Prospecto: information for the user

Adolonta 100 mg/ml oral solution

Tramadol, hydrochloride

Read this prospect carefully before starting to take this medicine, 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 medicine has been prescribed only for you, and you should not give it to others 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 Adolonta is and for what it is used

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

3.How to take 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 relieves pain by acting on specific nerve cells in the spinal cord and brain.

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

Do not take 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 the mood and emotions);
• if you are also taking MAO inhibitors (a certain type of medicine used for the treatment of depression) or if you have taken them in the last 14 days before starting treatment with this medicine (see "Taking 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 of age.

Warnings and precautions

Consult your doctor before starting to take 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 a state of shock (a sign of this state may be cold sweat);
• if you have increased intracranial pressure (for example, after a head injury or diseases that affect the brain);
• if you have difficulty breathing;
• if you are epileptic or have seizures, as the risk of seizures may increase;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Taking 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 medicine 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 your mood (depression, anxiety, or a personality disorder) or have followed treatment with a psychiatrist for other mental illnesses.

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 period 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 course of treatment for you, when it is appropriate to stop taking 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 serious syndrome (see section 4 "Possible side effects").

Clinical trials have reported seizures 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 Adolonta 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 metabolized 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 pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking 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.

Taking Adolonta with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Adolonta should not be used simultaneously with MAO inhibitors (a certain type of medicine used for the treatment of 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 tell you if you should take this medicine and in what dose.

The risk of adverse effects increases,

• if you are taking this medicine simultaneously with other analgesics such as morphine and codeine (even when used for cough treatment) and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.

The concomitant use of Adolonta with sedatives or sleep aids (such as benzodiazepines) or gabapentin or pregabalin for treating epilepsy or nerve pain (neuropathic pain) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, or can be potentially fatal. Therefore, only consider concomitant use 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 follow your doctor's dose recommendation strictly. 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 taking medicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Adolonta simultaneously with these medicines. Your doctor will tell you if Adolonta is suitable for you;
• if you are taking antidepressants. Adolonta may interact with these medicines and you may experience a serotonin syndrome (see section 4 "Possible side effects");
• if you are taking anticoagulant coumarins (medicines to thin the blood) such as warfarin, while taking Adolonta. The effect of these medicines on blood coagulation may be affected, and bleeding may occur;
• if you are taking 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).

Taking 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 Adolonta.

Children and adolescents

Use in children with respiratory problems:

Adolonta 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 administration of tramadol should be carried out 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 take more Adolonta than you should").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 take 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 take this medicine more than once during breastfeeding, or if you take Adolonta more than once, stop breastfeeding.

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

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with this medicine.

It is essential 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 vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medicines.

Adolonta contains saccharose, hydroxyestearate of macrogolglycerol, propylene glycol (E-1520), and sodium

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. If this medicine is to be used chronically (e.g., for two weeks or more), it may cause tooth decay.

This medicine may cause stomach discomfort and diarrhea because it contains hydroxyestearate of macrogolglycerol.

This medicine contains 150 mg of propylene glycol (E-1520) per 1 ml of solution. If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml of solution; this is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. If in 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 discontinue use (see also section 2).

The recommended dose is, unless your doctor has given you different instructions:

Adults and adolescents over 12 years old

Normally, the initial dose is 4-8 pulses from the Adolonta pump (equivalent to 50-100 mg of hydrochloride tramadol). Depending on the pain, the effect of the medication may last between 4-6 hours.

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 take more than 32 pulses from the Adolonta pump equivalent to 400 mg of hydrochloride tramadol per day, that is, 4 doses of 8 pulses in 24 hours, unless your doctor has indicated otherwise.

To adjust the dose in pulses, consult the following table of equivalences:

Table of equivalences of the number of pulses corresponding to the content in mg of hydrochloride tramadol

Children

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

Do not exceed 2 mg of hydrochloride tramadol per kg of body weight per dose.

Approximate usual and maximum doses per dose, according to weight, are as follows:

*Always round the number of pulses to the lower unit.

Use the most effective dose possible that produces pain relief. Do not exceed daily doses of 8 mg of hydrochloride tramadol per kg of body weight or 400 mg of hydrochloride tramadol, whichever is less.

Older adults

In older adults (over 75 years) 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 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 take Adolonta?

It is administered orally.

The solution can be dissolved in a sweet solution or in a little liquid.

You can take the medication with an empty stomach or with meals.

For how long should you take Adolonta?

This medication should not be administered for longer than strictly necessary. If you need 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 this medication and at what dose.

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

Information on the management of Adolonta 100 mg/ml oral solution, bottle with pump

Note on use

Before using the pump for the first time, actuate it several times until the oral solution appears (due to technical reasons, it is necessary for the pump mechanism to fill and the release of solution to be homogeneous).

Place the container (spoon, cup, etc.) under the opening of the dispenser and actuate the pump. One complete pulse releases a quantity of oral solution containing 12.5 mg of hydrochloride tramadol (for dosage instructions, see section 3.“How to take Adolonta”).

Note on the level of the contents of the container

Due to differences in the thickness of the glass walls and the bottom of the bottles, the level of the liquid may vary by a few millimeters from one bottle to another (even if these are original Adolonta bottles sealed).

If you take more Adolonta than you should

If you have taken an additional dose by mistake, generally there will be no negative effects. Take the next dose as prescribed.

After taking very high doses of tramadol, you may experience pupil constriction, 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. In this case, call a doctor immediately!

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

If you forget to take Adolonta

If you forget to takethe medicationit is likely that the pain will return. Do not take a double dose to compensate for the missed doses, simply continue taking Adolonta 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.

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

Generally, there are no side effects when treatment is discontinued. However, in rare cases, people who have been taking this medication for some time may feel unwell if they discontinue treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit 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 symptoms of the central nervous system 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 discontinuing 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 may 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.
• Constipation, dry mouth, vomiting.
• 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 mainly occur after taking 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 taking Adolonta") may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath (dyspnea).
• There have been reports of cases of asthma worsening, 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 cerebral 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 take 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 location, inaccessible to others. This medication may cause severe harm or even be fatal to individuals not prescribed it.

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

Once the packaging is opened, the solution must be used within a maximum period of 12 months.

Keep the packaging well closed.

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. In case of 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/ml oral solution

The active ingredient is tramadol hydrochloride. 1 ml of solution contains 100 mg of tramadol hydrochloride (1 pump stroke releases an amount of oral solution containing 12.5 mg of tramadol hydrochloride).

The other components are: glycerol (E-422), potassium sorbate (E-202), macrogolglycerol hydroxystearate, propylene glycol (E-1520), sodium cyclamate, sodium saccharin, saccharose (0.2 g/ml of solution), partially demetholated arvense peppermint essential oil, anise flavor, and purified water.

Appearance of the product and contents of the packaging

Clear, colorless to slightly yellowish, and slightly viscous solution.

The medicine is presented in brown glass bottles equipped with a pump dispenser containing 30 ml of oral solution.

Holder of the marketing authorization and manufacturer responsible

Holder of the marketing authorization:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 - 28027 Madrid, Spain

Manufacturer responsible:

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/