Tradogut: detailed information

Package leaflet: Information for the user

TRADOGUT 50 mg hard capsules

Tramadol hydrochloride
Generic medicine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

What TRADOGUT is and what it is used for
What you need to know before taking TRADOGUT
How to take TRADOGUT
Possible side effects
How to store TRADOGUT
Contents of the pack and other information

1. What TRADOGUT is and what it is used for

TRADOGUT belongs to a class of medicines called analgesics, commonly known as painkillers or analgesic drugs. The active substance, tramadol hydrochloride, interrupts the transmission of pain signals to your brain and also acts centrally in the brain to prevent pain signals from being perceived. This means that TRADOGUT does not prevent pain from occurring, but prevents you from feeling the pain.
TRADOGUT is used to relieve moderate to severe pain (for example, pain after surgery or following an injury).

2. What you should know before using TRADOGUT

Do not use TRADOGUT if:

you are allergic to tramadol hydrochloride or to any of the other ingredients of this medicine (listed in section 6), as this may cause skin rash, facial swelling, or breathing difficulties;
you are currently taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) to treat depression (see section 2, “Other medicines and TRADOGUT”);
you have epilepsy that is not controlled by treatment;
you have consumed enough alcohol to feel dizzy or intoxicated;
you have taken a higher-than-prescribed dose of your sleeping tablets, neuroleptics, antidepressants (neuroleptics and antidepressants are medicines that affect mood and emotions), or other painkillers, which may slow down your breathing and reactions.

Warnings and precautions
Talk to your doctor or pharmacist before using TRADOGUT if:

you have been taking TRADOGUT or any other medicine containing tramadol for a long period;
you are dependent on morphine;
you have severe liver or kidney problems;
you recently suffered a head injury or have a particularly severe headache causing vomiting;
you have ever had seizures (fits) or suffer from epilepsy;
you suffer from asthma or breathing difficulties;
you have recently felt confused, drowsy, weak, or lost consciousness;
you are scheduled for surgery under general anaesthesia;
you suffer from depression and are taking antidepressants, as some of these may interact with tramadol (see “Other medicines and TRADOGUT”).

If any of the above conditions apply to you, consult your doctor, as they may decide to adjust your treatment.

Sleep-related breathing disorders
TRADOGUT may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxaemia (low blood oxygen levels during sleep).
Symptoms may include breathing pauses during sleep, nighttime awakenings due to gasping for breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor, who may consider reducing your dose.

Contact your doctor if you experience any of the following symptoms while taking TRADOGUT:
Extreme tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
These symptoms may indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will determine whether hormone replacement therapy is needed.

There is a rare possibility that TRADOGUT may cause seizures (fits). The risk increases if doses higher than the maximum daily dose are taken, or if you are also taking antidepressants or neuroleptics.

If you have a tendency towards drug dependence or abuse, TRADOGUT capsules should only be administered for short periods. Inform your doctor, as they may wish to monitor your pain control more closely.

Do not take this medicine to treat withdrawal symptoms if you are drug-dependent.

There is a small risk that you may develop serotonin syndrome, which may occur after taking tramadol together with certain antidepressants or tramadol used as monotherapy. Contact your doctor immediately if you experience any of the symptoms associated with this serious condition (see section 4, “Possible side effects”).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation in this enzyme, which may lead to different effects in them. Some people may not get sufficient pain relief, while others may experience severe side effects. If you notice any of the following side effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite.

Children and adolescents
TRADOGUT must not be taken by children under 12 years of age.

Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be worse in these children.

Other medicines and TRADOGUT
Inform your doctor, pharmacist, or dentist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Do not take TRADOGUT at the same time as medicines called monoamine oxidase inhibitors (such as moclobemide or phenelzine for depression, or selegiline for Parkinson’s disease), or within 14 days of stopping them.

The pain-relieving effect of TRADOGUT may be weakened and/or shortened if you are also taking medicines containing:

carbamazepine (used to treat epilepsy)
buprenorphine, nalbuphine, or pentazocine (painkillers)
ondansetron (used to prevent nausea)

Your doctor will advise you whether you should take TRADOGUT and what dose to use.

The risk of side effects increases if you are taking medicines that may cause seizures (fits), such as certain antidepressants or neuroleptics. The risk of having a seizure may increase if you take TRADOGUT at the same time. Your doctor will advise you whether TRADOGUT is suitable for you.

