TRAMADOL AUROVITAS 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tramadol Aurovitas 50 mg Hard Capsules EFG

Tramadol hydrochloride

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

• Keep this leaflet, as 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 symptoms are the same as yours.
• If you experience 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 Package Leaflet

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

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

Tramadol hydrochloride, the active substance of Tramadol Aurovitas, is an opioid analgesic that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol is used for the treatment of moderate to severe pain.

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

Do not takeTramadolAurovitas

• if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are under the influence of alcohol, sleeping drugs, other analgesics, or sedatives.
• if you are taking, or have taken in the last two weeks, certain medicines called monoamine oxidase inhibitors (MAOIs) (used to treat, for example, depression, and the antibiotic linezolid). The combination may cause serious, potentially life-threatening interactions.
• if you have uncontrolled epilepsy.
• for the treatment of withdrawal syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol Aurovitas.

• if you have epilepsy or convulsions or have had them in the past, as tramadol may increase the risk of having convulsions.
• 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 medicines and Tramadol Aurovitas").
• there is a small risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

As with all analgesics of this type (opioids), tramadol should be used with caution and only under medical supervision in seriously ill patients, including those with respiratory difficulties, excessively low blood pressure (shock), loss of consciousness, severe brain damage, or brain diseases that may cause increased intracranial pressure.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine 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 life-threatening 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 medicine 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 drugs, 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 medicine for longer than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those 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 you feel better once you start taking it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to determine the best treatment option for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3 "If you stop taking Tramadol Aurovitas").

The dose needed to achieve the desired effect may increase over time. In patients addicted to other opioid analgesics, tramadol should be used with caution and only for short periods.

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 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.

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 can worsen in these children.

Sleep-related breathing disorders

Tramadol can cause sleep-related breathing disorders, such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms can include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell your doctor or pharmacist 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. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you should take a hormonal supplement.

Other medicines and Tramadol Aurovitas

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

Do not take tramadol at the same time as medicines called monoamine oxidase inhibitors (MAOIs) (used to treat depression, for example) or if you have taken them in the last two weeks.

Both the effect and duration of pain relief produced by tramadol may be reduced if you take medicines that contain:

• carbamazepine (used to treat epilepsy).
• pentazocine, nalbuphine, or buprenorphine (analgesics).
• ondansetron (used to prevent nausea).

The risk of side effects increases if you take tramadol at the same time as:

• medicines that can cause convulsions, such as certain types of antidepressants or antipsychotics. The risk of having a seizure may increase if you take tramadol at the same time. Your doctor will tell you if tramadol is suitable for you.
• if you are taking antidepressants, tramadol may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• sedative medicines, such as tranquilizers, sleeping drugs, antidepressants, and other analgesics (morphine, codeine); you may feel excessively drowsy or dizzy.
• medicines that prevent blood clotting, such as warfarin; it may be necessary to reduce the dose of these medicines, as otherwise, the risk of severe bleeding may increase.
• gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

Taking tramadol and sedative medicines, such as benzodiazepines or related medicines, at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may cause death. For this reason, taking them at the same time should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol with sedative medicines, they should limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking and follow the recommended dose carefully. It may be useful to ask friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Taking Tramadol Aurovitas with food, drinks, and alcohol

Do not drink alcohol during treatment with tramadol, as its effects may be intensified.

Pregnancy and breastfeeding

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.

Pregnancy

There is very limited information on the safety of tramadol during pregnancy. Therefore, tramadol should not be used during pregnancy. If you become pregnant, you should inform your doctor as soon as possible.

Breastfeeding

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

Driving and using machines

Ask your doctor if you can drive or use machines while taking tramadol. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after a dose increase, after a change in formulation, and/or when taking it with other medicines.

Tramadol Aurovitas contains sodium

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

3. How to take Tramadol Aurovitas

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

Before starting treatment and regularly during treatment, your doctor will also explain 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 capsules should be swallowed whole with a glass of water.

The capsules can be taken with or without food and should not be chewed.

The recommended doses are indicated below. Your doctor may increase or decrease your dose gradually, depending on how you respond to treatment.

The dose should be adjusted according to the intensity of the pain and your individual sensitivity to pain. In general, you should take the lowest dose that relieves the pain.

Adults and adolescents over 12 years

The recommended dose is 50 mg or 100 mg (1 or 2 capsules) every 6-8 hours, depending on the intensity of the pain. You should not take more than 400 mg (8 capsules) per day.

