Targinact Side Effects

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

What is Targinact?

Targinact contains the active ingredient Oxycodone Hydrochloride and Naloxone Hydrochloride.

• Active ingredient — Oxycodone Hydrochloride and Naloxone Hydrochloride
• Registration number — 53/2.9/0750; 53/2.9/0751; 53/2.9/0752; 53/2.9/0753
• Registration holder — Austell Pharmaceuticals (Pty) Ltd

It is approved for:

• CODEP XR is indicated for the treatment of severe pain, which requires the use of a strong opioid analgesic and to reduce the risk of constipation

Common side effects of Targinact

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

• dizziness
• headaches
• dry mouth
• heartburn (indigestion)
• flatulence (feeling full of wind)

Less frequent side effects

• breaking wind (burping)
• erectile dysfunction
• running nose
• cough
• yawning Side effects with frequency unknown:
• increased sensitivity to pain which cannot be improved by increasing the dose
• tooth decay
• problems with bile flow
• withdrawal symptoms in new-born infants

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 oxycodone or naloxone, or any of the other ingredients of CODEP XR
• if your doctor has told you not to take medicines called “opioids”, usually for treating pain
• if you are having breathing problems, such as breathing more slowly or weakly than expected (respiratory depression)
• if you have a condition called sleep apnoea (a sleep disorder in which your breathing repeatedly stops and starts)
• if you suffer from a severe lung disease which causes narrowing of the airways (chronic obstructive pulmonary disease or COPD)
• if you suffer from a condition known as cor pulmonale (a condition whereby the right side of the heart becomes enlarged, due to increased blood pressure in the lungs)
• if you suffer from severe bronchial asthma
• if you have a type of bowel (lower intestine) obstruction called paralytic ileus, which is not caused by opioid class (strong pain medication) medicines
• if you suffer from moderate to severe liver problems
• if you suffer from moderate to severe kidney problems

Use with care, and tell your doctor, if

• if you are elderly or debilitated (weak)
• if you have a type of bowel (lower intestine) obstruction called paralytic ileus, which is caused by opioid class (strong pain medication) medicines
• if you have mild kidney problems
• if you have mild liver problems
• if you have severe lung problems (breathing difficulty)
• if you have a condition called myxoedema (a thyroid disorder which may occur when your thyroid gland is not producing enough hormones, which results in swelling of the skin (puffiness), affecting the face and limbs)
• if your thyroid gland is not producing enough hormones (underactive thyroid or hypothyroidism)
• if your adrenal glands are not producing enough hormones (adrenal insufficiency or Addison’s disease)
• if you had been abusing medicines in the past and now suffer from a mental disorder (difficulty in thinking, understanding and judging clearly which causes loss of touch with reality)
• if you suffer from gallstone problems
• if your prostate gland is abnormally enlarged (prostate hypertrophy)
• if you are addicted to alcohol or have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping the use of alcohol or medicines
• if your pancreas is inflamed (pancreatitis)
• if you have low blood pressure (hypotension)
• if you have high blood pressure (hypertension)
• if you have heart problems
• if you have a head injury (due to the risk of increased pressure in the brain)
• if you suffer from epilepsy or are prone to fits (convulsions)
• if you are also taking a type of medicine known as a monoamine oxidase inhibitor (MAOI) (used to treat depression or Parkinson’s disease), which includes medicines containing tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid
• if you have been receiving long term opioid treatment with higher doses of opioids and are switched to CODEP XR as you may suffer from withdrawal symptoms
• if you have been receiving long term treatment with CODEP XR, as you may develop a tolerance to the prescribed dose, which may require higher doses to be prescribed to provide the desired pain relief
• if you have been receiving long term treatment with CODEP XR, as this may lead to physical or psychological (addiction) dependence
• if you have been receiving long term treatment with CODEP XR, and stop taking it immediately, as you may suffer from withdrawal symptoms
• if you are a professional athlete, as CODEP XR may produce positive results in doping controls
• if you are about to have an operation or for the first 12-24 hours after an operation. If any of these warnings apply to you, talk to your doctor before starting to take CODEP XR tablets. CODEP XR is not recommended for use in patients with advanced digestive (stomach or intestine) or pelvic cancers where bowel (lower intestine) obstruction may be a problem. Children and adolescents under 18 years: The safety and efficacy of CODEP XR in patients below the age of 18 years of age has not been established and CODEP XR is not recommended for use in this patient group

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 professional for advice before taking CODEP XR
• CODEP XR is not recommended for use in pregnancy or during labour
• Both oxycodone and naloxone pass into the placenta
• Use of CODEP XR tablets during pregnancy should be avoided
• If used over prolonged periods during pregnancy, oxycodone may lead to withdrawal symptoms in the newborn baby
• If oxycodone is given during childbirth, the baby may have breathing problems (respiratory depression)

Interactions and medicines to check

The approved leaflet names these interactions.

• if you are taking antibiotics (such as clarithromycin)
• if you are taking antifungal medicines (such as ketoconazole)
• if you are taking medicine to treat HIV (such as ritonavir)
• if you are taking medicine to treat tuberculosis (such as rifampicin)
• if you are taking medicine to treat epilepsy (such as carbamazepine or phenytoin)
• if you are taking medicine to treat depression (such as paroxetine or St.John’s Wort)
• if you are taking quinidine (a medicine to treat a fast heart beat). Grapefruit juice may also increase the blood levels of oxycodone and should not be drunk whilst taking CODEP XR. CODEP XR with food and drink You can take CODEP XR with or without food. Drinking alcohol during your treatment with CODEP XR may make you sleepy or increase the risk of serious side effects, such as shallow breathing with the risk to stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you are taking CODEP XR

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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