Tamoltra Forte 650 mg Film-Coated Tablets

TAMOLTRA and TAMOLTRA FORTE contain tramadol hydrochloride and paracetamol. Tramadol hydrochloride is a painkiller belonging to the class of the opioids that acts on the central nervous system. It is used for the management of moderate to moderately severe pain. Paracetamol, the other active substance, has centrally acting analgesic effects. TAMOLTRA and TAMOLTRA FORTE are used for the treatment of moderate to moderately severe pain in adults. TAMOLTRA and TAMOLTRA FORTE are not recommended for minor pain that may be treated adequately through lesser means. Your doctor will decide whether you qualify for treatment with TAMOLTRA or TAMOLTRA FORTE.

Do not take TAMOLTRA or TAMOLTRA FORTE:

• if you are hypersensitive (allergic) to tramadol, paracetamol or other opioids such as codeine or to any of the ingredients of TAMOLTRA OR TAMOLTRA FORTE (listed in section 6)
• if you have a severe liver disorder
• if you have been drinking alcohol
• if you are taking sleeping pills, pain relievers or medicines that affect mood and emotions
• if you are also taking medicines such as tranylcypromine and moclobemide or have taken them in the last 14 days before treatment with TAMOLTRA or TAMOLTRA FORTE. These medicines are used to treat depression and belong to a group called monoamine oxidase inhibitors (MAOIs)
• TAMOLTRA or TAMOLTRA FORTE must not be used for narcotic (an addictive substance) withdrawal treatment
• you should not take TAMOLTRA or TAMOLTRA FORTE if you suffer from severe breathing problems
• you should not take TAMOLTRA or TAMOLTRA FORTE if you are suffering from increased intracranial pressure or central nervous system depression (due to head injury), which are characterised by decreased rate of breathing, decreased heart rate, and loss of consciousness
• if you have epilepsy, which is not adequately controlled by your current medicine.

Warnings and precautions

Take special care with TAMOLTRA or TAMOLTRA FORTE:

• TAMOLTRA and TAMOLTRA FORTE contain paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic; the nearest doctor, hospital or Poison Centre must be contacted immediately.
• dosages in excess of those recommended may cause severe liver damage
• if you take other medicine containing paracetamol or tramadol, anaesthetic substances, phenothiazines (used for mental disorders), tranquilizers and sedative hypnotics
• If you are taking any other medicines for depression
• if you have severe kidney problems
• if you have liver problems or disease, as your eyes and skin may turn yellow, which may suggest jaundice
• if you have severe difficulty in breathing, for example asthma or severe lung problems
• if you have a history of addiction or dependence, especially to medicines of the same class as tramadol (opioids).
• The possibility of addiction or dependence increases if you have a personal or family history of substance abuse or if you have been diagnosed with a mental health disorder
• if you take other medicines to treat pain that contain buprenorphine, nalbuphine or pentazocine
• in the event of reduced consciousness for unknown reasons, respiratory disorders and patients suffering from emotional disturbances, shock, breathing problems or alcohol abuse, TAMOLTRA and TAMOLTRA FORTE should be taken with extreme caution
• if you have epilepsy or have experienced fits or seizures
• if you develop any skin reactions whilst taking TAMOLTRA or TAMOLTRA FORTE (flu-like symptoms appearing first, followed by a painful rash that spreads and blisters), stop taking TAMOLTRA or TAMOLTRA FORTE and immediately report to your doctor
• tramadol exerts its effect by converting (metabolising) into its active component. If you convert (metabolise) tramadol to this active component more rapidly and completely than other patients, you are known as an ultra-rapid metaboliser. This means you are more likely to have serious side effects, such as breathing difficulties, with slow or shallow breathing. If you experience these types of side effects, stop taking TAMOLTRA and TAMOLTRA FORTE and consult with your doctor immediately
• while taking TAMOLTRA and TAMOLTRA FORTE you may experience low levels of sodium in your blood (hyponatraemia). Symptoms may include nausea and vomiting, headaches, feeling confused, feeling very tired, feeling restless, feeling irritable, muscle weakness, spasms or cramps and seizures. Elderly patients and patients taking other medicines that lower sodium in the blood are most at risk for this side effect. If you experience any of these symptoms while taking TAMOLTRA and TAMOLTRA FORTE, consult your doctor immediately
• if you are going to have an anaesthetic (tell your doctor or dentist that you are taking this medicine)
• TAMOLTRA and TAMOLTRA FORTE should not be taken with alcohol containing beverages.

