Tramadol Krka

Leaflet accompanying the packaging: patient information

Tramadol Krka, 50 mg, hard capsules

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tramadol Krka and what is it used for
• 2. Important information before taking Tramadol Krka
• 3. How to take Tramadol Krka
• 4. Possible side effects
• 5. How to store 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 a pain-relieving medicine belonging to the class of opioids acting on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.
The hard capsules of Tramadol Krka are used to treat moderate to severe pain in adults and children over 12 years of age.

2. Important information before taking Tramadol Krka

When not to 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, sleeping pills, pain-relieving medicines or other medicines affecting mood and emotions;
• if you are taking MAO inhibitors (certain medicines used to treat depression) or have taken them in the last 14 days before starting treatment with Tramadol Krka (see "Tramadol Krka and other medicines");
• if you have epilepsy and your seizures are not adequately controlled by effective therapy;
• as a substitute therapy after withdrawal from narcotics.

Warnings and precautions

Before starting treatment with Tramadol Krka, you should inform your doctor or pharmacist:

• if you suspect that you are addicted to other pain-relieving medicines (opioids);
• if you have impaired consciousness (a feeling similar to fainting);
• if you are in shock (one of the symptoms may be cold sweats);
• if you have increased intracranial pressure (which may be caused by a head injury or brain disease);
• if you have difficulty breathing;
• if you have a history of epilepsy or have had seizures, as the risk of an attack may increase;
• if you have liver or kidney disease;
• if you have depression and are taking antidepressant medicines, as some of them may interact with tramadol (see "Tramadol Krka and other medicines").

Serotonin syndrome
After taking tramadol in combination with certain antidepressant medicines or tramadol alone, there is a small risk of so-called serotonin syndrome. If you experience any symptoms of this syndrome with a severe course, you should immediately consult a doctor (see section 4 "Possible side effects").
Sleep apnea
Tramadol Krka may cause sleep apnea, 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, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, you should contact your doctor. Your doctor may recommend reducing the dose.
There have been reports of seizures in patients taking tramadol at the recommended dose. This risk may be increased if tramadol doses exceed 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 lead to reduced efficacy of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Tramadol Krka may also lead to dependence, abuse, and addiction, which can cause life-threatening overdose. The risk of these side effects may increase with the dose and duration of treatment.
Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of its administration.
The risk of dependence on Tramadol Krka is different for different people. A higher risk of dependence on Tramadol Krka may apply to people in the following situations:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• the patient is a smoker;
• the patient has ever had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while taking Tramadol Krka, it may indicate dependence or addiction.

• Need to take the medicine for a longer period than recommended by the doctor.
• Need to take a higher dose than recommended.
• Taking the medicine for reasons other than those for which it was prescribed, such as "to calm down" or "to sleep better".
• Repeated, unsuccessful attempts to stop or control the use of the medicine.
• After stopping the medicine, the patient feels unwell, and after taking it again, they feel better ("withdrawal effects").

If you notice any of these symptoms, you should consult your doctor to discuss the best treatment option for you, including deciding when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramadol Krka).
If any of these problems occur during treatment with Tramadol Krka or have occurred in the past, you should inform your doctor.
You should contact your doctor if, while taking Tramadol Krka, you experience any of the following symptoms:
Excessive 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 such symptoms occur, you should contact your doctor, who will decide whether you need hormone replacement therapy.
Tramadol is converted in the liver by an enzyme. In some people, there is a certain variant of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, the risk of serious side effects may be higher.
You should stop taking the medicine and immediately contact your doctor if you experience any of the following side effects: slowed breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Children and adolescents

Use in children with breathing disorders
Tramadol should not be used in children with breathing disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Tramadol Krka and other medicines

You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tramadol Krka should not be taken at the same time as MAO inhibitors (certain medicines used to treat depression).
The pain-relieving effect of Tramadol Krka may be weakened, and its duration may be shortened during concurrent administration of medicines containing:

• carbamazepine (used to treat epilepsy),
• ondansetron (an antiemetic medicine).

