated with old age, chronic pain, and chronic somatic diseases. It is also used to treat obsessive-compulsive disorders, panic attacks, phobias, and nocturnal enuresis in children (over 5 years, provided that organic causes have been excluded).

2. Important information before taking Anafranil SR 75

When not to take Anafranil SR 75

• If the patient is allergic to the active substance or any of the other ingredients of this medication (listed in section 6);
• If the patient has cross-sensitivity to tricyclic antidepressants;
• If the patient is taking MAO inhibitor antidepressants and for 14 days before starting or after stopping MAO inhibitor treatment. It is also not recommended to take selective, reversible MAO-A inhibitors, such as moclobemide, at the same time;
• If the patient has recently had a myocardial infarction;
• If the patient has a congenital long QT syndrome.

Warnings and precautions

Before starting treatment with Anafranil SR 75, the patient should discuss it with their doctor or pharmacist.
The patient should inform about the following conditions:

• epileptic seizures,
• irregular heartbeat, cardiovascular diseases, especially rhythm disorders and circulatory failure,
• schizophrenia,
• glaucoma (increased eye pressure),
• liver or kidney disease,
• any blood diseases,
• difficulty urinating, e.g., due to prostate diseases,
• hyperthyroidism,
• constipation,
• alcohol abuse.

It is essential for the doctor to regularly assess the treatment effects, which allows for adjusting the dose and reducing the possibility of side effects. During the follow-up visit, the doctor may recommend a blood test and measure blood pressure and examine heart function before and during treatment.
Suicidal thoughts, suicidal ideation, or clinical worsening
The risk of suicidal thoughts, self-harm, or suicidal attempts, characteristic of severe depression, may persist until significant remission of the disease.
In patients with depressive disorders, both adults and children, there may be an increase in depression and (or) suicidal tendencies, or an increase in other psychiatric symptoms, regardless of whether other antidepressants are taken or not. Short-term clinical trials have shown that antidepressants increase the risk of suicidal thoughts and behaviors (suicidal tendencies) in children and adolescents with depressive disorders and other psychiatric disorders.
Particular attention should be paid to patients who have had suicidal events or significant suicidal tendencies before starting treatment.
Every patient taking Anafranil SR 75 (regardless of the indication) should be under close medical supervision. The doctor should pay attention to any worsening of the patient's condition, or the occurrence of suicidal tendencies or other psychiatric symptoms. Such medical supervision should take place in the initial stage of therapy and at times of dose changes. In such situations, especially if the changes are severe, their onset is sudden, or they exceed the characteristic symptoms of the patient's disease, it is necessary to consider changing the treatment regimen, or even discontinuing the medication.
Patients, as well as family members and caregivers of children and adults being treated with antidepressants for psychiatric and non-psychiatric indications, will be informed by the doctor about the need to immediately report any worsening of the patient's clinical condition, the occurrence of suicidal thoughts or behaviors, or unusual changes in behavior (see also section 4).

Anafranil SR 75 and other medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
They may interact with Anafranil SR 75, so it may be necessary to adjust the dose or discontinue one of the medications.
Do not take buprenorphine without consulting your doctor while taking Anafranil SR 75.
It is particularly important to inform your doctor about daily alcohol consumption and taking the following medications:

• affecting blood pressure or heart function,
• other antidepressants (e.g., fluoxetine),
• neuroleptics,
• sedatives,
• barbiturates,
• benzodiazepines,
• MAO inhibitors, e.g., moclobemide,
• antiepileptic drugs,
• anticoagulants (blood thinners),
• asthma or allergy medications,
• medications for Parkinson's disease,
• thyroid preparations,
• cimetidine,
• rifampicin,
• methylphenidate,
• oral contraceptives,
• estrogens,
• diuretics.

The information in this leaflet may also apply to medications taken in the past or to be taken in the future.

Using Anafranil SR 75 in elderly patients

Elderly patients require lower doses of the medication than younger patients. Side effects occur more frequently in elderly patients. The attending doctor should provide the patient with information about the exact dosage and the need for careful self-observation.

Children and adolescents

Anafranil SR 75 is indicated for the treatment of nocturnal enuresis in children over 5 years old (provided that organic causes have been excluded).

