Patient Information Leaflet: Package Leaflet

Tramadol Krka 50 mg Hard Capsules EFG

Tramadol hydrochloride

Read this leaflet carefully before you start to take 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 and you should 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 –the active ingredient 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 medication is used for the treatment of moderate to severe pain in adults and adolescents 12 years of age or older.

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 cases of acute intoxication caused by alcohol, sleeping pills, painkillers, or other medicines 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 “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 experience a decrease in level of consciousness (if you feel like 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 (possibly after a head injury 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 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 weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Respiratory problems related to sleep

Tramadol may cause respiratory problems related to sleep such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pause in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Cases of seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended maximum daily dose (400 mg).

Tolerance, dependence, and addiction

This medicine 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 lead to a potentially fatal overdose. The risk of these side 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 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.

If you notice any of these signs, consult your doctor to determine the best course of treatment for you, when it is appropriate to discontinue the medication, and how to do it safely (see section 3, if you interrupt treatment with tramadol).

Be aware that tramadol can cause physical and psychological dependence.

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

Inform your doctor if any of these problems occur during treatment with tramadol or if they have occurred at any time.

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

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 if you should take a hormone 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, 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.

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tramadol Krka

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

Tramadol treatment should be avoided 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 (epileptic seizures).

− Ondansetron (to prevent nausea).

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

The concomitant use of tramadol and sedatives such as benzodiazepines or related medications increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tramadol along with sedatives, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

The risk of adverse effects increases:

• if you are taking tramadol simultaneously with sleeping pills, other painkillers such as morphine and codeine (even when used to treat cough), 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 Krka simultaneously with these medications. Your doctor will tell you if Tramadol Krka is suitable for you.
• if you are taking depression medications, tramadol may interact with these medications and you may experience a serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking anticoagulants such as warfarin, while taking tramadol. The effect of these medications on coagulation may be affected, which may cause bleeding.
• Gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain).

Tramadol Krka with food and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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 take tramadol if you are pregnant.

Long-term tramadol treatment during pregnancy may cause fetal dependence syndrome and, consequently, withdrawal syndrome in the newborn.

Breastfeeding

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.

Fertility

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and operating machines

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

Tramadol Krka contains sodium

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

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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, 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, you should take the lowest dose possible that produces pain relief. Do not take more than 8 tramadol capsules per day (equivalent to 400 mg of tramadol hydrochloride), 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

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 in 30 to 60 minutes, a second capsule can be taken.

To relieve severe painyou can expect a greater analgesic demand, in this 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 medicationis not recommended for children under 12 years old.

Older patients

In elderly 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 severe liver or kidney failure and patients on dialysis:

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

How and when to 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 medication both with an empty stomach and with meals.

For how long should you take Tramadol Krka?

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 effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Tramadol Krka than you should

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

If you (or someone else) ingest many capsules of this medication at the same time, you should go to the hospital or call a doctor immediately. Signs of overdose include very small pupils, vomiting, decreased blood pressure, rapid heart rate, circulatory collapse, unconsciousness to coma (deep unconsciousness), seizures, and respiratory difficulties or shallow breathing to respiratory arrest. If these symptoms 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 medication and the amount taken. It is recommended to bring the medication 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 compensate for the missed doses, simply continue taking this medication as you have been doing until now.

If you interrupt treatment with Tramadol Krka

If you interrupt or discontinue treatment with tramadol too soon, it is likely that the pain will return.

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

You should not suddenly stop taking this medication 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 advise you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the possibility of unnecessary side effects (withdrawal symptoms).

Generally, no adverse effects occur when treatment is interrupted with this medication. 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 be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit problems. Very few people experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, tingling, 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 (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medication, consult your doctor or pharmacist.

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

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

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 up to 1 in 1,000 people)

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

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

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 adverse reactions, 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 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.

Do not use this medication 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 above 30°C.

Store in the original packaging to protect it from moisture.

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

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 coating.

Appearance of Tramadol Krkaand contents of the package:

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

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

Only some package sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.

Calle de Anabel Segura 10

28108 Alcobendas, Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of thisleaflet: July 2024

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