Addiction:

If you take TAMOLTRA or TAMOLTRA FORTE for extended periods, you may become dependent on (addicted to) the tramadol it contains. You may crave TAMOLTRA or TAMOLTRA FORTE even in the absence of pain and you may have to use higher doses to get the same effect. If you have been diagnosed with addiction to opioid medicines or drugs (e.g., heroin, morphine, codeine), you should not take TAMOLTRA or TAMOLTRA FORTE. Please inform your doctor.

Withdrawal symptoms:

If you abruptly stop treatment with TAMOLTRA or TAMOLTRA FORTE, especially if you have been taking it for an extended period, you may experience withdrawal effects. You may suffer from panic attacks, severe anxiety (feeling nervous or worried), hallucinations (hearing or seeing things that are not there), paraesthesia (burning or prickling sensation that is usually felt in the hands, arms, legs, or feet) and tinnitus (ringing or buzzing in the ears). Your doctor will gradually decrease your dose of TAMOLTRA or TAMOLTRA FORTE to prevent these side effects from occurring.

Do not share medicines prescribed for you with any other person. Always use TAMOLTRA or TAMOLTRA FORTE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. DO NOT EXCEED THE RECOMMENDED DOSE.

• swallow the tablets whole with sufficient liquid
• do not break or chew the tablets
• you may take TAMOLTRA or TAMOLTRA FORTE at any time of the day with or without food.

Adults: TAMOLTRA: The usual dose is 1 or 2 tablets every 4 to 6 hours, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor. Do not take more than 8 tablets per day.

TAMOLTRA FORTE: The usual dose is 1 tablet every 4 to 6 hours, unless otherwise prescribed by your doctor. If required, further doses may be taken, as instructed by your doctor. Do not take more than 4 tablets per day.

Patients with kidney or liver disease: Do not take TAMOLTRA or TAMOLTRA FORTE if you have severe liver problems. Tell your doctor if you have a kidney disorder (a creatinine clearance < 30 mL/min). Do not take more than 2 tablets every 12 hours.

Children: TAMOLTRA tablets are not indicated for use in children under the age of 16 years as safety and efficacy have not been established. TAMOLTRA FORTE tablets are not indicated for use in children under the age of 18 years as safety and efficacy have not been established. Your doctor will tell you how long your treatment with TAMOLTRA or TAMOLTRA FORTE will last.

If you have the impression that the effect of TAMOLTRA or TAMOLTRA FORTE is too strong or too weak, tell your doctor or pharmacist.

If you take more TAMOLTRA or TAMOLTRA FORTE than you should. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Immediate medical advice should be sought in the event of an overdose even if you feel well, because of the risk of delayed, serious liver damage from too much paracetamol. Your kidneys can also become damaged in the absence of liver damage. A delay in starting treatment may mean that the antidote is given too late to be effective. Please refer to the information on paracetamol overdosage under “Take special care with TAMOLTRA or TAMOLTRA FORTE”. Symptoms of overdose may include:

• tramadol overdose: breathing difficulties, seizures
• paracetamol overdose: an unhealthy pale appearance, nausea, vomiting, severe weight loss (anorexia), stomach pain, liver damage, kidney failure, metabolic acidosis (too much acid in the body fluids), irregular heartbeat.

