50 mg and 100 mg hard capsules
tramadol hydrochloride
What Tramadol Hexal is and what it is used for
Tramadol hydrochloride – the active substance in Tramadol Hexal – 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 Hexal is used to treat moderate to severe pain.
Tramadol hydrochloride contained in Tramadol Hexal 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 Hexal
Do not use Tramadol Hexal
- if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- in case of acute intoxication with alcohol, sleeping pills, painkillers, or psychopharmaceuticals (medicines that affect mood/mood and emotional life).
- if you simultaneously use MAO inhibitors (certain medicines for the treatment of depression or Parkinson’s disease ) or have taken such medicines in the last 14 days before treatment with Tramadol Hexal (see “Other medicines and Tramadol Hexal”).
- 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 using Tramadol Hexal:
- if you suspect that you are dependent on other painkillers ( opioids ).
- if you suffer from a reduced level of consciousness (if you feel blacked out).
- 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.
- if you have impaired liver or kidney function.
- if you have repeated pauses in breathing when you sleep ( sleep apnea ), this condition may worsen.
- if you suffer from depression and take antidepressants because some of them can interact with tramadol (see “Other medicines and Tramadol Hexal”).
Epileptic seizures have occurred in patients taking the recommended dose of tramadol hydrochloride. The risk may increase if a dose of tramadol hydrochloride exceeds the recommended upper daily dose (400 mg).
Please note that Tramadol Hexal can cause physical and psychological dependence. When Tramadol Hexal 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 Hexal for short periods and under strict medical supervision.
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.
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 Hexal 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.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol Hexal: Extreme tiredness, 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.
Inform your doctor if one or more of these problems occur during treatment with Tramadol Hexal or if they have affected you in the past.
Children and young people
Tramadol Hexal capsules 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 Hexal
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Tramadol Hexal should not be taken together with MAO inhibitors (certain medicines for the treatment of depression or Parkinson’s disease ).
The pain-relieving effect of Tramadol Hexal 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 may then need to adjust your dose.
The risk of side effects increases,
- if you take medicines that have a depressant effect on the nervous system at the same time as Tramadol Hexal. You may then feel drowsy and faint. In such a case, talk to your doctor. These drugs include tranquilizers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol.
- 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 Hexal at the same time. Your doctor will tell you if Tramadol Hexal is right for you
- if you are taking certain antidepressants, then Tramadol Hexal may interact with these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
- if you take anticoagulants of the coumarin type (blood-thinning drugs) eg warfarin together with Tramadol Hexal. The effect of these medicines on the clotting ability of the blood can be affected and bleeding can occur.
Concomitant use of Tramadol Hexal and sedative drugs or drugs for sleep disorders such as benzodiazepines or related 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 no other treatment options are possible.
If your doctor nevertheless prescribes Tramadol Hexal together with sedative drugs, the dose and duration of treatment should be limited by your doctor.
Tell your doctor if you are taking sedatives and follow your doctor’s dosage recommendations
carefully. It can help to inform friends and relatives to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience such symptoms.
Tramadol Hexal with food, drink, and alcohol
Do not drink alcohol during treatment with this medicine because alcohol can increase the effect of Tramadol Hexal.
The capsules can be taken with or without food along with the sufficient liquid.
Pregnancy, breastfeeding, and fertility
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 on the safety of using Tramadol Hexal 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. Therefore, if you are pregnant, your doctor will only prescribe Tramadol Hexal if necessary.
Tramadol is excreted in breast milk. You should therefore not take Tramadol Hexal more than once during breastfeeding. Alternatively, if you take Tramadol Hexal more than once, you should stop breastfeeding.
Experience based on humans does not indicate that Tramadol Hexal affects female or male fertility.
Driving ability and use of machinery
Tramadol Hexal 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 attention. 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. Therefore, always read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tramadol Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost “sodium-free”.
How to use Tramadol Hexal
Always use this medicine as directed by your doctor or pharmacist. 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.
The recommended dose is:
Adults and children over 12 years of age
Capsules 50 mg: 1-2 capsules 3-4 times daily.
