Tramadol krka

Package leaflet: Information for the patient

Tramadol Krka, 50 mg, hard capsules
Please read all of this leaflet carefully before taking the medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, 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 adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Tramadol Krka is and what it is 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 package 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 class of opioids acting on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.
Tramadol Krka capsules are used to treat moderate to severe pain in adults and children aged 12 years and older.

2. 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, painkillers or other medicines affecting mood and emotions;
• if the patient is currently taking or has taken MAO inhibitors (certain medicines used to treat depression) within the last 14 days before starting treatment with Tramadol Krka (see "Tramadol Krka and other medicines");
• if the patient has epilepsy and seizures are not adequately controlled by effective therapy;
• as substitution therapy after opioid withdrawal.

Warnings and precautions
Before starting to take Tramadol Krka, inform your doctor or pharmacist:

• if the patient suspects dependence on other painkillers (opioids);
• if the patient experiences disturbances in consciousness (a feeling similar to fainting);
• if the patient is in shock (one of the symptoms may be cold sweats);
• if the patient has increased intracranial pressure (which may be caused by head injury or brain diseases);
• if the patient has breathing difficulties;
• if the patient suffers from epilepsy or has had convulsive seizures, as the risk of seizure may increase;
• if the patient has liver or kidney disease;
• if the patient has depression and is taking antidepressant medicines, because some of them may interact with tramadol (see "Tramadol Krka and other medicines").

Serotonin syndrome
There is a small risk of developing serotonin syndrome when tramadol is taken together with certain antidepressants or even 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 sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.

Seizures have been reported in patients taking tramadol at the recommended dose. This risk may increase when tramadol doses exceed 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 prolonged 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 among individuals. Higher risk of dependence on Tramadol Krka may apply to individuals in the following situations:

• the patient or someone in their family has ever misused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction");
• 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 multiple unsuccessful attempts to stop or control medicine use.
• 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 stop taking the medicine safely (see section 3, "Stopping Tramadol Krka").

If any of these problems occur during treatment with Tramadol Krka or have occurred in the past, inform the doctor.

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 a 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 are more likely.

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

Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more pronounced in them.

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

Tramadol Krka must not be used together with MAO inhibitors (certain medicines used to treat depression).

The pain-relieving effect of Tramadol Krka may be reduced and its duration shortened when taken simultaneously with medicines containing:

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

The doctor will determine whether the patient can take Tramadol Krka and at what dose.

Concomitant use of Tramadol Krka and 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 should only be considered if no other treatment options are available.

If the doctor prescribes Tramadol Krka together with sedative medicines, the dose and duration of concomitant use should be minimized.

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

The risk of adverse effects increases:

• if the patient takes Tramadol Krka together with sleeping pills, other painkillers such as morphine and codeine (including as a cough medicine), and alcohol. Drowsiness and feeling faint may occur. If this happens, inform the doctor.
• if the patient takes medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase when taking Tramadol Krka. The doctor will decide whether Tramadol Krka is suitable.
• if the patient takes certain antidepressants. Tramadol Krka may interact with other medicines and cause serotonin syndrome (see section 4, "Possible side effects").
• if the patient takes anticoagulant medicines of the coumarin group (medicines preventing blood clotting), e.g., warfarin, together with Tramadol Krka. The effect of these medicines on blood clotting may change, leading to bleeding.
• if the patient takes gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain).

Tramadol Krka with food and alcohol
Do not drink alcohol during treatment with Tramadol Krka, as it may intensify its effects. 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 baby, she should consult her doctor or pharmacist before using this medicine.
There is limited information on the safety of tramadol use in pregnant women.
Therefore, Tramadol Krka should not be used if the patient is pregnant.
Prolonged use of Tramadol Krka during pregnancy may lead to tramadol dependence in the unborn child and, consequently, withdrawal symptoms in newborns.

Breastfeeding
Tramadol is excreted in 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
Observations from tramadol use in humans suggest that tramadol does not affect fertility in men or women.

Driving and operating machinery
Tramadol Krka may cause drowsiness, dizziness and visual disturbances (blurred vision), thus impairing reaction time. If such symptoms occur, the patient should not drive or operate machinery.

Tramadol Krka contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Tramadol Krka

