Package leaflet: Information for the user
ZYDOL 50 mg Hard Capsules
1. What ZYDOL Capsules is and what it is used for
2. What you need to know before you take ZYDOL Capsules
3. How to take ZYDOL Capsules
4. Possible side effects
5. How to store ZYDOL Capsules
6. Contents of the pack and other information
1. What ZYDOL is and what it is used for
The full name of your medicine is ‘ZYDOL 50 mg Hard Capsules’ it is referred to as ‘ZYDOL’ in the rest of this leaflet.
Tramadol - the active substance in ZYDOL - 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 is used for the treatment of moderate to severe pain.
2. What you need to know before you take ZYDOL
Talk to your doctor before taking ZYDOL
Sleep-related breathing disorders
ZYDOL 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 may lead to physical and psychological addiction.
When ZYDOL 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 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 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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ZYDOL should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of ZYDOL 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, and which dose.
The risk of side effects increases,
Do not drink alcohol during treatment with ZYDOL as its effect may be intensified. Food does not influence the effect of ZYDOL.
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.
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 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.
Small amounts of tramadol are excreted into breast milk. After a single dose it is usually not necessary to interrupt breast-feeding.
Based on human experience tramadol is suggested not to influence female or male fertility.
ZYDOL 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.
ZYDOL contains sodium
This medicines contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially ‘sodium-free’.
3. How to take ZYDOL
Always take this medicine exactly as your doctor has told you. You should 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 or two capsules (equivalent to 50mg - 100mg tramadol hydrochloride).
Depending on the pain, the effect lasts for about 4 – 8 hours.
Your doctor may prescribe a different, more appropriate dosage of ZYDOL if necessary.
ZYDOL 50 mg capsules are 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. 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?
ZYDOL Capsules are for oral use.
Always swallow ZYDOL Capsules whole, not divided or chewed, with sufficient liquid preferably in the morning and evening. You may take ZYDOL on an empty stomach or with meals.
How long should you take ZYDOL?
You should not take ZYDOL 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 Capsules and at what dose.
If you have the impression that the effect of ZYDOL is too strong or too weak, talk to your doctor or pharmacist.
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 capsules 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, fall in blood pressure, fast heartbeat, collapse, unconsciousness, fits, and breathing difficulties or shallow breathing.
If you forget to take ZYDOL, pain is likely to return. Do not take a double dose to make up for forgotten individual doses, simply continue taking ZYDOL as before.
If you interrupt or finish treatment with ZYDOL Capsules 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 Capsules is stopped. However, on rare occasions, people who have been taking ZYDOL Capsules 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, 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 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
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store ZYDOL
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. Store in the original container. Do not store above 25˚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
The active substance is tramadol hydrochloride.
Each capsule contains 50 mg tramadol hydrochloride.
The other ingredients are: Microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica, magnesium stearate.
Capsule shell contains: gelatine, sodium laurilsulfate and the colours yellow iron oxide (E172) and titanium dioxide (E171)
ZYDOL 50 mg capsules are yellow/yellow, shiny, hard gelatine capsules.
ZYDOL 50 mg Capsules are packed in blisters and are supplied in boxes of 10, 20 and 100 capsules.
Not all pack sizes may be marketed.
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Product name Reference number
ZYDOL 50 mg hard Capsules PA 2242/5/1
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