Tramadol krka

Package leaflet: Information for the patient

Tramadol Krka, 100 mg, prolonged-release tablets
Tramadol Krka, 150 mg, prolonged-release tablets
Tramadol Krka, 200 mg, prolonged-release tablets
tramadoli hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tramadol Krka is and what it is used for
2. What you need to know 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 Tramadol Krka is and what it is used for

Tramadol – the active substance in Tramadol Krka – is an analgesic belonging to the group of
opioids acting on the central nervous system. It exerts its analgesic effect by acting on specific nerve cell receptors in the spinal cord and brain.
Tramadol Krka is indicated for the treatment of moderate to severe pain.

2. Important information before using Tramadol Krka

When not to use Tramadol Krka

• if the patient is allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute alcohol intoxication, sedatives, analgesics, or psychotropic medicines (medicines affecting mood and emotions);
• when being treated with medicines from the group of MAO inhibitors (some antidepressants), and within 14 days before starting treatment with Tramadol Krka (see “Tramadol Krka and other medicines”);
• in patients with epilepsy that is not controlled by treatment;
• in the treatment of opioid dependence.

Warnings and precautions
Before starting to take Tramadol Krka, discuss this with your doctor or pharmacist:

• if the patient has dependence on other analgesic substances (opioids);
• in disorders of consciousness (if the patient feels fainting coming on);
• in shock (cold sweats may be a symptom);
• in increased intracranial pressure (which may occur after head injury or brain diseases);
• in respiratory disorders;
• if the patient has a tendency to seizures or convulsions, as the risk of convulsions may increase;
• in patients with liver or kidney disease;
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see “Tramadol Krka and other medicines”).

Serotonin syndrome
There is a small risk of developing so-called serotonin syndrome when tramadol is taken together with certain antidepressants or when tramadol is taken alone. If the patient experiences any symptoms of this serious condition, they should seek immediate medical advice (see section 4 “Possible side effects”).

Sleep-related breathing disorders
Tramadol Krka may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else observes these symptoms, they should contact a doctor. The doctor may recommend reducing the dose.

Seizures have been observed in patients taking tramadol at recommended doses. The risk of seizures may be higher if the tramadol dose exceeds the recommended maximum daily dose (400 mg).

Tolerance, dependence and abuse
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to the medicine, known as tolerance). Repeated use of Tramadol Krka may also lead to dependence, misuse and abuse, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of treatment.

Dependence or abuse may cause the patient to lose control over the amount or frequency of medicine intake.

The risk of dependence or abuse varies between individuals. The risk of dependence on Tramadol Krka may be higher in people in the following situations:

• the patient or a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs (“abuse”);
• the patient is a tobacco 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 the patient notices any of the following symptoms while taking Tramadol Krka, this may indicate dependence or abuse:

• Need to take the medicine for longer than recommended by the doctor.
• Need to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those for which it was prescribed, e.g. “to calm down” or “to sleep better”.
• The patient has made repeated, unsuccessful attempts to stop or control the use of the medicine.
• After stopping the medicine, the patient feels unwell, and feels better after taking the medicine again (“withdrawal effects”).

If the patient notices any of these symptoms, they should consult their doctor to discuss the best treatment approach, including when and how to safely stop taking the medicine (see section 3, “Stopping Tramadol Krka”).

Consult your doctor if any of the above situations occur during treatment with Tramadol Krka or have occurred in the past.

Contact your doctor if, while taking Tramadol Krka, the patient experiences any of the following symptoms:
Excessive tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact your doctor, who will decide whether hormone replacement is necessary.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may lead to different effects. In some individuals, pain relief may be insufficient, while in others, severe adverse effects may be more likely.

Stop using the medicine and contact your doctor immediately if the patient experiences any of the following adverse effects: slow or shallow breathing, disorientation, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents
Do not use this medicine in children under 12 years of age.
Tramadol is not recommended in children and adolescents with respiratory disorders, as symptoms of toxicity may be more pronounced in them.

Tramadol Krka and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Tramadol Krka together with MAO inhibitors (medicines used to treat depression).

The analgesic effect of Tramadol Krka may be reduced and its duration shortened when taken together with medicines containing:

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

Concomitant use of Tramadol Krka with sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered if 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.

Inform your doctor about all sedative medicines the patient is taking and strictly follow dosing instructions. It may be helpful to inform friends or family about the risks so they are aware of the mentioned symptoms. If these symptoms occur, contact your doctor.

