• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

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

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions);
• if you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with ZYDOL SR (see "Other medicines and ZYDOL SR");
• if you are an epileptic and your fits are not adequately controlled by treatment;
• as a substitute in drug withdrawal.

Talk to your doctor before taking ZYDOL SR, if

• you suffer from consciousness disorders (if you feel that you are going to faint);
• you are in a state of shock (cold sweat may be a sign of this);
• you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
• you have difficulty in breathing;
• you have a tendency towards epilepsy or fits because the risk of a fit may increase;
• you suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see “Other medicines and ZYDOL SR”);
• you suffer from a liver or kidney disease;
  Tolerance, dependence, and addiction
  This medicine contains tramadol which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of ZYDOL SR can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.
  Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.
  The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to ZYDOL SR if:
• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.
  If you notice any of the following signs whilst taking ZYDOL SR, it could be a sign that you have become dependent or addicted:
• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)
  If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop 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.

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).

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.

Talk to your doctor if you experience any of the following symptoms while taking ZYDOL SR:

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.

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

• carbamazepine (for epileptic fits);
• ondansetron (prevents nausea).

Your doctor will tell you whether you should take ZYDOL SR, and which dose.

The risk of side effects increases, if you are taking

• other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking ZYDOL SR. You may feel drowsier or feel that you might faint. If this happens tell your doctor.
  Concomitant use of ZYDOL SR and tranquillizers or sleeping pills (e.g. benzodiazepines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes ZYDOL SR together with sedating medicines the dose and the duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedating medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
• medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take ZYDOL SR at the same time. Your doctor will tell you whether ZYDOL SR is suitable for you.
• certain antidepressants, ZYDOL SR may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• coumarin anticoagulants (medicines for blood thinning), e.g. warfarin, together with ZYDOL SR. The effect of these medicines on blood clotting may be affected and bleeding may occur.
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Do not drink alcohol during treatment with ZYDOL SR as its effect may be intensified. Food does not influence the effect of ZYDOL SR.

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 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 SR more than once during breast-feeding, or alternatively, if you take Zydol SR more than once, you should stop breast-feeding. Based on human experience tramadol is suggested not to influence female or male fertility.

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.

This medicine can affect your ability to drive.

Do not drive whilst taking this medicine until you know how this medicine affects you.

It may be an offence to drive if your ability to drive safely is affected.

There is further information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law.

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.

If you have taken an additional dose by mistake, this will generally have no negative effects. You should take your next dose as prescribed.

After taking very high doses, pin-point pupils, vomiting, fall in blood pressure, fast heart beat, collapse, disturbed consciousness up to coma (deep unconsciousness), epileptic fits, and difficulty in breathing up to cessation of breathing may occur. In such cases a doctor should be called immediately!

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 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 prolonged-release 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 noise 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 stop taking ZYDOL SR, please consult your doctor.

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:

Ireland

UK

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.

The active substance is tramadol hydrochloride.

ZYDOL SR 50 mg, prolonged-release tablets:

Each tablet contains 50 mg tramadol hydrochloride.

The other ingredients are:

Tablet core: microcrystalline cellulose, hypromellose 100 000 mPa·s, magnesium stearate, colloidal anhydrous silica.

Film coating: hypromellose 6 mPa·s, lactose monohydrate (see section 2 “ZYDOL SR contains lactose”), macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).

ZYDOL SR 50 mg prolonged-release tablets are round, biconvex pale yellow coloured film-coated tablets marked with the manufacturer’s logo Ω on one side, marked T0 on the other side.

ZYDOL SR 50 mg prolonged-release tablets are packed in blister strips and are supplied in boxes of 10, 20, 30, 50, 60, 100 and 150 (10x15) tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer: