Prospecto: information for the user

ADOLONTA RETARD 50 mg prolonged-release tablets

Tramadol, hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Adolonta retard 50 mg and for what it is used

2.What you need to know before starting to take Adolonta retard 50 mg

3.How to take Adolonta retard 50 mg

4.Possible adverse effects

5.Storage of Adolonta retard 50 mg

6.Contents of the package and additional information

Tramadol - the active ingredient in Adolonta retard 50 mg - is a pain reliever 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 50 mg is indicated for the treatment of moderate to severe pain.

Do not take Adolonta retard 50 mg

• If you are allergic to tramadol or any of the other components of this medication (listed in section 6).
• In case of acute intoxications caused by alcohol, sleeping pills, analgesics, or psychotropic medications (medications that act on mood and emotions).
• If you are also taking MAO inhibitors (certain medications used to treat depression) or if you have taken them in the last 14 days before starting treatment with Adolonta retard 50 mg (see “Taking Adolonta retard 50 mg with other medications”).
• 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 retard 50 mg, if:

• You have consciousness disorders (if you think you are going to faint).

You are in shock (a sign of this state may be cold sweat).

• You have increased intracranial pressure (for example, after a head trauma or brain diseases).
• You have difficulty breathing.
• You are epileptic or have seizures, as the risk of these seizures may increase.
• You have depression and are taking antidepressants, as some may interact with tramadol (see “Taking Adolonta retard 50 mg with other medications”).
• You have any liver or kidney disease.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Adolonta retard 50 mg can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication to be used or the frequency with which it is used.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Adolonta retard 50 mg may be higher if:

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs (“addiction”).

- You are a smoker.

- You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment by a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using Adolonta retard 50 mg, it could be a sign of dependence or addiction:

– You need to use the medication for a longer period than indicated by your doctor.

– You need to use a higher dose than recommended.

– You are using the medication for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep”.

– You have made repeated and unsuccessful attempts to stop using the medication or control its use.

– You feel unwell when you stop using the medication, and you feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, consult your doctor to determine the best treatment for you, when it is appropriate to stop the medication, and how to do it safely (see section 3, if you interrupt treatment with Adolonta retard 50 mg).

Respiratory problems related to sleep

Adolonta retard 50 mg contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory problems related to sleep; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol in monotherapy. Consult your doctor immediately if you experience any of the symptoms linked to this severe syndrome (see section 4 “Possible adverse effects”).

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended maximum daily dose (400 mg).

Be aware that Adolonta retard 50 mg can cause physical and psychological dependence. When Adolonta retard 50 mg is used for a long period, its effect may decrease, requiring higher doses (development of tolerance).

In patients with a tendency to abuse medications or who have medication dependence, treatment with Adolonta retard 50 mg should only be carried out for short periods of time and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with Adolonta retard 50 mg or if they have occurred to you at any time.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you experience any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Inform your doctor if you experience any of the following symptoms while takingAdolonta retard 50 mg:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. They may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Taking Adolonta retard 50 mg with other medications

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

Adolonta retard 50 mg should be avoided when taken simultaneously with monoamine oxidase inhibitors (MAOIs) (certain medications for depression treatment).

The analgesic effect of Adolonta retard 50 mg and its duration may be reduced if you take medications that contain:

• Carbamazepine (for epilepsy seizures)
• Ondansetron (medication to prevent nausea)

Your doctor will indicate if you should take Adolonta retard 50 mg and at what dose.

The risk of adverse effects increases if you are taking:

• Other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Adolonta retard 50 mg. It may cause more sleepiness or the sensation of fainting. If this occurs, consult your doctor.

The concomitant use of Adolonta retard 50 mg with sedatives or sleep medications (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, only consider concomitant use when other treatment options are not possible. However, if your doctor prescribes this medication with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and strictly follow your doctor's recommended dose. 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.

• Medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Adolonta retard 50 mg simultaneously with these medications. Your doctor will tell you if Adolonta retard 50 mg is suitable for you.
• Depression medications. Adolonta retard 50 mg may interact with these medications and you may experience a serotonin syndrome (see section 4 “Possible adverse effects”).
• Anticoagulant medications, such as warfarin, taken with Adolonta retard 50 mg. The effect of these medications on blood coagulation may be affected and may lead to bleeding.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

Taking Adolonta retard 50 mg with food and alcohol

Do not consume alcohol during treatment with Adolonta retard 50 mg, as its effect may be intensified. Food does not affect the effect of Adolonta retard 50 mg.

Children and adolescents

Use in children with respiratory problems:

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is very little information available on the safety of tramadol in pregnant women. Therefore, do not take Adolonta retard 50 mg if you are pregnant.

