The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 16950/0091, PL 16950/0090, PL 16950/0089, PL 16950/0092.
Zydol XL Tabs
Zydol® XL 150 mg, 200 mg, 300 mg and 400 mg prolonged-release tablets
This medicine contains tramadol which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
1. What Zydol XL tablets are and what they are used for
2. What you need to know before you take Zydol XL tablets
3. How to take Zydol XL tablets
4. Possible side effects
5. How to store Zydol XL tablets
6. Contents of the pack and other information
These tablets have been prescribed for you to relieve moderate to severe pain over a period of 24 hours. They contain the active ingredient tramadol which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for you and should not be given to anyone else.
Opioids can cause addiction and you may get withdrawal symptoms if you stop taking Zydol XL tablets suddenly. Your prescriber should have explained how long you will be taking them for and when it is appropriate to stop, how to do this safely.
These tablets are only for use in adults and adolescents over 12 years of age.
Talk to your prescriber before taking these tablets if you:
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.
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’).
Sleep-related breathing disorders
Zydol XL tablets 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.
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, pharmacist or nurse if you experience any of the following symptoms while taking Zydol XL tablets: 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.
Children and adolescents
Use in children after an operation
If your child is given these tablets after an operation they will be monitored closely to ensure that they are not breathing more slowly or weakly than usual (respiratory depression). If you notice that your child is breathing slowly or weakly after an operation, tell their doctor or nurse immediately.
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, since any side effects of tramadol may be worse in these children.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Using Zydol XL tablets at the same time as other medicines that slow down the central nervous system can cause slow or difficulty breathing (respiratory depression), severe sleepiness, loss of consciousness and death. These medicines include:
Because of this, your doctor will only prescribe Zydol XL tablets where there are no other treatment options, and only in small doses for short periods of time. If you or your friends, family or caregivers notice that you are having difficulty breathing or that you have become very sleepy or lost consciousness you (or they) should inform your doctor immediately.
If you are taking any of the following, your risk of experiencing seizures, fits or convulsions may be increased whilst you are taking Zydol XL tablets:
The risk of side effects increases if you are taking certain antidepressants. Zydol XL tablets may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
Tell your doctor or pharmacist if you are taking:
Drinking alcohol whilst taking Zydol XL tablets may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended that you do not drink alcohol while you are taking Zydol XL tablets.
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 these tablets.
Do not take these tablets 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. Depending on the dose and duration of treatment with tramadol, slow and shallow breathing (respiratory depression) may occur in the newborn infant.
If you use these tablets during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Withdrawal symptoms may include high-pitched crying, irritability and restlessness, shaking (tremor), feeding difficulties and sweating.
Do not take these tablets while you are breast-feeding as tramadol passes into breast milk and will affect your baby.
These tablets may cause a number of side effects such as drowsiness, blurred vision and dizziness which could affect your ability to drive or use machinery (see section 4 ‘Possible side effects’ for a full list of side effects). These are usually most noticeable when you first start taking the tablets, or when changing to a higher dose.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
Always take these tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The label on your medicine will tell you how many tablets to take and how often. 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.
Your prescriber should have discussed with you how long the course of tablets 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 usual starting dose is one 150 mg tablet once a day. However, your doctor will prescribe the dose required to treat your pain. Do not exceed the dose recommended by your doctor. If you find that you are still in pain whilst taking these tablets discuss this with your doctor.
Swallow your tablets whole with water. Do not crush, dissolve or chew them.
Zydol XL tablets are designed to work properly over 24 hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 24‑hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
You should take your tablets at the same time every day. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock the next morning.
In elderly patients (above 75 years) it may take longer for tramadol to leave the body. If this applies to you, your doctor may recommend prolonging the interval between doses.
Severe liver or kidney disease (insufficiency)/ dialysis patients
In patients with severe liver and/or kidney insufficiency it may take longer for tramadol to leave the body. If this applies to you, your doctor may recommend prolonging the interval between doses.
Children under 12 years of age should not take the tablets.
Call your doctor or local hospital immediately. People who have taken an overdose may feel very sleepy, sick or dizzy. They may have seizures, fits or convulsions. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you.
If you remember within 10 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 10 hours late, please call your doctor for advice. Do not take a double dose to make up for a forgotten tablet.
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 these tablets, ask your doctor or pharmacist.
Like all medicines, these tablets can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. These may be signs of a serious allergic reaction.
The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect may affect up to 1 in 1,000 people and is more likely to occur when taking certain other medicines (see section 2 ‘Other medicines and Zydol XL tablets’). Tell your doctor immediately if this happens to you. You may wish to ask your friends, family or caregivers to monitor you for these signs and symptoms.
In patients treated with Zydol XL tablets the following other side effects have been reported:
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)
Long term use of Zydol XL tablets during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight.
You may see the remains of the tablets in your faeces. This should not affect how the tablets work.
When you stop taking Zydol XL tablets 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 Zydol XL, 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.
If you get any side effects talk to your doctor or pharmacist. This includes any 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.
Keep these tablets out of the sight and reach of children.
Do not take these tablets after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Do not store your tablets 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.
The active ingredient is tramadol hydrochloride. Each tablet contains 150 mg, 200 mg, 300 mg or 400 mg of tramadol hydrochloride.
The other ingredients are hydrogenated vegetable oil, talc, magnesium stearate, lactose monohydrate, macrogol, hypromellose (E464), titanium dioxide (E171).
They are white, film-coated, oval shaped tablets marked T followed by the strength (e.g. 150, 200, 300 or 400). The 150 mg strength tablets are approximately 13 mm in length, the 200 mg strength tablets are approximately 15 mm in length, the 300 mg strength tablets are approximately 17 mm in length and the 400 mg strength tablets are approximately 19 mm in length.
In each box there are 30 tablets.
The tablets are made by
for the marketing authorisation holder
Zydol XL 150 mg, 200 mg, 300 mg and 400 mg tablets are supplied by
This leaflet is also available in large print, Braille or as an audio CD.
To request a copy, please call the RNIB Medicine Information line (free of charge) on: 0800 198 5000
You will need to give details of the product name and reference number. These are as follows:
Product name: Zydol XL prolonged release tablets
Reference number: 16950/0089
This leaflet was last revised in July 2021
Zydol® XL 150 mg, 200 mg, 300 mg, and 400 mg tablets are protected by European Patent (UK) No. 0699436 and 0654263.
® ZYDOL is a registered trademark of Grünenthal GmbH.
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