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using Tramadol Krka, when and for how long the medicine should be taken, when to contact the doctor, and when the medicine should be discontinued (see also section 2).
The dosage should be adjusted according to the intensity of pain and the individual patient's sensitivity to pain. Usually, the lowest effective dose providing pain relief should be used. Do not take more than 8 capsules of Tramadol Krka per day (equivalent to 400 mg of tramadol hydrochloride), unless otherwise directed by your doctor.
Unless otherwise directed by the physician, the usual dose is:
Adults and adolescents aged 12 years and older
The usual dose is 1 or 2 capsules every 4 to 6 hours.
The recommended dose for moderate pain is 1 hard capsule of Tramadol Krka (corresponding to 50 mg of tramadol hydrochloride). If pain relief does not occur within 30 to 60 minutes, a second capsule may be taken.
In cases of severe pain, higher demand for pain relief may be expected; therefore, 2 hard capsules of Tramadol Krka may be taken as a single dose (corresponding to 100 mg of tramadol hydrochloride).
Children
Tramadol Krka must not be used in children under 12 years of age.
Elderly patients
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. In such cases, the doctor may recommend extending the interval between doses.
Patients with severe hepatic or renal impairment (failure) and/or patients undergoing dialysis
Tramadol Krka must not be used in patients with severe hepatic and/or renal failure.
If the patient has mild or moderate hepatic and/or renal impairment, the doctor may recommend extending the intervals between doses.
How and when to take Tramadol Krka?
Tramadol Krka is intended for oral use.
Tramadol Krka capsules must always be swallowed whole, not chewed or crushed, and taken with a large amount of water. The capsule may be taken with or without food.
How long to take Tramadol Krka?
Do not take Tramadol Krka longer than necessary. If long-term treatment is required, your doctor will regularly monitor, at short intervals (and if necessary, after treatment breaks), whether continued use of Tramadol Krka is still indicated and what dose should be taken.
If you feel that the effect of Tramadol Krka is too strong or too weak, consult your doctor or pharmacist.
Taking more than the recommended dose of Tramadol Krka
Accidentally taking an extra dose of Tramadol Krka usually does not cause any adverse effects. Take the next dose as directed.
If you take more capsules of Tramadol Krka than recommended, contact your doctor immediately or go to the nearest hospital emergency department. Symptoms of overdose may include: pinpoint pupils, vomiting, low blood pressure, rapid heartbeat, collapse, loss of consciousness, even coma (a state of deep unconsciousness), seizures, and breathing difficulties or shallow breathing up to respiratory arrest. If any of these symptoms occur, contact your doctor immediately.
Missing a dose of Tramadol Krka
Stopping treatment with Tramadol Krka will likely result in recurrence of pain symptoms. Do not take a double dose to make up for a missed dose; instead, continue taking Tramadol Krka as prescribed.
Stopping treatment with Tramadol Krka
Prematurely stopping or discontinuing treatment with Tramadol Krka will likely result in recurrence of pain symptoms.
If you intend to discontinue treatment due to unpleasant symptoms, inform your doctor.
Do not abruptly stop taking this medicine without medical advice. If you wish to stop taking the medicine, discuss this with your doctor, especially if the medicine has been taken long-term.
Your doctor will advise when and how to discontinue the medicine; this may involve gradually reducing the dose to minimize the risk of adverse effects (withdrawal symptoms).
Generally, no serious post-treatment symptoms are observed after discontinuation of Tramadol Krka. However, in rare cases, after abrupt discontinuation of Tramadol Krka following prolonged use, patients may feel unwell. Symptoms may include agitation, anxiety, restlessness, or tremor. Hyperactivity, difficulty falling asleep, and gastrointestinal disturbances may also occur. In rare cases, panic attacks, hallucinations, abnormal perception such as itching, tingling, and numbness, as well as ringing in the ears (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 been reported very rarely. If any of these symptoms occur after discontinuation of Tramadol Krka, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should immediately consult a doctor if symptoms of an allergic reaction occur, such as swelling
of the face, tongue and/or throat, and/or difficulty swallowing or hives, as well as breathing difficulties.

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 circulation (palpitations, rapid heartbeat (tachycardia), dizziness (orthostatic hypotension or circulatory collapse). These adverse effects may occur particularly in patients when standing up and after physical exertion,
• feeling unwell (nausea), stomach problems (e.g. feeling of pressure in the stomach, bloating), diarrhoea,
• skin reactions (e.g. itching, rash).

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

• very rare allergic reactions (e.g. breathing difficulties (dyspnoea), wheezing, fluid retention in tissues (angioedema), and shock reactions (sudden circulatory failure),
• slow heartbeat (bradycardia),
• increased blood pressure,
• unusual skin reactions (e.g. itching, tingling, numbness), tremor, involuntary muscle contractions, uncoordinated movements, temporary loss of consciousness (fainting), speech disorders,
• seizures have occurred when high doses of tramadol were taken or when tramadol was taken simultaneously with other medicines that may provoke seizures,
• changes in appetite,
• hallucinations, confusion, sleep disturbances, anxiety and nightmares,
• psychiatric disorders may occur after treatment with Tramadol Krka. Their intensity and nature may vary (depending on the patient's personality and duration of therapy). These may manifest as mood changes (mainly hyperexcitability, sometimes irritability), changes in activity (usually inhibition, sometimes increased activity), and reduced cognitive and sensory functions (reduced awareness and decision-making ability, which may lead to incorrect judgments),
• drug dependence may occur. Symptoms of withdrawal may appear after abrupt discontinuation of treatment (see Discontinuation of Tramadol Krka),
• blurred vision, excessive dilation of arteries, constriction of arteries,
• slowed breathing (respiratory depression), dyspnoea,
• worsening of asthma symptoms has been reported, although it has not been established whether tramadol use was the cause. If recommended doses are exceeded or tramadol is taken together with other medicines that suppress brain function, breathing may slow down,
• muscle weakness,
• difficulty and painful urination, reduced urine output compared to usual (urinary disorders and difficulty in urination).

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

• increased activity of liver enzymes.

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

• low blood sugar levels,
• hiccups,
• serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, 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 adverse effects
If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Adverse effects may also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Tramadol Krka

Keep this medicine out of 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 individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Do not store above 30 °C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 carboxymethyl starch (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 coating.

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 white or almost white powder. The capsule size is 4. The length of filled capsules is 14–15 mm.
Tramadol Krka is available in packs containing 10, 20, 30, 50, 60, 90 or 100 hard capsules in blister packs.
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 about the product names in other European Economic Area countries and in the United Kingdom (Northern Ireland), please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Poland
Tel. 22 57 37 500