Leaflet: information for the user

Tramadol Normon 100 mg hard capsules

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. See section 4.

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

2. What you need to know before you start taking Tramadol Normon

3. How to take Tramadol Normon

4. Possible side effects

5. Storage of Tramadol Normon

6. Contents of the pack 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 the brain.

Tramadol is used in the treatment of moderate or severe pain.

Do not take Tramadol 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, sleeping pills, analgesics, or other psychotropic drugs (medicines that act on the mood and emotions),
• if you are taking monoamine oxidase inhibitors (MAOIs), (a certain type of medicine for the treatment of depression) or if you have taken them in the last 14 days before treatment with tramadol (see “Other medicines and tramadol”),
• if you have epilepsy and your seizures are not adequately controlled with treatment,
• for the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you think you have dependence on other analgesics (opioids),
• if you have consciousness disorders (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 intracranial pressure (for example after a head trauma or brain diseases),
• if you have difficulty breathing,
• if you are epileptic or have seizures, because the risk of seizures may increase,
• if you have any liver or kidney disease.
• if you suffer from depression and are taking antidepressants, since some may interact with tramadol (see “Other medicines and Tramadol 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 monotherapy. Consult your doctor immediately if you experience any of the symptoms linked to this serious syndrome (see section 4 “Possible side effects”)

Respiratory disorders related to sleep

Tramadol 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 be included 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.

Cases of seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended maximum daily dose (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, known as pharmacological tolerance). Repeated use of Tramadol Normon can also cause dependence, abuse, and addiction, which could lead to 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 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 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 by a psychiatrist for other mental illnesses.

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 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 option for you, when it is appropriate to stop taking the medicine, and how to do it safely (see section 3, if you interrupt 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, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Consult your doctor if you experience any of the following symptoms while taking tramadol:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. They 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.

Other medicines and Tramadol Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

- Gabapentin or pregabalin for treating 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 for the treatment of depression).

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

• Carbamazepine (for epilepsy);
• Ondansetron (to prevent nausea).

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

The risk of adverse effects increases:

• if you are taking this medicine simultaneously with other analgesics such as morphine and codeine (even when used for cough treatment) 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 sleep medications (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, it should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's dose and duration recommendations strictly. 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 facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. Your doctor will tell you if tramadol is suitable for you;
• if you are taking antidepressants. Tramadol may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible side effects”);
• if you are taking anticoagulant coumarins (medicines to thin the blood), such as warfarin, while taking tramadol. The effect of these medicines on blood coagulation may be affected, and bleeding may occur;
• if you are taking medicines that can increase the accumulation of tramadol and, therefore, its adverse effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Tramadol Normon with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effect may be intensified.

Foods do not affect the effect of tramadol.

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.

Pregnancy, breastfeeding, 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, you should not take this medicine if you are pregnant.

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

Tramadol is excreted in breast milk. Therefore, you should not take tramadol more than once during breastfeeding, or if you take 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 operating machines

Ask your doctor if you can drive or operate machines during treatment with tramadol. It is essential to observe how this medicine affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly 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 less than 23 mg of sodium (1 mmol) per capsule; it 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 the individual sensitivity of the patient. Normally, the lowest dose possible that produces pain relief should be used. Do not take more than 4 capsules a day (400 mg of tramadol hydrochloride), 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

1 capsule per dose (equivalent to 100 mg of tramadol hydrochloride).

The effect may last between 4-6 hours, depending on the pain.

Normally, the initial dose is 50-100 mg of tramadol hydrochloride, depending on the patient and the intensity of the pain.

If your doctor decides to change or reduce the dose, other presentations of the medicine are available.

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

Children

This medicine is not recommended for children under 12 years old.

Older patients

In these older patients (over 75 years old), 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 severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the intervals between each dose.

How and when to take Tramadol Normon?

The capsules are administered orally.

Swallow the capsules whole without dividing or chewing them and with sufficient liquid.

You can take the capsules both with an empty stomach and with meals.

For how long should you take 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 this medicine and at what dose.

If you take more Tramadol Normon than you should

If you have taken an additional dose by mistake, this usually has no negative effects. You should continue with your next dose as prescribed.

High doses of tramadol can cause 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, 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 taken. It is recommended to bring the medicine packaging to the healthcare professional.

If you forget to take Tramadol Normon

If you forget to use this medicine, it is likely that the pain will return. Do not take a double dose to compensate for the missed doses. Simply continue taking this 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 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 side effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment with tramadol is discontinued. However, in rare cases, people who have been taking this medicine for some time may feel unwell if they discontinue treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit 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 discontinuing 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 itching accompanied by difficulty breathing.

The most common side effects during treatment with tramadol are nausea and dizziness, occurring in more than 1 in 10 patients.

Very common:may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common:may affect 1 in 10 people

• Headache, numbness.
• Fatigue.
• Constipation, dry mouth, vomiting.
• 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 effort.
• 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), tremors, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures mainly occur after the use of 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 (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• 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, decreased 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 level.
• Hypophagia.

Frequency indeterminate(cannot be estimated from the available data)

Serotonin syndrome, which may manifest itself through 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.

Store this medication in a safe and secure location, inaccessible to others. This medication may cause severe harm or even be fatal to individuals not prescribed it.

Store below 30°C.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition of Tramadol Normon

• The active ingredient is tramadol hydrochloride. Each hard capsule contains 100 mg of tramadol hydrochloride.
• The other components are: microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), magnesium stearate, and anhydrous colloidal silica. The hard gelatin capsule is composed of:cap- gelatin, yellow iron oxide (E-172), indigo carmine (E-132) and titanium dioxide (E-171);body- gelatin, red iron oxide (E-172) and titanium dioxide (E-171).

Appearance of Tramadol Normon and content of the packaging

Hard capsules with a pink opaque body and a green opaque cap containing white or almost white powder.

The medicine is supplied in packs of 30 and 60 capsules, conditioned in aluminum/PVC blister with a leaflet.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:May 2024

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