The risk of side effects increases if you are taking certain antidepressants. TRADOGUT may interact with these medicines and may lead to serotonin syndrome (see section 4, “Possible side effects”).

Medicines used to treat epilepsy may very rarely cause seizures (fits), but if you are also using TRADOGUT, the likelihood of having a seizure is higher. You should ask your doctor for advice.

Medicines that act on the nervous system, such as hypnotics, tranquillisers, sleeping tablets, and painkillers, may make you feel drowsy or weak when taken with TRADOGUT.

Anticoagulant medicines used to thin the blood, such as warfarin. The effectiveness of these medicines may be altered if you are also taking TRADOGUT.

Concomitant use of TRADOGUT and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes TRADOGUT together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow the doctor’s dose recommendations carefully. It may be helpful to inform friends or family members to watch for the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

Use of TRADOGUT with food, drinks and alcohol
TRADOGUT should be taken once daily with a sufficient amount of water, with or without food. Avoid drinking alcohol when taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Contact your doctor if you become pregnant during treatment.

Pregnancy
You must not take TRADOGUT during pregnancy, as tramadol crosses the placental barrier and its safety profile during pregnancy has not been established. If you suffer from severe pain, consult your treating doctor, who will decide whether a single dose may be taken.

Breastfeeding
Tramadol is excreted in breast milk. For this reason, you must not take TRADOGUT more than once during breastfeeding. Alternatively, if you take TRADOGUT more than once, you must stop breastfeeding.

Driving and using machines
TRADOGUT, even when taken as directed, may affect the reactions of drivers, machine operators, and workers. This effect may be enhanced by alcohol use, at the beginning of treatment, when switching medicines, or when taken with other central nervous system depressants or antihistamines. If affected, patients should be warned not to drive or operate machinery.

3. How to use TRADOGUT

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Important: Your doctor will choose the correct dose for you or your child. The dosage must be
determined based on the intensity of your pain and your individual sensitivity to pain. In general,
you should take the lowest dose that provides relief from pain. The number of capsules to take will be
clearly indicated on the label applied to the medicine by the pharmacist. If this is not the case, or if
you have any doubts, ask your doctor or pharmacist.
Swallow the capsules whole with water, without chewing.
If you have difficulty swallowing, you may open the capsules. You must open them very carefully by pulling and twisting each end over a spoon, so that the granules remain in the spoon. Do not chew.
Swallow all the granules with a little water.
Dosage for adults and adolescents aged 12 years and older:
One or two capsules of TRADOGUT (equivalent to 50–100 mg of tramadol hydrochloride). Depending on the type of pain, the effect lasts approximately 4–8 hours. Your doctor may increase this dose up to 150–200 mg twice daily, according to your needs.
The maximum dose is usually 400 mg per day. The prescribed daily dose will depend on the severity of your pain.
Use in children:
TRADOGUT must not be administered to children under 12 years of age.
Use in elderly patients:
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosing interval.
Use in patients with severe liver and/or kidney problems (insufficiency)/dialysis:
Patients with severe hepatic and/or renal insufficiency must not take TRADOGUT. In case of mild or moderate insufficiency, your doctor may recommend prolonging the dosing interval.
If you take more TRADOGUT than you should
If you accidentally take more capsules than prescribed, inform your doctor or pharmacist immediately and, if necessary, contact the nearest emergency department. Remember to bring the packaging and any remaining medicine with you.
If you forget to take TRADOGUT
Do not take a double dose to make up for the forgotten dose.
If you stop taking TRADOGUT
Do not stop taking TRADOGUT or reduce the dose without first discussing it with your doctor. Generally, there will be no consequences if TRADOGUT treatment is stopped. However, in rare cases, people who have taken TRADOGUT for a prolonged period may feel unwell if treatment is stopped suddenly. You may feel agitated, anxious, nervous, or shaky. You may become hyperactive, have difficulty falling asleep, or experience stomach or intestinal disturbances. If you experience any of these symptoms after stopping TRADOGUT, consult your doctor.
You must not stop taking this medicine suddenly, unless instructed by your doctor. If you intend to stop taking the medicine, discuss it with your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of developing unnecessary adverse effects (withdrawal symptoms).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
Consult your doctor or pharmacist:

if you are unsure how many drops to take or when to take them.
if you think the effect is too strong or too weak.

