Patient Information Leaflet

Tramadol Aurovitas 50 mg Hard Capsules EFG

Tramadol Hydrochloride

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Tramadol Aurovitas

3.How to take Tramadol Aurovitas

4.Possible side effects

5.Storage of Tramadol Aurovitas

6.Contents of the pack and additional information

Tramadol hydrochloride, the active ingredient in 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.

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, sleep medications, other painkillers, or tranquilizers.

•if you are taking, or have taken in the last two weeks, certain medicines called “monoamine oxidase inhibitors” or MAOIs (used to treat, for example, depression, and the antibiotic linezolid). The combination may cause severe, potentially fatal interactions.

•if you have uncontrolled epilepsy.

•for the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol Aurovitas.

•if you have epilepsy or seizures, or have had them in the past, as tramadol may increase the risk of seizures.

•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 weak 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 severe syndrome (see section 4 “Possible side effects”).

As with all medicines of this type (opioids), tramadol should be used with caution and only under medical supervision in severely 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 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 side 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 medicine you should use or the frequency with which you should use 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 experienced dependence on it, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment 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 a longer period 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 take it again (“withdrawal effects”).

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 medicine, and how to do it safely (see section 3 “If you interrupt treatment with Tramadol Aurovitas”).

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

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 side effects. If you notice any of the following side effects, stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, 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 may worsen in these children.

Respiratory disorders related to sleep

Tramadol may cause respiratory disorders related to sleep, such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pause in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Inform 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

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

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.

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 (painkillers).

-ondansetron (used to prevent nausea).

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

-medicines that can cause seizures, such as certain types of antidepressants or antipsychotics. The risk of seizures 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”).

-sedatives such as tranquilizers, sleep medications, antidepressants, and other painkillers (morphine, codeine); you may feel excessively drowsy or dizzy.

-blood thinners such as warfarin; you may need to reduce the dose of these medicines as the risk of severe bleeding may increase.

-gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain).

The simultaneous use of tramadol and sedatives, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may cause death. For this reason, simultaneous use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol together with sedatives, they should limit the dose and duration of simultaneous treatment.

Inform your doctor about all sedatives you are taking and follow the recommended dose closely. It may be helpful 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 consume alcohol during treatment with tramadol as its effects may be intensified.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

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

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with tramadol. It is essential 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 vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it together with other medicines.

Tramadol Aurovitas contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) 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.

Before starting treatment and regularly during it, 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 discontinue use (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 following are the recommended doses. Your doctor may increase or decrease your dose gradually depending on how you respond to treatment.

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

Adults and adolescents over 12 years old

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

Children under 12 years old

Tramadol is not recommended for children under 12 years old.

Senior patients

In elderly patients (over 75 years old), tramadol elimination may be delayed. If this is your case, 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 your liver or kidney disease is mild or moderate, 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, inform your doctor immediately or go to the emergency service. Several symptoms may appear, including: vomiting, decreased blood pressure, increased heart rate, collapse, fainting, and even coma, convulsions, 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 medication and the amount ingested.

If you forget to take Tramadol Aurovitas

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Tramadol Aurovitas

If you stop taking tramadol, the pain may appear again.

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

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Occasionally, tramadol may cause allergic reactions, although severe allergic reactions (including anaphylaxis and angioedema) are rare. Contact a doctor or emergency services immediately if you suddenly experience wheezing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially if it affects the entire 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, drowsiness, 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) that may lead to collapse. Diarrhea, hiccups, gastrointestinal irritation (sensation of pressure in the stomach, swelling), 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 alterations, sensation of tingling in the skin, tremor, 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 may lead to judgment errors.

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, hiccups. 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 starting to take Tramadol Aurovitas").

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 place, to which other people cannot access. This medication may cause serious harm or even be fatal to individuals who have not been prescribed it.

Do not usethis medicationafter the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREcollection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofTramadolAurovitas

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

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

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

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

Appearance of the product and contents of the package

Hard gelatin capsules of size “4” green/yellow 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 capsulesare available in blister packs.

Pack sizes: 20, 30, and 60 capsules.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: June 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).