Patient Leaflet Updated 31-Mar-2022 | Grunenthal Ltd
ZYDOL 50 mg/ml Solution for Injection
Package leaflet: Information for the user
ZYDOL® 50 mg/ml Solution for Injection
This medicine contains tramadol which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
Read all of this leaflet carefully before you start taking this medicine beacause it contains important information for you.
In this leaflet:
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
1. What ZYDOL Solution for Injection is and what it is used for
ZYDOL Solution for Injection has been given to you for the treatment of moderate to severe pain.
Tramadol - the active substance in ZYDOL Solution for Injection belongs to a class of medicines called opioids, which are ‘pain relievers’.
This medicine has been given to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. 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.
2. What you need to know before you receive ZYDOL Solution for Injection
Do not take ZYDOL Solution for Injection
Warnings and precautions
Talk to your doctor before receiving ZYDOL Solution for Injection if you:
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.
Other medicines and ZYDOL Solution for Injection
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
Your doctor will tell you whether you should take ZYDOL Solution for Injection, and what dose.
The risk of side effects increases,
ZYDOL Solution for Injection with food and alcohol
Do not drink alcohol during treatment with ZYDOL Solution for Injection as its effects may be intensified.
Children and adolescents
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.
Pregnancy, breast-feeding and fertility
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
Driving and using machines
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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Information on sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially 'sodium-free'.
3. How to use ZYDOL Solution for Injection
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 received. Normally, daily doses up to 8 ml of ZYDOL solution for injection (equivalent to 400 mg tramadol hydrochloride) will be sufficient. Exceptionally, if clinically required, your doctor may direct to use a higher daily dose.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years:
Depending on your pain you will receive 1-2 ml of ZYDOL Solution for Injection (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 ZYDOL Solution for Injection.
ZYDOL Solution for Injection 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.
Severe liver or kidney disease (insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency should not receive ZYDOL Solution for Injection. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
How and when should you receive ZYDOL Solution for Injection?
ZYDOL Solution for Injection 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, ZYDOL Solution for Injection will be diluted and infused into a vein.
How long should you receive ZYDOL Solution for Injection?
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 receive more ZYDOL Solution for Injection than you should
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 miss a dose of ZYDOL Solution for Injection
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.
If you stop receiving ZYDOL Solution for Injection
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
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.
The most common side effects during treatment with ZYDOL Solution for Injection are nausea and dizziness, which occur in more than 1 in 10 people.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
When you stop receiving ZYDOL Solution for Injection, 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 ZYDOL Solution for Injection, it could be a sign that you have become addicted.
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 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.
5. How to store ZYDOL Solution for Injection
Keep 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. The expiry date refers to the last day of that month. Do not store above 30°C.
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 ZYDOL Solution for Injection contains
The active substance is tramadol hydrochloride.
The other ingredients are: sodium acetate and water for injection
What ZYDOL Solution for Injection looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
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Product name Reference number
ZYDOL SOLUTION FOR INJECTION PL 21727/0002
This leaflet was last revised:
ZYDOL® is a registered trademark
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