4. Possible side effects

Like all medicines, TRADOGUT may cause side effects, although not everyone experiences them.
The most serious side effects that may occur include allergic reaction (difficulty breathing, weakness, and swelling of the face or throat), anaphylactic reaction (a severe allergic reaction leading to difficulty breathing, changes in heart rate, weakness, collapse, or loss of consciousness due to a drop in blood pressure), or seizures (fits). If any of these symptoms occur, stop taking TRADOGUT immediately and contact your doctor.

Very common (may affect more than 1 in 10 people)
Dizziness.
Vomiting and nausea (feeling unwell).

Common (may affect up to 1 in 10 people)
Headache, numbness.
Drowsiness (tiredness).
Constipation, dry mouth.
Sweating.

Uncommon (may affect up to 1 in 100 people)
Fast heartbeat, palpitations, sudden drops in blood pressure. These adverse events may occur especially with intravenous administration and in physically stressed patients.
Itching, skin rash.
Feeling of nausea, sensation of bloating or fullness.

Rare (may affect up to 1 in 1,000 people)
Allergic reaction such as difficulty breathing, weakness, swelling of the face or throat.
Anaphylactic reaction (severe allergic reaction).
Changes in appetite.
Psychiatric effects including: mood changes, changes in behaviour and perception of activities, hallucinations, confusion, restlessness, sleep disturbances, and nightmares.
Seizures (fits).
Tingling sensation and tremor.
Slow heartbeat, increase in blood pressure.
Muscle weakness.
Difficulty or inability to urinate.
Blurred vision.

Very rare (may affect up to 1 in 10,000 people)
Hot flushes.
Vertigo (sensation of dizziness or spinning).
Asthma and breathing difficulties.
Increased levels of liver enzymes.

Not known (frequency cannot be estimated from the available data)
Decreased blood sugar levels.
Low sodium levels in the blood, which may cause fatigue and confusion, muscle spasms, seizures, and coma.
Hiccups.
Serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2, "What you should know before using TRADOGUT").
Withdrawal syndrome includes: agitation, anxiety, nervousness, difficulty sleeping, restlessness, tremor, and gastrointestinal disturbances (see section 3, "How to take TRADOGUT").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRADOGUT

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use TRADOGUT after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TRADOGUT contains:
The active substance is tramadol hydrochloride. TRADOGUT contains 50 mg of tramadol hydrochloride.
The other components are: calcium hydrogen phosphate, anhydrous, magnesium stearate, anhydrous colloidal silica,
gelatin, titanium dioxide (E171), shellac, iron oxide, black (E172), propylene glycol, ammonium
hydroxide.
Description of the appearance of TRADOGUT and contents of the pack:
Immediate-release hard capsules. The capsules are white and marked with T50.
The capsules are packaged in a PVC/PVDC/aluminum blister. Each blister contains 10
capsules. Each package contains 10, 30, 50 or 100 capsules. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart Dublin 15, DUBLIN, Ireland
Manufacturer
Temmler Pharma GmbH, Temmlerstrasse 2, D-35039 Marburg (Germany)
MEDA Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg (Germany)
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Germany: Adamon Kaps
Italy: TRADOGUT

Package leaflet: Information for the user

TRADOGUT 50 mg/ml injection solution

Tramadol hydrochloride
Equivalent medicine
Please read this leaflet carefully before receiving this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are similar to yours, as it could be dangerous.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

What TRADOGUT is and what it is used for
What you need to know before you are given TRADOGUT
How TRADOGUT will be administered to you
Possible side effects
How to store TRADOGUT
Contents of the pack and other information

1. What TRADOGUT is and what it is used for

TRADOGUT belongs to a class of medicines called analgesics, commonly known as painkillers or analgesic drugs. The active substance, tramadol hydrochloride, blocks the transmission of pain signals to your brain and also acts in the brain to prevent pain signals from being perceived. This means that TRADOGUT does not prevent pain from occurring, but prevents you from feeling the pain.
TRADOGUT is used to relieve moderate to severe pain (for example, pain after surgery or following an injury).

2. What you should know before being administered TRADOGUT

Do not use TRADOGUT if:

you are allergic to tramadol hydrochloride or to any of the other ingredients of this medicine (listed in section 6), as skin rash, facial swelling, or breathing difficulties may occur;
you are currently taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) for the treatment of depression (see section 2, “Other medicines and TRADOGUT”);
you have epilepsy that is not controlled by treatment;
you have consumed enough alcohol to feel drowsy or intoxicated;
you have taken a higher than prescribed dose of your sleeping tablets, neuroleptics, antidepressants (neuroleptics and antidepressants are medicines that affect mood and emotions), or other painkillers, which may slow down your breathing and reactions.

