Doltrex 50 mg Film-Coated Tablets

Tramadol, the active substance in DOLTREX 50 MG tablets, 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.

Do not take or give DOLTREX 50 MG :

• if you are allergic to tramadol or any of the other ingredients of DOLTREX 50 MG tablets. (Refer to WHAT DOLTREX 50 MG CONTAINS, above);
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);
• if you are taking MAO inhibitors (certain medicines used for depression) or have taken them in the last 14 days before treatment with DOLTREX 50 MG tablets;
• If you have epilepsy;
• As a substitute in drug withdrawal;
• If you are pregnant or breastfeeding your baby (see Pregnancy and Breastfeeding).

Warnings and precautions

Take special care with DOLTREX 50 MG :

Some people will need special care from their doctors when they are taking DOLTREX 50 MG. Make sure that your doctor knows before you start taking DOLTREX 50 MG :

• if you think that you are addicted to other pain relievers (opioids);
• if you suffer from consciousness disorders (if you have fainting spells or you feel that you are going to faint);
• if you are in a state of shock (cold sweat may be a sign of it);
• 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 seizures because the risk of a seizure may increase; especially if the upper dose limit (400 mg) of DOLTREX 50 MG tablets is exceeded;
• if you suffer from a liver or kidney disease.

- Tramadol works by being converted (metabolised) 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. If you are an ultra rapid metaboliser 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 this medicine and consult with your doctor immediately.

- You may experience low levels of sodium in the blood (hyponatraemia) while taking this medicine. Symptoms of low blood sodium 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 get any of these symptoms while taking DOLTREX 50 MG, consult with your doctor immediately.

DOLTREX 50 MG tablets can 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. DOLTREX 50 MG tablets should be used with caution, and only for short periods under strict medical supervision, in patients who are addicted to other opioid pain-killers.

- DOLTREX 50 MG contains sugar (lactose monohydrate). If you have been told by our doctor that you have intolerance to some sugars, contact your doctor before taking DOLTREX 50 MG. Please also inform your doctor if any of these problems occur during DOLTREX 50 MG tablets treatment or if they applied to you in the past.

Use in children

DOLTREX 50 MG tablets are not suitable for children under the age of 12 years.

Other medicines and DOLTREX 50 MG

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

The following medicine is particularly important: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

Do not share medicines prescribed for you with any other person. Always take or give DOLTREX 50 MG exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

If you have the impression that the effect of DOLTREX 50 MG is too strong or too weak, talk to your doctor or pharmacist.

Always tell your healthcare professional if you are taking any other medicine (This includes complementary or traditional medicines). 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 DOLTREX 50 MG tablets daily.

Tablets are to be taken whole, not divided or chewed, with sufficient liquid, with or without food.

The usual dose is:

Adults and patients over 18 years of age:

Moderate pain: Take an initial dose of 50 mg tramadol (1 DOLTREX 50 MG capsule), followed by 50 mg or 100 mg every 4 to 6 hours.

Severe pain: Take an initial dose of 100 mg followed by 50 mg or 100 mg every 4 to 6 hours.

You should not take DOLTREX 50 MG tablets for longer than is absolutely necessary.

Children (below the age of 12) DOLTREX 50 MG tablets are not suitable for children under the age of 12 years.

Elderly patients (above 75 years): A dose reduction and/or prolongation of the interval between doses are recommended.

Liver or kidney disease (insufficiency)/dialysis patients If you suffer from liver and/or kidney insufficiency, the excretion of DOLTREX 50 MG tablets may be delayed. Your doctor may direct you to prolong your dosage intervals.

If you take more DOLTREX 50 MG than you should • Seek emergency medical attention if you think you have taken too much of DOLTREX 50 MG. If you have taken an additional dose by mistake, this will generally have no negative effects. You should have your next dose as your doctor prescribed it for you.

