Tramadol (Ultram) 50 mg

Pain Medications

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Tramadol (tramadol hydrochloride) – the active substance in Tramadol oral drops - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

WHAT IS TRAMADOL?

Tramadol tablet is a prescription drug, it is used to relieve severe pain immediately. Tramadol comes in 3 forms - tablet, liquid, and capsule. Along with immediate relief of severe pain, this drug is also used to eliminate long-lasting pain. This medicine should never be taken without a doctor's advice as it becomes addictive, especially when the medicine has been in operation for a long time.

 

What is in this leaflet

1. What Tramadol oral drops are and what they are used for
2. What you need to know before you take Tramadol oral drops
3. How to take Tramadol oral drops
4. Possible side effects
5. How to store Tramadol oral drops
6. Contents of the pack and other information

 

1. WHAT TRAMADOL ORAL DROPS ARE AND WHAT THEY ARE USED FOR

Tramadol (tramadol hydrochloride) – the active substance in Tramadol oral drops - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. Tramadol oral drops are used for the treatment of moderate to severe pain.

 

 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL ORAL DROPS

       Do not take Tramadol oral drops:

       If you are allergic to tramadol or any of the other ingredients of this medicine (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 the treatment of depression) or have taken them in          the last 14 days (see “Taking other medicines”)

      If you are an epileptic and your fits are not adequately controlled by treatment

      as a substitute for drug withdrawal.

 

   Warnings and precautions

     Talk to your doctor, pharmacist or nurse before taking Tramadol oral drops:

     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 breathing if you have a tendency towards epilepsy or fits because the risk of a fit may increase if         you suffer from a liver or kidney disease.

      In such cases please consult your doctor before taking the medicine.

Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be higher when doses of tramadol exceed the recommended upper daily dose limit (400mg). Tramadol is transformed into 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.

Please note that Tramadol oral drops may lead to physical and psychological addiction. When Tramadol oral drops are 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 oral drops 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 treatment with Tramadol oral drops or if they applied to you in the past.

Children and adolescents

Use in children with breathing problems

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

Other medicines and Tramadol oral drops

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Tramadol oral drops should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).

Concomitant use of Tramadol oral drops and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Tramadol oral drops together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all the sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

The pain-relieving effect of Tramadol oral drops may be reduced and the length of time it acts may be shortened, if you take medicines that contain

 carbamazepine (for epileptic fits)

  pentazocine, nalbuphine or buprenorphine (pain killers)

  ondansetron (prevents nausea).

Your doctor will tell you whether you should take Tramadol oral drops and which dose. The risk of side effects increases if you take tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol oral drops. You may feel drowsier or feel that you might faint.   

Tramadol oral drops with food, drink and alcohol. Do not drink alcohol during treatment with Tramadol oral drops as its effect may be intensified. Food does not influence the effect of Tramadol oral drops.

Pregnancy and breast-feeding, If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

 Pregnancy

There is very little information regarding the safety of tramadol in human pregnancy. Therefore, you should not use Tramadol oral drops if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.

 

Breast-feeding

Tramadol is excreted into breast milk. For this reason, you should not take tramadol more than once during breast-feeding, or alternatively, if you take Tramadol oral drops more than once, you should stop breast-feeding.

 

Driving and using machines

Tramadol oral drops may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. If you feel that your reactions are affected, do not drive a car or other vehicle, do not use electric tools or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

 do not drive while taking this medicine until you know how it affects you

 it is an offence to drive if this medicine affects your ability to drive

 however, you would not be committing an offence if:

 the medicine has been prescribed to treat a medical or dental problem and you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and it was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Tramadol oral drops contain sodium and sucrose. This medicine contains less than 1 mmol sodium(23 mg) per 100mg/ml, that is to say essentially ‘sodium-free’. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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