Tramadol STADA 200 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tramadol retard Stada 200 mg prolonged-release tablets EFG

Tramadol hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Tramadol retard Stada is and what it is used for
2. What you need to know before taking Tramadol retard Stada
3. How to take Tramadol retard Stada
4. Possible side effects
5. How to store Tramadol retard Stada
6. Contents of the pack and other information

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

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 used in the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol retard Stada

Do not take Tramadol retard Stada

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• In cases of acute intoxication caused by alcohol, hypnotic drugs, analgesics, or psychotropic agents (medications acting on mood and emotions).
• If you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression), or if you have taken them within the last 14 days before starting treatment with tramadol (see "Other medicines and Tramadol retard Stada").
• If you have epilepsy and your seizures are not adequately controlled by treatment.
• As treatment for withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• 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 (for example, after head trauma or brain disease).
• If you have difficulty breathing.
• If you have epilepsy or suffer from seizures, as the risk of such episodes 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 retard Stada").

In such cases, please consult your doctor before taking this 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 limit (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the drug (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol 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 loss 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 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 been treated by a psychiatrist for other mental illnesses.
• If you notice any of the following symptoms while using tramadol, 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 take 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 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).

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 experience any of the following adverse effects, you must 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.

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.

Talk to your doctor, pharmacist, or nurse 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 supplementation.

There is a weak risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Seek immediate medical advice if you develop any symptoms associated with this serious syndrome (see section 4, "Possible side effects").

Children

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

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.

Other medicines and Tramadol retard Stada

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

Concomitant treatment with tramadol and monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) should be avoided.

The analgesic effect of tramadol and its duration may be reduced if you take medicines containing:

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

Your doctor will advise you whether you should take tramadol and at what dose. The risk of adverse effects increases:

• If you take tranquilizers, hypnotic drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking tramadol. This may cause increased drowsiness or a feeling of fainting. If this occurs, consult your doctor.
• If you are taking medicines that lower the seizure threshold or may provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take tramadol at the same time. 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 (medicines that prevent abnormal blood clotting), such as warfarin, together with tramadol. The effect of these medicines on blood clotting may be altered, potentially leading to bleeding.
• The concomitant use of tramadol with sedative medicines such as benzodiazepines or related medicines increases the risk of sedation, respiratory depression, coma, or even death. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Tramadol retard together with sedatives, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and closely follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

• If you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain)

Taking Tramadol retard Stada with food, drinks, and alcohol

Do not consume alcohol during treatment with tramadol, as its effects may be intensified. Food does not affect the action of this medicine.

Pregnancy and breastfeeding

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 on the safety of tramadol during human pregnancy. Therefore, you should not take this medicine if you are pregnant.

Chronic use during pregnancy may lead to 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 stop breastfeeding.

Driving and using machines

Ask your doctor if you can drive or operate machinery while being treated with tramadol. 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 or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

3. How to take Tramadol retard Stada

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using tramadol, 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 to pain. Normally, the lowest analgesic dose that provides pain relief should be taken.

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

Adults and adolescents over 12 years of age

One tablet of Tramadol retard Stada 150 mg prolonged-release tablets twice daily (equivalent to 300 mg of tramadol hydrochloride per day), preferably in the morning and at night.

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

If needed, the dose may be increased up to 200 mg twice daily (equivalent to 400 mg of tramadol hydrochloride per day).

Do not take more than 400 mg of tramadol hydrochloride per day unless specifically instructed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), tramadol elimination may be slower. If this applies to you, your doctor may extend the dosing intervals.

Patients with hepatic or renal impairment / dialysis

If you have severe liver or kidney disease, you must not take this medicine. If you have mild or moderate disorders, your doctor may extend the dosing interval.

How and when should you take Tramadol retard Stada?

This medicine is administered orally.

The tablets must always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You may take the tablet on an empty stomach or with food.

How long should you take Tramadol retard Stada?

This medicine should not be administered for longer than strictly necessary.

If long-term treatment is required, your doctor will monitor at regular and short intervals (and if necessary with treatment interruptions) whether treatment with Tramadol should continue and at which dose.

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

Use in children

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

If you take more Tramadol retard Stada than you should

If you have accidentally taken more tramadol than you should, you generally will not experience negative effects. You should take the next dose as prescribed.

