TRAMADOL ASTA MEDICA 100 mg/ml ORAL DROPS IN SOLUTION

Introduction

Leaflet:information for the user

Tramadol ASTA Medica 100 mg/ml oral drops in EFG solution

tramadol hydrochloride

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• 1. If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Tramadol ASTA Medica is and what it is used for
2. What you need to know before taking Tramadol ASTA Medica
3. How to take Tramadol ASTA Medica
4. Possible side effects
5. Storage of Tramadol ASTA Medica
6. Package contents and additional information

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

Tramadol - the active substance 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 brain.

Tramadol is used in the treatment of moderate to severe pain in adults and children from 3 years of age.

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, analgesics, 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.
• in children under 3 years of age.

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 substance 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 level 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 a 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 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 could result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose 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 effects").

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 before.

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. 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 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 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.

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 other treatment options are not 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 useful 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 facilitate or 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 pain due to nerve problems (neuropathic 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 in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

In particular, in children, the first administration of tramadol should be done under strict medical supervision.

Monitor the child, especially during the first administration. In case of warning signs (such as altered consciousness, constricted pupils, vomiting, seizures, very slow breathing...), call a doctor immediately or consult an emergency service (see section "If you take more Tramadol ASTA Medica than you should").

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 important that before driving or using machines, you observe how this medication affects you. Do not drive or use machines if you feel drowsy, 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 in combination with other medications.

Tramadol ASTA Medica contains ethanol, sucrose, and propylene glycol

This medication contains 161.8 mg of ethanol (alcohol) per ml, which corresponds to 0.16 g per 40 drops. The amount in 1 ml of this medication corresponds to 4 ml of beer or 1.7 ml of wine.

The small amount of alcohol in this medication will not have noticeable effects.

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

This medication contains 124.5 mg of propylene glycol per ml of oral solution, equivalent to 100 mg/ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

3. How to take Tramadol ASTA Medica

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, 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 recommended dose is, unless your doctor has given you different instructions:

Adults and adolescents over 12 years

Normally, the recommended dose of tramadol hydrochloride is 50-100 mg every 4-6 hours. Do not exceed 100 mg of tramadol per dose.

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 160 drops equivalent to 400 mg of tramadol hydrochloride per day, i.e., 4 doses of 40 drops in 24 hours, unless your doctor has indicated otherwise.

For dose adjustment in drops, see the following equivalence table:

Equivalence table of the number of drops corresponding to the content in mg of tramadol hydrochloride

Children

For children over 3 years of age, the recommended dose is 1 mg of tramadol hydrochloride per kilogram of body weight.

Do not exceed 2 mg of tramadol hydrochloride per kilogram of body weight per dose.

Approximately, the recommended usual and maximum doses per dose, according to weight, are as follows:

*Always round the number of drops to the lower unit.

The effective lowest dose that produces pain relief should be used. Daily doses of 8 mg of tramadol hydrochloride per kilogram of body weight or 400 mg of tramadol hydrochloride should not be exceeded, whichever is lower.

• 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.

• Patient with liver or kidney failure/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 disorders, your doctor may prolong the dosing intervals.

How and when should you take Tramadol ASTA Medica?

It is administered orally.

The solution can be dissolved in a sugary solution or a little liquid.

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

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 think the effect of this medication is too strong or too weak, tell 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, pupil contraction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic 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 prospectus to the healthcare professional.

If you forget to take Tramadol ASTA Medica

If you forgot 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 early, it is likely that the pain will return. If you want to interrupt treatment due to adverse 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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Generally, no adverse effects are usually present 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 tremulous. They may be hyperactive, have difficulty sleeping, or have gastrointestinal problems and intestinal transit problems. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, more 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 questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

You should consult your doctor immediately if you present 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 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 circulation (strong heartbeats and fast heartbeats, feeling of dizziness or collapse). These side 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, loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after taking high doses of tramadol or when taken simultaneously with another medication that can induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological changes may appear after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and treatment duration). These may appear in the form of mood changes (usually euphoria, occasionally irritability), changes in activity (usually decrease and occasionally increase), 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 medication. When treatment is interrupted abruptly, withdrawal syndrome may appear (see "If you interrupt treatment with Tramadol ASTA Medica").
• Blurred vision, pupil contraction (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 medications 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 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 taking Tramadol ASTA Medica").

Reporting 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Tramadol ASTA Medica

Keep this medication out of sight and reach of children. Store this medication in a safe and protected place, to which others cannot access. This medication can cause serious harm and even be fatal to people who have not been prescribed it.

No special storage conditions are required.

Do not use this medication after 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 thrown away through the sewers or in the trash. Deposit the packaging and medications 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 medications 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.

One milliliter of solution contains 100 mg of tramadol hydrochloride as the active ingredient. 40 drops are equivalent to 1 milliliter.

• The other components are: potassium sorbate (E-202), ethanol (20% V/V), propylene glycol (E-1520), sucrose, polysorbate 80, peppermint oil, purified water.

Appearance of the product and package contents

Colorless to pale yellow transparent solution presented in 10 and 30 ml bottles, provided with a dropper.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Meda Pharma, S.L.

C/General Aranaz, 86

28027 Madrid

Spain.

Manufacturer:

Temmler Pharma GmbH.

Temmlerstraße, 2

35039 Marburg, Hessen

Germany

You can request more information about this medication 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:May 2024

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