Tramadol Vir 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol VIR 100 mg/ml oral drops solution EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Tramadol VIR is and what it is used for
2. Before you take Tramadol VIR
3. How to take Tramadol VIR
4. Possible side effects
5. How to store Tramadol VIR
6. Contents of the pack and other information

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

Tramadol VIR belongs to the group of centrally-acting opioid-type analgesic medicines that relieve pain by acting on specific nerve cells in the spinal cord and brain. These nerve cells reduce the intensity of pain sensation, a natural function that is enhanced 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 to any of the other components of Tramadol VIR
• In cases of acute intoxication with alcohol, medications used to facilitate or induce sleep, analgesics, opioids (such as nalbuphine, buprenorphine, or pentazocine), or psychotropic medicines (medications acting on mood and emotions)
• If you have been treated in the last 15 days or are being treated simultaneously with certain types of antidepressant medications (monoamine oxidase inhibitors or MAOIs)
• If you have severe liver or kidney problems
• If you have significant breathing difficulties
• If you suffer from epilepsy that is not controlled by treatment

Tramadol VIR must not be used to treat withdrawal syndrome. If you are unsure whether you should start taking this medicine, consult your doctor.

Take special care with Tramadol VIR:

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

• Are dependent on other strong painkillers (opioids)
• Experience reduced level of consciousness (dizziness or drowsiness)
• Are in shock (a sign of this condition may be cold sweating)
• Have increased intracranial pressure (for example, after head trauma or brain disease)
• Have difficulty breathing
• Are epileptic or suffer from seizures
• Have any liver or kidney disease
  • Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.
  • Suffer from depression and are taking antidepressants, as some of these may interact with tramadol (see "Other medicines and Tramadol").

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to tramadol may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs ("addiction")
• You are a smoker
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist 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 medicine for longer than prescribed 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, unsuccessful attempts to stop using the medicine or control its use
• You feel unwell when you stop using the medicine, and feel better once you take it again ("withdrawal effects")

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you interrupt treatment with Tramadol VIR).

Sleep-related breathing disorders

Tramadol may cause sleep-related breathing disorders, 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, nighttime awakenings due to breathlessness, 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, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Contact your doctor immediately if you experience any symptoms associated with this serious syndrome (see section 4, "Possible adverse effects").

Consult your doctor, even if any of the above-mentioned circumstances have occurred to you in the past.

Children and adolescents

Use in children with breathing problems

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Use of other medicines:

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

• Concomitant treatment with monoamine oxidase inhibitors (MAOIs) and certain types of antidepressants must be avoided

• 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 the treatment of epilepsy or nerve-related pain (neuropathic pain)

• Previous or concomitant treatment with carbamazepine (a medicine used to treat epileptic seizures) may reduce the analgesic effect of Tramadol VIR and shorten its duration

• Concomitant treatment of Tramadol VIR with medicines that may facilitate or provoke seizures (e.g., antidepressants or medicines used to treat certain psychological disorders, pain medicines, anesthetics) could, in rare cases, lead to the occurrence of such seizures

• Concomitant administration with medicines that may increase the accumulation of Tramadol VIR and thus its adverse effects (e.g., ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin)

• Concomitant administration of Tramadol VIR with serotonergic medicines (e.g., certain medicines used to treat depression) may, in isolated cases, lead to serotonin syndrome

• Concomitant administration of Tramadol VIR with medicines that prevent abnormal blood clotting, also known as coumarin derivatives (e.g., warfarin), may affect their anticoagulant action and lead to bruising

The risk of adverse effects increases:

• if you are taking antidepressants, Tramadol VIR may interact with these medicines and you may experience serotonin syndrome (see section 4, "Possible adverse 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 signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Taking Tramadol VIR with food and drinks:

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 medicine.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol VIR more than once during breastfeeding. If you take Tramadol VIR more than once, you must stop breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

Ask your doctor whether you can drive or use machines during treatment with Tramadol VIR. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machines if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Important information about some of the components of Tramadol VIR:

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine may cause stomach discomfort and diarrhea because it contains macrogol glycerol hydroxystearate.

