Tramazac SR Film-Coated Tablets

Tramadol, the active substance in TRAMAZAC SR, is a painkiller belonging to a class of medicines called opioids, that acts on the central nervous system. TRAMAZAC SR is used for the management of moderate to severe pain.

Do not take TRAMAZAC SR

• If you are hypersensitive (allergic) to tramadol hydrochloride, other opioid pain-relieving medicines or any of the other ingredients of TRAMAZAC SR (listed in section 6).
• If you have drunk enough alcohol to make you feel woozy or drunk or if you have taken more than the prescribed dose of your sleeping tablets, other painkillers or psychotropic medicines (medicines that affect your mood and emotions), which can slow down your breathing and reactions.
• If you are taking monoamine oxidase (MAO) inhibitors (medicine used to treat depression) or have taken them in the last 14 days before treatment with TRAMAZAC SR (see Other medicines and TRAMAZAC SR).
• If you have problems to breathe, if you have a bluish discolouration of your skin (due to decreased oxygen) or have excessive mucus.
• If you have growing pressure inside your skull (headache, blurred vision, weakness) or central nervous system depression due to a head injury, a disorder that affect blood supply to your brain, or previously had a stroke.
• If you or your child are younger than 18 years of age and you or your child have had an operation to remove your tonsils or adenoids.
• If you suffer from epilepsy (fits).
• If you are pregnant or breastfeeding your baby (see Pregnancy, breastfeeding and fertility).
• If you or your child are younger than 12 years of age.
• You should not receive TRAMAZAC SR for the treatment of withdrawal symptoms caused by narcotics/drugs.

Warnings and precautions

Take special care with TRAMAZAC SR:

• If you are taking medicines which may cause seizures/fits such as neuroleptics/antipsychotics (used to treat depression or a psychotic disorder). The risk of having a seizure/fit may increase if you use TRAMAZAC SR at the same time (see Other medicines and TRAMAZAC SR).
• If you are in a state of shock (cold sweat may be a sign).
• If you are taking sedating medicines, also known as central nervous system (CNS) depressants, such as benzodiazepines (used to treat anxiety, panic attacks and insomnia or trouble sleeping) (see Other medicines and TRAMAZAC SR).
• If you are not as awake/alert, or able to understand or react as you normally would, and the cause is uncertain.
• If you are addicted to other opioids, as TRAMAZAC SR is not a suitable substitute to suppress withdrawal symptoms.
• If you have any thoughts of harming or killing yourself.
• If you are sensitive to opioid pain relievers.
• If you have any liver or kidney problems.
• If you suffer from a lung disease, including asthma.
• If you have an underactive thyroid, an enlarged prostate (with symptoms such as urination difficulty), low blood pressure, disorder of your intestines causing inflammation (pain and swelling) or blockage, or myasthenia gravis (a long-term condition that causes weakness of your muscles).

Do not share medicines prescribed for you with any other person. Always take TRAMAZAC SR 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 400 mg tramadol daily. Tablets are to be taken whole, not divided or chewed, with sufficient liquid, with or without meals. Unless otherwise prescribed by your doctor, the usual dose is:

Adults and children over 12 years:

The usual initial dose is 100 mg twice daily, preferably in the mornings and evenings. If pain relief is not adequate, the dose may be increased to 150 mg or 200 mg twice daily. Dosage intervals should be at least 8 hours. If you have any liver or kidney problems or are over 75 years of age, your doctor may adjust your dosage. Your doctor will tell you how long your treatment with TRAMAZAC SR will last. You should not take TRAMAZAC SR for longer than is absolutely necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals whether you should continue to take TRAMAZAC SR and at what dose.

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

If you take more TRAMAZAC SR than you should

Possible signs and symptoms of overdosage include narrowing of the pupil of your eye, vomiting (being sick), slow heartbeat, low blood pressure, loss of sufficient blood flow to maintain consciousness due to sudden dysfunction of the heart, weakness, unconsciousness, coma, convulsions (fits), cold clammy skin, dizziness, breakdown of muscle tissue that releases a damaging protein into your blood which may damage your kidneys (symptoms include dark, reddish urine, a decreased amount of urine, weakness and muscle aches), breathing difficulty (slow and ineffective breathing) and breathing that stopped. Serotonin syndrome has also been reported (see section 4 – Possible side effects).

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and any remaining tablets with you, so that the doctor knows what you have taken.

If you forget to take TRAMAZAC SR

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, continue to take the next tablet at the usual time. Do not take a double dose to make up for the forgotten individual doses.

