Prospect: information for the user

Adolonta 100 mg/ 2 ml injectable solution and for perfusion

Tramadol, hydrochloride

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Adolonta and for what it is used

2.What you need to know before starting to use Adolonta

3.How to use Adolonta

4.Possible adverse effects

5.Storage of Adolonta

6. Contents of the package and additional information

Tramadol - the active ingredient in this medication - is a pain reliever belonging to the opioid group that acts on the central nervous system.It alleviates pain by acting on specific nerve cells in the spinal cord and the brain.

Adolonta is used in the treatment of moderate to severe pain in adults and in children aged 3 years and above.

No use Adolonta:

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute intoxications caused by alcohol, sleeping pills, analgesics, or other psychotropic drugs (medicines that act on mood and emotions);
• if you are also taking MAO inhibitors (a certain type of medicine used to treat depression) or if you have taken them in the last 14 days before starting treatment with this medicine (see “Use of Adolonta with other medicines”);
• if you have epilepsy and your seizures are not adequately controlled with treatment;
• for the treatment of withdrawal syndrome;
• in children under 3 years old.

Warnings and precautions

Consult your doctor before starting to use Adolonta:

• if you think you have dependence on other analgesics (opioids);
• if you have consciousness disorders (if you think you are going to faint);
• if you are in shock (a sign of this state can be cold sweat);
• if you have increased intracranial pressure (for example, after a head trauma or diseases that affect the brain);
• if you have breathing difficulties;
• if you are epileptic or have seizures, because the risk of seizures may increase;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Use of Adolonta with other medicines”);
• if you have any liver or kidney disease.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the drug less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of Adolonta can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you should use or the frequency with which you should use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Adolonta may be higher if:

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs (“addiction”).

- You are a smoker.

- You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental health conditions.

If you observe any of the following symptoms while using Adolonta, it could be a sign of dependence or addiction:

– You need to use the medicine for a longer time than indicated by your doctor.

– You need to use a higher dose than recommended.

– You are using the medicine for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep”.

– You have made repeated and unsuccessful attempts to stop using the medicine or control its use.

– You feel unwell when you stop using the medicine, and you feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, consult your doctor to determine the best treatment for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you interrupt treatment with Adolonta).

Respiratory problems related to sleep

Adolonta contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory problems related to sleep; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and hypoxemia related to sleep (low oxygen levels in the blood).

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

There is a high risk of experiencing a serotonin syndrome that can appear after taking tramadol in combination with certain antidepressants or tramadol in monotherapy. Consult your doctor immediately if you experience any of the symptoms linked to this severe syndrome (see section 4 “Possible adverse effects”).

Cases of seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum recommended daily dose (400 mg).

Be aware that this medicine can cause physical and psychological dependence. When used for a prolonged period, its effect may decrease, requiring the use of higher doses (development of tolerance). In patients with a tendency to abuse medicines or those with dependence on medicines, treatment with tramadol should only be carried out for short periods of time and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with this medicine or if they have occurred at any time:

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may not be possible to achieve sufficient relief from pain, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop using this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Inform your doctor if you experience any of the following symptoms while taking tramadol:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. They may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Use of Adolonta with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

It is recommended to avoid simultaneous treatment of Adolonta with MAO inhibitors (a certain type of medicine used to treat depression).

The effect and duration of pain relief produced by Adolonta may be reduced if you take medicines that contain:

• Carbamazepine (for epilepsy);
• Ondansetron (to prevent nausea).

Your doctor will indicate if you should use this medicine and in what dose.

The risk of adverse effects increases,

• if you are using this medicine simultaneously with other analgesics such as morphine and codeine (even when used to treat cough) and alcohol. In these cases, you may feel drowsiness or dizziness. If this happens, consult your doctor.

The concomitant use of Adolonta with sedatives or medicines for insomnia (such as benzodiazepines)or gabapentin or pregabalin for treating epilepsy or pain due to nervous system problems (neuropathic pain)increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, or may be potentially fatal. Therefore, it should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and strictly follow your doctor's recommended dose. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms;

• if you are takingmedicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you use Adolonta simultaneously with these medicines. Your doctor will tell you if Adolonta is suitable for you;
• if you are taking medicines for depression. Adolonta may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible adverse effects”);
• if you are taking anticoagulant coumarins (medicines to thin the blood) such as warfarin, while using Adolonta. The effect of these medicines on blood coagulation may be affected, and bleeding may occur;
• if you take medicines that can increase the accumulation of tramadol and, therefore, its adverse effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Use of Adolonta with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effect may be intensified. Food does not affect the effect of the medicine.

