Prospecto:Information for the Patient

Tramadol ASTA Medica 50 mg Hard Capsules EFG

tramadol, hydrochloride

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult yourdoctor or pharmacist.
• This medication has been prescribedonlyto you and should not be given to other people, evenif they havethe same symptomsas you,as it may harm them.
• If you experience adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospectus. See section 4.

1.What is Tramadol ASTA Medica and for what it is used

2.What you need to knowbeforestarting totake Tramadol ASTA Medica

3.How to take Tramadol ASTA Medica

4.Possible adverse effects

5.Storage of Tramadol ASTA Medica

6.Contents of the package and additional information

Tramadol - the active ingredient ofthis medication -is a pain reliever 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 is used in the treatment of moderate to severe pain.

Do not take Tramadol ASTA Medica

• if you are allergic to tramadol or any of the other ingredients of this medication (listed in section 6);
• in case of acute intoxications caused by alcohol, sleeping pills, analgesics, or other psychotropic medications (medications that act on the mood and emotions);
• if you are also taking MAO inhibitors (a certain type of medication used to treat depression) or if you have taken them in the last 14 days before starting treatment with this medication (see “Other medications and Tramadol ASTA Medica”);
• 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 ASTA Medica

• if you have consciousness disorders (if you think you are going to faint);
• ifyou are in shock (a sign of this state may be cold sweat);
• if you have increased intracranial pressure (for example, after a head trauma or diseases that affect the brain);
• ifyou have difficulty breathing;
• if you are epileptic or have seizures, as the risk of seizures may increase;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medications and Tramadol ASTA Medica”);
• if you have any liver or kidney disease.

Respiratory disorders related to sleep

This medication contains an active ingredient that belongs to the group of opioids. Opioids can cause respiratory disorders 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 monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side 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).

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 this medication 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 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 this medication may be higher if:

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

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 medication, and how to do it safely (see section 3, if you interrupt treatment with Tramadol ASTA Medica).

Also, inform your doctor if any of these 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 side effects. If you notice any of the following side 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 taking tramadol:

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.

Other medications and Tramadol ASTA Medica

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

You should avoid simultaneous treatment of tramadol with MAO inhibitors (a certain type of medication used to treat depression).

The effect and duration of pain relief produced by tramadol may be reduced if you take medications that contain:

• Carbamazepine (for seizures).
• Ondansetron (to prevent nausea).

Your doctor will tell you if you should take this medication and in what dose.

The risk of side effects increases,

• if you are taking this medication simultaneously with other analgesics such as morphine and codeine (even when used to treat cough) and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.

The concomitant use of Tramadol with sedatives or sleep medications (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, it should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol 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 mentioned above. Inform your doctor if you experience any of these symptoms;

• if you are takingmedications 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 is suitable for you;
• if you are taking gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain);
• if you are taking medications for depression. Tramadol may interact with these medications and you may experience a serotonin syndrome (see section 4 “Possible side effects”);
• if you are taking anticoagulant coumarins (medications to thin the blood) such as warfarin, while taking tramadol. The effect of these medications on blood coagulation may be affected and bleeding may occur;
• if you take medications that can increase the accumulation of tramadol and, therefore, its side effects (such as, for example, ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Tramadol ASTA Medica with food and alcohol

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

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,lactation, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Chronic treatment during pregnancy can cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. Therefore, you should not take this medication more than once during breastfeeding or, if you take tramadol more than once, you should stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects the fertility of men and women.

Driving and using machines

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

Tramadol ASTA Medica contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be used exactly as directed 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 ASTA Medica, 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 to the intensity of the pain and your individual sensitivity. Normally, the lowest dose possible 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

Normally, the initial dose is 1-2 capsules (equivalent to 50-100 mg of tramadol hydrochloride).

The effect may last between 4-6 hours, depending on the pain.

Children

This medication is not recommended 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 should you take Tramadol ASTA Medica?

The capsules are administered orally.

The Tramadol Asta Medica capsules are packaged in a child-resistant laminate to ensure their safety.

The child-resistant laminate is more resistant, making it more difficult to push the capsules through it.

Perforate the laminate beforehand and then push the capsule to remove it from the blister, in order to avoid damaging the capsules.

Swallow the capsules whole without dividing or chewing them and with sufficient liquid.

You can take the capsules with an empty stomach or with meals.

For how long should you take Tramadol ASTA Medica?

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 ASTA Medica than you should

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

After taking very high doses of tramadol, you may experience pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that may lead to respiratory arrest. 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 forget to take Tramadol ASTA Medica

If you forget to take the medication, it is likely that the pain will return. Do not take a double dose to compensate for the missed doses, simply continue taking tramadol as you have been doing until now.

If you interrupt treatment with Tramadol ASTA Medica

If you interrupt or discontinue treatment with this medication too soon, it is likely that the pain will return. 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 side effects occur when treatment is interrupted. However, in rare cases, people who have been taking this medication for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and ringing in the ears (tinnitus). Very rarely, more unusual central nervous system symptoms have been detected, such as confusion, delirium, change in perception of personality (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after stopping 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 medications,this medicationcan 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 facial swelling, tongue swelling, and/or throat swelling and/or difficulty swallowing and hives accompanied by difficulty breathing.

The most common side effects during treatment with tramadol 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.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, sensation of dizziness or collapse). These side effects may occur particularly in patients who are bedridden or who engage in physical exertion.
• Desire to vomit (retching), gastrointestinal discomfort (e.g., feeling of pressure in the stomach, swelling), diarrhea.
• Dermatological reactions (e.g., itching, skin rash).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, numbness), tremors, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures primarily occur after taking high doses of tramadol or when taken concomitantly with another medication that may induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological changes may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and the duration of treatment). These may appear as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased and occasionally increased), and decreased cognitive and sensory perception (alterations of the senses and perception that may lead to judgment errors).
• It may cause dependence on the medication. When treatment is stopped abruptly, withdrawal syndrome (see "If you stop taking Tramadol ASTA Medica") may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath.
• There have been reports of asthma exacerbation, however, it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or if taken concomitantly with other medications that depress cerebral 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: cannot be estimated from available data

• Decreased blood sugar levels.
• Hypotension.
• 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 ASTA Medica").

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:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children. Store this medication in a safe and protected place, to which no one else should have access. This medication can cause serious harm or even be fatal to individuals who have not been prescribed it.

No special storage conditions are required

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tramadol ASTA Medica

• The active ingredient is tramadol hydrochloride.Each capsule contains 50 mg of tramadol hydrochloride.

• The other componentsare: anhydrous calcium hydrogen phosphate, magnesium stearate, and anhydrous colloidal silica.

The capsule coating contains gelatin and titanium dioxide (E171). The printing ink contains: shellac, iron oxide black (E172), polyethylene glycol, and ammonium hydroxide.

Appearance of Tramadol ASTA Medicaand content of the container

Hard, white opaque, oblong capsules with the imprint T50, packaged in blisters. They are presented in containers of 20 and 60 capsules.

Holder of the marketing authorization:

Meda Pharma, S.L.

C/General Aranaz, 86

28027 Madrid

Spain

Responsible for manufacturing:

Temmler Pharma GmbH

Temmlerstrasse, 2

35039 Marburg, Hessen

Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/General Aranaz, 86

28027 Madrid

Spain

Date of the last review of this prospectus:June 2024

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)