Package Leaflet: Information for the User

Tramadol Retard Aurovitas Spain 150 mg prolonged-release tablets 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 is Tramadol Retard Aurovitas Spain and what it is used for

2.What you need to know before you start taking 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 additional information

Tramadol - the active ingredient 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 the brain.

Tramadol retard is indicated for the treatment of moderate to intense pain.

Do not take Tramadol Retard Aurovitas Spain

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

•In case of acute intoxications caused by alcohol, sleep aids, analgesics, or psychotropic drugs (medications that affect 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 medications 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 consciousness disorders (if you think you are going to faint).

•If you are in shock (a sign of this state can be cold sweat).

•If you have increased intracranial pressure (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 have 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 tramadol dose exceeds the recommended daily dose limit (400 mg).

•If you have depression and are taking antidepressants, as some may interact with tramadol (see “Other medications 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 your doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 “Possible side effects”).

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 if you should take a hormone supplement.

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 be possible to achieve insufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, you should stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort or vomiting, constipation, loss of appetite.

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 lead to 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 medication 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 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 notice any of the following symptoms while using tramadol, it could be a sign of dependence or addiction:

• You need to use the medication for longer 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 discontinue the medication, and how to do it safely (see section 3, If you interrupt treatment with Tramadol Retard Aurovitas Spain).

Respiratory problems related to sleep

Tramadol can cause respiratory problems 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 observes 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 may worsen in these children.

Other medications andTramadol Retard Aurovitas Spain

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

Tramadol retard should be avoided in combination with monoamine oxidase inhibitors (MAOIs) (a certain type of medication used to treat depression).

The concomitant use of tramadol and sedatives, such as benzodiazepines or related medications, increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol retard along with sedatives, they should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's recommended dose closely. It may be helpful to ask friends or family members to be aware of the signs and symptoms mentioned earlier. 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 medications that contain:

•carbamazepine (for epilepsy).

•pentazocine, nalbuphine, or buprenorphine (analgesics).

•ondansetron (medication 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 medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol retard simultaneously with these medications. 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 medications for depression, tramadol retard may interact with these medications and you may experiencea serotonin syndrome (see section 4 “Possible side effects”).

•If you take anticoagulant coumarins (medications to clarify the blood) such as, for example, warfarin, along with tramadol retard. The effect of these medications on blood coagulation may be affected and may lead to bleeding.

•If you take tranquilizers, sleep aids, 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 sensation of fainting. If you experience these side effects, inform your doctor.

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

Pregnancy

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

Breastfeeding

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

Driving and operating machinery

Tramadol retard may cause drowsiness, dizziness, and blurred vision, and may impair your reaction time. If you notice that your reaction time is impaired, do not drive cars or other vehicles, or operate electrical tools or heavy machinery.

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

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

The dose should be adjusted according to the intensity of the pain and your individual sensitivity. Normally, you should take the lowest dose possible that produces pain relief.

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

Adults and adolescents 12 years and older:

One tramadol retard tablet of 150 mg twice a day (equivalent to 300 mg of tramadol hydrochloride per day), preferably in the morning and at night.

Your doctor may prescribe a different and more suitable presentation of this medication if necessary.

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

Use in children

Tramadol retard is not suitable for children under 12 years.

Older patients

In older patients (over 75 years), 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 disease/patients on dialysis

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

How and when to take Tramadol Retard Aurovitas Spain

This medication is administered orally.

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

For 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 monitor you at short and regular intervals (if necessary, with interruptions in treatment) to determine if you should continue treatment with tramadol retard 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 Retard Aurovitas Spain than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 compensate for the missed doses, simply continue taking the tablets as you were taking them before.

If you interrupt treatment with Tramadol Retard Aurovitas Spain

You should not stop taking this medication suddenly, unless your doctor instructs you to do so. 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 treatment, which can be done by gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).

Generally, no unpleasant effects occur when treatment with tramadol is discontinued. 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 shaky. They may feel confused, hyperactive, have difficulty sleeping, and experience gastrointestinal or intestinal disorders. Very few people may experience panic attacks, hallucinations, delirium, paranoia, or a loss of identity. They may experience unusual perceptions such as itching, tingling, and numbness, and tinnitus (ringing in the ears). Additionally, very rarely, unusual central nervous system symptoms have been observed, such as confusion, delirium, changes in perception of one's own personality (derealization), and changes in perception of reality 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.

Normally, the frequency of side effects is classified in the following way:

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

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

•Uncommon (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 seek medical attention 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 common side effects during treatment with tramadol retard are nausea and dizziness, which occur in more than 1 in 10 patients.

Cardiovascular and blood disorders:

Uncommon: effects on the heart and blood circulation (strong and rapid heartbeats, fainting or collapse). These side effects may occur especially in patients who are bedridden or who engage in physical exertion.

Rare: slow heart rate, increased blood pressure.

Metabolic and nutritional disorders:

Frequency not known: decrease in blood sugar levels.

Nervous system disorders:

Very common: dizziness.

Common: headaches, sleep.

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

If the recommended doses are exceeded, or if other central nervous system depressants are taken at the same time, breathing may slow down.

Seizures may occur mainly after taking high doses of tramadol or when taking medications that can cause seizures.

Frequency not known: speech disorders.Serotonin syndrome, which may manifest as 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 rigidity, lack of coordination and/or gastrointestinal symptoms (such as nausea, vomiting, diarrhea) (see section 2 “What you need to know before starting to take Tramadol Retard Aurovitas Spain”).

Psychiatric disorders:

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

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 may manifest as a change in mood (usually excessive good humor, occasionally irritable mood), changes in activity (usually suppression, occasionally increase) and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to judgment errors).

Dependence may occur.

Eye disorders:

Rare: blurred vision, pupil constriction (miosis).

Frequency not known: excessive pupil dilation (mydriasis).

Respiratory disorders:

Rare: shortness of breath.

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

Frequency not known: hiccups.

Gastrointestinal disorders:

Very common: nausea.

Common: dizziness, constipation, dry mouth.

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

Skin disorders:

Common: sweating.

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

Musculoskeletal disorders:

Rare: muscle weakness.

Hepatobiliary disorders:

Very rare: increase in liver enzyme values.

Urinary disorders:

Rare: difficulty or pain urinating, decreased urine output.

General disorders:

Common: 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 stopped abruptly, signs of withdrawal may appear (see “If you stop taking Tramadol Retard Aurovitas Spain”).

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 Medicinal Products 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 no other people can access. This medication can cause serious harm or even be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date that appears on the box and on the blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Tramadol Retard Aurovitas Spain

•The active ingredient is tramadol hydrochloride. Each tablet contains 150 mg of tramadol hydrochloride.

•The other components are: calcium dihydrogen phosphate anhydrous (E341), hydroxypropylcellulose (E463), anhydrous colloidal silica (E551) and magnesium stearate (E470b).

Appearance of the product and contents of the packaging

Tramadol Retard Aurovitas Spain 150 mg are prolonged-release tablets of a white color, in capsule shape.

Tramadol Retard Aurovitas Spain 150 mg is available in blister packs or plastic bottles, with 10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the Marketing Authorization and responsible for manufacturing

Holder of the Marketing Authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Responsible for manufacturing

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 150 mg tablets with regulated release

Spain:Tramadol Retard Aurovitas Spain 150 mg prolonged-release tablets EFG

Last review date of this leaflet:October 2024

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