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Tramadol (Ultram) is prescribed for:
– treatment of the pain syndrome of average severity caused by the inflammatory, vascular or traumatic diseases.
– For pain relief during light surgeries and also painful clinic and laboratory diagnostics.
Way of use and dosage
– Tramadol (Ultram) is available in 50 mg tablets and also tablets of prolonged action of 100, 150, 200, 250 mg
– The schedule of the treatment and dosage regimen is indicated for each patient individually according to the general analyses and also the characteristics of the pain syndrome.
– For pain syndrome of middle severity patients are prescribed 50 mg every 6 hours.
– The tablets of the prolonged action containing 100 mg or 200 mg of the active component should be used once per 12 hours.
– The drug is allowed persons older than 14 years old.
– The maximally allowed daily dose of Tramadol (Ultram) is 400 mg.
– In exceptional cases the oncological patients are allowed using higher daily doses but only under the supervision of the doctor.
– The use of the tablets after meals will help to reduce the stomach upset and unpleasant side reactions of digestion organs.
– It is strictly forbidden to take Tramadol (Ultram) longer than it is indicated by your attending doctor. In case of the prolonged use of the drug the addiction may occur.
– It is contraindicated to use of the drug during pregnancy and in the period of the breast feeding because the active medical components may have bad influence on the development of the fetus/child.
– Children younger than 14 years old are forbidden to use this analgesic because of the high risk of the development of the physical addiction in the child age.
– It is not recommended to take the drug during epilepsy, central nervous system acute disorders, alcohol or narcotic poisoning, during central nervous system oppression, and increase of the intracranial pressure.
– The simultaneous use of Tramadol (Ultram) with other psychoactive medical products may cause the appearance of severe side effects.
If you take any medicines, it is necessary to find out about their medical interaction before the use Tramadol.
Tramadol (Ultram) should be used with special caution because the non-observance of the dosage regimen and prolonged use of the high doses of analgetic may cause the following side effects:
– deferred response
– stimulation of the central nervous system (nervousness, anxiety, tremor, spasms, hallucinations)
– sleep disorder
– stomach upset (diarrhea, vomiting, stomachache)
– sharp attacks of hypotension
If the side effects cause anxiety, it is necessary to see a doctor.
Information provided in this article is meant for the personal familiarization only and does not impel for the action. You have to realize all responsibility while taking strong medical products and use them by doctor’s recommendations only. The designers of this website are not responsible for the provided information and consequences which may happen while taking strong medical products
Tramadol hydrochloride 50mg capsules
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the leaflet.
1 What Tramadol capsules are and what they are used for 2 What you need to know before you take Tramadol capsules 3 How to take Tramadol capsules 4 Possible side effects 5 How to store Tramadol capsules 6 Contents of the pack and other information
Tramadol hydrochloride is one of a group of medicines called centrally acting analgesics and are used for the relief of moderate or severe pain.
Do not take Tramadol capsules if you:
- are allergic to tramadol hydrochloride, or any of the ingredients of this medicine (listed in section 6).
- are pregnant, planning to become pregnant or breast-feeding.
- have recently taken alcohol, sleeping tablets, other strong pain killers or medicines to treat mental illness.
- have taken a monoamine oxidase inhibitor (MAOI) antidepressant within the last two weeks.
- have severe liver, kidney or lung (breathing) problems.
- suffer from epilepsy (fits) not controlled by treatment from your doctor.
- are undergoing treatment to withdraw from use of narcotics.
Talk to your doctor or pharmacist before taking Tramadol capsules if you:
- have been or are presently addicted to alcohol or any other drug.
- have epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes)
- have liver, kidney or lung (breathing) problems which are not severe.
- are in shock following a severe injury or blood loss.
- are sensitive to opiates.
- taking a painkiller for headaches too often or for too long can make them worse.
The risk of side effects increases,
- if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Tramadol capsules at the same time. Your doctor will tell you whether Tramadol capsules is suitable for you.
- if you are taking certain antidepressants. Tramadol capsules may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 °C.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Especially:
- Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide), or have taken these within the last 2 weeks.
- any opioid medicines which include strong pain killers such as morphine, pethidine, buprenorphine, nalbuphine and pentazocine.
- medicines which slow your reactions and breathing down. carbamazepine (for epilepsy or nerve pain).
- sleeping tablets.
- cimetidine (for gastric ulcers).
- ketoconazole or erythromycin (for infections).
- ondansetron (to prevent feeling or being sick).
- warfarin (for thinning the blood).
