Tramadol Mabo 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol MABO 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 and you should not give it to others, even if they have the same symptoms, as 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 MABO is and what it is used for.
2. What you need to know before taking Tramadol MABO.
3. How to take Tramadol MABO.
4. Possible adverse effects.
5. How to store Tramadol MABO.
6. Contents of the pack and other information.

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

2. What you need to know before taking Tramadol MABO

Do not take Tramadol MABO

• 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 taking MAO inhibitors (a certain type of medicine used to treat depression) or have taken them within the last 14 days before starting treatment with this medicine (see section “Taking Tramadol MABO 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 MABO:

• If you think you are dependent on other strong analgesics (opioids).
• If you experience reduced level of consciousness (if you feel you might faint).
• If you are in shock (a sign of this condition may be cold sweat).
• If you have increased intracranial pressure (for example, 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 liver or kidney disease.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol MABO”).

Sleep-related breathing disorders

Tramadol MABO may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices 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 maximum recommended daily dose (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol 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 losing 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 alcohol 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 received treatment from a psychiatrist for other mental illnesses.

If you experience 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 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 resume taking it (“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).

Also inform your doctor if any of these problems occur during treatment with this medicine or if you have ever experienced them.

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure 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.

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.

There is a weak risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice if you experience any symptoms related to this serious syndrome (see section 4 “Possible side effects”).

Taking Tramadol MABO 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 Tramadol MABO 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 MABO 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 this medicine simultaneously with sedatives, sleeping medicines, other analgesics such as morphine and codeine (even when used to treat cough), and alcohol. In these cases, you may feel drowsy or dizzy. If this occurs, consult your doctor.
• If you are taking 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 MABO simultaneously with these medicines. Your doctor will tell you whether Tramadol MABO is suitable for you.
• If you are taking medicines for depression. Tramadol MABO may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• If you are taking coumarin anticoagulants (blood-thinning medicines), for example warfarin, while taking Tramadol MABO. The effect of these medicines on blood clotting may be affected, leading to bleeding.
• If you take drugs that may 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 nerve-related pain (neuropathic pain).

Taking Tramadol MABO with food and alcohol

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

Food does not affect the action of Tramadol MABO.

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 MABO more than once, you must stop breastfeeding.

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

Tramadol MABO contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free”.

3. How to take Tramadol MABO

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you 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 possible dose that provides pain relief should normally be taken. 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 or 2 capsules (equivalent to 50 mg or 100 mg of tramadol hydrochloride).

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

Use in children and adolescents

This medicine is not recommended 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 liver or kidney problems, 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 impairment, your doctor may extend the intervals between doses.

Method of administration:

How and when should you take Tramadol MABO?

The capsules of this medicine are taken 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 MABO?

This medicine should not be administered for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor at short, regular intervals (and 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 MABO than you should

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

After taking very high doses of tramadol, pinpoint pupils, vomiting, decreased blood pressure, increased pulse, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest may occur. In this 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, 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 MABO

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

If you stop taking Tramadol MABO

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

You should not stop taking this medicine suddenly unless your doctor tells you to do so. 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 likelihood of unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, on rare occasions, 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 experience tremors. They may become hyperactive, have difficulty sleeping, or develop digestive and intestinal transit problems. Very few people experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, or 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 stopping 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, occurring 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 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. bloating, heaviness), 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 heart rate
• Increased blood pressure
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, epileptic seizures, muscle twitches, 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 trigger 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 manifest as changes 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).
• May lead to drug dependence. When treatment is abruptly discontinued, withdrawal syndrome may occur (see “If you stop taking Tramadol MABO”).
• Blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• 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 the available data

• Decrease in blood sugar levels
• Hiccups

Frequency not determined (cannot be estimated from the available data)

• 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 MABO”).

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 MABO

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 following “EXP”. The expiry date refers to the last day of the month indicated.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point in 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 MABO:

• The active substance is tramadol. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other components (excipients) are: Capsule contents: microcrystalline cellulose, sodium carboxymethylstarch (type A) from potato, colloidal anhydrous 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 contents of the pack

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

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

This medicinal product is available in packs containing 20 or 60 hard capsules.

Marketing Authorization Holder

MABO-FARMA, S.A.

Calle 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 most recent revision of this leaflet: June 2024

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