ZAMADOL INJECTION - patient leaflet, side effects, dosage

Zamadol® Injection

tramadol hydrochloride

This medicine contains tramadol hydrochloride, which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

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 your pharmacist.

• – This medicine has been prescribed for you. 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. See section 4.

What is in this leaflet

• 1. What Zamadol is and what it is used for

• 2. What you need to know before you take Zamadol

• 3. How to take Zamadol

• 4. Possible side effects

• 5. How to store Zamadol

• 6. Contents of the pack and other information

1. what zamadol is and what it is used for

The name of your medicine is Zamadol® Injection (referred to as Zamadol throughout this leaflet).

It contains tramadol hydrochloride which belongs to a class of medicines called opioids, which are ‘pain relievers’. Tramadol interrupts the pain messages being sent to your brain, and it also acts in your brain to stop pain messages from being felt. This means that Zamadol does not stop the pain from happening, but you will not be able to feel the pain as much.

This medicine has been prescribed for moderate to severe pain (for example, pain after an operation, or after an injury) in adults and adolescents aged 12 years and older.

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 and when it is appropriate to stop, how to do this safely.

2. what you need to know before you take zamadol

Do not use Zamadol if:

• – you are allergic to tramadol hydrochloride or to any of the other ingredients of this medicine (listed in section 6) resulting in a skin rash, swelling of face or difficulty in breathing.

• – you are taking, or you have taken in the last two weeks, monoamine oxidase inhibitors (MAOIs), to treat depression (see section 2, “Other medicines and Zamadol”).

• – you have epilepsy which is not controlled by treatment.

• – you have drunk enough alcohol to make you feel woozy or drunk.

• – you have taken more than the prescribed dose of your sleeping tablets, antipsychotics, antidepressant (antipsychotics and antidepressant are medicines that affect mood and emotions) or other pain killers, which can slow down your breathing and reactions.

Warnings and precautions

Zamadol 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 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 Zamadol 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 and when it is appropriate to stop, 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.

Also, talk to your doctor before you are administered Zamadol, if:

• – you have been taking Zamadol or any other medicine containing tramadol for a long time.

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• – you are addicted to morphine.

• – you have severe problems with your liver or kidneys.

• – you have recently had a head injury or have a very bad headache that makes you sick.

• – you have ever had convulsions (fits) or you suffer from epilepsy.

• – you have asthma or trouble breathing.

• – you have recently felt confused, sleepy or faint, or you have fainted.

• – you are going to have surgery requiring a general anaesthetic.

• – you suffer from depression and you are taking antidepressants as some of them may interact with tramadol (see ‘Other medicines and Zamadol’).

If any of the above applies to you, you must tell your doctor as they may decide to alter your treatment.

There is rare possibility that Zamadol may cause convulsions (fits). The risk is increased if doses above the daily maximum are taken and if you are also taking anti-depressants or antipsychotics.

If you have a tendency to drug addiction or abuse you should take Zamadol for short periods only. Please tell your doctor about this as they may want to monitor your pain control more closely.

You should not take this product for the treatment of withdrawal symptoms, if you are addicted to drugs.

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.

You should also contact your doctor if you have these symptoms; 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). Your doctor will decide if you need to take hormone supplement.

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’).

Children and adolescents

Zamadol must not be used in children aged under 12 years of age.

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 Zamadol

Tell your doctor or pharmacist or dentist if you are taking, have recently taken or might take any other medicines. Do not use Zamadol at the same time, or within 14 days of taking medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression or selegiline for Parkinson’s di­sease).

The pain relieving effect of Zamadol may be weakened and/or shortened if you also take medicines containing: – carbamazepine (used to treat epilepsy)

• – buprenorphine, nalbuphine, or pentazocine (pain killers)

• – ondansetron (prevents nausea)

Your doctor will tell you whether you should take Zamadol and what dose.

The risk of side effects increases 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 Zamadol is being administered at the same time. Your doctor will tell you whether Zamadol is suitable for you.

The risk of side effects increases, if you are taking certain antidepressants. Zamadol may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’).

Medicines used to treat epilepsy may very rarely cause convulsions (fits), but if you are also taking Zamadol the possibility of having a convulsion is more likely. You must ask your doctor about this.

Medicines that act on the nervous system such as hypnotics, tranquillisers, sleeping pills and pain killers may make you feel drowsy or faint when taken with Zamadol.

Anticoagulants to thin your blood such as warfarin. The effectiveness of the medicines may be altered if you are also taking Zamadol.

Concomitant use of Zamadol 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 Zamadol 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, 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.

