TRAMADOL KRKA 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Tramadol Krka 50 mg Hard Capsules 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What Tramadol Krka is and what it is used for.
2. What you need to know before you take Tramadol Krka.
3. How to take Tramadol Krka.
4. Possible side effects.
5. Storage of Tramadol Krka.
6. Contents of the pack and further information.

1. What Tramadol Krka is and what it is used for

Tramadol - the active substance of Tramadol Krka - is an opioid analgesic that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

This medicine is used to treat moderate to severe pain in adults and adolescents aged 12 and over.

2. What you need to know before you take Tramadol Krka

Do not take Tramadol Krka

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in situations of acute intoxication caused by alcohol, sleeping pills, painkillers or other medicines that act on mood and emotions;
• if you are taking monoamine oxidase inhibitors (MAOIs), a certain type of medicine for the treatment of depression, or if you have taken them in the last 14 days before treatment with tramadol (see "Other medicines and Tramadol Krka");
• if you have uncontrolled epilepsy;
• for the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor before starting to take Tramadol Krka:

• if you think you are dependent on other painkillers (opioids);
• if you have decreased consciousness (if you feel like you are going to faint);
• if you are in shock (a sign of this state may be cold sweat);
• if you have increased intracranial pressure (possibly after a head injury or diseases that affect the brain);
• if you have difficulty breathing;
• if you are epileptic or have a history of seizures, as the risk of 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 Krka");

Serotonin Syndrome

There is a small risk that you may experience serotonin syndrome, which can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult 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 central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms can include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult 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 dose of tramadol 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 can make the medicine 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 can lead to potentially life-threatening overdose. The risk of these side effects may be greater with higher doses 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 or addicted to tramadol may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, 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 using tramadol, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period 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, unsuccessful attempts to stop using the medicine or control its use.

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 stop treatment with tramadol).

Keep in mind that tramadol can cause physical and psychological dependence.

When tramadol is used for a long period, its effect may decrease, requiring the use of higher doses (development of tolerance). In patients with a tendency to abuse medicines or those with drug dependence, treatment with tramadol should only be carried out for short periods and under strict medical control.

Tell your doctor if any of these problems occur during treatment with tramadol or if you have experienced them before.

Consult your doctor if you experience any of the following symptoms while taking this medicine:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you should take a hormonal supplement.

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, 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.

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 medicines and Tramadol Krka

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

Concomitant treatment with tramadol and monoamine oxidase inhibitors (MAOIs), a certain type of medicine for the treatment of depression, should be avoided.

Both the effect and duration of pain relief produced by tramadol may be reduced if you take medicines that contain:

• Carbamazepine (for epileptic seizures).
• Ondansetron (to prevent nausea).

Your doctor will tell you whether you should take tramadol and at what dose.

Concomitant use of tramadol and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tramadol along with sedative medicines, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedative medicines you are taking and follow your doctor's dose recommendation closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms indicated above. Contact your doctor when you experience these symptoms.

The risk of side effects increases:

• if you are taking tramadol simultaneously with sleeping pills, other painkillers such as morphine and codeine (even when used for the treatment of cough), and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.
• if you are taking medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol Krka simultaneously with these medicines. Your doctor will tell you whether Tramadol Krka is suitable for you.
• if you are taking medicines for the treatment of depression, tramadol may interact with these medicines, and you may experience serotonin syndrome (see section 4 "Possible side effects").
• if you are taking anticoagulant medicines, such as warfarin, while taking tramadol. The effect of these medicines on blood clotting may be affected, which can lead to bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

Taking Tramadol Krka with food and alcohol

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

Pregnancy, Breast-feeding, and Fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very little information available on the safety of tramadol in pregnant women. Therefore, you should not take tramadol if you are pregnant.

Chronic treatment with tramadol during pregnancy can cause dependence syndrome in the fetus and, consequently, withdrawal syndrome in the newborn.

Breast-feeding

Tramadol is excreted in breast milk. For this reason, you should not take tramadol more than once during breast-feeding, or if you take tramadol more than once, you should interrupt breast-feeding.

Fertility

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

Driving and using machines

Tramadol can cause dizziness, drowsiness, and visual disturbances (blurred vision) and affect your reaction ability. If you feel that your reaction ability is affected, do not drive a car or other vehicle, operate electrical tools or machines, and work without a secure grip.

Tramadol Krka contains sodium

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

3. How to take Tramadol Krka

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. 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.

Normally, you should take the lowest possible dose that produces pain relief. Do not take more than 8 capsules of tramadol per day (equivalent to 400 mg of tramadol hydrochloride), unless your doctor has instructed you to do so.

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

Adults and adolescents over 12 years

The usual dose is 1-2 capsules every 4-6 hours.

