- 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 21727/0004, PL 21727/0003, 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
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.
Tramadol - the active substance in ZYDOL SR - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain.
ZYDOL SR is used for the treatment of moderate to severe pain.
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
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).
Please note that ZYDOL SR may lead to physical and psychological addiction. When ZYDOL SR is taken for a long time, its effect may decrease, so that higher doses have to be taken (tolerance development). In patients with a tendency to abuse medicines or who are dependent on medicines, treatment with ZYDOL SR should only be carried out for short periods and under strict medical supervision.
Please also inform your doctor if one of these problems occurs during ZYDOL SR treatment or if they applied to you in the past.
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
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.
There is very little information regarding the safety of tramadol in human pregnancy. Therefore you should not use ZYDOL SR if you are pregnant.
Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Tramadol is excreted into breast milk. For this reason, you should not take Zydol more than once during breast-feeding, or alternatively, if you take Zydol more than once, you should stop breast-feeding. 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?
You should not take ZYDOL SR 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 ZYDOL SR tablets and at what dose.
If you have the impression that the effect of ZYDOL SR is too strong or too weak, talk to your doctor or pharmacist.
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
If you interrupt or finish treatment with ZYDOL SR too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please tell your doctor.
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, discuss this with your doctor first, particularly if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may be by lowering the dose gradually to reduce the chance of developing unnecessary side effects (withdrawal symptoms).
Generally there will be no after-effects when treatment with ZYDOL SR is stopped. However, on rare occasions, people who have been taking ZYDOL SR tablets for some time may feel unwell if they abruptly stop taking them. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and have stomach or bowel disorders. Very few people may get panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and “ringing” in the ears (tinnitus). Further unusual CNS symptoms, i.e. confusion, delusions, change of perception of the own personality (depersonalisation), and change in perception of reality (derealisation) and delusion of persecution (paranoia) have been seen very rarely. If you experience any of these complaints after stopping ZYDOL SR, please consult your doctor.
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 treatment is stopped abruptly, signs of withdrawal may appear (see “If you stop taking ZYDOL SR”).
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