Package Insert: Information for the User

Tramadol Normon 100 mg/ 2 ml injectable solution and for infusion EFG

Tramadol, hydrochloride

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. How to use Tramadol Normon
2. Possible adverse effects
3. Storage of Tramadol Normon
4. Contents of the package and additional information

Tramadol, the active ingredient of this medication, 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 Normon is used in the treatment of moderate to severe pain in adults and in children from 3 years old.

No use Tramadol Normon

Advertencias and precautions

Consult your doctor before starting to use tramadol:

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 alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Serious cases of seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum daily recommended dose (400 mg).

Tolerancia, dependencia and adicción

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the drug less effective (the body gets used to it, known as pharmacological tolerance). Repeated use ofTramadol Normoncan also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these side 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 medicine 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 toTramadol Normonmay be higher 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 any problems with mood (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while usingTramadol 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 symptoms").

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

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 may be 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:

Respiratory disorders related to sleep

Tramadol Normon 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).Among the symptoms may include pauses in breathing during sleep, nocturnal 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 reducing thedose.

Use of Tramadol Normon with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

- Gabapentina or pregabalina to treat epilepsy or pain due to nerve problems (neuropathic pain)

You should avoid simultaneous treatment of tramadol with MAO inhibitors (a certain type of medicine used to treat depression).

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

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

The risk of side effects increases,

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 for use in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Especially in children, the first injection with tramadol should be administered under strict medical supervision.

Observe the child, especially during the first administration. If you notice any warning signs (such as altered consciousness, constricted pupils, 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, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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, do not use this medicine if you are pregnant.

Long-term treatment during pregnancy can cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. Therefore, do not use this medicine more than once during breastfeeding, or if you use tramadol more than once, you should stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with this medicine. It is essential to observe how this medicine affects you before driving or using machines. Do not drive or use machines 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 medicines.

This medicine contains sodium

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

Always take this medicine exactly as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

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

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest effective dose 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 otherwise.

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

Adults and adolescents over 12 years old

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

Depending on the pain, the effect can 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 kg of body weight.

The lowest effective dose should be used. Daily doses should not exceed 8 mg of tramadol hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride, whichever is less.

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

Older patients

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

Patients with liver or kidney disease/patients on dialysis

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

How and when to use Tramadol Normon?

The administration will be performed 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 need 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 and at what dose.

If you estimate that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you use more Tramadol Normon than you should

If you have accidentally taken an additional dose, generally you will not have any negative effects. You should continue with the next dose as prescribed.

After using very high doses of the medicine, contraction of the pupil, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), 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 Toxicological 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 take the medicine, it is likely that the pain will return. Do not use a double dose to compensate for the missed doses, simply continue taking the medicine as you have been doing until now.

If you interrupt treatment with Tramadol Normon

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

You should not stop using this medicine suddenly unless your doctor tells you to. 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 discontinue 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 is interrupted. However, in rare cases, people who have been using this medicine for some time may feel unwell if they interrupt treatment abruptly. They may feel agitated, anxious, nervous, or shaky.

They may find themselves hyperactive, having difficulty sleeping, or experiencing digestive and intestinal problems. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, 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 (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after interrupting treatment with this medicine, consult your doctor.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 hives accompanied by difficulty breathing.

The most common side 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, sensation of dizziness or collapse). These side effects may occur particularly in patients who are lying down or who are engaging in physical activity.
• Desire to vomit (retching), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, swelling), 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 heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures occur mainly after taking high doses of tramadol or when another medicine that may induce them is taken simultaneously.
• Changes in appetite.
• Hallucinations, confusion, alterations in sleep, delirium, anxiety, and nightmares.
• Psychological changes may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and the duration of treatment). These may appear in the form of changes in mood (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 may lead to judgment errors).
• It may cause dependence on the medicine. When treatment is stopped abruptly, withdrawal syndrome (see "If you stop taking Tramadol Normon") may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath.
• There have been reports of cases of worsening asthma, however it has not been established if 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 urinating, reduced urine output (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

• Decreased blood sugar levels.
• Hypophagia.

Frequency indeterminate(cannot be estimated from the available data)

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 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 side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

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

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

This medication does not require special conservation conditions.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

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

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 injection preparations.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Other presentations

Tramadol Normon 50 mg hard capsules EFG

Last review date of this leaflet: May 2024

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

This information is intended solely for healthcare professionals:

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

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

1. Turn the ampoule with the tip upwards.
2. Open the ampoule along 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 intense pain requires a higher dose, 2 ml of injectable solution (equivalent to 100 mg of tramadol hydrochloride) can be administered.

It may be necessary to use higher doses on demand (pain treatment according to needs), for postoperative 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 medication is administered intravenously (usually in the veins under the surface of the arm), intramuscularly (usually 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 medication can be diluted in an appropriate solution for perfusion (e.g. 0.9% sodium chloride solution or 5% glucose solution) for administration by intravenous perfusion or controlled analgesia of the patient (PCA).

Incompatibilities of Tramadol Normon

It has been demonstrated that this medication 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 an appropriate 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 ampoule of tramadol hydrochloride 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 weighing 27 Kg who 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 solution with a concentration of 10 mg of tramadol hydrochloride per ml.

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