Patient Information Leaflet: Package Leaflet
Tramadol Krka 50 mg Hard Capsules EFG
Tramadol hydrochloride
Read this leaflet carefully before you start to take this medicine because it contains important information for you.
Tramadol –the active ingredient of Tramadol Krka- is an opioid analgesic that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.
This medication is used for the treatment of moderate to severe pain in adults and adolescents 12 years of age or older.
Warnings and precautions
Consult your doctor before starting to take Tramadol Krka:
Serotonin syndrome
There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).
Respiratory problems related to sleep
Tramadol may cause respiratory problems related to sleep such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may include pause in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.
Cases of seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended maximum daily dose (400 mg).
Tolerance, dependence, and addiction
This medicine contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol can also lead to dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these side effects may be higher with a higher dose and longer use.
Dependence or addiction can cause a feeling of lack of control over the amount of medication to be used or the frequency with which it is used.
The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to tramadol may be higher if:
If you observe any of the following symptoms while using tramadol, it could be a sign of dependence or addiction:
If you notice any of these signs, consult your doctor to determine the best course of treatment for you, when it is appropriate to discontinue the medication, and how to do it safely (see section 3, if you interrupt treatment with tramadol).
Be aware that tramadol can cause physical and psychological dependence.
When tramadol is used for a prolonged period, its effect may decrease, requiring the use of higher doses (development of tolerance). In patients with a tendency to abuse medications or those with medication dependence, tramadol treatment should only be carried out for short periods of time and under strict medical supervision.
Inform your doctor if any of these problems occur during treatment with tramadol or if they have occurred at any time.
Consult your doctor if you experience any of the following symptoms while taking this medication:
Extreme 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 you experience any of these symptoms, inform your doctor, who will decide if you should take a hormone supplement.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.
Children and adolescents
Use in children with respiratory problems
Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.
Other medicines and Tramadol Krka
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Tramadol treatment should be avoided with monoamine oxidase inhibitors (MAOIs), certain types of depression medications.
The effect and duration of pain relief produced by tramadol may be reduced if you take medications that contain:
− Carbamazepine (epileptic seizures).
− Ondansetron (to prevent nausea).
Your doctor will indicate if you should take tramadol and at what dose.
The concomitant use of tramadol and sedatives such as benzodiazepines or related medications increases the risk of somnolence, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tramadol along with sedatives, your doctor should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and follow your doctor's recommended dose closely. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.
The risk of adverse effects increases:
Tramadol Krka with food and alcohol
Do not consume alcohol during treatment with tramadol, as alcohol may intensify the effects of tramadol. Food does not affect the effect of tramadol.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.
There is very little information available on the safety of tramadol in pregnant women. Therefore, do not take tramadol if you are pregnant.
Long-term tramadol treatment during pregnancy may cause fetal dependence syndrome and, consequently, withdrawal syndrome in the newborn.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, do not take tramadol more than once during breastfeeding, or if you take tramadol more than once, stop breastfeeding.
Fertility
Based on human experience, it is not suggested that tramadol affects male and female fertility.
Driving and operating machines
Tramadol may cause dizziness, drowsiness, and visual disturbances (blurred vision) and affect your reaction time. If you feel that your reaction time is affected, do not drive a car or other vehicle, operate electrical tools or machines, or work without a secure grip.
Tramadol Krka contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially “sodium-free”.
Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of tramadol, when and for how long you should use it, when you should contact your doctor, and when you should discontinue use (see also section 2).
The dose should be adjusted to the intensity of the pain and your individual sensitivity.
Normally, you should take the lowest dose possible that produces pain relief. Do not take more than 8 tramadol capsules per day (equivalent to 400 mg of tramadol hydrochloride), unless your doctor has instructed you otherwise.
Unless your doctor has given you different instructions, the recommended dose is:
Adults and adolescents over 12 years old
The usual dose is 1-2 capsules every 4-6 hours.
The recommended dose for moderate pain is 1 hard capsule (corresponding to 50 mg of tramadol hydrochloride). If pain relief is not achieved in 30 to 60 minutes, a second capsule can be taken.
To relieve severe painyou can expect a greater analgesic demand, in this case, 2 hard capsules can be taken at the same time as a single dose (corresponding to 100 mg of tramadol hydrochloride).
Use in children
This medicationis not recommended for children under 12 years old.
Older patients
In elderly patients (over 75 years old), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.
Patients with severe liver or kidney failure and patients on dialysis:
If you have severe liver or kidney failure, treatment with tramadol is not recommended. If your liver or kidney failure is mild or moderate, your doctor may prolong the dosing intervals.
