Package leaflet: Information for the user

Zydol® 50 mg/ml Solution for Injection

Tramadol hydrochloride

Read all of this leaflet carefully before you start taking this medicine beacause 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® Solution for Injection is and what it is used for

2.    What you need to know before you take ZYDOL® Solution for Injection

3.    How to take ZYDOL® Solution for Injection

4.    Possible side effects

5.    How to store ZYDOL® Solution for Injection

6.    Contents of the pack and other information

1.    What ZYDOL Solution for Injection is and what it is used for

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

2.    What you need to know before you take ZYDOL Solution for Injection

Do not take ZYDOL Solution for Injection

-    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 Solution for Injection (see “Other medicines and ZYDOL Solution for Injection”);

-    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 Solution for Injection

-    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;

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 Solution for Injection may lead to physical and psychological addiction. When ZYDOL Solution for Injection 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 Solution for Injection 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 Solution for Injection treatment or if they applied to you in the past.

Other medicines and ZYDOL Solution for Injection

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

ZYDOL Solution for Injection should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).

The pain-relieving effect of ZYDOL Solution for Injection 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 Solution for Injection, and what dose.

The risk of side effects increases,

-    if you are taking tranquillizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while you are taking ZYDOL Solution for Injection. You may feel drowsier or feel that you might faint. If this happens tell your doctor.

-    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 Solution for Injection at the same time. Your doctor will tell you whether ZYDOL Solution for Injection is suitable for you.

-    i f you are taking certain antidepressants ZYDOL Solution for Injection 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 Solution for Injection. The effect of these medicines on blood clotting may be affected and bleeding may occur.

Taking ZYDOL Solution for Injection with food and alcohol

Do not drink alcohol during treatment with ZYDOL Solution for Injection as its effects may be intensified.

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 Solution for Injection if you are pregnant. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.

Generally, the use of tramadol is not recommended during breastfeeding. Small amounts of of tramadol are excreted into breast milk. After a single dose it is usually not necessary to interupt breast-feeding.

Based on human experience tramadol is suggested not to influence female or male fertility Driving and using machines

ZYDOL Solution for Injection 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 contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodium-free’.

3. How to use ZYDOL Solution for Injection

This medicine should always be used exactly as prescribed by your doctor. 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 received. Normally, daily doses up to 8 ml of ZYDOL solution for injection (equivalent to 400 mg tramadol hydrochloride) will be sufficient. Exceptionally, if clinically required, your doctor may direct to use a higher daily dose.

Unless otherwise prescribed by your doctor, the usual dose is: Adults and adolescents from the age of 12 years:

Depending on your pain you will receive 1-2 ml of ZYDOL Solution for Injection (equivalent to 50 - 100 mg tramadol hydrochloride). Depending on your pain the effect lasts for about 4-8 hours.

Your doctor may prescribe a different, more appropriate dosage of ZYDOL Solution for Injection.

For medical and healthcare professionals further information on administration is given in the ‘User leaflet - Information for the health professional’

Children

ZYDOL Solution for Injection 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 direct to prolong the dosage interval.

Severe liver or kidney disease (insufficiency)/dialysis patients Patients with severe liver and/or kidney insufficiency should not receive ZYDOL Solution for Injection. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

How and when should you receive ZYDOL Solution for Injection? ZYDOL Solution for Injection will be injected slowly usually into a blood vessel under the surface of the arm or injected into muscle (usually the buttocks) or under the skin. Alternatively, ZYDOL Solution for Injection will be diluted and infused into a vein.

For medical and healthcare professionals further information on administration is given in a separate leaflet ‘User leaflet -Information for the health professional’.

How long should you have ZYDOL Solution for Injection?

You should not receive ZYDOL Solution for Injection 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 receive ZYDOL Solution for Injection and at what dose.

If you have the impression that the effect of ZYDOL Solution for Injection is too strong or too weak, talk to your doctor or pharmacist. If you receive more ZYDOL Solution for Injection than you should

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

If you (or someone else) received a very high dose of ZYDOL Solution for Injection 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 miss a dose of ZYDOL Solution for Injection If you do not receive your ZYDOL Solution for Injection or infusion, pain is likely to return. You should not receive a double dose to make up for forgotten individual doses, simply continue receiving ZYDOL Solution for Injection as before.

If you stop receiving ZYDOL Solution for Injection If treatment with ZYDOL Solution for Injection is interrupted or finished too soon, pain is likely to return. If you wish to stop treatment on account of unpleasant effects, please tell your nurse or doctor. Generally there will be no after-effects when treatment with ZYDOL Solution for Injection is stopped. However, on rare occasions, people who have been treated with ZYDOL Solution for Injection for some time may feel unwell if the treatment is abruptly stopped. 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 Solution for Injection, please tell your nurse or 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 Solution for Injection 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 Solution for Injection. 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 (changes in senses and recognition, which may lead to errors in judgment).

•    Drug dependence may occur. If ZYDOL Solution for Injection is taken over a long period of time dependence may occur, although the risk is very low. When treatment is stopped abruptly, signs of withdrawal may appear (see “If the use of ZYDOL Solution for Injection solution is stopped”).

•    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 pan, passing less urine than normal (dysuria).

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

•    increase in liver enzyme values

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 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: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store ZYDOL Solution for Injection

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 label. The expiry date refers to the last day of that month. Do not store above 30°C.

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 Solution for Injection contains

The active substance is tramadol hydrochloride.

The other ingredients are: sodium acetate and water for injection What ZYDOL Solution for Injection looks like and contents of the pack

ZYDOL Solution for Injection is a clear colourless solution.

ZYDOL Solution for Injection is supplied in boxes of five ampoules, each containing 2 ml solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Grunenthal Ltd.

Regus Lakeside House 1 Furzeground Way Stockley Park East Uxbridge Middlesex UB111BD United Kingdom Manufacturer:

Grunenthal GmbH Zieglerstr. 6 D-52078 Germany

Other formats:

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

0800 198 5000 (UK Only)

ZYDOL® is a registered trademark    93022177 50/011/23