50 mg hard capsules
tramadol hydrochloride
What Tramadol Krka is and what it is used for
Tramadol – the active substance in Tramadol Krka – is an analgesic that belongs to the class of opioids that act on the central nervous system. Tramadol acts as a pain reliever by affecting specific nerve cells in the spinal cord and brain.
Tramadol Krka is used to treat moderate to severe pain in adults and children over 12 years of age.
Tramadol hydrochloride contained in Tramadol Krka may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tramadol Krka
Do not use Tramadol Krka
- If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
- In case of acute intoxication with alcohol, sleeping pills, painkillers, or other drugs that affect mood/mood and emotional life;
- If you are simultaneously using MAO inhibitors (some medicines for the treatment of depression) or have taken such medicines in the last 14 days before treatment with Tramadol Krka (see “Other medicines and Tramadol Krka”);
- If you suffer from epilepsy that is not well controlled with treatment;
- As a substitute for drug withdrawal.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol Krka:
- If you suspect that you are addicted to other painkillers (opioids er);
- If you suffer from a reduced level of consciousness (if you feel blacked out);
- If you are in a state of shock (cold sweating can be a sign of this);
- If you have increased pressure in your head (after a skull or brain injury);
- If you have breathing difficulties;
- If you are prone to epileptic seizures or convulsions as the risk of seizures may increase;
- If you suffer from liver or kidney disease;
- If you suffer from depression and take antidepressants because some of them can interact with tramadol (see “Other medicines and Tramadol Krka”).
Serotonergic syndrome
There is a small risk that you may get a so-called serotonin syndrome, which can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Seek immediate medical attention if you experience any of the symptoms of this serious syndrome (see section 4, “Possible side effects”).
Sleep-related breathing disorders
Tramadol Krka can cause sleep-related breathing disorders such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low oxygen content in the blood). The symptoms can be breathing pauses during sleep, awakenings during the night due to shortness of breath, difficulty maintaining sleep, or severe drowsiness during the day. Contact a doctor if you or someone else notices these symptoms. The doctor may consider lowering your dose.
Epileptic seizures have occurred in patients taking the recommended dose of tramadol. The risk may increase if the dose of tramadol exceeds the recommended upper daily dose (400 mg).
Please note that Tramadol Krka can cause physical and psychological dependence. When Tramadol Krka is taken for a longer period, the effect may decrease and higher doses may become necessary ( tolerance development ). Patients with a tendency to drug abuse or with drug dependence should only be treated with Tramadol Krka for short periods and under strict medical supervision.
Inform your doctor if one or more of these problems occur during treatment with Tramadol Krka or if they have affected you in the past.
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This can be a sign of adrenal cortex failure (low levels of cortisol ). Contact a doctor if you experience these symptoms. The doctor will decide if you need to take hormone replacement.
Tramadol is converted into the liver by an enzyme. Some people have a variation of this enzyme and it can affect different people in different ways. Some people may not get enough pain relief, while others are at greater risk of serious side effects. If you experience any of the following side effects, stop taking this medicine and see a doctor immediately: slow or shallow breathing, confusion, sleepiness, small pupils, nausea or vomiting, constipation, and poor appetite.
Children and young people
Use in children with breathing problems
Tramadol is not recommended for children with respiratory problems as the symptoms of tramadol poisoning may be worse in these children.
Other medicines and Tramadol Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tramadol Krka should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Tramadol Krka can be reduced and the duration of action can be shortened, if you simultaneously take other medicines that contain:
- Carbamazepine (for epilepsy );
- Ondansetron (for nausea).
Your doctor will tell you if you should take Tramadol Krka and in what dose.
Concomitant use of Tramadol Krka and sedative drugs or drugs for sleep disorders such as benzodiazepines or similar drugs increases the risk of drowsiness, breathing difficulties ( respiratory depression ), and coma, and can be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
If your doctor prescribes Tramadol Krka at the same time as sedative drugs, the dose and duration of treatment should be limited by the doctor.
Tell the doctor if you are taking any sedative medication and follow the doctor’s dosage recommendations carefully. It may be helpful to inform friends or relatives to be aware of the signs and symptoms described above. Contact a doctor if you experience any of these symptoms.
The risk of side effects increases:
- If you take sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while taking Tramadol Krka. You may then feel drowsy and faint. In such a case, talk to your doctor.
