Adolonta 100 mg/2 ml solution for injection and infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adolonta 100 mg/2 ml solution for injection and infusion

Tramadol hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Adolonta is and what it is used for
2. What you need to know before using Adolonta
3. How to use Adolonta
4. Possible adverse effects
5. How to store Adolonta
6. Contents of the pack and other information

1. What Adolonta is and what it is used for

Tramadol – the active substance in this medicine – is an analgesic belonging to the opioid group that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Adolonta is used to treat moderate to severe pain in adults and children aged 3 years and older.

2. What you need to know before using Adolonta

Do not use Adolonta:

• if you are allergic to tramadol or any of the other components of this medicine (listed in section 6);
• in cases of acute intoxication caused by alcohol, sleeping medications, painkillers, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are currently taking MAO inhibitors (a certain type of medicine used to treat depression) or have taken them within 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 by treatment;
• for the treatment of withdrawal syndrome;
• in children under 3 years of age.

Warnings and precautions

Consult your doctor before starting to use Adolonta:

• if you think you are dependent on other painkillers (opioids);
• if you have disturbances of consciousness (if you feel you might faint);
• if you are in shock (a sign of this condition may be cold sweating);
• if you have increased intracranial pressure (for example, after head trauma or brain diseases);
• if you have difficulty breathing;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you have depression and are taking antidepressants, since some may interact with tramadol (see “Use of Adolonta with other medicines”);
• if you have liver or kidney disease.

Tolerance, dependence, and addiction

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

Dependence or addiction may cause a feeling of losing control over how much medicine you need or how often you need to take 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 alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

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

• You need to use the medicine for longer than prescribed 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 stay calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and feel better once you take it again (“withdrawal effects”).

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

Sleep-related breathing disorders

Adolonta contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels).

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

There is a slight risk of developing serotonin syndrome after taking tramadol, either in combination with certain antidepressants or tramadol used as monotherapy. Seek immediate medical advice if you experience any symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

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).

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

Also inform your doctor if any of these problems occur during treatment with this medicine or if you have ever experienced them.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop using this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, 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. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Use of Adolonta with other medicines

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

Concomitant treatment with Adolonta and MAO inhibitors (a certain type of medicine used to treat depression) should be avoided.

The effect and duration of pain relief provided by Adolonta may be reduced if you take medicines containing:

• Carbamazepine (for epileptic seizures);
• Ondansetron (to prevent nausea).

Your doctor will advise you whether to use this medicine and at what dose.

The risk of adverse effects increases if you are taking:

• Medicines for anxiety or insomnia treatment (such as benzodiazepines) or medicines that may affect respiratory function (such as other opioids, certain cough medicines, some treatments for drug dependence, psychiatric medicines, allergy medicines such as antihistamines, or alcohol), as they increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol together with sedative medicines, your dose and duration of concomitant treatment will be limited.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. 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;

• Medicines that may lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you use Adolonta simultaneously with these medicines. Your doctor will determine whether Adolonta is suitable for you;
• Medicines for the treatment of depression. Adolonta may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”);
• Coumarin anticoagulants (blood-thinning medicines) such as warfarin, while using Adolonta. The effect of these medicines on blood clotting may be altered, leading to bleeding;
• Medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (e.g., ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin);
• Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain);
• Medicines that may have anticholinergic effects, such as
  • Medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics);
  • Medicines for psychiatric disorders (antipsychotics or neuroleptics);
  • Muscle relaxants;
  • Medicines used to treat Parkinson’s disease.

as they may increase the risk of adverse effects such as constipation, urinary retention, dry mouth, or dry eyes.

Use of Adolonta with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effects may be intensified. Food does not affect the medicine’s action.

Children and adolescents

Use in children with respiratory problems:

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

In particular, the first tramadol injection in children must be administered under strict medical supervision.

Monitor the child, especially during the first administration. In case of warning signs (such as altered consciousness, pupil constriction, vomiting, seizures, very slow breathing...), call a doctor immediately or contact an emergency service (see section “If you use more Adolonta than you should”).

Pregnancy, breastfeeding, and fertility

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

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

Chronic treatment during pregnancy may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not use this medicine more than once during breastfeeding. If you use Adolonta more than once, you must stop breastfeeding.

Based on human experience, tramadol is not considered to affect fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while taking this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulations, and/or when taking this medicine together with other medicines.

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

3. How to use Adolonta

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest possible dose that provides 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 specifically instructed otherwise.

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

Adults and adolescents over 12 years of age

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

Depending on the pain, the effect may last between 4–6 hours.

