100 mg, 150 mg, and 200 mg prolonged-release tablets are
tramadol hydrochloride
What Tramadol Retard Actavis is and what it is used for
Tramadol Retard Actavis is an analgesic drug. Tramadol Retard Actavis relieves pain by inhibiting certain substances in the central nervous system (in the brain and spinal cord)
Tramadol Retard Actavis can be used by adults and adolescents over 12 years of age. It is used in the treatment of moderate to severe pain.
Tramadol Retard Actavis is not suitable for children under 12 years of age.
The tramadol contained in Tramadol Retard 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 Retard Actavis
Do not take Tramadol Retard Actavis
- if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you have recently drunk too much alcohol or taken too many sleeping pills, painkillers, opiates, or other medicines that act via the brain ( psychopharmaceuticals ).
- if you use certain medicines against depression (so-called MAO inhibitors) or if you have used such medicine in the last 14 days.
- if you suffer from epilepsy that is not well controlled by medication.
- as a treatment for withdrawal symptoms in drug addiction.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol Retard Actavis
- if you have recently had a head injury or increased pressure in the head (e.g. after an accident).
- if you suffer from kidney or liver disease (see section 3. How to take Tramadol Retard Actavis).
- if you have breathing difficulties.
- if you tend to have epilepsy or convulsions, as the risk of seizures may increase. Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the highest recommended daily dose (400 mg).
- if you suffer from depression and take antidepressants because some of them can interact with tramadol (see “Other medicines and Tramadol Retard Actavis”).
- if you are addicted to opiates.
- if you are in a state of shock (cold sweating can be a sign of this).
- if you use other drugs or substances that act via the brain, including alcohol.
After long-term treatment (>3 months) headaches may occur or worsen.
When tramadol has been used to treat tension-type or cluster headaches or migraine (for which tramadol is not approved), cases of headache due to drug overuse have been reported.
Please note that Tramadol Retard Actavis can cause physical and psychological dependence. When Tramadol Retard Actavis 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 Actavis 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.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadol RetardActavis: 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.
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 Retard Actavis 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.
Children and young people
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 Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Tramadol Retard Actavis at the same time as or within 14 days of taking medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson’s disease ).
Concomitant use of Tramadol Retard Actavis and sedative drugs or drugs for sleep disorders such as benzodiazepines or similar drugs increases the risk of drowsiness, breathing difficulties ( respiratory depression ), 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 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 instructions carefully
and dosage recommendations. 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 pain-relieving effect of Tramadol Retard Actavis can be weakened and/or shortened if you also take medicines that contain:
- carbamazepine (used in the treatment of epilepsy )
- buprenorphine, nalbuphine or pentazocine (pain relievers)
- ondansetron (used for nausea)
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 Retard Actavis at the same time. Your doctor will tell you if Tramadol Retard Actavis is right for you.
- if you are taking certain antidepressants. Tramadol Retard Actavis may affect these medicines and you may develop serotonin syndrome (see section 4, “Possible side effects”).
- if you take Tramadol Retard Actavis together with sedatives such as sedatives, sleeping pills, antidepressants, and strong pain relievers (morphine, codeine, pethidine). You may feel very drowsy or faint.
- if you take Tramadol Retard Actavis together with blood-thinning medicines such as warfarin. The dose of one of these medicines may need to be reduced, otherwise, there may be an increased risk of serious bleeding.
- anticonvulsant drugs taken with tramadol may lower the seizure threshold and the risk of seizures may increase in these patients.
Tramadol Retard Actavis with alcohol
Do not drink alcohol during treatment with Tramadol Retard Actavis.
Pregnancy and breastfeeding
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.
Pregnancy
Tramadol passes from the placenta to the fetus. There is not enough information to know if it produces harmful effects on humans. Long-term treatment during pregnancy can lead to the newborn child developing withdrawal symptoms. Therefore, tramadol should not be used during pregnancy. Consult with your doctor about what is most suitable for you.
Breast-feeding
Tramadol is excreted in breast milk. You should therefore not take Tramadol Retard Actavis more than once during breastfeeding. Alternatively, if you take Tramadol Retard Actavis more than once, you should stop breastfeeding.
Driving ability and use of machinery
Tramadol Retard Actavis can cause drowsiness, dizziness, and blurred vision. This may affect your ability to drive and operate machinery. These effects can be enhanced by alcohol or by medications that act on or work via the brain. Do not drive or perform other activities that require alertness until you know how tramadol affects you. See section 4. “Possible side effects” for a full list of possible side effects that may impair your attention and coordination.
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 Retard Actavis
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dose
Does one should be adjusted to the severity of your pain and your pain sensitivity. Usually, you should take the lowest dose that provides pain relief.
The usual dose is:
Adults and adolescents over 12 years of age:
The starting dose is:
Tramadol Retard Actavis 100 mg: one tablet (100 mg tramadol hydrochloride) twice daily. If it does not provide sufficient pain relief, the dose can be increased to:
Tramadol Retard Actavis 150 mg: one tablet (150 mg tramadol hydrochloride) twice daily or
Tramadol Retard Actavis 200 mg: one tablet (200 mg tramadol hydrochloride) twice daily.
If the dose you are prescribed cannot be achieved with this tablet’s strength, the medicine is available in other strengths.
Elderly patients
For elderly patients (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.
Severe liver or kidney failure/dialysis patients
Patients with severe liver and/or kidney failure should not take Tramadol Retard Actavis. If you have mild or moderate liver and/or kidney failure, your doctor may recommend you extend the time between doses.
