Tramadol Aristo 50 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

TramadolAristo 50 mg Hard Capsules EFG

Tramadol hydrochloride

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

Package leaflet:

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

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

Tramadol is a centrally-acting analgesic.

This medicinal product 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 to any of the other ingredients of this medicine (listed in section 6).
• In cases of acute intoxication caused by alcohol or medications, such as analgesics, hypnotics, opioids, or psychotropic drugs.
• If you are taking or have taken antidepressant medications (monoamine oxidase inhibitors) within the last two weeks.
• If you have severe respiratory insufficiency, uncontrolled epilepsy, or severe renal or hepatic impairment.

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

Warnings and precautions

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

• If you are susceptible to opioid medicines.
• 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 medicine under medical supervision.
• If you have increased intracranial pressure (severe headache or dizziness).
• If you have suffered a head injury, feel dizzy, tired, cold, shaky, or appear 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 medicines and Tramadol Aristo").

There is a slight risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice if you experience any symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Sleep-related breathing disorders

Tramadol Aristo may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices 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 recommended daily dose (400 mg) is exceeded.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine used or the frequency of use.

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 alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a 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 longer than prescribed by your doctor.
  • You need to use a higher dose than recommended.
  • You are using the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help you sleep."
  • You have made repeated unsuccessful attempts to stop using the medicine or control its use.
  • You feel unwell when you stop using the medicine, and feel better once you take it again ("withdrawal effects").

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

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

Tramadol does not suppress morphine withdrawal syndrome.

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

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

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 experience these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse 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.

Use in athletes

This medicine contains tramadol, which may result in a positive finding in doping control tests.

Children and adolescents

Use in children with respiratory problems

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

Taking Tramadol with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. Especially medicines 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 medicines that may facilitate or cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. Your doctor will advise you whether this medicine is suitable for you.

• If you are taking antidepressants, Tramadol Aristo may interact with these medicines and you may experience serotonin syndrome (see section 4 "Possible side effects").

The concomitant use of Tramadol and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment is possible.

However, if your doctor prescribes Tramadol together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms mentioned above. Consult your doctor if you experience any symptoms.

• The administration of tramadol with central nervous system depressants, including alcohol, may enhance the effects on the central nervous system.
• If you are taking antiplatelet agents such as coumarins, for example, acenocoumarol (Sintrom®), as this may increase the risk of bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

Note that these instructions may also apply to medicines that have been taken or used previously or may be taken or used in the future.

Use of Tramadol with food, drink, and alcohol

This medicine should be taken with sufficient liquid, regardless of meals. Do not consume alcohol during treatment with tramadol, as alcohol may intensify the effects of this medicine.

Pregnancy and breastfeeding

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.

Pregnancy

Tramadol crosses the placental barrier; therefore, it should not be used in pregnant women unless absolutely necessary and always under strict medical supervision.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol more than once during breastfeeding, or if you take Tramadol more than once, you must interrupt breastfeeding.

Driving and using machines

Ask your doctor whether you can drive or use machines during treatment with tramadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machines if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution, as this medicine may cause drowsiness, and this effect may be enhanced by alcohol and other central nervous system depressants.

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Tramadol Aristo

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and on a regular basis during treatment, your doctor will also explain to you 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 pain and your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used.

As with all pain-relieving medicines, the dosage of tramadol in adults and adolescents over 12 years of age should be adjusted according to the intensity of pain and the individual patient's response.

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.

Patients 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 dysfunction, your doctor may extend the dosing intervals.

Elderly patients

In elderly patients (over 75 years of age), tramadol elimination may be slowed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

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

Your doctor will determine the duration of your treatment with this medicine. Do not stop treatment prematurely.

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

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

If you take more Tramadol Aristo than you should

Symptoms of overdose are similar to those of other centrally-acting analgesics (opioids). In particular, this condition includes pinpoint pupils, vomiting, cardiovascular disturbances, disturbances of consciousness up to coma, seizures, respiratory depression, or even respiratory arrest. Treatment will consist of maintaining clear airways and supporting respiration. Vomiting will be induced or gastric lavage performed.

In case of overdose or accidental ingestion, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915620420, indicating the name of the medicine and the amount taken.

If you forget to take Tramadol Aristo

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

If you stop taking Tramadol Aristo

You must not suddenly stop taking this medicine unless instructed by your doctor. If you wish to discontinue treatment, speak to your doctor first, especially if you have been taking the medicine for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The possible adverse effects associated with the use of tramadol are listed below:

• 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, drop in blood pressure upon standing, cardiovascular collapse (these adverse effects occur mainly in patients receiving intravenous administration or who are physically stressed), gastrointestinal irritation, feeling of pressure in the stomach, skin reactions (itching, urticaria).

• Rare (may affect 1 in 1,000 people): decreased heart rate, increased blood pressure, decreased appetite, diarrhoea, withdrawal syndrome (anxiety, restlessness, insomnia, involuntary body movements, gastrointestinal symptoms, panic attacks, hallucinations, hypersensitivity, tinnitus).

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

• Frequency not known: hiccups. Serotonin syndrome, which may present with 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 rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2, "What you need to know before taking Tramadol Aristo").

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 not listed in this leaflet. You can also report them directly via the reporting system included in the Spanish System of Pharmacovigilance for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Aristo.

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

Store this medicine in a safe and secure place, inaccessible to others. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol:

The active substance is tramadol hydrochloride.

Each capsule contains 50 mg of tramadol hydrochloride.

The other components are: monohydrate lactose, microcrystalline cellulose, sodium starch glycolate 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 contents of the pack

White hard gelatin capsules.

Tramadol Aristo is presented in PVC/PVDC blister strips. Packs containing 20 and 60 capsules, and hospital pack containing 500 capsules.

Only some pack 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 most recent review of this leaflet: June 2025.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/