3. How to take Tramadol VIR

Before starting treatment and regularly during treatment, your doctor will also explain to you what to 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 stop using it (see also section 2).

Always follow exactly the instructions for using Tramadol VIR provided by your doctor.

If you have any doubts, consult your doctor or pharmacist.

Instructions for correct administration of the preparation:

Administration is to be done orally. The drops should be taken with a small amount of liquid or dissolved on a teaspoon or a sugar cube.

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

2. Once the cap has been removed, place the bottle in an upright position and completely invert it. DO NOT SHAKE. WAIT A FEW SECONDS UNTIL THE FIRST DROP APPEARS.

Your doctor will inform you about the duration of treatment with Tramadol VIR.

Adults and adolescents over 12 years of age.

The usual 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 specifically instructed you to do so.

Elderly patients.

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

Patients with hepatic or renal impairment.

Tramadol VIR is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Tramadol VIR should not be administered for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor you at short, regular intervals (if necessary with treatment interruptions) to determine whether continued treatment with Tramadol VIR and which dose are still appropriate.

If you think that the effect of this medicine 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 have, contact your doctor or pharmacist immediately.

Poisoning due to very high doses of Tramadol VIR may cause pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, reduced level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest. In such a case, seek immediate medical help.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20. Take this leaflet with you.

If you forget to take Tramadol VIR:

If you forget to take Tramadol VIR, your pain is likely to return.

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

Then continue treatment as directed by your doctor.

If you stop taking Tramadol VIR:

Do not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking this medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).

If you stop or discontinue treatment with Tramadol VIR too early, your pain is likely to return.

If you wish to discontinue treatment due to undesirable effects, consult your doctor.

Some people undergoing prolonged treatment with strong analgesics may experience undesirable effects when stopping treatment. The risk of experiencing such effects after discontinuing Tramadol VIR is very low. However, if you feel agitated, anxious, nervous, or tremulous, if you feel hyperactive, have difficulty sleeping, or experience digestive problems, consult your doctor.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Tramadol VIR may cause adverse effects, although not everyone experiences them.

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

Frequency not known:

Decrease in blood sugar levels.

Hiccups.

Frequency indeterminate (cannot be estimated from the available data):

Serotonin syndrome, which may manifest as changes in mental status (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 adverse effects are:

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

Mood disturbances, increased or decreased activity, and cognitive and sensory impairments (e.g., in decision-making, perception). Dependence may occur.

• Frequent central and peripheral nervous system disorders (affecting between 1 and 10 out of every 100 patients), such as headache and confusion.

Changes in appetite, tingling, tremor, respiratory depression, and seizures may also occur.

• Uncommon cardiovascular disorders such as palpitations, increased pulse rate, decreased blood pressure upon standing, or transient circulatory failure.

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

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

Other uncommon disorders (affecting between 1 and 10 out of every 1,000 patients) may include nausea, gastrointestinal irritation (feeling of fullness, heaviness).

• Hepatic disorders: In isolated cases associated with tramadol use, an increase in transaminases (liver enzymes) has been observed.

• Frequent skin disorders such as increased sweating.

Uncommon skin reactions (e.g., itching, skin rash, urticaria) may also occur.

• Other rare disorders may include: blurred vision, muscle weakness, difficulty urinating, and urinary retention; allergic reactions ranging from difficulty breathing, bronchial obstruction, noisy or wheezing breathing, and edema, to generalized allergic reaction. The following symptoms, similar to those occurring with opioid administration, may occur: agitation, anxiety, restlessness, insomnia, excessive increase in motor activity, tremor, and gastrointestinal symptoms. Cases of worsening asthma have been reported, although no causal relationship has been established.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Tramadol VIR

Keep this medicine in a safe and secure place, out of reach of others. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Tramadol VIR after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Tramadol VIR:

• The active substance 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, macrogol glycerol hydroxystearate, mint flavor, anise flavor, purified water.

Appearance of the product and contents of the container:

Tramadol VIR is presented as drops in oral solution. Each container contains 10 or 30 ml of solution and a dropper cap.

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
Tel: 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 further information about this medicinal product by contacting the local representative of the Marketing Authorization Holder.

This leaflet was approved in May 2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/