Package Leaflet: Information for the User

Tramadol Aristo 100 mg prolonged-release tablets EFG

tramadol hydrochloride

Read 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Tramadol, the active ingredient of this medication, 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.

Tramadol is indicated for the treatment of moderate to severe pain.

Do not take tramadol

• If you are allergic to tramadol or any of the other components of this medication (listed in section 6).
• For acute intoxications caused by alcohol, sleeping pills, analgesics, or psychotropic medications (medications that affect 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 tramadol (see "tramadol 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 or pharmacist before starting to take tramadol, 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 disease).
• 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 section "Other medications and tramadol").
• 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 tramadol can also cause dependence, abuse, and addiction, which could lead to 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 tramadol may be higher if:

• You or any family member 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 with a psychiatrist for other mental illnesses.

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

If you notice any of these signs, consult your doctor to determine the best course of treatment for you, when it is appropriate to discontinue the medication, and how to do it safely (see section 3, if you interrupt tramadol treatment).

Respiratory problems related to sleep

Tramadol 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 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 maximum recommended daily dose (400 mg).

Be aware that tramadol can cause physical and psychological dependence. When this medication 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 tramadol 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 tramadol or if they have ever occurred:

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 notice 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 taking tramadol:

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.

Tramadol with other medications

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

Simultaneous treatment with tramadol and monoamine oxidase inhibitors (MAOIs) (certain medications for depression treatment) should be avoided.

The analgesic effect and duration of tramadol 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 tramadol and at what dose.

The risk of adverse effects increases if you are taking:

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

The concomitant use of tramadol with sedatives or sleep medications (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered 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 mentioned 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 tramadol simultaneously with these medications. Your doctor will tell you if tramadol is suitable for you.

• Depression medications. Tramadol may interact with these medications and you may experience a serotonin syndrome (see section 4 "possible adverse effects").

• Anticoagulant coumarins (medications that prevent abnormal blood coagulation), such as warfarin, with tramadol. 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).

Tramadol with food and alcohol

Do not consume alcohol during tramadol treatment, as its effect may be intensified. Food does not affect the effect of tramadol.

Use in athletes

This medication contains tramadol, which may produce a positive result in doping control tests.

Children and adolescents

Use in children with respiratory problems.

Tramadol is not recommended for use 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 or plan to become 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 tramadol 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 tramadol more than once during breastfeeding or, if you take it more than once, discontinue breastfeeding.

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

Driving and operating machines

Ask your doctor if you can drive or operate machines during tramadol treatment. It is essential to observe how this medication affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or administering it concurrently with other medications.

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

Follow exactly the administration instructions of this medication as 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 tramadol, when and for how long you should use it, when you should contact your doctor, and when you should discontinue use (see also section 2).

The dose should be adjusted according 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

A tramadol 100 mg tablet twice a day (equivalent to 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

Tramadol is not recommended for children under 12 years old.

Older adults

In older adults (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 disease/patients on dialysis

If you have a severe liver or kidney disease, treatment with tramadol is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

How and when to take tramadol

Tramadol is administered orally.

The tramadol tablets should always be swallowed 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 tramadol?

Tramadol 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 tramadol 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 tramadol than you should

If you have taken tramadol in error, you will generally 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 may lead to respiratory arrest. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call theService ofInformationToxicológica, telephone (91) 562.04.20, indicating the medication and the amount taken. It is recommended to bring the medication package insert to the healthcare professional.

If you forget to take tramadol

If you forget to take the tablets, it is likely that the pain will recur. 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 tramadol

If you interrupt or discontinue treatment with tramadol too soon, it is likely that the pain will recur. If you want to discontinue 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 discontinue 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 discontinuing treatment with tramadol. However, in rare cases, when some people who have been taking tramadol 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 (depersonalization), and delusions of persecution (paranoia), have been seen. If you experience any of these symptoms after stopping tramadol, 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 medicinemay 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 facial swelling, tongue swelling, and/or throat swelling and/or difficulty swallowing and hives accompanied by difficulty breathing.

The most common side 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 up to 1 in 10 people

• Headache, numbness.
• Fatigue.
• Vomiting, dry mouth, constipation.
• Sweating (hyperhidrosis).

Uncommon:may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, feeling of dizziness or collapse). These side effects may occur especially in patients who are lying down or who are physically exerting themselves.
• 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 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, 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 can cause seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may appear after treatment with tramadol. Their intensity and nature may vary (in accordance with 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 the senses and recognition, which may lead to judgment errors).
• Dependence on the drug 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. If the recommended doses are exceeded or if taken concomitantly with other medications that depress cerebral function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain urinating, decreased urine output (dysuria).

Very rare:may affect up to 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: thefrequency cannot be estimated from the 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 Tramadol Aristo").

When treatment is stopped abruptly, signs of drug withdrawal syndrome (see "If you stop taking Tramadol Aristo").

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 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.

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

Do not use this medicationafter 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. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Tramadol Aristo

- The active ingredient is tramadol hydrochloride. Each prolonged-release tablet contains 100 mg of tramadol hydrochloride.

- The other components are: hypromellose, microcrystalline cellulose, povidone, anhydrous colloidal silica, magnesium stearate, macrogol 6,000, titanium dioxide (E-171), talc, and a 30% dispersion of polyacrylate.

Appearance of the product and content of the packaging

Prolonged-release tablets coated with a white color, round, biconvex, and without scoring.

It is presented in packaging of 20 or 60 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Responsible for manufacturing

G.L. Pharma GmbH

Industriestrasse 1,

A-8502 Lannach

Austria

Last review date of this leaflet:April 2025

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/