Citalopram Film-Coated Tablets

CITALOPRAM 20 OETHMAAN contain the active substance citalopram which is one of a group of medicines called selective serotonin re-uptake inhibitors (SSRI) antidepressants.

CITALOPRAM 20 OETHMAAN is used for:

• Depression and prevention of relapse.
• Panic disorders.
• Obsessive-compulsive disorder (OCD).

Do not take CITALOPRAM 20 OETHMAAN:

• If you are allergic (hypersensitive) to citalopram or any of the ingredients in the formulation (see “What CITALOPRAM 20 OETHMAAN contains”).
• If you are taking any other medication for depression such as monoamine oxidase inhibitor (MAOI). At least 14 days should elapse between stopping the MAOI and starting with CITALOPRAM 20 OETHMAAN.
• If you have severely impaired kidney function.
• If you are taking pimozide (a medicine used in Tourette’s syndrome)
• If you are taking linezolid, an antibiotic.
• If you are born with or have had an episode of abnormal heart rhythm known as QT interval prolongation (seen at ECG; an examination to evaluate how the heart is functioning).
• If you are pregnant or breastfeeding.
• CITALOPRAM 20 OETHMAAN must not be used by children under the age of 18 years.

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

Always take CITALOPRAM 20 OETHMAAN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you have the impression that the effect of CITALOPRAM 20 OETHMAAN is too strong or too weak talk to your doctor or pharmacist.

You and your doctor should talk about the benefits and risks of treatment with CITALOPRAM 20 OETHMAAN.

The recommended dosage of CITALOPRAM 20 OETHMAAN is one tablet once a day either in the morning or the evening with or without food. The dose of CITALOPRAM 20 OETHMAAN will be different for different patients and may depend on a number of things, including what the medicine is being used for, and whether or not other medicines are also being taken.

If you take more CITALOPRAM 20 OETHMAAN than you should

In the event of overdosage consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison control centre. In the event of overdose, your doctor will treat the symptoms of the side effects which may include tiredness, weakness, sedation, dizziness, tremor, nausea, somnolence and increase heart rate.

If you forget to take CITALOPRAM 20 OETHMAAN

Take the missed dose as soon as possible. However, if it is almost time for you next dose, continue to take the next tablet at the usual time. Do not take a double dose.

If you stop taking CITALOPRAM 20 OETHMAAN

Do not stop taking your medication abruptly, as your doctor will prescribe the gradual lowering of the dose. Do not stop taking CITALOPRAM 20 OETHMAAN without asking your doctor first, even when you start to feel better. It is important that you keep taking CITALOPRAM 20 OETHMAAN. Stopping your treatment abruptly with CITALOPRAM 20 OETHMAAN may lead to the following effects (withdrawal symptoms), such as dizziness, feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), vomiting, sweating, feeling restless or agitated, tremor, feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations). When stopping CITALOPRAM 20 OETHMAAN, your doctor will help you to reduce your dose slowly over several weeks - this should help reduce the chance of withdrawal effects.

CITALOPRAM 20 OETHMAAN can have side effects. Not all side effects reported for CITALOPRAM 20 OETHMAAN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this CITALOPRAM 20 OETHMAAN, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking CITALOPRAM 20 OETHMAAN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Sudden signs of allergy – including skin rash, itching or hives; swelling of the face, lips or tongue, shortness of breath or difficulty breathing.
• If you have thoughts of harming or killing yourself at any time. These are all very serious side effects. If you have them, you may have had a serious reaction to CITALOPRAM 20 OETHMAAN. You may need urgent medical attention or hospitalisation.
• Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• If you feel restless and cannot sit or stand still, you may have akathisia (feeling of “inner restlessness”, a constant urge to be moving).
• A combination of symptoms (known as “serotonin syndrome”) including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness.
• Rapid and irregular heartbeat sensations
• Tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes (symptoms of abnormal liver function or hepatitis).
• Prolonged and painful erection.
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy in section 2 for more information.
• Symptoms of high fever, confusion, rigid muscles, variable blood pressure, sweating and fast heart rate (Symptoms of Neuroleptic Malignant Syndrome).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects
• Decreased sex drive (men and women)
• Sleep problems, sleepiness, tremor
• Nausea, diarrhoea, dry mouth
• Excessive sweating
• Sexual problems (including difficulty maintaining an erection for sexual activity)
• Tiredness

Frequency not known

• A decrease in blood platelets, which increases risk of bleeding or bruising
• Reduced water excretion due to high levels of a hormone
• Low levels of salt and potassium in the blood
• Decreased or increased appetite, decreased or increased weight
• Agitation, anxiety, nervousness, feeling confused, abnormal orgasms in women, sleep problems including unusual dreams, aggression, feeling detached from yourself, hallucinations, abnormally high mood, panic attacks, teeth grinding, restlessness
• Feeling of “pins and needles”, dizziness, poor concentration, fainting, fits (seizures), muscle twitching, involuntary movements or problems with balance or co-ordination
• Enlarged dilated pupils, vision problems
• Ringing in the ears
• Slow heartbeat, rapid and irregular heartbeat sensations
• Unexplained bleeding, low blood pressure that happens when standing up from sitting or lying down.
• Yawning, stuffy nose, nosebleed
• Indigestion, vomiting, constipation, bleeding from the gut including the back passage
• Itchy skin, hives, hair loss, rash, purplish rash, sensitivity to sunlight, bruising of the skin, rapid swelling of the tissues around the neck, face, mouth and/or throat
• Muscle pain, joint pain
• Difficulty passing urine, problems urinating
• Sexual dysfunction, ejaculation problems in men, heavy periods, producing breast milk in men and in women that are not nursing, irregular menstrual period
• Feeling weak, headache, feeling unwell, yawning, swollen ankles, feet and legs, high temperature
• Laboratory test may show the following: blood test results for liver function levels differing from normal

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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 CITALOPRAM 20 OETHMAAN.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Store below 25 °C.

Store in the original package/container.

Keep the blister in the carton until required for use.

Do not store in a bathroom.

Do not use the tablets after the expiry date printed on the container.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).