Palexia ® SR 50 mg Prolonged-Release Tablets

The active substance in PALEXIA SR is tapentadol. Tapentadol is a painkiller which belongs to the class of opioids. PALEXIA SR is used in adults for the treatment of moderate to severe long term pain that can only be adequately managed with an opioid painkiller. Only to be used by patients aged 18 years or older.

Do not take PALEXIA SR:

• If you are hypersensitive (allergic) to the active ingredient tapentadol, or any of the other ingredients of PALEXIA SR. PALEXIA SR contains lactose monohydrate (See PALEXIA SR contains)
• If you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia)
• If you have no bowel movement as shown by severe constipation and bloating, which may be accompanied by pain or discomfort of the lower stomach
• In cases of poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and emotions (see Other medicines and PALEXIA SR)
• If you have a head injury
• If you have severe kidney or liver impairment
• If you have inflammation of your pancreas (pancreatitis)
• If you are pregnant or breastfeeding your baby
• If you are taking or have taken a type of medicine known as monoamine oxidase inhibitor (MAOI) during the last 14 days. MAOIs are used for the treatment of depression (see Other medicines and PALEXIA SR)

Warnings and precautions

Take special care with PALEXIA SR:

• If you have slow or shallow breathing
• If you suffer from increased pressure in the brain or are not fully conscious
• If you have had an epileptic fit or if you are at risk of having epileptic fits or if you are taking other medicines known to increase the risk of seizures because the risk of a fit may increase.
• If you suffer from liver or kidney problems (See How to take PALEXIA SR)
• If you suffer from a pancreatic disease or disease of the bile duct (biliary tract disease)
• If you have a tendency to abuse medicines or if you are dependent on medicines, as PALEXIA SR may lead to addiction. In this case you should only take these tablets for short periods of time and under strict medical supervision.

Sleep-related breathing disorders

PALEXIA contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep related hypoxemia (low level of oxygen in the blood). The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea. If any of the above applies to you, talk to your doctor before you take PALEXIA SR.

Other medicines and PALEXIA SR

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines)

Do not share medicines prescribed for you with any other person. Always take PALEXIA SR exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with PALEXIA SR will last. Do not stop treatment because your pain is likely to return. If you have the impression that the effect of PALEXIA SR is too strong or too weak, tell your doctor or pharmacist. Your doctor will change the dose and time between doses of PALEXIA SR according to your pain level and your needs. Generally, the lowest pain-relieving dose should be taken.

Adults

The usual dose is 1 tablet every 12 hours. Daily doses of PALEXIA SR greater than 500 mg tapentadol are not recommended. Your doctor may prescribe a different, more appropriate dose or timing of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.

How and when should you take PALEXIA SR

PALEXIA SR is for oral use. Swallow the tablets with a glass of water. You may take the tablets on an empty stomach or with food. Do not chew, break or crush the tablet, as it may result in overdose due to the quick release of PALEXIA SR in your body. The empty shell of the tablet may not be digested completely and thus be seen in stool. This should not worry you, since the drug (active substance) of the tablet has already been absorbed in your body and what you see is just the empty shell.

How long should you take PALEXIA SR

Do not take the tablets for longer than as your doctor has told you. Elderly patients

In elderly patients (above 65 years) usually no dose adjustment is necessary. However, your doctor may adjust your dose or time between doses if required. Patients with liver or kidney problems (insufficiency) Do not take PALEXIA SR if you have severe liver or kidney problems. If you have moderate liver problems, your doctor will adjust your dose or time between doses. If you have mild liver problems or mild to moderate kidney problems, a dose adjustment is not required. Children Not recommended for children and adolescents below the age of 18 years.

If you take more PALEXIA SR 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. Taking too much PALEXIA SR may be life-threatening. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Not all side-effects reported for PALEXIA SR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PALEXIA SR, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking PALEXIA SR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• PALEXIA SR may cause allergic reactions (less frequent). Symptoms may be wheeziness, difficulty breathing, swelling of the eyelids, face or lips, or rash or itching, which may cover your whole body
• Another serious side effect is a condition where you breathe more slowly or weakly than expected (less frequent). Elderly and weak patients are more susceptible to this. These are all very serious side-effects. If you have them, you may have had a serious allergic reaction to PALEXIA SR. You may need urgent medical attention or hospitalisation.

Frequent:

• Feeling sick (nausea)
• Constipation
• Dizziness, drowsiness, headache.
• Decreased appetite, anxiety, being sick (vomiting), diarrhoea, indigestion
• Sleep problem, tiredness or exhaustion (fatigue), feeling of weakness, trembling, muscle twitches, shortness of breath
• Feeling depressed, nervousness, restlessness, lack of attention
• Feeling hot (flushing), increased sweating, feeling of body temperature change, dry areas like nostrils, mouth, lips, eyelids, ears, genitals and anus
• Itching, rash
• Water retention (oedema)

Less frequent:

• Weight loss
• Low awareness of time, place or identity (disorientation), confusion, excitable (agitated) disturbances in perception, abnormal dreams, forgetfulness, mental impairment
• Very happy (euphoria), less consciousness, fainting, sedation, feeling unsteady, difficulty in speaking, numbness
• Abnormal sensations of the skin (e.g. tingling, prickling), skin reactions (hives)
• Abnormal vision
• Faster or slower heart beat, low blood pressure
• Stomach discomfort, delay in passing urine, passing urine more often than usual
• Sexual dysfunction
• Drug withdrawal effects (See If you stop taking PALEXIA SR)
• Feeling strange, irritable
• Addiction
• Thinking abnormal, epileptic fits, near fainting, uncoordinated, feeling drunk or relaxed
• Delayed emptying of the stomach (impaired gastric emptying)
• Increased blood pressure.
• Delirium

Suicidal thoughts have been reported in patients taking PALEXIA SR. 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. 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 PALEXIA SR.

Store all medicines out of reach of children. Store at or below 30 °C. Blisters must be kept in the cartons until required for use. Do not use PALEXIA SR after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).