TRAMADOL RETARD NORMON 200 mg PROLONGED-RELEASE TABLETS

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

Do not take Tramadol retard 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, sleep-inducing drugs, analgesics, or psychotropic drugs (drugs that act on mood and emotions).
• If you are taking MAO inhibitors (certain drugs used to treat depression) or if you have taken them in 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 with treatment.
• As treatment for withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol retard NORMON.

• 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 pressure inside the skull (for example, after a head injury or brain disease).
• If you have difficulty breathing.
• If you are epileptic or have convulsive seizures, because the risk of these 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 retard NORMON").

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 a doctor immediately if you experience any of the 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 dose of tramadol exceeds the recommended daily limit (400 mg).

Tolerance, dependence, and addiction

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, 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 drugs, 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 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 a longer time 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 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 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 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 should 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.
• 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.

Respiratory disorders related to sleep

Tramadol retard Normon can 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 reducing the dose.

Also, inform your doctor if any of these problems occur during treatment with Tramadol retard NORMON or if they have happened to you before.

Children

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

Use in children with respiratory problems

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Using Tramadol retard 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 retard NORMON and monoamine oxidase inhibitors (MAOIs) (drugs for the treatment of depression) should be avoided.

The analgesic effect of Tramadol retard NORMON, as well as its duration, may be reduced if you take medicines that contain:

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

Your doctor will tell you if you should take Tramadol retard NORMON and at what dose.

The risk of side effects increases,

• If you take tranquilizers, sleep-inducing drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol retard NORMON. It may cause more drowsiness or make you feel like you are going to faint. If this happens, consult your doctor.

• If you are taking medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol retard NORMON at the same time as these medicines. Your doctor will tell you if 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 a serotonin syndrome (see the section 4 "possible side effects").

• If you take anticoagulant coumarins (medicines that prevent abnormal blood clotting), such as warfarin, with Tramadol retard NORMON. The effect of these medicines on blood clotting may be affected, and it 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 effect of Tramadol retard NORMON.

Pregnancy and breastfeeding

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 on the safety of tramadol during human pregnancy. Therefore, you should not take Tramadol retard NORMON if you are pregnant.

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

Tramadol is generally not recommended during breastfeeding. 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 should interrupt breastfeeding.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol retard NORMON. 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 double vision, or have difficulty concentrating. Be especially careful when administering it in combination with other medicines.

3. How to take Tramadol retard 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 the use of 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 using the lowest possible dose that produces pain relief.

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

Adults and adolescents over 12 years

One Tramadol retard NORMON 200 mg prolonged-release tablet twice a day (equivalent to 400 mg of tramadol hydrochloride per day), preferably in the morning and at night.

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

Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has told you to do so.

Elderly patients

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

Patient with hepatic or renal impairment / dialysis

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

How and when should you take Tramadol retard NORMON?

Tramadol retard prolonged-release tablets are administered orally.

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

For how long should you take Tramadol retard NORMON?

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

If you require prolonged treatment, your doctor will regularly check you at short intervals (if necessary with interruptions in treatment) to see if you should continue treatment with Tramadol retard NORMON and at what dose.

If you think the effect of this medicine is too strong or too weak, tell 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 taken more Tramadol retard NORMON than you should by mistake, you will generally not have negative effects. You should take the next dose as prescribed.

After taking very high doses, it may cause constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and difficulty breathing that can lead to respiratory arrest. In such a case, contact a doctor immediately.

If you forget to take Tramadol retard NORMON

If you forget to take the tablets, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses, simply continue treatment as prescribed by your doctor.

If you stop treatment with Tramadol retard NORMON

If you stop or finish treatment with Tramadol retard NORMON too early, it is likely that the pain will return. If you want to stop treatment due to undesirable effects, consult your doctor.

Generally, no undesirable effects occur when stopping treatment with Tramadol retard NORMON. However, in rare cases, when some people who have been taking Tramadol retard NORMON for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembly. They may feel hyperactive, have difficulty sleeping, or have gastrointestinal or intestinal disorders. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Rarely, other unusual symptoms of the central nervous system have been seen, such as confusion, delirium, distorted perception of one's own personality (depersonalization), and 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.

Do not stop taking this medicine suddenly unless your doctor tells you to do so. 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 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).

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

4. Possible Adverse Effects

Like all medicines, Tramadol retard NORMON can cause adverse effects, although not all people suffer from them. Normally, the frequency of adverse effects is classified as follows:

• Very frequent (may affect more than 1 in 10 people)
• Frequent (may affect up to 1 in 10 people)
• Infrequent (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 and rash along with difficulty breathing.

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

Undetermined frequency (cannot be estimated from the available data)

Serotonin syndrome, which can manifest through changes in mental state (such as 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 (such as nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Tramadol Retard Normon").

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

5. Conservation of Tramadol retard NORMON

Keep 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 box and on the blister 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 containers 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 containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Tramadol retard NORMON

The active principle is tramadol hydrochloride. Each tablet contains 200 mg of tramadol hydrochloride.

The other components are:

Core of the tablet: microcrystalline cellulose, polyethylene oxide, povidone, and magnesium stearate.

Coating of the tablet: hypromellose, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172), and yellow quinoline lacquer (E104).

Appearance of the product and package contents

Tramadol retard NORMON 200 mg prolonged-release tablets are coated tablets of light brown color, round, biconvex, with the mark "200" printed on one face and smooth on the other.

Tramadol retard NORMON 200 mg is packaged in blisters containing 20 or 60 prolonged-release tablets.

Tramadol retard NORMON is also available in 100 and 150 mg prolonged-release tablets 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 prospectus was revised in 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/