Leaflet: information for the user

Tramadol retard Stada 200 mg prolonged-release tablets EFG

Hidrocloruro de tramadol

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 isTramadol retard Stadaand what it is used for

2. What you need to know before you start takingTramadol retard Stada

3. How to takeTramadol retard Stada

4. Possible side effects

5. Storage ofTramadol retard Stada

6. Contents of the pack and additional information

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

Do not take Tramadol retard Stada

- If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

- In cases of acute intoxications caused by alcohol, sleep-inducing drugs, analgesics, or psychotropic medications (medications that affect mood and emotions).

- If you are also taking MAO inhibitors (certain medications used to treat depression) or if you have taken them in the last 14 days before starting treatment with tramadol (see “Other medications and Tramadol retard Stada”).

- If you have epilepsy and your seizures are not adequately controlled with treatment.

- As a treatment for withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication

- If you think you have dependence on other analgesics (opioids).

- If you experience 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 injury or brain disease).

- If you have difficulty breathing.

- If you are epileptic or have seizures, because the risk of these 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 medications and Tramadol retard Stada”).

Please consult your doctor before taking the medication.

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended daily dose limit (400 mg).

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol can 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 a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication to be used or the frequency with which it is used.

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 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 a personality disorder) or have followed treatment by a psychiatrist for other mental health conditions.

- If you observe any of the following symptoms while using tramadol, it could be a sign of dependence or addiction:

- You need to use the medication for a longer period than indicated by your doctor.

- You need to use a higher dose than recommended.

- You are using the medication 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 medication or control its use.

- You feel unwell when you stop using the medication, 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 course of treatment for you, when it is appropriate to stop the medication, and how to do it 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, 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 medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Respiratory disorders related to sleep

Tramadol can 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). Symptoms may include 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.

Consult 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 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.

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 severe syndrome (see section 4 “Possible adverse effects”).

Children

This medication is not suitable for children under 12 years old.

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.

Other medications and Tramadol retard Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Concomitant treatment with tramadol and monoamine oxidase inhibitors (MAOIs) (certain medications for depression treatment) should be avoided.

The analgesic effect of tramadol and its duration may be reduced if you take medications that contain:

- Carbamazepine (for epilepsy seizures)

- Pentazocine, nalbuphine, or buprenorphine (analgesics);

- Ondansetron (medication to prevent nausea)

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

• If you take tranquilizers, sleep-inducing medications, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking tramadol. It may cause more sleepiness or the sensation of fainting. If this occurs, consult your doctor.
• If you are taking medications that facilitate or may cause seizures, such as some antidepressants or antipsychotics. The risk of 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 medications and you may experience a serotonin syndrome (see section 4 “Possible adverse effects”).
• If you take anticoagulant medications, such as warfarin, along with tramadol. The effect of these medications on blood coagulation may be affected and may lead to bleeding.
• The concomitant use of tramadol with sedatives such as benzodiazepines or related medications increases the risk of sedation, respiratory depression, coma, or even death. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tramadol retard along with sedatives, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommended dosage. It may be helpful to inform friends or relatives about 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)

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 medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is very little information about the safety of tramadol during human pregnancy. Therefore, do not take this medication if you are pregnant.

Long-term use during pregnancy may lead to withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. Therefore, do not take this medication more than once during breastfeeding, or if you take tramadol more than once, stop breastfeeding.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with tramadol. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubts, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, 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 discontinue use (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity to pain. Normally, the lowest analgesic dose that produces pain relief should be taken.

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

Adults and adolescents over 12 years old

A 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.

Your doctor may prescribe a different and more suitable dose of this medication if necessary.

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 indicated otherwise.

Older patients

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

Patients with liver or kidney insufficiency / dialysis

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

How and when to take Tramadol retard Stada?

This medication is administered orally.

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

For how long should you take Tramadol retard Stada??

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

If you require 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 Tramadol and at what dose.

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

Use in children

This medication is not suitable for children under 12 years old.

If you take more Tramadol retard Stada than you should

If you have taken tramadol by mistake in excess of what you should have, generally you will not have any negative effects. Take the next dose as prescribed.

After taking very high doses, you may experience 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, inform your 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 medication 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 reappear. Do not take a double dose to compensate for the missed doses, simply continue treatment as indicated by your doctor.

If you interrupt treatment with Tramadol retard Stada

If you interrupt or discontinue treatment with Tramadol retard Stada too soon, it is likely that the pain will reappear. If you want to discontinue treatment due to undesirable effects, consult your doctor.

Generally, there are no undesirable effects when discontinuing tramadol treatment. 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 tremulous. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disorders. Very few people may experience 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, such as confusion, delirium, distorted perception of one's own personality (derealization), and alterations in the perception of reality (depersonalization) and delusions of persecution (paranoia), have been seen. If you experience any of these symptoms after discontinuing tramadol, please consult your doctor.

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

Like all medications, tramadol may have side effects, although not everyone will experience them. Side effects are usually classified by frequency 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 unknown (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 hives along with difficulty breathing. The most common side effects during treatment with tramadol retard are nausea and dizziness, which occur in more than 1 in 10 patients.

Metabolic and nutritional disorders

Unknown frequency: Decreased blood sugar levels.

Cardiovascular and blood disorders:

Uncommon: Effects on the heart and blood circulation (strong and rapid heartbeats, fainting or collapse). These side effects may occur especially in patients who are bedridden or who engage in physical activity.

Rare: Slow heart rate, increased blood pressure.

Nervous system disorders

Very common: Dizziness.

Common: Headaches, sleepiness.

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

Unknown frequency: 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 (depending on the patient's personality and the duration of treatment). These problems may manifest as a change in mood (usually excessive good humor, occasionally irritable mood), changes in activity (usually suppression, occasionally increase), and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to judgment errors). Dependence may occur.

Eye disorders

Rare: Blurred vision.

Unknown frequency: Excessive pupil dilation (mydriasis).

Respiratory, thoracic, and mediastinal disordersRare: Shortness of breath. Asthma exacerbation has been reported, although a causal relationship with tramadol has not been established.

Unknown frequency: Hiccup

Digestive disorders

Very common: Nausea.

Common: Vomiting, constipation, dry mouth. P

oco common: Hiccups, stomach problems (such as feeling of pressure in the stomach, bloating), diarrhea.

Skin disorders

Common: Sweating.

Uncommon: Skin reactions (such as itching, hives).

Musculoskeletal disorders

Rare: Muscle weakness.

Liver and biliary tract disorders

Very rare: Increased liver enzyme values.

Urinary disorders

Rare: Difficulty or pain urinating, decreased urine output.

General disorders

Common: Fatigue.

Rare: In rare cases, allergic reactions (such as 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 stopped abruptly, withdrawal symptoms may appear (see "If you stop taking Tramadol retard Stada").

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Unknown frequency (cannot be estimated from available data)

Serotonin syndrome, which may manifest as changes in mental state (such as 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 (such as nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting Tramadol retard Stada").

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 not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Store this medication in a safe and protected place, to which other people cannot access. This medication can cause serious harm or even be fatal to individuals who have not been prescribed it.

This medication does not require special storage conditions.

Do not use this medication 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.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol retard Stada

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

The other components are: Calcium dihydrogen phosphate (E341), Hydroxypropylcellulose (E463), Anhydrous colloidal silica (E551), Magnesium stearate (E470b)

Appearance of the product and contents of the packaging

Tramadol retard Stada 200 mg prolonged-release capsules are white in color and capsule-shaped.

Packaging sizes:

Blister pack: 20 and 60 tablets

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible 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 leaflet was approved in May 2024

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