TRAMADOL RETARD AUROVITAS SPAIN 100 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol Retard Aurovitas Spain 100 mg prolonged-release tablets 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

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

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

Tramadol - the active substance of Tramadol Retard Aurovitas Spain - 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 retard is indicated for the treatment of moderate to severe pain.

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

Do not take Tramadol Retard Aurovitas Spain

• If you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• In case of acute intoxications caused by alcohol, drugs that facilitate or induce sleep, analgesics, or psychotropic substances (drugs that act on mood and emotions).
• If you are taking monoamine oxidase inhibitors (MAOIs) (a certain type of medication used to treat depression) or have taken them in the last 14 days before treatment with tramadol retard (see “Other medicines and Tramadol Retard Aurovitas Spain”).
• If you are epileptic and your seizures are not adequately controlled with treatment.
• As a substitute in the case of withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol Retard Aurovitas Spain:

• If you have disorders 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 have increased pressure inside the skull (for example, after a head injury or brain disease).
• If you have any liver or kidney disease.
• If you have difficulty breathing.
• If you are epileptic or suffer from seizures, because the risk of these seizures may increase.

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

• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol Retard Aurovitas Spain”).

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 a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

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, he will decide if you should take a hormonal supplement.

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 suffer from serious side effects. If you notice any of the following side effects, you should 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.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the drug 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 medicine you should use or how often you should 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 a longer time 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 and 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 symptoms”).

If you notice any of these signs, consult 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 Retard Aurovitas Spain).

Respiratory disorders related to sleep

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

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.

Other medicines and Tramadol Retard Aurovitas Spain

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

Concomitant treatment with tramadol retard and monoamine oxidase inhibitors (MAOIs) (medicines for the treatment of depression) should be avoided.

The concomitant use of tramadol and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol retard along with sedative medicines, he 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 as indicated by your doctor. It may be useful to ask friends or family members to be aware of the signs and symptoms indicated above. Contact your doctor if you experience these symptoms.

The analgesic effect of tramadol retard, as well as its duration, may be reduced if you use medicines that contain:

• carbamazepine (for epileptic seizures).
• pentazocine, nalbuphine, or buprenorphine (analgesics).
• ondansetron (medicine to prevent nausea).

Your doctor will indicate if you should take tramadol retard and what dose.

The risk of side effects increases:

• If you are taking medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol retard simultaneously with these medicines. Your doctor will tell you if tramadol retard is suitable for you.
• If you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• If you are taking medicines for the treatment of depression, tramadol retard may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible side effects”).
• If you take coumarin anticoagulants (medicines to thin the blood) such as warfarin, along with tramadol retard. The effect of these medicines on blood coagulation may be affected and may lead to bleeding.
• If you take tranquilizers, sleeping pills, other analgesics such as morphine and codeine (also used to treat cough) and alcohol while taking tramadol retard. You may feel dizzy or have a feeling of fainting. If you notice these side effects, inform your doctor.

Taking Tramadol Retard Aurovitas Spain with food and alcohol

Do not consume alcohol during treatment with tramadol retard, as its effect may be intensified. Food does not affect the effect of tramadol retard.

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.

Pregnancy

There is very little information on the safety of tramadol during human pregnancy. Therefore, you should not take tramadol retard if you are pregnant. Chronic use during pregnancy can lead to withdrawal syndrome in newborns.

Breastfeeding

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

Driving and using machines

Tramadol retard can cause drowsiness, dizziness, and blurred vision, and therefore may affect your ability to react. If you notice that your ability to react is altered, do not drive cars or other vehicles, or operate electrical tools or heavy machinery.

3. How to take Tramadol Retard Aurovitas Spain

Follow exactly the administration instructions of this medicine given 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 retard, 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 to the intensity of the pain and your individual sensitivity. Normally, you should take the smallest possible dose that produces pain relief.

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

Adults and adolescents from 12 years

One tramadol retard tablet of 100 mg twice a day (equivalent to 200 mg of tramadol hydrochloride per day), preferably in the morning and at night.

If necessary, your doctor may prescribe a different and more suitable presentation of this medicine.

Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has indicated otherwise.

Use in children

Tramadol retard is not suitable for children under 12 years.

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.

Patient with hepatic or renal impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with tramadol retard is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the dosing intervals.

How and when should you take Tramadol Retard Aurovitas Spain?

This medicine is administered orally.

Tramadol retard tablets should always be swallowed whole, without dividing or chewing, with sufficient liquid, preferably in the morning and at night. You can take the tablet with an empty stomach or with food.

How long should you take Tramadol Retard Aurovitas Spain?

Tramadol retard should not be administered for longer than strictly necessary.

If you require prolonged treatment, your doctor will check you at short and regular intervals (if necessary with interruptions in treatment) to see if you should continue treatment with tramadol retard and with what dose.

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

If you take more Tramadol Retard Aurovitas Spain than you should

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

After taking very high doses, you may experience constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, unconsciousness up to coma (deep unconsciousness), seizures, and difficulty breathing or respiratory arrest. In these cases, you should contact your doctor immediately.

