Anafranil ® Tablets

ANAFRANIL belongs to a group of medicines called tricyclic antidepressants. ANAFRANIL is believed to work by increasing the levels of two naturally occurring chemicals within the brain, noradrenaline and 5-hydroxytryptamine (also called serotonin). ANAFRANIL is used to treat depression and mood disorders. Other psychological conditions that can be treated with ANAFRANIL are obsessions and muscular weakness (cataplexy) associated with recurrent attacks of extreme sleepiness (narcolepsy) in adults. In children aged above 5 years, ANAFRANIL is used to treat obsessive-compulsive disorders.

It is important to tell your doctor if you have other medical problems or if you are taking other medicines.

Do not take ANAFRANIL

• If you are hypersensitive (allergic) to clomipramine, to any other tricyclic antidepressant, or any of the other ingredients of ANAFRANIL (listed in section 6).
• If you are taking certain medicines used to treat depression such as monoamine oxidase inhibitors (MAO inhibitors), selective serotonin reuptake inhibitors (SSRI), or serotonin and noradrenergic reuptake inhibitors (SNRI).
• If you have recently had a heart attack or if you suffer from a serious heart disease.
• If you have heart disorders such as abnormal heart rhythm.
• If you have any serious liver disease.
• If you have low levels of potassium in your blood (hypokalaemia).
• If you have glaucoma (increased pressure in the eye).
• If you have difficulty in passing urine.
• If you have a mental health condition called mania.

If the answer to any of these is YES, ANAFRANIL is probably not suitable for you.

If you think you may be allergic, ask your doctor for advice.

Warnings and precautions

Take special care with ANAFRANIL:

• If you are having thoughts of suicide.
• If you have epileptic fits.
• If you have had a head injury or have suffered brain damage.
• If you are going to have electric shock therapy (ECT).
• If you have schizophrenia or other mental disorder.
• If you have liver or kidney disease.
• If you have any blood disorder.
• If you have difficulties in passing urine (e.g. due to diseases of the prostate).
• If you have an overactive thyroid gland.
• If you have persisting constipation.
• If you easily faint or have low blood pressure.
• A history of increased eye pressure or glaucoma.
• If you have cancer in a gland called the adrenal gland, which produces hormones.
• If you are elderly, as the chances are greater that you could get side effects.

Your doctor will take these conditions into account before and during your treatment with ANAFRANIL.

If any of these apply to you, tell your doctor before you take ANAFRANIL.

Further safety measures

It is important for your doctor to check your progress regularly to allow dosage adjustments and help reduce side effects. He or she may want to take some blood tests and measure your blood pressure and heart function before and during treatment.

Do not share medicines prescribed for you with any other person.

Always take ANAFRANIL exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

If you have low blood potassium levels (hypokalaemia), your doctor will treat this before you can start treatment with ANAFRANIL. Your doctor will decide on the most suitable dosage for your particular case. Take ANAFRANIL as directed by your doctor. Do not take more of it, and do not take it more often or for longer than your doctor ordered. In some cases, the doctor may decide to treat you with injections of ANAFRANIL. The 75 mg SR divitabs can be halved, but should not be chewed. You can take ANAFRANIL with or without food. For depression and obsessive-compulsive disorders, the daily dosage is normally between 75 mg and 150 mg. Max daily dose is 250 mg. For muscular weakness (cataplexy) accompanied by extreme sleepiness (narcolepsy), the daily dose is between 25 mg to 75 mg.

ANAFRANIL and older people

Elderly patients generally need lower doses than young and middle-aged patients. Side effects are more likely to occur in older patients. Your doctor will provide any special information about careful dosage and close observation needed.

ANAFRANIL and children

ANAFRANIL should not be given to children or adolescents unless specifically prescribed by a doctor. Your doctor will provide any special information about careful dosage and close observation needed. The starting dose for children/adolescents for the treatment of obsessive disorders is 25 mg daily. The maximum dose is 3 mg/kg or 200 mg, whichever is smaller.

If you take more ANAFRANIL than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, rush the patient to the nearest hospital or poison centre. The following symptoms of overdose usually appear within a few hours: severe drowsiness, poor concentration, fast, slow, or irregular heartbeat, the inability of the heart to pump as much blood as it should, low blood pressure, restlessness and agitation, loss of muscle coordination and muscle stiffness, shortness of breath, fits, vomiting or fever. Breathing difficulty, cyanosis (low levels of oxygen in your blood), mydriasis (widening of the pupils of the eyes), sweating, and very low or no urine being created by your body, may also occur.

If you forget to take ANAFRANIL

If you forget to take a dose of ANAFRANIL, take the missed dose as soon as possible and then go back to your normal dosage schedule. If it is almost time for your next dose, skip the missed dose and continue with your normal dosage schedule. Do not take a double dose to make up for forgotten individual doses. If you have any questions about this, ask your doctor.