Additional information on administration for doctors and healthcare professionals is provided 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 provides pain relief should be used. Daily doses must not exceed 8 mg of tramadol hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride, whichever is lower.

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

Elderly patients

In elderly patients (over 75 years of age), tramadol elimination may be slow. If this applies to you, your doctor may recommend extending the dosing intervals.

Patients with hepatic or renal impairment / patients on dialysis

If you have severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when to use Adolonta?

Administration is by parenteral route: intramuscular, subcutaneous, intravenous (slow injection), or by infusion.

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

How long should you use Adolonta?

This medicine should not be administered for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor you at short, regular intervals (if necessary with treatment interruptions) to determine whether treatment with tramadol should continue and at what dose.

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

If you use more Adolonta than you should

If you have accidentally taken an additional dose, you will generally not experience negative effects. Continue with the next dose as prescribed.

After taking very high doses of the medicine, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (profound unconsciousness), epileptic seizures, and breathing difficulties that may progress to respiratory arrest and death may occur. In such a case, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine's package leaflet to the healthcare professional.

If you forget to use Adolonta

If you forget to take the medicine, your pain may return. Do not take a double dose to make up for missed doses; simply continue using the medicine as you have been doing.

If you stop using Adolonta

If you stop or discontinue treatment with this medicine too soon, your pain is likely to return. If you wish to stop treatment due to adverse effects, consult your doctor.

Do not suddenly stop using this medicine unless instructed by your doctor. If you wish to stop taking this medicine, speak with your doctor first, especially if you have been using 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 unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, on rare occasions, individuals who have been using this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, altered perception of personality (depersonalization), altered perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, consult your doctor.

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

4. Possible adverse effects

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

You must 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, rash, and difficulty breathing.

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

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heart rate, feeling of dizziness or collapse). These adverse effects may particularly occur in patients who are standing up or performing physical exertion.
• Feeling of wanting to vomit (nausea), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g. itching, rash).

Rare: may affect up to 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 twitching, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Seizures occur mainly after using high doses of tramadol or when taken simultaneously with another medicine that may trigger them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological disturbances may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These may manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• May lead to drug dependence. If treatment is abruptly discontinued, withdrawal syndrome may occur (see “If you stop taking Adolonta”).
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• Cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

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

• Increased liver enzymes.

Frequency not known: frequency cannot be estimated from available data

• Decreased blood sugar levels.
• 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, diarrhea) (see section 2 “What you need to know before starting to use Adolonta”).

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Conservation of Adolonta

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

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Adolonta 100 mg/2 ml injectable and infusion solution

The active substance 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 injections.

Appearance of the product and contents of the container

Clear, colourless solution. It is supplied in clear glass ampoules, available in packs of 5 and 100 ampoules of 2 ml.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 - 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse 6 - D-52078 Aachen, Germany

Date of the most recent revision of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

___________________________________________________________________________

This information is intended for healthcare professionals only:

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

The medicine is supplied in breakable ampoules. The ampoule has a scored line and can be opened easily:

1. Rotate the ampoule with the tip pointing upwards.
2. Break the ampoule along the scored line.

Additional information on administration

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

In cases of severe pain requiring a higher dose, 2 ml of injectable solution (equivalent to 100 mg of tramadol hydrochloride) may be administered.

Higher on-demand doses may be required (pain treatment according to need), particularly for postoperative pain management during the first hours after surgery. The total doses required within 24 hours after surgery are generally not higher than those used in normal administration.

This medicine is administered intravenously (usually into the veins on the surface of the arm), intramuscularly (usually into the buttocks), or subcutaneously under the skin.

Intravenous administration must be slow, at a rate of 1 ml of injectable solution (equivalent to 50 mg of tramadol hydrochloride) per minute.

Alternatively, the medicine may be diluted in a suitable infusion solution (e.g. 0.9% sodium chloride solution or 5% glucose solution) for intravenous infusion or for patient-controlled analgesia (PCA).

Incompatibilities of Adolonta

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

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

Calculation of injection volume

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

Table: Dilution of Adolonta 100 mg/2 ml injectable and infusion solution (suitable diluent, 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 any remaining injectable solution.

Example

For a child weighing 27 kg who is to receive a dose of 1.5 mg of tramadol hydrochloride per kg of body weight.

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

An appropriate concentration of diluted solution is 10.0 mg/ml; therefore, the volume to be injected would be approximately 4 ml (40.5 mg / 10.0 mg/ml = 4.05 ml).

Accordingly, 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 diluted solution with a concentration of 10 mg of tramadol hydrochloride per ml.

Administer 4 ml of the diluted solution (40 mg of tramadol hydrochloride).