Warnings and precautions
Consult your doctor before being administered TRADOGUT if:

you have been taking TRADOGUT or any other medicine containing tramadol for a long period;
you are morphine-dependent;
you have severe liver or kidney problems;
you have recently suffered a head injury or have a particularly severe headache causing vomiting;
you have ever had seizures (fits) or suffer from epilepsy;
you suffer from asthma or breathing difficulties;
you have recently felt confused, drowsy, weak, or have lost consciousness;
you suffer from depression and are taking antidepressants, as some of these may interact with tramadol (see section 2, “Other medicines and TRADOGUT”).

If any of the above conditions apply to you, consult your doctor, as they may decide to modify your treatment.

Sleep-related breathing disorders
TRADOGUT may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
Symptoms may include breathing pauses during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor, who may consider reducing the dose.

Contact your doctor if you experience any of the following symptoms while taking TRADOGUT:
Extreme tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
These symptoms may indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether hormone replacement therapy is needed.

If you have a tendency towards drug dependence or abuse, TRADOGUT should only be administered for short periods. Inform your doctor, as they may wish to monitor your pain control more closely.

Do not take this medicine to treat withdrawal symptoms if you are drug-dependent.

There is a slight risk that you may develop the so-called serotonin syndrome, which may occur after taking tramadol together with certain antidepressants or tramadol used as monotherapy. Contact your doctor immediately if you experience any of the symptoms associated with this serious condition (see section 4, “Possible side effects”).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation in this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience serious side effects. If you notice any of the following side effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite.

Children and adolescents
TRADOGUT must not be administered to children under one year of age.

Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may be worse in these children.

Other medicines and TRADOGUT
Inform your doctor, pharmacist, or dentist if you are taking or have recently taken any other medicines, including those without a prescription.

Do not take TRADOGUT at the same time as medicines called monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide or phenelzine for depression, or selegiline for Parkinson’s disease), or within 14 days of stopping them.

The pain-relieving effect of TRADOGUT may be weakened and/or shortened if you are also taking medicines containing:

carbamazepine (used to treat epilepsy)
buprenorphine, nalbuphine, or pentazocine (painkillers)
ondansetron (used to prevent nausea)

Your doctor will advise you whether you should take TRADOGUT and at what dosage.

The risk of side effects increases if you are taking medicines that may cause seizures (fits), such as certain antidepressants or neuroleptics. The risk of having a seizure may increase if TRADOGUT is administered at the same time. Your doctor will decide whether TRADOGUT injection solution is suitable for you.

The risk of side effects increases if you are taking certain antidepressants. TRADOGUT may interact with these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).

Medicines used to treat epilepsy may very rarely cause seizures (fits), but if you are also using TRADOGUT, the likelihood of having a seizure is higher. You should ask your doctor for advice.

Medicines that act on the central nervous system, such as hypnotics, tranquillizers, sleeping tablets, and painkillers, may make you feel drowsy or weak when taken with TRADOGUT.

Anticoagulant medicines used to thin the blood, such as warfarin. The effectiveness of these medicines may be altered if you are also taking TRADOGUT.

However, if your doctor prescribes TRADOGUT together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives to watch for the signs and symptoms listed above. Contact your doctor if you experience such symptoms.

TRADOGUT is incompatible with injectable solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam, and nitroglycerin.

TRADOGUT with food, drinks, and alcohol
Avoid drinking alcohol when taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Contact your doctor if you become pregnant during treatment.

Pregnancy
You must not take TRADOGUT during pregnancy except in serious cases, where your doctor may decide to administer single doses.

Breastfeeding
Tramadol is excreted in breast milk. Therefore, you must not take TRADOGUT, or alternatively, if you take TRADOGUT more than once, you must stop breastfeeding.

Driving and using machines
TRADOGUT may cause drowsiness, especially when used with alcohol, antihistamines, or other medicines that cause drowsiness. Do not drive or operate machinery unless you know how TRADOGUT affects you.

TRADOGUT injection solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. it is essentially “sodium-free”.