After taking very high doses, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest may occur. In such a case, seek immediate medical help.

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, indicating the medicine and the amount taken.

If you forget to take Tramadol retard Stada

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for missed doses; simply continue treatment as directed by your doctor.

If you stop taking Tramadol retard Stada

If you stop or discontinue treatment with Tramadol retard Stada too early, your pain is likely to return. If you wish to discontinue treatment due to undesirable effects, consult your doctor.

Generally, no undesirable effects occur when stopping treatment with tramadol. However, in rare cases, when some people who have been taking tramadol for some time stop suddenly, they may feel unwell. They may feel restless, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Rarely, other uncommon central nervous system (CNS) symptoms have been observed, such as confusion, delirium, distorted perception of self (depersonalization), disturbances in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping tramadol, please consult your doctor.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, tramadol may cause adverse effects, although not everyone experiences them. The frequency of adverse 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 1 in 1,000 people)
• Very rare (may affect 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, rash together with difficulty breathing. The most common adverse effects during treatment with tramadol retard are nausea and dizziness, which occur in more than 1 in 10 patients.

Metabolism and nutrition disorders

Frequency not known: Decrease in blood sugar levels.

Cardiac and blood disorders

Uncommon: Effects on the heart and circulation (strong and rapid heartbeat, fainting or collapse). These adverse effects may occur especially in patients who are dehydrated or undergoing physical exertion.

Rare: Slow heartbeat, increased blood pressure.

Nervous system disorders

Very common: Dizziness.

Common: Headache, drowsiness.

Rare: Changes in appetite, abnormal sensations (such as itching, tingling, and numbness), tremor, slow breathing, epileptic seizures, muscle twitching, uncoordinated movements, temporary loss of consciousness (syncope). If recommended doses are exceeded, or if other medicines that depress brain function are taken simultaneously, breathing may slow down. Seizures may occur mainly after taking high doses of tramadol or when taking medicines that may provoke seizures.

Frequency not known: Speech disorders.

Psychiatric disorders

Rare: Hallucinations, confusion, sleep disturbances, anxiety, and nightmares. Psychological problems may appear after treatment with tramadol. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (usually excessive euphoria, occasionally irritability), changes in activity (usually suppression, occasionally increased activity), and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to impaired judgment). Dependence may occur.

Eye disorders

Rare: Blurred vision.

Frequency not known: Excessive dilation of the pupils (mydriasis).

Respiratory, thoracic and mediastinal disorders

Rare: Shortness of breath (dyspnea). Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established.

Frequency not known: Hiccups.

Gastrointestinal disorders

Very common: Nausea.

Common: Vomiting, constipation, dry mouth.

Uncommon: Nausea, stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea.

Skin disorders

Common: Sweating.

Uncommon: Skin reactions (e.g., itching, rash).

Musculoskeletal disorders

Rare: Muscle weakness.

Hepatobiliary disorders

Very rare: Increase in liver enzyme values.

Urinary disorders

Rare: Difficulty or pain when urinating, reduced urine output.

General disorders

Common: Fatigue.

Rare: Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have been reported very rarely. If tramadol is taken for a long period of time, dependence may occur, although the risk is very low. If treatment is stopped abruptly, withdrawal symptoms may occur (see section "If you stop taking Tramadol retard Stada").

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Frequency not known (cannot be estimated from 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, diarrhea) (see section 2 “What you need to know before you start taking Tramadol retard Stada”).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 retard Stada

Keep 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.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol retard Stada

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

The other components are: Calcium hydrogen phosphate dihydrate (E341), Hydroxypropylcellulose (E463), Colloidal anhydrous silica (E551), Magnesium stearate (E470b)

Appearance of the product and contents of the pack

Tramadol retard Stada 200 mg prolonged-release tablets are whitish, capsule-shaped tablets.

Pack sizes:

Blister pack: 20 and 60 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Farmaceutisch Analytisch Laboratorium Duiven B.V (FAL Duiven B.V)

Dijkgraaf 30, 6921 RL, Duiven

Netherlands

Or

Medochemie Ltd (Factory AZ)

2 Michael Erakleous Street, Agios Athanassios Industrial Area, Limassol, 4101

Cyprus

This patient information leaflet was approved in May 2024

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