Tramadol Andromaco 100 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol retard Andrómaco 100 mg prolonged-release tablets 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tramadol retard Andrómaco is and what it is used for

Tramadol – the active substance in 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 retard Andrómaco is used in the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol retard Andrómaco

Do not take Tramadol retard Andrómaco

• 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, sleeping medications, analgesics, or psychotropic drugs (medications acting on mood and emotions).
• If you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression) or have taken them within the last 14 days before starting treatment with this medicine (see "Taking Tramadol retard Andrómaco 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 before starting to take Tramadol retard Andrómaco:

• If you think you are dependent on other analgesics (opioids).
• If you have disturbances in consciousness (if you feel you might faint).
• If you are in shock (a sign of this condition may be cold sweating).
• If you have increased intracranial pressure (e.g., after head trauma or diseases affecting the brain).
• If you have difficulty breathing.
• If you have epilepsy or suffer from seizures, as the risk of seizures may increase.
• If you have depression and are taking antidepressants, as some of them may interact with tramadol (see "Taking Tramadol retard Andrómaco with other medicines").
• If 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 drug to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol retard Andrómaco 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 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 retard Andrómaco 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 retard Andrómaco, 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, 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 retard Andrómaco).

Sleep-related breathing disorders

Tramadol retard Andrómaco contains an active substance belonging to the opioid group. 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 that you may develop a serotonin syndrome 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 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 tramadol dose exceeds the recommended maximum daily dose (400 mg).

Please note that this medicine may cause physical and psychological dependence. When used over a long period, its effect may decrease, requiring higher doses (development of tolerance).

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

Also inform your doctor if any of these problems occur during treatment with this medicine 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 retard Andrómaco:

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 whether you need hormonal supplements.

Taking Tramadol retard Andrómaco with other medicines

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

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 this medicine and at what dose.

The risk of adverse effects increases if you are taking:

• Medicines for anxiety or insomnia (such as benzodiazepines) or medicines that may affect respiratory activity (such as other opioids, certain cough medicines, some treatments for drug dependence, medicines for mental health, antiallergic medicines such as antihistamines, or alcohol), as they increase 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 sedatives, your dose and duration of concomitant treatment will 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 signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

• Medicines that facilitate or may cause 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 retard Andrómaco is suitable for you.
• Medicines used to treat depression. Tramadol may interact with these medicines, and you may experience serotonin syndrome (see section 4 "Possible side effects").
• Coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, together with tramadol. The effect of these medicines on blood clotting may be affected, leading to bleeding.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).
• Medicines that may have anticholinergic effects, such as:
  • Medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics);
  • Medicines for psychiatric disorders (antipsychotics or neuroleptics);
  • Muscle relaxants;
  • Medicines used to treat Parkinson's disease.

as they may increase the risk of adverse effects such as constipation, urinary retention, dry mouth, or dry eyes.

Taking Tramadol retard Andrómaco with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effect may be intensified. Food does not affect the medicine's action.

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 this medicine if you are pregnant.

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

Tramadol may pass into breast milk. For this reason, you should not take this medicine more than once during breastfeeding; otherwise, if you take it more than once, you must stop breastfeeding.

Based on human experience, tramadol is not suggested to affect fertility in men and women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with this medicine. 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 retard Andrómaco 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 retard Andrómaco

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from using Tramadol retard Andrómaco, 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 possible 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 to do so.

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

Adults and adolescents over 12 years of age

One 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

This medicine 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 this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when to take Tramadol retard Andrómaco

This medicine is taken orally.

The tablets must 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 retard Andrómaco?

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

If prolonged treatment is required, your doctor will monitor you at short, regular intervals (and if necessary with treatment interruptions) to determine whether treatment with this medicine should continue and at what dose.

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 retard Andrómaco than you should

If you have accidentally taken more tramadol tablets than prescribed, you will generally 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, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest and death may occur. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 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 retard Andrómaco

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

If you stop taking Tramadol retard Andrómaco

If you interrupt or discontinue treatment with this medicine too early, your pain is likely to return. If you wish to stop treatment due to adverse effects, consult your doctor.

Do not stop taking this medicine suddenly unless instructed by your doctor. 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not usually occur when stopping treatment with this medicine. However, in rare cases, individuals who have taken this medicine for some time may feel unwell if they stop taking it suddenly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive or intestinal transit problems. 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, changes in personality perception (depersonalization), disturbances in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, 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 may cause adverse effects, although not everyone will experience 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 and rash together with difficulty breathing.

The most common adverse effects during treatment with this medicine 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 1 in 10 people

• Headache, numbness.
• Fatigue.
• Vomiting, dry mouth, constipation.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, feeling dizzy or fainting). These adverse effects may occur especially in patients who are standing up or who are physically exerting themselves.
• 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 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 twitching, 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 this medicine. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as a change in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• Medication dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• Cases of worsening asthma have been reported; however, a causal relationship with tramadol has not been established. If recommended doses are exceeded or if taken concomitantly with other medicines that depress brain function, a decrease in respiratory rate may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 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 retard Andrómaco”).

When treatment is stopped abruptly, signs of drug withdrawal syndrome may occur (see "If you stop taking Tramadol retard Andrómaco").

Reporting of adverse effects

If you experience any 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol retard Andrómaco

Keep this medicine out of 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 drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol retard Andrómaco 100 mg prolonged-release tablets EFG

• The active substance is tramadol hydrochloride. Each tablet contains 100 mg of tramadol hydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose, hypromellose 100,000 mPa·s, magnesium stearate, colloidal anhydrous silica.

Film coating: hypromellose 6 mPa·s, lactose monohydrate, macrogol 6000, propylene glycol (E1520), talc, and titanium dioxide (E171).

Appearance of the medicine and pack contents

This medicine is presented as white, round, biconvex film-coated tablets, marked with "T1" on one side and the manufacturer's logo ? on the other, packed in blister strips and boxed in packs of 20 and 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Andrómaco Pharma, S.L.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

Date of the most recent revision of this leaflet: October 2025

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