100 mg, 150 mg, 200 mg prolonged-release tablets
What Tramadol Retard Krka is and what it is used for
Tramadol – the active substance in Tramadol Retard Krka – is a painkiller 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 Retard Krka is used to treat moderate to severe pain.
Tramadol hydrochloride contained in Tramadol Retard Krka may also be approved to treat other diseases 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 Retard Krka
Do not use Tramadol Retard 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 Retard Krka (see “Other medicines and Tramadol Retard Krka”);
- if you suffer from epilepsy that is not well controlled with treatment;
- as a substitute for drug withdrawal.
Warnings and precautions
Talk to a doctor or pharmacist before taking Tramadol Retard Krka:
- if you suspect that you are dependent on other painkillers (opioids er);
- if you suffer from a reduced level of consciousness (if you feel faint);
- if you are in a state of shock (cold sweating may 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 fits 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 Retard 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 highest recommended daily dose (400 mg).
Please note that Tramadol Retard Krka can cause physical and psychological dependence.
When Tramadol Retard 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 drug dependence should only be treated with Tramadol Retard Krka for short periods and under strict medical supervision.
Also, inform your doctor if one or more of these problems arise during treatment with Tramadol Retard Krka or if they 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
This medicine should not be given to children under 12 years of age.
Tramadol is not recommended for children and adolescents with respiratory problems because the symptoms of tramadol poisoning may be worse in these children and adolescents.
Other medicines and Tramadol Retard Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tramadol Retard Krka should not be taken together with MAO inhibitors (certain medicines for the treatment of depression).
The pain-relieving effect of Tramadol Retard 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).
Simultaneous use of Tramadol Retard Krka and sedative drugs 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 the doctor prescribes Tramadol Retard Krka at the same time as sedative drugs, the dose and duration of treatment must 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.
Your doctor will tell you if you should take Tramadol Retard Krka and in what dose.
The risk of side effects increases:
- if you take tranquilizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while taking Tramadol Retard Krka. You may then feel drowsy and faint. In such a case, talk to a 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 Retard Krka at the same time. Your doctor will tell you if Tramadol Retard Krka is right for you.
- if you take certain antidepressants, then Tramadol Retard Krka can interact with these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
- if you take coumarin-type anticoagulants (blood-thinning drugs) e.g. warfarin together with Tramadol Retard Krka. The effect of these medicines on the clotting ability of the blood can be affected and bleeding can occur.
Tramadol Retard Krka with food, drink, and alcohol
Do not drink alcohol during treatment with this medicine because alcohol can increase the effect of Tramadol Retard Krka. The effect of Tramadol Retard 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 Retard Krka should therefore not be used during pregnancy.
Long-term treatment during pregnancy may lead to the child experiencing withdrawal symptoms after birth.
Breast-feeding
Tramadol is excreted in breast milk. You should therefore not take Tramadol Retard Krka more than once during breastfeeding. Alternatively, if you take Tramadol Retard 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 Retard 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 Retard Krka contains lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to use Tramadol Retard Krka
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Your doctor will adjust the dosage 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 400 mg tramadol hydrochloride daily without a doctor’s prescription.
The recommended dose is:
Adults and adolescents from the age of 12:
- One tablet of Tramadol Retard Krka 100 mg twice daily (equivalent to 200 mg tramadol hydrochloride per day) preferably in the morning and in the evening.
If necessary, the dose can be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg tramadol hydrochloride per day).
Children
Tramadol Retard Krka is 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 liver and/or kidney insufficiency should not take Tramadol Retard Krka. If you have mild or moderate insufficiency, your doctor may recommend you extend the time between doses.
Mode of administration
Tramadol Retard Krka prolonged-release tablets should always be swallowed whole, not divided or chewed, together with a sufficient amount of liquid. Preferably in the morning and in the evening. You can take the tablets on an empty stomach or with a meal.
How long should you take Tramadol Retard Krka?
You should not take Tramadol Retard Krka 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 Retard Krka and in what dose.
If you feel that the effect of Tramadol Retard Krka is too strong or too weak, contact your doctor or pharmacist.