Children under 12 years

Tramadol is not recommended for children under 12 years.

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with severe liver or kidney disease/patients on dialysis

Patients with severe liver or kidney disease should not take tramadol. If you have mild or moderate liver or kidney disease, your doctor may recommend prolonging the dosing intervals.

If you take more Tramadol Aurovitas than you should

If you take more capsules than you have been told, talk to your doctor immediately or go to the emergency department. Several symptoms may appear, which could include: vomiting, low blood pressure, increased heart rate, collapse, fainting, and even coma, seizures, and difficulty breathing.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tramadol Aurovitas

If you forget your dose of tramadol, take it as soon as you remember, and then continue as before.

Do not take a double dose to make up for forgotten doses.

If you stop taking Tramadol Aurovitas

If you stop taking tramadol, the pain may come back.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will tell 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).

If you want to stop treatment due to side effects, consult your doctor. If you have been taking this medicine for a long time, you may experience the following side effects when you stop treatment abruptly: restlessness, anxiety, nervousness, tremors, or stomach pain. Consult your doctor if you experience any of these effects after stopping treatment with tramadol.

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 can cause adverse effects, although not all people suffer from them.

Occasionally, tramadol may cause allergic reactions, although severe allergic reactions (including anaphylaxis and angioedema) are rare. Contact a doctor or emergency service immediately if you suddenly experience wheezing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially if it affects the whole body). Also, if you have seizures.

The following effects may occur:

Very common (may affect more than 1 in 10 people):

Nausea, dizziness.

Common (may affect up to 1 in 10 people):

Headache, somnolence, fatigue, vomiting, constipation, dry mouth, sweating.

Uncommon (may affect up to 1 in 100 people):

Fast or irregular heartbeats, increased heart rate, low blood pressure (especially when standing up) that can lead to collapse. Diarrhea, nausea, gastrointestinal irritation (feeling of pressure in the stomach, bloating), skin disorders (e.g., itching, rash, sudden redness of the skin).

Rare (may affect up to 1 in 1,000 people):

Slow heart rate, increased blood pressure, changes in appetite, speech disorders, tingling sensation on the skin, tremors, breathing difficulties, epileptic seizures (crisis), uncoordinated movements, muscle spasms, fainting, blurred vision, difficulty urinating, and urinary retention. Muscle weakness. Generalized allergic reactions (e.g., anaphylaxis and angioedema, see below). Hallucinations, confusion, anxiety, sleep disorders, and nightmares, mood changes, changes in activity (usually slowing down, sometimes increased activity), decreased consciousness, and decision-making ability, which can lead to errors in judgment.

Frequency not known (cannot be estimated from available data):

Increased liver enzymes. Worsening of asthma has been reported, although it has not been established whether it was caused by tramadol. Decreased blood sugar levels, hypothermia. Serotonin syndrome, which can 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tramadol Aurovitas").

During the use of tramadol, dependence, abuse, or addiction may occur. When treatment is discontinued, withdrawal symptoms such as agitation, anxiety, nervousness, insomnia, uncontrolled muscle movements (hyperkinesia), tremors, and gastrointestinal symptoms may occur. Other symptoms that have been observed very rarely when discontinuing treatment with tramadol are panic attacks, severe anxiety, hallucinations, tingling sensation on the skin, or hearing sounds like buzzing or ringing without an external cause (tinnitus).

Reporting of Adverse Effects

If you experience any type of adverse effect, 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: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Tramadol Aurovitas

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

Store this medicine in a safe and protected place, where others cannot access it. 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 shown on the box after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. 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 ofTramadolAurovitas

• The active ingredient is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other ingredients are:

Capsule content: Microcrystalline cellulose (grade 112), anhydrous colloidal silica, sodium carboxymethyl starch (type A) of potato, magnesium stearate.

Capsule shell: Gelatin, sodium lauryl sulfate, carmine indigo (E132), yellow iron oxide (E172), and titanium dioxide (E171).

Printing ink: Shellac lacquer, black iron oxide (E172).

Appearance of the Product and Package Contents

Hard gelatin capsules, size "4", green/yellow in color, filled with a white to off-white powder, with "T" printed on the green cap and "02" on the yellow body with black ink.

Tramadol Aurovitas hard capsules are available in blister packs.

Package sizes: 20, 30, and 60 capsules.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: June 2024

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