Tramadol Normon 100 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol Normon 100 mg hard capsules

Tramadol hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, 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. 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 side 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 is used to treat 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 ingredients of this medicine (listed in section 6),
• in cases of acute intoxication caused by alcohol, sleeping medicines, analgesics, or other psychotropic medicines (medicines that affect mood and emotions),
• if you are taking monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression), or have taken them within the last 14 days prior to treatment with tramadol (see "Other medicines and tramadol"),
• if you have epilepsy and your seizures are not adequately controlled by treatment,
• for the treatment of withdrawal syndrome.

Warnings and precautions

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

• if you think you are dependent on other analgesics (opioids),
• if you have disorders of 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 (for example, after head trauma 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 of them may interact with tramadol (see "Other medicines and Tramadol Normon").

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

Sleep-related breathing disorders

Tramadol 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.

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 (your body gets used 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 make you feel a lack of control over how much 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 or been dependent 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 stay 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.

Talk to 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. 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.

Other medicines and Tramadol Normon

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

• Gabapentin or pregabalin for treating 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 to treat cough) 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, your dose and duration of concomitant treatment should be limited.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dosing 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 medicines for depression. 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), for example: warfarin, while taking tramadol. The effect of these medicines on blood clotting may be affected, leading to bleeding;
• if you are taking medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (such as 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 action 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 are planning 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 use during pregnancy may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take tramadol more than once during breastfeeding, or if you take tramadol more than once, you must stop breastfeeding.

Based on human experience, tramadol is not expected to affect fertility in men and women.

Driving and using machines

Ask your doctor whether you can drive or use machines while being treated with tramadol. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Tramadol Normon

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to 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 individual patient sensitivity. The lowest possible dose that provides pain relief should normally be used. Do not take more than 4 capsules per day (400 mg of tramadol hydrochloride), 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

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

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

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

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

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

Children

This medicine is not recommended for use in 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 extending the dosing intervals.

Patients with hepatic or renal impairment / patients on dialysis

If you have severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the intervals between doses.

How and when to 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 long-term treatment is required, your doctor will monitor you at regular, short intervals (possibly with treatment interruptions) to determine whether treatment with this medicine should continue and at what dose.

If you take more Tramadol Normon than you should

If you have taken an extra dose by mistake, this usually does not cause negative effects. You should continue with your next dose as prescribed.

Poisoning due to very high doses of tramadol may cause pinpoint pupils, vomiting, low blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may progress 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 this medicine, your pain may return. Do not take a double dose to make up for missed doses. Simply continue taking this medicine as you have been doing.

If you stop treatment with Tramadol Normon

If you stop or end treatment with this medicine too soon, your pain may return. If you wish to stop treatment due to adverse effects, consult your doctor.

You must not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking your medicine, speak to 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, in rare cases, individuals who have been taking this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and noises 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 may 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 and rash together with difficulty breathing.

The most common adverse effects during treatment with tramadol are nausea and dizziness, occurring in more than 1 in every 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, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are standing up or who are performing physical exertion.
• Nausea (feeling like vomiting), gastrointestinal discomfort (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
• Skin reactions (e.g. itching, 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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after using high doses of tramadol or when taken simultaneously with another medicine that may induce 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 and occasionally increased), and decreased cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• May lead to drug dependence. When treatment is abruptly discontinued, withdrawal syndrome may occur (see “If you stop taking Tramadol Normon”).
• 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, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increase in liver enzymes.

Frequency not known: frequency cannot be estimated from the available data

• Decrease in blood sugar level.
• Hiccups.

Frequency not determined (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, diarrhoea) (see section 2 “What you need to know before taking Tramadol Normon”).

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 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. Unwanted medicines and their containers should be taken to the SIGRE collection point at your pharmacy. 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 Normon

• The active substance 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 colloidal anhydrous silica. The hard gelatin capsule consists of: cap – gelatin, yellow iron oxide (E-172), indigo carmine lake (E-132) and titanium dioxide (E-171); body – gelatin, red iron oxide (E-172) and titanium dioxide (E-171).

Appearance of Tramadol Normon and contents of the pack

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

The medicine is supplied in packs of 30 and 60 capsules, presented in aluminum/PVC blisters with a package leaflet.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

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

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

You can access detailed information about this medicine by scanning the QR code included in the package leaflet and carton with your mobile phone (smartphone). You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/85977/P_85977.html