Package Insert: Information for the User

Tramadol MABO 50 mg Hard Capsules EFG

Tramadol Hydrochloride

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Tramadol, the active ingredient of this medication, 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 the brain.

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

Do not take Tramadol MABO

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

• In case of acute intoxications caused by alcohol, sleeping pills, analgesics, or other psychotropic medications (medications that act on mood and emotions).
• If you are taking monoamine oxidase inhibitors (a certain type of medication used to treat depression) or if you have taken them in the last 14 days before starting 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 powerful analgesics (opioids).
• If you experience a decrease in level of 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 experience an increase in intracranial pressure (for example, after a head trauma 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 levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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).

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 becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication to be 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 family member have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs (“addiction”).

• You are a smoker.
• You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental health conditions.

If you observe any of the following symptoms while using tramadol, it may 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 symptoms”).

If you notice any of these signs, consult your doctor to determine the best course of treatment 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 occurred in the past.

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 hormone supplements.

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

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult your doctor immediately if you experience any of the symptoms linked to this severe syndrome (see section 4 “Possible adverse effects”).

Taking Tramadol MABO with other medications

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

It is recommended to avoid simultaneous treatment of Tramadol MABO with monoamine oxidase inhibitors (a certain type of medication used to treat depression).

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

• Carbamazepine (for epilepsy).
• Ondansetron (to prevent nausea).

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

The risk of adverse effects increases:

• If you are taking this medication simultaneously with tranquilizers, sleeping pills, other analgesics such as morphine and codeine (even when used to treat cough), and alcohol. In these cases, you may feel drowsiness or dizziness. If this happens, consult your doctor.
• If you are taking medications that facilitate or may cause 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 depression. Tramadol MABO may interact with these medications and you may experience a serotonin syndrome (see section 4 “Possible adverse effects”).
• If you are taking anticoagulant coumarins (medications to thin the blood), such as warfarin, while taking Tramadol MABO. The effect of these medications on coagulation may be affected, resulting in bleeding.
• If you take medications that can increase the accumulation of tramadol and, therefore, its adverse 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 use in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Chronic treatment during pregnancy may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. Therefore, do not take this medication more than once during breastfeeding, or if you take Tramadol MABO more than once, stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it 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”.

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

Your doctor will also explain to you 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 discontinue use (see also section 2).

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

Normally, you should take the lowest dose possible that produces pain relief. 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 old

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

The effect may last between 4 to 6 hours, depending on the pain.

Use in children and adolescents

This medication is not recommended for children under 12 years old.

Older patients

In older patients (over 75 years old), 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 a severe liver or kidney disease, treatment with this medication is not recommended. If you have moderate liver or kidney problems, your doctor may prolong the dosing intervals.

Administration form:

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 an empty stomach or with meals.

For 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 estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Tramadol MABO than you should

If you have taken an additional dose by mistake, this usually has no negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, you may experience pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that may lead to respiratory arrest. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological 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 forgot to take Tramadol MABO

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

If you interrupt treatment with Tramadol MABO

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

You should 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 discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment is discontinued with tramadol. However, in rare cases, people who have been taking this medication for some time may not feel well when treatment is stopped abruptly. They may feel agitated, anxious, nervous, or experience tremors. They may be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit problems. Very few people experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, tingling, and buzzing 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 (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after discontinuing treatment with this medication, consult your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 hives along with difficulty breathing.

The most common side 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

Common: may affect 1 in 10 people

Uncommon: may affect 1 in 100 people

Rare: may affect 1 in 1,000 people

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

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

• Decreased blood sugar level.
• Hypophagia.

Indeterminate frequency (cannot be estimated from available data)

• Serotonin syndrome, which may 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 rigidity, 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 side effects:

If you experience any of the side effects, consult your doctor or pharmacist, even if they are possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store this medication in a safe and protected location, inaccessible to others. This medication may cause severe harm or even be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date appearing on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If unsure, ask your pharmacist how to properly dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tramadol MABO:

• The active ingredient is tramadol. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other components (excipients) are:Capule contents: microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, anhydrous colloidal silica, and magnesium stearate.Capsule coating: 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 contents of the packaging

Tramadol MABO is presented in hard gelatin capsules, yellow opaque, 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 medication is presented in containers containing 20 or 60 hard capsules.

Marketing authorization holder

MABO-FARMA, S.A.

Calle Rejas 2, 1st floor.

28821, Coslada, Madrid (Spain)

Responsible for manufacturing

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Last review date of this leaflet: June 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/