PATIENT INFORMATION LEAFLET

Tramadol VIR 100 mg/ml oral drops in solution EFG

Read this leaflet carefully before starting to take the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before taking Tramadol VIR

3. How to take Tramadol VIR

4. Possible side effects

5. Storage of Tramadol VIR

6. Contents of the pack and additional information

Tramadol VIR belongs to central-acting opioid analgesics 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.

Do not take Tramadol VIR:

- If you are allergic (hypersensitive) to tramadol hydrochloride or to any of the other components of Tramadol VIR.

- In case of acute intoxications by alcohol, sleep aids, analgesics, opioids (such as nalbuphine, buprenorphine, or pentazocine), or psychotropic drugs (drugs that act on the mood and emotions).

- During treatment in the last 15 days or simultaneously with certain types of antidepressant medications (monoamine oxidase inhibitors or MAOIs).

- If you have severe liver or kidney problems.

- If you have significant respiratory problems.

- If you have uncontrolled epilepsy.

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

Be especially careful with Tramadol VIR:

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

- Have dependence on other potent analgesics (opioids).

- Present a decrease in the level of consciousness (feeling of dizziness or drowsiness).

- Are in a state of shock (a sign of this state can be cold sweat).

- Present an increase in intracranial pressure (for example, after a head trauma or brain disease).

- Have difficulty breathing.

- Are epileptic or have 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, it may not be possible to achieve sufficient pain relief, while others are more likely to experience severe adverse effects. If you notice any of the following adverse 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.
• 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 becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse 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 tramadol may be higher 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 any problems with mood (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental health conditions.

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 symptoms").

If you notice any of these signs, consult your doctor to determine the best course of treatment for you, when it is appropriate to stop taking 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 levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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 in monotherapy. Consult your doctor immediately if you experience any of the symptoms linked to this severe syndrome (see section 4 "Possible adverse effects").

Consult your doctor, even if any of the above circumstances have occurred at any time.

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.

Use of other medications:

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

- Avoid simultaneous treatment of Tramadol VIR with monoamine oxidase inhibitors (MAOIs), certain types of antidepressant medications.

- Simultaneous 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 for epilepsy or neuropathic pain.

- Previous or simultaneous treatment with carbamazepine (medication for epilepsy) may reduce the analgesic effect of Tramadol VIR as well as its duration.

- Simultaneous treatment of Tramadol VIR with medications that facilitate or may cause seizures (for example, antidepressants or medications for certain psychological disorders, pain medications, anesthetics) may lead to rare 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 serotoninergic medications (for example, certain antidepressants) may lead, in isolated cases, to a serotonin syndrome.

- Concomitant administration of Tramadol VIR with medications that prevent abnormal blood coagulation, also known as coumarin derivatives (for example, warfarin), may affect its anticoagulant action and cause bleeding.

The risk of adverse effects increases:

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

Consult 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 hormone supplements.

Taking Tramadol VIR with food and drinks:

Avoid consuming alcohol during treatment with Tramadol VIR.

Pregnancy and lactation:

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

Lactation

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery:

Ask your doctor if you can drive or operate machinery during treatment with Tramadol VIR. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery 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 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 discomfort and diarrhea because it contains hydroxyethylstearate macrogolglycerol.

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

Follow exactly the administration instructions for Tramadol VIR indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Instructions for correct administration of the preparation:

The administration will be carried out orally. The drops must be taken with a little liquid or dissolved in a spoonful of sugar or a sugar cube.

1. To extract the safety cap from the bottle, press on the surface of it (A) and at the same time unscrew in a counterclockwise direction (B).

2. Once the cap has been extracted, place the bottle in a vertical position and upside down. DO NOT SHAKE. WAIT FOR 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 old.

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.

Geriatric patients.

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

Patients with liver or kidney insufficiency.

If you have any severe liver or kidney disease, treatment with Tramadol VIR is not recommended. If you have moderate liver or kidney disorders, 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 see if you should continue treatment with Tramadol VIR and at what dose.

If you estimate that the action 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 may cause 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, inform 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. Bring this leaflet with you.

If you forget to take Tramadol VIR:

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

Do not take a double dose to compensate for the missed 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 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 risk of unnecessary side effects (withdrawal symptoms).

If you stop or finish treatment with Tramadol VIR too soon, it is likely that the pain will reappear.

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

Some people on prolonged treatment with potent analgesics may experience undesirable effects when they stop their treatment. The risk of experiencing effects after stopping treatment with Tramadol VIR is very low. However, if you feel agitated, anxious, nervous, or tremulous, 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.

Like all medicines, Tramadol VIR can cause side effects, although not everyone will experience them.

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

Unknown frequency:

Decrease in blood sugar levels.

Abdominal cramps.

Indeterminate frequency (cannot be estimated from available data)

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 rigidity, 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 side effects are:

- Rare psychiatric alterations such as hallucinations, confusion, sleep disturbances, and nightmares.

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

- Frequent alterations in the central and peripheral nervous system (affecting between 1 and 10 of every 100 patients) such as headaches and confusion.

Such as appetite changes, tingling, tremors, respiratory depression, and seizures.

- Infrequent cardiovascular alterations such as palpitations, increased pulse rate, decreased blood pressure upon standing, or transient circulatory insufficiency.

Such as rare alterations may present decreased pulse rate and increased blood pressure.

- Frequent gastrointestinal alterations such as vomiting, constipation, and dry mouth.

Other infrequent alterations (affecting between 1 and 10 of every 1,000 patients) may be hiccups, gastrointestinal irritation (sensation of fullness, heaviness).

- Liver alterations: In some isolated cases coinciding with tramadol use, an increase in liver enzymes has been observed.

- Frequent skin alterations such as increased sweating.

Such as infrequent alterations may appear skin reactions (e.g. itching, skin rash, urticaria).

- Other rare alterations may be: blurred vision, muscle weakness, urinary difficulties, and urinary retention; allergic reactions ranging from difficulty breathing, bronchial obstruction, wheezing or whistling sounds while breathing, and edema, to general allergic reaction. The following symptoms, similar to those that appear with opioid use, may also occur: agitation, anxiety, nervousness, insomnia, excessive 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 side effects you are experiencing are severe or if you do not appreciate any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Store this medication in a safe and protected place, where it cannot be accessed by others. This medication may cause serious harm or even be fatal to individuals who have not been prescribed it.

Keep out of the reach and sight of children.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Tramadol VIR:

- The active ingredient is tramadol hydrochloride. Each milliliter 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 aroma, anise aroma, purified water.

Appearance of the product and contents of the package:

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Industria Química y Farmacéutica VIR, S.A.

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

Tel: 0034 91 486 29 90 Fax: 0034 91 486 29 91

e-mail:[email protected]

Responsible for Manufacturing:

Industria Química y Farmacéutica VIR, S.A.

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

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

This prospectus was approved in May 2024

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