Tramadol Normon 100 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tramadol retard NORMON 100 mg prolonged-release tablets EFG

Tramadol hydrochloride

Read the entire leaflet carefully before you start taking 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What Tramadol retard NORMON is and what it is used for

Tramadol 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 retard is indicated for the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol retard NORMON

Do not take Tramadol retard NORMON

• If you are allergic to tramadol or to any of the other components of this medicine (listed in section 6).
• In cases of acute intoxication caused by alcohol, hypnotic drugs, analgesics, or psychotropic medicines (medicines that affect mood and emotions).
• If you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression), or if you have taken them within the last 14 days before starting treatment with Tramadol retard NORMON (see "Taking Tramadol retard NORMON with other medicines").
• If you have epilepsy and your seizures are not adequately controlled by treatment.
• As treatment for withdrawal syndrome.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tramadol retard NORMON.

• If you think you are dependent on other analgesics (opioids).
• If you have disturbances in 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 pressure inside the skull (for example, after head injury or brain disease).
• 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 of them may interact with tramadol (see "Other medicines and Tramadol retard NORMON").

There is a low risk that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact a doctor immediately if you develop any symptoms associated with this serious syndrome (see section 4 "Possible side effects").

In such cases, please consult your doctor before taking the medicine.

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended daily limit (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 result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to 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

or addicted to Tramadol Normon may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment 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 those prescribed, for example, "to feel calm" or "to help you sleep."
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and feel better once you take it again ("withdrawal effects").

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

Sleep-related breathing disorders

Tramadol retard Normon may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). 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.

Also inform your doctor if any of these problems occur during treatment with Tramadol retard NORMON or if you have ever experienced them.

Children

Tramadol retard NORMON is not suitable for children under 12 years of age.

Use in children with respiratory problems

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

Taking Tramadol retard NORMON with other medicines

Inform your doctor or pharmacist if you are 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 retard NORMON and monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) should be avoided.

The analgesic effect of Tramadol retard NORMON and its duration may be reduced if you take medicines containing:

• Carbamazepine (for epileptic seizures)
• Pentazocine, nalbuphine, or buprenorphine (analgesics);
• Ondansetron (a medicine to prevent nausea)

Your doctor will advise you whether to take Tramadol retard NORMON and at what dose.

The risk of adverse effects increases:

• If you take tranquilizers, hypnotic drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol retard NORMON. This may cause increased drowsiness or feeling faint. If this occurs, consult your doctor.

• If you are taking medicines that may lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol retard NORMON simultaneously with these medicines. Your doctor will tell you whether Tramadol retard NORMON is suitable for you.

• If you are taking medicines for the treatment of depression. Tramadol retard NORMON may interact with these medicines and you may experience serotonin syndrome (see section 4 "Possible side effects").

• If you are taking coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, together with Tramadol retard NORMON. The effect of these medicines on blood clotting may be affected and may lead to bleeding.

Taking Tramadol retard NORMON with food, drinks, and alcohol

Do not consume alcohol during treatment with Tramadol retard NORMON, as its effect may be intensified. Food does not affect the action of Tramadol retard NORMON.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very limited information regarding the safety of tramadol during human pregnancy. Therefore, you should not take Tramadol retard NORMON if you are pregnant.

Chronic use during pregnancy may lead to withdrawal syndrome in newborns.

Generally, the use of tramadol during breastfeeding is not recommended. Tramadol is excreted in breast milk. For this reason, you should not take Tramadol retard NORMON more than once during breastfeeding, or if you take Tramadol retard NORMON more than once, you must stop breastfeeding.

Driving and using machines

Ask your doctor if you can drive or operate machinery during treatment with Tramadol retard NORMON. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution when taking it together with other medicines.

3. How to take Tramadol retard NORMON

Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from the use of [product name], 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. Generally, the lowest effective dose that provides pain relief should be used.

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

Adults and adolescents over 12 years of age

One Tramadol retard NORMON 100 mg prolonged-release tablet twice daily (equivalent to 200 mg of tramadol hydrochloride per day), preferably in the morning and at night.

If necessary, your doctor may prescribe a different and more appropriate dose of this medicine.

If needed, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).

Do not take more than 400 mg of tramadol hydrochloride per day unless otherwise directed by your doctor.

Elderly patients

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

Patients with hepatic or renal impairment / dialysis

Tramadol retard NORMON is not recommended in patients with severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when to take Tramadol retard NORMON

Tramadol retard prolonged-release tablets are taken orally.

Tramadol retard NORMON tablets must always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You may take the tablet on an empty stomach or with food.

How long should you take Tramadol retard NORMON?

Tramadol retard NORMON should not be administered for longer than strictly necessary.

If long-term treatment is required, your doctor will monitor regularly and at short intervals (and if necessary, with treatment interruptions) whether continued treatment with Tramadol retard NORMON and at what dose is still appropriate.

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

Use in children

Tramadol retard NORMON is not suitable for children under 12 years of age.

If you take more Tramadol retard NORMON than you should

If you have accidentally taken more Tramadol retard NORMON than prescribed, you generally will not experience negative effects. You should take the next dose as prescribed.

After taking very high doses, 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 may occur. In such a case, seek immediate medical attention.

If you forget to take Tramadol retard NORMON

If you miss a dose, your pain may return. Do not take a double dose to make up for the missed dose; simply continue your treatment as directed by your doctor.

If you stop taking Tramadol retard NORMON

If you stop or discontinue treatment with Tramadol retard NORMON too early, your pain is likely to return. If you wish to stop treatment due to undesirable effects, consult your doctor.

Generally, no adverse effects occur when stopping treatment with Tramadol retard NORMON. However, in rare cases, some individuals who have been taking Tramadol retard NORMON for a prolonged period may feel unwell when stopping abruptly. Symptoms may include restlessness, anxiety, nervousness, or tremors. You may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very rarely, individuals may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Rarely, other uncommon central nervous system (CNS) symptoms have been reported, such as confusion, delirium, distorted perception of self (depersonalization), altered perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping Tramadol retard NORMON, please consult your doctor.

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

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

4. Possible adverse effects

Like all medicines, Tramadol retard NORMON may produce adverse effects, although not everyone experiences them. The frequency of adverse effects is usually classified as follows:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Frequency not known (cannot be estimated from the available data)

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, rash, and difficulty breathing.

The most common adverse effects during treatment with Tramadol retard are nausea and dizziness, which occur in more than 1 in 10 patients.

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

Serotonin syndrome, which may present with 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 Retard Normon").

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Tramadol retard NORMON

Keep 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.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol retard NORMON

The active substance is tramadol hydrochloride. Each tablet contains 100 mg of tramadol hydrochloride.

The other components are:

Tablet core: microcrystalline cellulose, polyethylene oxide, povidone, and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol, and talc.

Appearance of the product and contents of the container

Tramadol retard NORMON 100 mg prolonged-release tablets are white or almost white, round, biconvex, coated tablets, marked with "100" on one side and smooth on the other.

Tramadol retard NORMON 100 mg is packaged in blisters containing 20 or 60 prolonged-release tablets.

Tramadol retard NORMON is also available as prolonged-release tablets of 150 mg and 200 mg in packages containing 20 or 60 tablets.

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was last revised in May 2024.

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