How and when to take Tramadol Krka?
The capsules are administered orally.
You should swallow the capsules whole without dividing or chewing them and with sufficient liquid.
You can take this medication both with an empty stomach and with meals.
For how long should you take Tramadol Krka?
This medication should not be administered for longer than strictly necessary. If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary with interruptions in treatment) to see if you should continue treatment with tramadol and at what dose.
If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.
If you take more Tramadol Krka than you should
If you have taken an additional dose of tramadol by mistake, this usually has no negative effects. You should take the next dose as prescribed.
If you (or someone else) ingest many capsules of this medication at the same time, you should go to the hospital or call a doctor immediately. Signs of overdose include very small pupils, vomiting, decreased blood pressure, rapid heart rate, circulatory collapse, unconsciousness to coma (deep unconsciousness), seizures, and respiratory difficulties or shallow breathing to respiratory arrest. If these symptoms appear, contact your doctor immediately.
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication leaflet to the healthcare professional.
If you forget to take Tramadol Krka
If you forget to take tramadol, it is likely that the pain will return. Do not take a double dose to compensate for the missed doses, simply continue taking this medication as you have been doing until now.
If you interrupt treatment with Tramadol Krka
If you interrupt or discontinue treatment with tramadol too soon, it is likely that the pain will return.
If you want to interrupt treatment due to side effects, consult your doctor.
You should not suddenly stop taking this medication unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the possibility of unnecessary side effects (withdrawal symptoms).
Generally, no adverse effects occur when treatment is interrupted with this medication. However, in rare cases, people who have been taking tramadol for some time may not feel well when treatment is stopped abruptly. They may feel agitated, anxious, nervous, or have tremors. They may be hyperactive, have difficulty sleeping, or experience gastrointestinal and intestinal transit problems. Very few people experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, tingling, and ringing in the ears (tinnitus). Very rarely, more unusual symptoms of the central nervous system have been detected, such as confusion, delirium, change in perception of one's own personality (derealization), and change in perception of reality (depersonalization) and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medication, consult your doctor or pharmacist.
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
You should consult a doctor immediately if you experience symptoms of an allergic reaction, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or hives along with difficulty breathing.
Very common(may affect more than 1 in 10 people)
Common(may affect up to 1 in 10 people)
Uncommon(may affect up to 1 in 100 people)
Rare(may affect up to 1 in 1,000 people)
Very rare(may affect up to 1 in 10,000 people)
Frequency not known(frequency that cannot be estimated from available data)
Reporting of adverse reactions:
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Store this medication in a safe and protected place, to which other people cannot access. This medication can cause serious harm or even be fatal to individuals who have not been prescribed it.
Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.
Do not store above 30°C.
Store in the original packaging to protect it from moisture.
Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
Composition of Tramadol Krka
Appearance of Tramadol Krkaand contents of the package:
Hard capsules (capsules): the capsule body is white and the cap is blue. Capsules containing a white or almost white powder. Capsule size No. 4. Capsule length 14-15 mm.
It is presented in packages containing 10, 20, 30, 50, 60, 90, and 100 hard capsules in blisters.
Only some package sizes may be marketed.
Marketing Authorization Holder
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
Responsible for manufacturing
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
KRKA Farmacéutica, S.L.
Calle de Anabel Segura 10
28108 Alcobendas, Madrid
Spain
This medication is authorized in the member states of the European Economic Area with the following names:
Member state | Name |
Croatia | Awardix 50 mg hard capsules |
Belgium | Tramadol Krka 50 mg |
Bulgaria | ???????? ????50 mg???????, ?????? |
Czech Republic | Tramadol Krka |
Denmark | Tramadol Krka |
Hungary | Tramadol Krka 50 mg hard capsule |
Ireland | Tramadol Krka 50 mg capsule, hard |
Italy | Tramadolo Krka |
Spain | Tramadol Krka 50 mg hard capsules EFG |
Poland | Tramadol Krka |
Portugal | Tramadol Krka 50 mg capsules |
Sweden | Tramadol Krka 50 mgkapslar, hårda |
Slovakia | Tramadol Krka 50 mgtvrdé kapsuly |
United Kingdom | Tramadol Krka 50 mg capsule, hard |
Last review date of thisleaflet: July 2024
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).
Tramadol krka 50 mg capsulas duras efg коштує в середньому 2.5 євро у липень, 2025 році. Ціна може змінюватися залежно від регіону, аптеки та наявності рецепта. Рекомендуємо перевіряти актуальну вартість у місцевих аптеках або через онлайн-сервіси.
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