TRAMADOL NORMON 100 mg/2 mL Injectable Solution and Perfusion Solution

2. What you need to know before you use Tramadol Normon

Do not use Tramadol Normon

• 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, analgesics or other psychotropic medicines (medicines that act on mood and emotions);
• if you are taking MAO inhibitors (a certain type of medicine used to treat depression) or if you have taken them in the last 14 days before treatment with this medicine (see "Use of tramadol 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 use tramadol:

• if you think you are dependent on other analgesics (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 convulsive 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 Normon").

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 monotherapy. Consult a doctor immediately if you present any of the symptoms related 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 dose of tramadol 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 Tramadol Normon can also lead to dependence, abuse, and addiction, which could result in 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 Tramadol Normon may be greater 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 problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using Tramadol Normon, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer time 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 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 medicine, and how to do it safely (see section 3, if you stop treatment with Tramadol Normon).

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person in different ways. 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 should stop using this medicine and consult a doctor immediately:

• slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

• extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These can 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.

Respiratory disorders related to sleep

Tramadol Normon may cause sleep-related respiratory disorders, 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 lack 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.

Use of Tramadol Normon with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)

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

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

• Carbamazepine (for epileptic seizures);
• Ondansetron (to prevent nausea).

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

The risk of side effects increases,

• if you are using this medicine simultaneously with other analgesics 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 with sedatives or medicines 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 other treatment options are not possible. However, if your doctor prescribes tramadol with sedative medicines, you should limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines 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. Inform your doctor if you experience any of these symptoms;
• if you are taking medicines that can cause convulsive seizures, such as certain antidepressants or antipsychotics. The risk of convulsive seizures increases if you use tramadol simultaneously with these medicines. Your doctor will tell you if tramadol is suitable for you;
• if you are taking medicines for the treatment of depression. Tramadol may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects");
• if you are taking anticoagulant medicines such as warfarin while using 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 ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Use of Tramadol Normon 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 the medicine.

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 injection with tramadol should be administered under strict medical supervision.

Monitor the child, especially during the first administration. In case of warning signs (such as changes in consciousness, pupillary constriction, vomiting, seizures, very slow breathing...), call a doctor immediately or consult an emergency service (see section "If you use more Tramadol Normon than you should").

Pregnancy, breastfeeding, and fertility

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.

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

Chronic treatment during pregnancy can cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not use this medicine more than once during breastfeeding, or if you use tramadol 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 drowsy, dizzy, have blurred vision, or see double, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administered concomitantly with other medicines.

This medicine contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per 2 ml ampoule; this is essentially "sodium-free".

3. How to use Tramadol Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure.

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

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used. Do not administer more than 8 ml of tramadol (equivalent to 400 mg of tramadol hydrochloride) per day, unless your doctor has told you to do so.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents over 12 years of age

Depending on your pain, doses of 1-2 ml of tramadol (equivalent to 50-100 mg of tramadol hydrochloride) may be administered.

Depending on the pain, the effect may last between 4-6 hours.

Additional information on administration is provided for doctors and healthcare professionals at the end of this leaflet.

Children

For children over 3 years of age, the recommended single dose is 1-2 mg of tramadol hydrochloride per kilogram of body weight.

The effective lowest dose that produces pain relief should be used. Daily doses of more than 8 mg of tramadol hydrochloride per kilogram of body weight or 400 mg of tramadol hydrochloride should not be exceeded, whichever is lower.

Additional information on administration is provided for doctors and healthcare professionals at the end of this leaflet.

Elderly patients

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

Patients with liver or kidney impairment/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 impairment, your doctor may prolong the dosing intervals.

How and when should you use Tramadol Normon?

Administration will be by parenteral route: intramuscular, subcutaneous, intravenous (slow injection), or by infusion.

Additional information on administration is provided for doctors and healthcare professionals at the end of this leaflet.

For how long should you use Tramadol Normon?

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 tramadol 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 use more Tramadol Normon than you should

If you have used an extra dose by mistake, it will generally not have negative effects. You should continue with the next dose as prescribed.

After using very high doses of the medicine, contraction of the pupil, vomiting, decrease in blood pressure, increase in heart rate, collapse, decrease in level of consciousness up to coma (deep unconsciousness), epileptic 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used. It is recommended to bring the medicine leaflet to the healthcare professional.

If you forget to use Tramadol Normon

If you forget to use the medicine, it is likely that the pain will return. Do not use a double dose to make up for forgotten doses; simply continue using the medicine as you have been doing until now.

If you stop treatment with Tramadol Normon

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

Do not stop using this medicine suddenly unless your doctor tells you to do so. If you want to stop using your medicine, talk to your doctor first, especially if you have been using 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 likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no side effects are experienced when treatment with tramadol is stopped. However, in rare cases, people who have been using 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 experience digestive problems and changes in bowel movements. Very few people may experience 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.
• Vomiting, constipation, dry mouth.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats 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 the use of high doses of tramadol or when another medicine that may induce them has been taken simultaneously.
• 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 decrease and occasionally increase), and decreased cognitive and sensory perception (alterations of the senses and perception that may 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 Normon").
• 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.
• Hiccup.

Indeterminate frequency (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 Normon")

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 Normon

Keep this medicine out of sight and reach of children.

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

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.

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Tramadol Normon 100 mg/2 ml injectable and infusion solution

The active ingredient is tramadol hydrochloride. Each milliliter of solution contains 50 mg of tramadol hydrochloride.

The other components are: sodium acetate and water for injectable preparations.

Appearance of the product and package contents

Transparent and colorless or slightly yellowish solution. It is presented in transparent glass ampoules supplied in packages of 5 ampoules of 2 ml.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other Presentations

Tramadol Normon 50 mg hard capsules EFG

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/

This information is intended only for healthcare professionals:

Information on the handling of Tramadol Normon 100 mg/2 ml injectable and infusion solution

This medicine is supplied in ampoules with a breaking point. The ampoule has a breaking line and can be easily opened.

1. Turn the ampoule with the tip upwards.
2. Open the ampoule at the breaking line.

Additional information on administration

For moderate pain, administer 1 ml of the solution (corresponding to 50 mg of tramadol hydrochloride). If there is no effect after 30-60 minutes, another ml can be administered.

If in the case of intense pain a higher dose is required, 2 ml of injectable solution can be administered (equivalent to 100 mg of tramadol hydrochloride).

Higher doses may be required on demand (pain treatment according to needs) for the treatment of post-surgical pain in the first hours after surgery. The doses required in 24 hours after surgery are usually not higher than those of a normal administration.

This medicine is administered intravenously (generally in the blood vessels under the surface of the arm), intramuscularly (generally in the buttocks), or subcutaneously under the skin.

Intravenous administration should be slow with 1 ml of injectable solution (equivalent to 50 mg of tramadol hydrochloride) per minute.

Alternatively, the medicine can be diluted in a suitable solution for perfusion (e.g., 0.9% sodium chloride solution or 5% glucose solution) for intravenous perfusion or patient-controlled analgesia (PCA) administration.

Incompatibilities of Tramadol Normon

It has been shown that this medicine is incompatible (immiscible) with injectable solutions containing diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, midazolam, and glyceryl trinitrate.

How to use Tramadol Normon for the treatment of children over 3 years old(see section 3. "How to use Tramadol Normon")

Calculation of the injection volume

1. Calculate the total dose of tramadol hydrochloride (mg) required: body weight (Kg) x dose (mg/Kg).
2. Calculate the volume (ml) of the diluted solution to be injected: divide the total dose (mg) by a suitable concentration of solution (mg/ml; see table below).

Table: Dilution of Tramadol Normon (suitable solvent see section "How and when to use Tramadol Normon")

According to your calculations, dilute the contents of the tramadol hydrochloride ampoule by adding the appropriate amount of solvent, mix, and administer the calculated volume of diluted solution. Discard the remaining injectable solution.

Example

For a child who weighs 27 Kg and is to be administered a dose of 1.5 mg of tramadol hydrochloride per Kg of body weight.

The total required dose is 27 kg × 1.5 mg/Kg = 40.5 mg of tramadol hydrochloride.

A suitable concentration of diluted solution is 10.0 mg/ml, so the volume to be injected would be approximately 4 ml (40.5 mg/10.0 mg/ml = 4.05 ml).

According to the above, 1 ml of injectable solution is diluted by adding 4 ml of solvent (e.g., 0.9% sodium chloride solution or 5% glucose solution) to obtain a diluted solution with a concentration of 10 mg of tramadol hydrochloride per ml.

Administer 4 ml of diluted solution (40 mg of tramadol hydrochloride).