How to take Tramadol Retard Actavis
Tramadol Retard Actavis is a tablet with a special core designed to release the active substance slowly over a longer period. Because of this, it may take a little longer before you notice the effect.
Swallow the tablet whole (without chewing or crushing it) with a glass of water. Preferably take the tablet in the morning and the evening. The tablets can be taken on an empty stomach or during a meal.
Duration of treatment with Tramadol Retard Actavis
Your doctor will tell you how long to use Tramadol Retard Actavis. It depends on the cause of the pain. Do not use Tramadol Retard Actavis for longer than necessary.
Talk to your doctor or pharmacist if you feel that the effect of Tramadol Retard Actavis is too strong or weak.
If you have taken too much Tramadol Retard 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.
Possible symptoms that may occur are small pupils, vomiting, drop in blood pressure, palpitations, collapse, impaired consciousness including coma (deep unconsciousness), epileptic seizures, and breathing difficulties.
If you forget to take Tramadol Retard Actavis
If you forget to take tablets, the pain is likely to return. Do not take a double dose to make up for missed doses, just continue taking the medicine as before.
If you stop taking Tramadol Retard Actavis
If you stop or stop treatment with Tramadol Retard Actavis 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).
In general, no side effects occur when the treatment with Tramadol Retard Actavis ends. However, in rare cases, people who have abruptly stopped taking Tramadol Retard Actavis have experienced discomfort. 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, unusual sensations such as itching, tingling and numbness, and ringing in the ears ( tinnitus ). If you experience any of these discomforts after stopping Tramadol Retard Actavis consult your doctor.
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.
The following side effects may occur:
Very common (may affect more than 1 in 10 users):
- Nausea and dizziness.
Common (may affect up to 1 in 10 users):
- Headache, vomiting, constipation, dry mouth, sweating.
Uncommon (may affect up to 1 in 100 users):
- Palpitations, irregular heartbeats, low blood pressure (especially when standing up), cardiovascular collapse, retching, feeling of pressure in the stomach, feeling of fullness, itching, rashes and special rashes with severe itching (hives or hives ), diarrhea.
Rare (may affect up to 1 in 1,000 users):
- Blurred vision, slower heart rate than normal, increased blood pressure, changes in appetite, itching or tingling sensation for no reason, tremors, slower than normal breathing, convulsions, hallucinations, confusion, sleep disturbances, and nightmares. Allergic reactions (e.g. shortness of breath), tightness in the chest due to spasm in the muscles of the respiratory tract ( bronchospasm ), gasping, sudden accumulation of fluid in the skin and mucous membranes (e.g. in the throat and tongue), difficulty breathing and/or itching and hypersensitivity. The following have also been reported: mood changes, changes in activity level, disturbances in perception or ability to make decisions, muscle weakness, difficulty throwing water, involuntary muscle contractions, impaired coordination, and fainting.
Has been reported (occurring in an unknown number of users):
- Dilated pupils, low blood sugar, hiccups, serotonin syndrome, which may manifest as altered mental status (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 (eg nausea, vomiting, diarrhea) (see section 2 “What you need to know before you take Tramadol Retard Actavis”).
Adverse effects that may occur upon discontinuation of treatment are identical to those upon withdrawal from opiates and may include: restlessness, anxiety, fear, nervousness, insomnia, motor restlessness (hyperkinesia), shaking ( tremor ), and gastrointestinal disturbances.
Allergic reactions (eg difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure ) have occurred very rarely (in fewer than 1 in 10,000 users). Contact a doctor immediately if you experience symptoms such as the swollen face, tongue, and/or throat with/or without difficulty swallowing or hives with difficulty breathing.
How to store Tramadol Retard Actavis
Store out of sight and reach of children.
Use before the expiry date stated on the blister card and/or the can after “Exp:” or “EXP:”. The expiration date is the last day of the specified month.
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 deal with 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 tablet of Tramadol Retard Actavis 100 mg contains 100 mg of tramadol hydrochloride.
One tablet of Tramadol Retard Actavis 150 mg contains 150 mg of tramadol hydrochloride.
One tablet of Tramadol Retard Actavis 200 mg contains 200 mg of tramadol hydrochloride.
– Other ingredients are calcium hydrogen phosphate (E341), hydroxypropyl cellulose (E463), colloidal silicon dioxide (E551), and magnesium stearate (E470b).
Appearance and package sizes of the medicine
Tramadol Retard Actavis 100 mg tablets are off-white, round, biconvex tablets.
Tramadol Retard Actavis 150 mg tablets are off-white, capsule-shaped tablets.
Tramadol Retard Actavis 200 mg tablets are off-white, capsule-shaped tablets.
Tramadol Retard Actavis 100 mg: packs of 10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 tablets in blister cards or in plastic cans.
Tramadol Retard Actavis 150 mg: packs of 10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 tablets in blister cards or in plastic cans.
Tramadol Retard Actavis 200 mg: packs of 10, 20, 30, 50, 60, 90, 100, 120, 180 or 500 tablets in blister cards or in plastic cans.
Not all pack sizes may be marketed.
Marketing authorization holder
Actavis Group PTC EHF.
Reykjavik travel guide 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Farmaceutisch Analytisch Laboratorium Duvien BV
Dijkgraaf 30
NL-6921 RL Pigeon
Holland
Medochemie Ltd, Facility A – Z
Ayios Athanasios Industrial St
Limassol
Cyprus