TRAMADOL FARMALIDER 100 mg/ml ORAL SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol Farmalider 100 mg/ml oral drops in EFG solution

tramadol hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Tramadol Farmalider is and what it is used for.
2. What you need to know before you take Tramadol Farmalider.
3. How to take Tramadol Farmalider.
4. Possible side effects.
5. Storing Tramadol Farmalider.
6. Contents of the pack and other information.

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

Tramadol, the active substance in this medicine, 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 Farmalider is used to treat moderate to severe pain.

2. What you need to know before you take Tramadol Farmalider

Do not take Tramadol Farmalider:

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• In case of acute intoxication caused by alcohol, sleeping pills, painkillers or other psychotropic drugs (drugs 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 medicine (see "Taking Tramadol Farmalider with other medicines");
• 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 Farmalider:

• if you think you are dependent on other potent painkillers (opioids)
• 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 a history of seizures, as the risk of seizures may increase;
• if you have any liver or kidney disease.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol Farmalider").

There is a weak risk that you may experience a serotonin syndrome that may occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Respiratory disorders related to sleep

Tramadol Farmalider 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). Among the 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 observes these symptoms, contact your doctor. Your doctor may consider a dose reduction.

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 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 Tramadol Farmalider can also lead to dependence, abuse, and addiction, which could lead to 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 medicine 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 Farmalider 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 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 Farmalider, 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 start taking it again ("withdrawal symptoms").

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 medicine, and how to do it safely (see section 3, if you stop treatment with Tramadol Farmalider).

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.

Also, inform your doctor if any of these problems occur during treatment with this medicine or if you have had them before.

• 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, 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 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.

Taking Tramadol Farmalider with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant treatment with Tramadol Farmalider and MAO inhibitors (a certain type of medication used to treat depression) should be avoided.

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

• Carbamazepine (for epilepsy);
• Ondansetron (to prevent nausea)

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

The risk of side effects increases,

• if you are taking this medicine at the same time as 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.
• Concomitant use of Tramadol Farmalider 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 no other treatment options are possible.

However, if your doctor prescribes tramadol with sedative medications, they will limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medications you are taking and strictly follow your doctor's recommended dose. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Tell your doctor if you experience any of these symptoms;

• If you are taking medications that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol Farmalider at the same time as these medications. Your doctor will tell you if Tramadol Farmalider is suitable for you.
• If you are taking antidepressant medications, Tramadol Farmalider may 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 Farmalider. 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 its side effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).
• if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Taking Tramadol Farmalider 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 Farmalider.

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 with 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, pupillary constriction, vomiting, seizures, very slow breathing...), call a doctor immediately or consult an emergency service (see section "If you take more Tramadol Farmalider than you should").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Chronic treatment during pregnancy may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or if you take Tramadol Farmalider 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 medicine. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel sleepy, dizzy, have blurred vision or double vision, 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 medicines.

Tramadol Farmalider contains sucrose, ethanol, and propylene glycol.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. If this medicine is to be used chronically (e.g., for two weeks or more), it may cause tooth decay.

This medicine contains 19.95% ethanol (alcohol), which corresponds to an amount of 161.8 mg per dose, equivalent to 4.1 ml of beer or 1.7 ml of wine. This medicine is harmful to people with alcoholism. The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

This medicine contains 124.50 mg of propylene glycol in 1 ml of solution.

3. How to take Tramadol Farmalider

Follow exactly the administration instructions of this medicine 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 the use of Tramadol Farmalider, 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).

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

The dose should be adjusted to the intensity of the pain and individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used.

Your doctor will indicate the duration of treatment with Tramadol Farmalider oral drops in solution.

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

Adults and adolescents over 12 years.

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

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be slower. If this is your case, your doctor may prolong the dosing intervals.

Patients with liver or kidney problems/patients on dialysis

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

This medicine 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 this medicine and at what dose.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Tramadol Farmalider than you should:

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

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 up to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest may occur. In this case, contact a doctor immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine leaflet to the healthcare professional.

If you forget to take Tramadol Farmalider.

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

Do not take a double dose to make up for forgotten doses; simply continue taking Tramadol Farmalider as you have been doing until now.

If you stop treatment with Tramadol Farmalider

If you stop or finish treatment with this medicine too soon, it is likely that the pain will return. If you want to stop treatment due to side effects, consult your doctor.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will tell you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no side effects occur when treatment with tramadol is stopped. However, in rare cases, people who have been taking this medicine for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or trembly. They may be overactive, have difficulty sleeping, or have digestion and bowel 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 delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, consult your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should 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 rash along with difficulty breathing.

The most frequent adverse 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 and rapid heartbeats, feeling of dizziness or collapse). These adverse 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.
• 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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, numbness), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after taking high doses of tramadol or when taken simultaneously with another medicine that may induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological alterations may appear after treatment with tramadol. Their intensity and nature may vary (according to 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 can lead to errors of judgment).
• It may cause dependence on the medicine. When treatment is interrupted abruptly, withdrawal syndrome may appear (see "If you stop treatment with Tramadol Farmalider").
• Blurred vision, pupil constriction (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 medicines 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

• Increased liver enzymes.

Frequency not known: frequency that cannot be estimated from the available data

• Decrease in blood sugar levels.
• Hypo.
• 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Tramadol Farmalider").

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol Farmalider

Keep this medicine out of sight and reach of children.

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol Farmalider

The active ingredient is tramadol hydrochloride. 1 ml (40 drops) of oral drops in solution contains 100 mg of tramadol hydrochloride.

The other components are: potassium sorbate (E-202), 96% ethanol, propylene glycol (E-1520), sucrose, polysorbate 80, peppermint essential oil, and purified water.

Appearance of the Product and Package Contents

Tramadol Farmalider is presented in the form of oral drops in solution. The solution is colorless or slightly yellow, with a mint aroma. The packages contain 10 ml and 30 ml.

Marketing Authorization Holder

FARMALIDER, S.A.

C/ Aragoneses, 15. Alcobendas

28108 Madrid

Spain

Manufacturer

FARMALIDER S.A.

C/ Aragoneses 2

28108 Alcobendas, Madrid

Spain

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante, Valencia

Spain

SALUTAS PWO GMBH

Lange Gohren 3 – Osterweddingen

39171

Germany

Date of the Last Revision of this Prospectus: May 2024

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