Tramadol Krka 100 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: 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 the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet 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 opioid group that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

This medicine is used for the treatment of moderate to severe pain.

2. What you need to know before taking Tramadol Krka

Do not take Tramadol Krka

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6);
• in cases of acute intoxication caused by alcohol, hypnotic drugs, analgesics, or psychotropic medicines (medicines acting on mood and emotions);
• if you are currently taking or have taken monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression) within 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 by 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 disturbances in consciousness (if you feel you might faint);
• if you are in shock (a sign of this condition may be cold sweating);
• if you have increased intracranial pressure (for example, after head trauma or brain diseases);
• if you have difficulty breathing;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you have liver or kidney disease;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol Krka").

Serotonin syndrome

There is a low risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Contact a doctor immediately if you develop any symptoms associated with this serious condition (see section 4, "Possible side effects").

Sleep-related breathing disorders

Tramadol Krka may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). These symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum recommended daily dose (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may result in reduced effectiveness of the drug (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of loss of control over the amount of medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to tramadol may be higher if:

• You or a family member have abused alcohol or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using tramadol, this could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.
• You need to take 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 unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking the medicine, and feel better once you take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so 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 you have ever experienced them.

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. These may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Children and adolescents

This medicine must not be given to children under 12 years of age.

The use of tramadol is not recommended in children and adolescents with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tramadol Krka

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Concomitant treatment with Tramadol Krka and monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) must be avoided.

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

• Carbamazepine (for epileptic seizures)
• Ondansetron (a medicine to prevent nausea)

The concomitant use of Tramadol Krka and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are available.

However, if your doctor prescribes Tramadol Krka together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and closely follow your doctor's dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Your doctor will advise you whether to take Tramadol Krka and at what dose.

The risk of adverse effects increases:

• if you are taking tranquilizers, hypnotic drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tramadol Krka. This may cause increased drowsiness or a feeling of fainting. If this occurs, consult your doctor.
• if you are taking medicines that may lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol Krka simultaneously with these medicines. Your doctor will advise whether Tramadol Krka is suitable for you.
• if you are taking medicines for the treatment of depression. Tramadol Krka may interact with these medicines and you may experience serotonin syndrome (see section 4, "Possible side effects").
• if you are taking coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, together with Tramadol Krka. The effect of these medicines on blood clotting may be affected, potentially leading to bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain).

Taking Tramadol Krka with food and alcohol

Do not consume alcohol during treatment with Tramadol Krka, as its effects may be intensified. Food does not affect the action of Tramadol Krka.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very limited information on the safety of tramadol during human pregnancy. Therefore, you should not take Tramadol Krka if you are pregnant.

Chronic use during pregnancy may lead to withdrawal syndrome in newborns.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol Krka more than once during breastfeeding. If you take Tramadol Krka more than once, you must stop breastfeeding.

Fertility

Based on human experience, there is no indication that tramadol affects fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while taking Tramadol Krka. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taking it together with other medicines.

Tramadol Krka contains lactose

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

3. How to take Tramadol Krka

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from using tramadol, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

The dose should be adjusted according to the intensity of pain and your individual sensitivity. The lowest effective dose that provides pain relief should normally be used. Do not take more than 400 mg of tramadol hydrochloride per day unless otherwise instructed by your doctor.

Recommended dose:

Adults and adolescents over 12 years of age

One tablet twice daily (equivalent to 200 mg of tramadol hydrochloride per day), preferably in the morning.

If necessary, the dose may be increased to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).

Children

This medicine is not suitable for children under 12 years of age.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slower.

If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment / patients on dialysis

Treatment with tramadol is not recommended in patients with severe liver or kidney disease.

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

Method of administration

This medicine is administered orally.

The tablets must always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and in the evening. You may take the tablet on an empty stomach or with food.

How long should you take Tramadol Krka?

This medicine should not be used for longer than strictly necessary.

If long-term treatment is required, your doctor will regularly monitor you at short intervals (and if necessary with treatment interruptions) to assess whether treatment with tramadol should continue and at what dose.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Tramadol Krka than you should

If you have accidentally taken an additional dose of tramadol, you will generally not experience any adverse effects. Take the next dose as prescribed.

If you (or someone else) ingest a large number of tablets at the same time, go to hospital or contact a doctor immediately. After taking very high doses, symptoms may include pupil constriction, nausea (vomiting), sudden drop in blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and difficulty breathing or shallow breathing which may lead to respiratory arrest.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to bring the package leaflet to the healthcare professional.

If you forget to take Tramadol Krka

If you forget to take your tablets, your pain may return. Do not take a double dose to make up for missed doses; simply continue your treatment as prescribed by your doctor.

If you stop taking Tramadol Krka

If you interrupt or stop treatment with tramadol too early, your pain is likely to return.

If you wish to discontinue treatment due to undesirable effects, consult your doctor.

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking this medicine, especially if you have been taking it for a long time, speak to your doctor first. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).