If you stop taking TRAMAZAC SR

Treatment with TRAMAZAC SR should not be stopped abruptly, as you may experience withdrawal symptoms. If you no longer require treatment or wish to stop treatment due to adverse effects, please tell your doctor. Your doctor will gradually reduce your dose of TRAMAZAC SR before you finally stop taking TRAMAZAC SR. If you suddenly stop taking TRAMAZAC SR, you may experience withdrawal symptoms such as agitation, anxiety, hallucinations, tingling or prickling (“pins and needles”) sensation, ringing in your ears, confusion, paranoia, nervousness, difficulty sleeping (insomnia), muscle spasms, uncontrolled shaking and upset stomach. If you experience any of these symptoms, or any other side effects while stopping treatment with TRAMAZAC SR, please contact your doctor.

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

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

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, wheezing.
• Rash or itching.
• Fainting.
• Heart attack.

These are all very serious side effects. If you have them, you may have had a serious reaction to TRAMAZAC 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:

• Serotonin syndrome (agitation, hallucinations, fever, increased heart rate, increased blood pressure, involuntary muscle twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms, such as nausea, vomiting and diarrhoea).
• Convulsions/fits (mainly after administration of high doses or when taken at the same time as other medicines which may cause fits).
• Changes in the way your heart beats, such as pounding of your heart, beating faster or slower than normal, irregular heartbeat, chest pain or the lack of blood flow through your body (due to cardiac or circulatory collapse).
• Passing urine with difficulty or pain, difficulty in emptying your bladder completely (urinary retention), frequent urination or blood in your urine.
• Slow/ineffective breathing, shortness of breath, tightening of your chest which causes wheezing and coughing, worsening of asthma.
• Yellowing of your skin and eyes, dark urine, fever and tiredness, which may be symptoms of liver problems such as increased liver enzymes.
• Severe forms of skin reactions, sometimes accompanied by fever, causing a painful, blistering or peeling skin rash. These may be signs of a condition known as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN).
• Bacterial skin infection known as cellulitis (swollen, red skin that may be hot and tender).
• Medicine dependence, withdrawal reactions (see If you stop taking TRAMAZAC SR).
• Low blood levels of sodium (tiredness, confusion, muscle twitching, nausea, headache) and/or syndrome of inappropriate antidiuretic hormone secretion (cramping, nausea, vomiting, and in severe cases seizures and coma).
• Inflammation of your appendix (nausea, vomiting, fever, pain on lower right area of your stomach), gallbladder inflammation (severe pain in the upper right portion of your stomach and bloating), gallstones (sudden and rapidly intensifying pain in the upper right portion of your stomach, back pain, nausea or vomiting).
• Stomach pain, including pancreas inflammation (upper stomach pain, nausea, vomiting, fever).

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:

• Sedation, drowsiness, dizziness, headache.
• Nausea (feeling sick), vomiting (being sick), dry mouth, heartburn, constipation, diarrhoea, stomach pain.
• Increased sweating.
• Fatigue (extreme tiredness, lack of energy).
• Anorexia (severe weight loss).
• Abnormal physical weakness, flu-like illness (fever, cough, sore throat, runny nose, body aches).
• Feeling depressed.
• Spinning sensation, feeling confused and unable to think clearly.

Less frequent side effects:

• Changes in your appetite.
• Hallucinations (seeing or hearing things that are not real), feeling confused, reduced awareness of surroundings, sleep disturbances, feeling anxious/agitated, nightmares.
• Changes in your mood (mostly feeling happy, occasionally irritated/unhappy), decreased/increased activity, restlessness, nervousness, changes in mental and sensory perception (errors in judgement, changes in senses and recognition).
• Speech disorders, memory loss, uncontrolled shaking (tremor), involuntary muscle contractions, uncoordinated movement, walking abnormal/unusual.
• Reduced touch sensitivity (numbness).
• Tingling or prickling (“pins and needles”) sensation.
• Narrowing or excessive widening of your pupils, blurred vision.
• Increased blood pressure (dizziness, headache).
• Postural hypotension (a form of low blood pressure that happens when standing up from sitting or lying down, which may cause dizziness or light-headedness).
• Flushing (reddening of your face, neck or upper chest).
• Runny/stuffy nose.
• Gagging (retching), bloating.
• Blisters (fluid-filled sac in the outer layer of your skin).
• Raised, itchy rash (urticaria).
• Skin inflammation/irritation (itchy, dry skin or rash).
• Muscle weakness or pain.
• Joint pain, stiffness or swelling, back pain.
• Cold chills (shivering or shaking).

Side effects that occur with unknown frequency:

• Low blood sugar levels (light-headedness, tiredness, weakness).
• Hiccups.

• Store all medicines out of reach of children.

• Store at or below 25 °C.

• Protect from light and moisture.

• Keep the blister strips in the outer carton until required for use.

• Do not use after the expiry date printed on the packaging.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).