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

Tramadol may pass into breast milk. Therefore, do not take Adolonta retard 50 mg more than once during breastfeeding or, if you take it more than once, stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Adolonta retard 50 mg. It is essential to observe how this medication affects you before driving or using machines. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Adolonta retard 50 mg contains lactose,if your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Adolonta retard 50 mg, when and for how long you should use it, when you should contact your doctor and when you should suspend use (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest dose possible that produces pain relief should 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 old

One or two Adolonta retard 50 mg prolonged-release tablets twice a day (equivalent to 100 mg – 200 mg of tramadol hydrochloride per day), preferably in the morning and at night.

Your doctor may prescribe a different and more suitable dose of this medication if necessary.

If necessary, the dose can be increased to 150 mg or 200 mg twice a day (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).

Children

Adolonta retard 50 mg is not suitable for children under 12 years old.

Older patients

In elderly patients (over 75 years old), 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 disease/patients on dialysis

If you have a serious liver or kidney disease, treatment with Adolonta retard 50 mg is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

How and when to take Adolonta retard 50 mg?

Adolonta retard 50 mg prolonged-release tablets are administered orally.

Always swallow the Adolonta retard 50 mg tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You can take the tablet with an empty stomach or with meals.

For how long should you take Adolonta retard 50 mg?

Adolonta retard 50 mg should not be administered for longer than strictly necessary.

If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary with interruptions in treatment) to see if you should continue treatment with Adolonta retard 50 mg and at what dose.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Adolonta retard 50 mg than you should

If you have taken Adolonta retard 50 mg by mistake more than you should, generally you will not have any negative effects. You should take the next dose as prescribed.

After taking very high doses, you may experience pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness 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 Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the medication leaflet to the healthcare professional.

If you forget to take Adolonta retard 50 mg

If you forget to take the tablets, it is likely that the pain will return. Do not take a double dose to compensate for the missed doses, simply continue treatment as instructed by your doctor.

If you interrupt treatment with Adolonta retard 50 mg

If you interrupt or discontinue treatment with Adolonta retard 50 mg too soon, it is likely that the pain will return. If you want to interrupt treatment due to undesirable effects, consult your doctor.

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment with Adolonta retard 50 mg is discontinued. However, in rare cases, when some people who have been taking Adolonta retard 50 mg for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disorders. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, other unusual central nervous system symptoms, such as confusion, delirium, distorted perception of one's own personality (derealization), and altered perception of reality (despersonalization), and delusions of persecution (paranoia), have been seen. If you experience any of these symptoms after discontinuing Adolonta retard 50 mg, please consult your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 hives along with difficulty breathing.

The most common side effects during treatment with Adolonta retard 50 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 and rapid heartbeats, sensation of dizziness or collapse). These side effects may occur especially in patients who are lying down or who are engaging in physical effort.
• Desire to vomit (retching), stomach problems (e.g. feeling of pressure in the stomach, swelling), diarrhea.
• Skin reactions (e.g. itching, hives).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g. difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, and numbness), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medications that may cause seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may appear after treatment with Adolonta retard 50 mg. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These problems may manifest as a change in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased) and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to judgment errors).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath (dyspnea).
• Worsening of asthma has been reported, however, no causal relationship with tramadol has been established. Exceeding the recommended doses or taking it concomitantly with other medications that depress brain function may cause a decrease in respiratory rate.
• Muscle weakness.
• Difficulty or pain urinating, decreased urine output (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

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

• Decreased blood sugar level.
• Hypophagia.
• Serotonin syndrome, which may 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 “What you need to know before starting to take ADOLONTA RETARD 50 MG”).

When treatment is stopped abruptly, signs of drug withdrawal syndrome may appear (see "If you stop taking Adolonta retard 50 mg").

Reporting of side effects:

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

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

Conserve this medication in a safe and protected place, to which other people cannot access. This medication can cause serious and even fatal harm to individuals who have not been prescribed it.

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

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Adolonta retard 50 mg prolonged-release tablets

• The active ingredient is tramadol hydrochloride. Each tablet contains 50 mg of tramadol hydrochloride.
• The other components are:

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

Coating: 6 mPa·s hypromellose, lactose monohydrate (see section 2 “Adolonta retard 50 mg contains lactose”), macrogol 6000, propylene glycol (E1520), talc, titanium dioxide (E171) and yellow iron oxide (E172).

Appearance of the product and contents of the package

Adolonta retard 50 mg prolonged-release tablets are yellowish pale-coated, round, biconvex tablets marked with "T0" on one side and the manufacturer's logo on the other.

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

Only some package sizes may be marketed.

Adolonta retard 50 mg tablets are presented in 10x1, 20x1, 30x1, 50x1, 60x1, 100x1 and 150x1 pre-cut single-dose blisters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Responsible manufacturer:

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

This medicinal product is authorized in the member states of the European Economic Area with the following names:

GermanyTramal retard 50 mg
BelgiumContramal retard 50 mg
Slovenia Tramal 50 mg
SpainAdolonta retard 50 mg

FinlandTramal retard 50 mg
LuxembourgContramal retard 50 mg

PolandTramal retard 50 mg

Last review date of this leaflet: July 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/