TRAMADOL ARISTO 100 mg PROLONGED-RELEASE TABLETS

2. What you need to know before you take Tramadol Aristo

Do not take tramadol

• 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, painkillers, or psychotropic drugs (drugs that act on mood and emotions).
• If you are 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 "Taking tramadol 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 or pharmacist before starting to take tramadol if:

• you have disorders of consciousness (if you think you are going to faint).
• you are in a state of shock (a sign of this state may be cold sweat).
• you have increased pressure inside the skull (e.g., after a head injury or diseases that affect the brain).
• you have difficulty breathing.
• you are epileptic or have seizures, as the risk of these seizures may increase.
• you suffer from depression and are taking antidepressants, as some may interact with tramadol (see section "Other medicines and tramadol").
• 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 tramadol can also lead to dependence, abuse, and addiction, which could lead to a potentially fatal 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 tramadol may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription drugs, 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 tramadol, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period 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 and 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 for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you stop treatment with tramadol).

Respiratory disorders related to sleep

Tramadol 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 level 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 a 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 tramadol can cause physical and psychological dependence. When this medicine is used for a long period, its effect may decrease, and higher doses may be needed (development of tolerance).

In patients with a tendency to abuse medicines or who have dependence on medicines, treatment with tramadol 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 tramadol 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.

Tell 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 Tramadol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant treatment with Tramadol and monoamine oxidase inhibitors (MAOIs) (medicines for the treatment of depression) should be avoided.

The analgesic effect of Tramadol and its duration may be reduced if you take medicines that contain:

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

Your doctor will indicate if you should take Tramadol and at what dose.

The risk of side effects increases if you are taking:

• other painkillers such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol. It can cause more drowsiness or make you feel like you are going to faint. If this happens, consult your doctor.

Concomitant use of Tramadol with sedatives or medicines for the treatment of insomnia (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and 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 this medicine with sedative medicines, you must limit the dose and duration of concomitant treatment.

• Tell your doctor about all sedative medicines you are taking and strictly follow your doctor's dose recommendation. It may be useful to inform your friends and family about the signs and symptoms indicated above. Tell your doctor if you experience any of these symptoms.

• medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol simultaneously with these medicines. Your doctor will tell you if Tramadol is suitable for you.

• medicines for the treatment of depression. Tramadol can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "possible side effects").

• cumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, together with Tramadol. The effect of these medicines on blood clotting may be affected, and it can lead to bleeding.

• gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Taking Tramadol with food and alcohol

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

Use in athletes

This medicine contains tramadol, which can produce a positive result in doping 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 can 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 little information available on the safety of tramadol in pregnant women. Therefore, you should not take tramadol if you are pregnant.

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

Tramadol can pass into breast milk. For this reason, you should not take tramadol more than once during breastfeeding, or if you do, you should stop 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 tramadol. 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 drowsy, 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 administering it concomitantly with other medicines.

Tramadol Aristo contains lactose, if your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Tramadol Aristo

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 tramadol, 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, you should use the lowest possible dose that produces pain relief. 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

One tramadol 100 mg tablet twice a day (equivalent to 200 mg of tramadol hydrochloride per day), preferably in the morning and at night.

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

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 indicated 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.

Patient with hepatic or renal impairment/patients on dialysis

If you have 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 should you take tramadol?

Tramadol is administered orally.

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 food.

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

If you take more tramadol than you should

If you have taken more tramadol than you should by mistake, you will not usually have negative effects. You should take the next dose as prescribed.

After taking very high doses, you may experience constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic 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 medicine and the amount taken. It is recommended to carry the professional medicinal leaflet.

If you forget to take tramadol

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

If you stop treatment with tramadol

If you stop or finish treatment with tramadol too early, it is likely that the pain will return. If you want to stop treatment due to undesirable 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 undesirable effects occur when finishing 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 trembly. They may feel overactive, have difficulty sleeping, or have gastrointestinal or intestinal disorders. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, other unusual symptoms of the central nervous system have been seen, such as confusion, delirium, distorted perception of one's own personality (depersonalization), and altered perception of reality (derealization) and delusions of persecution (paranoia). 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 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 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 circulation (strong and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g., itching, 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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, and numbness), tremors, epileptic seizures, muscle twitches, 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 can cause epileptic 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 (according to the patient's personality and the duration of treatment). These problems can 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 can lead to errors in judgment).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• A worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. 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 up to 1 in 10,000 people

• Increased liver enzymes.

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

• Decrease in blood sugar levels.
• Hypothermia.
• Serotonin syndrome, which can manifest through 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 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 Tramadol Aristo").

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

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 www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol Aristo

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

Store 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 after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of 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 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, vegetable magnesium stearate, macrogol 6,000, titanium dioxide (E-171), talc, 30% dispersion of polyacrylate.

Appearance of the Product and Package Contents

White, round, biconvex, and uncoated tablets.

It is presented in packages of 20 or 60 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer

G.L. Pharma GmbH

Industriestrasse 1,

A-8502 Lannach

Austria

Date of the Last Revision of this Prospectus:April 2025

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