Pregnancy and breastfeeding

Pregnancy
Before taking any medication, consult a doctor or pharmacist.
Inform your doctor about the pregnancy or suspected pregnancy. Anafranil SR 75 should not be taken during pregnancy unless explicitly prescribed by a doctor.
Breastfeeding
Before taking any medication, consult a doctor or pharmacist.
Inform your doctor about breastfeeding. The active substance in Anafranil SR 75 passes into breast milk, so the medication should be gradually discontinued or breastfeeding should be stopped.

Driving and operating machinery

Anafranil SR 75 may cause drowsiness and reduced concentration in some individuals, as well as decreased visual acuity. If such symptoms are observed, do not drive vehicles, operate machinery, or perform other activities that require high concentration. Alcohol consumption may increase drowsiness.
Anafranil SR 75 contains macrogol glycerol hydroxystearate.
The medication may cause indigestion and diarrhea.

3. How to take Anafranil SR 75

Always take this medication exactly as your doctor has told you.
If you are not sure, ask your doctor or pharmacist.
The dosage and administration method should be individualized and adjusted according to the patient's condition. To achieve the optimal effect, the smallest possible dose should be used. If necessary, it should be increased cautiously. This recommendation applies especially to elderly patients and adolescents. These groups usually show greater sensitivity to Anafranil SR 75 than other patients.
Due to the possibility of QTc interval prolongation and toxic effects on the serotoninergic system, the recommended doses of Anafranil SR 75 should be followed.
When taking medications that prolong the QT interval or act on the serotoninergic system with Anafranil SR 75, dose increases should be made with caution.
Adults
Depression, obsessive-compulsive disorders, and phobias
Treatment should be started with 1 tablet of 25 mg 2-3 times a day or 1 prolonged-release tablet of 75 mg, 1 time a day (preferably in the evening). The daily dose should be increased gradually, e.g., by 25 mg every few days (depending on the patient's tolerance) to 4-6 tablets of 25 mg or 2 prolonged-release tablets of 75 mg during the first week of treatment. In severe cases, the dose can be increased to a maximum of 250 mg per day.
Once significant improvement is achieved, the daily dose should be adjusted to the maintenance dose, usually about 2-4 tablets of 25 mg or 1 prolonged-release tablet of 75 mg.
Panic attacks, agoraphobia
Treatment should be started with 1 tablet of 10 mg per day. Depending on the patient's tolerance, the dose should be increased until a satisfactory clinical condition is achieved. The daily dose is determined individually for each patient and ranges from 25 mg to 100 mg. If necessary, the dose can be increased to 150 mg/day. It is recommended not to discontinue treatment for at least 6 months. During this period, the maintenance dose should be gradually decreased.
Elderly patients
Treatment should be started with 1 tablet of 10 mg per day. Then, the dose is increased gradually to achieve an optimal dose of 30-50 mg/day after about 10 days.
This dose should be maintained throughout the treatment period.
Use in children and adolescents
Nocturnal enuresis
The initial daily dose for children aged 5-8 years is 2-3 tablets of 10 mg; for children aged 9-12 years, 1-2 tablets of 25 mg; and for children over 12 years, 1-3 tablets of 25 mg. Higher doses should be used in patients who do not respond fully to treatment within 1 week. The tablets should be taken as a single dose after dinner. In children who wet their beds early at night, part of the dose should be taken earlier (around 4 pm). After achieving the required clinical response, treatment should be continued (for 1-3 months), and the dose should be gradually decreased.
There is no data on the use of Anafranil SR 75 in children under 5 years.
Prolonged-release tablets can be divided in half, but should not be chewed.

Taking a higher dose of Anafranil SR 75 than recommended

In case of taking more tablets than prescribed by the doctor, seek medical help immediately.
Usually, within a few hours after overdosing, the following symptoms appear: increased drowsiness; concentration disorders; rapid, slow, or irregular heart rhythm; restlessness and agitation; loss of muscle coordination and stiffness; shortness of breath; seizures; vomiting; fever. Overdosing is particularly dangerous in small children.

Missing a dose of Anafranil SR 75

If a dose of Anafranil SR 75 is missed, take the missed dose as soon as possible and return to the regular dosing schedule. If it is close to the time for the next dose, do not take the missed dose, just take the next one according to the dosing schedule. In case of doubts, consult a doctor.
Do not take a double dose to make up for the missed dose.

