TRAMADOL RETARD STADA 100 mg PROLONGED-RELEASE TABLETS

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

Do not take Tramadol retard Stada

• If you are allergic to the active substance 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 (drugs that act on mood and emotions).
• If you are taking MAO inhibitors (certain drugs used to treat depression) or if you have taken them in 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 with 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 disorders of consciousness (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 pressure inside the skull (e.g. 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 suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol retard Stada").

In such cases, 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 dose of tramadol exceeds the recommended daily dose limit (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, which is known as pharmacological tolerance). Repeated use of tramadol can also lead to dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on tramadol may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription drugs, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.
• If you notice any of the following symptoms while taking tramadol, it could be a sign of dependence or addiction:
• You need to use the medicine for longer 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 the medicine, and how to do it safely (see section 3, if you interrupt treatment with tramadol).

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person in different ways. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side effects, you should 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.

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 level in the blood). 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 a dose reduction.

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. They can be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

There is a slight risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you present any of the symptoms related to 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

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Other medicines and Tramadol retard Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Concomitant treatment with tramadol and monoamine oxidase inhibitors (MAOIs) (drugs for the treatment of depression) should be avoided.

The analgesic effect of tramadol, as well as its duration, may be reduced if you take medicines that contain:

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

Your doctor will tell you if you should take tramadol and at what dose. The risk of side effects increases,

• If you take sedatives, sleep-inducing drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking tramadol. It can cause more sleepiness or make you feel like you are going to faint. If this happens, consult your doctor.
• If you are taking medicines that facilitate or may cause seizures, such as some antidepressants or antipsychotics. The risk of having seizures may increase if you take tramadol at the same time. 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 take anticoagulant coumarins (medicines that prevent abnormal blood clotting), such as warfarin, together with tramadol. The effect of these medicines on blood clotting may be affected, and it may lead to bleeding.
• Concomitant use of tramadol with sedative medicines such as benzodiazepines or related medicines increases the risk of sedation, respiratory depression, coma, or even death. Due to this, 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 should be limited by your doctor.

Tell your doctor about all sedative medicines you are taking and closely follow your doctor's dosage recommendation. It may be useful to inform friends or relatives so that they are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

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

Taking Tramadol retard Stada with food, drinks, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is very little 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 should interrupt breastfeeding.

Driving and using machines

Ask your doctor if you can drive or use machines while taking tramadol. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel sleepy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administered concomitantly with other medicines.

3. How to take Tramadol retard Stada

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from the use of 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 to the intensity of the pain and your individual sensitivity to pain. Normally, you should take the lowest analgesic dose that produces pain relief.

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

Adults and adolescents over 12 years

One Tramadol retard Stada 150 mg prolonged-release tablet twice a day (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 suitable dose of this medicine for you.

If necessary, the dose can be increased up to 200 mg twice a day (equivalent to 400 mg of tramadol hydrochloride per day).

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

Elderly patients

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

Patient with hepatic or renal impairment / dialysis

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

How and when should you take Tramadol retard Stada?

This medicine is administered orally.

Always swallow the tablets whole, without dividing or chewing them, with sufficient liquid, preferably in the morning and at night. You can take the tablet with an empty stomach or with food.

For how long should you take Tramadol retard Stada?

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

If you require prolonged treatment, your doctor will regularly check you at short intervals (if necessary with interruptions in treatment) to see if you should continue treatment with Tramadol and at what dose.

If you think the effect of this medicine is too strong or too weak, tell 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 taken more tramadol than you should by mistake, it will generally not have negative effects. You should take the next dose as prescribed.

After taking very high doses, it may cause constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and difficulty breathing that can lead to respiratory arrest. In such a case, immediately contact a doctor.

In case of overdose or accidental ingestion, immediately consult your doctor, pharmacist, or call the Toxicology Information Service, phone 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, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses; simply continue treatment as your doctor has indicated.

