TRAMADOL 100 MG / ML ORAL DROPS SOLUTION - Patient leaflet, side effects, dosage

2. what you need to know before you take tramadol oral drops

Do not take Tramadol oral drops:

• 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.

Warnings and precautions

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.

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking

alcohol or drugs.

• feel you need to take more of Tramadol oral drops 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.

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’).

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.

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. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking 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.

Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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

Children and adolescents (1) continued over

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.

Other medicines and Tramadol oral drops

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 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.

Tramadol oral drops with food, drink and alcohol

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.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

Tramadol oral drops contain:

• 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.

3. how to take tramadol oral drops

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your prescriber should have discussed with you, how long the course of oral drops will last.

They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.

Unless otherwise prescribed by your doctor, the recommended dose is:

Adults and adolescents from the age of 12 years

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.

Use in Children

Tramadol oral drops are not suitable for children below the age of 12 years.

Elderly patients

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.

Severe liver or kidney disease (insufficiency)/di­alysis patients

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.

How and when should you take Tramadol oral drops?

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.

How long should you take Tramadol oral drops?

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 take more Tramadol oral drops than you should

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.

Urine tests for Phencyclidine

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 forget to take 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.

If you stop taking Tramadol oral drops

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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. _____________­________________________­__

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• You should see a doctor immediately if you experience symptoms of an allergic reaction such as swollen face, tongue and/or throat, and/or difficulty swallowing or hives together with difficulties in breathing.

Stop taking this medicine if you experience any of the following:

• 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

continued over

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

• indigestion (dyspepsia)

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

• anorexia
• stomach trouble (e.g. feeling of pressure in the stomach, bloating)

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

• confusion

• change in mood (mostly high spirits,

occasionally irritated mood)

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.

How do I know if I am addicted?

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

Reporting of side effects

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: 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.

5. how to store tramadol oral drops

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Tramadol oral drops contain

• – 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).

What Tramadol oral drops look like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK

This leaflet was last revised in July 2021.

LF-101873–148–01

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