Consumer Medicine Information
Tramadol Hydrochloride
Tramadol hydrochloride 50 mg Capsules
What is in this leaflet
Please read this carefully before you start to take your medicine.
This leaflet provides a summary of the information available about your medicine.
All medicines have risks and benefits. Your doctor has weighed the risks of you using TRAMADOL against the benefits this medicine is expected to have for you.
If you have any concerns about this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What TRAMADOL is used for and how it works:
TRAMADOL capsules contain an ingredient called tramadol hydrochloride which is used for the treatment and prevention of moderate to severe pain.
Ask your doctor if you have any questions about why TRAMADOL has been prescribed for you.
Before you use TRAMADOL
When you must not use it
Do not take TRAMADOL if you:
- are allergic to tramadol or to any of the other ingredients;
- have been drinking alcohol or taking other medicines that affect the nervous system such as hypnotics (used to relieve sleeplessness; e.g., nitrazepam), opioids (used to relieve moderate to severe pain; e.g., morphine and codeine) or psychotropic drugs (e.g., chlorpromazine; used to treat schizophrenia and severe anxiety);
- have had a head injury or feel faint from shock;
- are also taking drugs known as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), which are used to treat depression, or have been taking them within the past two weeks.
Tramadol may make you sleepy so be careful about driving or operating machinery.
Before you have a general anaesthetic, tell your doctor if you are taking Tramadol.
Before you start to use it,
Tell your doctor if you:
- suffer from kidney or liver disease
- suffer from epilepsy or convulsions or have had them in the past
- suffer from asthma or have trouble breathing
- are taking antidepressant drugs known as selective serotonin re-uptake inhibitors (e.g., fluoxetine and paroxetine) and tricyclic antidepressants (e.g., amitriptyline and desipramine) or carbamazepine (used to treat epilepsy and manic-depressive illness) or lithium (used to treat mania and depression)
- are pregnant or breast-feeding
How to take TRAMADOL capsules
How much to take
The directions given may differ from information contained in this leaflet.
Always take Tramadol exactly as your doctor tells you to.
Your pharmacist will help if you are not sure.
For moderate pain, one Tramadol capsule may be sufficient for the first dose, followed by one or two capsules two to three times a day as required.
For moderate to severe pain, two Tramadol capsules are usually required for the first dose, followed by one or two capsules every four to six hours as required.
Do not take more than eight Tramadol capsules (400mg) in 24 hours.
Tramadol capsules are not recommended for use in children under 12 years of age.
Elderly people over 75 years of age may require a lower daily dose.
How to take it
Tramadol capsules should be swallowed whole with a glass of water.
If you forget to take it
Take your dose as soon as you remember and then go on as before. Do not take a double dose to make up the forgotten dose.
These capsules shall not to be given to children under 12 years of age.
Side Effects
After taking Tramadol Hydrochloride Capsules, you may experience some of the following side effects: feeling sick, vomiting, constipation, tiredness, drowsiness, sleepiness, dizziness, headache, confusion, hallucinations, dependence, agitation, anxiety, nervousness, sleeplessness, hyperactivity, tremor, sweating, appearance of "nettle rash" on the skin, itching, difficulty in breathing, wheezing, worsening of existing asthma, difficulty in passing urine, urinary retention (i.e. inability to pass urine) and blurred vision.
Occasionally some people may feel faint from the blood pressure dropping. A few people may develop a skin rash, dry mouth, flushing, allergic reactions, high blood pressure or alteration of the heart beat and breathing. Rarely, dysphoria (ie feeling down) and convulsions have been reported.
If you experience these or any other side effects, tell your doctor or pharmacist immediately and ask if you should continue with your medication.
In Case of Overdose
Immediately telephone your doctor or Poisons Information Centre (0800-POISON or 0800 764-766), or go to the accident and emergency centre at your nearest hospital, if you think that you or anyone else may have taken too much tramadol.
After using TRAMADOL
Storage
Do not use Tramadol capsules after the expiry date stated on the packaging.
Do not store above 25 °C.
Store in the original package
Keep it secure where children cannot reach it. Your medicine could harm them.
REMEMBER this medicine is for you. Never give it to others even if their symptoms are the same as yours.
Disposal
If your doctor tells you to stop taking TRAMADOL or the capsules have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Tramadol Hydrochloride 50mg capsules are olive green / yellow capsules imprinted TRM on the cap and 50 on the body.
Ingredients
They also contain the following inactive ingredients: croscarmellose sodium, microcrystalline cellulose, lactose, magnesium stearate, ferric oxide, gelatin, indigo carmine, titanium dioxide, erythrosine, butyl alcohol, lecithin, methylated spirits, shellac, simeticone and water.
Distributor
AFT Pharmaceuticals Limited
PO Box 33-203
Takapuna
AUCKLAND
Date of preparation: 20 November 2007