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

Generally, no undesirable effects occur when stopping treatment with tramadol. However, on rare occasions, some people who have taken this medicine for some time may feel unwell if they stop suddenly. They may feel agitated, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, other uncommon central nervous system (CNS) symptoms have been reported, such as confusion, delirium, distorted perception of self (depersonalization), altered perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping tramadol, please consult your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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, rash, and difficulty breathing.

Very common: may affect more than 1 in 10 people

• Dizziness
• Nausea

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats, rapid heartbeat, feeling dizzy or fainting). These adverse effects may occur especially in patients who are standing up or performing physical exertion.
• Nausea (feeling the need to vomit), stomach 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

• Allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heartbeat
• Increased blood pressure
• Abnormal sensations (such as itching, tingling, and numbness), tremor, epileptic seizures, muscle twitching, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders
• Epileptic seizures may occur mainly after taking high doses of tramadol or when tramadol is taken simultaneously with other medicines that may provoke epileptic seizures
• Changes in appetite
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares
• Psychological problems may occur after treatment with Tramadol Krka 100 mg. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced 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 (mydriasis)
• Slow breathing, shortness of breath (dyspnea)
• Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease
• Muscle weakness
• Difficulty or pain when urinating, less urine than normal (dysuria)

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

• Increase in liver enzymes

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

• Decreased blood sugar levels
• Hiccups
• Serotonin syndrome, which may present as changes in mental status (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 adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Krka

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals 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 month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol Krka

• The active substance is tramadol hydrochloride.

Each tablet contains 100 mg of tramadol hydrochloride.

Each tablet contains 150 mg of tramadol hydrochloride.

Each tablet contains 200 mg of tramadol hydrochloride.

• The other components are:

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

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

Nature of the product and contents of the container

Tramadol Krka 100 mg prolonged-release tablets:

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

Tramadol Krka 150 mg prolonged-release tablets:

Each tablet is pale orange-pink, round, biconvex, film-coated, with the imprint T2 on one side and plain on the other. Tablet diameter: approximately 10 mm.

Tramadol Krka 200 mg prolonged-release tablets:

Each tablet is light pink, round, biconvex, film-coated, with the imprint T3 on one side and plain on the other. Tablet diameter: approximately 10 mm.

These medicines are available in the following pack sizes:

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

Unit-dose child-resistant perforated blister packs: 10, 20, 28, 30, 50, 60, 90, 100 prolonged-release tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Manufacturer responsible for batch release

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

For further information on this medicine, please contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L.

Calle de Anabel Segura 10

28108 Alcobendas, Madrid

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Member State	Name
Estonia	Olteron
Belgium	Tramadol Krka 100 mg tabletten met verlengde afgifte Tramadol Krka 150 mg tabletten met verlengde afgifte Tramadol Krka 200 mg tabletten met verlengde afgifte
Bulgaria	Трамадол Крка 100 mg таблети с продължено освобождаване Трамадол Крка 150 mg таблети с продължено освобождаване Трамадол Крка 200 mg таблети с продължено освобождаване
Czech Republic	Tramadol Krka
Denmark	Tramadol Krka
Spain	Tramadol Krka 100 mg comprimidos de liberación prolongada Tramadol Krka 150 mg comprimidos de liberación prolongada Tramadol Krka 200 mg comprimidos de liberación prolongada
Finland	Tramadol Krka 100 mg, Depottabletti Tramadol Krka 150 mg, Depottabletti Tramadol Krka 200 mg, Depottabletti
France	Tramadol Krka LP 100 mg, comprimé à libération prolongée Tramadol Krka LP 150 mg, comprimé à libération prolongée Tramadol Krka LP 200 mg, comprimé à libération prolongée
Croatia	Tramadol Krka 100 mg tablete s produljenim oslobadanjem Tramadol Krka 150 mg tablete s produljenim oslobadanjem
Hungary	Tramadol Krka 100 mg retard tabletta Tramadol Krka 150 mg retard tabletta Tramadol Krka 200 mg retard tabletta
Iceland	Tramadol Krka 100 mg Tramadol Krka 150 mg Tramadol Krka 200 mg
Poland	Tramadol Krka
Portugal	Tramadol TAD 100 mg Tramadol TAD 150 mg Tramadol TAD 200 mg
Sweden	Tramadol Retard Krka 100 mg, Depottabletter Tramadol Retard Krka 150 mg, Depottabletter Tramadol Retard Krka 200 mg, Depottabletter
Slovakia	Tramadol Retard Krka 100 mg, Depottabletter Tramadol Retard Krka 150 mg, Depottabletter Tramadol Retard Krka 200 mg, Depottabletter
United Kingdom	Tramadol hydrochloride Krka 100 mg prolonged-release tablets Tramadol hydrochloride Krka 150 mg prolonged-release tablets Tramadol hydrochloride Krka 200 mg prolonged-release tablets

Date of the most recent review of this leaflet: July 2024

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