- tramadol hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 21727/0002.
ZYDOL 50 mg/ml Solution for Injection
Package leaflet: Information for the user
ZYDOL® 50 mg/ml Solution for Injection
Read all of this leaflet carefully before you start taking this medicine beacause it contains important information for you.
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
Warnings and precautions
Talk to your doctor before taking ZYDOL Solution for Injection
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.
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 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
Your doctor will tell you whether you should take ZYDOL Solution for Injection, and what dose.
The risk of side effects increases,
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.
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 Solution for Injection 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 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.
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’
ZYDOL Solution for Injection is not suitable for children below the age of 12 years.
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.
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 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
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
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 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 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:
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0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name Reference number
ZYDOL SOLUTION FOR INJECTION PL 21727/0002
This leaflet was last revised:
ZYDOL® is a registered trademark