Prospect: 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 this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

3.How to take Tramadol Krka

4.Possible adverse effects

5.Storage of Tramadol Krka

6.Contents of the package and additional information

Tramadol - the active ingredient 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 the brain.

This medication is used in the treatment of moderate to severe pain.

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 intoxications caused by alcohol, sleep-inducing drugs, analgesics, or psychotropic drugs (medicines that act on the mood and emotions);
• if you are also taking MAO inhibitors (certain medicines used to treat depression) or if you have taken them in the last 14 days before starting treatment with Tramadol Krka (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 consciousness disorders (if you think 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 (for example after a head trauma or brain diseases);
• if you have difficulty breathing;
• if you are epileptic or have seizures, as the risk of these seizures may increase;
• if you have any liver or kidney disease.
• if you are depressed and 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 Krka may cause respiratory problems related to sleep such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). These symptoms may be, 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 epilepsy 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 medicine. Repeated use of opioids can make the drug 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 medicine you should use or how often you should use it.

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 medicine for a longer time 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 and 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 for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you interrupt treatment with tramadol).

Also inform your doctor if any of these problems occur during treatment with Tramadol Krka or if they have occurred to you at any time.

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, and he will decide if you should take a hormonal supplement.

Tramadol is transformed 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 side effects. If you notice any of the following side effects, stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Children and adolescents

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

Tramadol should not be used in children and adolescents 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 medicine.

Tramadol Krka should be avoided when taken simultaneously with monoamine oxidase inhibitors (MAOIs) (certain medicines for depression treatment).

The analgesic effect of Tramadol Krka and its duration may be reduced if you take medicines that contain:

• Carbamazepine (for epilepsy seizures)
• Ondansetron (medication to prevent nausea)

The concomitant use of Tramadol Krka and sedatives such as benzodiazepines or related medicines 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 Krka 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 dose closely. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.

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

The risk of side effects increases:

• if you are taking tranquilizers, sleep-inducing drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol Krka. It may cause more sleepiness or the sensation of fainting. If this occurs, consult your doctor.
• if you are taking medicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Tramadol Krka simultaneously with these medicines. Your doctor will tell you if Tramadol Krka is suitable for you.
• if you are taking antidepressants. Tramadol Krka may interact with these medicines and may experience a serotonin syndrome (see section 4 "Possible side effects").
• if you are taking anticoagulant coumarins (medicines that prevent abnormal blood coagulation), such as warfarin, along with Tramadol Krka. The effect of these medicines on blood coagulation may be affected and 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 consume 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, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Lactation

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

Fertility

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

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with Tramadol Krka. It is essential to observe how this medicine affects you before driving or operating machines. Do not drive or operate 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 medicines.

Tramadol Krka contains lactose

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

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, 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 indicated otherwise.

The recommended dose is:

Adults and adolescents over 12 years old

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 medication is not suitable 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 tramadol is not recommended.

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

Method of administration

This medication is administered orally.

Always swallow the tablets whole, not divided or chewed, with sufficient liquid, preferably in the morning and evening. You can take the tablet with an empty stomach or 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 action 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, you will generally not have any negative effects. You should take the next dose as prescribed.

If you (or someone else) have ingested many tablets at the same time, you should go to the hospital or inform a doctor immediately. After taking very high doses, you may experience pupil constriction, nausea (vomiting), sudden drop in blood pressure, increased heart rate, collapse, decreased level of consciousness 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 medication and the amount taken. It is recommended to bring the medication package insert to the healthcare professional.

If you forgot 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 compensate for the missed doses, simply continue treatment as instructed by your doctor.

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 discontinue treatment due to undesirable 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 treatment, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

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

Generally, no adverse effects occur when discontinuing treatment with tramadol. However, in rare cases, when some people who have been taking this medication for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or shaky. 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). Very rarely, other unusual central nervous system symptoms, such as confusion, delirium, distorted perception of one's own personality (derealization), and altered perception of reality (depersonalization), and persecutory delusions (paranoia), have been seen. If you experience any of these symptoms after discontinuing tramadol, please 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 can 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 swelling of the face, tongue, and/or throat and/or difficulty swallowing and hives accompanied by difficulty breathing.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect 1 in 10 people

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

Uncommon: may affect 1 in 100 people

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

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 heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, and numbness), tremors, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medications that can cause 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 the duration of treatment). These problems may 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 may lead to judgment errors).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath (dyspnea).
• Worsening of asthma has been reported, however, no causal relationship with tramadol has been established. If the recommended doses are exceeded or if 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 1 in 10,000 people

• Increased liver enzymes.

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

• Decreased blood sugar level.
• Hypophagia.
• 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 taking Tramadol Krka”).

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 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 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 people 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.

This medication does not require special storage conditions.

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 pointat the pharmacy. Please 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 ofTramadol Krka

• The active ingredient is tramadol hydrochloride.

Each prolonged-release tablet contains 100 mg of tramadol hydrochloride.

Each prolonged-release tablet contains 150 mg of tramadol hydrochloride.

Each prolonged-release tablet contains 200 mg of tramadol hydrochloride.

• The other components are:

Tablet core: hypromellose, microcrystalline cellulose (E460(i)), anhydrous colloidal silica, hypromellose, magnesium stearate (E470b).

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

Appearance of the product and contents of the pack

Tramadol Krka 100 mg prolonged-release tablets:

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

Tramadol Krka 150 mg prolonged-release tablets:

Each tablet is pale pinkish-orange, round, biconvex, coated with a film with the imprint T2 on one face and smooth on the other. Tablet diameter: approximately 10 mm.

Tramadol Krka 200 mg prolonged-release tablets:

Each tablet is pale pink, round, biconvex, coated with a film with the imprint T3 on one face and smooth on the other. Tablet diameter: approximately 10 mm.

These medicines are available in the following pack sizes:

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

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

Only some pack sizes may be marketed.

Marketing authorisation 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

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

KRKA Farmacéutica, S.L.

Calle de Anabel Segura 10

28108 Alcobendas, Madrid

Spain

This medicinal product is authorised in the member states of the European Economic Area with the following names:

Last update of thisleaflet:July 2024

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