Cipramil 20 mg Tablets

How does Cipramil work:

Cipramil 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.

What is Cipramil used for:

Cipramil is used to treat depression and when you feel better, to help prevent these symptoms recurring. Cipramil is also beneficial in relieving symptoms in patients prone to panic attacks and in patients with obsessive - compulsive disorder (OCD).

Do not take Cipramil • if you are allergic (hypersensitive) to citalopram or any of the other ingredients of Cipramil (see What Cipramil contains) • if you take other medicines which belongs to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson´s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic) • at the same time as taking pimozide • if you suffer from severely impaired kidney function (creatinine clearance less than 30 ml/min) • if you are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning) (QT prolongation) • if you are under the age of 18 years • if taking other medicine that prolong the QT interval. Even if you have finished taking MAOIs you will need to wait 2 weeks before you start getting your Cipramil treatment. After stopping Cipramil you must allow 1 week before taking any MAOI

Warnings and precautions

Take special care with Cipramil Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor: • if you have episodes of mania or anxiety • if you suffer from reduced liver or kidney function. Your doctor may need to adjust your dosage • if you have diabetes. Treatment with Cipramil may alter glycaemic control. Insulin and/or oral hypoglycaemic (anti - diabetic) dosage may need to be adjusted. • if you have epilepsy. Treatment with Cipramil should be stopped if seizures (fits) occur or if there is an increase in the seizure frequency (see also Possible Side effects) • if you have bleeding disorders, or if you are pregnant (see Pregnancy, breastfeeding and fertility) • if you have a decreased level of sodium in the blood • if you are receiving electroconvulsive treatment (ECT) • if you suffer or have suffered from heart problems or have recently had a heart attack • if you have a low resting heart rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets) • if you experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate • if you have or have previously had eye problems, such as certain kinds of glaucoma (increased pressure in the eye).

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting Cipramil, since it takes time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: • if you have previously had thoughts about killing or harming yourself • if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Use in children and adolescents under 18 years of age Cipramil should not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side - effects such as suicide attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger) when they take this class of medicines.

Special information relating to your disease Improvement is not achieved immediately. After the start of Cipramil treatment it may take several weeks before you experience any improvement. In the treatment of panic disorder it usually takes 3 months before any improvement is seen. In the beginning of the treatment certain patients may experience increased anxiety, which will disappear during the continued treatment. Therefore, it is very important that you follow exactly your doctor’s orders and do not stop the treatment or change the dose without consulting your doctor. Occasionally, the symptoms of depression or panic disorder may include thoughts of suicide or self - harm. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur if you are a young adult, i.e. under 25 years of age and you have not used antidepressive medicines before. Some patients with manic - depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor. Symptoms such as restlessness or difficulty to sit or stand still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms. Sometimes you may be unaware of the above - mentioned symptoms and therefore you may find it helpful to ask a friend of relative to help you to observe the possible signs of change in your behavior. Tell your doctor immediately or contact the nearest hospital if you have distressing thoughts or experiences or if any of the above - mentioned symptoms occurs during the treatment.

Do not share medicines prescribed for you with any other person. Always take Cipramil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure or need further information.

Adults

Depression

The usual dose is 20 mg per day. The dose may be increased by your doctor to a maximum of 40 mg per day.

Panic disorder

The starting dose is 10 mg per day for the first week before increasing the dose to 20 - 30 mg per day. The dose may be increased by your doctor to a maximum of 40 mg per day.

Obsessive - compulsive disorder (OCD)

The starting dose is 20 mg per day. The dose may be increased by your doctor to a maximum of 40 mg per day.

Elderly patients (above 65 years of age)

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

Patients with special risks

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

Children and adolescents (< 18 years)

Cipramil should not be given to children or adolescents. For further information please see Contraindications - Do not take Cipramil.

How and when to take Cipramil:

Cipramil is taken every day as a single daily dose. Cipramil can be taken any time of the day with or without food. Swallow the tablets with a drink of water. Do not chew them (they have a bitter taste).

Duration of treatment:

For depression, panic disorder and OCD these tablets may take a few weeks before you feel any improvement. Continue to take Cipramil 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.

If you take more Cipramil 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. Do this even if there are no signs of discomfort or poisoning. Take the Cipramil box/container with you if you go to a doctor or hospital. Some of the signs of an overdose could be life - threatening irregular heartbeat, convulsion, change in heart rhythm, drowsiness, coma, vomiting, tremor, decreased blood pressure, increased blood pressure, nausea (feeling sick), Serotonin syndrome (see Possible Side effects), agitation, dizziness, dilated pupils of the eye, sweating, blue - ish skin, hyperventilation.

If you forget to take Cipramil:

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.

If you stop taking Cipramil:

Do not stop taking Cipramil until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Cipramil is gradually reduced over a number of weeks. Abrupt cessation of the medication may cause mild and transient discontinuation 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 you have completed your course of treatment it is therefore advised that the dose of Cipramil is gradually reduced over a couple of weeks rather than stopped abruptly. If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

Some patients have reported the following serious side effects. If you get any of the following symptoms you should stop taking Cipramil and see your doctor immediately: • high fever, agitation, confusion, trembling and abrupt contractions of muscles; this may be signs of a rare condition called serotonin syndrome. • If you experience swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction). • Unusual bleeds, including gastrointestinal bleeds.

If you get any of the following symptoms you should stop taking Cipramil and see your doctor immediately: • Hyponatraemia: low blood levels of sodium which can cause tiredness, confusion, and muscle twitching.

The following side effects are often mild and usually disappear after a few days’ treatment. Be aware that several of the below mentioned effects also can be symptoms of your illness and therefore wanes when you start to get better. If side effects are troublesome or last for more than a few days tell your doctor.

Frequent side effects: • Sleepiness • Difficulty in sleeping • Increased sweating • Dry mouth • Nausea (feeling sick) • Decreased appetite • Agitation • Decreased sexual drive • Anxiety • Nervousness • Confusional state • Abnormal dreams • Tremor • Tingling or numbness in the hands or feet • Dizziness • Disturbance in attention • Ringing in the ears (tinnitus) • Yawning • Diarrhoea • Vomiting • Constipation • Itching • Pain in muscle and joints • Men may experience problems with ejaculation and erection • For females, failure to achieve an orgasm • Fatigue • Fever • Prickling of the skin • Decreased weight.

Less frequent side effects: • Cutaneous bleeding disorder (easily bruising) • Increased appetite • Aggression • Depersonalization • Hallucination • Mania • Fainting • Enlarged pupils • Fast heart beat • Slow heart beat • Nettle rash • Loss of hair • Rash • Light sensitiveness • Difficulties urinating • Vaginal bleeding • Swelling of the arms or legs • Increased weight • Convulsions • Involuntary movements • Taste disturbance • Bleeding • Hepatitis.

Some patients have reported (frequency not known): • Thoughts of harming yourself or thoughts of killing yourself, see Warnings and precautions: Take special care with Cipramil. • Reduction in blood platelets, which increases risk of bleeding or bruising • Hypersensitivity (rash) • Serious allergic reaction which causes difficulty in breathing or dizziness • Increase in the amount of urine excreted • Hypokalaemia: low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm • Panic attack • Grinding one’s teeth • Restlessness • Unusual muscle movements or stiffness • Akathisia (involuntary movements of the muscles) • Visual disturbance • Low blood pressure • Nosebleed • Bleeding disorders including skin and mucous bleeding (ecchymosis) • Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy, breastfeeding and fertility in section 2 for more information • Sudden swelling of skin or mucosa • Painful erections • Increased blood levels of the hormone prolactin • Flow of milk in men and in women that are not nursing • Irregular menstrual period • Abnormal liver function test • An increased risk of bone fractures has been observed in patients taking this type of medicines • Abnormal heart rhythm.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell 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 Cipramil.

Store at or below 25 ºC. Store all medicines out of reach of children. Do not use Cipramil after the expiry date, which is stated on the blister and or carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.