TRAMADOL ARISTO 50 mg HARD CAPSULES

1. What Tramadol Aristo is and what it is used for

Tramadol is a centrally acting analgesic.

This medication is used for the symptomatic treatment of moderate to severe pain in adults and adolescents over 12 years of age.

2. What you need to know before taking Tramadol Aristo

Do not take Tramadol Aristo:

• If you are allergic to tramadol or any of the other components of this medication (listed in section 6).
• In acute intoxications caused by alcohol or medications, such as analgesics, hypnotics, opioids, or psychotropics.
• If you are taking or have taken medications for depression (monoamine oxidase inhibitors) in the last two weeks.
• If you have severe respiratory failure, uncontrolled epilepsy, severe renal or hepatic impairment.

Do not use this medication as a treatment for withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you are susceptible to opioid medications.
• Tramadol should be used with caution if you have acute porphyria.
• If you have epilepsy or are prone to seizures, you should only take this medication under medical supervision.
• If you have increased intracranial pressure (severe headache or feeling of dizziness).
• If you have had a head injury, if you feel dizzy, tired, cold, trembly, or pale (you may be in shock).
• If you have chronic diseases such as liver or kidney failure.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol Aristo").

There is a slight risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult immediately if you experience any symptoms related to this serious syndrome (see section 4 "Possible side effects").

Sleep-related respiratory disorders

Tramadol Aristo may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Seizures may occur in patients treated with tramadol at the recommended doses. This risk may increase if the maximum recommended daily dose is exceeded (400 mg).

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 gets used to it, which is known as pharmacological tolerance). Repeated use of tramadol can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication 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 medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had mood problems (depression, anxiety, or personality disorder) or have been treated by 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:
• • 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, 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 tramadol).

When tramadol is used for a prolonged period, its effect may decrease, and higher doses may be needed (development of tolerance).

Tramadol does not suppress morphine withdrawal syndrome.

In patients with a tendency to abuse medications, this medication should only be administered for short periods and under strict medical control.

Consult your doctor, even if any of the above circumstances have occurred to you at some point.

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure 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.

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 should stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Use in athletes

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

Children and adolescents

Use in children with respiratory problems

Tramadol is not recommended for children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Taking Tramadol with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take other medications. Especially medications such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, erythromycin, cimetidine, carbamazepine, buprenorphine, nalbuphine, and pentazocine.

The risk of side effects increases,

• If you are taking medications that can cause or facilitate 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 this medication is suitable for you.

3. How to take Tramadol Aristo

Follow your doctor's instructions for taking this medication exactly. 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 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 according to the intensity of the pain and individual sensitivity. Normally, the smallest possible dose that provides pain relief should be used.

As with all pain medications, the dosage of tramadol in adults and adolescents over 12 years of age should be adjusted according to the intensity of the pain and the individual response of each patient.

The recommended dose is:

Adults and adolescents over 12 years of age

Normally, the initial dose is 1 or 2 capsules (50-100 mg of tramadol) followed by 1 or 2 capsules (50 or 100 mg of tramadol) every 6-8 hours, without exceeding a daily dose of 8 capsules (400 mg of tramadol).

Use in children

Tramadol is not recommended for children under 12 years of age.

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 disorders, your doctor may prolong the dosing intervals.

Elderly patients

In elderly patients (over 75 years of age), the elimination of tramadol may be slow. If this is the case, your doctor may recommend prolonging the dosing intervals.

Follow these instructions unless your doctor has given you different instructions. Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment before.

This medication should not be administered for longer than strictly necessary.

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

If you take more Tramadol Aristo than you should

The symptoms of overdose are similar to those of other central-acting analgesics (opioids). In particular, this includes constricted pupils, vomiting, cardiovascular alterations, disturbances of consciousness up to coma, seizures, and respiratory depression or even respiratory arrest. Treatment will consist of keeping the airways clear and maintaining breathing. Vomiting will be induced or gastric lavage will be performed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service, phone: 915620420, indicating the medication and the amount taken.

If you forget to take Tramadol Aristo

Do not take a double dose to make up for forgotten doses. Consult your doctor or pharmacist.

If you interrupt treatment with Tramadol Aristo

Do 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 side effects (withdrawal symptoms).

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The possible side effects due to the use of tramadol are as follows:

• Very common (may affect more than 1 in 10 people): nausea, dizziness, headache.

• Common (may affect 1 in 10 people):vomiting, constipation, dry mouth, sweating.

• Uncommon (may affect 1 in 1,000 people):palpitations, increased heart rate, low blood pressure when standing up, cardiovascular collapse (these side effects occur mainly in patients with intravenous administration or physical stress), gastrointestinal irritation, feeling of pressure in the stomach, skin reactions (itching, hives)

• Rare (may affect 1 in 1,000 people):decreased heart rate, increased blood pressure, decreased appetite, diarrhea, withdrawal syndrome (anxiety, nervousness, insomnia, involuntary body movements, gastrointestinal symptoms, panic attacks, hallucinations, hypersensitivity, ringing in the ears)

• Very rare (may affect 1 in 10,000 people):increased liver enzymes.

• Frequency not known: hiccups. Serotonin syndrome, which can manifest 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Tramadol Aristo").

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this summary of product characteristics, tell your doctor or pharmacist.

Reporting 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 summary of product characteristics. You can also report them directly through the notification system included in the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tramadol Aristo

Keep this medication out of sight and reach of children.

Store this medication in a safe and protected place, where others cannot access it. This medication can cause serious harm and even be fatal for people it has not been prescribed for.

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

Store below 30°C

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Tramadol Composition:

The active ingredient is tramadol hydrochloride.

Each capsule contains 50 mg of Tramadol hydrochloride.

The other components are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate, povidone K 30.

The hard gelatin capsule is composed of: gelatin and titanium dioxide (E-171).

Product Appearance and Container Content

White hard gelatin capsules.

Tramadol Aristo is presented in PVC/PVDC blister strips. Containers containing 20 and 60 capsules and a clinical package of 500 capsules.

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

Laboratorios Alcalá Farma, S.L.

Ctra. M-300, km. 29,920

28802 Alcalá de Henares (Madrid)

Or

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26.

28850 Torrejón de Ardoz

Madrid - Spain

Date of the Last Revision of this Prospectus:June 2025.

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