Adolonta Retard 200 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ADOLONTA RETARD 200 mg prolonged-release tablets

Tramadol hydrochloride

Read all of this 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 other people, 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Adolonta Retard 200 mg is and what it is used for
2. What you need to know before taking Adolonta Retard 200 mg
3. How to take Adolonta Retard 200 mg
4. Possible side effects
5. How to store Adolonta Retard 200 mg
6. Contents of the pack and other information

1. What ADOLONTA RETARD 200 MG is and what it is used for

Tramadol – the active substance in Adolonta Retard 200 mg – 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 Retard 200 mg is indicated for the treatment of moderate to severe pain.

2. What you need to know before taking ADOLONTA RETARD 200 MG

Do not take Adolonta retard 200 mg

• If you are allergic to tramadol or any of the other components of this medicine (listed in section 6).
• In cases of acute intoxication caused by alcohol, sleeping medications, analgesics, or psychotropic drugs (medications that affect mood and emotions).
• If you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression) or have taken them within the last 14 days before starting treatment with Adolonta retard 200 mg (see "Taking Adolonta retard 200 mg 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 retard 200 mg if:

• You experience disturbances in 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 a head injury 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 them may interact with tramadol (see "Taking Adolonta retard 200 mg 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 cause the drug to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Adolonta retard 200 mg 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 lack of control over the amount of medicine you need to take 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 retard 200 mg may be higher if:

• You or any member of your family has abused alcohol or experienced dependence 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 received psychiatric treatment for other mental illnesses.

If you notice any of the following symptoms while using Adolonta retard 200 mg, 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 take a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to stay 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 taking 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 interrupt treatment with Adolonta retard 200 mg).

Sleep-related breathing disorders

Adolonta retard 200 mg 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 experience central sleep apnea.

There is a slight risk of developing serotonin syndrome after taking tramadol, either in combination with certain antidepressants or tramadol used alone. Consult a doctor immediately if you experience any 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 tramadol dose exceeds the maximum recommended daily dose (400 mg).

Please note that Adolonta retard 200 mg may cause physical and psychological dependence. When Adolonta retard 200 mg is used over a long period, its effect may decrease, requiring higher doses (development of tolerance).

In patients with a tendency to misuse medicines or who have medicine dependence, treatment with Adolonta retard 200 mg should only be carried out over short periods and under strict medical supervision.

Also inform your doctor if any of these problems occur during treatment with Adolonta retard 200 mg 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 Adolonta retard 200 mg:

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 retard 200 mg 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 retard 200 mg and monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) should be avoided.

The analgesic effect of Adolonta retard 200 mg and its duration may be reduced if you take medicines containing:

• Carbamazepine (for epileptic seizures)
• Ondansetron (a medicine to prevent nausea)

Your doctor will advise you whether you should take Adolonta retard 200 mg 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, antiallergic medicines such as antihistamines, 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 this medicine 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 retard 200 mg simultaneously with these medicines. Your doctor will tell you whether Adolonta retard 200 mg is suitable for you;
• Medicines for the treatment of depression. Adolonta retard 200 mg may interact with these medicines, and you may experience serotonin syndrome (see section 4, "Possible side effects");
• Coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, together with Adolonta retard 200 mg. The effect of these medicines on blood clotting may be affected, potentially leading to bleeding;
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain);
• Medicines that may have 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 for Parkinson's disease.

as they may increase the risk of adverse effects such as constipation, urinary retention, dry mouth, or dry eyes.

Taking Adolonta retard 200 mg with food and alcohol

Do not consume alcohol during treatment with Adolonta retard 200 mg, as its effects may be intensified. Food does not affect the action of Adolonta retard 200 mg.

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 Adolonta retard 200 mg if you are pregnant.

Chronic treatment during pregnancy may lead to withdrawal syndrome in newborns.

Tramadol may pass into breast milk. For this reason, you should not take Adolonta retard 200 mg more than once during breastfeeding; otherwise, if you take it 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 being treated with Adolonta retard 200 mg. 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 vision 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 taken together with other medicines.

Adolonta retard 200 mg contains lactose; if your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take ADOLONTA RETARD 200 MG

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 what you can expect from using Adolonta Retard 200 mg, 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 provides pain relief should normally be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has specifically instructed you to do so.

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

Adults and adolescents over 12 years of age

One Adolonta Retard 200 mg prolonged-release tablet twice daily (equivalent to 400 mg of tramadol hydrochloride per day), preferably in the morning and at night.