The recommended dose for moderate pain is 1 hard capsule (corresponding to 50 mg of tramadol hydrochloride). If pain relief is not achieved within 30-60 minutes, a second capsule can be taken.

To relieve severe pain, a higher analgesic demand can be expected, in which case 2 hard capsules can be taken at the same time as a single dose (corresponding to 100 mg of tramadol hydrochloride).

Use in children

This medicine is not recommended for children under 12 years.

Elderly patients

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

Patient with severe hepatic or renal impairment and patients on dialysis:

If you have severe liver or kidney impairment, treatment with tramadol is not recommended. If you have mild or moderate liver or kidney impairment, your doctor may prolong the dosing intervals.

How and when should you take Tramadol Krka?

The capsules are administered orally.

You should swallow the capsules whole, without dividing or chewing them, and with sufficient liquid.

You can take this medicine with or without food.

How long should you take Tramadol Krka?

This medicine 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 think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Tramadol Krka than you should

If you have taken an extra dose of tramadol by mistake, this will normally not have negative effects. You should take the next dose as prescribed.

If you (or someone else) have taken many capsules of this medicine at the same time, you should go to the hospital or call a doctor immediately. The signs of an overdose include very small pupils, vomiting, decreased blood pressure, rapid heartbeat, circulatory collapse, unconsciousness up to coma (deep unconsciousness), seizures, and breathing difficulties or shallow breathing up to respiratory arrest. If these signs appear, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine package leaflet to the healthcare professional.

If you forget to take Tramadol Krka

If you forget to take tramadol, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses; simply continue taking this medicine as you have been doing until now.

If you stop taking Tramadol Krka

If you stop or finish treatment with tramadol too early, it is likely that the pain will return.

If you want to stop treatment due to side effects, consult your doctor.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk 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 it, which can be done by gradually reducing the dose to reduce the possibility of developing unnecessary side effects (withdrawal symptoms).

Generally, no side effects are experienced when treatment with this medicine is stopped. However, in rare cases, people who have been taking tramadol for some time may not feel well when stopping treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be overactive, have difficulty sleeping, or experience digestive problems and changes in bowel movements. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, numbness, and ringing 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 one's own personality (depersonalization), and change 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 or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should consult a doctor immediately if you experience symptoms of an allergic reaction, such as swelling in the face, tongue, and/or throat, and/or difficulty swallowing, or hives along with breathing difficulties.

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
• Excessive sweating (hyperhidrosis)

Uncommon (may affect up to 1 in 100 people)

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats (tachycardia), feeling of dizziness (orthostatic hypotension or circulatory collapse). These adverse effects may occur particularly in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g., feeling of pressure in the stomach, 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 (dyspnea), wheezing, water retention in tissues (angioedema), and shock (sudden circulatory failure) have occurred in very rare cases
• Slow heart rate (bradycardia)
• Increased blood pressure
• Abnormal skin sensations (e.g., itching, tingling, numbness), tremors, involuntary muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders
• Seizures occur mainly after taking 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 alterations may appear 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 decrease and occasionally increase), and decreased cognitive and sensory perception (being less aware and less able to make decisions, which can lead to errors in judgment).
• It can cause drug dependence
• When treatment is interrupted abruptly, withdrawal syndrome may appear (see "If you stop treatment with Tramadol Krka")
• Blurred vision, excessive dilation of the pupils (mydriasis), contraction of the pupils (miosis)
• Slow breathing (respiratory depression), shortness of breath (dyspnea)
• There have been reports of worsening asthma, 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 medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness
• Difficulty or pain when urinating, less urine than normal (urination and dysuria disorders)

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

• Increased liver enzymes

Frequency not known (frequency that cannot be estimated from the available data)

• Decrease in blood sugar levels
• Hypo
• 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 taking Tramadol Krka").

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 Krka

Keep this medicine out of sight and reach of children.

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

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from moisture.

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. 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 Krka

• The active ingredient is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other components are: microcrystalline cellulose, sodium carboxymethyl starch (type A), talc, magnesium stearate (E470b) in the capsule core, and titanium dioxide (E171), indigo carmine (E132), and gelatin in the capsule shell.

Appearance of Tramadol Krka and package contents:

Hard capsules (capsules): the body of the capsule is white and the cap is blue. Capsules that contain a white or almost white powder. Capsule size No. 4. Length of the capsules 14-15 mm.

It is presented in packages that contain 10, 20, 30, 50, 60, 90, and 100 hard capsules in blisters.

Only some package sizes may be commercialized.

Marketing Authorization Holder

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Manufacturer

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L.

Calle de Anabel Segura 10

28108 Alcobendas, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this prospectus: July 2024

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