TRAMADOL VIR 100 mg/ml ORAL SOLUTION DROPS EFG

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol VIR 100 mg/ml oral drops in EFG solution

Read the entire package leaflet carefully before starting to take the medication

• Keep this package leaflet, as you may need to read it again.
• 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 consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet

1. What Tramadol VIR is and what it is used for
2. Before taking Tramadol VIR
3. How to take Tramadol VIR
4. Possible side effects
5. Storage of Tramadol VIR
6. Package contents and additional information

1. What Tramadol VIR is and what it is used for

Tramadol VIR belongs to the centrally acting analgesic medications of the opioid type that relieve pain by acting on specific nerve cells in the spinal cord and brain. These nerve cells decrease the intensity of the pain sensation, a natural function that is increased by Tramadol VIR.

Tramadol VIR is indicated for the treatment of moderate to severe pain.

2. Before taking Tramadol VIR

Do not take Tramadol VIR:

• If you are allergic (hypersensitive) to tramadol hydrochloride or any of the other components of Tramadol VIR
• In case of acute intoxication with alcohol, medications to facilitate or induce sleep, analgesics, opioids (such as nalbuphine, buprenorphine, or pentazocine) or psychotropic medications (medications that act on mood and emotions).
• In the case of treatment during the last 15 days or simultaneously with certain types of medications for the treatment of depression (monoamine oxidase inhibitors or MAOIs)
• If you have severe liver or kidney problems.
• If you have significant breathing difficulties.
• If you have uncontrolled epilepsy.

Tramadol VIR should not be used as treatment for withdrawal syndrome. If you are unsure whether you should start taking this medication, consult your doctor.

Be careful with Tramadol VIR:

Before starting treatment with Tramadol VIR, inform your doctor if you:

• Are dependent on other potent analgesics (opioids)
• Have decreased level of consciousness (feeling of dizziness or drowsiness)
• Are in a state of shock (a sign of this state may be cold sweat)
• Have increased intracranial pressure (for example, after a head trauma or brain disease).
• Have difficulty breathing
• Are epileptic or have convulsive seizures.
• Have any liver or kidney disease
  • 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 adverse effects. If you notice any of the following adverse 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.
  • If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol").

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 tramadol can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse 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 on or addicted to tramadol 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 tramadol, 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 VIR).

Respiratory disorders related to sleep

Tramadol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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 symptoms related to this serious syndrome (see section 4 "Possible side effects").

Consult your doctor, even if any of the above circumstances have occurred to you at some point.

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 can worsen in these children.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

• Concomitant treatment with Tramadol VIR and monoamine oxidase inhibitors (MAOIs), a certain type of medication for the treatment of depression, should be avoided.
• Concomitant administration with alcohol or other central nervous system depressants, including anesthetics, may intensify the adverse effects of Tramadol VIR on the brain.
  • The risk of adverse effects increases if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

• Prior or concomitant treatment with carbamazepine (a medication for the treatment of epileptic seizures) may reduce the analgesic effect of Tramadol VIR as well as its duration.
• Concomitant treatment with Tramadol VIR and medications that may cause convulsive seizures (such as antidepressants or medications for the treatment of certain psychological disorders, pain medications, anesthetics) could rarely lead to the occurrence of such seizures.
• Concomitant administration with medications that may increase the accumulation of Tramadol VIR and, therefore, its adverse effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).
• Concomitant administration of Tramadol VIR with serotonergic medications (such as certain medications for the treatment of depression) may rarely lead to a serotonin syndrome.
• Concomitant administration of Tramadol VIR with medications that prevent abnormal blood clotting, also known as coumarin derivatives (such as warfarin), may affect their anticoagulant action, potentially leading to bruising.

The risk of adverse effects increases:

-if you are taking antidepressants, Tramadol VIR may interact with these medications, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

Talk to your doctor or pharmacist if you experience:

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.

Taking Tramadol VIR with food and beverages:

You should avoid consuming alcohol during treatment with Tramadol VIR.

Pregnancy and breastfeeding:

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.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol VIR more than once during breastfeeding, or if you take Tramadol VIR more than once, you should interrupt breastfeeding.

Consult your doctor or pharmacist before using any medication.

Driving and using machines:

Ask your doctor if you can drive or use machines during treatment with Tramadol VIR. 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 drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it concomitantly with other medications.

Important information about some of the components of Tramadol VIR:

This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause stomach upset and diarrhea because it contains macrogolglycerol hydroxystearate.

3. How to take Tramadol VIR

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using tramadol, 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).

Follow your doctor's instructions for administering Tramadol VIR exactly.

Consult your doctor or pharmacist if you have doubts.

Instructions for correct administration of the preparation:

Administration will be by oral route. The drops should be taken with a little liquid or dissolved in a spoon or a sugar cube.

1. To remove the safety cap from the bottle, press on the surface of the cap (A) and simultaneously unscrew it counterclockwise (B).

