Zydol 50mg caps

Package leaflet: Information for the user

ZYDOL 50 mg Hard Capsules

Tramadol hydrochloride

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).

In this leaflet:

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

Do not take ZYDOL

-       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 (see "Other medicines and ZYDOL")

-       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, 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”)

-       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 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 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, 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).

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.

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 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.

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

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.

Other medicines and ZYDOL

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

-           carbamazepine (for epileptic fits);

-           ondansetron (prevents nausea).

Your doctor will tell you whether you should take ZYDOL, 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. You may feel drowsier or feel that you might faint. If this happens tell your doctor.

-       Concomitant use of ZYDOL 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 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 at the same time. Your doctor will tell you whether ZYDOL is suitable for you.

-       certain antidepressants ZYDOL 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. 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).

ZYDOL with food and alcohol

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.

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 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 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.

Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using ZYDOL, 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).

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.

Children

ZYDOL 50 mg capsules are 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. 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. 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 take more ZYDOL 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 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

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 stop taking ZYDOL Capsules

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

·      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 Capsules. 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 (slowing down but sometimes an increase in activity) and decreased cognitive and sensory perception (being less aware and less able to make decisions, which may lead to errors in judgement).

·      Drug dependence may occur. When treatment is stopped abruptly, signs of withdrawal may appear (see “If you stop taking ZYDOL”).

·      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

·      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 ZYDOL”).

Reporting of side effects

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 HPRA Pharmacovigilance, Website: www.hpra.ie.

By reporting side effects you can help provide more information on the safety of this medicine.

5.      How to store ZYDOL

Keep this medicine out of the sight and reach of children.

Store this medicine in 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 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^oC.

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 ZYDOL contains

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).

What ZYDOL looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grünenthal Pharma Ltd.

4045 Kingswood Road

Citywest Business Park

Citywest, Co. Dublin

Ireland

Manufacturer:

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Other formats:

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0044 173 3375 370

Please be ready to give the following information:

Product name

Reference number

ZYDOL 50 mg hard Capsules

PA 2242/5/1

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This leaflet was last revised in:

May 2024