Your doctor will advise you on the use and dosing of Tramadol Krka.

The risk of adverse effects increases:

• when taking Tramadol Krka together with sedatives, sleep aids, other analgesics such as morphine and codeine (also as a cough suppressant), and alcohol. Drowsiness or fainting may occur. In such cases, consult your doctor.

• if the patient is taking other medicines that may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Tramadol Krka together 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 taking anticoagulant medicines derived from coumarin (to reduce blood clotting), e.g. warfarin, together with Tramadol Krka. 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-related pain (neuropathic pain).

Tramadol Krka with food and alcohol
Do not drink alcohol while taking Tramadol Krka, as the effect of the medicine may be intensified. Food does not affect the action of Tramadol Krka.

Pregnancy, breastfeeding and fertility

Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. There is limited data on the safety of tramadol use in pregnant women. Therefore, Tramadol Krka should not be used in pregnant women.

Long-term use of tramadol during pregnancy may lead to withdrawal symptoms in the newborn.

Breastfeeding
Tramadol passes into breast milk. Therefore, during breastfeeding, Tramadol Krka should not be taken more than once, or if Tramadol Krka has been taken more than once, breastfeeding should be discontinued.

Fertility
Experience with tramadol use in humans does not indicate that tramadol affects fertility in men and women.

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

Tramadol Krka contains lactose
If the patient has been diagnosed with intolerance to certain sugars, contact your doctor before using this medicine.

3. How to use Tramadol Krka

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to
expect from using Tramadol Krka, when and for how long it should be taken, when to contact the
doctor, and when the medicine should be discontinued (see also section 2).
The doctor will adjust the dose according to the intensity of pain and the individual patient's sensitivity to
pain. The lowest effective dose that adequately relieves pain will be used. More than 400 mg of
tramadol hydrochloride per day should not be used except when otherwise directed by a doctor.
Recommended dose:
Adults and adolescents over 12 years of age:
One tablet of Tramadol Krka 100 mg twice daily (corresponding to 200 mg of tramadol hydrochloride
per day), preferably in the morning and evening.
If necessary, the dose may be increased to 150 mg or 200 mg twice daily (corresponding to 300 mg –
400 mg of tramadol hydrochloride per day).
Children
Tramadol Krka is not suitable for use in children under 12 years of age.
Elderly patients
In elderly patients (over 75 years of age), elimination of tramadol may be delayed.
In these patients, the doctor may recommend extending the interval between doses.
Patients with severe hepatic or renal impairment, dialysis patients
Tramadol Krka should not be taken in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, the doctor may recommend extending the dosing intervals.
Method of administration
Tramadol Krka extended-release tablets are intended for oral use.
Extended-release tablets must always be taken whole, with sufficient fluid, and should not be split or
chewed. Tablets may be taken on an empty stomach or with food.
How long to take Tramadol Krka
Do not take Tramadol Krka longer than absolutely necessary. If long-term treatment is required, the
doctor will regularly monitor the patient's condition (temporarily interrupting treatment if necessary)
to determine whether and at what dose treatment with Tramadol Krka should continue.
If the patient feels that the effect of Tramadol Krka is too strong or too weak, consult a doctor or
pharmacist.
Taking more than the recommended dose of Tramadol Krka
If a patient accidentally takes an extra dose of the medicine, this usually does not cause any adverse
effects. The next dose should be taken as directed by the doctor.
If a patient (or anyone in their surroundings) takes too many Tramadol Krka tablets at once, they should
immediately go to hospital or contact a doctor. After taking doses higher than recommended, the
following may occur: pinpoint pupils, vomiting, drop in blood pressure, rapid heartbeat, collapse, loss of
consciousness, seizures, breathing difficulties, or shallow breathing.
Missing a dose of Tramadol Krka
If a dose is missed at the scheduled time, pain symptoms may return.
Do not take a double dose to make up for a missed dose. Resume the usual dosing schedule.
Stopping Tramadol Krka treatment
If treatment with Tramadol Krka is stopped abruptly or discontinued prematurely, pain symptoms are
likely to return.
Do not stop taking this medicine suddenly unless otherwise directed by a doctor. If a patient wishes to
discontinue treatment, this should be discussed with the doctor, especially if the medicine has been
taken for a prolonged period. The doctor will advise when and how to stop taking the medicine; this may
involve gradually reducing the dose to reduce the likelihood of withdrawal symptoms.
If a patient wishes to discontinue treatment due to adverse effects, they should inform the doctor.
Generally, no serious post-treatment symptoms are observed after discontinuation of Tramadol Krka.
However, in rare cases, after abrupt discontinuation of Tramadol Krka used for some time, the patient
may feel unwell. Symptoms may include agitation, anxiety, nervousness, tremors, excessive
restlessness, difficulty sleeping, and gastrointestinal or intestinal disturbances. Very rarely, panic
attacks, hallucinations, abnormal sensations such as itching, tingling, numbness, and tinnitus may
occur. Other rare central nervous system disturbances, such as confusion, delusions, altered
perception of self (depersonalization), altered perception of reality (derealization), and persecutory
delusions (paranoia) have occurred very rarely.
If any of the above symptoms occur after discontinuation of Tramadol Krka, consult a doctor
immediately.
If there are any further questions regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should consult a doctor immediately if you experience symptoms of allergic reactions such as: swelling of the face, tongue and (or) throat, and (or) difficulty swallowing, or hives combined with breathing difficulties.