If you forget to take TAMOLTRA or TAMOLTRA FORTE: If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking TAMOLTRA or TAMOLTRA FORTE: Withdrawal symptoms may occur if TAMOLTRA or TAMOLTRA FORTE is discontinued abruptly. You may experience anxiety, nervous excitement, difficulty sleeping, excessive abnormal movements, tremor and gastrointestinal symptoms. Other symptoms that have very rarely been seen if tramadol hydrochloride is discontinued abruptly include panic attacks, severe anxiety, hallucinations, tingling or prickling sensation and ringing in the ears.

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

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

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TAMOLTRA or TAMOLTRA FORTE. 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:

• increased bleeding time - unexpected or prolonged bleeding when using TAMOLTRA or TAMOLTRA FORTE with medicines used to thin the blood (e.g. warfarin)
• irregular heartbeat that is much more rapid and more pronounced than usual, increase in blood pressure, rapid, strong, or irregular heartbeat, very fast heartbeat, dysrhythmia
• elevated liver enzymes, resulting in abdominal pain, dark urine, pale stools, weakness, fatigue
• chills, chest pain, hot flushes
• if your liver is inflamed - symptoms may include stomach pain or yellowing of the skin and whites of the eyes (hepatitis)
• difficulty breathing, slower or weaker breathing
• feeling faint when getting up from a lying or sitting position, slow heart rate
• worsening of existing asthma
• hallucinations (seeing or hearing things that are not there), depression, memory lapses, suicidal thoughts, amnesia, delirium, addiction (becoming dependent on TAMOLTRA or TAMOLTRA FORTE), unusual thoughts
• inability to completely empty the bladder, kidney failure
• serious skin disorders including Stevens-Johnson Syndrome/ toxic epidermal necrolysis (TEN) with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, skin sores and peeling of the skin, which could be fatal.

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:
• confusional state, sleep disorders, mood changes (anxiety, nervousness, feeling of high spirits), anorexia
• dizziness, excessive sleepiness, headache, trembling
• nausea, vomiting, constipation, dry mouth, diarrhoea, stomach pain, indigestion, stomach gas
• skin rash, sweating.
• Less frequent side effects:
• low number of red blood cells (anaemia)
• impotence, nightmares
• the loss of full control of bodily movements, fits, uncoordinated movements (stumbling), muscle weakness, muscle tension, migraine, aggravated migraine, tingling, numbness or feeling of pins and needles in the limbs, involuntary muscle twitching, speech disorders, slurred speech, spinning sensation and loss of balance, inability to act or think normally
• vision blurred, constriction of the pupil (miosis), excessive dilation of the pupils (mydriasis), abnormal vision
• ringing in the ear
• shortness of breath
• difficulty swallowing, coughing or choking when eating or drinking, bringing food back up, sometimes through the nose, inability to chew properly, blood in the stools, tongue swelling
• if your pancreas is inflamed - symptoms may include upper abdominal pain, abdominal pain that radiates to your back, tenderness when touching the abdomen, fever, rapid pulse, nausea and vomiting (acute pancreatitis)
• skin reactions (for example rashes, hives)
• problems with urination, difficulty or pain when urinating, abnormal urine test results, kidney stones
• nose bleeds or bleeding gums, which may result from low platelet count, bruising, prolonged bleeding with injury
• changes in appetite, weakness, weight loss.

The following side effects have been reported but the frequency for them to occur is not known:

• low blood sugar, low sodium levels in the blood (with symptoms that include nausea, headache, confusion and fatigue), water retention
• Serotonin syndrome (symptoms include high body temperature, sweating, shivering, clumsiness, tremors, and confusion and other mental changes, diarrhoea, vomiting, overactive reflexes and muscle spasms)
• hiccups
• drug withdrawal syndrome (symptoms include agitation, anxiety, nervousness, insomnia, facial movements, slow uncontrolled movements, jerking movements, abnormal gait, tremor, stomach problems, panic attacks, severe anxiety, hallucinations, pins and needles, ringing in the ears).

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of TAMOLTRA and TAMOLTRA FORTE. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children.

TAMOLTRA: Store at or below 30 °C in a cool, dry place.

TAMOLTRA FORTE: Store at or below 25 °C in a cool, dry place. Keep the blisters in the carton until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).