Tramadol 100 mg Tablets

Tramadol SR Biotech is a painkiller belonging to the class of medicines called opioids that act on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. Tramadol SR Biotech is used for the treatment of moderate to severe pain.

Do not take Tramadol SR Biotech:

• if you are hypersensitive (allergic) to tramadol hydrochloride or opioids, or any of the other ingredients of Tramadol SR Biotech, listed in section 6;
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);
• if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with Tramadol SR Biotech (see "Other medicines and Tramadol SR Biotech");
• if you are an epileptic;
• as a substitute in drug withdrawal;
• if you have difficulty breathing or if you have poor circulation or inadequate oxygenation of the blood;
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
• if you are pregnant or breastfeeding your baby;
• if you are younger than 12 years of age;
• If you are younger than 18 years of age following tonsillectomy and/or adenoidectomy.

Warnings and precautions

Take special care with Tramadol SR Biotech: Tell your doctor:

• if you think that you are addicted to other pain relievers (opioids)
• if you suffer from consciousness disorders (if you feel that you are going to faint)
• if you are in a state of shock (cold sweat may be a sign of this)
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease)
• if you have difficulty in breathing
• if you have a tendency towards epilepsy or fits because the risk of a fit may increase, especially if you are taking a higher dose of Tramadol SR Biotech
• if you suffer from a liver or kidney disease
• if you have any sleep-related breathing problems, e.g., sleep apnoea, where breathing repeatedly stops and starts. Tramadol SR Biotech may increase the risk of these breathing problems.

Please note that Tramadol SR Biotech may lead to physical and psychological addiction. When Tramadol SR Biotech is taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development). In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with Tramadol SR Biotech should only be carried out for short periods and under strict medical supervision. Please also inform your doctor if one of these problems occurs during Tramadol SR Biotech treatment or if they applied to you in the past.

Tramadol as in Tramadol SR Biotech is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief, but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite. Hyponatraemia (when the concentration of sodium in your blood is abnormally low) can occur in some patients e.g., the elderly or if you are also taking other medicines that may cause hyponatraemia. Please inform your doctor if you experience symptoms such as decreased ability to think, headaches, nausea, poor balance, confusion, seizures, coma.

Children and adolescents

On account of the dosage strength, Tramadol SR Biotech is not recommended for children below the age of 12 years. Tramadol SR Biotech should not be used in children who have reduced lung function due to other conditions.

Other medicines and Tramadol SR Biotech

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) If you are taking any of the following medicines, please inform your doctor before taking Tramadol SR Biotech:

• MAO inhibitors (certain medicines for the treatment of depression), it should not be taken together with Tramadol SR Biotech

The pain-relieving effect of Tramadol SR Biotech may be reduced and the length of time it acts may be shortened, if you take medicines which contain:

• carbamazepine (for epileptic fits)
• ondansetron (prevents nausea)

The risk of side effects increases, if you are taking tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol SR Biotech. You may feel drowsier, have difficulty breathing or feel that you might faint. If this happens tell your doctor.

if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Tramadol SR Biotech at the same time. Your doctor will tell you whether Tramadol SR Biotech is suitable for you.

if you are taking certain antidepressants Tramadol SR Biotech may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 ˚C.

if you are taking anticoagulants (medicines for blood thinning), e.g., warfarin, together with Tramadol SR Biotech. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Tramadol SR Biotech with food and alcohol: Do not drink alcohol during treatment with Tramadol SR Biotech as its effect may be intensified.

Do not share medicines prescribed for you with any other person. Always take Tramadol SR Biotech exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and adolescents from the age of 12 years: The usual dose is one Tramadol 100 SR Biotech sustained-release tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening. Take the doses at least 8 hours apart, unless your doctor has advised otherwise. If pain is not relieved, your doctor may increase your dose to 150 mg or 200 mg sustained-release tablet twice daily, preferably in the morning and evening. Do not exceed a total daily use of 400 mg Tramadol SR Biotech.

How and when should you take Tramadol SR Biotech?

Swallow the tablet whole with some liquid with or without meals. Do not break or chew the tablet. Your doctor will tell you how long your treatment with Tramadol SR Biotech will last. Do not stop treatment early because you feel better. If you have the impression that the effect of Tramadol SR Biotech is too strong or too weak, tell your doctor or pharmacist.

Children: Tramadol SR Biotech should not be used in children below the age of 12 years.

Elderly patients: Your doctor may recommend increasing the time between doses.

Severe liver or kidney disease (insufficiency)/dialysis patients: Patients with severe liver and/or kidney insufficiency should not take Tramadol SR Biotech. If in your case the insufficiency is mild or moderate, your doctor may recommend increasing the time between doses.

If you take more Tramadol SR Biotech than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take a dose of Tramadol SR Biotech: Do not take a double dose to make up for forgotten individual doses.

If you stop taking Tramadol SR Biotech: If you interrupt or finish treatment with Tramadol SR Biotech too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, you should discuss it with your doctor. You should not suddenly stop taking Tramadol SR Biotech unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).

It is advisable to slowly reduce your dosage when you want to stop taking Tramadol SR Biotech. People who have been taking Tramadol SR Biotech tablets for some time may feel unwell if they abruptly stop taking them. They may experience the following:

• Feeling agitated, anxious, nervous or shaky.
• They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders.
• Panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus).
• Confusion, delusions, change of perception of the own personality (depersonalisation), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely.

If you experience any of these complaints after stopping Tramadol SR Biotech, please consult your doctor.

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

If any of the following happens, stop taking Tramadol SR Biotech 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 Tramadol SR Biotech. 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:

• slow breathing, shortness of breath (dyspnoea)
• difficulty breathing and bronchospasm
• irregular heartbeat, pounding of the heart, fast heartbeat, slow heartbeat
• seizures
• severe abdominal pain, nausea and vomiting, low blood pressure, extreme fatigue, decreased appetite, and weight loss (may indicate adrenal your adrenal glands are not functioning properly)
• twitching muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, muscle rigidity (these may be signs of a condition called serotonin syndrome)

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:

• dizziness
• difficulty in sleeping
• headache
• nausea
• constipation, dry mouth, vomiting
• excessive sweating
• tiredness

Less frequent side effects:

• changes in appetite
• hallucination, confusion, sleep disorders, delirium, anxiety and nightmares
• changes in mood (high spirits or irritable)
• increased or decreased activity
• difficulty making decisions
• abnormal sensations (e.g., itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders
• blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• low blood pressure that happens when you stand up from sitting or lying down
• feeling faint or collapse, increase in blood pressure
• urge to be sick, stomach trouble, diarrhoea
• hives, blistering and peeling of skin
• weak muscles
• passing urine with difficulty or pain, passing less urine than normal (dysuria)

Side effects with unknown frequency:

• decreased blood sugar level
• hiccups
• worsening of asthma
• low sodium levels (you may experience nausea, vomiting, headache, confusion, loss of energy, drowsiness and fatigue
• cramping, fatigue, muscle weakness, headache (may indicate a condition in which high levels of a hormone cause the body to retain water)

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 this medicine.

Store all medicines out of reach of children. Store at or below 25 °C. Store in a cool dry place. Store in the original blister strip until required for use. Do not use after the expiry date printed on the label/ carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).