TRAMADOL MABO 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tramadol MABO 50 mg Hard Capsules EFG

Tramadol hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Tramadol MABO and what is it used for.
2. What you need to know before you take Tramadol MABO.
3. How to take Tramadol MABO.
4. Possible side effects.
5. Storage of Tramadol MABO.
6. Pack contents and further information.

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

Tramadol, the active substance in this medicine, is an analgesic belonging to the group of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol MABO is indicated for the treatment of moderate to severe pain in adults and adolescents from 12 years of age.

2. What you need to know before you take Tramadol MABO

Do not take Tramadol MABO

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).

• In case of acute intoxications caused by alcohol, sleeping pills, painkillers, or other psychotropic medications (medications that act on mood and emotions).
• If you are taking MAO inhibitors (a certain type of medication used to treat depression) or if you have taken them in the last 14 days before treatment with this medication (see the section "Taking Tramadol MABO with other medications").

• If you have epilepsy and your seizures are not adequately controlled with treatment.
• For the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor before starting to take Tramadol MABO:

• If you think you are dependent on other potent painkillers (opioids).
• If you have decreased consciousness (if you think you are going to faint).
• If you are in a state of shock (a sign of this state may be cold sweat).
• If you have increased intracranial pressure (for example, after a head injury or diseases that affect the brain).
• If you have difficulty breathing.
• If you are epileptic or have seizures, because the risk of seizures may increase.
• If you have any liver or kidney disease.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol MABO")

Respiratory disorders related to sleep

Tramadol MABO may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider a dose reduction.

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the dose of tramadol exceeds the maximum recommended daily dose (400 mg).

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 gets used to it, which is known as pharmacological tolerance). Repeated use of tramadol can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to tramadol may be greater 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 problems with your mood (depression, anxiety, or 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 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 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 medication, and how to do it safely (see section 3, if you interrupt treatment with tramadol).

Also, inform your doctor if any of these problems occur during treatment with this medication or if they have happened to you before.

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 if you need to take hormonal supplements.

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side effects, you should stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

There is a slight risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you present any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

Taking Tramadol MABO with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Concomitant treatment with Tramadol MABO and MAO inhibitors (a certain type of medication for the treatment of depression) should be avoided.

Both the effect and the duration of the pain relief produced by Tramadol MABO may be reduced if you take medications that contain:

• Carbamazepine (for epileptic seizures).
• Ondansetron (to prevent nausea).

Your doctor will indicate if you should take this medication and in what dose.

The risk of side effects increases:

• If you are taking this medication simultaneously with tranquilizers, sleeping pills, other painkillers such as morphine and codeine (even when used for the treatment of cough), and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.
• If you are taking medications that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol MABO simultaneously with these medications. Your doctor will tell you if Tramadol MABO is suitable for you.
• If you are taking medications for the treatment of depression. Tramadol MABO may interact with these medications, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• If you are taking anticoagulant medications, such as warfarin, while taking Tramadol MABO. The effect of these medications on blood coagulation may be affected, which can lead to bleeding.
• If you take medications that can increase the accumulation of tramadol and, therefore, its side effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).
• If you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)

Taking Tramadol MABO with food and alcohol

Do not consume alcohol during treatment with this medication, as its effect may be intensified.

Food does not affect the effect of Tramadol MABO.

Children and adolescents

Use in children with respiratory problems: Tramadol is not recommended for children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is very little information available on the safety of tramadol in pregnant women. Therefore, you should not take this medication if you are pregnant.

Chronic treatment during pregnancy can cause withdrawal syndrome in newborns.

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

Based on human experience, it is not suggested that tramadol affects fertility in men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with this medication. It is important that before driving or using machines, you observe how this medication affects you. Do not drive or use machines if you feel sleepy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it in combination with other medications.

Tramadol MABO contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

3. How to take Tramadol MABO

Follow exactly the instructions for administration of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain 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 stop using it (see also section 2).

The dose must be adjusted to the intensity of the pain and your individual sensitivity.

Normally, you should take the smallest possible dose that produces pain relief. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has indicated otherwise.

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

Adults and adolescents over 12 years

Normally, the initial dose is 1 or 2 capsules (equivalent to 50 mg or 100 mg of tramadol hydrochloride).

