WHAT TRAMADOL SANDOZ SR IS USED FOR

The name of your medicine is Tramadol Sandoz SR. This medicine is used to relieve severe pain which requires daily, long term treatment.

It contains the active ingredient tramadol hydrochloride. Tramadol hydrochloride belongs to a group of medicines called opioid analgesics (pain relievers).

Tramadol Sandoz SR tablets are designed to release active medicine gradually over several hours.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Tramadol Sandoz SR is available only on a doctor’s prescription.

Tramadol Sandoz SR tablets is for use in adults and children over 12 years of age. It should not be used in children under the age of 12 years or following the removal of tonsils and/or adenoids in people under 18.

BEFORE YOU TAKE TRAMADOL SANDOZ SR

When you must not take it

Do not take this medicine if you have an allergy to:

• tramadol hydrochloride, the active ingredient or to any of the other ingredients listed at the end of this leaflet under Product Description.
• any other similar medicines known as opioid analgesics e.g. morphine, codeine.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take this medicine if you have or have had any of the following medical conditions:

• have respiratory disease or slow or shallow breathing
• if you have taken large amounts of alcohol or other substances which can affect your level of consciousness. Some examples of these substances include sleeping pills, pain relievers or other psychotropic medicines (medicine that affect mood and emotions)
• taking medicines for depression containing a “monoamine oxidase inhibitors” also known as MAOI, or have taken any within the last two weeks (e.g. Nardil, Parnate)
• uncontrolled epilepsy or if your epilepsy is not well controlled by treatment.
• you are younger than 12 years old or if you are between 12-18 years of age and are recovering from an operation to remove your tonsils and/or adenoids.

Tramadol Sandoz SR is for use in adults and children over 12 years of age. It should not be used in children under the age of 12 years or following the removal of tonsils and/or adenoids in people under 18.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

Do not take Tramadol Sandoz SR if any tablets look damaged or discoloured. If it has expired or is damaged, return it to your pharmacist for disposal.

Addiction

You can become addicted to Tramadol Sandoz SR even if you take it exactly as prescribed. Tramadol Sandoz SR may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Dependence

As with all other opioid containing products, your body may become used to you taking Tramadol Sandoz SR. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Tramadol Sandoz SR suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance

Tolerance to Tramadol Sandoz SR may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

Withdrawal

Continue taking your medicine for as long as your doctor tell you. If you stop having this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms:

• nervousness, restlessness, agitation, trouble sleeping or anxiety
• body aches, weakness or stomach cramps
• loss of appetite, nausea, vomiting or diarrhoea
• increased heart rate, breathing rate or pupil size
• watery eyes, runny nose, chills or yawning
• increased sweating.

Very rarely, some patients have experienced the following withdrawal reactions:

• panic attacks
• severe anxiety
• hallucinations
• tingling or numbness (pins and needles)
• ringing in your ears
• confusion, delusions or paranoia.

Tramadol Sandoz SR given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

You must tell your doctor if:

• you know you are sensitive to opioids
• you drink alcohol
• you have any health problems including:
  – any condition that may affect how your kidney or liver work
  – any stomach problems
  – any lung or breathing problems
  – sleep-related breathing disorders
  – fits or convulsions, or take medicines for epilepsy
  – severe headache or feel sick due to a head injury
• you have, or have had, any drug or alcohol dependence problems
• you have galactose intolerance or lactase deficiency or glucose-galactose malabsorption.

Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding. Tramadol Sandoz SR is not recommended for use during pregnancy. Tramadol Sandoz SR can pass to your unborn baby when you are pregnant. Talk to your doctor about the risks and benefits of using Tramadol Sandoz SR during pregnancy.

Tramadol Sandoz SR is not recommended for use during breastfeeding. Talk to your doctor about the risks and benefits of using Tramadol Sandoz SR during breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking Tramadol Sandoz SR.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Tramadol Sandoz SR may interfere with each other. These include:

• medicines for depression, sleeplessness or mental conditions such as selective serotonin reuptake inhibitors (SSRI’s), serotonin-noradrenaline reuptake inhibitors (SNRI’s) and tricyclic anti-depressants (TCA’s), quinidine, phenothiazines or anti-psychotics
• medicines to help you sleep
• medicine for irregular or rapid heartbeats
• carbamazepine (e.g. Tegretol)
• coumarin derivatives (e.g. warfarin, brand names are Coumadin or Marevan)
• some antibiotics.

These medicines may be affected by Tramadol Sandoz SR, or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines. Other interactions not listed above may also occur.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.