Adolonta 50 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adolonta 50 mg hard capsules

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 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 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.

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 medications, analgesics, or other psychotropic medicines (medicines that act on mood and emotions);
• if you are currently taking monoamine oxidase inhibitors (MAO inhibitors – a certain type of medicine used to treat depression), or if you have taken them within the last 14 days prior to 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.

Warnings and precautions

Talk to your doctor before starting to take Adolonta:

• if you think you are dependent on other analgesics (opioids);
• if you have disorders 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 a head injury 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 of these may interact with tramadol (see "Taking 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 lead to the medicine becoming less effective (the 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 you to feel a lack of control over how much medicine you use or how often you 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 or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have previously 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 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 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 interrupt treatment with 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 pauses in breathing 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 low 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 related to 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 recommended daily 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 misuse medicines or those with medicine 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

Tell 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 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 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, psychiatric medicines, antiallergic medicines such as antihistamines, or alcohol), as these 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 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 take Adolonta simultaneously with these medicines. Your doctor will tell you whether Adolonta is suitable for you;

• Medicines used to treat depression. Adolonta may interact with these medicines, and you may experience 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 altered, 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 with 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 these 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 respiratory problems:

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

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 a change in formulation, and/or when taking this medicine together with other medicines.

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; thus, it is essentially "sodium-free".

3. How to take Adolonta

Follow exactly the instructions for administering this medicine as given by your doctor. If you are unsure, 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 dose should be adjusted according to the intensity of pain and your individual sensitivity. The lowest effective dose that relieves pain should normally be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has instructed you otherwise.

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

Adults and adolescents over 12 years of age

Normally, the initial dose is 1–2 capsules (equivalent to 50–100 mg of tramadol hydrochloride).

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

Children

This medicine is not recommended for children under 12 years of age.

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 prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

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

How and when to take Adolonta

The capsules are taken orally.

Swallow the capsules whole without dividing or chewing them, with sufficient liquid.

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

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 short, regular intervals (if necessary, 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.

If you take more Adolonta than you should

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

After taking very high doses of tramadol, pinpoint pupils, vomiting, low blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties may occur, which can lead to respiratory arrest and death. 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 at 91 562 04 20 immediately, stating 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 a missed dose. Simply continue taking Adolonta as you have been doing.

If you stop taking Adolonta

If you stop or end 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 stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking this 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not usually occur when stopping treatment with tramadol. However, on rare occasions, people who have been taking this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel restless, 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 ringing in the ears (tinnitus). Very rarely, other 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, 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.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeat, feeling of dizziness or collapse). These adverse effects may particularly occur in patients who are standing up or performing physical exertion.
• Feeling the need to vomit (nausea), gastrointestinal discomfort (e.g. sensation of pressure in the stomach, bloating), diarrhoea.
• Skin reactions (e.g. itching, skin 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, epileptic seizures, muscle jerks, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic 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 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 (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 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, diarrhoea) (see section 2 “What you need to know before taking Adolonta”).

Reporting of adverse effects

If you experience any 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 blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

6. Contents of the pack and other information

Composition of Adolonta 50 mg hard capsules

The active substance is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.

The other components are: microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), colloidal anhydrous silica, magnesium stearate.

Capsule shell: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.

Appearance of the product and contents of the pack

Hard gelatin capsules, size 4, with snap-fit closure, shiny, yellow/yellow, oblong.

Each capsule contains a fine powder, white to pale yellow in colour.

The medicine is supplied in packs of 20, 60 and 500 capsules, presented in blisters.

Only certain pack sizes may be marketed.

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 most recent revision of this leaflet: October 2025

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