- If you are taking medicines that can cause convulsions (seizures), such as some antidepressants and antipsychotic medicines. The risk of having a seizure may increase if you take Tramadol Krka at the same time. Your doctor will tell you if Tramadol Krka is right for you
- If you are taking certain antidepressants, then Tramadol Krka may interact with these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”)
- If you are taking anticoagulants of the coumarin type (blood-thinning drugs) such as warfarin together with Tramadol Krka. The effect of these medicines on the clotting ability of the blood can be affected and bleeding can occur.
Tramadol Krka with food, drink, and alcohol
Do not drink alcohol during treatment with this medicine because alcohol can increase the effect of Tramadol Krka. The effect of Tramadol Krka is not affected by food.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
There is very little information regarding the safety of tramadol during pregnancy. Tramadol Krka should therefore not be used during pregnancy.
Long-term treatment during pregnancy can lead to habituation in the unborn child, which can result in the child experiencing withdrawal symptoms after birth.
Breast-feeding
Tramadol is excreted in breast milk. You should therefore not take Tramadol Krka more than once during breastfeeding. Alternatively, if you take Tramadol Krka more than once, you should stop breastfeeding.
Fertility
Experience based on humans does not indicate that tramadol affects female or male fertility.
Driving ability and use of machinery
Tramadol Krka can cause drowsiness, dizziness, and blurred vision and can therefore impair your ability to react. Do not drive a car or other vehicle, and do not use electric tools or machines if you feel that your ability to react is affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tramadol Krka contains excipients
This medicine contains less than 1 mmol (23 mg) sodium per capsule, i.e. is next to “sodium-free”.
How to use Tramadol Krka
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Does one should be adjusted to the severity of your pain and your sensitivity to pain. Usually, you should take the lowest dose that provides pain relief. Do not take more than 8 hard capsules of Tramadol Krka (equivalent to 400 mg tramadol hydrochloride) per day without a doctor’s prescription.
If the doctor has not prescribed anything else, the recommended dose is:
Adults and adolescents from 12 years of age: The usual dose is 1 or 2 capsules every 4-6 hours.
The recommended dose for moderate pain is 1 hard capsule of Tramadol Krka (equivalent to 50 mg tramadol hydrochloride). If pain relief is not achieved within 30 to 60 minutes, a second capsule may be taken.
A higher need for pain relief can be expected in severe pain. In this case, 2 hard capsules can be taken as a single dose of Tramadol Krka (equivalent to 100 mg tramadol hydrochloride).
Children
Tramadol Krka capsules are not suitable for children under 12 years of age.
Elderly
For older people (over 75 years), it may take longer for tramadol to disappear from the body. If this concerns you, your doctor may advise you to extend the time between doses.
Patients with severe liver or kidney disease ( insufficiency )/dialysis
Patients with severe hepatic and/or renal insufficiency should not take Tramadol Krka. If you have mild or moderate insufficiency, your doctor may recommend an extended dosing interval.
How and when should you take Tramadol Krka?
For oral use.
The capsules should be swallowed whole, not split or chewed, together with sufficient liquid.
You can take Tramadol Krka both on an empty stomach and in connection with a meal.
How long should you take Tramadol Krka?
You should not take Tramadol Krka for longer than necessary. If you need to be treated for a longer period, your doctor will carefully check at regular, short intervals (interrupting the treatment if necessary) whether you should continue to take Tramadol Krka and at what dose.
If you feel that the effect of Tramadol Krka is too strong or too weak, contact your doctor or pharmacist.
If you have used too much Tramadol Krka
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
After very high doses, pupil dilation, vomiting, drop in blood pressure, palpitations, collapse, loss of consciousness, coma (deep unconsciousness), epileptic seizures, difficulty breathing, and respiratory arrest may occur. In these cases, a doctor must be called immediately!
If you forget to use Tramadol Krka
If you forget to take the Tramadol Krka capsules, the pain is likely to return. Do not take a double dose to make up for a missed dose, simply continue taking the capsules as before.
If you stop using Tramadol Krka
If you interrupt or stop treatment with Tramadol Krka too soon, the pain is likely to return.
Contact your doctor if you wish to discontinue treatment due to unwanted effects.
You should not suddenly stop taking this medicine unless your doctor tells you to. If you want to stop taking your medicine, you should first discuss it with your doctor, especially if you have been taking it for a long time. The doctor will tell you when and how to stop, which can be done by gradually lowering the dose to reduce the risk of developing unnecessary side effects (withdrawal symptoms).