If necessary, your doctor may prescribe a different and more appropriate dose of this medicine.

If needed, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).

Children

Adolonta Retard 200 mg is not suitable 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

If you suffer from severe liver or kidney disease, treatment with Adolonta Retard 200 mg is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when to take Adolonta Retard 200 mg

Adolonta Retard 200 mg prolonged-release tablets are taken orally.

Adolonta Retard 200 mg tablets must always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You may take the tablet on an empty stomach or with food.

How long should you take Adolonta Retard 200 mg?

Adolonta Retard 200 mg should not be administered for longer than strictly necessary.

If prolonged treatment is required, your doctor will monitor you at short and regular intervals (if necessary with treatment interruptions) to determine whether treatment with Adolonta Retard 200 mg 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 Retard 200 mg than you should

If you have accidentally taken more Adolonta Retard 200 mg than prescribed, you generally will not experience negative effects. Take the next dose as prescribed.

After taking very high doses, 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 Retard 200 mg

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for the missed doses; simply continue treatment as directed by your doctor.

If you stop taking Adolonta Retard 200 mg

If you stop or discontinue treatment with Adolonta Retard 200 mg too early, your pain is likely to return. If you wish to stop treatment due to undesirable effects, consult your doctor.

Do not stop taking this medicine suddenly unless instructed by your doctor. 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 on when and how to stop, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).

Generally, no undesirable effects occur when stopping treatment with Adolonta Retard 200 mg. However, in rare cases, some individuals who have been taking Adolonta Retard 200 mg for some time may feel unwell when stopping abruptly. They may feel agitated, anxious, nervous, or tremulous. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, other uncommon central nervous system (CNS) symptoms have been observed, such as confusion, delirium, distorted perception of one's own personality (depersonalization), altered perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping Adolonta Retard 200 mg, please 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 may cause adverse effects, although not everyone experiences 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, rash together with difficulty breathing.

The most common adverse effects during treatment with Adolonta retard 200 mg 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.
• Vomiting, dry mouth, constipation.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are standing up or performing physical exertion.
• Feeling of wanting to vomit (nausea), stomach problems (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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (such as itching, tingling, and numbness), tremor, epileptic seizures, muscle twitching, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medicines that may provoke seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may occur after treatment with Adolonta retard 200 mg. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (changes in senses and recognition, which may lead to impaired judgment).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. 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 RETARD 200 MG”).

When treatment is stopped abruptly, signs of drug withdrawal syndrome may occur (see "If you stop taking Adolonta retard 200 mg").

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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ADOLONTA RETARD 200 MG

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

Store this medicine in a safe and secure place, inaccessible to others. 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 after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adolonta retard 200 mg prolonged-release tablets

• The active substance is tramadol hydrochloride. Each tablet contains 200 mg of tramadol hydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose, hypromellose 100,000 mPa·s, magnesium stearate, anhydrous colloidal silica.

Film coating: hypromellose 6 mPa·s, lactose monohydrate (see section 2 “Adolonta retard 200 mg contains lactose”), macrogol 6000, propylene glycol (E1520), talc, titanium dioxide (E171), quinoline yellow lake (E104), red iron oxide (E172), and brown iron oxide (E172).

Nature of the product and pack contents

Adolonta retard 200 mg prolonged-release tablets are orange film-coated tablets with a slightly brownish hue, round and biconvex, marked with "T3" on one side and the manufacturer's logo ? on the other.

Adolonta retard 200 mg tablets are contained in blister strips and packaged in boxes containing 10, 20, 30, 50, 60, 100 and 150 (10x15) tablets.

Only certain pack sizes may be commercially available.

Adolonta retard 200 mg tablets are available in packs of 10x1, 20x1, 30x1, 50x1, 60x1, 100x1 and 150x1 in single-dose precut blisters.

Only certain pack sizes may be commercially available.

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany Tramal retard 200 mg
Belgium Contramal retard 200 mg
Denmark Nobligan retard 200 mg
Spain Adolonta retard 200 mg
Finland Tramal retard 200 mg
France Topalgic L.P. 200 mg
Italy Contramal 200 mg
Luxembourg Contramal retard 200 mg
Portugal Tramal retard 200 mg
Sweden Nobligan retard 200 mg

Date of the most recent revision of this leaflet: October 2025

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