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Especially in children, the first injection with tramadol should be administered under strict medical supervision.

Observe the child, especially during the first administration. If you notice any warning signs (such as altered consciousness, constricted pupils, vomiting, seizures, very slow breathing ...), call a doctor immediately or consult an emergency service (see section "If you use more Adolonta than you should").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very little information available on the safety of tramadol in pregnant women. Therefore, do not use this medicine if you are pregnant.

Long-term treatment during pregnancy can cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. Therefore, do not use this medicine more than once during breastfeeding, or if you use Adolonta more than once, you should stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment withthis medicine. It is essential to observe how this medicine affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when administering it concomitantly with other medicines.

This medicine contains less than 23 mg (1 mmol) of sodium per 2 ml ampoule; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Adolonta, when and for how long you should use it, when you should contact your doctor and when you should suspend use (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest dose possible that produces pain relief should be used.Do not administer more than 8 ml of Adolonta (equivalent to 400 mg of tramadol hydrochloride) per day, unless your doctor has instructed you otherwise.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents over 12 years old

Depending on your pain, doses of 1-2 ml of Adolonta (equivalent to 50-100 mg of tramadol hydrochloride) can be administered.

Depending on the pain, the effect can last between 4-6 hours.

Additional information on administration is provided for doctors and healthcare professionals at the end of this leaflet.

Children

For children over 3 years of age, the recommended single dose is 1-2 mg of tramadol hydrochloride per kg of body weight.

The lowest effective dose that produces pain relief should be used.Do not exceed daily doses of 8 mg of tramadol hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride, whichever is less.

Additional information on administration is provided for doctors and healthcare professionals at the end of this leaflet.

Older patients

In older patients (over 75 years old), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney disease/patients on dialysis

If you have any severe liver or kidney disease, treatment with this medication is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

How and when to use Adolonta?

Administration will be performed via parenteral route: intramuscular, subcutaneous, intravenous (slow injection) or by infusion.

Additional information on administration is provided for doctors and healthcare professionals at the end of this leaflet.

For how long should Adolonta be used?

This medication should not be administered for longer than strictly necessary. If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary with interruptions in treatment) to see if you should continue treatment with tramadol and at what dose.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you use more Adolonta than you should

If you have accidentally used an additional dose, generally you will not have any negative effects. You should continue with the next dose as prescribed.

After using very high doses of the medication, contraction of the pupil, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest may occur. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the medication leaflet to the healthcare professional.

If you forget to use Adolonta

If you forget to use the medication, it is likely that the pain will return. Do not use a double dose to compensate for the missed doses, simply continue using the medication as you have been doing until now.

If you interrupt treatment with Adolonta

If you interrupt or discontinue treatment with this medication too soon, it is likely that the pain will return. If you want to discontinue treatment due to side effects, consult your doctor.

You should not stop using this medication suddenly unless your doctor tells you to. If you want to stop using your medication, talk to your doctor first, especially if you have been using it for a long time. Your doctor will inform you when and how to interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment with tramadol is interrupted. However, in rare cases, people who have been using this medication for some time may feel unwell if they interrupt treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, or experience digestive and intestinal problems. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and ringing in the ears (tinnitus). Very rarely, more unusual central nervous system symptoms have been detected, such as confusion, delirium, change in perception of personality (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after interrupting treatment with this medication, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You should consult your doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue, and/or throat and/or difficulty swallowing and hives along with difficulty breathing.

