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Tramadol

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Generic Name: Tramadol HCI

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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.

The active ingredient of Tramadol is tramadol hydrochloride.

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 Tramadol after the expiry date indicated on the pack.

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