Very common (may occur in more than 1 in 10 patients):

• dizziness
• nausea

Common (may occur in up to 1 in 10 patients):

• headache, drowsiness
• feeling tired
• constipation, dry mouth, vomiting
• excessive sweating

Uncommon (may occur in up to 1 in 100 patients):

• heart and circulatory disorders (palpitations, rapid heartbeat, feeling of impending fainting or collapse). Such side effects may occur especially when changing body position to standing, and after physical exertion.
• vomiting reflex, gastrointestinal disturbances (e.g. feeling of pressure in the stomach, bloating), diarrhoea
• skin reactions (e.g. itching, rash)

Rare (may occur in up to 1 in 1,000 patients):

• in rare cases, allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred
• slow heartbeat
• increased blood pressure
• abnormal sensations (e.g. itching, tingling, numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders
• seizures occurred mainly after administration of high doses of tramadol or when used concomitantly with other medicines that may provoke seizures
• changes in appetite
• hallucinations, confusion, sleep disturbances, delirium, restlessness, nightmares
• psychiatric disorders may occur after administration of Tramadol Krka. Their severity and type may vary (depending on the patient's personality and duration of treatment). These may include mood disturbances (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), and reduced sensory and cognitive perception (changes in sensations and recognition which may lead to incorrect assessment of situations)
• dependence may occur. If treatment is stopped abruptly, withdrawal symptoms may occur (see section “Stopping treatment with Tramadol Krka”).
• blurred vision, excessive pupil dilation (mydriasis), pupil constriction (miosis)
• slow breathing, "shortness of breath" (dyspnoea)
• worsening of asthma symptoms has been reported during tramadol treatment, although a causal relationship between these events has not been established. In case of ingestion of doses significantly higher than recommended, or concomitant use of other medicines that suppress brain function, respiratory depression may occur.
• muscle weakness
• difficulty or pain during urination, reduced urine volume (dysuria)

Very rare (may occur in up to 1 in 10,000 patients):

• increased liver enzyme activity

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

• low blood sugar levels
• hiccups

Serotonin syndrome, which may present with changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms 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, diarrhoea) (see section 2 “Important information before taking Tramadol Krka”).

Reporting of side effects
If any side effects occur, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tramadol Krka

Keep this medicine out of the sight and reach of children.
This medicine should be stored in a closed and secure place, inaccessible to others.
It may cause serious harm or be fatal to people for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Tramadol Krka contains

• The active substance 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, colloidal anhydrous silica, magnesium stearate in the tablet core; and in the tablet coating: 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). 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, film-coated tablets with the imprint “T1” on one side of the tablet. Tablet diameter: approximately 10 mm.
Tramadol Krka, 150 mg, prolonged-release tablets
Light orange-pink, round, biconvex, film-coated tablets with the imprint “T2” on one side of the tablet. Tablet diameter: approximately 10 mm.
Tramadol Krka, 200 mg, prolonged-release tablets
Pinkish, round, biconvex, film-coated tablets with the imprint “T3” on one side of the tablet. Tablet diameter: approximately 10 mm.
Tramadol Krka is available in cardboard packs containing:

• 30, 50 prolonged-release tablets in blisters with child-resistant protection

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
For further information, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
telephone: + 48 22 573 75 00