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.


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