Tramadol 100 mg/ml oral drops, solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Tramadol 100mg/ml oral drops, solution. It will be referred to as “Tramadol oral drops” for ease of use hereafter.

1. What Tramadol oral drops are and what they are used for
2. What you need to know before you take Tramadol oral drops
3. How to take Tramadol oral drops
4. Possible side effects
5. How to store Tramadol oral drops
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 “Taking other medicines”)
• if you are an epileptic and your fits are not adequately controlled by treatment
• as a substitute in drug withdrawal.

Talk to your doctor, pharmacist or nurse before taking Tramadol oral drops:

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

In such cases please consult your doctor before taking the medicine.

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

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.

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 drops 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 drops 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 drops, 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 drops).

Talk to your prescriber before taking this medicine if you:

• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.

Addiction can cause withdrawal symptoms when you stop taking 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.

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’).

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, including medicines obtained without a prescription.

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

Concomitant use of Tramadol oral drops and sedative medicines such as benzodiazepines or related drugs 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 oral drops 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.

The pain-relieving effect of Tramadol oral drops may be reduced and the length of time it acts may be shortened, if you take medicines which contain

• carbamazepine (for epileptic fits)
• pentazocine, nalbuphine or buprenorphine (pain killers)
• ondansetron (prevents nausea).

Your doctor will tell you whether you should take Tramadol oral drops, and which dose. The risk of side effects increases

• if you take tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking Tramadol oral drops. You may feel drowsier or feel that you might faint.

If this happens tell your doctor

• if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Tramadol oral drops at the same time. Your doctor will tell you whether Tramadol oral drops are suitable for you
• if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• if you are taking certain antidepressants, Tramadol oral drops may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
• if you take coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with Tramadol oral drops. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Do not drink alcohol during treatment with Tramadol oral drops as its effect may be intensified. Food does not influence the effect of Tramadol oral drops.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breast-feeding

Do not take Tramadol oral drops while you are breastfeeding as tramadol passes into breast milk and will affect your baby.

Tramadol oral drops 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.

• Less than 1 mmol sodium (23 mg) per 100mg/ml, that is to say essentially ‘sodium-free’.
• Sucrose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

The recommended dose for adults and children aged 12 and over is 50 mg to 100 mg tramadol (20 to 40 drops), three to four times per day. The maximum allowed dose of Tramadol oral drops is generally 400 mg (160 drops) per day. For acute pain, a starting dose of 100 mg is generally required since the effect begins later than with other pain relievers. If Tramadol oral drops are taken for acute pain, the user must be aware that the effect begins somewhat later than with a number of other pain-relievers.

For chronic pain, a starting dose of 50 mg is recommended.

Tramadol oral drops are 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 recommend prolonging the dosage interval.

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

Tramadol oral drops are for oral use.

Mix the drops in one glass of water. Then drink the whole content of the glass.

The drops may be taken before, during or after meals.

You should not take Tramadol oral drops for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take Tramadol oral drops and at what dose. If you have the impression that the effect of Tramadol oral drops is too strong or too weak, talk to your doctor or pharmacist.

If you have taken an additional dose by mistake, this will generally have no negative effects. You should take 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 may occur.

In such cases a doctor should be called immediately.

In people who have taken tramadol overdose, urine tests may show ‘false-positive’ results. If your doctor has prescribed a urine test, tell your doctor you are taking Tramadol oral drops.

If you have forgotten 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 drops as before.

Do not suddenly stop taking this medicine. If you want to stop taking your medicine, discuss this with your presriber 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. They may be hyperactive and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and noise in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonalization), and change in perception of reality (derealization) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stopping Tramadol oral drops, please consult your doctor.

• Symptoms of severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome), cross reactivity with other painkillers (such as acetylsalicylic acid, ibuprofen, naproxen).
• Thoughts of suicide

Other side effects include:

Very common (may affect more than 1 in 10 people):

• dizziness
• nausea

Common (may affect up to 1 in 10 people):

• headaches
• drowsiness
• constipation
• dry mouth
• vomiting
• indigestion (dyspepsia)
• abdominal pain
• sweating
• menopausal symptoms
• fatigue
• low energy (weakness).

Uncommon (may affect up to 1 in 100 people):

• effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapse)
• anorexia
• stomach trouble (e.g. feeling of pressure in the stomach, bloating)
• diarrhoea
• skin reactions (e.g. itching, rash)

Rare (may affect up to 1 in 1,000 people):

• slow heartbeat
• increase in blood pressure
• changes in appetite
• abnormal sensations (e.g. itching, tingling, numbness)
• trembling, slow breathing
• epileptic fits
• muscle twitches
• uncoordinated movement
• transient loss of consciousness (syncope)
• increased muscle stiffness
• taste disturbance
• hallucinations
• confusion
• sleep disorders
• anxiety and nightmares
• psychological complaints
• change in mood (mostly high spirits, occasionally irritated mood)
• changes in activity (usually suppression, occasionally increase)
• decreased cognitive function
• sensory perception (changes in senses and recognition)
• miosis (excessive constriction of the pupil of the eye)
• blurred vision
• shortness of breath (dyspnoea)
• worsening of asthma
• weak muscles
• passing urine with difficulty or pain
• passing less urine than normal
• weight loss
• allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin)
• shock (sudden circulation failure)
• stomach and bowel disorders
• menstrual disorders.

Very rare (may affect up to 1 in 10,000 people):

• increase in liver enzyme values.

Not known (frequency cannot be estimated based on available data):

• low sodium concentration in the blood
• decrease in blood sugar level
• speech disorders
• excessive dilation of the pupils (mydriasis).
• dependence and addiction (see section “How do I know if I am addicted?”)
• Serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 ‘What you need to know before you take Tramadol Oral drops’).

Drug Withdrawal

When you stop taking Tramadol oral drops, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

If you notice any of the following signs whilst taking Tramadol oral drops, 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 use 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 (as the hydrochloride).
  Each 1ml oral drops, solution contains 100mg/ml Tramadol (as the hydrochloride).
• The other ingredients are Sucrose, Saccharin sodium, Potassium sorbate (E202), Polysorbate 20, Aniseed oil, Peppermint oil, Purified water and Hydrochloric acid (for pH adjustment).

Tramadol oral drops are clear, colourless or faint yellowish solution. They are delivered in boxes containing one, three or five amber glass bottles of 10ml, with an inserted dropper applicator and sealed with a child safe screw cap. Not all pack sizes may be marketed.