Epstell 50 mg Capsules

Tramadol, the active substance in EPSTELL capsules, is a painkiller belonging to the class of the opioids that acts on the central nervous system. EPSTELL capsules are used for the management of moderate to moderately severe pain.

Do not take EPSTELL capsules

• If you are hypersensitive (allergic) to tramadol, opioids or any ingredients in EPSTELL (listed in section 6).
• if you are younger than 12 years of age
• if you are younger than 18 years of age following tonsillectomy (surgical removal of the tonsils) and/or adenoidectomy (surgical removal of the adenoids)
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)
• if you are taking MAO inhibitors (certain medicines used for depression) or have taken them in the last 14 days before treatment with EPSTELL capsules
• if you have epilepsy
• as a substitute in drug withdrawal
• if you have difficulty breathing or breathing problems (respiratory depression) especially in the presence of cyanosis (bluish or greyish colour of the skin, nails, lips or around the eyes) and excessive bronchial secretions
• if you have previously had head injuries, brain tumour or if you have a condition in which the pressure in your skull has increased
• if you are pregnant or breastfeeding your baby (see Pregnancy and Breastfeeding).

Warnings and precautions

Take special care with EPSTELL if you

• are or have ever been addicted to opioids, alcohol, prescription medicines or illegal medicines
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating when you have stopped taking alcohol or drugs
• feel you need to take more of EPSTELL to get the same level of pain relief, this may mean you are becoming tolerant to the effects of EPSTELL or are becoming addicted to it. Speak to your doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever
• suffer from consciousness disorders (if you feel that you are going to faint)
• are in a state of shock (cold sweat may be a sign of this)
• suffer from increased pressure in the brain (possibly after a head injury or brain disease)
• have difficulty in breathing
• have a history of epilepsy or are susceptible to seizures (“fits”) because the risk of a fit may increase
• suffer from a liver or kidney disease
• suffer from depression and you are taking antidepressants as some of them may interact with EPSTELL (see “Other medicines and EPSTELL”)

Sleep-related breathing disorders EPSTELL 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. There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken EPSTELL in combination with certain antidepressants or EPSTELL alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 “Possible side effects”). Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg).

Do not share medicines prescribed for you with any other person. Always take EPSTELL exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. The lowest pain-relieving dose should be taken. Do not take more than 8 capsules (400 mg) in a 24-hour period.

Adults and children over 12 years:

Moderate pain:

Take an initial dose of 50 mg tramadol (1 EPSTELL capsule), followed by 50 mg or 100 mg every 4 to 6 hours.

Severe pain:

Take an initial dose of 100 mg followed by 50 mg or 100 mg every 4 to 6 hours.

Elderly patients (above 75 years)

A dose reduction and/or prolongation of the interval between doses are recommended.

Liver or kidney disease (insufficiency)/dialysis patients

If you suffer from liver and/or kidney insufficiency, the excretion of EPSTELL capsules may be delayed. Your doctor may direct you to prolong your dosage intervals.

Duration of administration

You should not take EPSTELL capsules for longer than absolutely necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take EPSTELL capsules and at what dose.

Method of administration

Capsules are to be taken whole, not divided or chewed, with sufficient liquid, with or without food.

If you take more EPSTELL than you should

If you have taken too much EPSTELL you may experience pinprick pupils, heart problems, difficulty breathing, seizures “fits” and cold, clammy skin. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take EPSTELL

If you forgot to take a dose, take it as soon as you remember and then take the next dose at the right time. Do not take a double dose to make up for a missed dose.

If you stop taking EPSTELL

If you stop taking EPSTELL, your pain may come back. Some people may become dependent on medicines containing tramadol. If you want to stop taking EPSTELL, contact your doctor who will gradually decrease the dose you are taking.

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

If any of the following happens, stop taking EPSTELL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• wheezing, difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing, collapse. These may be signs of a serious allergic reaction.
• rash, swelling or itching of skin
• slowed breathing usually when high doses of EPSTELL are taken.
• shock (sudden circulation failure). These are very serious side effects. If you have them, you may have had a serious reaction to EPSTELL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Less frequent: Seizures (“fits”),
• Feeling faint or collapsing.
• loss of consciousness
• slow breathing
• shortness of breath

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following frequent side effects:

• nausea (feeling “sick”), vomiting, dry mouth, indigestion, constipation, diarrhoea, lack of appetite, pain in the stomach,
• Sweating, dizziness, headaches.

Less frequent side effects:

• hallucinations (seeing or hearing things that are not there), feeling confused or forgetting (“memory loss”), sleepiness or drowsiness,
• postural hypotension (feeling dizzy or light-headed when standing up after you have been sitting or lying down), flushing
• sleep disorders
• delirium
• anxiety
• nightmares
• changes in mood for example you may feel happy or irritated
• decreased activity
• restlessness
• changes in the way you see or view things
• speech disorder
• muscle twitches
• tingling of skin “pins and needles”
• blurred vision, dilation of the pupil, constriction of the pupil
• changes in heartbeat, dysrhythmias (abnormal rhythm of heart), palpitation (heartbeat very fast in an irregular way), increase in blood pressure.
• increase in liver enzymes (seen on a blood test)
• needing to urinate frequently or difficulty urinating
• itching of the skin, hives, fluid filled rash, skin rash
• muscle weakness

Side effects with frequency unknown:

• drug dependence
• Serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
• Low blood sugar level (hypoglycaemia)
• Hiccups

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 or 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 EPSTELL.

Store all medicines out of reach of children

Store in a cool dry place at or below 25 °C. Protect from light. Keep in outer carton until required for use. Do not transfer the medicine to any other container. Do not use after the date, which is stamped on the pack. Return all unused medicines to your doctor or pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).