Depending on the pain, the effect can last between 4 to 6 hours.

Use in children and adolescents

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

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney problems, patients on dialysis:

If you have severe liver or kidney disease, treatment with this medication is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the intervals between doses.

Form of administration:

How and when should you take Tramadol MABO?

The capsules of this medication are administered orally.

Swallow the capsules whole, without dividing or chewing them, and with sufficient liquid. You can take the capsules with or without food.

How long should you take Tramadol MABO?

This medication should not be administered for longer than strictly necessary. If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary, with interruptions in treatment) to see if you should continue treatment with this medication and at what dose.

If you think the effect of this medication is too strong or too weak, tell your doctor or pharmacist.

If you take more Tramadol MABO than you should

If you have taken an extra dose by mistake, this will normally not have negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, contraction of the pupil, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest 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, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication package insert to the healthcare professional.

If you forget to take Tramadol MABO

If you forget to take this medication, it is likely that the pain will return. Do not take a double dose to make up for the missed doses; simply continue taking this medication as you have been doing until now.

If you stop taking Tramadol MABO

If you stop or finish treatment with this medication too soon, it is likely that the pain will return. If you want to stop treatment due to side effects, consult your doctor.

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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no side effects are usually present when treatment with tramadol is stopped. However, in rare cases, people who have been taking this medication for some time may not feel well when stopping treatment abruptly. They may feel agitated, anxious, nervous, or have tremors. They may be overactive, have difficulty sleeping, or have problems with digestion and bowel movements. Very few people suffer from panic attacks, hallucinations, unusual perceptions such as itching, tingling, numbness, and ringing in the ears (tinnitus). Very rarely, more unusual symptoms of the central nervous system have been detected, such as confusion, delirium, change in perception of personality (depersonalization), and change in perception of reality (derealization) and persecution delusions (paranoia). If you experience any of these symptoms after stopping treatment with this medication, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should 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 along with difficulty breathing.

The most frequent 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 and numbness.
• Fatigue.
• Vomiting, constipation, and dry mouth.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g., feeling of fullness, heaviness), diarrhea.
• Skin reactions (e.g., itching, skin 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), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after the use of high doses of tramadol or when another medicine that may induce them has been taken simultaneously.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological alterations may appear after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These may appear in the form of mood changes (usually euphoria, occasionally irritability), changes in activity (usually decrease and occasionally increase), and decreased cognitive and sensory perception (alterations of the senses and perception that can lead to errors of judgment).
• It may cause dependence on the medicine. When treatment is interrupted abruptly, withdrawal syndrome may appear (see "If you stop treatment with Tramadol MABO").
• Blurred vision, excessive dilation of the pupils (mydriasis), contraction of the pupils (miosis).
• Slow breathing, shortness of breath (dyspnea).
• Cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or if it is taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: frequency that cannot be estimated from the available data

• Decrease in blood sugar levels.
• Hypo.

Indeterminate frequency (cannot be estimated from the available data)

• Serotonin syndrome, which can 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Tramadol MABO").

Reporting of adverse effects:

If you experience any of the adverse effects, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol MABO

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

Store this medicine in a safe and protected place, to which other people cannot access. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Alu-PVC/PVdC blister: Store below 30°C.

Alu-PVC/PE/PVdC blister: No special storage conditions are required.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol MABO:

• The active ingredient is tramadol. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other components (excipients) are: Capsule content: microcrystalline cellulose, sodium carboxymethyl starch (type A) of potato, anhydrous colloidal silica, and magnesium stearate. Capsule shell: gelatin, yellow iron oxide (E-172), titanium dioxide (E-171), and purified water. Printing ink: shellac lacquer, anhydrous ethanol, isopropyl alcohol, butanol, propylene glycol, concentrated ammonia solution, black iron oxide (E-172), potassium hydroxide, and purified water.

Appearance of the Product and Package Contents

Tramadol MABO is presented in hard gelatin capsules, opaque yellow in color, marked on the body with black ink with "T50" and filled with a white or almost white powder.

The capsules are presented in Alu-PVC/PVdC or Alu-PVC/PE/PVdC blisters.

This medicine is presented in packages containing 20 or 60 hard capsules.

Marketing Authorization Holder

MABO-FARMA, S.A.

Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the Last Revision of this Prospectus: June 2024

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