Prospecto:Information for the User

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

Tramadol hydrochloride

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

• Conserve this prospect, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospect. 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 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 in children from 3 years old.

Do not take Tramadol ASTA Medica

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

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);
• if you are in shock (a sign of this state may be cold sweat);
• if you have increased intracranial pressure (for example, after a head injury or brain diseases);
• if you have difficulty breathing;
• if you are epileptic or have seizures, because the risk of seizures may increase;
• if you have depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol ASTA Medica”);
• if you have any liver or kidney disease.

Respiratory disorders related to sleep

This medicine 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 alone. Consult your doctor immediately if you experience any of the symptoms linked to 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 maximum daily recommended dose (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of this medicine 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 medicine 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 medicine may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, 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 this medicine, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than indicated by your doctor.
• You need to use 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 and unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, 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 taking the medicine, 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 medicine or if they have occurred to you 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 medicine 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 medicines and Tramadol ASTA Medica

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

It is recommended to avoid simultaneous treatment of tramadol with MAO inhibitors (a certain type of medicine used to treat depression).

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

•Carbamazepine (for epilepsy seizures).

•Ondansetron (to prevent nausea).

Your doctor will indicate if you should take this medicine and in what dose.

The risk of side effects increases,

• if you are taking this medicine simultaneously with other painkillers 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, only consider concomitant use 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 follow your doctor's recommended dose strictly. 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 medicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. 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 antidepressants. Tramadol may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible side effects”);
• if you are taking anticoagulant coumarins (medicines to thin the blood) such as warfarin, while taking tramadol. The effect of these medicines on blood coagulation may be affected, and bleeding may occur;
• if you take medicines 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 medicine, 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.

Especially in children, the first administration of tramadol should be made under strict medical supervision.

Observe the child, especially during the first administration. If you notice any 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

Chronic treatment during pregnancy can cause withdrawal syndrome in newborns.

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

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

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with this medicine. It is essential to observe how this medicine 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 with other medicines.

Tramadol ASTA Medica contains ethanol, sucrose, and propylene glycol

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

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

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

This medicine contains 124.5 mg of propylene glycol in each ml of oral solution equivalent to 100 mg/ml. If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

Follow exactly the administration instructions of this medication as indicated by your doctor. If in 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 suspend use (see also section 2).

The recommended dose is, unless your doctor has given you different instructions:

Adults and adolescents over 12 years old

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 effective dose that produces pain relief should be used.Do not take more than 160 drops equivalent to 400 mg of tramadol hydrochloride per day, that is, 4 doses of 40 drops in 24 hours, unless your doctor has indicated otherwise.

To adjust the dose in drops, consult the following equivalence table:

Table of equivalences 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 kg of body weight.

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

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

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

Use the lowest effective dose that produces pain relief. Do not exceed daily doses of 8 mg of tramadol hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride, whichever is less.

• Older patients

In elderly patients (over 75 years old), 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 any serious 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?

It is administered orally.

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

You can take the medication 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 need 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 there will be no negative effects. Take the next dose as prescribed.

After taking very high doses of tramadol, contraction of the pupil, vomiting, decrease in blood pressure, increase in heart rate, collapse, decrease in 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 ASTA Medica

If you forgot 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 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 interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, there are no side effects when treatment 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 shaky. They may be hyperactive, have difficulty sleeping, or experience digestive and intestinal 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 such as confusion, delirium, change in perception of personality (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia) have been detected. If you experience any of these symptoms after interrupting 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 medicines, this medicine may cause side effects, although not everyone will experience them.

You must 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 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 taking medication or who are physically exerting themselves.
• 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), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures mainly occur after taking high doses of tramadol or when taken simultaneously 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 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 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 cases of asthma worsening, however, it has not been established whether they were caused by tramadol. If recommended doses are exceeded or if taken concomitantly with other medications that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain urinating, less urine than normal (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 location, inaccessible to others. This medication can cause severe harm or even be fatal to individuals not prescribed it.

No special storage conditions are required.

Do not usethis medicationafter the expiration date appearing onthe packagingafter CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGREpoint at the pharmacy. If unsure, ask your pharmacist how to properly dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tramadol ASTA Medica

• The active principle is tramadol hydrochloride.

One milliliter of solution contains 100 mg of tramadol hydrochloride as active principle. 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 content of the container

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

Holder of the marketing authorization and responsible for manufacturing

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

Last review date of this prospectus: May 2024

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