Generally, no side effects occur when treatment with Tramadol Krka is terminated. In rare cases, however, patients who have been treated with Tramadol Krka for a long time may feel unwell if they suddenly stop treatment. They may feel worried, anxiety, nervousness, or become shaky. They may be hyperactive, suffer from sleeping difficulties, or have stomach and intestinal disorders. Very rarely, panic attacks, hallucinations, and unusual sensations such as itching, tingling, numbness, and ringing in the ears ( tinnitus ) can occur. Unusual central nervous system symptoms have been observed in very rare cases, such as mental confusion, delusion, change in the perception of one’s personality (depersonalization), change in the perception of reality (derealization), and persecution mania ( paranoia ). If you experience any of these side effects after you have finished your treatment with Tramadol Krka, you should contact your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should see a doctor immediately if you develop symptoms of an allergic reaction such as the swollen face, tongue, and/or throat and/or difficulty swallowing or if you develop hives along with difficulty breathing.
Very common (may affect more than 1 in 10 users)
- Dizziness
- Nausea
Common (may affect up to 1 in 10 users)
- Headache, drowsiness
- Fatigue
- Constipation, dry mouth, vomiting
- Sweating (hyperhidrosis)
Uncommon (may affect up to 1 in 100 users)
- Effects on the heart and blood circulation (fast strong heartbeats, fast pulse, feeling faint or collapse). These side effects occur preferentially in patients who quickly get up or sit up or who are under physical exertion.
- Nausea, stomach discomfort (feeling of pressure in the stomach, bloating), diarrhea
- Skin reactions (e.g. itching, rash)
Rare (may affect up to 1 in 1,000 users)
- Allergic reactions (difficulty breathing, wheezing, swelling of the skin) and shock (sudden circulatory collapse) have occurred in very rare cases
- Slow pulse
- Increased blood pressure
- Abnormal sensations (eg itching, tingling, numbness), tremors, muscle twitching, uncoordinated movements, transient loss of consciousness (syncope), and speech difficulties.
- Epileptic seizures have occurred mainly with high doses of tramadol or when tramadol was taken at the same time as other drugs that can induce seizures.
- Appetite changes
- Hallucinations, confusion, sleep disturbances, anxiety, and nightmares
- Psychological problems can occur during treatment with Tramadol Krka. Their intensity and nature vary individually (depending on the patient’s personality and treatment time). The complaints can appear in the form of mood swings (mostly elevated mood, occasionally irritated mood), change in activity (usually inhibited temporarily increased), and reduced perception (changes in mind and recognition, which can lead to altered decision-making behaviors).
- Drug dependence may occur. When treatment is stopped suddenly, withdrawal symptoms may occur (see “If you stop taking Tramadol Krka”).
- Blurred vision, pupil dilation ( mydriasis ), pupil narrowing ( miosis )
- Slow breathing ( respiratory depression ), shortness of breath ( dyspnoea )
- Worsening of asthma has been reported, however, it is not clear if this is caused by tramadol. If the recommended dose is significantly exceeded, or if any drug that lowers brain function is taken at the same time, the breathing rate may decrease ( respiratory depression ).
- Muscle weakness
- Bladder emptying problems (difficulty or painful passing water), decreased urine output ( dysuria )
Very rare (may affect up to 1 in 10,000 users)
- Elevated liver values
Has been reported (occurring in an unknown number of users)
- Lowering blood sugar level
- Hiccup
- Serotonergic syndrome, may manifest as altered mental status (eg, restlessness, hallucinations, coma ) and other symptoms such as fever, increased heart rate, unstable blood pressure, involuntary twitching, muscle stiffness, lack of coordination of movements, and/or gastrointestinal symptoms (eg nausea, vomiting, diarrhea) (see section 2 “What you need to know before you take Tramadol Krka”).
How to store Tramadol Krka
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tramadol hydrochloride. One hard capsule contains 50 mg tramadol hydrochloride.
- Other ingredients (excipients) are microcrystalline cellulose, sodium starch glycolate (type A), talc, and magnesium stearate (E 470b) in the capsule core and titanium dioxide (E 171), indigo carmine (E 132) and gelatin in the capsule shell.
Appearance and package sizes of the medicine
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 no. 4. The length of the filled capsules is 14-15 mm.
Tramadol Krka is available in boxes containing 10, 20, 30, 50, 60, 90, and 100 hard capsules in blisters.
Not all pack sizes may be marketed.
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia