Cabrexxa Side Effects

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Answer the side-effect intent for cabrexxa without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Cabrexxa?

Cabrexxa contains the active ingredient Varenicline tartrate.

• Active ingredient — Varenicline tartrate
• Registration number — 55/2.11/0517; 55/2.11/0518
• Registration holder — Abex Pharmaceutica (Pty) Ltd

It is approved for:

• CABREXXA contains the active substance varenicline tartrate
• CABREXXA is a medicine which is used in adults to help them stop smoking
• CABREXXA can help to relieve the craving and withdrawal symptoms associated with stopping smoking
• CABREXXA can also reduce the enjoyment of cigarettes if you do smoke when on treatment

Common side effects of Cabrexxa

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• inflammation of the nose, throat and sinuses
• chest infection
• increased weight
• decreased appetite or increased appetite
• abnormal dreams
• difficulty sleeping
• headache
• drowsiness
• changes in the way things taste
• shortness of breath, cough
• nausea, vomiting
• acid reflux
• constipation, feeling bloated
• toothache
• abdominal pain, indigestion, flatulence
• dry mouth
• skin rash, itching
• joint ache, muscle ache, back pain
• chest pain
• fatigue
• abnormal liver function tests (shown with laboratory tests)

Less frequent side effects

• recurrent viral or fungal infections
• decrease in blood platelets
• high blood sugar, excessive thirst, diabetes
• suicidal thoughts, changes in thinking or behaviour (such as aggression), feeling of panic, difficulty thinking, restlessness, mood swings, depression, anxiety, hallucinations
• changes in sex drive
• loss of contact with reality and unable to think or judge clearly (psychosis)
• sleep walking
• abnormal behaviour, melancholy, slowed thinking
• seizure, tremor, feeling sluggish, less sensitive to touch
• sleep disorders
• conjunctivitis (inflammation/infection of the eye), eye pain
• disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light, shortsightedness, watery eyes
• ringing in the ears
• increased blood pressure, hot flush
• congestion of nose, throat and chest, hoarseness, hay fever, throat irritation, congested sinuses, excess mucus from nose causing cough, runny nose
• throat pain, snoring
• red blood in stools, irritated stomach, change of bowel habit, belching, mouth ulcers, pain in the gums
• blood in vomit, abnormal stools, coated tongue
• reddening of the skin, acne, increased sweating, night sweats
• muscle spasms, chest wall pain
• stiff joints, rib pain
• abnormal frequent urination, high volumes of urine, urination at night
• glucose in urine
• increased menstrual flow
• vaginal discharge, changes in sexual ability
• chest discomfort, flu like illness, fever, feeling weak or unwell
• feeling cold, cyst

Frequency not known side effects

• Transient loss of consciousness

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to varenicline tartrate or any of the other ingredients of CABREXXA (listed in section 6)

Use with care, and tell your doctor, if

• if you are taking other medicines
• Tell your doctor if you have kidney problems. Your doctor may prescribe a lower dose of CABREXXA for you
• Tell your doctor if you have an existing heart condition. New or worse heart or blood vessel (cardiovascular) problems have been reported primarily in people who already have cardiovascular problems. Tell your doctor if you have any changes in symptoms during treatment with CABREXXA. Get emergency medical help right away if you have symptoms of a heart attack or stroke
• Tell your doctor if you have depression or other mental health problems (e.g. schizophrenia, bipolar disorder). There have been reports of depression, suicidal ideation and behaviour and suicide attempts in patients taking CABREXXA. If you are taking CABREXXA and develop agitation, depressed mood, changes in behaviour that are of concern to you or your family, or if you develop suicidal thoughts or behaviour, you should stop taking CABREXXA and contact your doctor immediately for treatment assessment. The effects of stopping smoking The effects of changes in your body resulting from stopping smoking, with or without treatment with CABREXXA, may alter the way other medicines work. Therefore, in some cases an adjustment of the dose may be necessary. Tell your doctor if you take other medicines; see ‘Other medicines and CABREXXA’ for further details. For some people, stopping smoking with or without treatment has been associated with an increased risk of experiencing changes in thinking or behaviour, feelings of depression and anxiety and can be associated with a worsening of psychiatric disorder. If you have a history of psychiatric disorder, you should discuss this with your doctor. Seizures Tell your doctor if you have experienced seizures or have epilepsy before you start CABREXXA treatment. Some people have reported seizures while taking CABREXXA. Children and adolescents CABREXXA is not recommended for use in paediatric patients as efficacy was not demonstrated

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking CABREXXA
• Pregnancy: You should not take CABREXXA while you are pregnant
• If you are pregnant or planning to become pregnant, you should try to stop smoking
• Stopping smoking has benefits for both you and the health of your baby
• Talk to your doctor if you are intending to become pregnant
• If you want to start treatment with CABREXXA, your treatment should be timed so that you have completed the course before becoming pregnant

Interactions and medicines to check

The approved leaflet names these interactions.

• theophylline (a medicine to treat breathing problems)
• warfarin (a medicine to reduce blood clotting)
• insulin, metformin (medicines to treat diabetes)
• digoxin (a medicine for heart problems)
• cimetidine: If you have severe kidney disease you should avoid taking cimetidine (a medicine used for gastric problems) at the same time as CABREXXA as this may cause increased blood levels of CABREXXA. Use of CABREXXA with other therapies for smoking cessation Consult your doctor before using CABREXXA in combination with other smoking cessation therapies, for example bupropion, nicotine replacement patches. CABREXXA with food and drink CABREXXA can be taken with or without food. There have been some reports of increased intoxicating effects of alcohol in patients taking CABREXXA

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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