TRAMADOL ASTA MEDICA 50 mg CAPSULES

2. What you need to know before taking Tramadol ASTA Medica

Do not take Tramadol ASTA Medica

• if you are allergic to tramadol or any of the other components of this medication (listed in section 6);
• in case of acute intoxications caused by alcohol, sleeping pills, pain relievers, or other psychotropic medications (medications that act on mood and emotions);
• if you are taking MAO inhibitors (a certain type of medication used to treat depression) or if you have taken them in the last 14 days before 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 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 intracranial pressure (e.g., after a head injury or diseases that affect the brain);
• if you 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, such as 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 slight 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 associated with this severe 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 dose of tramadol exceeds the maximum recommended 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 gets used to it, which is known as pharmacological tolerance). Repeated use of this medication can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication you need to use or how often you need to 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 greater 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 problems with your mood (depression, anxiety, or personality disorder) or have undergone psychiatric treatment for other mental illnesses.

If you notice any of the following symptoms while using this medication, 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 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 you experience any of these problems during treatment with this medication or if you have experienced them in the past.

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 experience serious side effects. If you notice any of the following side effects, you should stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, 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. These 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 hormonal supplements.

Other medications and Tramadol ASTA Medica

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

Concomitant treatment with tramadol and MAO inhibitors (a certain type of medication used to treat depression) should be avoided.

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

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

Your doctor will indicate 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 pain relievers 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.

Concomitant use of Tramadol with sedatives or medications for the treatment of insomnia (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (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 with sedative medications, they will limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medications you are taking and strictly follow your doctor's dosage recommendation. 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 can 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 neuropathic pain (nerve pain);
• if you are taking medications for the treatment of depression. Tramadol can interact with these medications, and you may experience a serotonin syndrome (see section 4 "Possible side effects");
• if you are taking anticoagulant medications 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 ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Taking 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 children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

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 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. For this reason, you should not take this medication more than once during breastfeeding, or if you take tramadol more than once, you should interrupt breastfeeding.

Based on human experience, it is not suggested that tramadol affects fertility in 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 that before driving or using machines, you observe how this medication affects you. Do not drive or use machines if you feel sleepy, dizzy, have blurred vision, or see double, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering 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; that is, it is "essentially sodium-free".

3. How to take Tramadol ASTA Medica

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Tramadol ASTA Medica, 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 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 indicated otherwise.

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

Adults and adolescents over 12 years

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

Depending on the pain, the effect can last between 4-6 hours.

Children

This medication is not recommended 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.

Patients with liver or kidney failure/patients on dialysis

If you have severe liver or kidney disease, treatment with this medication 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 ASTA Medica?

The capsules are administered orally.

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

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

Pre-puncture the blister pack and then push the capsule to remove it from the blister pack, 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 or without food.

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 determine if you should continue treatment with this medication and at what dose.

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

After taking very high doses of tramadol, you may experience constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), seizures, and difficulty breathing that can 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication leaflet 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 make up 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 finish treatment with this medication too soon, it is likely that the pain will return. If you want to interrupt treatment due to side effects, consult your doctor.

Do 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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no side effects are experienced when treatment with tramadol is interrupted. However, in rare cases, people who have been taking this medication for some time may feel unwell if they interrupt treatment abruptly. They may feel agitated, anxious, nervous, or trembly. They may be overactive, have difficulty sleeping, or experience digestive problems and changes in 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, unusual symptoms of the central nervous system have been detected, such as confusion, delirium, change in perception of personality (depersonalization), and change in perception of reality (derealization) and persecution delusions (paranoia). If you experience any of these symptoms after interrupting treatment with this medication, consult your doctor.

If you have any other doubts about the use of this medication, 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.

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 rash along with difficulty breathing.

The most frequent adverse 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 circulation (strong and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g., itching, 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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, numbness), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after taking high doses of tramadol or when taken simultaneously with another medicine that may induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological alterations may appear after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These may appear in the form of mood changes (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 can lead to errors of judgment).
• It can cause dependence on the medicine. When treatment is interrupted abruptly, a withdrawal syndrome may appear (see "If you stop treatment with Tramadol ASTA Medica").
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• Cases of worsening asthma have been reported, however, it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or if it is taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increase in liver enzymes.

Frequency not known: cannot be estimated from the available data

• Decrease in blood sugar levels.
• Hiccups.
• Serotonin syndrome, which can 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 stiffness, lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before you start taking Tramadol ASTA Medica").

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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol ASTA Medica

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.

It does not require special storage conditions

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

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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 ASTA Medica

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

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

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

Appearance of Tramadol ASTA Medica and Package Contents

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

Marketing Authorization Holder:

Meda Pharma, S.L.

C/General Aranaz, 86

28027 Madrid

Spain

Manufacturer:

Temmler Pharma GmbH

Temmlerstrase, 2

35039 Marburg, Hessen

Germany

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

Viatris Pharmaceuticals, S.L.

C/General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this prospectus:June 2024

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