Zydol 50 mg/ml Solution for Injection

• 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 provided 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 (section 4).

1. What ZYDOL^® Solution for Injection is and what it is used for
2. What you need to know before you receive ZYDOL^® Solution for Injection
3. How to take ZYDOL^® Solution for Injection
4. Possible side effects
5. How to store ZYDOL^® Solution for Injection
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 before treatment with ZYDOL Solution for Injection (see "Other medicines and ZYDOL Solution for Injection");
• 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 receiving ZYDOL Solution for Injection, if:

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

Sleep-related breathing disorders

ZYDOL Solution for Injection contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnea (shallow/pause of breathing during sleep) and sleep-related hypoxemia (low level of oxygen in the blood).

The risk of experiencing central sleep apnea is dependent on the dose of opioids. Your doctor may consider decreasing your total opioid dosage if you experience central sleep apnea.

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.

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.

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 doctor if you experience any of the following symptoms while taking ZYDOL Solution for Injection:

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.

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

ZYDOL Solution for Injection should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).

The pain-relieving effect of ZYDOL Solution for Injection 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 ZYDOL Solution for Injection, 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 ZYDOL Solution for Injection. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
• Concomitant use of Zydol Solution for Injection and tranquillizers or sleeping pills (e.g. benzodiazepines) 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 or may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor gives Zydol Solution for Injection 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 medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take ZYDOL Solution for Injection at the same time. Your doctor will tell you whether ZYDOL Solution for Injection is suitable for you.
• if you are taking certain antidepressants ZYDOL Solution for Injection 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 ZYDOL Solution for Injection. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Do not drink alcohol during treatment with ZYDOL Solution for Injection as its effects may be intensified.

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.

Do not take ZYDOL Solution for Injection 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 ZYDOL Solution for Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take ZYDOL Solution for Injection 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

ZYDOL Solution for Injection 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 given 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 medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially 'sodium-free'.

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

If you (or someone else) received a very high dose of ZYDOL Solution for Injection you should go to hospital or call a doctor straight away. Signs of an overdose include very small pupils, being sick, fall in blood pressure, fast heartbeat, collapse, unconsciousness, fits and breathing difficulties or shallow breathing.

If you do not receive your ZYDOL Solution for Injection or infusion, pain is likely to return. You should not receive a double dose to make up for forgotten individual doses, simply continue receiving ZYDOL Solution for Injection 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 ZYDOL Solution for Injection, 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 or pharmacist. 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.

The other ingredients are: sodium acetate and water for injection.

ZYDOL Solution for Injection is a clear colourless solution.

ZYDOL Solution for Injection is supplied in boxes of five ampoules, each containing 2 ml solution.

Not all pack sizes may be marketed.

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