The most common side effects during treatment with tramadol are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect 1 in 10 people

• Headache, numbness.
• Fatigue.
• Vomiting, constipation, dry mouth.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, feeling of dizziness or collapse). These side effects may occur particularly in patients who are lying down or who are engaging in physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, swelling), diarrhea.
• Dermatological reactions (e.g. itching, skin rash).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures occur mainly after the use of high doses of tramadol or when another medicine that may induce them is taken simultaneously.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological changes may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and the duration of treatment). These may appear in the form of mood changes (usually euphoria, occasionally irritability), changes in activity (usually decreased and occasionally increased) and decreased cognitive and sensory perception (alterations of the senses and perception that may lead to judgment errors).
• It may cause dependence on the medicine. When treatment is stopped abruptly, withdrawal syndrome (see "If you stop treatment with Adolonta") may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath (dyspnea).
• Cases of worsening asthma have been reported, however it has not been established if they were caused by tramadol. If recommended doses are exceeded or if taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain urinating, decreased urine output (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: frequency that cannot be estimated from available data

• Decreased blood sugar levels.
• Hypophagia.
• Serotonin syndrome, which may manifest as changes in mental state (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, diarrhea) (see section 2 "What you need to know before starting to use Adolonta").

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store this medication in a safe and protected place, inaccessible to other individuals. This medication may cause severe harm or even be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date displayed on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Adolonta 100 mg/ 2 ml injectable solution and for perfusion

The active ingredient is tramadol hydrochloride. Each ampoule contains 100 mg of tramadol hydrochloride in 2 ml of injectable solution.

The other components are: sodium acetate and water for injection.

Aspect of the product and content of the packaging

Clear and colorless solution. It is presented in transparent glass ampoules supplied in packs of 5 and 100 ampoules of 2 ml.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 - 28027 Madrid, Spain

Responsible for manufacturing:

Grünenthal GmbH

Zieglerstrasse 6 - D-52078 Aachen, Germany

Last review date of this leaflet: June 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

___________________________________________________________________________

This information is intended solely for healthcare professionals:

Information on the handling of Adolonta 100 mg/2 ml injectable solution and for perfusion

The medicine is supplied in ampoules with a breaking point. The ampoule has a breaking point and can be easily opened:

1. Turn the ampoule with the tip upwards.
2. Open the ampoule at the breaking point.

Additional information on administration

For moderate pain, administer 1 ml of the solution (corresponding to 50 mg of tramadol hydrochloride). If there is no effect after 30-60 minutes, another ml can be administered.

If intense pain requires a higher dose, 2 ml of injectable solution (equivalent to 100 mg of tramadol hydrochloride) can be administered.

It may be necessary to use higher doses as needed (pain treatment according to needs), for the treatment of postoperative pain in the first hours after surgery. The doses required in 24 hours after surgery are usually not higher than those of a normal administration.

This medicine is administered intravenously (usually in the blood vessels under the surface of the arm), intramuscularly (usually in the buttocks) or subcutaneously under the skin.

Intravenous administration should be slow with 1 ml of injectable solution (equivalent to 50 mg of tramadol hydrochloride) per minute.

Alternatively, the medicine can be diluted in an appropriate solution for perfusion (e.g. 0.9% sodium chloride solution or 5% glucose solution) for administration in intravenous perfusion or in controlled analgesia of the patient (PCA).

Incompatibilities of Adolonta

This medicine has been shown to be incompatible (immiscible) with injectable solutions containing diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam, and glyceryl trinitrate.

How to use Adolonta for the treatment of children over 3 years (see section 3. “How to use Adolonta”)

Calculation of the injection volume

1. Calculate the total dose of tramadol hydrochloride (mg) required: body weight (Kg) × dose (mg/Kg).
2. Calculate the volume (ml) of the diluted solution to be injected: divide the total dose (mg) by an appropriate concentration of solution (mg/ml; see table below).

Table: Dilution of Adolonta 100 mg/2 ml injectable solution and for perfusion (suitable solvent see section “How and when to use Adolonta”).

According to your calculations, dilute the contents of the Adolonta ampoule by adding the appropriate amount of solvent, mix, and administer the calculated volume of diluted solution. Discard the remaining injectable solution.

Example

For a child weighing 27 Kg who is to be administered a dose of 1.5 mg of tramadol hydrochloride per Kg of body weight.

The total dose required is 27 Kg × 1.5 mg/Kg = 40.5 mg of tramadol hydrochloride.

A suitable concentration of diluted solution is 10.0 mg/ml, so the volume to be injected would be approximately 4 ml (40.5 mg/10.0 mg/ml = 4.05 ml).

According to the above, 1 ml of injectable solution is diluted by adding 4 ml of solvent (e.g. 0.9% sodium chloride solution or 5% glucose solution) to obtain a solution with a concentration of 10 mg of tramadol hydrochloride per ml.

4 ml of diluted solution (40 mg of tramadol hydrochloride) are administered.