Leaflet: information for the user

Tramadol retard NORMON 200 mg prolonged-release tablets EFG

Tramadol hydrochloride

Read this 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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

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

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

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

3. How to take Tramadol retard NORMON

4. Possible side effects

5. Storage of Tramadol retard NORMON

6. Contents of the pack and additional information

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

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 (medicines that act on the mood and emotions).
• If you are also taking monoamine oxidase inhibitors (certain medicines 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 a 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 consciousness disorders (if you think you are going to faint).
• If you are in shock (a sign of this state can be cold sweat).
• If you have increased intracranial pressure (for example, after a head injury or brain disease).
• If you have difficulty breathing.
• If you are epileptic or have seizures, as the risk of these seizures may increase.
• If you have any liver or kidney disease.
• If you have 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 your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

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 dose limit (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body becomes accustomed to it, 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 adverse 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 medication 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 to Tramadol Normon may be higher if:

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, 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 health conditions.

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 medication for a longer period than indicated by your doctor.

– You need to use a higher dose than recommended.

– You are using the medication 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 medication or control its use.

– You feel unwell when you stop using the medication, 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 medication, and how to do it 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, and this can affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe adverse effects.

If you notice any of the following adverse effects, you should stop taking this medication and consult a doctor immediately:

• slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, 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 hormone 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 levels in the blood)..Between the symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. 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 occurred at any time.

Children

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

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Use of Tramadol retard NORMON with other medicines

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

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

Tramadol retard NORMON should be avoided when taken simultaneously with monoamine oxidase inhibitors (MAOIs) (certain antidepressants).

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

• Carbamazepine (for epilepsy)
• Pentazocine, nalbuphine, or buprenorphine (analgesics);
• Ondansetron (anti-nausea medication)

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

The risk of adverse 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 drowsiness or the sensation of fainting. If this occurs, consult your doctor.

• If you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol retard NORMON simultaneously with these medications. Your doctor will tell you if Tramadol retard NORMON is suitable for you.

• If you are taking antidepressants. Tramadol retard NORMON may interact with these medications and may experience a serotonin syndrome (see section 4 “Possible side effects”).

• If you take anticoagulant coumarins (medications that prevent abnormal blood clotting), such as warfarin, along with Tramadol retard NORMON. The effect of these medications 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 effect of Tramadol retard NORMON.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is very little information on the safety of tramadol during human pregnancy. Therefore, do not take Tramadol retard NORMON if you are pregnant.

Long-term use during pregnancy may lead to withdrawal syndrome in newborns.

Generally, tramadol should not be used during breastfeeding.Tramadol is excreted in breast milk. Therefore, do not take Tramadol retard NORMON more than once during breastfeeding, or if you take Tramadol retard NORMON more than once, you should stop breastfeeding.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Tramadol retard NORMON. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful when taking it with other medications.

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, usually the lowest dose possible that produces pain relief should be used.

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

Adults and adolescents over 12 years old

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.

Your doctor may prescribe a different and more suitable dose of this medicine if necessary.

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

Older patients

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

Patients with liver or kidney disease / dialysis

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

How and when to take Tramadol retard NORMON?

Tramadol retard prolonged-release tablets are administered orally.

Always swallow the Tramadol retard NORMON tablets 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 meals.

For how long should you take Tramadol retard NORMON?

Tramadol retard NORMON should not be administered for longer than 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 retard NORMON and at what dose.

If you estimate 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 old.

If you take more Tramadol retard NORMON than you should

If you have taken Tramadol retard NORMON by mistake more than you should, you will usually not have any negative effects. Take the next dose as prescribed.

After taking very high doses, you may experience pupil constriction, 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. In this case, inform your 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 compensate for the missed doses, simply continue treatment as instructed by your doctor.

If you interrupt treatment with Tramadol retard NORMON

If you interrupt or discontinue treatment with Tramadol retard NORMON too soon, it is likely that the pain will return. If you want to discontinue treatment due to unwanted effects, consult your doctor.

Generally, there are no unwanted effects when discontinuing 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 shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disorders. Very few people may experience 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, such as confusion, delirium, distorted perception of one's own personality (derealization) and altered perception of reality (depersonalization), and delusions of persecution (paranoia) have been seen. If you experience any of these symptoms after stopping Tramadol retard NORMON, please consult your doctor.

You should not stop taking this medicine suddenly unless your doctor tells you to. 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 discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

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

Like all medicines, Tramadol retard NORMON can cause side effects, although not everyone will experience them. The frequency of side 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 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 hives along with difficulty breathing.

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

Frequency unknown(cannot be estimated from 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 Retard Normon").

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

Keep 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 and even fatal harm to people who have not been prescribed it.

This medication does not require special storage conditions.

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol retard NORMON

The active ingredient is tramadol hydrochloride. Each tablet contains 200 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, talc, yellow iron oxide (E172), red iron oxide (E172), and quinoline yellow (E104) lake.

Appearance of the product and content of the packaging

Tramadol retard NORMON 200 mg prolonged-release tablets are brownish-yellow, round, biconvex tablets 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 prolonged-release tablets of 100 and 150 mg in packaging containing 20 or 60 tablets.

Marketing authorization holder

LABORATORIOS NORMON, S.A.

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

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

This leaflet has been reviewed in 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/