Tramadol Aristo 100 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol Aristo 100 mg prolonged-release tablets EFG

tramadol hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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, as it may 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.

Leaflet Contents

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, the active substance of this medicine, is an analgesic belonging to the opioid group 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.

2. What you need to know before taking Tramadol Aristo

Do not take tramadol

• If you are allergic to tramadol or to any of the other components of this medicine (listed in section 6).
• In cases of acute intoxication caused by alcohol, sleeping medicines, painkillers, or psychotropic medicines (medicines that affect mood and emotions).
• If you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression) or have taken them within 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 by treatment.
• For the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tramadol if:

• You experience disturbances in consciousness (if you feel you might faint).
• You are in shock (a sign of this condition may be cold sweating).
• You have increased pressure inside the skull (e.g., after a head injury or brain diseases).
• You have difficulty breathing.
• You have epilepsy or suffer from seizures, as the risk of seizures may increase.
• You have depression and are taking antidepressants, as some of these may interact with tramadol (see section “Other medicines and tramadol”).
• You have liver or kidney disease.

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 (your body gets used to it, known as pharmacological tolerance). Repeated use of tramadol may also lead to dependence, abuse, and addiction, which could result in a 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 you need to take or how often you need to take it.

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 or been dependent 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 take 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 unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking 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 stop the medicine, and how to do so safely (see section 3, if you interrupt treatment with tramadol).

Sleep-related breathing disorders

Tramadol contains an active substance belonging to the group of opioids. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels).

The risk of experiencing central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnea.

There is a low risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact a doctor immediately if you experience any symptoms related to this serious condition (see section 4 “Possible side 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).

Note that tramadol may cause physical and psychological dependence. When this medicine is used for a long period, its effect may decrease, requiring higher doses (development of tolerance).

In patients with a tendency to abuse medicines or who have medicine dependence, treatment with tramadol should only be carried out for short periods and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with tramadol or if you have ever experienced them:

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.

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. These may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Taking Tramadol with other medicines

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

Concomitant treatment with monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) should be avoided.

The analgesic effect of tramadol and its duration may be reduced if you take medicines containing:

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

Your doctor will advise you whether you should take tramadol and at what dose.

The risk of adverse effects increases if you are taking:

• Other painkillers such as morphine and codeine (also when used for cough), and alcohol while taking tramadol. This may cause increased drowsiness or a feeling of fainting. If this occurs, consult your doctor.

The concomitant use of tramadol with sedatives or medicines for insomnia (such as benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with sedative medicines, your dose and duration of concomitant treatment should be limited.

• Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the symptoms listed above. Inform your doctor if you experience any of these symptoms.

• Medicines that may lower the seizure threshold or provoke 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 whether tramadol is suitable for you.

• Medicines used to treat depression. Tramadol may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”).

• Coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, taken together with tramadol. The effect of these medicines on blood clotting may be affected, potentially leading to bleeding.

• Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (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 action of tramadol.

Use in athletes

This medicine contains tramadol, which may result in a positive doping test.

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.

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 limited information available on the safety of tramadol in pregnant women. Therefore, you should not take tramadol if you are pregnant.

Chronic treatment during pregnancy may 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; otherwise, if you take it more than once, you must stop breastfeeding.

Based on human experience, there is no indication that tramadol affects fertility in men and women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery during treatment with tramadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Tramadol Aristo contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Tramadol Aristo

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 pain and your individual sensitivity. The lowest effective dose that provides pain relief should normally be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has specifically instructed you otherwise.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents over 12 years of age

One 100 mg tramadol tablet twice daily (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 appropriate dose of this medicine.

If needed, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).

Children

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

Elderly patients

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

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 disorders, your doctor may extend the dosing intervals.

How and when to 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 may take the tablet on an empty stomach or with food.

How long should you take tramadol?

Tramadol should not be administered for longer than strictly necessary.

If long-term treatment is required, your doctor will regularly and frequently monitor (if necessary with treatment interruptions) whether tramadol treatment should continue and at what dose.

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

If you take more tramadol than you should

If you have accidentally taken more tramadol than prescribed, you usually will not experience negative effects. Take the next dose as prescribed.

After taking very high doses, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, reduced level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest can occur. In such a case, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone (91) 562.04.20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s package leaflet to the healthcare professional.

If you forget to take tramadol

If you forget to take your tablets, your pain may return. Do not take a double dose to make up for a missed dose; simply continue your treatment as directed by your doctor.

If you stop taking tramadol

If you stop or discontinue tramadol treatment too early, your pain is likely to return. If you wish to discontinue treatment due to side effects, consult your doctor.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking this medicine, speak to your doctor first, especially if you have been taking it 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 unnecessary adverse effects (withdrawal symptoms).

Generally, no undesirable effects occur when stopping tramadol treatment. However, in rare cases, some people who have taken tramadol for some time may feel unwell when stopping it suddenly. They may feel restless, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, other uncommon central nervous system (CNS) symptoms have been observed, such as confusion, delirium, distorted perception of one's own personality (depersonalization), disturbances in 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 further 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 everyone experiences them.

You must 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, rash, together with difficulty breathing.

The most common 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 heartbeats, rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are standing up or who are performing physical exertion.
• Feeling the need to vomit (nausea), stomach problems (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
• 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 (such as itching, tingling, and numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Epileptic seizures may occur, mainly after taking high doses of tramadol or when taken concomitantly with other medicines that may provoke seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may occur after treatment with tramadol. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (changes in senses and recognition, which may lead to impaired judgment).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

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

• Increase in liver enzymes.

Frequency not known: frequency cannot be estimated from available data

• Decrease in blood sugar levels.
• Hiccups.
• Serotonin syndrome, which may present 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 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").

When treatment is stopped abruptly, signs of drug withdrawal syndrome may occur (see "If you stop treatment with 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 other people. 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.

This medicine does not require any special storage conditions.

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 in doubt, ask your pharmacist how to 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 Aristo

• The active substance 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% polyacrylate dispersion.

Appearance of the product and contents of the pack

White, round, biconvex, film-coated tablets without a break line.

Packaged in packs of 20 or 60 tablets.

Only certain 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

G.L. Pharma GmbH

Industriestrasse 1,

A-8502 Lannach

Austria

Date of the most recent review of this leaflet: April 2025

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