Discontinuing Anafranil SR 75

The following symptoms usually occur after sudden discontinuation of the medication or dose reduction: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, nervousness, and anxiety.
In case of any further doubts related to the use of this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Anafranil SR 75 can cause side effects, although not everybody gets them.
Usually, they do not require medical intervention and may disappear during treatment as the patient's body gets used to the medication.
Inform your doctor immediately about any unexpected symptoms during treatment with Anafranil SR 75. This also applies to symptoms that do not seem to be related to the medication.

Seek medical help immediately if you experience any of the following side effects, as medical intervention may be necessary:

jaundice, skin reactions (itching or redness), fever and sore throat, balance disorders, eye pain, severe abdominal pain, weakness or muscle stiffness, muscle spasms, difficulty urinating, breast swelling and milk production, rapid or irregular heart rhythm (tachycardia, palpitations), speech difficulties, confusion or delirium, hallucinations, seizures.
Suicidal thoughts, worsening of depression or anxiety disorders
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medications usually start working after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm, or suicidal attempts is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trials indicate an increased risk of suicidal behavior in people under 25 years of age with mental disorders who have been treated with antidepressants.

If suicidal thoughts or self-harm occur, seek medical help immediately.
Side effects are listed starting from the most common ones:
Very common (more than 1 in 10 patients)
Drowsiness, fatigue, restlessness, increased appetite, lethargy, dizziness, tremors, headache, seizures, muscle spasms, nausea, dry mouth, constipation, excessive sweating, accommodation disorders, blurred vision, urination disorders, weight gain, sexual dysfunction, impotence.
Common (less than 1 in 10 patients)
Delirium, confusion (consciousness disorders), disorientation, hallucinations (especially in elderly patients and those with Parkinson's disease), anxiety, agitation, sleep disorders, manic states, aggression, memory disorders, depersonalization (feeling of losing one's identity), worsening of depression, concentration disorders, insomnia, nightmares, yawning, speech disorders, paresthesia (tingling, burning), muscle weakness, increased muscle tension, hot flashes, pupil dilation, sinus tachycardia, palpitations, orthostatic hypotension (sudden blood pressure drop when changing body position), changes in ECG in patients with normal heart function, vomiting, abdominal complaints, diarrhea, loss of appetite, increased liver enzyme activity, allergic skin reactions, photosensitivity, itching, milk production, breast enlargement, taste disorders, tinnitus.
Uncommon (less than 1 in 100 patients)
Activation of psychotic symptoms, ataxia (coordination disorders), irregular heartbeat, increased blood pressure.
Rare (less than 1 in 1000 patients)
Conduction disorders in the heart.
Very rare (less than 1 in 10,000 patients)
Changes in EEG, hyperpyrexia (significant body temperature increase), glaucoma, urinary retention, hepatitis with or without jaundice, edema (local or generalized), hair loss, syndrome of inappropriate antidiuretic hormone secretion (SIADH), allergic pneumonia with or without eosinophilia, anaphylactic or anaphylactoid reactions, including hypotension, abnormal blood count (leukopenia, agranulocytosis, thrombocytopenia, eosinophilia), purpura.
Frequency not known (frequency cannot be estimated from available data)
Suicidal thoughts, suicidal behavior, fractures.
If any side effect worsens, including any possible side effects not listed in the leaflet, consult a doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medication.
Side effects can also be reported to the marketing authorization holder.

5. How to store Anafranil SR 75

No special precautions.
Store the medication out of sight and reach of children.
Do not use this medication after the expiry date stated on the carton after: Expiry date (EXP). The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Anafranil SR 75 contains

The active substance of the medication is clomipramine hydrochloride.

• One prolonged-release tablet contains 75 mg of clomipramine hydrochloride.
• Other ingredients of the medication are: Calcium hydrogen phosphate dihydrate Methacrylic acid and ethyl acrylate copolymer (1:1) Eudragit NE 30 D Calcium stearate Colloidal silica

Tablet coating:

Hypromellose
Makrogol glycerol hydroxystearate (Kremofor RH 40)
Iron oxide red
Talc
Titanium dioxide

What Anafranil SR 75 looks like and contents of the pack

Prolonged-release tablets, pink, oblong, with a dividing line, marked with CG on one side and GD on the other.
2 blisters of 10 prolonged-release tablets in a cardboard box (20 tablets).

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Poland

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

Date of last revision of the leaflet: