Tramal – composition, action, indications, dosage, precautions

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Tramal is an opioid analgesic, the active substance of which is tramadol. It is used to treat moderate to severe pain. Tramal is available in the form of tablets, capsules, oral drops, injection solution, and rectal suppositories. What are the indications for the use of Tramal? Are there any contraindications to its use? How to dose this preparation? Can its use cause side effects?

Tramal – general characteristics of the drug

Tramal is a preparation whose active substance is tramadol, which belongs to the opioid drug. Tramadol is primarily a pain reliever that acts on the central nervous system. This medicine works to relieve pain in specialized nerve cells in the spinal cord and brain.

Tramal is available in pharmacies in the following forms:

1. prolonged-release tablets – tablets are white, pale orange or slightly brownish in color depending on the dose of tramadol. The tablets are round and engraved with T1, T2 or T3 on one side and the manufacturer’s logo on the other side. Packages contain 10, 30 or 50 tablets in blisters of 10 pieces in a cardboard box;
2. hard capsules – yellow, shiny, oblong capsules packed in blisters and available in packs of 20;
3. oral drops – is a clear, slightly viscous, colorless to pale yellow solution of Tramal. The dose of the drug is 100 mg / ml. The oral drops are packed in amber glass bottles, 96 ml with a dosing pump. Each bottle is packed in a cardboard box;
4. rectal suppositories – white-yellowish wax suppositories are packed individually in aluminum foil and 5 in a cardboard box;
5. injection fluid – is a clear, colorless solution in glass ampoules of 1 or 2 ml packed in 5 boxes in a cardboard box.

The entity responsible for the production and distribution of Tramal is STADA Arzneimittel AG. Stada Arzneimittel AG is a pharmaceutical company based in Bad Vilbel, Germany, which specializes in the production of generic and over-the-counter medicines.

What is worth knowing about the types and effects of opioids? Read on: Opioids

Tramal – composition and action of the drug

Tramal is a pain reliever whose most important active ingredient is tramadol. Tramadol is a powerful opioid pain reliever, also called narcotic pain reliever.

Tramadol is a synthetic drug. It works by attaching to and stimulating the μ, dik opioid receptors in the body.

This compound also affects the pain transmission in the spinal cord by increasing the concentration of certain neurotransmitters, including serotonin and norepinephrine in synapses. Orally administered tramadol is about 5 times weaker than oral morphine. In contrast, parenteral tramadol is about 10 times weaker than parenteral morphine.

Tramadol is well absorbed after oral and rectal administration, about 75% of the drug is excreted into the blood. The analgesic effect begins approximately 15–30 minutes after administration and usually lasts for 3–4 hours. In turn, the effect of the prolonged-release tablets lasts for 6-8 hours.

The metabolism of this drug occurs in the liver. Excretion is mainly via the kidneys, to a lesser extent via the faeces.

Tramadol is the main ingredient of Tramal in all its forms. In addition, depending on the selected form of the drug, the following excipients are indicated:

1. prolonged-release tablets – hypromellose 100 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, hypromellose 000 mPas, lactose monohydrate, macrogol 6, propylene glycol, talc, titanium dioxide, red iron oxide (E 6000), quinoline yellow lake ( E 172) and brown iron oxide (E 104);
2. hard capsules – microcrystalline cellulose, sodium carboxymethyl starch, colloidal silica, magnesium stearate, yellow iron oxide (E 172), titanium dioxide (E 171), gelatin and sodium laurilsulfate;
3. oral drops – sucrose 0,2 g / ml, potassium sorbitan, glycerol 85%, propylene glycol, sodium cyclamate, sodium saccharin, macroglycerol hydroxystearate, partially dementolized peppermint oil, anise flavor and purified water;
4. rectal suppositories – hard fat;
5. injection liquid – sodium acetate trihydrate and water for injections.

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Tramal – indications for the use of the drug

Tramal is primarily a pain reliever, so the main indication for its use is moderate to severe pain.

Indications for the use of the drug Tramal are:

1. acute and chronic post-traumatic pain;
2. postoperative pains;
3. pain in neoplastic diseases;
4. pharmacological preparation of the patient before surgery;
5. treatment of coronary pain;
6. in terminally ill patients with terminal disease, it is used to treat acute and chronic pain, also with a neuropathic component.

What medications should not be used for chronic pain? Check: Paracetamol, ibuprofen, and aspirin are not suitable for the treatment of chronic pain. They can do “more harm than good”

Tramal – contraindications to the use of the drug

Tramal, despite its effectiveness in combating acute pain, cannot be used by every patient with this type of ailments.

Contraindications to the use of Tramal are:

1. Known hypersensitivity to tramadol, other opioid analgesics or to any of the excipients;
2. acute intoxication with alcohol, hypnotics, centrally acting analgesics, including opiods or psychotropic drugs;
3. taking or in the 14 days prior to treatment taking MAO inhibitors;
4. epilepsy that does not respond to treatment;
5. treatment of opioid dependence.

How Can I Deal With Pain? Read on: Five natural remedies for pain. You don’t have to take the pills

Tramal – precautions

Before and during the use of Tramal, follow the precautions included in the package leaflet.

Special precautions should be taken in the following cases:

1. dependence on other painkillers (opioids);
2. disturbance of consciousness – especially if you feel you are going to faint;
3. in shock – cold sweat may be a symptom; 
4. in case of increased intracranial pressure – may occur after a head injury or in diseases of the brain;
5. in case of breathing problems;
6. in patients with increased sensitivity to opioid drugs; 
7. in patients with epilepsy or an increased risk of seizures;
8. in patients with liver or kidney disease;
9. if you are depressed and you are taking antidepressants as some of them may interact with tramadol;
10. in patients with respiratory depression and concomitant use of drugs that depress the central nervous system;

It is also worth remembering that the drug should not be used after the expiry date stated on the box. The expiry date refers to the last day of that month. The drug should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

What should you know about proper drug storage? Check: Medications that are stored wrongly are poisonous

Tramal – proper dosage and method of use

Always use Tramal exactly as described in the package leaflet or as directed by your doctor or pharmacist.

The method of use and dosage of Tramal depends, inter alia, on the selected form of the drug.

For prolonged-release tablets, Tramal is used in adults and children over 12 years of age as follows:

1. one tablet of Tramal 100 twice a day (equivalent to 200 mg of tramadol hydrochloride), preferably in the morning and evening;
2. one tablet of Tramal 150 twice a day (equivalent to 300 mg of tramadol hydrochloride), preferably in the morning and evening;
3. one tablet of Tramal 200 twice a day (equivalent to 400 mg tramadol hydrochloride), preferably in the morning and evening. 

If necessary, the dose can be increased to 150 or 200 mg twice a day. Tramal prolonged-release tablets should be administered orally. The tablet should always be taken whole with a little liquid and should not be divided or chewed. The drug can be used regardless of meals.

For hard capsules, Tramal is used in adults and children over 12 years of age as follows:

1. 1-2 capsules (i.e. 50-100 mg of tramadol hydrochloride). Depending on the intensity of the pain, the analgesic effect lasts for approximately 4 to 8 hours.

Tramal hard capsules are for oral use. Always take the capsule with enough liquid and do not divide or chew the capsule.

In the case of oral drops, Tramal is used in adults and children over 12 years of age as follows:

1. 20 to 40 drops (equivalent to 50-100 mg of tramadol hydrochloride). Depending on the intensity of the pain, the analgesic effect lasts for about 4 to 6 hours.

In children over 1 year of age, the usual dose is 4 to 8 drops per 10 kg (1-2 mg of tramadol hydrochloride per kilogram of body weight). The drug Tramal in drops is used orally. The drops should be taken with a little liquid or sugar.

For the solution for injection, Tramal is used in adults and children over 12 years of age as follows:

1. depending on the severity of the pain, 1-2 ml of solution for injection (equivalent to 50-100 mg of tramadol hydrochloride) is usually used every 4-6 hours. 

Tramal in solution is given by slow injection into a vein under the skin, such as the elbow flexion, or into a muscle, or subcutaneously. It can also be diluted and given as an intravenous drip infusion.

For rectal suppositories, Tramal is used in adults and children over 12 years of age as follows:

1. one 100 mg suppository (corresponding to 100 mg of tramadol hydrochloride) every 4 to 6 hours.

The suppository should be placed in the rectum, preferably after a bowel movement. To make it easier, you can warm the suppository in your hand immediately before its application.

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Tramal – side effects

The drug Tramal, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Bearing in mind the above rules, side effects of Tramal can be indicated, which occur with different frequency:

1. very common side effects after taking Tramal (affects more than 1 in 10 people): dizziness and nausea;
2. common side effects after taking Tramal (affects 1 to 10 users in 100): headache, drowsiness, vomiting, constipation, dry mouth, excessive sweating, fatigue;
3. uncommon side effects after taking Tramal (affects 1 to 10 users in 1): disorders of the heart and circulatory system (palpitations, rapid heartbeat, feeling faint as a result of low blood pressure in patients moving from lying down to standing and collapse), retching irritation of the stomach and intestines (stomach tightness, flatulence), diarrhea, skin reactions (e.g. itching, rash, hives);
4. rare side effects after taking Tramal (affects 1 to 10 in 10 people): slow heart rate, increase in blood pressure, changes in appetite, slow breathing, “shortness of breath” (shortness of breath), worsening of bronchial asthma, inhibition of breathing, abnormal sensation (e.g. itching, tingling) numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders hallucinations, confusion, sleep disturbances, delirium, restlessness and nightmares, mood disturbances, changes in activity, decreased sensory and cognitive perception;
5. very rare side effects after taking Tramal (affects less than 1 in 10 people): increase in liver enzymes;
6. unknown frequency of side effects after taking Tramal: too low blood sugar, serotonin syndrome whose symptoms may include changes in your mental state (e.g. agitation, hallucinations, coma), fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, incoordination and symptoms of gastrointestinal tract (e.g. nausea, vomiting, diarrhea).

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Tramal – interactions with other drugs

Before starting treatment with Tramal, please inform your doctor or pharmacist about all the medicines you are taking or have recently taken. You should also inform what medications the patient plans to take in the near future.

First of all, Tramal should not be used with the simultaneous use of antidepressants, i.e. MAO inhibitors. You should wait 14 days after stopping them to be able to use Tramal safely.

It is also worth remembering that the analgesic effect of Tramal may be reduced, and the duration of action may be shortened in the case of simultaneous use of medicines containing:

1. carbamazepine (an anti-epileptic drug);
2. pentazocine, nalbuphine or buprenorphine (medicines used to relieve pain);
3. ondansetron (an anti-sickness medicine).

In addition, the risk of side effects increases if the use of Tramal is combined with the concomitant use of the following preparations:

1. other painkillers such as morphine or codeine – feel sleepy or start to faint;
2. sedatives or sleeping pills – you may feel drowsy, you may have difficulty breathing, coma and even be life-threatening;
3. Medicinal products that can cause seizures – antidepressants and antipsychotics. Selective reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics and other drugs that lower the seizure threshold (such as buproprion, mirtazapine or tetrahydrocannabinol) should not be used;
4. antidepressants;
5. coumarin derivative anticoagulants (to reduce blood clotting), e.g. warfarin – bleeding may occur due to the action of these drugs on the clotting system.
6. ketoconazole (antifungal medicine) and erythromycin (antibacterial antibiotic) – may inhibit the metabolism of tramadol and possibly its active metabolite.

Which drugs should never be combined with each other? Check: Dangerous interactions

Tramal and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. 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 taking Tramal.

Tramal penetrates the placenta stronglytherefore its use is not recommended during pregnancy. The decision to start or continue the therapy is always made by the doctor, based on the individual situation of the patient. If the pregnant woman uses therapy for a longer period, the newborn may become dependent on the active substance and, therefore, withdrawal symptoms may occur after delivery.

Tramal also passes into breast milk. The decision regarding the possibility of breastfeeding a child depends on the therapy that has been started. If the mother took a single dose, then, as a rule, it is not necessary to stop breastfeeding. However, if the drug is to be used for a longer period, consideration should be given to either discontinuing the treatment or weaning the baby from the breast for the duration of the treatment.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Tramal and alcohol consumption

You should not consume alcoholic beverages while using Tramal. Simultaneous use of Tramal and drinking alcohol may increase the effect of the drug, and in extreme cases even stop breathing. The food you eat does not affect the way Tramal works.

What drugs must absolutely not be combined with alcohol? Check: Eight drugs that are better not to be combined with alcohol

Tramal – the price of the drug

Scene leku Tramal may differ depending on the city in which the preparation will be purchased or the pharmacy chosen by the patient. The price of the product also depends on the selected form of the drug, the dose of the active substance and the number of tablets or the volume of ampoules or bottles.

The price of the drug Tramal in prolonged-release tablets:

1. 100 mg dose of the drug; 10 tablets – approx. PLN 7, after reimbursement: PLN 1- 3;
2. 100 mg dose of the drug; 30 tablets – about PLN 20, after refund: PLN 2-7;
3. 100 mg dose of the drug; 50 tablets – about PLN 34, after reimbursement: PLN 2-12;
4. dose of the drug 150 mg; 10 tablets – about PLN 11, after reimbursement: PLN 1-5;
5. 150 mg dose of the drug; 30 tablets – about PLN 30, after refund: PLN 1-10;
6. 150 mg dose of the drug; 50 tablets – about PLN 50, after refund: PLN 2-16;
7. dose of the drug 200 mg; 10 tablets – about PLN 14, after reimbursement: PLN 1-5;
8. 200 mg dose of the drug; 30 tablets – about PLN 40, after refund: PLN 2-13;
9. 200 mg dose of the drug; 50 tablets – about PLN 65, after refund: PLN 1-20;
10. 50 mg dose of the drug; 10 tablets – about PLN 3, after reimbursement: PLN 0,5-1,5;
11. 50 mg dose of the drug; 30 tablets – about PLN 11, after refund: PLN 1-4;
12. 50 mg dose of the drug; 50 tablets – about PLN 18, after refund: PLN 2-6.

Price of Tramal in hard capsules:

1. 50 mg dose of the drug; 20 capsules – approx. PLN 7, after refund: PLN 1-3;

The price of the drug Tramal in oral drops:

1. drug dose 100 mg / ml; 10 ml with a dropper – about PLN 10, after refund: PLN 2-4;
2. drug dose 100 mg / ml; 96 ml with a dispenser – about PLN 75, after refund: PLN 0-22.

The price of the drug Tramal in rectal suppositories:

1. 100 mg dose of the drug; 5 suppositories – approx. PLN 7, after refund: PLN 0-2.

The price of Tramal in liquid for injection:

1. drug dose 50 mg / ml; 5 ampoules of 1 ml – about PLN 5, after reimbursement: PLN 1-2;
2. drug dose 50 mg / ml; 5 ampoules 2 ml – ol. PLN 9, after refund: PLN 0-2.

The drug Tramal is issued free of charge in indications for diagnosed malignant neoplasms.

Check the November 2020 reimbursement list: New reimbursement list from November 2020. Changes for flu vaccines