50 mg capsules, hard
tramadol hydrochloride
What Tramadol Actavis is and what it is used for
Tramadol hydrochloride belongs to a group of medicines called centrally acting analgesics and is used to treat moderate to severe pain.
The tramadol contained in Tramadol Actavis may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Tramadol Actavis
Do not take Tramadol Actavis if you:
- are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- are pregnant, planning to become pregnant, or breastfeeding
- have recently used alcohol, sleeping pills, other strong painkillers, or psychopharmaceuticals (agents that affect mood/mood and emotional life)
- have been treated with MAO inhibitors (some medicines to treat depression) in the last 2 weeks
- have serious liver, kidney, or lung disease (breathing difficulties)
- suffer from epilepsy (convulsions) that are not well controlled with treatment
- treated with substitutes during drug withdrawal.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol Actavis if you:
- are or have been addicted to alcohol or other substances
- suffer from epilepsy or have a head injury or increased pressure in the skull (can cause pain in the eyes, vision changes, or headaches behind the eyes)
- have liver, kidney, or lung disease (breathing difficulties) which is not serious
- suffering from shock after a severe injury or blood loss
- is sensitive to opiates
- if you suffer from depression and are taking antidepressants because some of them can interact with tramadol (see “Other medicines and Tramadol Actavis”).
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.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol Actavis: 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.
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 Actavis can cause sleep-related breathing disorders such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low oxygen levels 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.
Other important warnings:
- using painkillers for headaches too often and for too long can make them worse.
Other medicines and Tramadol Actavis
Concomitant use of Tramadol Actavis 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 the doctor prescribes Tramadol Actavis 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.
The risk of side effects increases,
- 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 Actavis at the same time. Your doctor will tell you if Tramadol Actavis is right for you.
- if you are taking certain antidepressants. Tramadol Actavis may affect these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially:
- MAO inhibitors (eg moclobemide), or if you have taken these in the last 2 weeks
- opioids, including strong pain relievers such as morphine, pethidine, buprenorphine, nalbuphine, and pentazocine.
- medicines that inhibit your reactions and breathing.
- carbamazepine (for epilepsy or nerve pain).
- sleeping pills.
- cimetidine (medicine for stomach ulcers ).
- ketoconazole or erythromycin (anti-infection medicines ).
- ondansetron (medicine to prevent nausea or vomiting).
- warfarin (blood thinner).
- medicines for depression (including fluoxetine, paroxetine, amitriptyline, or lofepramine.
- medication for anxiety or mental illness
Children and young people
Use in children and adolescents with breathing problems
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.
Tramadol Actavis with food, drink, and alcohol
You are advised NOT to drink alcohol while taking this medicine.
The effect of Tramadol Actavis is not affected by food.
Pregnancy, breastfeeding, and fertility
Do not take Tramadol Actavis if you are pregnant. 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 insufficient information on the safety of tramadol use during pregnancy. Therefore, Tramadol Actavis should not be used during pregnancy. Long-term treatment during pregnancy can lead to the newborn child developing withdrawal symptoms.
Tramadol is excreted in breast milk. You should therefore not take Tramadol Actavis more than once during breastfeeding. Alternatively, if you take Tramadol Actavis more than once, you should stop breastfeeding.
Experience based on humans does not indicate that tramadol affects female or male fertility.
Driving ability and use of machinery
Tramadol Actavis may cause drowsiness or, in rare cases, blurred vision. This may be worsened if you drink alcohol or take other medicines together with Tramadol Actavis, such as strong painkillers. Make sure you are not affected before driving or using machinery.
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.
How to use Tramadol Actavis
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Swallow the capsules whole with a glass of water at the same time each day.
Dosage:
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.
- Adults and children from 12 years of age: Acute pain (e.g. after surgery): the recommended dose is 1-2 capsules 3-4 times daily, as long as the doctor prescribes this.Chronic pain(e.g. associated with cancer): the recommended dose is 1-2 capsules at first, then 1-2 capsules every 4-6 hours depending on the severity of your pain. Do not take more than 8 capsules (400 mg) per day unless prescribed by a doctor.
- Elderly: For elderly patients (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.
- For patients with impaired liver or kidney function: the recommended dose is 1-2 capsules every 12 hours. Patients with severe liver and/or kidney failure should not take Tramadol Actavis. If you have mild or moderate liver and/or kidney failure, your doctor may recommend you extend the time between doses.
- Use for children and adolescents: use is not recommended for children under 12 years of age.
How long should you take Tramadol Actavis?
You should not take Tramadol Actavis 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 the capsules and in what dose.
If you feel that the effect of the capsules is too strong or too weak, contact your doctor or pharmacist.
If you have taken too much Tramadol Actavis
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 will not usually cause any adverse effects.
You must take the next dose as directed.
Symptoms of overdose include pupil dilation, vomiting, drop in blood pressure, palpitations, collapse, unconsciousness, convulsions, and difficulty breathing.
If you forget to take Tramadol Actavis
Do not take a double dose to make up for a missed dose. If you forget to take a dose, take it as soon as you remember and then take the next dose at the usual time.
If you stop taking Tramadol Actavis
If you stop or stop treatment with Tramadol Actavis too soon, the pain is likely to come back. Contact your doctor if you wish to discontinue the 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).
As a rule, no side effects occur when the treatment with Tramadol Actavis ends. However, it has happened in rare cases that people who have used Tramadol Actavis for some time felt unwell if they suddenly stopped taking the medicine. They may experience restlessness, anxiety, nervousness, and shakiness. They may become hyperactive, have difficulty falling asleep, and experience gastrointestinal distress. A few people may suffer from panic attacks, hallucinations, abnormal experiences such as itching, tingling and numbness, and ringing in the ears ( tinnitus ). Several unusual central nervous system symptoms such as confusion, delusions, altered personality perception (depersonalization), altered perception of reality (derealization), and persecutory mania (paranoia ) have occurred in very rare cases. Talk to your doctor if you experience any of these symptoms after stopping treatment with Tramadol Actavis.
If you have further questions about this medicine, contact 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 get symptoms of an allergic reaction such as the swollen face, tongue, and/ or throat and/ or difficulty swallowing or if you get hives along with breathing difficulties.
The most common side effects during treatment with Tramadol Actavis are nausea and dizziness, which occur in more than 1 in 10 users.
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 can especially occur in patients in an upright position or during physical exertion.
- retching, 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 users):
- allergic reactions (eg difficulty breathing, wheezing, severe swelling of the skin) and shock (sudden circulatory collapse) have occurred in rare cases
- slow pulse
- increased blood pressure
- abnormal sensations (e.g. 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 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 may occur during treatment with Tramadol Actavis. Their intensity and nature vary individually (depending on the patient’s personality and treatment time). The problems can appear in the form of mood swings (mostly elevated mood, occasionally irritated mood), changes in activity (usually inhibited, temporarily increased) and reduced perception, and changes in the ability to think and feel (impaired attention and ability to make decisions, which can lead to misjudgments).
- drug dependence may occur. If treatment is stopped suddenly, withdrawal symptoms may occur (see “If you stop taking Tramadol Actavis”).
- blurred vision, pupil dilation ( mydriasis ), pupil reduction ( 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 ( 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
- hiccup
- serotonergic syndrome, which can manifest as an altered mental state (e.g. anxiety, 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 symptoms from the gastrointestinal tract (e.g. eg nausea, vomiting, diarrhea) (see section 2 “What you need to know before taking Tramadol Actavis”).
How to store Tramadol Actavis
Keep this medicine out of the sight and reach of children.
Store at a maximum of 30 ºC.
Use before the expiry date stated on the label/carton/can after “EXP/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
- Other ingredients are pregelatinized starch, microcrystalline cellulose (E460), and magnesium stearate.
- The capsule shell contains gelatin, iron oxide (E172), titanium dioxide (E171), and indigo carmine (E132). The printing ink contains shellac, black iron oxide (E172), and propylene glycol.
Appearance and package sizes of the medicine
Tramadol Actavis capsules are yellow and green, opaque, hard gelatin capsules.
Package sizes:
Blisters: 7, 10, 20, 28, 30, 50, 100 and 112 capsules
Jar with child-resistant snap lid: 7, 10, 20, 28, 30, 50, 100 and 112 capsules
P Jar with child-resistant lid: 200 capsules
Marketing authorization holder
Actavis Group PTC EHF.
Reykjavikurvegi 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str, Dupnitsa, 2600 Bulgaria