Tramadol Hydrochloride 10mg/ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Tramadol oral solution is and what it is used for
2. What you need to know before you take Tramadol oral solution
3. How to take Tramadol oral solution
4. Possible side effects
5. How to store Tramadol oral solution
6. Contents of the pack and other information

• If you 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);
• if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days (see “Other medicines and Tramadol oral solution”);
• if you are an epileptic and your fits are not adequately controlled by treatment;
• as a substitute in drug withdrawal.

Talk to your doctor before taking Tramadol oral solution if you:

• Suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Tramadol oral solution’).

Sleep-related breathing disorders

Tramadol oral solution can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol oral solution:

• if you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs;
• if you have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs;
• if you feel you need to take more of Tramadol oral solution to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;
• if you suffer from consciousness disorders (if you feel that you are going to faint);
• if you are in a state of shock (cold sweat may be a sign of this);
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
• if you have difficulty in breathing;
• if you have a tendency towards epilepsy or fits because the risk of a fit may increase;
• if you suffer from a liver or kidney disease.

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.

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.

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.

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 oral solution 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 oral solution 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 oral solution, 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 oral solution).

Epileptic fits have been reported in patients taking Tramadol oral solution at the recommended dose level. The risk may be higher when doses of Tramadol oral solution exceed the recommended upper daily dose limit 400 mg (40 ml).

Please also inform your doctor if one of these problems occurs during treatment with Tramadol oral solution or if they applied to you in the past.

Tramadol hydrochloride 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’).

Children and adolescents

Use in children with breathing problems:

Tramadol oral solution 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, including medicines obtained without a prescription.

Tramadol oral solution should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).

The pain-relieving effect of Tramadol oral solution 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 oral solution, and which 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 oral solution. You may feel drowsier or feel that you might faint. If this happens tell your doctor;
• concomitant use of Tramadol oral solution and tranquillizers or sleeping pills (e.g. benzodiazepines), 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 prescribes Tramadol oral solution together with sedating medicines the dose and the duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedating 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;
• if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Tramadol oral solution at the same time. Your doctor will tell you whether Tramadol oral solution is suitable for you;
• if you are taking certain antidepressants Tramadol oral solution may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’);
• if you are taking coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol oral solution. The effect of these medicines on blood clotting may be affected and bleeding may occur.
• if you are taking medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics).
• if you are taking medicines to treat psychiatric disorders (antipsychotics or neuroleptics).
• if you are taking muscle relaxants.
• if you are taking medicines to treat Parkinson’s’ disease.

Do not drink alcohol during treatment with Tramadol oral solution as its effect may be intensified.

Food does not influence the effect of Tramadol oral solution.

Do not take Tramadol oral solution 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 use Tramadol oral solution during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Tramadol oral solution while you are breast-feeding as Tramadol hydrochloride passes into breast milk and will affect your baby.

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

Tramadol oral solution 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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• 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.

This medicine contains:

Propylene glycol: This medicine contains 101.96 mg propylene glycol in each ml which is equivalent to 509.8 mg per dose of 5 ml or 1019.6 mg per dose of 10ml.

Glycerol (E 422): This medicine contains 100mg in each ml, which is equivalent to 500 mg per dose of 5 ml or 1g per dose of 10ml.

Sodium: This medicine contains 1.70 mg in each ml, which is equivalent to 8.5 mg per dose of 5 ml and 17 mg per dose of 10ml.

5 ml to 10 ml Tramadol oral solution (equivalent to 50 mg – 100 mg tramadol hydrochloride).

Depending on the pain the effect lasts for about 4 to 6 hours.

Your doctor may prescribe a different, more appropriate dosage of Tramadol oral solution if necessary.

Tramadol oral solution is not suitable for children below the age of 12 years.

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

Patients with severe liver and/or kidney insufficiency should not take Tramadol oral solution. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

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

If you (or someone else) take a lot of Tramadol oral solution at the same time you should go to hospital or call a doctor straight away. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heart beat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.

If you forget to take a dose, pain is likely to return.

Do not take a double dose to make up for forgotten individual doses, simply continue taking the medicine as before.

Do 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 taking Tramadol oral solution, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to take more than the recommended dose
• You are taking 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 affects you can help provide more information on the safety of this medicine.

• each 1ml of oral solution contains 10mg of the active substance tramadol hydrochloride.
• the other ingredients are: potassium sorbate, propylene glycol, sucralose, sodium cyclamate, saccharin sodium, glycerol, caramel powder, orange flavour, hydrochloric acid and purified water.

Tramadol Hydrochloride 10 mg/ml Oral Solution is a clear, brown solution with orange odour. It is packed in amber, type III 100ml or 150ml glass bottles sealed with a child-resistant tamper-evident screw cap and with a dosing cup of 15ml with 5ml and 10ml graduations.