After taking very high doses, pin-point or wide pupils, vomiting, fall in blood pressure, fast heartbeat, feeling faint, reduced level of consciousness up to coma (deep unconsciousness), epileptic seizures and difficulty in breathing up to stoppage of breathing may occur. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take DOLTREX 50 MG If you forget to take a dose, take it as soon as you remember, and then continue as before. Do not take a double dose to make up for forgotten individual doses.

If you stop taking DOLTREX 50 MG If treatment with DOLTREX 50 MG is stopped earlier than your doctor has prescribed, your disease may become worse. Always take DOLTREX 50 MG for as long as your doctor has prescribed. If you interrupt or finish treatment with DOLTREX 50 MG tablets too soon, your pain may return. If you wish to stop treatment on account of unpleasant effects, please tell your doctor.

If you have been taking DOLTREX 50 MG tablets for some time you may feel unwell if you abruptly stop treatment. You may feel agitated, anxious, nervous or shaky. You may be hyperactive, have difficulty in sleeping and have stomach or bowel disorders. You may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in ears (tinnitus). Further unusual Central Nervous System (CNS) symptoms, i.e. confusion, delusion, change in how you see (perceive) your own personality (depersonalisation), and change in how you see (perceive) reality (derealisation) and delusion of persecution (paranoia) have been reported. If you experience any of these effects after you stop taking DOLTREX 50 MG tablets, consult your doctor.

DOLTREX 50 MG can have side effects. Not all the side effects reported for DOLTREX 50 MG are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DOLTREX 50 MG, please consult your healthcare provider for advice.

If any of the following happens, stop taking DOLTREX 50 MG tablets and tell your doctor immediately or go to your casualty department at your nearest hospital:

• swollen face, tongue and/or throat, and/or difficulty swallowing or breathing or wheezing;
• rash, swelling or itching of skin;
• shock (sudden circulation failure).

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DOLTREX 50 MG tablets. 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 or experience any of the following:

• changes in the way your heart beats, for example, if you notice that your heart is beating faster;
• pounding (this may particularly occur when you are under strain, have a slow heartbeat, an increase in blood pressure or change position from an upright position to sitting or laying down;
• feeling faint;
• loss of consciousness;
• slow breathing;
• shortness of breath;
• seizures (fits);
• passing urine with difficulty or pain, passing less urine than is normal for you.

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;
• headaches;
• drowsiness;
• nausea (feeling sick urge to vomit);
• vomiting;
• constipation;
• dry mouth;
• sweating more than is normal for you;
• fatigue.

Less frequent side effects

• abnormal sensations for example if you experience itching, tingling, or numbness;
• trembling;
• muscle twitches;
• uncoordinated movement;
• changes in appetite;
• hallucination;
• confusional state;
• sleep disorders;
• delirium;
• anxiety;
• nightmares;
• changes in mood for example you may feel happy or irritated;
• decreased activity;
• restlessness;
• changes in the way you see or view things;
• blurred vision;
• narrowing of the pupil;
• stomach trouble (e.g. feeling of pressure in the stomach, bloating);
• diarrhoea (frequent or loose watery stools);
• weak muscles;
• liver enzyme increased;
• acute pancreatitis;
• abdominal pain.

The following side effects have been reported in post-marketing surveillance:

• speech disorder;
• excessive widening of your pupils;
• Stevens-Johnson syndrome - a rare, serious disorder of the skin and mucous membranes. It starts with flu-like symptoms, followed by a painful rash that spreads and blisters.
• Low levels of sodium in the blood and/or inappropriate antidiuretic hormone secretion (SIADH)
• Increased risk of abdominal pain, including acute pancreatitis. Frequency: rare

If any of the side effects get serious, or if you experience one of the above –mentioned serious side effects, call the nearest doctor immediately. If you experience any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 ° C (room temperature). Keep the HDPE container closed. Protect from light and moisture. Store all medicines out of reach of children. Store in the original package / container. Do not store in a bathroom. Do not use after the expiry date stated on the label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).