Tramadol Andromaco 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

1. What Tramadol 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 Andrómaco is used to treat moderate to severe pain.

2. What you need to know before taking Tramadol Andrómaco

Do not take Tramadol Andrómaco:

• 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 medications, analgesics, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are currently taking or have taken monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression) within the last 14 days before starting treatment with this medicine (see "Taking Tramadol 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 Andrómaco:

• if you think you are dependent on other analgesics (opioids);
• if you have disorders of 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 brain diseases);
• 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, since some of them may interact with tramadol (see "Taking Tramadol 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 medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol 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 Andrómaco 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 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 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 stop the medicine, and how to do so safely (see section 3, if you interrupt treatment with Tramadol Andrómaco).

Sleep-related breathing disorders

Tramadol contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or pauses in breathing 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 used as monotherapy. Seek immediate medical advice if you experience any symptoms associated with 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 maximum recommended daily dose (400 mg).

Please note that this medicine may cause physical and psychological dependence. When used over a prolonged period, its effect may decrease, requiring higher doses (development of tolerance). In patients with a tendency to misuse medicines or those with medicine dependence, treatment with tramadol should only be carried out over 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 experience any of the following adverse effects, 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 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 tramadol and MAO inhibitors (a certain type of medicine used to treat depression) should be avoided.

The effect and duration of pain relief provided by tramadol may be reduced if you take medicines containing:

• Carbamazepine (for epileptic seizures);
• Ondansetron (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 treatment (such as benzodiazepines) or medicines that may affect respiratory activity (such as other opioids, some cough medicines, certain 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 tramadol together with sedative medicines, 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 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 advise you whether tramadol is suitable for you;

• Medicines for the treatment of depression, as tramadol may interact with these medicines and may cause serotonin syndrome (see section 4, "Possible side effects");

• Coumarin anticoagulants (blood-thinning medicines), such as warfarin, while taking tramadol. The effect of these medicines on blood clotting may be affected, leading to bleeding;

• Medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (e.g., ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin);

• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (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 for Parkinson's disease.

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

Taking Tramadol Andrómaco with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effects may be intensified.

Food does not affect the action of tramadol.

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 cause withdrawal syndrome in newborns.

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

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

Driving and using machines

Ask your doctor whether you can drive or operate machinery while taking 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.

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; hence, it is essentially "sodium-free."

3. How to take Tramadol Andrómaco

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

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from the use of Tramadol Andrómaco, 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 according to the intensity of pain and your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has instructed you otherwise.

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

Adults and adolescents over 12 years of age

The usual initial dose is 1-2 capsules (equivalent to 50-100 mg of tramadol hydrochloride).

Depending on the pain, the effect may last between 4-6 hours.

Children

This medicine is not recommended for children under 12 years of age.

Elderly patients

In elderly patients (over 75 years of age), tramadol elimination 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 should you take Tramadol Andrómaco?

The capsules are administered orally.

Swallow the capsules whole without dividing or chewing them, with sufficient liquid.

You may take the capsules either on an empty stomach or with food.

How long should you take Tramadol Andrómaco?

This medicine should not be administered for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor regularly and at short intervals (if necessary with treatment interruptions) 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 Andrómaco than you should

If you have taken an extra dose by mistake, you will generally not experience adverse effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, symptoms may include pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest and death. 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 number 91 562 04 20, stating the name of 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 Andrómaco

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

If you stop taking Tramadol Andrómaco

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

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

Generally, adverse effects are not common when stopping tramadol treatment. However, in rare cases, individuals who have been taking this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, or numbness, and ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (depersonalization), changes in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after discontinuing treatment with this medicine, 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 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, and 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 1 in 10 people

• Headache, numbness.
• Fatigue.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are standing up or performing physical exertion.
• Nausea (feeling of needing to vomit), gastrointestinal discomfort (e.g. sensation 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 (e.g. itching, tingling, numbness), tremor, epileptic seizures, muscle twitching, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after using high doses of tramadol or when taken simultaneously with another medicine that may induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological disturbances may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These may appear as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and decreased cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• May lead to drug dependence. When treatment is abruptly discontinued, withdrawal syndrome may occur (see “If you stop taking Tramadol Andrómaco”).
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• Cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol. 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 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 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 rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you need to know before taking Tramadol 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Andrómaco

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 and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, 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 Andrómaco 50 mg hard capsules EFG

The active substance is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.

The other components are: microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), colloidal anhydrous silica, magnesium stearate.

Capsule shell: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.

Appearance of the product and contents of the pack

Hard gelatin capsules, size 4, with snap-fit closure, shiny, yellow/yellow, oblong.

Each capsule contains a fine white to pale yellow powder.

The medicine is supplied in packs of 20, 60 and 500 capsules in blister packs.

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 review of this leaflet: October 2025

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