Capsules 100 mg: 1 capsule 3-4 times daily.
You should not take more than 8 capsules of 50 mg or 4 capsules of 100 mg (equivalent to 400 mg tramadol hydrochloride) per day without a doctor’s prescription.
Older
For older people (over 75 years), it may take longer for tramadol hydrochloride to disappear from the body. If this concerns you, your doctor may advise you to extend the time between doses.
Impaired kidney and/or liver function
In patients with impaired liver and/or kidney function, the excretion of tramadol hydrochloride may be slow. If this applies to you, the doctor may prescribe an extended dosing interval. Tramadol Hexal is not recommended for patients with severely impaired liver and/or kidney function.
How long should you take Tramadol Hexal?
You should not take Tramadol Hexal for longer than necessary. If you need to be treated for a longer period, your doctor will periodically check whether you should continue to take Tramadol Hexal and in what dose.
Your doctor may judge that a break must be made for a period before resuming treatment.
If you feel that the effect of Tramadol Hexal is too strong or too weak, contact your doctor or pharmacist.
How and when should you take Tramadol Hexal?
For oral use.
The capsules should be swallowed whole with sufficient liquid. The capsules must not be split or chewed. You can take Tramadol Hexal both on an empty stomach and with meals.
The capsules are packed in a blister intended to be difficult for children to open. To get the capsules out undamaged, push the nail or a sharp object down through the aluminum foil along the long side of the capsule before pushing the capsule out.
If you have used too much Tramadol Hexal
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, doctors must be called immediately.
If you forget to use Tramadol Hexal
If you forget to take the 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 Hexal
If you interrupt or stop treatment with Tramadol Hexal too soon, the pain is likely to 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. 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).
Patients who have been treated with Tramadol Hexal for a long time and who suddenly stop their treatment may suffer withdrawal symptoms and experience that they do not feel well. They may feel worried, anxiety, nervousness, or become shaky. They may be hyperactive, suffer from sleep difficulties, or
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 symptoms from the central nervous system 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 Hexal, 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 such as a swollen face, tongue, and/or throat and/or difficulty swallowing or if you develop hives along with breathing difficulties.
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)
- slow pulse
- increased blood pressure
- abnormal sensations (e.g. itching, tingling, numbness), tremors, epileptic seizures, muscle twitching, uncoordinated movements, transient loss of consciousness (syncope), and speech difficulties.
- epileptic seizures have occurred mainly with high doses of tramadol hydrochloride or when tramadol hydrochloride was taken at the same time as other drugs that can induce seizures.
- appetite changes
- hallucinations, confusion, sleep disturbances, delirium, restlessness, and nightmares
- psychological problems may occur during treatment with Tramadol Hexal. 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
- blurred vision, pupil reduction ( miosis ), pupil dilation ( mydriasis )
- slow breathing, shortness of breath ( dyspnoea )
- worsening of asthma has been reported, however, it is not clear whether this was caused by tramadol hydrochloride. 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 of blood sugar level
- repeated pauses in breathing during sleep ( sleep apnea )
- hiccup
- serotonin syndrome, which 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 use Tramadol Hexal”).
How to store Tramadol Hexal
Store at a maximum of 30°C.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
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 capsule contains 50 mg and 100 mg of tramadol hydrochloride respectively.
- Other ingredients are Potato starch, microcrystalline cellulose, sodium starch glycolate, povidone, macrogol 6000, calcium hydrogen phosphate dihydrate, sodium stearyl fumarate, gelatin, titanium dioxide (E171), shellac, indigo carmine (E132), propylene glycol, ammonia.
Appearance and package sizes of the medicine
Appearance
Tramadol Hexal 50 mg capsule, hard: white, marked GZ 50 and GEA
Tramadol Hexal 100 mg capsule, hard: white, marked HB 100 and GEA
Package sizes
PVC/A1 Blister: 50 mg: 20, 50×1 and 100 capsules
100 mg: 10, 30, 50×1 and 100 capsules
Polyethylene bottle: 50 mg and 100 mg: 250 capsules (for dose dispensing only)
Not all pack sizes may be marketed.
Hexal A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark