Poltram Combo – composition, action, dosage, overdose, interactions

Proven content

Poltram Combo is a medicine that is used by patients to relieve moderate pain. Two active substances, tramadol and paracetamol, are responsible for the property of relieving pain. This preparation is available on prescription. How does Poltram Combo work and when should you use it? What are the contraindications to the use of this preparation? How to dose Poltram Combo and what may be the consequences of an overdose? Can the use of Poltram Combo cause side effects in a patient?

Poltram Combo – general characteristics of the drug

Poltram Combo is a pain reliever, available in the form of film-coated tablets. The tablets are light yellow, oblong, biconvex, and are approximately 16,5 mm in length.

This preparation is used in the case of pain of various origins, of moderate or severe intensity. The drug contains two active substances – tramadol and paracetamol. Poltram Combo is available on prescription. Pharmacies sell drug packages containing tablets packed in PVC / Aluminum blisters. One cardboard package may contain:

1. 10 tablets;
2. 20 tablets;
3. 30 tablets;
4. 60 tablets;
5. 90 tablets.

The entity responsible for the production and distribution of the Poltram Combo drug on the Polish market is Polpharma. Zakłady Farmaceutyczne Polpharma SA is a Polish pharmaceutical company based in Starogard Gdański. This concern mainly produces drugs that are used in cardiology, gastroenterology and neurology. The company was founded in 1935 as the Polish Chemical and Pharmaceutical Factory “Polpharma”. The company has 7 production plants located in Poland, Our Country and Kazakhstan, as well as seven research and development centers.

What is pain? How does it affect our body and how to deal with it? Check: Pain – types, mechanism of action, treatment

Poltram Combo – composition and action

Poltram Combo is an analgesic, which contains two main active substances. These are tramadol and paracetamol.

Paracetamol, also known in pharmaceuticals as acetaminophen, is a substance that was introduced to the medicinal market in 1956 in Great Britain. Today, it is the drug that patients most often choose for pain relief. On the Polish market, there are several dozen medical products that contain paracetamol in their composition.

Paracetamol is a substance that works not only to relieve pain, but also to reduce fever. The action of paracetamol takes place in the central nervous system, and the compound crosses the blood-brain barrier.

The mechanism of action of paracetamol consists in inhibiting the activity of cyclooxygenase in the brain and spinal cord. Cyclooxygenase is an enzyme responsible for the synthesis of prostaglandins.

Paracetamol is different from non-steroidal anti-inflammatory drugs. First of all, it does not have an anti-inflammatory effect. This compound does not inhibit platelet aggregation and does not affect the coagulation process.

Paracetamol is used for pain of any nature. The most common are:

1. headaches; 
2. toothache;
3. pain in muscles, bones and joints;
4. painful menstruation. 

It can also be used as an antipyretic drug.

Paracetamol is very often combined with other substances, such as, for example, sympathomimetics – phenylephrine, pseudoephedrine, diphenhydramine. It is also combined with antihistamines, such as chlorphenamine or pheniramine.

The second important ingredient in Poltram Combo is tramadol. It is a strong pain reliever that belongs to the group of opioids, or narcotic pain relievers. It also has an antitussive effect.

Tramadol is a synthetic medicine and 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. The mechanism of action of tramadol is related to the influence on communication between nerve cells dependent on norepinephrine and serotonin. The information-transmitting cell in front of the synapse releases a so-called mediator into the synaptic cleft, i.e. a substance that is captured and recognized by the cell receiving the information. Some mediator molecules get caught back on the receptors of the neuron ahead of the synapse, which is called reuptake. The action of tramadol is to inhibit the process of norepinephrine reuptake, and thus extend the time of its action in the synapse and the time of stimulation of the recipient cell.

Tramadol, when taken orally, is 5 times weaker than morphine. Parenteral administration makes its effect ten times lower than that of parenteral administration of morphine.

Tramadol is used in cases of acute and chronic post-traumatic pain, postoperative pain and cancer pain. In terminally ill patients with terminal disease, it is used in the treatment of acute and chronic pain, also with a neuropathic component.

It is worth remembering that One tablet of Poltram Combo contains 37,5 mg of tramadol hydrochloride and 325 mg of paracetamol.

Other excipients are also used to produce Poltram Combo film-coated tablets.

Poltram Combo tablet core ingredients:

1. pregelatinized corn starch;
2. microcrystalline cellulose;
3. sodium carboxymethyl starch (Type A);
4. colloidal anhydrous silica;
5. magnesium stearate.

Ingredients of the Poltram Combo tablet coating:

1. hypromeloza (6 mPa·s);
2. macrogol 400;
3. titanium dioxide (E171);
4. iron oxide yellow (E172).

What are opioids and how to use them? Read: Opioids

Poltram Combo – indications for use

Poltram Combo is recommended for the symptomatic treatment of moderate to severe pain. It is a drug that can be used by adults and adolescents over 12 years of age.

It is very important that the use of Amoxiclav should be limited mainly to those patients with moderate to severe pain who require a combination of tramadol and paracetamol.

What anti-inflammatory drugs are good for pain? Check: Anti-inflammatory drugs – which ones to choose for your ailment?

Poltram Combo – contraindications

The drug Poltram Combo, despite its effectiveness in the treatment of pain, cannot be used by every patient struggling with pain.

Among the contraindications to the use of Poltram Combo are:

1. allergic to paracetamol, tramadol or any of the other ingredients of this medicine;
2. alcohol abuse;
3. the occurrence of acute alcohol poisoning;
4. the use of drugs that can make you sleepy or reduce attention; incl. opioids (painkillers) such as morphine and codeine or other psychotropic drugs (drugs that affect mood and emotions);
5. use of monoamine oxidase inhibitors MAO (medicines used to treat depression or Parkinson’s disease);
6. severe liver disease;
7. epilepsy that is not properly corrected with the medications prescribed to the patient.

What are the negative effects of excessive alcohol consumption? Check: Do you like a drink? The effects can be dire

Poltram Combo – precautions

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

Precautions to keep in mind include:

1. do not take more than 8 tablets a day;
2. Poltram Combo should not be used in patients with severe renal insufficiency (creatinine clearance <10 ml / min); 
3. Poltram Combo should not be used in patients with severe liver failure. In patients with moderate hepatic impairment, cautious use may be considered, provided that the dosing intervals are prolonged;
4. the drug should not be used in cases of severe respiratory failure;
5. the drug should not be used while treating opioid addiction;
6. Seizures have been reported in patients at increased risk of seizures or taking concomitant medications that lower the seizure threshold, especially selective serotonin reuptake inhibitors, tricyclic antidepressants, neuroleptics, and centrally acting and local analgesics.

Additionally, special care should be taken in the case of patients:

1. after head injuries;
2. prone to seizures;
3. with disorders of the biliary tract;
4. in shock;
5. with disturbances of consciousness of unknown origin;
6. with respiratory disorders or disorders of the respiratory center;
7. with increased intracranial pressure.

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

Poltram Combo – dosage

Always use Poltram Combo exactly as described in the package leaflet or according to the doctor’s or pharmacist’s instructions.

As previously mentioned, Poltram Combo should be used only in patients over 12 years of age who are struggling with moderate to severe pain. Additionally, this drug should be used only when the indicated ailments require the combined administration of tramadol with paracetamol.

The dose of Poltram Combo should be individually adjusted to the intensity of the pain. It is recommended to administer the lowest possible dose that is effective in relieving pain.

Initial recommended dose of Poltram Combo is 2 tablets, corresponding to 75 mg tramadol and 650 mg paracetamol. In case of need or further discomfort, further doses can be taken, however not exceeding 8 tablets a day. The dose interval should not be less than 6 hours.

In no case should Poltram Combo be used for longer than absolutely necessary. If, due to the type and severity of the disease, long-term use of the medicinal product is necessary, regular medical consultations should be made.

Poltram Combo is administered orally. The tablet should be swallowed whole with a sufficient amount of liquid. Poltram Combo tablets should not be broken, bitten or chewed.

How to take medication correctly? Check: How to take medications effectively?

Poltram Combo – drug overdose

Poltram Combo is a drug that, due to its composition, can be easily overdosed. This drug is also addictive. Symptoms that occur in overdose are related to the action of its active substances, i.e. tramadol and paracetamol.

Among symptoms of tramadol poisoning lists:

1. constriction of the pupils;
2. vomiting;
3. circulatory collapse;
4. disturbance of consciousness up to coma;
5. seizures;
6. respiratory depression up to respiratory arrest.

Among symptoms of paracetamol overdose while the following are listed:

1. paleness;
2. nausea;
3. vomiting;
4. anorexia and abdominal pain;
5. liver damage;
6. glucose metabolism disorders and metabolic acidosis;
7. heart rhythm disturbances and pancreatitis. 

In the case of overdosage with Amoxicillin emergency treatment is required. After an overdose, the patient should be transferred to the hospital and the respiratory and circulatory functions should be maintained. Before starting treatment, the patient must have a blood sample to measure the levels of both active substances in the blood. Then the patient undergoes tests that check the liver function. If the patient is conscious, vomiting is usually induced to empty the stomach. If the patient is unconscious, gastric lavage is performed.

What are the causes of a headache on the top? Read: What does a headache on the tip mean? Causes, diagnosis, treatment

Poltram Combo – side effects

Poltram Combo, 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).

Very common side effects of taking Poltram Combo:

1. nausea;
2. dizziness, drowsiness. They are usually mild.

