Tramadol hydrochloride 50 mg/ml solution for injection or infusion

• are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)
• are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion (see “Other medicines and Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion”)
• are an epileptic and your fits are not adequately controlled by treatment
• as a substitute in drug withdrawal.

Talk to your doctor or nurse before being given Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion if you:

• suffer from consciousness disorders (if you feel that you are going to faint)
• are in a state of shock (cold sweat may be a sign of this)
• suffer from increased pressure in the brain (possibly after a head injury or brain disease);
• have difficulty in breathing;
• have a tendency towards epilepsy or fits because the risk of a fit may increase
• suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion’)
• suffer from liver or kidney disease

Tolerance, dependence, and addiction

This medicine contains tramadol which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs whilst taking Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion).

Addiction can cause withdrawal symptoms when you stop receiving this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop receiving the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Receiving higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects.

If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite. There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken tramadol in combination with certain antidepressants or tramadol alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 ‘Possible side effects’).

Epileptic fits have been reported in patients taking tramadol at the recommended dose level. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg). Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Sleep-related breathing disorders

Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion can cause sleep-related breathing disorders such as central sleep apnoea (shallow/breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The risk of experiencing central sleep apnoea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnoea.

Talk to your doctor if you experience any of the following symptoms while taking Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion:

Extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement.

Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion is not suitable for children below the age of 12 years.

Use in children with breathing problems

Tramadol is not recommended in children with breathing problems, since the symptoms of tramadol toxicity may be worse in these children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).

The pain-relieving effect of Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion may be reduced and the length of time it acts may be shortened, if you take medicines which contain:

• carbamazepine (for epileptic fits);
• ondansetron (prevents nausea).

Your doctor will tell you whether you should take Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion, and what dose.

The risk of side effects increases, if you are taking:

• other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
• Concomitant use of Tramadol and tranquillizers, sleeping pills (e.g. benzodiazepines) or other sedatives or medicines that impair breathing activity (e.g. opioids) or gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
• However if your doctor does prescribe Tramadol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
• Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion at the same time. Your doctor will tell you whether Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion is suitable for you.
• certain antidepressants Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion. The effect of these medicines on blood clotting may be affected and bleeding may occur.
• medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics).
• medicines to treat psychiatric disorders (antipsychotics or neuroleptics).
• muscle relaxants.
• medicines to treat Parkinson’s disease.

You should not be given Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you are given Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

You should not be given Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion while you are breastfeeding as tramadol passes into breast milk and will affect your baby.

Based on human experience tramadol is suggested not to influence female or male fertility.

Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion may cause drowsiness, dizziness and blurred vision and therefore may impair your reactions. If you feel that your reactions are affected do not drive a car or other vehicle, do not use electric tools or operate machinery.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Do not drink alcohol during treatment with Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion as its effects may be intensified

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

Depending on your pain you will receive 1-2 ml of Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion (equivalent to 50 – 100 mg tramadol hydrochloride). Depending on your pain the effect lasts for about 4-8 hours.

Your doctor may prescribe a different, more appropriate dosage of Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion.

Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion is not suitable for children below the age of 12 years.

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you, your doctor may direct to prolong the dosage interval.

Patients with severe liver and/or kidney insufficiency should not receive Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

How and when should you receive Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion?

Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion will be injected slowly usually into a blood vessel under the surface of the arm or injected into muscle (usually the buttocks) or under the skin. Alternatively, Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion will be diluted and infused into a vein.

How long should you receive Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion?

Your prescriber should have discussed with you, how long the course of injections will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

If you have received an additional dose by mistake, this will generally have no negative effects. You should receive your next dose as prescribed.

After taking very high doses, pin-point pupils, vomiting, fall in blood pressure, fast heart beat, collapse, disturbed consciousness up to coma (deep unconsciousness), epileptic fits, and difficulty in breathing up to cessation of breathing and death may occur. In such cases a doctor should be called immediately.

You should not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you notice any of the following signs whilst receiving Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion, it could be a sign that you have become addicted.

• You need to receive the medicine for longer than advised by your prescriber
• You feel you need to receive more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber.

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is tramadol hydrochloride. In Tramadol hydrochloride 50 mg/ml Solution for Injection or Infusion each ml of solution contains 50 mg of tramadol hydrochloride.

The other ingredients are sodium acetate trihydrate and water for injections.

The solution for injection or infusion is supplied in 1 or 2 ml clear glass ampoules. 1, 5 or 10 ampoules supplied in each carton.