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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Tramadol hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Tramadol, the active substance of this medicine, is an analgesic belonging to the opioid group 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 to treat moderate to severe pain in adults and children from the age of 3 years.

2. What you need to know before using Tramadol Normon

Do not use Tramadol Normon

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6);
• in cases of acute intoxication caused by alcohol, sleeping medications, analgesics, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression) or have taken them within the last 14 days prior to treatment with this medicine (see "Use of tramadol with other medicines");
• if you have epilepsy and your seizures are not adequately controlled by 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 feel you might faint);
• if you are in shock (a sign of this condition may be cold sweating);
• if you have increased intracranial pressure (for example, after head trauma or brain diseases);
• if you have difficulty breathing;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you have 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 slight risk of developing 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 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 tramadol dose 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 may cause the medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Normon may also lead to dependence, abuse, and addiction, which could potentially result in 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

or addicted to Tramadol Normon may be higher if:

• You or any member of your family have abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood disorders (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 Normon, 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 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 stop treatment with Tramadol Normon).

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 experience any of the following adverse effects, you must 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 may be signs of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.

Sleep-related breathing disorders

Tramadol Normon 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 shortness of breath, 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.

Use of Tramadol Normon with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain)

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

The effect and duration of pain relief from tramadol may be reduced if you take medicines containing:

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

Your doctor will advise you whether you should use this medicine and at what dose.

The risk of adverse 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. The concomitant use of tramadol with sedatives or medicines for insomnia (such as benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes tramadol with sedative medicines, your dose and duration of concomitant treatment should be limited. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms;
• if you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you use tramadol simultaneously with these medicines. Your doctor will advise you whether tramadol is suitable for you;
• if you are taking medicines for depression. Tramadol may interact with these medicines and you may experience serotonin syndrome (see section 4 "Possible side effects");
• if you are taking coumarin anticoagulants (blood-thinning medicines) such as warfarin while using tramadol. The effect of these medicines on blood clotting may be affected, leading to bleeding;
• if you take medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (e.g., 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 effects may be intensified. Food does not affect the medicine's action.

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.

In particular, the first injection of tramadol in children should be administered under strict medical supervision.

Monitor the child, especially during the first administration. If any warning signs occur (such as changes in consciousness, constricted pupils, vomiting, seizures, very slow breathing, etc.), call a doctor immediately or contact 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 limited 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 may 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 must stop breastfeeding.

Based on human experience, tramadol is not considered to affect fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or use machines while being treated with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when used 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 unsure.

Before starting treatment and regularly during treatment, your doctor will also explain to you 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 according to the intensity of pain and your individual sensitivity. The lowest possible dose that provides pain relief should normally be used. Do not administer more than 8 ml of tramadol (equivalent to 400 mg of tramadol hydrochloride) per day, unless your doctor has specifically instructed otherwise.

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 for doctors and healthcare professionals is provided 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 that provides pain relief should be used. Daily doses must not exceed 8 mg of tramadol hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride, whichever is lower.

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

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slower. If this applies to you, your doctor may recommend extending the dosing intervals.

Patients with hepatic or renal 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 disorders, your doctor may extend the dosing intervals.

How and when to use Tramadol Normon?

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

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

How long should you use Tramadol Normon?

This medicine should not be used for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor you at short, regular intervals (and if necessary with treatment interruptions) to determine whether treatment with tramadol should continue 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 accidentally taken an extra dose, you will generally not experience negative effects. You should continue with the next dose as prescribed.

After taking very high doses of the medicine, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest can occur. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine's package leaflet to the healthcare professional.

If you forget to use Tramadol Normon

If you forget to take the medicine, your pain is likely to return. Do not use a double dose to make up for missed doses; simply continue using the medicine as you have been doing.

If you stop using Tramadol Normon

If you stop or discontinue treatment with this medicine too soon, your pain is likely to return. If you wish to discontinue treatment due to adverse effects, consult your doctor.

