- tramadol hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
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 21727/0003, PL 21727/0004, PL 21727/0005.
Zydol SR Tabs 100 150 200 mg
Package leaflet: Information for the user
ZYDOL® SR 100 mg, 150 mg and 200 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.
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 SR is and what it is used for
2. What you need to know before you take ZYDOL SR
3. How to take ZYDOL SR
4. Possible side effects
5. How to store ZYDOL SR
6. Contents of the pack and other information
1. What ZYDOL SR is and what it is used for
The full name of your medicine is ‘ZYDOL SR 100 mg, 150 mg or 200mg prolonged-release tablets’. It is referred to as ‘ZYDOL SR’ in the rest of this leaflet.This medicine has been prescribed for you for the treatment of moderate to severe pain.
Tramadol - the active substance in ZYDOL SR belongs to a class of medicines called opioids, which are ‘pain relievers’.
This medicine has been prescribed 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 take ZYDOL SR
Do not take ZYDOL SR,
Warnings and precautions
Talk to your doctor before taking ZYDOL SR if you:
Sleep-related breathing disorders
ZYDOL SR 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.
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.
Other medicines and ZYDOL SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ZYDOL SR should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of ZYDOL SR 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 SR, and which dose.
The risk of side effects increases,
ZYDOL SR with food and alcohol
Do not drink alcohol during treatment with ZYDOL SR as its effect may be intensified. Food does not influence the effect of ZYDOL SR.
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 SR 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 SR during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take ZYDOL SR 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 SR 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.
ZYDOL SR contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This is because the tablets contain lactose
3. How to take Zydol SR
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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. Do not take more than 400 mg tramadol hydrochloride daily, except if your doctor has instructed you to do so.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years
One ZYDOL SR 100 mg prolonged-release tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day), preferably in the morning and evening.
One ZYDOL SR 150 mg prolonged-release tablet twice daily (equivalent to 300 mg tramadol hydrochloride per day), preferably in the morning and evening.
One ZYDOL SR 200 mg prolonged-release tablet twice daily (equivalent to 400 mg tramadol hydrochloride per day), preferably in the morning and evening.
Your doctor may prescribe a different, more appropriate dosage strength of ZYDOL SR if necessary.
If necessary, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg tramadol hydrochloride per day).
ZYDOL SR 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 recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency should not take ZYDOL SR. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
How and when should you take ZYDOL SR?
ZYDOL SR tablets are for oral use.
Always swallow ZYDOL SR tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You may take the tablets on an empty stomach or with meals.
How long should you take ZYDOL SR?
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.
If you take more ZYDOL SR 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.
If you (or someone else) swallow a lot of ZYDOL SR tablets at the same time you should go to hospital or call a doctor straight away. Signs of an overdose include very small pupils, being sick, a fall in blood pressure, a fast heartbeat, collapse, unconsciousness, fits and breathing difficulty or shallow breathing.
If you forget to take ZYDOL SR
If you forget to take the tablets, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking the tablets as before.
If you stop taking ZYDOL SR
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 SR 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 taking ZYDOL SR, 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 SR, 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 SR
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 blister. 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 any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What ZYDOL SR contains
The active substance is tramadol hydrochloride.
Each tablet contains 100 mg tramadol hydrochloride.
The other ingredients are: microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene glycol, talc and titanium dioxide (E171).
Each tablet contains 150 mg tramadol hydrochloride.
The other ingredients are: microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E171), quinoline yellow lake (E104) and red iron oxide (E172).
Each tablet contains 200 mg tramadol hydrochloride.
The other ingredients are: microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E171), quinoline yellow lake (E104), red iron oxide (E172) and brown iron oxide (E172).
What ZYDOL SR looks like and contents of the pack
ZYDOL SR 100 mg tablets are white and round and have “T1” and ♎︎ marked on them.
ZYDOL SR 150 mg tablets are pale orange and round and have marked “T2” and ♎︎ marked on them.
ZYDOL SR 200 mg tablets are slightly brownish orange and round and have marked “T3” and ♎︎ marked on them.
ZYDOL SR 100 mg, 150mg and 200mg prolonged-released tablets are packed in blisters and are supplied in boxes of 2, 4, 10, 30 and 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name Reference number
ZYDOL SR 100 mg prolonged-release tablets PL 21727/003
ZYDOL SR 150 mg prolonged-release tablets PL 21727/004
ZYDOL SR 200 mg prolonged-release tablets PL 21727/005
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This leaflet was last revised:
ZYDOL® is a registered trademark