Use for children and adolescents
Tramadol Retard Krka is not suitable for children under 12 years of age.
If you have used too much Tramadol Retard 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.
If you have taken an extra dose by mistake, this method will generally not have any negative effects. You should take the next dose as directed.
If you (or someone else) take many Tramadol Retard Krka tablets at the same time, you should go to the hospital or contact a doctor immediately. Signs of overdose include dilated pupils, vomiting, drop in blood pressure, palpitations, collapse, unconsciousness, epileptic seizures, and difficulty breathing or shallow breathing.
If you forget to use Tramadol Retard Krka
If you forget to take the tablets, the pain is likely to return. Do not take a double dose to make up for a missed dose, but simply continue taking the tablets as before.
If you stop using Tramadol Retard Krka
If you interrupt or end the treatment with Tramadol Retard Krka too soon, the pain will likely return.
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. Your doctor will tell you when and how to stop, which can be done by gradually reducing the dose to reduce the risk of developing unnecessary side effects (withdrawal symptoms).
Contact your doctor if you wish to discontinue the treatment due to unwanted effects.
As a rule, no side effects occur when treatment with Tramadol Retard Krka ends. In rare cases, however, patients who have been treated with Tramadol Retard Krka for a long time may feel unwell if they suddenly stop the 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 few patients may experience panic attacks, hallucinations, and unusual sensations such as itching, tingling, numbness, and ringing in the ears ( tinnitus ). Additional unusual central nervous system symptoms have been observed in very rare cases, such as 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 Retard 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 a 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 (eg 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, epileptic seizures, muscle twitching, uncoordinated movements, transient loss of consciousness (syncope), and difficulty speaking.
- 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, delirium, anxiety, and nightmares
- Psychological problems can occur during treatment with Tramadol Retard 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. If treatment is stopped suddenly, withdrawal symptoms may occur (see “If you stop taking Tramadol Retard Krka”).
- blurred vision, pupil dilation ( mydriasis ), pupil narrowing ( miosis )
- slow breathing, shortness of breath ( dyspnoea )
- worsening of asthma has been reported, however, it is not clear whether this was 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.
- 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
- with elevated liver values
Has been reported: frequency cannot be estimated from the available data
- lowering of blood sugar level
- hiccup
The 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 (e.g. nausea, vomiting, diarrhea) (see section 2 “What you need to know before you take Tramadol Retard Krka”).
How to store Tramadol Retard 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.
No special storage instructions.
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. Each prolonged-release tablet contains 100 mg tramadol hydrochloride. Each prolonged-release tablet contains 150 mg of tramadol hydrochloride. Each prolonged-release tablet contains 200 mg tramadol hydrochloride.
- Other ingredients are hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate in the tablet core and hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol, triacetin, red iron oxide (E172) – (only for 150 mg and 200 mg prolonged-release tablets ), yellow iron oxide (E172) – (only for 150 mg and 200 mg prolonged-release tablets ) in the film coating. See section 2 “Tramadol Retard Krka contains lactose”.
Appearance and package sizes of the medicine
Tramadol Retard Krka 100 mg prolonged-release tablet er
White, round, biconvex, film-coated tablets debossed with T1 on one side of the tablet. Tablet diameter: approx. 10 mm.
Tramadol Retard Krka 150 mg prolonged-release tablet er
Light orange-pink, round, biconvex, film-coated tablets with imprint T2 on one side of the tablet. Tablet diameter: approx. 10 mm.
Tramadol Retard Krka 200 mg prolonged-release tablet er
Light pink, round, biconvex, film-coated tablets with imprint T3 on one side of the tablet. Tablet diameter: approx. 10 mm.
Tramadol Retard Krka is available in cartons containing:
- 10, 20, 28, 30, 50, 60, 90, 100 prolonged-release tablets in child-resistant blisters.
- 10 x 1, 20 x 1, 28 x 1, 30 x 1, 50 x 1, 60 x 1, 90 x 1, 100 x 1 prolonged-release tablets in perforated child-resistant single-dose blisters.
Not all pack sizes may be marketed.
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia