Tramadol Krka

Leaflet attached to the packaging: patient information

Tramadol Krka, 100 mg, prolonged-release tablets

Tramadol Krka, 150 mg, prolonged-release tablets

Tramadol Krka, 200 mg, prolonged-release tablets

Tramadol hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 packaging 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 group of opioids that affect the central nervous system. It has a pain-relieving effect by acting on specific receptors of nerve cells in the spinal cord and brain.
Tramadol Krka is indicated for moderate to severe pain.

2. Important information before taking Tramadol Krka

When not to take Tramadol Krka

• in case of acute alcohol poisoning, sleeping pills, painkillers, or psychotropic drugs (mood- and emotion-affecting drugs);
• in case of concurrent treatment with MAO inhibitors (certain antidepressants) and for 14 days before starting treatment with Tramadol Krka (see "Tramadol Krka and other medicines");
• in patients with uncontrolled epilepsy;
• for the treatment of opioid dependence.

Warnings and precautions

Before starting to take Tramadol Krka, the patient should discuss it with their doctor or pharmacist:

• in case of dependence on other pain-relieving substances (opioids);
• in case of impaired consciousness (if the patient feels faint);
• in case of shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (may occur after head injury or brain diseases);
• in case of respiratory disorders;
• if the patient has a tendency to develop epilepsy or convulsions, as the risk of convulsions may increase;
• in patients with liver or kidney disease,

Serotonin syndrome
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of serotonin syndrome. If the patient experiences any symptoms of this syndrome with a severe course, they 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 the patient or someone else observes these symptoms, they should contact their doctor. The doctor may recommend reducing the dose.
Seizures have been observed in patients taking tramadol in recommended doses. The risk of seizures may be higher if 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 lead to decreased effectiveness 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 taking it.
The risk of dependence on Tramadol Krka may be higher in people who:

• have a history of substance abuse or dependence on prescription or illegal drugs ("addiction");
• are smokers;
• have a history of mood problems (depression, anxiety, or personality disorders) or have been treated by a psychiatrist for other mental health problems.

If the patient notices 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 prescribed by the doctor.
• Need to take a higher dose than prescribed.
• 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 symptoms").

If the patient notices any of these symptoms, they should consult their doctor to discuss the best treatment option, including deciding when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramadol Krka).
The patient should consult their doctor if they experience any of the above situations during treatment with Tramadol Krka or if they have occurred in the past.
The patient should contact their doctor if, while taking Tramadol Krka, they experience any of the following symptoms:
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should contact their doctor, who will decide whether the patient needs 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.
The patient should stop taking the medicine and immediately contact their doctor if they experience any of the following side effects: slow breathing or shallow breathing, disorientation, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Children and adolescents

This medicine should not be used in children under 12 years of age.
Tramadol is not recommended for children and adolescents with respiratory disorders, as the symptoms of its toxicity may be more severe in them.

Tramadol Krka and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Tramadol Krka should not be taken concurrently with MAO inhibitors (medicines used to treat depression).
The pain-relieving effect of Tramadol Krka may be weakened, and the duration of action shortened, if taken concurrently with medicines containing:

• carbamazepine (an antiepileptic medicine),
• ondansetron (an antiemetic medicine).

Concurrent use of Tramadol Krka with sedative medicines, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory failure), coma, and can be life-threatening. Therefore, concurrent use of these medicines can only be considered if other treatment options are not possible.
If the doctor prescribes Tramadol Krka together with sedative medicines, they should limit the dose and duration of concurrent use.
The patient should inform their doctor about all sedative medicines they are taking and strictly follow the dosage instructions. It may be helpful to inform friends or family members about the risk, so they are aware of the symptoms. If these symptoms occur, the patient should contact their doctor.
The doctor will inform the patient about the use of Tramadol Krka and its dosage.
The risk of side effects increases:

• when Tramadol Krka is taken concurrently with sedative medicines, sleeping pills, other painkillers, such as morphine and codeine (also as a cough medicine), and alcohol. Drowsiness or fainting may occur. In this case, the patient should consult their doctor.
• if the patient is taking other medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Tramadol Krka concurrently with these medicines. The doctor will decide whether Tramadol Krka is suitable for the patient.
• if the patient is taking certain antidepressants, Tramadol Krka may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects").
• when Tramadol Krka is taken concurrently with anticoagulant medicines, such as warfarin, which are used to reduce blood clotting. Bleeding may occur due to the effect of these medicines on the blood clotting system.
• if the patient is taking gabapentin or pregabalin for the treatment of epilepsy or nerve pain (neuropathic pain).

Tramadol Krka with food and alcohol

The patient should not drink alcohol while taking Tramadol Krka, as the effect of the medicine may be enhanced. Food does not affect the effect of Tramadol Krka.

Pregnancy, breastfeeding, and fertility

Pregnancy
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. There is limited data on the safety of tramadol in pregnant women. Therefore, Tramadol Krka should not be used in pregnant women.
Long-term administration of tramadol during pregnancy may lead to withdrawal symptoms in the newborn.
Breastfeeding
Tramadol passes into breast milk. Therefore, Tramadol Krka should not be taken during breastfeeding, or breastfeeding should be stopped if the patient has taken more than one dose of Tramadol Krka.
Fertility
Experience with tramadol in humans does not indicate that it affects fertility in men and women.

Driving and using machines

Tramadol Krka may cause drowsiness, dizziness, and blurred vision, which may affect reaction time. If the patient feels that their reaction time is impaired, they should not drive vehicles, use electrical tools, or operate any machines.

Tramadol Krka contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Tramadol Krka

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Tramadol Krka, when and how long to take it, when to contact the doctor, and when to stop taking the medicine (see also section 2).
The doctor will adjust the dose according to the severity of the pain and the patient's individual sensitivity to pain. This will be the smallest dose that effectively relieves the pain. The patient should not take more than 400 mg of tramadol hydrochloride per day, unless the doctor prescribes otherwise.
The recommended dose is:

Adults and adolescents over 12 years of age:
One Tramadol Krka tablet of 100 mg twice a day (corresponding to 200 mg of tramadol hydrochloride per day), preferably in the morning and evening.
If necessary, the dose can be increased to 150 mg or 200 mg twice a day (corresponding to 300 mg - 400 mg of tramadol hydrochloride per day).
Children
Tramadol Krka is not suitable for children under 12 years of age.
Elderly patients
In elderly patients (over 75 years of age), the elimination of tramadol may be delayed.
The doctor may recommend prolonging the interval between doses in these patients.
Patient with severe liver or kidney impairment, patients on dialysis
Tramadol Krka should not be taken in case of severe liver or kidney impairment.
In case of mild or moderate impairment, the doctor may recommend prolonging the intervals between doses.
Method of administration
Tramadol Krka prolonged-release tablets are intended for oral use.
The prolonged-release tablets should always be taken whole, with a sufficient amount of liquid, and should not be divided or chewed. The tablets can be taken on an empty stomach or with food.

How long to take Tramadol Krka

Tramadol Krka should not be taken for longer than necessary. In case of long-term treatment, the doctor will regularly monitor the patient's condition (interrupting the treatment for a while if necessary) to determine whether and at what dose the treatment with Tramadol Krka should be continued.
If the patient feels that the effect of Tramadol Krka is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of Tramadol Krka than recommended

If the patient accidentally takes an extra dose of the medicine, it will usually not cause any negative effects. The patient should take the next dose of the medicine as prescribed by the doctor.
If the patient (or someone else) takes too many Tramadol Krka tablets at the same time, they should immediately go to the hospital or contact their doctor. After taking higher doses than recommended, the following symptoms may occur: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, loss of consciousness, seizures, breathing difficulties, or shallow breathing.

Missing a dose of Tramadol Krka

If the patient forgets to take the medicine at the right time, the pain symptoms will likely return.
The patient should not take a double dose to make up for the missed dose. The patient should return to the previous dosing schedule.

Stopping Tramadol Krka

If the patient stops taking Tramadol Krka suddenly or prematurely, the pain symptoms will likely return.
The patient should not stop taking the medicine suddenly, unless the doctor advises otherwise. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if they have been taking it for a long time. The doctor will advise 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).
If the patient wants to stop the treatment due to side effects, they should inform their doctor.
Generally, after stopping Tramadol Krka, no serious withdrawal symptoms are observed.
However, in rare cases, after sudden cessation of Tramadol Krka taken for a certain period, the patient may feel unwell. They may experience agitation, anxiety, nervousness, tremors, difficulty sleeping, and gastrointestinal disorders. Very rarely, the following symptoms may occur: panic attacks, hallucinations, abnormal sensations such as itching, tingling, numbness, and ringing in the ears. Other unusual central nervous system disorders, such as confusion, delusions, depersonalization, derealization, and paranoid delusions, have occurred very rarely.
If the patient experiences any of the above symptoms after stopping Tramadol Krka, they should immediately consult their doctor.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramadol Krka can cause side effects, although not everybody gets them.
The patient should immediately consult their doctor if they experience symptoms of an allergic reaction, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives accompanied by difficulty breathing.
Very common (may affect more than 1 in 10 people):

• dizziness
• nausea

Common (may affect up to 1 in 10 people):

• headaches, drowsiness
• fatigue
• constipation, dry mouth, vomiting
• excessive sweating

Uncommon (may affect up to 1 in 100 people):

• heart and blood vessel disorders (palpitations, rapid heartbeat, feeling of impending fainting or fainting). These side effects may occur especially when changing body position to standing and after physical exertion.
• vomiting reflex, gastrointestinal disorders (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):

• in rare cases, allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and anaphylactic shock (sudden circulatory failure) have occurred
• slow heartbeat
• high blood pressure
• abnormal sensations (e.g., itching, tingling, numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders
• seizures have occurred mainly after taking high doses of tramadol or concurrently with other medicines that can cause seizures
• changes in appetite
• hallucinations, confusion, sleep disorders, delirium, anxiety, nightmares
• after taking Tramadol Krka, psychiatric disorders may occur. Their severity and type may vary (depending on the patient's personality and treatment duration). They may include mood disorders (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), and decreased sensory and cognitive perception (changes in feelings and recognition, which can lead to incorrect assessment of the situation)
• addiction may occur. In case of sudden cessation of treatment, withdrawal symptoms may occur (see section "Stopping Tramadol Krka").
• blurred vision, excessive pupil dilation (mydriasis), pinpoint pupils (miosis)
• slow breathing, "short breath" (dyspnea)
• reports of exacerbation of asthma symptoms during tramadol treatment have been received, although a causal relationship between these facts has not been established. In case of taking doses significantly higher than recommended or concurrent use of other medicines that depress brain activity, respiratory depression may occur.
• muscle weakness
• difficulty or pain when urinating, decreased urine output (dysuria)

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

• increased liver enzyme activity

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

• low blood sugar
• hiccups

Serotonin syndrome, whose symptoms 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 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramadol Krka").

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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:
Jerozolimskie Avenue 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, more information can be collected on the safety of the medicine.

5. How to store Tramadol Krka

The medicine should be stored out of 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 take this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tramadol Krka contains

• The active substance of Tramadol Krka 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 ingredients are: hypromellose, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate in the tablet core, and hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol 3000, triacetin, iron oxide red (E 172) (only in 150 mg and 200 mg prolonged-release tablets), iron oxide yellow (E 172) (only in 150 mg and 200 mg prolonged-release tablets) in the tablet coating. See section 2 "Tramadol Krka contains lactose".

What Tramadol Krka looks like and contents of the pack

Tramadol Krka, 100 mg, prolonged-release tablets
White, round, biconvex tablets with a coating, with the inscription "T1" on one side of the tablet. Tablet diameter: approximately 10 mm.
Tramadol Krka, 150 mg, prolonged-release tablets
Light orange-pink, round, biconvex tablets with a coating, with the inscription "T2" on one side of the tablet. Tablet diameter: approximately 10 mm.
Tramadol Krka, 200 mg, prolonged-release tablets
Pink, round, biconvex tablets with a coating, with the inscription "T3" on one side of the tablet. Tablet diameter: approximately 10 mm
Tramadol Krka is available in cartons containing:

• 30, 50 prolonged-release tablets in child-resistant 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, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: +48 22 573 75 00

Date of last revision of the leaflet: 12.07.2024