Your doctor will determine whether you can take Tramadol Krka and in what dose.
Concomitant use of Tramadol Krka and sedative medicines, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, concomitant use of these medicines can only be considered when other treatment options are not possible.
If your doctor prescribes Tramadol Krka together with sedative medicines, they should limit the dose and duration of concomitant use.
You should inform your doctor about all sedative medicines you are taking and strictly follow the dosage recommendations. It may be helpful to inform friends or family members to be aware of these symptoms. If such symptoms occur, you should contact your doctor.
The risk of side effects increases,

• if you take Tramadol Krka at the same time as sleeping pills, other pain-relieving medicines, such as morphine and codeine (also as a cough medicine), and alcohol. Drowsiness and a feeling of fainting may occur. If this happens, you should inform your doctor.
• if you take medicines that can cause seizures (fits), such as certain antidepressant or antipsychotic medicines. The risk of seizures may increase when taking Tramadol Krka. Your doctor will determine whether Tramadol Krka is suitable for you.
• if you take certain antidepressant medicines. Tramadol Krka may interact with other medicines and cause serotonin syndrome (see section 4 "Possible side effects").
• if you take anticoagulant medicines from the coumarin group (medicines that prevent blood clotting), such as warfarin, at the same time as Tramadol Krka. The effect of these medicines on blood clotting may change, and bleeding may occur.
• if you take gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain (nerve pain).

Tramadol Krka with food and alcohol

You should not drink alcohol while being treated with Tramadol Krka, as it may enhance its effect. 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 have a baby, you should consult your doctor or pharmacist before taking this medicine.
There is limited information on the safety of tramadol in pregnant women.
Therefore, Tramadol Krka should not be used if you are pregnant.
Long-term use of Tramadol Krka during pregnancy may lead to dependence on tramadol in the unborn child, resulting in withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, during breastfeeding, you should not take Tramadol Krka more than once, or if you have taken Tramadol Krka more than once, you should stop breastfeeding.
Fertility
Observations on the use of tramadol in humans indicate that tramadol does not affect fertility in women and men.

Driving and using machines

Tramadol Krka may cause drowsiness, dizziness, and blurred vision, and therefore may impair your reactions. If you experience these symptoms, you should not drive or operate machinery.

Tramadol Krka contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means that it is essentially "sodium-free".

3. How to take Tramadol Krka

This medicine should always be taken exactly as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from Tramadol Krka, when and for how long to take it, when to contact your doctor, and when to stop taking it (see also section 2).
The dose should be adjusted based on the severity of the pain and the individual patient's sensitivity to pain. The smallest dose that provides pain relief should be used. You should not take more than 8 Tramadol Krka capsules per day (which corresponds to 400 mg of tramadol hydrochloride), unless your doctor has recommended otherwise.
Unless your doctor has recommended otherwise, the usual dose is:

Adults and adolescents over 12 years of age
Usually, the dose is 1 or 2 capsules every 4-6 hours.
The recommended dose for moderate pain is 1 hard capsule of Tramadol Krka (which corresponds to 50 mg of tramadol hydrochloride). If pain relief does not occur within 30-60 minutes, a second capsule can be taken.
In cases of severe pain, increased demand for pain relief can be expected, so in this situation, 2 hard capsules of Tramadol Krka can be taken as a single dose (which corresponds to 100 mg of tramadol hydrochloride).
Children
Tramadol Krka should not be used in children under 12 years of age.
Elderly patients
In elderly patients (over 75 years), tramadol may be eliminated more slowly.
In such cases, your doctor may recommend prolonging the interval between doses.
Patient with severe liver or kidney impairment (failure) and (or) patients on dialysis
Tramadol Krka should not be used in patients with severe liver or kidney failure.
If you have mild or moderate liver or kidney failure, your doctor may recommend prolonging the intervals between doses of Tramadol Krka.
How and when to take Tramadol Krka?
Tramadol Krka is intended for oral use.
Tramadol Krka should always be swallowed whole, without chewing or crushing, with a large amount of water. The capsule can be taken with or without food.
How long to take Tramadol Krka?
You should not take Tramadol Krka for longer than necessary. If long-term use is required, your doctor will regularly monitor you at short intervals (if necessary, with breaks in treatment) to determine whether continued use of Tramadol Krka is justified and what dose you should take.
If you feel that the effect of Tramadol Krka is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of Tramadol Krka than recommended

Accidental ingestion of an additional dose of Tramadol Krka usually does not cause any side effects. You should take the next dose as recommended.
In case of ingestion of a higher number of Tramadol Krka capsules than recommended, you should immediately contact your doctor or go to the emergency department of the nearest hospital. Symptoms of overdose may include: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, loss of consciousness, and even coma (a state of deep unconsciousness), seizures, and breathing difficulties or shallow breathing up to respiratory arrest. If these symptoms occur, you should immediately contact your doctor.

Missing a dose of Tramadol Krka

Stopping Tramadol Krka will cause the return of pain symptoms. You should not take a double dose of the medicine to make up for the missed dose, but simply continue taking Tramadol Krka.