If you stop taking ANAFRANIL

Depression and obsessive-compulsive disorders require long-term treatment with ANAFRANIL. Do not change or stop the treatment without first asking your doctor. Your doctor may want you to reduce the dosage gradually before stopping completely. This is to prevent any worsening of your condition and reduce the risk of withdrawal symptoms such as headache, nausea, vomiting, stomach pain, diarrhoea, sleeping difficulty, nervousness and feeling anxious.

ANAFRANIL can have side effects. Not all side effects reported for ANAFRANIL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ANAFRANIL, please consult your health care provider for advice.

If any of the following happens, stop taking ANAFRANIL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• A lower than normal level of sodium in the blood, which may make you feel weak and confused with sudden contraction of the muscles, muscle spasms. This may be due to inappropriate ADH secretion, a hormone that causes the body to retain water and dilute the blood, reducing the amount of sodium.
• Seeing or hearing things that are not really there.
• Allergic reactions with/without coughing and difficulty in breathing, skin reactions (itching or reddening), fast heartbeat (racing, pounding), swelling of the hands, face, tongue, neck or throat, increased fluid in tissues and very low blood pressure.
• Stomach pain.
• Loss of appetite.
• Muscle weakness or stiffness.
• Difficulty in speaking.
• Confusion, delirium.
• Inability to coordinate movement.
• Irregular heartbeat (racing, pounding), and fainting (especially if you have low potassium levels in your blood).
• Fits.
• A nervous system disorder characterized by muscle stiffness, high fever and impaired consciousness. These may be the symptoms of a serious condition known as neuroleptic malignant syndrome.
• Disease of the liver (known as hepatitis), this may result in jaundice. You may feel sick, be sick, generally feel unwell, lose your appetite, have a fever, yellowing of the skin or whites of the eyes, light coloured stools and dark-coloured urine.
• Frequent infection with fever and sore throat (due to decreased number of white blood cells).
• Increase pressure in the eye.
• Difficulty in passing urine.
• Thoughts of suicide or self-harm (see section 2 for more information).
• Serotonin syndrome (caused by an increase in naturally occurring messenger, serotonin, in the brain; symptoms include agitation, confusion, diarrhoea, high temperature, increased blood pressure, excessive sweating and rapid heartbeat).
• Breakdown of muscle, causing muscle pain, weakness or tenderness accompanied by dark urine (rhabdomyolysis). These are all very serious side effects. If you have them, you may have had a serious reaction to ANAFRANIL. You may need urgent medical attention or hospitalisation.

Frequent side effects:

• Drowsiness.
• Tiredness.
• Dizziness.
• Restlessness.
• Increase in appetite.
• Dry mouth.
• Constipation.
• Problem with your eye sight including blurred vision.
• Trembling.
• Headache.
• Nausea.
• sweating.
• Weight gain.
• Changes in the amount of sugar in the blood.
• Sexual difficulties.
• Anxiety.
• Changes to the amount of urine you produce or frequency of urination.
• Disorientation.
• Agitation.
• Palpitations.
• Minor changes to your electrocardiogram (ECG – a test, which shows how your heart conducts electricity) may show up if your heart is tested.
• Disturbance in attention.
• Sleep disturbances.
• Over-excitedness.
• Aggressiveness.
• Poor memory.
• Yawning.
• Nightmares.
• Numbness or tingling of the extremities.
• Hot flushes.
• Dilated pupils.
• Fall in blood pressure associated with dizziness after abrupt standing or sitting up.
• Vomiting, abdominal disorders, diarrhoea.
• Skin sensitivity to sunlight.
• Rash, hives or itching.
• Worsening depression.
• Swelling of the breasts and discharge of milk.
• Women may not be able to orgasm.
• Unpleasant taste.
• Ringing in the ears.
• Feeling detached from a situation (like watching it from afar).
• Changes in liver function tests.

Less frequent side effects:

• Higher than normal level of white blood cells (eosinophilia) as seen in a blood test.
• Swelling of the lungs which can cause flu-like effects such as coughing, chest tightness, chills, wheezing and difficulty breathing.
• Blue or purplish spots on the skin (ecchymosis or purpura).
• Abnormal reading of the electrical activity of the brain (as seen in an electroencephalogram).
• Changes in how you think and feel.
• Vaginal bleeding.
• Oedema (swollen ankles and/or hands and/or swelling of any other part of the body).
• Hair loss.
• Patients aged 50 years or older and taking a medicine of this group are more likely to experience bone fractures.

The frequency of the following side effects are unknown:

• Repetitive, uncontrollable movements.
• Inability to ejaculate or a delay in ejaculation.
• Increase in prolactin (a hormone) level in the blood.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of ANAFRANIL.

ANAFRANIL ® 10 tablets and ANAFRANIL ® 25 Tablets: Store at or below 30 °C and protect from moisture and light. ANAFRANIL ® SR 75 divitabs: Store at or below 30 °C and protect from moisture. KEEP OUT OF REACH AND SIGHT OF CHILDREN. Do not use after the expiry date stated on the label and/or carton. Return all used ANAFRANIL to your pharmacist. Do not dispose of unused ANAFRANIL in drains or sewerage system.