1. Once the cap is removed, place the bottle in a vertical position and completely inverted. DO NOT SHAKE. WAIT A FEW SECONDS UNTIL THE FIRST DROP COMES OUT.

Your doctor will indicate the duration of treatment with Tramadol VIR.

Adults and adolescents over 12 years.

Normally, the initial dose is 20-40 drops of Tramadol VIR (50-100 mg of tramadol hydrochloride) followed by 20-40 drops every 6-8 hours. Do not take more than 160 drops of Tramadol VIR per day unless your doctor has indicated otherwise.

Elderly patients.

In elderly patients (over 75 years), the elimination of the active ingredient may be slower. Therefore, your doctor may prolong the dosing intervals.

Patient with liver or kidney insufficiency.

If you have severe liver or kidney disease, treatment with Tramadol VIR is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Tramadol VIR 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 Tramadol VIR 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 VIR than you should:

If you have taken more Tramadol VIR than you should, consult your doctor or pharmacist immediately.

Overdose with very high doses of Tramadol VIR can cause constricted pupils, 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. In this case, contact 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. Bring this package leaflet with you.

If you forget to take Tramadol VIR

If you forget to take Tramadol VIR, it is likely that the pain will return.

Do not take a double dose to make up for forgotten doses. Take a new dose as soon as possible.

Then continue treatment as indicated by your doctor.

If you interrupt treatment with Tramadol VIR:

You should not stop taking this medication suddenly unless your doctor indicates otherwise. 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).

If you interrupt or finish treatment with Tramadol VIR too early, it is likely that the pain will return.

If you want to interrupt treatment due to undesirable effects, consult your doctor.

Some people undergoing prolonged treatment with potent analgesics may experience undesirable effects when finishing their treatment. The risk of experiencing effects after interrupting treatment with Tramadol VIR is very low. However, if you feel agitated, anxious, nervous, or trembling, if you are hyperactive or have difficulty sleeping or digestive problems, consult your doctor.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Tramadol VIR can cause adverse effects, although not all people suffer from them.

The frequently observed adverse effects are nausea and dizziness, occurring in more than 10% of patients.

Unknown frequency:

Decrease in blood sugar levels.

Hypo.

Indeterminate frequency (cannot be estimated from the available data)

Serotonin syndrome, which can manifest through 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 VIR").

Other possible adverse effects are:

• Rare psychiatric disorders such as hallucinations, confusion, sleep disturbances, and nightmares.

Mood changes, increased or decreased activity, and changes in cognitive and sensory abilities (e.g., in decision-making, perception). It can cause dependence.

• Frequent central and peripheral nervous system disorders (affecting 1 to 10 out of 100 patients) such as headaches and confusion.

Such as changes in appetite, tingling, tremors, respiratory depression, and convulsions.

• Infrequent cardiovascular disorders such as palpitations, increased pulse rate, decreased blood pressure when standing up, or transient circulatory failure.

Rare changes may include decreased pulse rate and increased blood pressure.

• Frequent gastrointestinal disorders such as vomiting, constipation, and dry mouth.

Other infrequent changes (affecting 1 to 10 out of 1,000 patients) may be retching, gastrointestinal irritation (feeling of fullness, heaviness).

• Liver disorders: In some isolated cases, coinciding with the use of tramadol, an increase in transaminases (liver enzymes) has been observed.

• Frequent skin disorders such as increased sweating.

Infrequent changes may include skin reactions (e.g., itching, skin scratching, hives).

• Other rare changes can be: blurred vision, muscle weakness, difficulty urinating, and urinary retention; allergic reactions ranging from difficulty breathing, bronchial obstruction, wheezing, or whistling when breathing, and edema, to general allergic reaction. The following symptoms may occur, similar to those that appear with the use of opiates: agitation, anxiety, nervousness, insomnia, excessive increase in motor activity, tremors, and gastrointestinal symptoms. Cases of worsening asthma have been reported, although no causal relationship was established.

If you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Conservation of Tramadol VIR

Keep this medicine in a safe and protected place, inaccessible to other people. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Tramadol VIR after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through drains or into the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Tramadol VIR:

• The active ingredient is tramadol hydrochloride. Each ml of solution contains 100 mg of tramadol hydrochloride, equivalent to 88.2 mg of tramadol.

• The other components are: glycerol (E-422), propylene glycol, sucrose, sodium cyclamate, sodium saccharin, potassium sorbate, macrogolglycerol hydroxystearate, peppermint flavor, anise flavor, purified water.

Appearance of the product and packaging content:

Tramadol VIR is presented in the form of drops in oral solution. Each package contains 10 or 30 ml of solution and a drop counter.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II, 28923 Alcorcón (Madrid) Spain

Phone: 0034 91 486 29 90 Fax: 0034 91 486 29 91

e-mail: [email protected]

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II, 28923 Alcorcón (Madrid) Spain

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

This prospectus was approved in May 2024

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