Tramadol retard Aurovitas Spain 150 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol Retard Aurovitas Spain 150 mg prolonged-release tablets 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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Tramadol Retard Aurovitas Spain is and what it is used for
2. What you need to know before taking Tramadol Retard Aurovitas Spain
3. How to take Tramadol Retard Aurovitas Spain
4. Possible side effects
5. How to store 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 in Tramadol Retard Aurovitas Spain – 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 retard is indicated for the treatment of moderate to severe pain.

2. What you need to know before taking 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 cases of acute intoxication caused by alcohol, sleeping medications, analgesics, or psychotropic medicines (medicines that affect mood and emotions).
• If you are taking monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression) or have taken them within the last 14 days before starting treatment with tramadol retard (see “Other medicines and Tramadol Retard Aurovitas Spain”).
• If you have epilepsy and your seizures are not adequately controlled by treatment.
• As a substitute in cases of withdrawal syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol Retard Aurovitas Spain if:

• You have disorders of consciousness (if you feel you might faint).
• You are in shock (a sign of shock may be cold sweating).
• You have increased pressure inside the skull (for example, after head injury or brain disease).
• You have liver or kidney disease.
• You have difficulty breathing.
• You have epilepsy or suffer from seizures, as the risk of 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 limit (400 mg).

• You have depression and are taking antidepressants, as some of these may interact with tramadol (see “Other medicines and Tramadol Retard Aurovitas Spain”).

There is a weak risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Contact a doctor immediately if you experience any of the symptoms associated with this serious condition (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. These may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

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, adequate 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.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become 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 potentially result in 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 loss of 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 on or addicted to tramadol may be higher if:

• You or any member of your family have abused 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 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 prescribed by your doctor.
• You need to take 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 but 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 take it again (“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 stop taking Tramadol Retard Aurovitas Spain”).

Sleep-related breathing disorders

Tramadol may cause sleep-related breathing disorders, such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). These symptoms may include pauses in breathing during sleep, waking up at night 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:

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may 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 need to take any other medicines.

Concomitant treatment with tramadol retard and monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) should be avoided.

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

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

Inform your doctor about all sedative medicines you are taking and follow the recommended dose carefully. It may be helpful to ask friends or family members to watch for the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

The analgesic effect of tramadol retard, as well as its duration, may be reduced if you are taking medicines containing:

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

Your doctor will advise you whether you should take tramadol retard and what dose to use.

The risk of adverse effects increases:

• If you are taking medicines that may lower the seizure threshold, 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 whether tramadol retard is suitable for you.
• If you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain).
• If you are taking medicines for depression, tramadol retard may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• If you take coumarin anticoagulants (blood-thinning medicines) such as warfarin, together with tramadol retard. The effect of these medicines on blood clotting may be altered, potentially leading to bleeding.
• If you take tranquilizers, sleeping pills, other analgesics such as morphine and codeine (also used to treat cough) or alcohol while taking tramadol retard. You may feel dizzy or faint. If you experience these adverse effects, inform your doctor.

Taking Tramadol Retard Aurovitas Spain with food and alcohol

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

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.

Pregnancy

There is very limited information regarding the safety of tramadol during human pregnancy. Therefore, you should 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. For this reason, you should not take tramadol retard more than once during breastfeeding. If you need to take tramadol retard more than once, you must stop breastfeeding.

Driving and using machines

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

3. How to take Tramadol Retard Aurovitas Spain

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

Before starting treatment and regularly during treatment, 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 stop using it (see also section 2).

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

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

Adults and adolescents aged 12 years and older:

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

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

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 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 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 to take Tramadol Retard Aurovitas Spain?

This medicine is administered orally.

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

For how long should you take Tramadol Retard Aurovitas Spain?

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

If prolonged treatment is required, your doctor will monitor at short and regular intervals (if necessary with treatment interruptions) whether treatment with tramadol retard should continue and at which 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 Retard Aurovitas Spain than you should

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

After taking very high doses, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, unconsciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties or respiratory arrest may occur. In such cases, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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, your pain is likely to return.

Do not take a double dose to make up for forgotten doses. Simply continue taking the tablets as previously directed.

If you stop taking Tramadol Retard Aurovitas Spain

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking your 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, no undesirable effects occur when stopping treatment with tramadol. However, in rare cases, when some people who have been taking tramadol tablets for some time stop suddenly, they may feel unwell. They may feel restless, anxious, nervous, or shaky. They may feel confused, hyperactive, have difficulty sleeping, and experience gastric or intestinal disturbances. Very few people may experience panic attacks, hallucinations, delusions, paranoia, or a sense of loss of identity. They may experience unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Additionally, very rare unusual symptoms of the CNS have been observed, for example, confusion, delusions, changes in the perception of one's own personality (depersonalization), and altered perception of reality and delusions of persecution (paranoia). If you experience any of these symptoms after stopping 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 can cause adverse effects, although not everyone experiences them.

The frequency of adverse effects is usually classified as follows:

• 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 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 together with difficulty breathing.

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

Cardiac and blood disorders:

Uncommon: effects on the heart and blood circulation (strong and rapid heartbeat, fainting or collapse). These adverse effects may occur especially in patients who are getting up or engaging in physical exertion.

Rare: slow heartbeat, increased blood pressure.

Metabolism and nutrition disorders:

Frequency not known: decrease in blood sugar levels.

Nervous system disorders:

Very common: dizziness.

Common: headache, drowsiness.

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

If 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 may trigger seizures.

Frequency not known: speech disorders. Serotonin syndrome, which may present with 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, 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.

Psychological problems may occur after treatment with tramadol retard. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (usually excessive good mood, 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 impaired judgment).

Dependence may occur.

Eye disorders:

Rare: blurred vision, pupil constriction (miosis).

Frequency not known: excessive pupil dilation (mydriasis).

Respiratory disorders:

Rare: shortness of breath (dyspnea).

Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established.

Frequency not known: hiccups.

Gastrointestinal disorders:

Very common: nausea.

Common: dizziness, constipation, dry mouth.

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

Skin disorders:

Common: sweating.

Uncommon: skin reactions (e.g., itching, rash).

Musculoskeletal disorders:

Rare: muscle weakness.

Liver and biliary disorders:

Very rare: increased liver enzyme values.

Urinary disorders:

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

General disorders:

Common: fatigue.

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

When treatment is abruptly discontinued, withdrawal symptoms may occur (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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Retard Aurovitas Spain

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to others. 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 carton and blister pack after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Do not dispose of medicines via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol Retard Aurovitas Spain

• The active substance is tramadol hydrochloride. Each tablet contains 150 mg of tramadol hydrochloride.
• The other components are: calcium hydrogen phosphate dihydrate (E341), hydroxypropylcellulose (E463), anhydrous colloidal silica (E551), and magnesium stearate (E470b).

Appearance of the product and contents of the container

Tramadol Retard Aurovitas Spain 150 mg are prolonged-release tablets, whitish in colour and capsule-shaped.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

The Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

The Netherlands: Tramadol HCl Duiven Retard 150 mg tabletten met gereguleerde afgifte

Spain: Tramadol Retard Aurovitas Spain 150 mg comprimidos de liberación prolongada EFG

Date of the most recent review of this leaflet: October 2024

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