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 ingested.

If you forget to take Tramadol Retard Aurovitas Spain

If you forget to take the tablets, it is likely that the pain will return.

Do not take a double dose to make up for forgotten doses, simply continue taking the tablets as you were doing before.

If you stop taking Tramadol Retard Aurovitas Spain

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 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 undesirable effects occur when finishing treatment with tramadol. However, in rare cases, when some people who have been taking tramadol tablets for some time stop taking them suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembling. They may feel confused, hyperactive, have difficulty sleeping, and have gastrointestinal or intestinal disorders. Very few people may have panic attacks, hallucinations, delirium, paranoia, or feel a loss of identity. They may experience unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Additionally, very rare unusual CNS symptoms have been observed, such as confusion, delirium, changes in the perception of one's own personality (depersonalization), and changes in the perception of reality and delusions of persecution (paranoia). If you experience any of these symptoms after stopping the use of this medicine, consult your doctor.

If you have any other 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.

Normally, the frequency of adverse effects is classified as follows:

• Very frequent (may affect more than 1 in 10 people)
• Frequent (may affect up to 1 in 10 people)
• Infrequent (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Frequency not known (cannot be estimated from available data)

You should see a doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or rash along with difficulty breathing.

The most frequent adverse effects during treatment with tramadol retard are nausea and dizziness, which occur in more than 1 in 10 patients.

Cardiac and blood disorders:

Infrequent: effects on the heart and blood circulation (strong and rapid heartbeats, fainting or collapse). These adverse effects may occur especially in patients who are incorporated or who make physical effort.

Rare: slow heartbeat, increased blood pressure.

Metabolism and nutrition disorders:

Frequency not known: decrease in blood sugar levels.

Nervous system disorders:

Very frequent: dizziness.

Frequent: headaches, sleepiness.

Rare: changes in appetite, abnormal sensations (such as itching, tingling, and numbness), tremors, slow breathing, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope).

If the recommended doses are exceeded, or if other medicines that depress brain function are taken at the same time, breathing may slow down.

Epileptic seizures may occur mainly after taking high doses of tramadol or when taking medicines that can cause epileptic seizures.

Frequency not known: speech disorders. Serotonin syndrome, which can manifest through changes in mental state (such as 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 (such as nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tramadol Retard Aurovitas Spain").

Psychiatric disorders:

Rare: hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.

Psychological problems may appear after treatment with tramadol retard. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These problems can manifest as a change in mood (usually excessive good mood, occasionally irritated mood), changes in activity (usually suppression, occasionally increase), and decreased cognitive and sensory perception (changes in senses and recognition, which can lead to errors in judgment).

Dependence may occur.

Eye disorders:

Rare: blurred vision, contraction of the pupils (miosis).

Frequency not known: excessive dilation of the pupils (mydriasis).

Respiratory disorders:

Rare: shortness of breath (dyspnea).

Worsening of asthma has been reported, however, no causal relationship with tramadol has been established.

Frequency not known: hiccups.

Gastrointestinal disorders:

Very frequent: nausea.

Frequent: dizziness, constipation, dry mouth.

Infrequent: vomiting, stomach problems (such as feeling of pressure in the stomach, bloating), diarrhea.

Skin disorders:

Frequent: sweating.

Infrequent: skin reactions (such as itching, rash).

Muscle disorders:

Rare: muscle weakness.

Liver and biliary disorders:

Very rare: increase in liver enzyme values.

Urinary disorders:

Rare: difficulty or pain when urinating, less urine than normal.

General disorders:

Frequent: fatigue.

Rare: in very rare cases, allergic reactions (such as difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have been reported.

When treatment is abruptly stopped, signs of withdrawal may appear (see "If you stop taking Tramadol Retard Aurovitas Spain").

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. Conservation of Tramadol Retard Aurovitas Spain

Keep this medicine out of 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 that appears on the box and on the blister pack after "CAD". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in 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 Retard Aurovitas Spain

• The active ingredient is tramadol hydrochloride. Each tablet contains 100 mg of tramadol hydrochloride.
• The other components are: calcium hydrogen phosphate anhydrous (E341), hydroxypropyl cellulose (E463), colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Appearance of the Product and Package Contents

Tramadol Retard Aurovitas Spain 100 mg are prolonged-release tablets, white, round, and biconvex.

Tramadol Retard Aurovitas Spain 100 mg is available in blister packs or plastic bottles, with 10, 20, 30, 50, 60, 90, 100, 120, 180, or 500 tablets.

Only some 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

Medochemie Ltd.

Facility A-Z, Ayios Athanassios Industrial St.

Limassol

Cyprus

or

Farmaceutisch Analytisch Laboratorium Duiven BV

Dijkgraaf 30

6921 RL Duiven

Netherlands

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

Netherlands: Tramadol HCl Duiven Retard 100 mg tabletten met gereguleerde afgifte

Spain: Tramadol Retard Aurovitas Spain 100 mg comprimidos de liberación prolongada EFG

Date of the Last Revision of this Prospectus:October 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/).