3. How TRADOGUT will be administered to you

TRADOGUT will be administered to you by a doctor or a nurse.
Important: The doctor will choose the correct dose for you or your child. The volume to be
administered will be clearly indicated on the label applied by the pharmacist to the medicine.
The injection may be given 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 must be
administered slowly over 2–3 minutes.
The dose should be chosen according to the intensity of pain and your individual sensitivity to pain. In
general, the lowest effective dose that relieves pain should be used.
The maximum dose is usually 400 mg per day (8 ml), but may be higher if the pain is severe.
The daily dose will depend on the severity of your pain.
Use in children:
TRADOGUT must not be used in children under one year of age.
Dosage for children aged 1 to 12 years: the usual dose is a single dose of tramadol hydrochloride of
1–2 mg per kg of body weight.
Use in elderly patients:
In elderly patients (over 75 years), elimination of tramadol may be delayed. If this applies to you, your
doctor may recommend prolonging the dosing interval.
Use in patients with severe liver and/or kidney problems (insufficiency)/dialysis:
TRADOGUT must not be administered to patients with severe hepatic and/or renal insufficiency. In cases
of mild or moderate insufficiency, your doctor may recommend prolonging the dosing interval.
Consult your doctor or pharmacist if you feel the effect is too strong or too weak.
If you are given more TRADOGUT than you should have
If you are given a dose higher than prescribed, inform your doctor or pharmacist immediately and, if
necessary, contact the nearest emergency department. Remember to bring the medicine pack and any
unused TRADOGUT with you.
If you miss a dose of TRADOGUT
Do not receive a double dose to make up for a missed dose.
If you stop receiving TRADOGUT
In general, there will be no consequences if treatment with TRADOGUT is stopped.
However, in rare cases, people who have been given TRADOGUT for some time may feel unwell if their
treatment is stopped suddenly. You may feel agitated, anxious, nervous, or shaky. You may become
hyperactive, have difficulty sleeping, or experience stomach or intestinal disturbances. If you experience
any of these symptoms after stopping TRADOGUT, consult your doctor.
You must not stop taking this medicine suddenly, unless instructed by your doctor. If you intend to stop
taking the medicine, discuss this first with your doctor, especially if you have been taking it for a long time.
Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to
minimize the risk of developing unnecessary adverse effects (withdrawal symptoms).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TRADOGUT can cause side effects, although not everyone gets them.
The most serious side effects that may occur include allergic reaction (difficulty breathing, weakness and swelling of the face or throat), anaphylactic reaction (a severe allergic reaction leading to difficulty breathing, changes in heart rate, weakness, collapse or loss of consciousness due to a drop in blood pressure) or seizures (fits). If any of these symptoms occur, stop taking TRADOGUT immediately and contact your doctor.

Very common (may affect more than 1 in 10 people)
Dizziness.
Vomiting and nausea (feeling unwell).

Common (may affect up to 1 in 10 people)
Headache, numbness.
Somnolence (drowsiness, fatigue).
Constipation, dry mouth.
Sweating.

Uncommon (may affect up to 1 in 100 people)
Rapid heartbeat, palpitations, sudden drops in blood pressure. These adverse events may occur especially with intravenous administration and in physically stressed patients.
Itching, skin rash.
Feeling of nausea, sensation of bloating or fullness.

Rare (may affect up to 1 in 1,000 people)
Allergic reaction such as difficulty breathing, weakness, swelling of the face or throat.
Anaphylactic reaction (severe allergic reaction).
Changes in appetite.
Psychiatric effects including: mood changes, changes in behaviour and perception of activities, hallucinations, confusion, restlessness, sleep disturbances and nightmares.
Seizures (fits).
Tingling sensation and tremor.
Slow heartbeat, increase in blood pressure.
Muscle weakness.
Difficulty or inability to urinate.
Blurred vision.

Very rare (may affect up to 1 in 10,000 people)
Hot flushes.
Vertigo (sensation of dizziness or spinning).
Asthma and breathing difficulties.
Increased levels of liver enzymes.

Not known (frequency cannot be estimated from the available data)
Decreased blood sugar levels.
Low sodium levels in the blood, which may cause tiredness and confusion, muscle spasms, seizures and coma.
Hiccups.
Serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2, “What you need to know before TRADOGUT is administered to you”).
Withdrawal syndrome includes: agitation, anxiety, nervousness, difficulty sleeping, restlessness, tremor and gastrointestinal disturbances (see section 3. How TRADOGUT injectable solution will be administered to you).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRADOGUT

Keep this medicine out of the sight and reach of children.
TRADOGUT must not be used after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
TRADOGUT must be used immediately after first opening/dilution. Any remaining solution must be immediately discarded.

6. Package contents and other information

What TRADOGUT contains:
The active substance is tramadol hydrochloride. TRADOGUT contains 50 mg of tramadol hydrochloride per ml of solution.
The other components of the formulation are:
Sodium acetate trihydrate (equivalent to 0.7 mg sodium/ml)
Water for injection

Description of the appearance of TRADOGUT and package contents:
Injectable solution. Clear, colourless solution.
TRADOGUT injectable solution is supplied in packs of 5, 10 and 50 coloured glass vials, each containing 2 ml of solution. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart Dublin 15, DUBLIN, Ireland

Manufacturer
Meda Pharma GmbH & Co. KG, Bad Homburg (Germany)
Gruenenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Adamon Inject
Italy: TRADOGUT

This Patient Information Leaflet was last approved on

Package leaflet: Information for the user

TRADOGUT 100 mg/ml oral drops, solution

Tramadol hydrochloride
Equivalent medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist (see section 4).

Contents of this leaflet:

What TRADOGUT is and what it is used for
What you need to know before using TRADOGUT
How to use TRADOGUT
Possible side effects
How to store TRADOGUT
Contents of the pack and other information

1. What TRADOGUT is and what it is used for

TRADOGUT belongs to a class of medicines called analgesics, commonly known as painkillers or pain-relieving drugs. TRADOGUT contains the active substance tramadol hydrochloride. The active substance, tramadol hydrochloride, blocks the transmission of pain signals to your brain and also acts in the brain to prevent pain signals from being perceived. This means that TRADOGUT does not prevent pain from occurring, but prevents you from feeling the pain. TRADOGUT is used to relieve moderate to severe pain (for example, pain after surgery or following an injury).

2. What you need to know before taking TRADOGUT

Do not take TRADOGUT:

if you are allergic to tramadol hydrochloride, menthol, or any of the other ingredients of this medicine (listed in section 6), as skin rash, facial swelling, or breathing difficulties may occur;
if you are taking or have taken monoamine oxidase inhibitors (MAOIs) within the last two weeks to treat depression (see section 2, “Other medicines and TRADOGUT”);
if you have epilepsy that is not controlled by treatment;
if you have consumed enough alcohol to feel dizzy or intoxicated;
if you have taken a higher dose than prescribed of your sleeping tablets, neuroleptics, antidepressants (neuroleptics and antidepressants are medicines that affect mood and emotions), or other painkillers, which may slow down your breathing and reactions.

If you have a tendency towards drug dependence or abuse, you should take TRADOGUT only for short periods. Inform your doctor, as they may wish to monitor your pain control more closely.
You must not take this medicine to treat withdrawal symptoms if you are drug-dependent.

Warnings and precautions
Talk to your doctor or pharmacist before taking TRADOGUT if:

you are pregnant or breastfeeding;
you have taken TRADOGUT or any other medicine containing tramadol for a long time;
you are morphine-dependent;
you have had an allergic reaction to any morphine-like medicine;
you have severe liver or kidney problems;
you have recently had a head injury or have a particularly severe headache causing vomiting;
you have ever had seizures (fits) or suffer from epilepsy;
you suffer from asthma or breathing difficulties;
you have recently felt confused, drowsy, weak, or lost consciousness;
you are taking other medicines;
you are due to undergo surgery under general anaesthesia;
you suffer from depression and are taking antidepressants, as some of these may interact with tramadol (see section 2, “Other medicines and TRADOGUT”).

There is a rare possibility that TRADOGUT may cause seizures (fits). The risk increases if doses higher than the maximum daily dose are taken and if you are also taking antidepressants or neuroleptics.

If any of the above conditions apply to you, consult your doctor, as they may decide to modify your treatment.

Sleep-related breathing disorders
TRADOGUT may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
Symptoms may include pauses in breathing during sleep, waking up at night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor, who may consider reducing the dose.

There is a small but possible risk that you may develop serotonin syndrome, which may occur after taking tramadol together with certain antidepressants or tramadol used as monotherapy. Contact your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Children and adolescents
TRADOGUT must not be taken by children under one year of age.

Other medicines and TRADOGUT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Do not take TRADOGUT at the same time as medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression or selegiline for Parkinson’s disease) or within 14 days of stopping them.

The pain-relieving effect of TRADOGUT may be weakened and/or shortened if you are also taking medicines containing:

carbamazepine (used to treat epilepsy)
buprenorphine, nalbuphine, or pentazocine (painkillers)
ondansetron (used to prevent nausea)

Your doctor will advise you whether to take TRADOGUT and what dose to use.

The risk of side effects increases if you are taking medicines that may cause seizures (fits), such as certain antidepressants or neuroleptics. The risk of having a seizure may increase if you take TRADOGUT oral drops at the same time. Your doctor will advise whether TRADOGUT is suitable for you.

The risk of side effects increases if you are taking certain antidepressants. TRADOGUT may interact with these medicines and you may develop serotonin syndrome (see section 4 “Possible side effects”).

Medicines used to treat epilepsy may very rarely cause seizures (fits), but if you are also using TRADOGUT, the likelihood of having a seizure is higher. You should ask your doctor for advice.

Medicines that act on the nervous system, such as hypnotics, tranquillisers, sleeping tablets, and painkillers, may make you feel drowsy or weak when taken with TRADOGUT.

Anticoagulant medicines used to thin the blood, such as warfarin. The effectiveness of these medicines may be altered if you are also taking TRADOGUT.

The concomitant use of TRADOGUT and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes TRADOGUT together with sedative medicines, the dose and duration of concomitant treatment must be limited by the doctor.

TRADOGUT with food, drinks and alcohol
TRADOGUT should be taken with a little water, during or apart from meals. Avoid drinking alcohol when taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy and fertility
Only limited information is available on the safety of tramadol in human pregnancy.
Therefore, you should not take TRADOGUT if you are pregnant.

Repeated use of this medicine during pregnancy may lead to the unborn baby becoming dependent on tramadol and consequently experiencing neonatal withdrawal symptoms after birth.

Based on human experience, tramadol hydrochloride is not expected to affect male or female fertility.

Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take TRADOGUT more than once while breastfeeding. However, if you take TRADOGUT more than once, you must stop breastfeeding.

Driving and using machines
TRADOGUT may cause drowsiness, especially when used with alcohol, antihistamines, and other medicines that may cause drowsiness. Do not drive or operate machinery if you do not know how TRADOGUT affects you.

TRADOGUT contains ethanol (alcohol) and sucrose
This medicine contains 75.92 mg of ethanol (alcohol) per dose (20 drops). The amount in one dose of this medicine is equivalent to less than 1.9 ml of beer or 0.8 ml of wine. The small amount of alcohol in this medicine has no noticeable effect.

This medicine also contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take TRADOGUT

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Important: Your doctor will determine the correct dose for you or your child. The number of drops to
be taken will be clearly indicated on the label affixed to the medicine by the pharmacist. If this is not
the case, or if you have any doubts, ask your doctor or pharmacist.
The bottle containing the medicine has an integrated dropper and a child-resistant screw cap.
To dispense the drops:

press firmly on the cap and then unscrew it;
turn the bottle upside down;
gently tap the base of the bottle until the first drop appears;
count the desired number of drops onto a spoon.

Dosage for adults and adolescents aged 12 years and older:
The usual initial dose is 50–100 mg (20 to 40 drops) twice daily, in the morning and evening. Your doctor
may increase this dose up to 150–200 mg (60 to 80 drops) twice daily, depending on your needs.
Typically, TRADOGUT should be taken every 12 hours at the same time each day, in the morning and
evening.
Take TRADOGUT with a small amount of water, with or without food.
The dosage should be based on the intensity of pain and your individual sensitivity to pain. In general, the
lowest effective dose that relieves pain should be used.
The maximum dose is usually 400 mg per day (160 drops). The prescribed daily dose will depend on
the severity of your pain.
Use in children:
TRADOGUT is not indicated for children under 1 year of age.
For children aged between 1 and 12 years, administer a single dose of tramadol hydrochloride of 1–2 mg
per kg of body weight.

The following table shows typical dosage examples based on specific age groups (each drop of oral
solution contains approximately 2.5 mg of tramadol hydrochloride):

Age	Weight	Number of drops per single dose
1 year	10 kg	4  8
3 years	15 kg	6  12
6 years	20 kg	8  16
9 years	30 kg	12  24
11 years	45 kg	18  36

Use in elderly patients:
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your doctor may recommend that you extend the dosing interval.

Use in patients with severe liver and/or kidney problems (insufficiency)/dialysis:
Patients with severe hepatic and/or renal insufficiency must not take TRADOGUT. In case of mild or moderate insufficiency, your doctor may recommend extending the dosing interval.

