Zeridame SR 100mg, 150mg, 200mg Prolonged Release tablets – patient leaflet, side effects, dosage

1. What Zeridame SR is and what is it used for

This medicine has been prescribed for you for the treatment of moderate to severe pain. It contains tramadol hydrochloride which 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 doctor should have explained how long you will be taking it for, when it is appropriate to stop and how to do this safely.

Zeridame SR is a pain killer. Zeridame SR eases the pain by inhibition of certain chemicals of the central nervous system (in the brain and the spinal cord).

Zeridame SR can be used in adults and adolescents over 12 years of age. .

Zeridame SR is not suitable for children under the age of 12 years.

2. What you need to know before you take Zeridame SR Talk to your doctor before taking this medicine 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 Zeridame 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 doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be taking it for, when it is appropriate to stop and 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 doctor 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 doctor 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.

DO NOT take Zeridame SR:

• If you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have recently drunk too much alcohol or taken too many sleeping tablets, pain killers, opiates or any medicines that work via the brain (psychotropic medicines).
• When using certain medicines against depression (so-called MAO-inhibitors) or when these have been used the last 14 days.
• If you suffer from epilepsy that is not controlled by medication.
• For the treatment of withdrawal symptoms in drug addicts.
• If you have pain which lasts only for a short period or pain after having an operation because of the increased risk of dependence and developing serious breathing problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zeridame SR:

• If you have recently had any head injuries, or an increased pressure in the head (e.g. after an accident)
• If you suffer from disorders of the kidneys or liver (see section 3: how to take Zeridame SR)
• If you suffer from difficulty to breathe
• If you have a tendency towards epilepsy or fits because the risk of a fit may increase. Seizures 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).
• If you suffer from shock (cold sweat may be a sign of this)
• If you use other medicines or substances that work via the brain, including alcohol.
• If you suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Zeridame SR’).

If you are going to have an operation, or have just had an operation, please tell the doctor at the hospital if you are currently treated with Zeridame SR to discuss your pain management.

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 Zeridame 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 Zeridame 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 Zeridame 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 Zeridame SR).

After long term treatment (> 3 months) headache may develop or aggravate. When tramadol has been used to treat tension or cluster headache or migraine (which is not a registered use for tramadol) cases have been reported of medication overuse headache (MOH).

Please note that Zeridame SR may lead to physical and psychological addiction. When Zeridame 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 Zeridame SR should only be carried out for short periods and under strict medical supervision.

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.

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’).

Sleep-related breathing disorders

Zeridame SR can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Zeridame 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.

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.

Other medicines and Zeridame SR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Zeridame SR at the same time, or within 14 days of taking medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson’s disease).

Concomitant use of Zeridame SR and sedative medicines such as benzodiazepines or related drugs 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 does prescribe Zeridame SR together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, such as tranquillizers, sleeping pills, antidepressants and other pain relievers (morphine, codeine), 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.

The pain relieving effect of Zeridame SR may be weakened and / or shortened if you also take medicines containing:

• Carbamazepine (used to treat epilepsy)
• Buprenorphine, nalbuphine, or pentazocine (pain killers)
• Ondansetron (used to stop you feeling sick)

The risk of side effects increases if you are taking:

• 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 Zeridame SR at the same time. Your doctor will tell you whether Zeridame SR is suitable for you.
• if you are taking certain antidepressants. Zeridame SR may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).
• if you take Zeridame SR at the same time as sedative medicines such as tranquillisers, sleeping pills, antidepressants and strong pain relievers (morphine, codeine, pethidine). You may feel excessively drowsy or feel that you might faint.
• if you take Zeridame SR at the same time as blood thinning medicines, such as warfarin. The dose of these medicines may need reducing, otherwise there could be an increased risk of serious bleeding.
• anticonvulsant drugs taken with tramadol can lower the seizure threshold and the risk of convulsions may increase in these patients.
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)

Zeridame SR with alcohol:

Zeridame SR should not be used in combination with alcohol.

Pregnancy and breast-feeding:

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.

Pregnancy

Do not take Zeridame SR if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use Zeridame SR during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breast-feeding:

Do not take Zeridame SR while you are breastfeeding as tramadol hydrochloride passes into breast milk and will affect your baby. For this reason, you should not take Zeridame SR more than once during breast-feeding, or alternatively, if you take Zeridame SR more than once, you should stop breast-feeding.

Driving and using machines:

Zeridame SR can cause drowsiness and dizziness, and blurred vision. Because of this Zeridame SR can affect your ability to drive and operate machinery. This can be intensified by alcohol or by medicine that acts or works via the brain.

Do not drive a car or do other activities that need you to be alert, until you know how tramadol affects you. Please see 4. Possible Side Effects for a full list of possible effects that may impair alertness and coordination.

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.

3. How to take Zeridame SR

Your doctor 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Zeridame SR, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also section 2).

Dose

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. The usual dosage is:

Adults and adolescents over 12 years of age:

The starting dose is:

Zeridame SR 100mg: one tablet (100mg tramadol hydrochloride) twice a day

If this is not sufficient to kill the pain the dose can be increased to:

Zeridame SR 150mg: one tablet (150mg tramadol hydrochloride) twice a day or Zeridame SR 200mg: one tablet (200mg tramadol hydrochloride) twice a day.

