Leaflet: information for the user

Tramadol Stada 50 mg hard capsules EFG

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, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must 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.

Tramadol Stada is indicated forthetreatment of moderate to severe pain.

Do not take Tramadol 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 intoxication caused by alcohol, sleep medications, analgesics, or other psychotropic medications (medications that affect mood and emotions);
• if you are taking monoamine oxidase inhibitors (MAOIs), certain types of depression medications, or if you have taken them in the last 14 days before treatment with tramadol (see "Taking Tramadol Stada with other medications");
• if you have uncontrolled epilepsy;
• for the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol Stada:

• if you think you are dependent on other strong analgesics (opioids);
• if you experience a decrease in 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 experience an increase in intracranial pressure (for example, after a head trauma or brain disease);
• if you have difficulty breathing;
• if you are epileptic or have seizures, as the risk of seizures may increase;
• if you have any liver or kidney disease.
• Tramadol should be used with caution if you have acute porphyria.
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol Stada").

Cases of 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).

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 be possible to achieve insufficient 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.

Consult your doctor, even if any of the above circumstances have occurred at any time.

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 Stada can also cause dependence, abuse, and addiction, which could lead to 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 Stada 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 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 Stada, 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 taking the medication, and how to do it safely (see section 3, if you interrupt treatment with Tramadol Stada).

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 sleepiness. 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 and adolescents

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 medications and Tramadol Stada

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

Tramadol should be avoided in combination with monoamine oxidase inhibitors (MAOIs), certain types of depression medications.

The effect and duration of pain relief produced by tramadol may be reduced if you take medications that contain:

• Carbamazepine (for epilepsy).
• Ondansetron (to prevent nausea).

Your doctor will indicate if you should take tramadol and in what dose.

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 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 dosage recommendation closely. It may be helpful to inform friends or family members about the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

The risk of adverse effects increases:

• if you are taking tramadol simultaneously with tranquilizers, sleep medications, 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;
• if you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medications. 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 are taking antiplatelet medications such as, for example, acenocoumarol (Sintrom?), as it may increase the risk of bleeding.
• if you take medications that can increase the accumulation of tramadol and, therefore, its adverse effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).
• if you are taking gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain).

Taking Tramadol Stada with food and alcohol

Do not consume alcohol during treatment with tramadol, as alcohol can intensify the effects of tramadol. Food does not affect the effect of tramadol.

Pregnancy, breastfeeding, and fertility

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 available on the safety of tramadol in pregnant women. Therefore, do not use tramadol if you are pregnant.

Long-term treatments during pregnancy can cause withdrawal syndrome in the child after birth.

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

Based on human experience, it is not suggested that tramadol affects the fertility of men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with tramadol. It is essential to observe how this medication affects you before driving or using machines. Do not drive or use machines 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.

Tramadol Stada contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, 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 Stada, 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. Normally, the lowest dose possible that produces 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 old

Normally, the initial dose is 1 or 2 capsules oftramadol(equivalent to 50-100 mg of tramadol).

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

Use in children

Tramadol is not recommended for children under 12 years old.

Older patients

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

Patients with liver or kidney insufficiency/patients on dialysis

If you have a severe liver or kidney disease, treatment with tramadolis not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

How and when to take Tramadol Stada?

Tramadolcapsules are administered orally.

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

You can take the capsules with an empty stomach or with meals.

For how long should you take Tramadol 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 this medication and at what dose.

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

If you take more Tramadol Stada than you should

If you have taken an additional dose by mistake, this normally has no negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, contraction of the pupil, 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 may occur. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.It is recommended to bring the medication package insert to the healthcare professional.

If you forgot to take Tramadol Stada

If you forgot to take the medication, it is likely that the pain will return. Do not take a double dose to compensate for the missed doses, simply continue taking tramadol as you have been doing until now.

If you interrupt treatment with Tramadol Stada

If you interrupt or discontinue treatment with this medication too soon, it is likely that the pain will return. If you want to discontinue treatment due to side effects, consult your doctor.

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no adverse effects usually occur when treatment with tramadol is discontinued. However, in rare cases, people who have been taking tramadol for some time may not feel well when treatment is stopped abruptly. They may feel agitated, anxious, nervous, or have tremors. They may find themselves hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people suffer from panic attacks, hallucinations, unusual perceptions such as itching, tingling, numbness, and buzzing in the ears (tinnitus). Very rarely, more unusual symptoms of the central nervous system have been detected, such as confusion, delirium, change in perception of personality (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after discontinuing treatment with tramadol, consult your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

You should consult your doctor immediately if you experience symptoms of an allergic reaction such as facial swelling, tongue swelling, and/or throat swelling and/or difficulty swallowing and hives accompanied by difficulty breathing.

The most common side 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 and numbness.
• Fatigue.
• Vomiting, constipation, and dry mouth.
• Sweating (hyperhidrosis).

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, sensation of dizziness or collapse). These side effects may occur particularly in patients who are bedridden or who engage in physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g. feeling full, heaviness), diarrhea.
• Skin reactions (e.g. itching, skin 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), tremors, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures occur mainly after taking high doses of tramadol or when another medicine that may induce them is taken simultaneously.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological changes may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and the duration of treatment). These may appear in the form of mood changes (usually euphoria, occasionally irritability), changes in activity (usually decreased and occasionally increased) and decreased cognitive and sensory perception (alterations of the senses and perception that may lead to judgment errors).
• It may cause dependence on the drug. If tramadol is used for prolonged periods, it may produce dependence, although the risk is very low. When treatment is stopped abruptly, withdrawal syndrome (see "If you stop taking Tramadol Stada") may occur.
• Blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis).
• Slow breathing, shortness of breath (dyspnea).
• Cases of worsening asthma have been reported, however it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or if it is taken concomitantly with other medications that depress cerebral function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain urinating, decreased urine output (dysuria).

Very rare: may affect up to 1 in 10,000 people

• Increased liver enzymes.

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

• Decreased blood sugar level.
• Hiccups.

Indeterminate frequency (cannot be estimated from available data)

Serotonin syndrome, which may manifest as 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting Tramadol 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 that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store this medication in a safe and protected location, inaccessible to other individuals. This medication may cause severe 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 indicated on the packaging and blister after CAD. 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 packaging and unused medications at the SIGRE Pointat the pharmacy. In case of doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tramadol Stada

• The active ingredient is tramadol hydrochloride. Each capsule contains 50 mg of tramadol hydrochloride.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate, and povidone K 30.

Composition of the capsule coating: gelatin and titanium dioxide

Appearance of the product and contents of the packaging

Tramadol Stada 50 mg are hard gelatin capsules. They are presented in packaging of 20, 60, and 500 capsules.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: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.gob.es/