Talk to your doctor or pharmacist:

if you are unsure about how many drops you should take or when you should take them.
if you think the effect is too strong or too weak.

If you take more TRADOGUT than you should
If you accidentally take more drops than prescribed, inform your doctor or pharmacist immediately and, if necessary, contact the nearest emergency department. Remember to bring the packaging and any remaining medicine with you.

If you forget to take TRADOGUT
Do not take a double dose to make up for the forgotten dose.

If you stop taking TRADOGUT
Do not stop taking TRADOGUT or reduce the dose without first discussing it with your doctor. Generally, there will be no consequences if treatment with TRADOGUT is discontinued. However, in rare cases, people who have taken TRADOGUT for some time may experience withdrawal syndrome and feel unwell if treatment is stopped suddenly. You may feel agitated, anxious, nervous, or shaky. You may become hyperactive, have difficulty sleeping, and experience stomach or intestinal disturbances. If you experience any of these symptoms after stopping TRADOGUT, consult your doctor.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, TRADOGUT may cause side effects, although not everybody gets them.
The most serious side effects that may occur include allergic reactions (difficulty breathing, weakness, and swelling of the face or throat), anaphylactic reactions (severe allergic reactions leading to difficulty breathing, changes in heart rate, weakness, collapse or loss of consciousness due to a drop in blood pressure), or seizures (fits). If any of these symptoms occur, stop taking TRADOGUT immediately and contact your doctor.

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

Dizziness.
Vomiting and nausea (feeling unwell).

Common (may affect up to 1 in 10 people)

Headache, numbness.
Drowsiness (tiredness).
Constipation, dry mouth.
Sweating.

Uncommon (may affect up to 1 in 100 people)

Rapid heartbeat, palpitations, sudden drops in blood pressure. These adverse events may occur especially with intravenous administration and in physically stressed patients.
Itching, skin rash.
Nausea, sensation of bloating or fullness, diarrhoea.

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

Allergic reaction, such as difficulty breathing, weakness, swelling of the face or throat.
Anaphylactic reaction (severe allergic reaction).
Changes in appetite.
Psychiatric effects including: mood, activity, behaviour and perception changes, hallucinations, confusion, restlessness, sleep disturbances and nightmares.
Seizures (fits).
Tingling sensation and tremor.
Slow heartbeat, increased blood pressure.
Muscle weakness.
Difficulty or inability to urinate.
Slow breathing and shortness of breath (dyspnoea).
Blurred vision, small (constricted) pupil, dilated pupil.
Worsening of asthma; however, it has not been established whether this was caused by tramadol hydrochloride.

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

Hot flushes.
Vertigo (sensation of dizziness or spinning).
Increased levels of liver enzymes.

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

Decrease in blood sugar levels.
Low sodium levels in the blood which may cause tiredness and confusion, muscle spasms, seizures and coma.
Hiccups.
Serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2, “What you need to know before you use TRADOGUT”).

Withdrawal syndrome includes: agitation, anxiety, nervousness, difficulty sleeping, restlessness, tremor and gastrointestinal disturbances (see section 3, “How to take TRADOGUT”).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TRADOGUT

Keep this medicine out of the sight and reach of children.
Do not use TRADOGUT after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
This medicine should be used within 3 months of first opening.

6. Package contents and other information

What TRADOGUT contains:
The active substance is tramadol hydrochloride. TRADOGUT contains 100 mg of tramadol hydrochloride per
ml of solution.
The other components of the solution are: potassium sorbate, propylene glycol, ethanol,
sucrose, polysorbate 80, peppermint oil, a cidiﬁed puriﬁed water.
Description of the appearance of TRADOGUT and contents of the pack:
Oral drops, solution. A clear solution, colourless to slightly yellow.
TRADOGUT is contained in a brown glass bottle with a child-resistant plastic cap and a dropper. Each bottle contains 10 ml of solution. Packs contain 1, 2, 5,
10, 20 or 50 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart Dublin 15, DUBLIN, Ireland
Manufacturer(s)
Temmler Pharma GmbH, Temmlerstrasse 2, 35039 Marburg (Germany)
MEDA Pharma GmbH & Co. KG, Benzstrasse 1, 61352 Bad Homburg (Germany)
This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Germany: Adamon Tropfen
Italy: TRADOGUT
This summary of product characteristics was last approved on