ADOLONTA 100 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Adolonta 100 mg/ml Oral Solution

Tramadol, Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Adolonta and what is it used for

Tramadol - the active substance of this medicine - is an analgesic belonging to the group of opioids 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 from 3 years of age.

2. What you need to know before you take Adolonta

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 medicines (medicines that act on mood and emotions);
• if you are taking MAO inhibitors (a certain type of medicine used to treat depression) or if you have taken them in the last 14 days before 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 taking Adolonta:

• if you think you are dependent on other analgesics (opioids);
• if you have disorders of consciousness (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 (e.g. 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 lead to dependence, abuse and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Adolonta may be greater 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 problems with your mood (depression, anxiety or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

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

• You need to use the medicine for longer 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 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 stop taking Adolonta).

Sleep-related respiratory disorders

Adolonta contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related respiratory disorders; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (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 weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you experience any of the 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 dose of tramadol exceeds the maximum daily recommended dose (400 mg).

Note that this medicine can cause physical and psychological dependence. When this medicine is used for a long period, its effect may decrease, and higher doses may be needed (development of tolerance). In patients with a tendency to abuse medicines or those with drug dependence, treatment with Adolonta should only be carried out for short periods and under strict medical control.

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

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, sufficient pain relief may not be achieved, while others are more likely to 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, 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. 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 hormonal supplements.

Taking Adolonta with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

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

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

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

The risk of side effects increases

• if you are taking 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 drowsy or dizzy. If this happens, consult your doctor.

Concomitant use of Adolonta with sedatives or medicines for the treatment of insomnia (such as benzodiazepines) or gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma or can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol with sedative medicines, they will limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dose recommendation. It may be useful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms;

• if you are taking medicines that can cause or facilitate 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 medicines for the treatment of depression. Adolonta can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects");
• if you are taking anticoagulant medicines such as warfarin while taking 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 side 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:

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

In particular, in children, the first administration of tramadol should be carried out under strict medical supervision.

Monitor the child, especially during the first administration. In case of 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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Chronic treatment during pregnancy can cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or if you take Adolonta more than once, you should interrupt breastfeeding.

Based on human experience, it is not suggested that tramadol affects fertility in men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with this medicine. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel sleepy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation and/or when administered concomitantly with other medicines.

Adolonta contains sucrose, macrogolglycerol hydroxystearate, propylene glycol (E-1520) and sodium

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult 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 can cause stomach upset and diarrhea because it contains macrogolglycerol hydroxystearate.

This medicine contains 150 mg of propylene glycol (E-1520) in 1 ml of solution. If the baby is less than 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".

3. How to Take Adolonta

Follow your doctor's administration instructions for this medication exactly. 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 recommended dose is, unless your doctor has given you different instructions:

Adults and Adolescents Over 12 Years

Normally, the initial dose is 4-8 sprays of the Adolonta dosing pump (equivalent to 50-100 mg of tramadol hydrochloride). 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 possible dose that produces pain relief should be used. Do not take more than 32 sprays of the Adolonta dosing pump per day, equivalent to 400 mg of tramadol hydrochloride, i.e., 4 doses of 8 sprays in 24 hours, unless your doctor has instructed you to do so.

For dose adjustment in sprays, consult the following equivalence table:

Table of Equivalences of the Number of Sprays Corresponding to the Content in mg of Tramadol Hydrochloride

Children

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

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

Approximately, the recommended usual and maximum doses per dose, according to weight, are as follows:

*Always round the number of sprays down to the nearest unit.

The effective lowest dose that produces pain relief should be used. Daily doses of 8 mg of tramadol hydrochloride per kilogram of body weight or 400 mg of tramadol hydrochloride should not be exceeded, whichever is lower.

Elderly Patients

In elderly patients (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 Hepatic or Renal Insufficiency/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 disorders, your doctor may prolong the dosing intervals.

How and When Should You Take Adolonta?

It is administered orally.

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

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

How Long Should You Take Adolonta?

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 this medication and at what dose.

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

Information on Handling Adolonta 100 mg/ml Oral Solution, Bottle with Dosing Pump

Note on Use

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

Place the container (spoon, cup, etc.) under the dispenser opening and actuate the pump. One complete spray releases an amount of oral solution that contains 12.5 mg of tramadol hydrochloride (for dosing 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 liquid level may vary by a few millimeters from one bottle to another (even if they are originally sealed Adolonta bottles).

If You Take More Adolonta Than You Should

If you have taken an extra dose by mistake, it will generally not have negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, pupil contraction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication prospectus to the healthcare professional.

If You Forget to Take Adolonta

If you forget to take the medication, it is likely that the pain will return. Do not take a double dose to make up for the forgotten doses; simply continue taking Adolonta as you have been doing until then.

If You Interrupt Treatment with Adolonta

If you interrupt or finish treatment with this medication too early, it is likely that the pain will reappear. If you want to interrupt treatment due to adverse effects, consult your doctor.

You should not stop taking this medication suddenly unless your doctor tells you to do so. 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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Generally, no adverse effects are usually present when treatment with tramadol is interrupted. However, in rare cases, people who have been taking this medication for some time may feel unwell if they interrupt treatment abruptly. They may feel agitated, anxious, nervous, or tremulous. They may be overactive, have difficulty sleeping, or have digestion and intestinal problems. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, 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 (depersonalization), and change in perception of reality (derealization) and persecution delusions (paranoia). If you experience any of these symptoms after interrupting treatment with this medication, consult your doctor.

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

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

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

The most frequent adverse 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 circulation (strong and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g., itching, 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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, numbness), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after taking high doses of tramadol or when another medication that can induce them has been taken simultaneously.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological alterations may appear after treatment with tramadol. Their intensity and nature may vary (according to 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 decrease and occasionally increase), and decreased cognitive and sensory perception (alterations of the senses and perception that can lead to errors of judgment).
• It can cause dependence on the medication. When treatment is interrupted abruptly, withdrawal syndrome may appear (see "If you interrupt treatment with Adolonta").
• Blurred vision, pupil contraction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• There have been reports of worsening asthma, but it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or if it is taken concomitantly with other medications that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

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

• Decrease in blood sugar levels.
• Hypo.
• Serotonin syndrome, which can 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before you start taking Adolonta").

Reporting of Adverse Effects

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

5. Conservation of Adolonta

Keep this medication out of sight and reach of children.

Keep this medication in a safe and protected place, where others cannot access it. This medication can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medication after the expiration date that appears on the packaging and on 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 tightly closed.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Adolonta 100 mg/ml Oral Solution

The active principle is tramadol hydrochloride. 1 ml of solution contains 100 mg of tramadol hydrochloride (1 spray of the dosing pump releases an amount of oral solution that contains 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, sucrose (0.2 g/ml of solution), partially demetholized peppermint essential oil, anise flavor, and purified water.

Appearance of the Product and Contents of the Packaging

Transparent solution, colorless to slightly yellowish and slightly viscous.

The medication is presented in brown glass bottles with a dosing pump that contains 30 ml of oral solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 - 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse 6 - D-52078 Aachen, Germany

Date of the Last Revision of this Prospectus: June 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/