ADOLONTA 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Adolonta50 mg hard capsules

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 pack

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

1. What Adolonta is and what it is 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 in the treatment of moderate to severe pain.

2. What you need to know before you take Adolonta

Do not takeAdolonta:

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute intoxication 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.

Warnings and precautions

Consult 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 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 a history of 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 can lead to a potentially life-threatening 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 using 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 option for you, when it is appropriate to stop the medicine and how to do it safely (see section 3, if you stop treatment with Adolonta).

Respiratory disorders related to sleep

Adolonta contains an active substance that belongs to the group of opioids. Opioids can cause respiratory disorders related to sleep, such as 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 your doctor immediately if you experience any symptoms related to 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 recommended daily dose (400 mg).

Keep in mind 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 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 experienced 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. These 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 epilepsy);
• 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 no other treatment options are 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 dosage recommendation. It may be helpful 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 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.

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.

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

3. How to take Adolonta

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, 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 stop using it (see also section 2).

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 400 mg of tramadol hydrochloride per day, unless your doctor has indicated otherwise.

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

Adults and adolescents over 12 years

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

Depending on the pain, the effect can last between 4-6 hours.

Children

This medicine is not recommended for children under 12 years.

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 liver or kidney 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 impairment, your doctor may prolong the dosing intervals.

How and when should you take Adolonta?

The capsules are administered orally.

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

You can take the capsules with or without food.

How long should you take Adolonta?

This medicine 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 determine if you should continue treatment with this medicine and at what dose.

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

If you take more Adolonta than you should

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

After taking very high doses of tramadol, you may experience constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up 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 medicine and the amount taken. It is recommended to take the medicine leaflet to the healthcare professional.

If you forget to take Adolonta

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

If you stop treatment with Adolonta

If you stop or finish treatment with this medicine too early, it is likely that the pain will return. If you want to stop treatment due to side effects, consult your doctor.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no side effects are experienced when treatment with tramadol is stopped. However, in rare cases, people who have been taking this medicine for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or trembly. They may be overactive, have difficulty sleeping or have digestion and bowel 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, 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 stopping treatment with this medicine, consult your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from 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 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.
• 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 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 taken simultaneously with another medicine that may induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological disturbances may appear 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 can lead to errors of judgment).
• It may cause dependence on the medicine. When treatment is interrupted abruptly, a withdrawal syndrome may appear (see "If you stop treatment with Adolonta").
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• There have been reports of worsening asthma, however, 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 medicines 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 medicine.

5. Conservation of Adolonta

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

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

Do not use this medicine after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Adolonta 50 mg hard capsules

The active ingredient 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 Package Contents

Hard gelatin capsules, size 4, with a pressure closure, shiny, yellow/yellow, oblong.

Each capsule contains a fine white to pale yellow powder.

The medicine is supplied in packages of 20, 60, and 500 capsules packaged in blisters.

Only some package 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 Last Revision of this Prospectus: June 2024

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