TRAMADOL KRKA 200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Tramadol Krka 100 mg prolonged-release tablets EFG

Tramadol Krka 150 mg prolonged-release tablets EFG

Tramadol Krka 200 mg prolonged-release tablets EFG

tramadol hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 only. 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 package leaflet. See section 4.

Contents of the package leaflet

1. What is Tramadol Krka and what is it 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 other information

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

Tramadol - the active substance of Tramadol Krka - is an analgesic belonging to the group of opioids 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.

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 case of acute intoxication with alcohol, hypnotics, analgesics, or psychotropic drugs (medicines that act on mood and emotions);
• if you are taking, or have taken in the last 14 days, monoamine oxidase inhibitors (MAOIs) (certain medicines for the treatment of depression) (see “Taking Tramadol Krka with other medicines”);
• if you have epilepsy and your seizures are not adequately controlled with treatment;
• 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 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 within the skull (e.g. after a head injury or diseases affecting the brain);
• if you have difficulty breathing;
• if you are epileptic or have a history of 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 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 of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Sleep-related breathing disorders

Tramadol Krka 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 be 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 result in 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 loss 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 prescribed 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.
• 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 taking tramadol).

Also, inform your doctor if you experience any of these problems during treatment with Tramadol Krka or if you have experienced them in the past.

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 if you need to 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 must 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

This medicine must not be administered to children under 12 years of age.

Tramadol is not recommended for use in children and adolescents 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 Krka and monoamine oxidase inhibitors (MAOIs) (medicines for the treatment of depression) should be avoided.

Both the analgesic effect of Tramadol Krka and its duration may be reduced if you are taking medicines that contain:

• Carbamazepine (for epilepsy)
• Ondansetron (a medicine to prevent nausea)

Concomitant use of Tramadol Krka and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (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 Krka with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Tell your doctor about all sedative medicines you are taking and follow your doctor's dosing recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

Your doctor will tell you if you should take Tramadol Krka and at what dose.

The risk of side effects increases:

• if you are taking tranquilizers, hypnotics, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol Krka. It may cause more drowsiness or make you feel like you are going to faint. If this happens, consult your doctor.
• if you are taking medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol Krka at the same time as these medicines. Your doctor will tell you if Tramadol Krka is suitable for you.
• if you are taking medicines for the treatment of depression. Tramadol Krka 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 with Tramadol Krka. The effect of these medicines on blood clotting may be affected, and it may lead to bleeding.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

Taking Tramadol Krka with food and alcohol

Do not drink alcohol during treatment with Tramadol Krka, as its effect may be intensified. Food does not affect the effect of Tramadol Krka.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

There is very little information on the safety of tramadol during human pregnancy. Therefore, you should not take Tramadol Krka if you are pregnant.

Chronic use during pregnancy may lead to withdrawal syndrome in newborns.

Breastfeeding

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

Fertility

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

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol Krka. 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 drowsy, 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 administering it concomitantly with other medicines.

Tramadol Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Tramadol Krka

Follow exactly the administration instructions 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. Normally, the lowest possible dose that produces pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has told you to do so.

The recommended dose is:

Adults and adolescents over 12 years

One tablet twice a day (equivalent to 200 mg of tramadol hydrochloride per day), preferably in the morning.

If necessary, the dose can be increased to 150 mg or 200 mg twice a day (equivalent to 300 mg - 400 mg of tramadol hydrochloride per day).

Children

This medicine is not suitable for children under 12 years of age.

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.

Patients with liver or kidney impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with tramadol is not recommended.

If you have mild or moderate liver or kidney impairment, your doctor may recommend prolonging the dosing intervals.

Method of administration

This medicine 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 or without food.

How long should you take Tramadol Krka?

This medicine should not be taken 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, it will generally not have negative effects. You should take the next dose as prescribed.

If you (or someone else) have taken many tablets at the same time, you should go to the hospital or contact a doctor immediately. After taking very high doses, it can cause constricted pupils, nausea (vomiting), sudden drop in blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), seizures, and difficulty breathing or shallow breathing that can lead to respiratory arrest.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological 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 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 prescribed by your doctor.

If you stop taking Tramadol Krka

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

If you want to stop treatment due to undesirable 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 tell you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you want to stop treatment due to unpleasant effects, inform your doctor.

Generally, no undesirable effects occur when stopping treatment with tramadol. However, in rare cases, when some people who have been taking this medicine for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembly. They may feel overactive, have difficulty sleeping, or have stomach 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). Very 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 experience any of these symptoms after stopping tramadol, please consult your doctor.

If you have any further questions on the use of this medicine, ask 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 your doctor immediately if you present 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.

Very frequent: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Frequent: may affect 1 in 10 people

• Headache, numbness.
• Fatigue.
• Vomiting, dry mouth, constipation.
• Sweating (hyperhidrosis).

Less frequent: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g., itching, rash).

Rare: may affect 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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, and numbness), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medicines that can cause epileptic seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may appear after treatment with Tramadol Krka 100 mg. Their intensity and nature may vary (according to the patient's personality and treatment duration). These problems can manifest as a change in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and decreased cognitive and sensory perception (changes in senses and recognition, which can lead to errors in judgment).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• A worsening of asthma has been reported; however, no causal relationship with tramadol has been established. 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 (dysuria).

Very rare: may affect 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 place, protected from others. 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.

This medicine does not require special storage conditions.

Medicines should not be thrown away through drains or into 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 ofTramadol Krka

• The active ingredient is tramadol hydrochloride.

Each tablet contains 100 mg of tramadol hydrochloride.

Each tablet contains 150 mg of tramadol hydrochloride.

Each tablet contains 200 mg of tramadol hydrochloride.

• The other components are:

Core of the tablet: hypromellose, microcrystalline cellulose (E460(i)), anhydrous colloidal silica, hypromellose, magnesium stearate (E470b).

Coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol, triacetin, red iron oxide (E172) (only for 150 mg and 200 mg doses). See section 2 "Tramadol Krka contains lactose".

Appearance of the Product and Package Contents

Tramadol Krka 100 mg prolonged-release tablets:

Each tablet is white, round, biconvex, film-coated with the engraving T1 on one side and smooth on the other. Tablet diameter: approximately 10 mm.

Tramadol Krka 150 mg prolonged-release tablets:

Each tablet is pale orange-pink, round, biconvex, film-coated with the engraving T2 on one side and smooth on the other. Tablet diameter: approximately 10 mm.

Tramadol Krka 200 mg prolonged-release tablets:

Each tablet is light pink, round, biconvex, film-coated with the engraving T3 on one side and smooth on the other. Tablet diameter: approximately 10 mm.

These medicines are available in the following package sizes:

Child-resistant blister pack: 10, 20, 28, 30, 50, 60, 90, 100 prolonged-release tablets.

Child-resistant unit dose blister pack: 10, 20, 28, 30, 50, 60, 90, 100 prolonged-release tablets.

Not all package sizes may be marketed.

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 thisprospectus: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