If you stop taking Tramadol retard Stada

If you stop or finish treatment with Tramadol retard Stada too early, it is likely that the pain will return. If you want to stop 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 taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembly. They may feel hyperactive, have difficulty sleeping, or have gastrointestinal or intestinal disorders. Very few people may have 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 have been seen, such as confusion, delirium, distorted perception of one's own personality (depersonalization), and altered perception of reality (derealization) and persecution delusions (paranoia). If you present any of these symptoms after stopping tramadol, please consult your doctor.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist

4. Possible Adverse Effects

Like all medicines, tramadol can have adverse effects, although not all people suffer from them. Normally, the frequency of adverse effects is classified as follows:

• Very frequent (may affect more than 1 in 10 people)
• Frequent (may affect up to 1 in 10 people) - Infrequent (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 and rash, along with difficulty breathing. The most frequent adverse effects during treatment with tramadol retard are nausea and dizziness, which occur in more than 1 in 10 patients.

Metabolic and Nutritional Disorders

Frequency not known: Decrease in blood sugar levels.

Cardiac and Blood Disorders:

Infrequent: Effects on the heart and blood circulation (strong and rapid heartbeats, fainting or collapse). These adverse effects may occur especially in patients who are incorporated or who make physical effort.

Rare: Slow heartbeat, increased blood pressure.

Nervous System Disorders

Very frequent: Dizziness.

Frequent: Headaches, sleepiness.

Rare: Changes in appetite, abnormal sensations (such as itching, tingling, and numbness), tremors, slow breathing, epileptic seizures, muscle spasms, uncoordinated movements, transient loss of consciousness (syncope). If the recommended doses are exceeded, or if other central nervous system depressant medications are taken at the same time, breathing may slow down. Epileptic seizures may occur mainly after taking high doses of tramadol or when taking medications that can cause epileptic seizures.

Frequency unknown: Speech disorders.

Psychiatric Disorders

Rare: Hallucinations, confusion, sleep disturbances, anxiety, and nightmares. Psychological problems may appear after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These problems can manifest as a change in mood (usually excessive cheerfulness, occasionally irritability), changes in activity (usually suppression, occasionally increase), and decreased cognitive and sensory perception (changes in senses and recognition, which can lead to errors in judgment). Dependence may occur.

Ocular Disorders

Rare: Blurred vision.

Frequency unknown: Excessive dilation of the pupils (mydriasis).

Respiratory, Thoracic, and Mediastinal DisordersRare: Shortness of breath (dyspnea). Worsening of asthma has been reported, however, no causal relationship with tramadol has been established.

Frequency not known: Hiccup

Gastrointestinal Disorders

Very frequent: Nausea.

Frequent: Vomiting, constipation, dry mouth. Infrequent: Hiccups, stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea.

Skin Disorders

Frequent: Sweating.

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

Muscular Disorders

Rare: Muscle weakness.

Hepatobiliary Disorders

Very rare: Increase in liver enzyme values.

Urinary Disorders

Rare: Difficulty or pain when urinating, less urine than normal.

General Disorders

Frequent: Fatigue.

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

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Indeterminate frequency (cannot be estimated from available data)

Serotonin syndrome, which can manifest 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 stiffness, 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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol retard Stada

Keep out of sight and reach of children.

Store this medicine in a safe place, protected from other people. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol retard Stada

The active ingredient is tramadol hydrochloride. Each tablet contains 100 mg of tramadol hydrochloride.

The other components are: Dihydrate calcium hydrogen phosphate (E341), Hydroxypropylcellulose (E463), Anhydrous colloidal silica (E551), Magnesium stearate (E470b)

Appearance of the Product and Package Contents

Tramadol retard Stada 100 mg prolonged-release tablets are white, round, biconvex tablets.

Package 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

O

Medochemie Ltd (Factory AZ)

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

Cyprus

This prospectus was approved in May 2024

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