Prospecto: information for the user

Tramadol retard Andrómaco 200 mg prolonged-release tablets EFG

Tramadol, hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Tramadol retard Andrómaco and for what it is used

2.What you need to know before starting to take Tramadol retard Andrómaco

3.How to take Tramadol retard Andrómaco

4.Possible adverse effects

5.Storage of Tramadol retard Andrómaco

6.Contents of the package and additional information

Tramadol - the active ingredient of this medication - 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 Andrómaco is used in the treatment of moderate to intense pain.

Do not take Tramadol retardAndrómaco

• If you are allergic to tramadol or any of the other ingredients of this medication (listed in section 6).
• In cases of acute intoxications caused by alcohol, sleeping pills, analgesics, or psychotropic drugs (medications that act on mood and emotions).
• If you are also taking MAO inhibitors (certain medications used to treat depression) or if you have taken them in the last 14 days before starting treatment with this medication (see "Taking Tramadol retard Andrómaco with other medications").
• If you have epilepsy and your seizures are not adequately controlled with treatment.
• For the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor before starting to take Tramadol retardAndrómaco:

• If you think you are dependent on other analgesics (opioids).
• 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 trauma or brain diseases).
• If you have difficulty breathing.
• If you are epileptic or have seizures, as the risk of these seizures may increase.
• If you have depression and are taking antidepressants, as some may interact with tramadol (see "Taking Tramadol retard Andrómaco with other medications").
• If you have any liver or kidney disease.

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 retard Andrómaco can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse 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 retard Andrómaco 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 illnesses.

If you observe any of the following symptoms while using Tramadol retard Andrómaco, it could be a sign of dependence or addiction:

– You need to use the medication for a longer period 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 treatment for you, when it is appropriate to stop the medication, and how to do it safely (see section 3, if you interrupt treatment with Tramadol retard Andrómaco).

Respiratory problems related to sleep

Tramadol retard Andrómaco contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory problems related to sleep; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

The risk of experiencing central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you experience central sleep apnea.

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 linked to this severe syndrome (see section 4 "Possible adverse effects").

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

Be aware that this medication can cause physical and psychological dependence. When used for a long period, its effect may decrease, requiring higher doses (development of tolerance).

In patients with a tendency to abuse medications or who have medication dependence, treatment with tramadol should only be carried out for short periods of time and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with this medication or if they have occurred at any time.

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 adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Inform your doctor if you experience any of the following symptoms while takingTramadol retard Andrómaco:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. They may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Taking Tramadol retardAndrómacowith other medications

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

Simultaneous treatment with this medication and monoamine oxidase inhibitors (MAOIs) (certain medications for depression treatment) should be avoided.

The analgesic effect of tramadol and its duration may be reduced if you take medications that contain:

• Carbamazepine (for epilepsy seizures)
• Ondansetron (medication to prevent nausea)

Your doctor will indicate if you should take this medication and at what dose.

The risk of adverse effects increases:

• If you are taking other analgesics such as morphine and codeine (also when used for coughing), and alcohol while taking this medication. It may cause more sleepiness or the sensation of fainting. If this occurs, consult your doctor.

The concomitant use of tramadol with sedatives or sleep medications (such as benzodiazepines) or gabapentin or pregabalin for epilepsy or neuropathic pain (pain due to nerve problems) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, or may be potentially fatal. Therefore, only consider concomitant use when other treatment options are not possible. However, if your doctor prescribes this medication with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and strictly follow your doctor's recommended dose. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms.

• 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 simultaneously with these medications. Your doctor will tell you if Tramadol retard Andrómaco is suitable for you.
• If you are taking medications for depression treatment. Tramadol may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible adverse effects").
• If you are taking anticoagulant medications (medications that prevent abnormal blood coagulation), such as warfarin, along with tramadol. The effect of these medications on blood coagulation may be affected and may lead to bleeding.

Taking Tramadol retard Andrómaco with food and alcohol

Do not consume alcohol during treatment with this medication, as its effect may be intensified. Food does not affect the medication's effect.

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.

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.

There is very little information available on the safety of tramadol in pregnant women. Therefore, do not take this medication if you are pregnant.

Chronic treatment during pregnancy may lead to withdrawal syndrome in newborns.