Stopping Tramadol Krka

Stopping treatment with Tramadol Krka too early will likely cause the return of pain symptoms.
If you want to stop treatment due to unpleasant symptoms, you should inform your doctor.
You should not suddenly stop taking this medicine without your doctor's advice. If you want to stop taking the medicine, you should discuss it with your doctor, especially if you have been taking it for a long time.
Your doctor will advise you on when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms).
Essentially, after stopping Tramadol Krka, no serious side effects have been reported. However, in rare cases, after sudden cessation of Tramadol Krka taken for some time, the patient may feel unwell. Agitation, restlessness, nervousness, or tremors may occur. Insomnia and gastrointestinal disorders may also occur. In rare cases, panic attacks, hallucinations, abnormal perception of stimuli, such as itching, tingling, and numbness, and "ringing" in the ears (tinnitus) may occur. Other unusual central nervous system disorders, such as confusion, delusions, changes in self-perception (depersonalization), and changes in the perception of reality (derealization), as well as persecutory delusions (paranoia), have occurred very rarely. If you experience any of these symptoms after stopping Tramadol Krka, you should consult your doctor.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramadol Krka can cause side effects, although not everybody gets them.
You should immediately contact your doctor if you experience symptoms of an allergic reaction, such as swelling of the face, tongue, and (or) throat, and (or) difficulty swallowing or hives, as well as difficulty breathing.
Very common (may affect more than 1 in 10 people)

• dizziness,
• nausea.

Common (may affect up to 1 in 10 people)

• headache, drowsiness,
• fatigue,
• constipation, dry mouth, vomiting,
• excessive sweating.

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and circulatory system (palpitations, rapid heartbeat (tachycardia), dizziness (orthostatic hypotension or circulatory collapse). These side effects may occur especially in patients when standing up and after physical exertion,
• feeling sick (nausea), gastrointestinal problems (e.g., feeling of pressure in the stomach, bloating), diarrhea,
• skin reactions (e.g., itching, rash).

Rare (may affect up to 1 in 1,000 people)

• very rare allergic reactions (e.g., difficulty breathing (dyspnea), wheezing, fluid retention (angioedema) and anaphylactic reactions (sudden circulatory failure)),
• slow heartbeat (bradycardia),
• increased blood pressure,
• unusual skin reactions (e.g., itching, tingling, numbness), tremors, involuntary muscle contractions, uncoordinated movements, transient loss of consciousness (fainting), speech disorders,
• seizures have occurred in cases of high doses of tramadol or when tramadol was taken concomitantly with other medicines that can cause seizures,
• changes in appetite,
• hallucinations, disorientation, sleep disturbances, anxiety, and nightmares,
• after treatment with Tramadol Krka, psychiatric disorders may occur. Their intensity and nature may vary (depending on the patient's personality and duration of therapy). They may manifest as mood changes (mainly agitation, sometimes irritation), changes in activity (usually inhibition, sometimes increased activity), and reduced cognitive and sensory abilities (decreased awareness and decision-making ability, which can lead to incorrect judgments),
• addiction to the medicine may occur. After sudden cessation of treatment, withdrawal symptoms may occur (see "Stopping Tramadol Krka"),
• blurred vision, excessive dilation of blood vessels, constriction of blood vessels,
• slow breathing (respiratory depression), shortness of breath,
• reports of exacerbation of asthma symptoms have been received, but it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or taken concomitantly with other medicines that depress brain activity, breathing may slow down,
• muscle weakness,
• difficulty and painful urination, passing less urine than usual (urination disorders and difficulty urinating).

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

• increased activity of liver enzymes.

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

• low blood sugar,
• hiccups,
• serotonin syndrome, the symptoms of which may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramadol Krka").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramadol Krka

The medicine should be kept out of the sight and reach of children.
This medicine should be stored in a closed and secure place, to which other people do not have access. It can cause serious harm and be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tramadol Krka contains

• The active substance is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.
• The other ingredients (excipients) are microcrystalline cellulose (type 101), sodium carboxymethylcellulose (type A), talc, magnesium stearate (E 470b) in the capsule core, and titanium dioxide (E 171), indigo carmine (E 132), and gelatin in the capsule shell.

What Tramadol Krka looks like and contents of the pack

The body of the capsule is white, and the cap is blue. The capsules are filled with a white or almost white powder. The capsule has a size of 4. The length of the filled capsules is 14-15 mm.
Tramadol Krka is available in packs containing 10, 20, 30, 50, 60, 90, or 100 hard capsules in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
To obtain more detailed information on the names of the medicine in other EU member states and the UK (Northern Ireland), you should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: 19.07.2024