Palexia ® 50 mg Tablets

The active substance in PALEXIA is tapentadol. Tapentadol is a painkiller which belongs to the class of opioids.

PALEXIA is used for the short term treatment of acute moderately severe post-operative pain in patients aged 18 years and older. The duration of use should not exceed 10 days.

Do not use PALEXIA if you :

• Are hypersensitive (allergic) to the active ingredient tapentadol, or any of the other ingredients of PALEXIA. PALEXIA contains lactose. (see WHAT PALEXIA CONTAINS).
• Have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia).
• Have paralysis of the gut.
• Have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) (see "Other medicines and Palexia ").
• Have a head injury.
• Have severe kidney or liver impairment.
• Have inflammation of your pancreas (pancreatitis).
• Are pregnant or breastfeeding your baby.
• Are taking or have taken monoamine oxidase (MAO) inhibitors (certain medicines for the treatment of depression) during the last 14 days (see “Other medicines and Palexia ”).

Warnings and precautions

Take special care with PALEXIA if you

• Have slow or shallow breathing.
• Suffer from increased pressure in the brain or disturbed consciousness.
• Have had an epileptic fit or if you have an increased 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.
• Suffer from a liver or kidney disease (see “How to take PALEXIA”).
• Suffer from a pancreatic or biliary tract disease. In such cases please consult your doctor before taking PALEXIA.

PALEXIA may lead to physical and psychological addiction. If you have a tendency to abuse medicines or if you are dependent on medicines, you should only take these tablets for short periods 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.

Do not share medicines prescribed for you with others. Always take PALEXIA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will adjust the dosage according to the intensity of your pain and your individual pain sensitivity. In general, the lowest pain-relieving dose should be taken.

Adults

The usual dose is 50 – 100 mg every 4 to 6 hours. Your doctor may prescribe a different, more appropriate dose or interval 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 to take PALEXIA

PALEXIA is for oral use. Swallow the tablets with sufficient liquid. You may take the tablets on an empty stomach or with meals.

How long should you take PALEXIA

Do not take the tablets for longer than as your doctor has told you. PALEXIA should not be taken for longer than 10 days.

Elderly patients

In elderly patients (above 65 years) usually no dose adjustment is necessary. However, the excretion of PALEXIA may be delayed in some patients of this age group. If this applies to you, your doctor may recommend a different dosage regimen.

Liver and Kidney disease (insufficiency)

Patients with severe liver problems should not take these tablets. If you have moderate problems, your doctor will recommend a different dosage regimen. In case of mild liver problems, a dosage adjustment is not required. Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, a dosage adjustment is not required.

Children

PALEXIA is not suitable for children and adolescents below the age of 18 years.

If you take more PALEXIA 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. Immediate medical advice should be sought in the event of an overdose, even if you feel well. The following may be experienced: pin-point pupils, vomiting, drop in blood pressure, fast heart beat, collapse, disturbed consciousness or coma (deep unconsciousness), epileptic fits, dangerously slow or shallow breathing or stopping breathing may occur. If this happens a doctor should be called immediately!

If you forget to take PALEXIA

If you forget to take the tablets, your pain is likely to return. Do not take a double dose to make up for a forgotten dose, simply continue taking the tablets as before.

If you stop taking PALEXIA

Please tell your doctor first before stopping treatment. Patients who have been taking PALEXIA may feel unwell if they abruptly stop taking them. Symptoms may be: restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain and dilated pupils, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, difficulty in sleeping, nausea, loss of appetite, vomiting, diarrhoea, and increases in blood pressure, breathing or heart rate. If you experience any of these complaints after stopping treatment, please consult your doctor.

Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PALEXIA, please consult your doctor, pharmacist or other healthcare professional for advice.

PALEXIA can have side effects. The following side effects may happen. Important side effects or symptoms to look out for and what to do if you are affected: PALEXIA may cause allergic reactions. Symptoms may be wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching, especially those covering your whole body. Another serious side effect is a condition where you breathe more slowly or weakly than expected. Elderly and weak patients are more likely to develop this. If you are affected by these important side effects contact a doctor immediately.

Frequent side effects:

• Nausea
• Vomiting
• Dizziness
• Drowsiness
• Headache
• Decreased appetite
• Anxiety
• Confusion
• Hallucination
• Sleep problem
• Abnormal dreams
• Trembling
• Flushing
• Constipation
• Diarrhoea
• Indigestion
• Dry mouth
• Itching
• Increased sweating
• Rash
• Muscle cramps
• Feeling of weakness
• Fatigue
• Feeling of body temperature change.

Less frequent side effects:

• Depressed mood
• Disorientation
• Excitability (agitation)
• Nervousness
• Restlessness
• Euphoric mood
• Disturbance in attention
• Memory impairment
• Near fainting
• Sedation
• Difficulty in controlling movements
• Difficulty in speaking
• Numbness
• Abnormal sensations of the skin (e.g. tingling, prickling)
• Muscle twitches
• Abnormal vision
• Faster heart beat
• Decreased blood pressure
• Dangerously slow or shallow breathing (respiratory depression)
• Less oxygen in the blood
• Shortness of breath
• Abdominal discomfort
• Hives
• Sensation of heaviness
• Delay in passing urine
• Frequent urination
• Drug withdrawal syndrome (see “Effects when treatment with PALEXIA is stopped”)
• Accumulation of water in the tissue (oedema)
• Feeling abnormal
• Feeling drunk
• Irritability
• Feeling of relaxation
• Allergic reaction
• Thinking abnormal
• Epileptic fit
• Depressed level of consciousness
• Coordination abnormal
• Slower heart beat
• Impaired gastric emptying
• Increased blood pressure
• Delirium
• Suicidal thoughts have been reported in patients taking PALEXIA.

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.

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 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).