Tramadol may pass into breast milk. Therefore, do not take this medication more than once during breastfeeding or, if you take it more than once, stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful at the beginning of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Tramadol retard Andrómaco contains lactose, if your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 retard Andrómaco, when and for how long you should use it, when you should contact your doctor and when you should suspend use (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has instructed you otherwise.

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

Adults and adolescents over 12 years old

One tablet, twice a day (equivalent to 400 mg of tramadol hydrochloride per day), preferably in the morning and at night.

If necessary, your doctor may prescribe a different and more suitable dose of this medication for you.

If necessary, the dose can be increased up to 150 mg or 200 mg twice a day (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).

Children

This medication is not suitable for children under 12 years old.

Older adults

In older adults (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 this medication 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 Andrómaco

This medication is administered orally.

Always swallow the tablets whole, not divided or chewed, with enough 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 Andrómaco

This medication 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 see if you should continue treatment with this medication 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 Andrómaco than you should

If you have taken by mistake more tramadol tablets than you should, generally you will not have any negative effects. You should take the next dose as prescribed.

After taking very high doses, contraction of the pupil, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest may occur. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication package insert to the healthcare professional.

If you forgot to take Tramadol retard Andrómaco

If you forget to take the tablets, it is likely that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue treatment as instructed by your doctor.

If you interrupt treatment with Tramadol retard Andrómaco

If you interrupt or discontinue treatment with this medication too soon, it is likely that the pain will reappear. If you want to discontinue treatment due to side effects, consult your doctor.

You should 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 side effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment with this medication is discontinued. However, in rare cases, people who have been taking this medication for some time may feel unwell if they stop taking it suddenly. They may feel agitated, anxious, nervous, or shaky. They may find themselves hyperactive, have difficulty sleeping, or experience problems with digestion or bowel movements. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, other unusual central nervous system symptoms such as confusion, delirium, change in perception of personality (derealization), and alterations in perception of reality (depersonalization), and delusions of persecution (paranoia) have been detected. If you experience any of these symptoms after discontinuing treatment with this medication, please 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 may cause side effects, although not everyone will experience them.

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

The most common side effects during treatment with this medicine are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect 1 in 10 people

• Headache, numbness.
• Fatigue.
• Vomiting, dry mouth, constipation.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, feeling of dizziness or collapse). These side effects may occur especially in patients who are lying down or who are physically exerting themselves.
• Desire to vomit (retching), stomach problems (e.g. feeling of pressure in the stomach, swelling), diarrhea.
• Skin reactions (e.g. itching, hives).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g. difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling and numbness), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medicines that may cause seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may appear after treatment with this medicine. Their intensity and nature may vary (depending on the patient's personality and the duration of treatment). These problems may manifest as a change in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased) and decreased cognitive and sensory perception (alterations of the senses and perception that may lead to judgment errors).
• Dependence on the medicine may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath (dyspnea).
• Cases of worsening asthma have been reported, however no causal relationship with tramadol has been established. If the recommended doses are exceeded or if taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain urinating, decreased urine output (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: frequency that cannot be estimated from available data

• Decreased blood sugar level.
• Hypophagia.
• 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 retard Andrómaco”).

When treatment is stopped abruptly, signs of drug withdrawal syndrome may appear (see "If you stop treatment with Tramadol retard Andrómaco").

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:https://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.

Conserve this medication in a safe and protected place, to which other people cannot access. This medication can cause serious and even fatal harm to people who have not been prescribed it.

Do not use this medication after the expiration date that appears on the packaging 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.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol retard Andrómaco 200 mg prolonged-release tablets EFG

• The active ingredient is tramadol hydrochloride. Each tablet contains 200 mg of tramadol hydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose, 100 000 mPa·s hypromellose, magnesium stearate, anhydrous colloidal silica.

Coating: 6 mPa·s hypromellose, lactose monohydrate, macrogol 6000, propylene glycol (E1520), talc, titanium dioxide (E171), quinoline yellow (E104) lake, red iron oxide (E172), and brown iron oxide (E172).

Appearance of the product and contents of the packaging

This medicine is presented in the form of coated tablets with an orange color and a slightly brown tone, round and biconvex, marked with "T3" on one side and the manufacturer's logo on the other, packaged in blister strips and in boxes of 20 and 60 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Andrómaco Pharma, S.L.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Responsible manufacturer:

Grünenthal GmbH

Zieglerstrasse, 6 – D-52078 Aachen, Germany

Last review date of this leaflet: June 2024

The 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/