Tramadol Normon 50 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol Normon 50 mg hard capsules 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 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 taking Tramadol Normon
3. How to take Tramadol Normon
4. Possible adverse 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 in 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 for the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol Normon

Do not take Tramadol 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 due to 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 if you have taken them within the last 14 days prior to treatment with this medicine (see “Taking Tramadol Normon with other medicines”);
• if you have epilepsy and your seizures are not adequately controlled by treatment;
• for the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor before starting to take Tramadol 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 intracranial pressure (e.g., after head injury 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 that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Contact a doctor immediately if you develop 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 result in 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 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 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, e.g., “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 taking 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 notice 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 indicators of adrenal insufficiency (low cortisol levels). If you experience 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 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.

Taking Tramadol Normon with other medicines

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

• Gabapentin or pregabalin for the treatment of 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 provided by 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 take this medicine and at 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 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 together with sedative medicines, they will limit the dose and duration of concomitant treatment.

• 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 lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. Your doctor will advise you whether tramadol is suitable for you;
• if you are taking antidepressants. 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 taking tramadol. The effect of these medicines on blood coagulation 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).

Taking 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 effect of tramadol.

Children and adolescents

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.

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 take 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 take this medicine more than once during breastfeeding, or if you take tramadol more than once, you must interrupt 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 operate machinery 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 operate machinery if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulation, and/or when taking it concomitantly with other medicines.

This medicine contains sunset yellow FCF (E-110), which may cause allergic reactions because it contains sunset yellow FCF (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; hence, it is essentially “sodium-free”.

3. How to take Tramadol Normon

Always take this medicine exactly as prescribed by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

Before starting treatment and regularly during treatment, your doctor will also explain 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. Normally, the lowest effective dose that provides pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has instructed you otherwise.

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

Adults and adolescents over 12 years of age

The usual initial dose is 1–2 capsules (equivalent to 50–100 mg of tramadol hydrochloride).

Depending on the pain, the effect may last between 4–6 hours.

Children

This medicine is not recommended for children under 12 years of age.

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/patients on dialysis

This medicine is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when should you take Tramadol Normon?

The capsules are administered orally.

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

You may take the capsules either on an empty stomach or with food.

How long should you take Tramadol Normon?

This medicine should not be used for longer than strictly necessary. If prolonged treatment is required, your doctor will regularly monitor (if necessary with treatment interruptions) whether continued treatment with this medicine 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.

If you take more Tramadol Normon than you should

If you have taken an extra dose by mistake, you will generally not experience any adverse effects. Take the next dose as prescribed.

After taking very high doses of tramadol, the following may occur: pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest. In such a 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 number 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 take Tramadol Normon

If you forget to take the medicine, your pain may return. Do not take a double dose to make up for missed doses; simply continue taking tramadol as previously directed.

If you stop treatment with Tramadol Normon

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

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

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

They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few individuals may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (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 can cause adverse effects, although not everyone experiences 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, rash, and difficulty breathing.

The most common adverse effects during treatment with tramadol are nausea and dizziness, occurring 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.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeats, feeling dizzy or fainting). These adverse effects may particularly occur in patients who are standing up or performing physical exertion.
• Feeling the need to vomit (nausea), 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 heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, seizures, muscle jerks, 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 manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (alterations in senses and perception that may lead to impaired judgment).
• May lead to drug dependence. If treatment is stopped abruptly, withdrawal syndrome may occur (see "If you stop taking tramadol").
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• 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 available data

• Decrease in blood sugar levels.
• Hiccups.

Frequency not determined (cannot be estimated from 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 ").

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 the 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.

Store below 30 °C.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Punto Sigre collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Tramadol Normon 50 mg hard capsules

The active substance is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.

The other components are: microcrystalline cellulose, sodium starch glycolate from potato, magnesium stearate and colloidal silica. The hard gelatin capsule consists of: gelatin, brilliant blue (E-133), quinoline yellow (E-104), sunset yellow (E-110) and titanium dioxide (E-171).

Appearance of the product and contents of the container

It is presented as green and yellow gelatin capsules.

The medicine is supplied in packs of 20, 60 and 500 capsules, packaged in aluminum/PVC blisters with a patient information leaflet.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Other presentations

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

Date of the most recent revision of this leaflet: May 2024

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