Patient Information Leaflet

TramadolAristo50mgHard Capsules 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.

Contents of the Leaflet:

1. What Tramadol Aristo is and what it is used for.
2. What you need to know before you start taking Tramadol Aristo
3. How to take Tramadol Aristo
4. Possible side effects.
5. Storage of Tramadol Aristo
6. Contents of the pack and additional information

Tramadol is a centrally acting analgesic.

This medication is usedfor thesymptomatic treatment of moderate to severe pain in adults and adolescents 12 years of age or older.

Do not take Tramadol Aristo:

- If you are allergic to tramadol or any of the other ingredients 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 failure.

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 susceptible to seizures, you should only take this medication on medical prescription.

- If you have high intracranial pressure (severe headache or dizziness).

- If you have had a head injury, feel dizzy, tired, cold, shaky, or pale (you may be in shock).

- If you have chronic diseases such as liver or kidney insufficiency.

- If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol Aristo").

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 immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible side effects").

Respiratory disorders related to sleep

Tramadol Aristo may cause respiratory disorders related to sleep, 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, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. 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 recommended doses. This risk may increase if the upper limit of the maximum recommended daily dose (400 mg) is exceeded.

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 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 with a psychiatrist for other mental health conditions.
• 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 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 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 treatment with tramadol).

When tramadol is used for a prolonged period, its effect may decrease, requiring the use of higher doses (development of pharmacological tolerance).

Tramadol does not suppress morphine withdrawal syndrome.

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

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

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 hormone supplements.

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.

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.

Tramadol with other medications

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

The risk of adverse effects increases,

• If you are taking 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 this medication is suitable for you.

if you are taking antidepressants, Tramadol Aristo may interact with these medications and you may experience a serotonin syndrome (see section 4«Possible side effects».

The concomitant use of Tramadol and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, respiratory depression, coma, and may put your life at risk. Therefore, concomitant use should only be considered when no other treatment is possible.

However, if your doctor prescribes Tramadol along with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking, and follow your doctor's recommended dose. It may be helpful to inform friends or relatives to be aware of the signs and symptoms mentioned above. Consult your doctor if you experience any symptoms.

• The administration of tramadol with central depressants, including alcohol, may potentiate the effects on the central nervous system.
• If you are taking anticoagulants such as, for example, acenocoumarol (Sintrom?), as it may increase the risk of bleeding.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

Take note that these instructions may also apply to medications that have been taken/utilized before or may be taken/utilized afterwards.

Tramadol with food, drink, and alcohol

This medication is administered with sufficient liquid, regardless of meals. Do not consume alcohol during treatment with tramadol, as alcohol may intensify the effects of this medication.

Pregnancy and breastfeeding

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

Pregnancy

Tramadol crosses the placental barrier, so it should not be used in pregnant women, unless there is an absolute need and always under strict medical supervision.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, do not take Tramadol more than once during breastfeeding, or if you take Tramadol more than once, you should stop breastfeeding.

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with tramadol. 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 especially careful because it may cause drowsiness, and this effect may be potentiated by alcohol and other central nervous system depressants.

This medication 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.

Your doctor will also explain to you 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 to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used.

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

The recommended dose is:

Adults and adolescents over 12 years old

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 old.

Patients with liver or kidney insufficiency/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.

Older patients

In older 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.

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 discontinue treatment before.

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

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

If you take more Tramadol Aristo than you should

The symptoms of overdose are similar to those of other central analgesic (opioid) medications. In particular, this condition includes small pupils, vomiting, cardiovascular disturbance, alteration of consciousness up to comatose states, convulsions, and respiratory depression or even respiratory arrest. Treatment will consist of keeping airways clear and maintaining respiration. 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 Toxicological Information Service, tel.: 915620420, indicating the medication and the amount taken.

If you forgot to take Tramadol Aristo

Do not take a double dose to compensate for the missed 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 discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Like all medications,this medicationcan 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, headaches.

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

• Uncommon (may affect 1 in 1,000 people):palpitations, increased heart rate, drop in blood pressure upon standing, 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, urticaria)

• Rare (may affect1 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, tinnitus)

• Very rare (may affect1 in 10,000 people):increase in liver enzymes.

• Unknown frequency: 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 taking Tramadol Aristo").

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly through the notification system included in the Spanish System of 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 medication.

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

Store this medication in a safe and protected place, to which others cannot access. This medication can cause severe 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.

Store below 86°F (30°C)

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

Composition of Tramadol:

The active ingredient is tramadol hydrochloride.

Each capsule contains 50 mg of tramadol hydrochloride.

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

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

Appearance of the product and content of the container

Hard gelatin capsules of white color.

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

Only some container 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

Laboratorios Alcalá Farma, S.L.

Ctra. M-300, km. 29,920

28802 Alcalá de Henares (Madrid)

O

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26.

28850 Torrejón de Ardoz

Madrid - Spain

Date of the last review of this prospectus:May 2024.

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