Tapexia 50

Indications

Tapentadol is a strong prescription painkiller used in adults for:

• moderate to severe short-term (acute) pain, such as after surgery or injury, when other painkillers are not enough;
• severe long-term (chronic) pain that needs round-the-clock treatment, including some nerve pain such as painful diabetic neuropathy (long-acting tablets).

How It Works

Tapentadol works in two ways in the brain and spinal cord. It acts on opioid (mu) receptors, like Morphine, and it also increases the level of noradrenaline, a chemical that helps block pain signals. Together these reduce how much pain you feel.

Dosage and Administration

• Acute pain, immediate-release tablets, adults: usually 50 to 100 mg every 4 to 6 hours as needed, as prescribed. Do not take more than the total daily amount your doctor sets.
• Chronic pain, long-acting tablets: as prescribed, usually twice a day about 12 hours apart. Swallow whole; never crush, chew, split or dissolve them, as this can release a dangerous dose at once.
• Older people and people with moderate liver problems: lower doses or longer gaps may be needed.
• Children and teenagers under 18: not for use.

Take with or without food. Use the lowest dose that works for the shortest time. Do not stop suddenly after regular use; your doctor will lower the dose slowly.

Interactions

Taking it with alcohol, sleeping tablets, benzodiazepines (such as Diazepam), other opioids, some antihistamines or other sedating medicines can cause dangerous drowsiness and slow breathing. It must not be taken with or within 14 days of an MAO inhibitor. With antidepressants such as SSRIs or SNRIs, or with Tramadol or Triptans, it can cause serotonin syndrome (agitation, fever, sweating, shaking, fast heartbeat). Tell your doctor about all medicines you take.

Contraindications

• Allergy to Tapentadol
• Severe breathing problems or slow, shallow breathing
• Acute or severe asthma
• Blocked or paralysed bowel (paralytic ileus)
• Use of an MAO inhibitor within the last 14 days
• Severe liver or kidney disease (not recommended)

Side Effects

Common: nausea, vomiting, dizziness, drowsiness, headache, constipation, dry mouth, itching, sweating and tiredness. Long-term use can lead to tolerance, physical dependence and misuse.

Get medical help at once (call for emergency help) if someone taking it has: slow, shallow or difficult breathing; extreme sleepiness or cannot be woken; blue lips; fits; severe confusion; or signs of serotonin syndrome such as high fever, stiffness, shaking and agitation. Also seek help for swelling of the face or throat or a severe rash.

Pregnancy and Lactation

Avoid in pregnancy unless the doctor decides it is essential. Regular use late in pregnancy can cause breathing problems and withdrawal symptoms in the newborn baby. It is not recommended during breastfeeding.

Precautions and Warnings

• It is a controlled medicine; take only as prescribed, keep it safe and never share it.
• Take extra care with lung disease, sleep apnoea, head injury, epilepsy, liver or kidney problems, low thyroid, or a history of drug or alcohol misuse.
• Do not drive or use machines if it makes you drowsy or dizzy.
• Do not drink alcohol while taking it.

Overdose

An overdose can be fatal. Signs include pinpoint pupils, extreme drowsiness, slow or stopped breathing, fits and coma. Call for emergency help at once. In hospital, staff can give Naloxone to reverse the effect.

Therapeutic Class

Centrally acting opioid analgesic (painkiller).

Storage

Store below 30°C in a dry place, away from light. Keep locked away and out of the reach and sight of children, as an accidental dose can be fatal.