If the dose you are prescribed cannot be achieved with this strength tablet, other strengths of this medicinal product are available to achieve the dose.

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 Zeridame SR. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Method of administration

Zeridame SR is a tablet with a special core to let out the active ingredient slowly and long-lasting in the body. Because of this it can take a bit longer before you notice the effect.

Swallow the tablet whole (without chewing or breaking), with a glass of water.

Preferably administer in the morning and evening. The tablets may be taken on an empty stomach or during the meal.

Duration of the treatment with Zeridame SR

Your doctor will tell you how long you should use Zeridame SR. This depends on the cause of the pain. Do not use Zeridame SR any longer than necessary.

If you notice that Zeridame SR is too strong or is not strong enough, talk to your doctor or pharmacist.

If you take more Zeridame SR than you should:

If you have taken too many Zeridame SR you should immediately contact your doctor, nearest hospital or clinic. The possible symptoms that may occur are: pin-point pupils, vomiting, a fall in blood pressure, a fast heartbeat, collapse, disturbed consciousness including coma (deep unconsciousness), epileptic fits and difficulties in breathing.

If you forget to take Zeridame SR:

If you forgot 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 tablets as before.

If you stop taking Zeridame SR:

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your doctor 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.

Generally there will be no after effects when treatment with Zeridame SR is stopped. However, on rare occasions, people who have been taking Zeridame 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 noise in the ears (tinnitus). If you experience any of these complaints after stopping Zeridame 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, Zeridame SR tablets can cause side effects, although not everybody gets them. The following side effects can occur:

Very common (may affect more than 1 in 10 people): nausea and dizziness.

Common (may affect up to 1 in 10 people): headache, vomiting, constipation, dry mouth, sweating, drowsiness, fatigue.

Uncommon (may affect up to 1 in 100 people): heart palpitations, irregular heart beat, low blood pressure - especially when standing up, heart failure (cardiovascular collapse), uneasiness (qualm), pressure on the stomach, feeling of fullness, itch, rash and rash with severe itch and forming of lumps (hives or urticaria), diarrhoea.

Rare (may affect up to 1 in 1,000 people): blurred vision, slower heartbeat than normal, increase in blood pressure, changes in appetite, itch or tingling without cause, shaking, breathing slower than normal, convulsions, hallucinations, confusion, sleep disturbances and nightmares, allergic reactions (e.g. shortness of breath), tightness of the chest by cramp of the muscles of the airways (bronchospasm), gasping, sudden fluid accumulation in the skin and mucosa (e.g. throat or tongue), breathing problems (respiration difficulties) and / or itch and hypersensitiveness. Also reported: mood changes, changes in activity, changes in the observation or the ability to make decisions, muscle weakness, difficulties passing water, involuntary muscle contractions, abnormal coordination, and fainting (syncope).

Not known (frequency cannot be estimated from the available data): dependence and addiction (see section ‘How do I know if I am addicted?’), enlarged pupils. Decrease in blood sugar level, hiccups. 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 Zeridame SR’).

Drug Withdrawal

When you stop taking Zeridame 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 Zeridame SR, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your doctor
• 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 doctor.

Allergic reaction (e.g difficulty in breathing, wheezing, swelling of skin), shock (sudden circulation failure) and increase in liver enzyme values have occurred in very rare cases (affects less than 1 user in 10,000). You should see a doctor immediately if you experience symptoms such as swollen face, tongue and / or throat and / or difficulty to swallow or hives together with difficulties in breathing.

Reporting of side effects

If you get any side effects, talk to your doctor, or pharmacist or nurse. 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 Zeridame SR

• Keep this medicine out of the sight and reach of children. Store this medicine a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.

Do not use this medicine after the expiry date which is stated on the blister and / or bottle and the carton after “exp”. The expiry date refers to the last day of that month.

• Store in the original package in order to protect from moisture.

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

What Zeridame SR contains:

The active substance is: tramadol hydrochloride

• 1 tablet of Zeridame SR 100mg, contains 100mg tramadol hydrochloride.
• 1 tablet of Zeridame SR 150mg, contains 150mg tramadol hydrochloride.
• 1 tablet of Zeridame SR 200mg, contains 200mg tramadol hydrochloride.

The other ingredients are: calcium hydrogen phosphate (E341), hydroxypropyl cellulose (E463), colloidal anhydrous silica (E551), and magnesium stearate (E470b).

What Zeridame SR looks like and contents of the pack:

Zeridame SR 100mg Prolonged Release Tablets are off white, round biconvex tablets. Zeridame SR 150mg Prolonged Release Tablets are off white, capsule shaped tablets. Zeridame SR 200mg Prolonged Release Tablets are off white, capsule shaped tablets.

Zeridame SR 100mg; 150mg; 200mg: packs of -10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 white tablets in blisters or in plastic tablet containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Accord Healthcare Limited

Sage House

319 Pinner Road

North Harrow

Middlesex

HA1 4HF

United Kingdom

Manufacturer:

Medochemie Ltd

Facility A – Z, Mich. Erakleous, Ayios Athanassios Industrial Area, Limassol, Cyprus.

Revision date of leaflet: May 2025.