Cilift 20 mg Tablets

CILIFT 20 mg TABLET belongs to a group of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

CILIFT 20 mg TABLET is used for the:

• Treatment of depression and prevention of the return of the depression.
• Treatment of panic disorder with or without fear of public places or open spaces (agoraphobia).
• Treatment of obsessive compulsive disorder (OCD).

Do not take CILIFT 20 mg TABLET:

• if you are hypersensitive (allergic) to citalopram or any of the other ingredients of CILIFT 20 mg TABLET (listed in section 6).
• if you are suffering from severe kidney impairment.
• if you are younger than 18 years.
• if you are receiving monoamine oxidase inhibitors (MAOIs), a class of antidepressant medicine prescribed for the treatment of depression, or for at least 14 days after stopping their use. MAOIs should not be introduced for 7 days after stopping CILIFT 20 mg TABLET.
• if you are born with or have had an episode of abnormal heart rhythm (seen on an ECG; an examination to evaluate how the heart is functioning) (QT prolongation).
• if you are taking medicines for heart rhythm problems or that may affect the heart’s rhythm, as an additive effect of CILIFT 20 mg TABLET and these medicines cannot be excluded. These medicines include, but are not limited to, medicines that treat:
• Irregular heartbeat (referred to as CLASS IA and III antidysrhythmics) e.g. amiodarone and quinidine.
• Psychoses e.g. phenothiazine derivatives, pimozide, haloperidol.
• Depression referred to as tricyclic antidepressants (e.g. imipramine, desipramine) or moclobemide.
• Parkinson´s disease e.g. selegiline.
• Certain antibiotics e.g. moxifloxacin, erythromycin IV (intravenous), pentamidine.
• Malaria particularly halofantrine.
• Allergies e.g. mizolastine.
• HIV e.g. ritonavir, saquinavir, lopinavir.
• if you are taking a medicine containing linezolid (an antibiotic).

Warnings and precautions

Take special care with CILIFT 20 mg TABLET:

• if you suffer from reduced liver or kidney function. Your doctor may need to adjust your dosage.
• if you need to undergo electro-convulsive treatment, as there is limited experience with the combination.
• if you enter a manic state (feeling excessively cheerful and euphoric) you should stop taking CILIFT 20 mg TABLET immediately.

Do not share medicines prescribed for you with any other person. Always take CILIFT 20 mg TABLET exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose depends on the condition it is used for and your age. Dosages range from 10 mg (half a tablet) daily to 40 mg (two tablets) daily, as instructed by your doctor.

Adults

Treating depression

The usual dose is 20 mg (1 tablet) per day. The dose may be increased by your doctor to a maximum of 40 mg (2 tablets) per day.

Treating panic disorder

The starting dose is 10 mg (half a tablet) per day for the first week before increasing the dose to 20 mg (1 tablet) per day. The dose may be increased by your doctor to a maximum of 40 mg (2 tablets) per day.

Treating obsessive - compulsive disorder (OCD)

The starting dose is 20 mg (1 tablet) per day. The dose may be increased by your doctor to a maximum of 40 mg (2 tablets) per day.

Elderly patients (above 65 years of age)

The starting dose should be decreased to half of the recommended dose, e.g. 10 mg to 20 mg per day. Elderly patients should not receive more than 20 mg (1 tablet) per day.

Patients with special risks

For patients with liver complaints, the starting dose should be 10 mg daily for the first two weeks of treatment. The dose may be increased by your doctor to a maximum of 20 mg (1 tablet) per day.

Children and adolescents (< 18 years)

CILIFT 20 mg TABLET should not be given to children or adolescents under the age of 18 years.

CILIFT 20 mg TABLET is taken as a single daily dose. CILIFT 20 mg TABLET can be taken with or without food, in the morning or in the evening.

Duration of treatment

For depression, panic disorder and OCD these tablets may take a few weeks before you feel any improvement. Continue to take CILIFT 20 mg TABLET even if it takes some time before you feel any improvement in your condition. Never change the dose of the medicine without talking to your doctor first. The duration of treatment is individual, usually at least 6 months. Continue to take the tablets for as long as your doctor recommends. Do not stop taking them even if you begin to feel better, unless you are told to do so by your doctor. The underlying illness may persist for a long time and if you stop your treatment too soon your symptoms may return. Patients who have recurrent depressions benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes. Your doctor will tell you how long your treatment with CILIFT 20 mg TABLET will last.

CILIFT 20 mg TABLET can have side effects. Not all side effects reported for CILIFT 20 mg TABLET are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CILIFT 20 mg TABLET please consult your healthcare provider for advice.

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

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to CILIFT 20 mg TABLET. 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:

• Suicidal ideation, suicidal behaviour,
• in children hostility, suicidal ideation and self-harm. Symptoms include, but are not limited to anxiety, agitation, panic attacks, sleeplessness, irritability, hostility (aggressiveness), impulsivity, restlessness, constant elevated or irritable mood,
• if you have palpitations, dizziness, fainting, shortness of breath and chest discomfort as this can be symptoms of irregular heartbeat or abnormal heart rhythm,
• swelling and inflammation of the liver, symptoms include, but are not limited to, abdominal pain, dark urine and pale or clay-coloured stools, fatigue, fever, yellowing of the skin or eyes, loss of appetite,
• memory loss,
• unusual bleeding, including bleeding in the stomach with symptoms such as stomach cramps, blood in vomit, black or tarry stools,
• heavy vaginal bleeding shortly after birth (postpartum haemorrhage),
• high fever, agitation, confusion, trembling and abrupt contractions of muscles; this may be signs of a rare condition called serotonin syndrome,
• a life-threatening reaction called neuroleptic malignant syndrome, characterised by a very high fever, altered mental status, muscle rigidity, accelerated heartbeat, increased rate of breathing,
• fitting (convulsions, seizures).

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:
• Weight loss, weight gain, decreased appetite,
• nervousness, confusional state, anxiety,
• agitation,
• decreased libido, abnormal orgasm (female), ejaculation disorder, impotence, ejaculation failure,
• sleep disorders, abnormal dreams, sleeplessness, sleepiness, drowsiness,
• feeling indifferent or lacking emotion,
• feeling of ‘needles and pins’ in the extremities,
• headaches of varying intensity, sometimes with nausea and sensitivity to light and sound,
• tremor, dizziness,
• disturbance in attention,
• blurred vision, eye strain, eye fatigue (eye accommodation disturbances),
• ringing in the ears,
• yawning,
• stuffy or runny nose,
• dry mouth, nausea, vomiting, indigestion, constipation, diarrhoea,
• stomach pain, wind, increased saliva,
• increased sweating,
• muscle pain, body aches, joint pain or stiffness,
• abnormal physical weakness or lack of energy,
• fainting shortly after or during urination or other abnormalities in the process of urinating,
• tiredness (fatigue).

Less frequent side effects:

• Low sodium levels in the blood, symptoms may include but are not limited to weakness, seizures, headache, confusion (especially in elderly patients),
• increased appetite,
• elevated or irritable mood, aggression, depersonalisation,
• hallucination (seeing and hearing things that are not real),
• excessive grinding of the teeth,
• restlessness, panic attacks,
• confusion, fainting,
• taste disturbances,
• movement disorders, uncontrolled, unusual, involuntary muscle movements or stiffness,
• nasal congestion and/or bleeding,
• coughing,
• hair loss,
• dilated pupils,
• head rush or dizzy spell, when you stand up or stretch,
• the passage of blood from ruptured blood vessels into subcutaneous tissue, marked by a purple discolouration of the skin or bruising,
• sensitivity to light,
• urinary retention,
• fever,
• abnormal bleeding between regular menstrual periods or menstrual periods with abnormally heavy or prolonged bleeding,
• increased sexual desire, priapism (a potentially painful medical condition in which the erect penis does not return to its flaccid state),
• milky secretions from the breast,
• general sense of feeling unwell,
• water retention.

Side effects with an unknown frequency:

• Vision disturbances,
• low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm.

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: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088/ +27 (0)11 239-6200

By reporting side effects, you can help provide more information on the safety of CILIFT 20 mg TABLET.

Store all medicines out of reach of children. Store at or below 25 °C. Protect from moisture. Keep the blisters in the carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).