ZYDOL SR 200 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Zydol® SR 200mg Prolonged-release Tablets (tramadol hydrochloride)

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 because it contains important information for you.

• 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 (section 4).
• The name of this medicine is Zydol SR 200mg Prolonged-release Tablets but will be referred to as Zydol SR throughout the remainder of this leaflet.
• Zydol SR Prolonged-release Tablets are also available in other strengths.

• 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

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,

• – 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.

Warnings and precautions

Talk to your doctor before taking Zydol SR if you:

– are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs;

• – have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating when you have stopped taking alcohol or drugs;

• – feel you need to take more of Zydol SR to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;

• – suffer from consciousness disorders (if you feel that you are going to faint);

• – are in a state of shock (cold sweat may be a sign of this);

• – suffer from increased pressure in the brain (possibly after a head injury or brain disease);

• – have difficulty in breathing;

• – have a tendency towards epilepsy or fits because the risk of a fit may increase;

• – suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Zydol SR‘);

• – suffer from a liver or kidney disease.

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 (400mg).

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

• – 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.

• – if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of 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.

• – if you are taking certain antidepressants Zydol SR may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).

• – if you are taking 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.

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, breastfeeding 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.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely

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 400mg 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 100mg Prolonged-release Tablet twice daily (equivalent to 200mg tramadol hydrochloride per day), preferably in the morning and evening.

One Zydol SR 150mg Prolonged-release Tablet twice daily (equivalent to 300mg tramadol hydrochloride per day), preferably in the morning and evening.

One Zydol SR 200mg Prolonged-release Tablet twice daily (equivalent to 400mg 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 150mg or 200mg twice daily (equivalent to 300mg – 400mg tramadol hydrochloride per day).

Children

Zydol SR is not suitable for children below the age of 12 years.

Elderly patients

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

• dizziness
• feeling sick (nausea)

Common: may affect up to 1 in 10 people

• headaches, drowsiness
• fatigue
• constipation, dry mouth, being sick (vomiting)
• sweating (hyperhidrosis)

Uncommon: may affect up to 1 in 100 people

• effects on the heart and blood circulation (pounding of the heart, fast heartbeat, feeling faint or collapse). These adverse effects may particularly occur in patients in an upright position or under physical strain.
• urge to be sick (retching), stomach trouble (e.g. feeling of pressure in the stomach, bloating), diarrhoea
• skin reactions (e.g. itching, rash)

Rare: may affect up to 1 in 1,000 people

• allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin) and shock (sudden circulation failure) have occurred in very rare cases
• slow heartbeat
• increase in blood pressure
• abnormal sensations (e.g. itching, tingling, numbness), trembling, epileptic fits, muscle twitches, uncoordinated movement, transient loss of consciousness (syncope), speech disorders
• epileptic fits have occurred mainly at high doses of tramadol or when tramadol was taken at the same time as other medicines which may induce fits
• changes in appetite
• hallucination, confusional state, sleep disorders, delirium, anxiety and nightmares
• psychological complaints may appear after treatment with Zydol SR. Their intensity and nature may vary (according to the patient’s per­sonality and length of therapy). These may appear as a change in mood (mostly high spirits, occasionally irritated mood), changes in activity (usually suppression, occasionally increase) and decreased cognitive and sensory perception (being less aware and less able to make decisions, which may lead to errors in judgment).
• blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• slow breathing, shortness of breath (dyspnoea)
• worsening of asthma has been reported, however it has not been established whether it was caused by tramadol. If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.
• weak muscles
• passing urine with difficulty or pain, passing less urine than normal (dysuria)

Very rare: may affect up to 1 in 10,000 people

• hepatic enzyme increased

Not known: frequency cannot be estimated from the available data

• decrease in blood sugar level
• serotonin syndrome, that can manifest as mental status changes (e.g. agitation, hallucinations, coma), and other effects, such as fever, increase in heart rate, unstable blood pressure, involuntary twitching, muscular rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 ‘What you need to know before you take Zydol SR’)
• dependence and addiction (see section ‘How do I know if I am addicted’)

Drug Withdrawal

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.

• – You need to take the medicine for longer than advised by your prescriber

• – You feel you need to use more than the recommended dose

• – You are using the medicine for reasons other than prescribed

• – When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

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:

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 Zydol SR 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 30oC.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6) contents of the pack and other information

What Zydol SR contains

Each prolonged-release tablet contains 200mg of tramadol hydrochloride.

Also contains lactose monohydrate.

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 200mg Prolonged-release Tablets are round, biconvex, peach coloured film-coated tablets, marked with the manufacturer’s logo on one side and marked ‘T3’ on the other side.

Zydol SR Prolonged-release Tablets are available in packs of 10, 30, 50, 60 tablets.

Manufactured by

Grunenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany

STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel, Germany

Procured from within the EU by the Product Licence Holder: MPT Pharma Ltd., Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall, WS9 8ER.

Repackaged by MPT Pharma Ltd.

PL: 33532/0221

Leaflet dated 21st December 2021

Leaflet coded xxxxxxxxx

Zydol® is a registered trademark of Grunenthal GmbH

To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.