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Generic name: Tramadol
Brand name: Ultram
Tramadol is a centrally acting analgesic with opioid-like
effects. It relieves pain by acting on the specific nerve endings
of the spinal cord and brain. These nerve endings diminish the severity
of the pain you feel, a natural function that is increased with
the administration of Tramadol. Tramadol is used to treat moderate and severe pain and most types of neuralgia,
including trigeminal neuralgia. It has been suggested that tramadol could be effective for alleviating symptoms of depression and anxiety because of its action on the noradrenergic and serotonergic systems, the involvement of which appear
to play a part in its ability to alleviate the perception of pain. The active ingredient of Tramadol is tramadol hydrochloride.
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The other ingredients in Tramadol are:
Microcrystalline cellulose, hypromellose, magnesium stearate, colloidal
anhydrous silica, lactose monohydrate, macrogol 6000, propylene
glycol, talc, titanium dioxide (E 171), quinoline yellow aluminium
lake (E 104), red iron oxide (E 172), brown iron oxide (E 172).
What is Tramadol ?
Tramadol is a centrally acting analgesic with opioid-like effects.
It relieves pain by acting on the specific nerve endings of the
spinal cord and brain. These nerve endings diminish the severity
of the pain you feel, a natural function that is increased with
the administration of Tramadol. Tramadol is indicated for the treatment
of moderate to severe pain.
Before taking Tramadol
If you are allergic to tramadol hydrochloride or to any of its ingredients.
In cases of acute intoxication with alcohol, sleeping pills, analgesics,
or psychotropic agents (medications that affect your mood and emotions).
If you are taking certain medications for the treatment of depression
(monoamine oxidase inhibitors or MAOIs) or have taken any within
the last two weeks Tramadol must not be used for withdrawal treatment.
If you are not sure whether you should start taking Tramadol, consult
your doctor.
Take special care with Tramadol
Before you start taking Tramadol, inform your doctor if you:
Are dependent on other potent analgesics (opioids).
Experience a decreased level of consciousness (sensation of dizziness
or confusion).
Are in a state of shock (a sign of this may be cold sweat).
Experience increased intracranial pressure (for example, after head
injury or brain disease).
Have difficulty in breathing.
Are epileptic or are susceptible to fits or seizures.
Suffer from any liver or kidney disease.
Are lactose tolerant.
Consult your doctor, even if you experience any of these symptoms
only once during treatment with this medication.
Taking Tramadol with food and drink:
Alcohol should be avoided during treatment with Tramadol.
Pregnancy:
If you are pregnant or think you could be, do no take Tramadol.
There is inadequate evidence available on the safety of Tramadol
in human pregnancy.
Ask your doctor or pharmacist for advice before taking any medication.
Lactation:
Tramadol should not be administered during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medication.
Driving and using machines:
Tramadol may affect your reaction ability, therefore caution should
be exercised when driving, using machinery or carrying out dangerous
activities.
Taking other medications:
It is important that you tell your doctor or pharmacist if you are
taking or have recently taken any other medications, including any
you have bought without a prescription.
Patients should avoid the concomitant treatment of Tramadol with
monoamine oxidase inhibitors (MAOIs), a certain type of medication
used to treat depression.
The simultaneous administration of alcohol or other brain depressants
may intensify the adverse effects Tramadol on the brain.
Previous or simultaneous treatment with carbamazepine (a medication
used in the treatment of epileptic fits) may reduce the analgesic
effect of Tramadol, as well as shorten the duration of action.
Concomitant treatment of Tramadol with medications that may provoke
convulsions (eg. antidepressants or medications used to treat certain
psychological illnesses) may, on rare occasions, induce these convulsions.
The concomitant treatment of Tramadol with serotonergic agents (eg.
certain medications used to treat depression) in isolated cases
may lead to serotonin syndrome.
The concomitant treatment of Tramadol with medications used to prevent
the abnormal coagulation of blood, also called coumarin derivatives
(eg. warfarin), may affect the anticoagulation action and may cause
haematomas.
How To take Tramadol
Follow these instructions unless otherwise specified by your doctor.
Remember to take your medication. Tramadol is administered orally.
The tablets must be swallowed whole, not divided or chewed with
sufficient liquid, preferably in the morning and in the evening.
The tablets can be taken irrespective of food intake. Your doctor
will indicate the duration of your treatment with Tramadol.
Adults and children aged 12 years and over The recommended dose
is 1 tablet of Tramadol (200 mg. of tramadol hydrochloride) twice
a day, preferably morning and evening. Do not take more than 2 tablets
of Tramadol per day unless indicated by your doctor.
Children
Tramadol should not be administered to children below the age of
12 years.
Elderly
In elderly patients (over 75 years of age), the elimination of the
active ingredient may be slower. Therefore, your doctor may increase
the dosage interval.
Patients with hepatic or renal insufficiency
Tramadol is not recommended in patients with a severe hepatic or
renal disease. If you suffer moderate hepatic or renal insufficiency
your doctor may increase the dosage interval. Tramadol should not
be taken for longer than is strictly necessary. If prolonged treatment
is essential, you doctor should assess you at regular intervals
(and if necessary with interruptions during treatment), he / she
will also decide whether you should continue taking Tramadol and
the dosage to be taken. If you think that the effect of Tramadol
is too strong or too weak, inform your doctor or pharmacist.
If you take more Tramadol than you should:
If you take more Tramadol than you should, consult your doctor or
pharmacist immediately. An overdose due to high doses of Tramadol
may cause contraction of the pupil, vomiting, a fall in blood pressure,
a fast heartbeat, collapse, disturbed consciousness including coma
(deep unconsciousness), epileptic fits and difficulties in breathing
that may lead to respiratory arrest. In this case contact your doctor
immediately.
If you forget to take Tramadol:
If you forget to take Tramadol, pain is likely to return. Do not
take a double dose to make up for forgotten individual doses. Take
the missed dose as soon as possible. Then continue taking the tablets
as usual.
Effects that may appear when the treatment with Tramadol
is stopped:
If you interrupt or stop the treatment with Tramadol abruptly, pain
is likely to return. If you want to discontinue treatment with this
medication because of its side effects, consult your doctor. Some
patients on long-term therapy with potent analgesics may experience
withdrawal symptoms when finalizing treatment. The risk of experiencing
these withdrawal symptoms is low. However, if you feel agitated,
anxious, nervous or shaky, hyperactive or have difficulty sleeping
or digestion problems, consult your doctor.
POSSIBLE SIDE EFFECTS
As with all medications, Tramadol may have adverse effects. The
most commonly reported adverse effects are nausea and vertigo. These
effects were observed in more than 10% of the patients treated with
Tramadol.
Central and peripheral nervous system disorders:
Common (1-10 %): headache and confusion.
Rare (< 0.1 %): changes in appetite, paraesthesia, tremor, respiratory
depression and convulsions.
Gastrointestinal disorders:
Common (1-10%): vomiting, constipation and dry mouth.
Uncommon (< 1 %): retching; gastrointestinal irritation (a feeling
of pressure in the stomach, bloating).
In some isolated cases, increases in transaminases (liver enzyme
values) have been reported in connection with the use of tramadol.
Skin and appendages disorders:
Common (1-10 %): increased sweating.
Uncommon (< 1 %): dermal reactions (e.g. pruritus, skin rash,
urticaria).
Cardiovascular system disorders:
Uncommon (< 1 %): palpitation, tachycardia, postural hypotension
or cardiovascular collapse.
Rare (< 0.1%): bradycardia, increase in blood pressure.
Psychiatric disorders:
Rare (< 0.1 %): hallucinations, confusion, sleep disturbance
and nightmares. Other side effects that may occur, which vary individually
in intensity and nature, include changes in mood, increase or suppression
in activity and changes in cognitive and sensorial ability (e.g.
decision behaviour, perception disorders). Dependence may occur.
Other disorders:
Rare (< 0.1%): blurred vision, muscle weakness, difficulty in
passing urine and urinary retention; allergic reactions, from difficulty
in breathing, bronchospasm, wheezing and oedema, to general allergic
reactions.
Symptoms of withdrawal reactions, similar to those occurring during
opiate withdrawal, may occur as follows: agitation, anxiety, nervousness,
insomnia, hyperkinesia, tremor and gastrointestinal symptoms. Worsening
of asthma has been reported, though a causal relationship has not
been established.
If you notice any of these side effects or any other reaction not
mentioned in this leaflet, please inform your doctor or pharmacist.
Storage of Tramadol
No special storage conditions are necessary for Tramadol.
Do not use this medication after the expiry date indicated on the
pack.
Tramadol recreational use and abuse
As an opioid analgesic, Tramadol has been proposed as a possible recreational drug. However, due to the possibility of convulsions at high doses, recreational use is very dangerous. It can, however, via agonism of μ opioid receptors, produce effects similar to those of other opioids (e.g., morphine or hydrocodone), although not nearly as intense due to Tramadol's much lower affinity for the receptor. However, the metabolite M1 is produced after demethylation of the drug in the liver. The M1 metabolite has an estimated 200x greater affinity for the mu1, and mu2 opioid receptors. In addition to acting as an opioid, Tramadol is also a very weak but rapidly acting serotonin-norepinephrine reuptake inhibitor. When taken in amounts larger than normal therapeutic doses, Tramadol can cause seizures (typically tonic-clonic) and severe nausea, which could deter abuse to some extent. Tramadol has been known to produce severe withdrawal symptoms with abrupt cessation after prolonged use. In addition, Tramadol can help alleviate withdrawal symptoms from more addictive opiates, and is much easier to lower quantity of usage compared to opiates such as hydrocodone and oxycodone. Tramadol may also have large effect on sleeping patterns. High doseage may prevent sleeping.
In addition, Tramadol is sometimes combined with stronger opiates to potentiate and prolong the effects. Tramadol is a weaker opioid than oxycodone or hydrocodone but has a longer half-life, so when combined it results in a longer duration of the euphoric effects.
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