Common side effects of taking Poltram Combo:

1. vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth;
2. itching, excessive sweating;
3. headache, tremor;
4. confusion, sleep disturbances, mood disorders (anxiety, nervousness, feeling agitated).

Uncommon side effects of taking Poltram Combo:

1. increased blood pressure, fast heartbeat, or irregular heartbeat;
2. difficulty or pain when urinating, protein in the urine;
3. skin reactions (for example rash, hives);
4. tingling, numbness or a prickling sensation in the limbs;
5. ringing in the ears;
6. involuntary muscle tremors;
7. depression, nightmares, hallucinations (seeing, hearing or feeling things that are not there);
8. memory loss;
9. difficulty swallowing;
10. the presence of blood in the stool;
11. trembling;
12. hot flushes;
13. pain in the chest;
14. breathing difficulties;
15. increased levels of liver enzymes.

Rare side effects of taking Poltram Combo:

1. convulsions, difficulty coordinating movements, fainting;
2. addiction;
3. blurred vision.

The frequency of side effects of using Poltram Combo is unknown:

1. decrease in blood sugar.

It is also worth paying attention to the side effects that may occur due to the use of substances such as tramadol and paracetamol.

The side effects that may cause taking tramadol include:

1. orthostatic hypotension, bradycardia, collapse;
2. rare cases of changes in the action of warfarin, including prolongation of prothrombin time;
3. respiratory hypersensitivity reactions (e.g., dyspnoea, bronchospasm, wheezing, angioedema) and anaphylaxis;
4. changes in appetite;
5. weakness of the musculoskeletal system and inhibition of breathing;
6. mental disorders – mood changes (usually euphoria, occasionally dysphoria), changes in activity (usually a decrease, occasionally an increase) and changes in the ability to cognitive and sensory perception (e.g. decision-making behavior, perceptual disturbances);
7. worsening of asthma symptoms;

After discontinuation of tramadol, agitation, restlessness, nervousness, insomnia, hyperkinesia, tremors and gastrointestinal disorders may occur. Patients also reported panic attacks, severe anxiety, hallucinations, paraesthesia, ringing in the ears, and other central nervous system symptoms.

Side effects that may cause taking paracetamol include:

1. hypersensitivity reactions including skin rash;
2. severe skin reactions;
3. blood count disorders including thrombocytopenia and agranulocytosis;
4. the possibility of hypoprothrombinemia with concomitant use with drugs from the warfarin group. 

Why can a rash appear after taking an antibiotic? Read on: Antibiotic rash – is it an allergy symptom?

Poltram Combo – interactions with other drugs and substances

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

The active substances of Poltram Combo may interact with other drugs or substances contained in medicinal products.

Poltram Combo must not be used simultaneously with the following medicines:

1. non-selective MAO inhibitors – there is a risk of serotonin syndrome: diarrhea, tachycardia, excessive sweating, tremors, confusion, and even coma;
2. selective MAO inhibitors type A – there is a risk of serotonin syndrome: diarrhea, tachycardia, excessive sweating, tremors, confusion, and even coma;
3. selective MAO inhibitors type B – there are symptoms of agitation suggesting the occurrence of serotonin syndrome: diarrhea, tachycardia, excessive sweating, tremors, confusion, and even coma. 

In addition, Ramipril should not be used simultaneously with:

1. alcohol – alcohol consumption increases the sedative effect of opioid analgesics and may interfere with breathing;
2. carbamazepines and other enzyme activators – there is a risk of decreased efficacy and shortened duration of action due to decreased plasma concentrations of tramadol;
3. agonist-antagonist opioids (buprenorphine, nalbuphine, pentazocine) – there is a risk of reducing the analgesic effect by blocking the effects on receptors, with the risk of withdrawal syndrome.

However, special care should be taken when taking Poltram Combo together with:

1. serotonergic drugs, such as serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), MAO inhibitors, tricyclic antidepressants and mitrazapine – may cause serotonin toxicity;
2. other opioid derivatives – including antitussives, benzodiazepines and barbiturates. There is a risk of respiratory depression, which may be fatal in case of overdose;
3. other central nervous system depressants, such as other opioid derivatives – including antitussive drugs, barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, antihypertensive drugs centrally acting, thalidomide and baclofen. These drugs can cause an excessive depression of the central nervous system;
4. coumarin derivatives (such as warfarin);
5. other drugs known to inhibit CYP3A4, such as ketoconazole and erythromycin, which may inhibit the metabolism of tramadol (N-demethylation) and possibly also the metabolism of its active O-demethylated metabolite;
6. metoclopramide, cholestyramine or domperidone – affect the rate of absorption of paracetamol;

In addition, a limited number of pre- and post-operative studies with the 5-HT3 receptor antagonist ondansetron have shown an increased need for tramadol in patients with post-operative pain.

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

Poltram Combo 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 Poltram Combo.