- medicines to treat depression (including fluoxetine, paroxetine, amitriptyline or lofepramine).
- medicines to treat anxiety or mental illness.
Tramadol capsules with food, drink or alcohol You are advised NOT to drink alcohol with this medicine. The effects of Tramadol capsules are not affected by food.
Do not take Tramadol capsules if you are pregnant, think you may be pregnant or are breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.
Tramadol capsules may make you feel drowsy, dizzy or in rare cases blur your vision. This may be made worse if you drink alcohol or take other medicines such as strong painkillers with tramadol. Make sure you are not affected before you drive or operate machinery. The medicine can affect your ability to drive as it may make you sleepy or dizzy.
- Do not drive while taking this medicine until you know how it affects you.
- It is an offence to drive if this medicine affects your ability to drive.
- However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Swallow these capsules whole with a glass of water at the same times each day.
The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity. In general the lowest pain-relieving dose should be taken.
- Adults and children aged 12 years and over Acute pain (such as after an operation): The recommended dose is one to two capsules three to four times a day. To be taken for as long as prescribed by your doctor. Chronic pain (such as that associated with cancer): The recommended dose is one or two capsules at first, then one to two capsules every 4 to 6 hours according to the severity of your pain. Take no more than eight capsules (400mg) in any 24 hour period unless told to by your doctor.
- Older people above 75 years: the excretion of tramadol may be delayed. If this applies to you, your doctor may recommend prolonging the dosage interval.
- Patients with liver or kidney impairment: The recommended dose is one to two capsules every 12 hours. Patients with severe liver and/or kidney insufficiency should not take Tramadol capsules. If in your case the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
- Use in children and adolescents: Not recommended for use in children aged under 12 years.
You should not take Tramadol Capsules for longer than necessary. If you need to be treated for a longer period, your doctor will check at regular short intervals (if necessary with breaks in treatment) whether you should continue to take Tramadol Capsules and at what dose. If you have the impression that the effect of Tramadol Capsules is too strong or too weak, talk to your doctor or pharmacist.
If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include narrowed pupils, being sick, heart problems, sleepiness, coma, fits and breathing difficulties.
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.
Do not stop treatment early because you may experience withdrawal effects. If you stop taking the capsules you may develop agitation, anxiety, nervousness, panic attacks, difficulty sleeping, tremor, over-activity, pins and needles or ringing in the ears. Talk to your doctor before you stop taking the capsules and follow their advice.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor at once if you experience:
- an allergic reaction: itching, skin rashes, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing, narrowing of airways, worsening of existing asthma, shock or collapse.
- slowed breathing - usually when high doses of Tramadol capsules are being taken or with other medicines that slow breathing.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
- Very common (more than 1 in 10 users): dizziness, feeling sick.
- Common (less than 1 in 10 users): increased sweating, tiredness, drowsiness, sleepiness, headache, stomach ache, dry mouth, being sick, constipation.
- Uncommon (less than 1 in 100 users): itchy rash, itching, fast heart beat, palpitations and sudden heart problems, dizziness on standing up due to low blood pressure, diarrhoea, retching and bloating.
- Rare (less than 1 in 1000 users): extreme sense of wellbeing (euphoria), false sense of uneasiness (dysphoria), confusion, hallucinations (sensing things that are not real), altered mental state (delirium), changes in ability to think or sense clearly, sleeping problems (including nightmares), anxiety, ‘pins and needles’, tremor, muscle spasms, fits, fainting, blurred vision, slow heart beat, high blood pressure, changes in appetite, muscle weakness, difficulty urinating or inability to urinate.
- Very rare (less than 1 in 10,000 users): flushing.
- Not known (cannot be estimated from the available data): changes in liver enzyme levels (detected through blood tests), speech disorders, decrease in blood sugar level.
You may become dependent on the capsules and find it difficult to stop taking them or feel you need to take them more often than necessary. If you stop taking the capsules suddenly you may suffer from withdrawal reactions (see section 3 for withdrawal symptoms).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children. Do not store above 30°C. Do not use Tramadol capsules after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month. Do not throw away this medicine of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
- The active substance is tramadol hydrochloride.
- The other ingredients are pregelatinised starch, microcrystalline cellulose (E460), magnesium stearate
- The capsule shell contains gelatin, iron oxide (E172), titanium dioxide (E171), indigo carmine (E132). The printing ink contains shellac glaze, iron oxide black (E172) and propylene glycol.
Tramadol capsules are yellow and green, opaque, hard gelatin capsules. Pack sizes are 30 and 100.