Zamadol with food and drink and alcohol

Avoid drinking alcohol while taking this medicine.

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. Please contact your doctor if you become pregnant during your treatment.

Pregnancy

Do not take Zamadol 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 Zamadol 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 Zamadol while you are breastfeeding as tramadol passes into breast milk and will affect your baby.

Driving and using machines

Zamadol may cause drowsiness, particularly if taken with alcohol, anti-histamines and other medicines that may cause drowsiness.

Do not drive or operate heavy machinery unless you know how Zamadol affects you.

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:

– This medicine has been prescribed to treat a medical and 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.

Zamadol contains sodium

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

3. how to take zamadol

Zamadol will be administered to you by a doctor or nurse.

Important: Your doctor will choose the dose that is right for you or your child. The volume to be given will be clearly shown on the label that the pharmacist puts on your medicine.

Your doctor should have discussed with you, how long the course will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. The injection is injected intravenously, intramuscularly or subcutaneously.

The recommended dose is:

Dosage for adults and adolescents from 12 years of age:

The usual dose is 50 mg (1 ml) or 100 mg (2 ml) every 4–6 hours. Intravenous injections should be given slowly over 2–3 minutes.

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 maximum dose is usually 600 mg daily (12 ml).

Your daily dose will depend on the severity of your pain.

Dosage for children and adolescent:

Under 12 years – Zamadol should not be given to children under 12.

Use in 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.

Use in patients with severe liver or kidney disease (insufficiency)/di­alysis patients:

Patients with severe liver or kidney insufficiency should not be given Zamadol injection. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.

Ask your doctor or pharmacist if you think that the effect is too strong or too weak.

If you are administered more Zamadol than you should

If you accidentally given more than your prescribed dose, tell your doctor or pharmacist immediately and if necessary, contact your nearest hospital casualty department. Remember to take the pack and any remaining ampoules with you.

If you miss a dose of Zamadol

You should not be given a double dose to make up for a forgotten dose.

If you stop being administered Zamadol

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.

If you have further questions on the use of this product, ask your doctor or pharmacist.

There is a risk that you may become addicted to or dependent on these tablets (a need to keep taking the medicines). If you take these for a long time you can become used to the effects and you may need to take higher doses to control your pain.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Please stop taking this medicine and contact your doctor as soon as possible if you experience any of the following rare reactions:

• Allergic reaction such as difficulty in breathing, wheezing, swelling of the face or throat.
• Anaphylactic reaction (an extreme allergic reaction)

Other side effects

Very Common (may affect more than 1 in 10 people)

• – dizziness

• – vomiting and nausea (being and feeling sick)

Common (may affect up to 1 in 10 people)

• – headache

• – drowsiness sleepiness (fatigue)

• – constipation, dry mouth

• – sweating

Uncommon (may affect up to 1 in 100 people)

• – rapid heart beat, palpitation, sudden drops in blood pressure. These adverse effects may occur especially on intravenous administration and in patients who are physically stressed

• – itching, skin rash

• – retching, feeling bloated or full

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Rare (may affect up to 1 in 1,000 people)

• – appetite changes

• – psychic effects including: changes in mood, activity behaviour and perception, hallucinations, confusion, restlessness, sleep disturbances and nightmares

• – convulsions (fits)

• – tingling sensation and trembling

• – slow heart beat, increase in blood pressure

• – muscle weakness

• – difficulty or inability in passing urine

• – blurred vision

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

• – flushing

• – vertigo (feeling of dizziness or “spinning”)

• – asthma and breathing difficulties

• – elevated liver enzymes

Not known (frequency cannot be estimated from the available data)

• – low blood sugar level

• – hiccups

• – Dependence and addiction (see section ‘How do I know if I am addicted?’

• – 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 Zamadol’).

Drug Withdrawal

When you stop taking Zamadol, 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 Zamadol, 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.

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: 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 zamadol

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

• – Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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

• – Do not store this medicine above 30"C.

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

• – This medicine has to be used immediately after first opening/dilution. Any remaining solution should be immediately discarded.

6. contents of the pack and other information

What Zamadol contains:

The active substance in is tramadol hydrochloride.

Zamadol contains 50 mg tramadol hydrochloride in each ml of solution.

The other ingredients of the contents are: Sodium acetate (is equal to 0.7 mg sodium/ml); Water for injection

What Zamadol Injection looks like and contents of the pack

Solution for injection. A clear, colourless solution.

Zamadol is supplied in packs of 5, 10 and 50 ampoules made of coloured glass, each containing 2 ml of solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

MEDA Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg, Germany

This leaflet was last revised in July 2021.

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2521583 / 56UK22902006–05

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