Poltram Combo is a combination of such active substances, including tramadol, that should not be used during pregnancy.

Epidemiological studies have not shown harmful effects of paracetamol in pregnant women. However, the data on tramadol are less optimistic. Due to the lack of sufficient evidence for the safety of the drug during pregnancy, pregnant women should completely refrain from taking it. Tramadol given before or during labor does not inhibit uterine contractions, but may cause changes in the respiratory rate in neonates.

It is worth mentioning that repeated administration of tramadol during pregnancy may lead to withdrawal symptoms in the newborn.

Poltram Combo should also not be used during lactation and breastfeeding. Paracetamol is excreted in breast milk, but in not clinically significant amounts.

In turn, about 0,1% of the maternal tramadol dose is excreted in breast milk. This means that in the immediate postpartum period, following an oral ingestion by the mother of doses of up to 400 mg per day, the average dose of tramadol taken by breastfed infants is 3% of the dose calculated on the mother’s body weight. For this reason, tramadol should not be used during breastfeeding.

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

Poltram Combo — cena

The price of Poltram Combo may vary 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 number of tablets contained in the package.

Cena Leku Poltram Combo produced by the Polpharma concern are:

1. 10 coated tablets, where 1 g of a tablet contains 37,5 mg of tramadol hydrochloride and 325 mg of paracetamol, costs about PLN 11;
2. 20 coated tablets, where 1 g of a tablet contains 37,5 mg of tramadol hydrochloride and 325 mg of paracetamol, costs about 5-6 zlotys; After the refund, the price is about PLN 2;
3. 30 coated tablets, where 1 g of a tablet contains 37,5 mg of tramadol hydrochloride and 325 mg of paracetamol, costs about 8-9 zlotys; After the refund, the price is about PLN 3;
4. 60 coated tablets, where 1 g of a tablet contains 37,5 mg of tramadol hydrochloride and 325 mg of paracetamol, costs about PLN 15; After the refund, the price is about PLN 5;
5. 90 coated tablets, where 1 g of a tablet contains 37,5 mg of tramadol hydrochloride and 325 mg of paracetamol, costs about PLN 22; After the refund, the price is around PLN 6-7.

It is worth mentioning that Poltram Combo is dispensed free of charge up to the limit in cases of diagnosed malignant neoplasm.

How much money does the average Pole spend on treatment? Check: The Pole is not expected to see a doctor

Poltram Combo – replacements

Products that have the same international name and exist in the same form do not have to be substitutes, because the use of a given drug is determined by the content of the active substance, i.e. the dose of the drug.

It should be remembered that even when the dose of the active substance is similar, the patient may not always use the substitute, because he may be allergic to any of the other excipients of the drug.

Therefore, before using a substitute for Poltram Combo, read the package leaflet or consult your doctor or pharmacist.

The preparations containing the same ingredients as Poltram Combo and showing similar properties include:

1. Doreta in coated tablets – the producer of the drug is the Krka concern. The active substances in Doreta come in two doses. 1 g tablet may contain 37,5 mg of tramadol hydrochloride and 325 mg of paracetamol or 75 mg of tramadol hydrochloride and 650 mg of paracetamol. As in the case of Poltram Combo, packages with 10, 20, 30, 60 and 90 tablets are available;
2. Exbol in coated tablets – the manufacturer of the drug is the Bausch Health concern. The active substances in Exbol come at a dose of 37,5 mg tramadol hydrochloride and 325 mg paracetamol. Packs of 30, 60 and 90 tablets are available;
3. Padolten – the manufacturer of the drug is Teva Pharmaceuticals Polska. The active substances in Padolten come at a dose of 37,5 mg tramadol hydrochloride and 325 mg paracetamol. Packs of 30, 60 and 90 tablets are available;
4. Palgotal – the manufacturer of the drug is the concern Zentiva. The active substances in Padolten are at a dose of 75 mg tramadol hydrochloride and 650 mg paracetamol. Packs of 30 tablets are available;
5. Tramadol + Paracetamol Genoptim – the manufacturer of the drug is Synoptis Pharma. The active substances in Tramadol + Paracetamol Genoptim are at a dose of 37,5 mg tramadol hydrochloride and 325 mg paracetamol. Packs of 30, 60 and 90 tablets are available;
6. Tramapar – the manufacturer of the drug is the Polfarmex concern. The active substances in Tramapar come at a dose of 37,5 mg tramadol hydrochloride and 325 mg paracetamol. Packs of 10, 20, 30, 60 and 100 tablets are available;
7. Zaldiar – the manufacturer of the drug is the Stada concern. The active substances in Tramadol + Paracetamol Genoptim are at a dose of 37,5 mg tramadol hydrochloride and 325 mg paracetamol. Packs of 10, 20, 30, 50 and 90 tablets are available.

When is it worth asking the pharmacy about drug substitutes? Check: Swap when you can