Tramaspen SR 100 mg Tablets

TRAMASPEN SR belongs to a group of medicines called opioid analgesics or painkillers. Its pain-relieving action is due to its effect on specific nerve cells in the spinal cord and brain. TRAMASPEN SR is used in the treatment of moderate to severe pain.

Do not take TRAMASPEN SR:

• If you are hypersensitive (allergic) to tramadol hydrochloride or any of the other ingredients of TRAMASPEN SR (listed in section 6).
• If you are intoxicated with alcohol or with sedative medicines including sleeping pills, other painkillers or medicines that affect mood and emotions (psychotropic medicines).
• If you are taking, or have taken in the last two weeks, certain medicines called "monoamine oxidase inhibitors" or MAOIs (used to treat depression). The combination could result in a serious, potentially life-threatening interaction (see section Other medicines and TRAMASPEN SR).
• If you have epilepsy that is not controlled with your current medicine.
• If you have illnesses of the lungs, affecting your breathing, especially if you have low levels of oxygen in your blood causing a blueish colour on your body, or if you have excessive mucus (bronchial secretions).
• If you have high pressure within your head, or have a head injury, or have any conditions affecting your brain.

TRAMASPEN SR is not suitable in the treatment of drug addiction. The safety of TRAMASPEN SR in pregnancy and breastfeeding has not been established (see section Fertility, pregnancy, lactation).

Warnings and precautions

Take special care with TRAMASPEN SR:

• TRAMASPEN SR may cause serious breathing problems. Tell your doctor immediately if you experience difficulty breathing, slow shallow breathing or daytime sleepiness.
• You may experience epileptic fits when taking TRAMASPEN SR even when taking it at the recommended dose level. The risk may be increased when doses of TRAMASPEN SR exceed the recommended upper daily dose limit.
• If you suffer from epilepsy or fits (seizures) or have had them in the past, because tramadol could increase the risk of you having further fits.
• As with all strong painkillers, TRAMASPEN SR may lead to psychological and physical dependence or addiction in some people, especially with long term use. The dose needed to achieve the desired effect may increase with time. TRAMASPEN SR should be used with caution, and only for short periods, in patients who are addicted to other opioid painkillers.
• If you have liver or kidney problems.
• If you are in a state of shock (cold sweat may be a sign of this).
• You may stop feeling the pain-killing effects of TRAMASPEN SR if you take TRAMASPEN SR for a very long time. This called tolerance.
• When your doctor stops your treatment with TRAMASPEN SR, he will gradually lower your dose until you finally stop taking TRAMASPEN SR (see section below). You may feel severe pain if TRAMASPEN SR is stopped suddenly.
• If you take high dose of TRAMASPEN SR you may experience increased levels of pain (hyperalgesia). Your doctor may lower your dose or change your treatment.
• TRAMASPEN SR 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 TRAMASPEN SR and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.
• Long term use of TRAMASPEN SR may cause decreased hormones, which may result in a low sex drive (libido), loss of ability to attain an erection (impotence) and inability to conceive a baby (infertility). Tell your doctor if you notice these symptoms.

Children

TRAMASPEN SR is not recommended for children below the age of 12 years. Caution is advised against use of TRAMASPEN SR in adolescents between 12 and 18 years of age who are extremely overweight (obese), have airflow blockage while sleeping (obstructive sleep apnoea syndrome), or have serious lung disease. If a child accidently swallows TRAMASPEN SR, rush the child to the casualty department at your nearest hospital. Ensure that TRAMASPEN SR is disposed of correctly and kept out of reach of children at all times.

TRAMASPEN SR is not recommended in children with breathing problems, since the symptoms of toxicity may be worse in these children.

Do not share medicines prescribed for you with any other person. Always take TRAMASPEN SR exactly as your doctor 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. In general, the lowest pain-relieving dose should be taken. TRAMASPEN SR should only be used if other treatment options have been ineffective, not tolerated or otherwise inadequate in managing the pain. Your doctor will make this decision.

The usual dose of TRAMASPEN SR is:

Adults and children over 12 years

The usual initial dose is 100 mg twice daily, to be taken whole, not divided or chewed, with sufficient liquid, with or without meals, preferably mornings and evenings. You should not normally take more than 400 mg a day. TRAMASPEN SR is not recommended for children below the age of 12 years. Your doctor will tell you how long your treatment with TRAMASPEN SR will last. If you have the impression that the effect of TRAMASPEN SR is too strong or too weak, tell your doctor or pharmacist.

If you take more TRAMASPEN SR 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. Symptoms of overdosage include but are not limited to vomiting, narrowing of the pupil, severe lowering of blood pressure which may result in loss of consciousness (cardiovascular collapse), prolonged unconsciousness (coma), rapid/shallow breathing, racing/irregular heartbeat and profuse sweating (respiratory collapse).

If you forget to take TRAMASPEN SR

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of TRAMASPEN SR, take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

If you stop taking TRAMASPEN SR

You should not suddenly stop taking TRAMASPEN SR 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). If you have been taking this medicine for a very long time, you may get the following side effects if you suddenly stop treatment: restlessness, anxiety, nervousness, shaking or an upset stomach. Very few people may get panic attacks, seeing or hearing things that are not really there (hallucinations), unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus). Further unusual CNS symptoms, e.g. 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 get any of these effects after stopping treatment with TRAMASPEN SR, please talk to your doctor.

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

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

• Swelling of the hands, feet, ankles, face, lips and 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 reaction to TRAMASPEN SR. 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:

• Mental and physical dependence or addiction to TRAMASPEN SR,
• fits (convulsions),
• changes in the way your heart beats (palpitations, tachycardia, bradycardia),
• severe stomach pain, which may reach to your back. This could be a sign of inflammation of your pancreas (pancreatitis),
• difficulty breathing (dyspnoea) in adults and children, worsening of asthma,
• difficulty passing urine (micturition disorders).

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, headache, feeling very sleepy (somnolence),
• nausea, vomiting, difficulty passing stools, dry mouth,
• sweating,
• feeling very tired (fatigue).

Less frequent side effects:

• Changes in appetite,
• seeing or hearing things that are not really there (hallucinations), confusion, sleep disorders, anxiety, nightmares, changes in mood, changes in your activity levels, changes in your decision-making behaviour, mental confusion (delirium),
• tingling or prickling in the fingers or toes (paraesthesia),
• uncontrollable rhythmic movement of one part or one limb of your body (tremor),
• uncontrollable muscle movements, loss of coordination of muscles, fainting (syncope),
• changes in the way you speak (speech disorders),
• blurred vision, constriction of the pupil in the eye (miosis), dilation of the pupil in the eye (mydriasis),
• high blood pressure,
• drop in blood pressure when standing up (postural hypotension),
• feeling the urge to vomit (retching),
• stomach discomfort, feeling pressure in the stomach, loose stools (diarrhoea), hiccups,
• increases in liver enzymes which show up in blood tests,
• muscle weakness.

Side effects with an unknown frequency

Low blood sugar levels (hypoglycaemia). 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. You can also report side effects to: SAHPRA: via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare:

E-mail: [email protected]

Tel: 0800 118 088

By reporting side effects, you can help provide more information on the safety of TRAMASPEN SR.

Store all medicines out of reach of children. Store at or below 25 °C. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).