Do not stop using this medicine suddenly unless your doctor tells you to. If you wish to stop taking your 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, in rare cases, individuals who have been using this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky.

They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in perception of personality (depersonalization), changes 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

You must 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 together with difficulty breathing.

The most common 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 up to 1 in 10 people

• Headache, numbness.
• Fatigue.
• Vomiting, constipation, dry mouth.
• Sweating (hyperhidrosis).

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeat, feeling of dizziness or collapse). These adverse effects may particularly occur in patients who are standing up or performing physical exertion.
• Nausea (feeling like vomiting), gastrointestinal discomfort (e.g. sensation of pressure in the stomach, bloating), diarrhoea.
• Skin reactions (e.g. itching, rash).

Rare: may affect up to 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), tremor, seizures, muscle twitching, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Seizures occur mainly after using high doses of tramadol or when taken simultaneously with another medicine that may trigger them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety and nightmares.
• Psychological disturbances may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These may present as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• May lead to drug dependence. When treatment is abruptly discontinued, withdrawal syndrome may occur (see “If you stop taking 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 recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• Muscle weakness.
• Difficulty or pain when urinating, reduced urine output (dysuria).

Very rare: may affect up to 1 in 10,000 people

• Increase in liver enzymes.

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

• Decrease in blood sugar levels.
• Hiccups.

Frequency not determined (cannot be estimated from the available data)

Serotonin syndrome, which may present 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, diarrhoea) (see section 2 “What you need to know before taking Tramadol Normon”).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Normon

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

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

The active substance is tramadol hydrochloride. Each millilitre of solution contains 50 mg of tramadol hydrochloride.

The other components are: sodium acetate and water for injections.

Appearance of the product and contents of the pack

Clear, colourless or slightly yellowish solution. It is supplied in clear glass ampoules, packaged in packs of 5 ampoules of 2 ml.

Marketing Authorisation 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 most recent revision of this leaflet: May 2024

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

This information is intended for healthcare professionals only:

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

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

1. Rotate the ampoule with the tip pointing upwards.
2. Break the ampoule at the break 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 1 ml may be administered.

In cases of severe pain requiring a higher dose, 2 ml of the injection solution (equivalent to 100 mg of tramadol hydrochloride) may be administered.

Higher doses on demand (pain treatment according to need) may be required for the treatment of postoperative pain during the first hours after surgery. The doses required within 24 hours after surgery are usually not higher than those of normal administration.

This medicine is administered by intravenous route (usually into the blood vessels of the arm), by intramuscular route (usually into the buttocks), or by subcutaneous route under the skin.

Intravenous administration must be slow, at a rate of 1 ml of injection solution (equivalent to 50 mg of tramadol hydrochloride) per minute.

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

Incompatibilities of Tramadol Normon

This medicine has been shown to be 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 of age (see section 3. “How to use Tramadol Normon”)

Calculation of injection volume

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

Table: Dilution of Tramadol Normon (suitable diluent, see section “How and when to use Tramadol Normon”)

Concentration of diluted injectable solution (mg of tramadol hydrochloride/ml)	Tramadol Normon 100 mg/2 ml injectable solution and for infusion + added solvent
25.0 mg/ml	2 ml + 2 ml
16.7 mg/ml	2 ml + 4 ml
12.5 mg/ml	2 ml + 6 ml
10.0 mg/ml	2 ml + 8 ml
8.3 mg/ml	2 ml + 10 ml
7.1 mg/ml	2 ml + 12 ml
6.3 mg/ml	2 ml + 14 ml
5.6 mg/ml	2 ml + 16 ml
5.0 mg/ml	2 ml + 18 ml

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

Example

For a child weighing 27 kg who is to receive 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.

An appropriate concentration of the diluted solution is 10.0 mg/mL; therefore, the volume to be injected would be approximately 4 mL (40.5 mg / 10.0 mg/mL = 4.05 mL).

Accordingly, 1 mL of the 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 the diluted solution (40 mg of tramadol hydrochloride).