Adolonta 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adolonta 100 mg/ml oral solution

Tramadol hydrochloride

Read the entire leaflet carefully before you start taking 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are 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 taking Adolonta
3. How to take Adolonta
4. Possible side 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 for the treatment of moderate to severe pain in adults and children from 3 years of age.

2. What you need to know before taking 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 cases of acute intoxication due to alcohol, sleeping pills, painkillers, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (a type of medicine used to treat depression) or have taken them within 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 by treatment;
• for the treatment of withdrawal syndrome;
• in children under 3 years of age.

Warnings and precautions

Talk to your doctor before starting Adolonta if:

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

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (your body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Adolonta may also lead to dependence, abuse, and addiction, which could result in 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 the amount of 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 a family member have abused or been dependent 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 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 taking the medicine, and feel better once you resume it ("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 taking Adolonta).

Sleep-related breathing disorders

Adolonta contains an active ingredient 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 experience central sleep apnea.

There is a small risk of developing serotonin syndrome after taking tramadol, either in combination with certain antidepressants or with tramadol alone. Seek immediate medical advice if you experience any symptoms associated with this serious condition (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 daily recommended dose (400 mg).

Please note that this medicine may cause physical and psychological dependence. When used over a prolonged period, 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 Adolonta 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 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. 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.

Taking Adolonta with other medicines

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

Concomitant treatment with Adolonta and MAO inhibitors (a 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 seizures);
• Ondansetron (to prevent nausea).

Your doctor will advise you whether you should take this medicine and at what dose.

The risk of adverse effects increases if you are taking:

• Medicines for anxiety or insomnia (such as benzodiazepines) or medicines that may affect respiratory function (such as other opioids, certain cough medicines, some treatments for drug dependence, medicines for mental health, antihistamines for allergies, or alcohol), as they increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Because of this, 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 should 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 listed 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 take Adolonta simultaneously with these medicines. Your doctor will advise you whether Adolonta is suitable for you;
• Medicines used to treat 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 taking Adolonta. The effect of these medicines on blood clotting may be affected, potentially leading to bleeding;
• Medicines that may increase the accumulation of tramadol and thus 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 used to treat 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.

Taking 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 action of Adolonta.

Children and adolescents

Use in children with breathing problems:

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

In particular, the first dose of tramadol in children should be administered under strict medical supervision.

Monitor the child, especially during the first dose. If warning signs occur (such as altered consciousness, constricted pupils, vomiting, seizures, very slow breathing...), call a doctor immediately or contact 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 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 take 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 take this medicine more than once during breastfeeding, or if you take Adolonta more than once, you must stop breastfeeding.

Based on human experience, there is no indication that tramadol affects 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 formulation, and/or when taking it together with other medicines.

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

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him 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 macrogol glycerol hydroxystearate.

This medicine contains 150 mg of propylene glycol (E-1520) per 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 containing 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 exactly the instructions for using 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 to you what to 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 of age

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

The dose should be adjusted according to the intensity of pain and your individual sensitivity. The lowest possible dose that provides pain relief should normally be used. Do not take more than 32 pumps from the Adolonta dosing pump per day, equivalent to 400 mg of tramadol hydrochloride, i.e., 4 doses of 8 pumps within 24 hours, unless otherwise instructed by your doctor.

For dose adjustment in pumps, refer to the following equivalence table:

Equivalence table showing the number of pumps corresponding to the amount in mg of tramadol hydrochloride

Number of actuations	Tramadol hydrochloride content
1 actuation	12.5 mg
2 actuations	25 mg
3 actuations	37.5 mg
4 actuations	50 mg
5 actuations	62.5 mg
6 actuations	75 mg
7 actuations	87.5 mg
8 actuations	100 mg

Children

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

Doses should not exceed 2 mg of tramadol hydrochloride per kg of body weight per administration.

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

Child's weight	Child's age (approximate)	Usual dose by child's weight and per administration (in sprays*)	Maximum dose by child's weight and per administration (in sprays*)
15 kg-20 kg	3 -5 years	1 spray	2 sprays
20 kg-25 kg	5 -8 years	1 spray	3 sprays
25 kg- 35 kg	8 - 11 years	2 sprays	4 sprays
35 kg-37 kg	11 years	3 sprays	5 sprays
37 kg-44 kg	11 -13 years	3 sprays	6 sprays
44 kg- 45 kg	>13 years	3 sprays	7 sprays

*Always round the number of pump actuations down to the nearest whole number.

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.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slower. If this applies to you, your doctor may recommend increasing 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 should you take Adolonta?

It is administered orally.

The solution may be diluted in a sweetened solution or a small amount of liquid.

You may take the medicine either on an empty stomach or with food.

For how long should you take Adolonta?

This medicine should not be administered for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor you at regular and frequent intervals (possibly with treatment interruptions) to determine whether treatment with this medicine 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.

Information on handling Adolonta 100 mg/ml oral solution, pump dispenser bottle

Note on use

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

Place a container (spoon, cup, etc.) under the dispenser opening and press the pump. One complete actuation delivers an amount of oral solution containing 12.5 mg of tramadol hydrochloride (for dosing instructions, see section 3. “ How to take Adolonta”).

Note on the level of the container's content

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 between bottles (even if they are originally sealed Adolonta bottles).

If you take more Adolonta than you should

If you have taken an additional dose by mistake, you will generally not experience negative effects. Take the next dose as prescribed.

After taking very high doses of tramadol, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead 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, indicating the medicine and the amount taken. It is recommended to bring the medicine's package leaflet to the healthcare professional.

If you forget to take 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 taking Adolonta as you have been doing.

If you interrupt treatment with Adolonta

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

You must not stop taking this medicine suddenly unless your doctor tells you to do so. If you wish to stop taking your medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, in rare cases, individuals who have taken 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, and noises in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (depersonalization), changes in 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 produce 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 and rash together with difficulty breathing.

The most common 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 blood circulation (strong heartbeats and rapid heartbeats, feeling dizzy or fainting). These adverse effects may occur particularly in patients who are standing up or who are performing physical exertion.
• Feeling the need to vomit (nausea), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
• 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 heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, seizures, muscle jerks, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Seizures mainly occur 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 present 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. When 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 (dyspnoea).
• 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 1 in 10,000 people

• Increase in liver enzymes.

Frequency not known: frequency cannot be estimated from available data

• Decrease in 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, diarrhoea) (see section 2 “What you need to know before 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 and on the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

After opening the container, the solution must be used within a maximum of 12 months.

Keep the container tightly closed.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adolonta 100 mg/ml oral solution

The active substance is tramadol hydrochloride. 1 ml of solution contains 100 mg of tramadol hydrochloride (1 pump actuation delivers an amount of oral solution containing 12.5 mg of tramadol hydrochloride).

The other components are: glycerol (E-422), potassium sorbate (E-202), macrogol glycerol hydroxystearate, propylene glycol (E-1520), sodium cyclamate, sodium saccharin, sucrose (0.2 g/ml of solution), partially demethylated arvensis mint essential oil, anise flavour, and purified water.

Appearance of the product and contents of the container

Clear, colourless to slightly yellowish slightly viscous solution.

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

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 summary: October 2025

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