Grunenthal Pharma Ltd.

Zydol SR 150mg

Package leaflet: Information for the user

ZYDOL SR 100 mg, 150 mg, and 200 mg, prolonged-release tablets

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 symptoms 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:

What ZYDOL SR is and what it is used for
What you need to know before you take ZYDOL SR
How to take ZYDOL SR
Possible side effects
How to store ZYDOL SR
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 SR 100 mg, 150 mg or 200mg prolonged-release tablets’. It is referred to as ‘ZYDOL SR’ in the rest of this leaflet.

Tramadol - the active substance in ZYDOL SR - 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 SR is used for the treatment of moderate to severe pain

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 think that you are addicted to other pain relievers (opioids);
if you suffer from consciousness disorders (if you feel that you are going to faint);
if you are in a state of shock (cold sweat may be a sign of this);
if you suffer from increased pressure in the brain (possibly after a head injury or brain disease);
if you have difficulty in breathing;
if you have a tendency towards epilepsy or fits because the risk of a fit may increase;
if you 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.

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.

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 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 symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C.
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, 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 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 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 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.

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. You should check with your doctor or pharmacist if you are not sure.

The dosage should be adjusted according 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 ZYDOL SR 100 mg tablet twice daily (equivalent to 200 mg tramadol hydrochloride per day) preferably in the morning and evening or,
One ZYDOL SR 150 mg tablet twice daily (equivalent to 300 mg tramadol hydrochloride per day) preferably in the morning and evening or,
One ZYDOL SR 200 mg tablet twice daily (equivalent to 400 mg 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 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg 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 prolonged-release tablets are for oral use.

Always swallow ZYDOL SR prolonged-release 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?

You should not take ZYDOL SR 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 SR and at what dose.

If you have the impression that the effect of ZYDOL SR is too strong or too weak, talk to your doctor or pharmacist.

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, fall in blood pressure, fast heartbeat, collapse, unconsciousness, fits, and breathing difficulties 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

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 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 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, 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 (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 pupil (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 enzymes increased
Not known: frequency cannot be estimated from the available data
decrease in blood sugar level
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

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

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 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 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ZYDOL SR contains

The active substance is tramadol hydrochloride.

ZYDOL SR 100 mg tablets:

Each tablet contains 100 mg tramadol hydrochloride.

The other ingredients are:

microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171).

ZYDOL SR 150 mg tablets:

Each tablet contains 150 mg tramadol hydrochloride.

The other ingredients are:

microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171) quinoline yellow lake (E 104), red iron oxide (E 172).

ZYDOL SR 200 mg tablets:

Each tablet contains 200 mg tramadol hydrochloride.

The other ingredients are: microcrystalline cellulose, hypromellose, magnesium stearate, colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171) quinoline yellow lake (E 104), red and brown iron oxides (E 172).

What ZYDOL SR looks like and contents of the pack

ZYDOL SR 100 mg tablets are white, round film-coated tablets, marked with the manufacturer’s logo on one side and marked “T1” on the other side.

ZYDOL SR 150 mg tablets are pale orange, round film-coated tablets, marked with the manufacturer’s logo on one side and marked “T2” on the other side.

ZYDOL SR 200 mg tablets are slightly brownish orange, round film-coated tablets, marked with the manufacturer’s logo on one side and marked “T3” on the other side.

ZYDOL SR are packed in blisters strips and are supplied in boxes of 2, 4 or 10 (sample/starter packs), 30 or 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketinig Authorisation Holder:

Grünenthal Pharma Ltd.

4045 Kingswood Road

Citywest Business Park

Citywest

Co Dublin

Ireland

Manufacturer:

Grünenthal GmbH

Zweifaller Strasse 112

52224 Stolberg

Germany

Other formats:

To request a copy of this leaflet in Braille, large print or audio please call:

0044 173 3375 370

Please be ready to give the following information:

Product name Reference number

ZYDOL SR 100 mg prolonged-release tablets PA 2242/5/3

ZYDOL SR 150 mg prolonged-release tablets PA 2242/5/4

ZYDOL SR 200 mg prolonged-release tablets PA 2242/5/5

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