Padolten

Leaflet attached to the packaging: information for the user

Padolten, 37.5 mg + 325 mg, coated tablets

Tramadol hydrochloride + Paracetamol

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Padolten and what is it used for
• 2. Important information before taking Padolten
• 3. How to take Padolten
• 4. Possible side effects
• 5. How to store Padolten
• 6. Contents of the pack and other information

1. What is Padolten and what is it used for

Padolten is a combination medicine that contains two painkillers - tramadol and paracetamol, which work together to relieve pain. Padolten is used to treat moderate or severe pain, when the doctor considers it necessary to use a combination of tramadol and paracetamol. Padolten should only be taken by adults and adolescents aged 12 and over.

2. Important information before taking Padolten

When not to take Padolten

• if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute alcohol poisoning, sedatives, painkillers or other psychotropic substances (drugs that affect mood and emotions);
• if you are taking MAO inhibitors (drugs used to treat depression or Parkinson's disease) or have taken them within 14 days before starting treatment with Padolten;
• if you have severe liver failure;
• if you have epilepsy that is not controlled by treatment.

Warnings and precautions

Before starting to take Padolten, you should discuss it with your doctor:

• if you are taking other medicines that contain paracetamol or tramadol;
• if you have liver problems or liver disease or if you have jaundice or yellowing of the skin and eyes. These symptoms may indicate liver problems or bile duct disorders;
• if you have kidney problems;
• if you have severe breathing difficulties, such as asthma or severe lung disease;
• if you have epilepsy or have had seizures;
• if you have recently had a head injury, shock or have had severe headaches with vomiting;
• if you are addicted to any medicines, including painkillers, such as morphine;
• if you are taking other painkillers that contain buprenorphine, nalbuphine or pentazocine;
• if you are going to have an anaesthetic. You should tell your doctor or dentist that you are taking Padolten;
• if you have depression and are taking antidepressants, as some of them may interact with tramadol (see "Other medicines and Padolten").

While taking Padolten, you should immediately inform your doctor if:

• you have severe illnesses, including severe kidney problems or sepsis (when bacteria and their toxins are in the blood, leading to organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). There have been reports of a serious condition called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol regularly for a long time or have taken paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Sleep apnea:
Padolten may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep or excessive daytime sleepiness. If you or someone else observes these symptoms, you should contact your doctor. Your doctor may consider reducing the dose.
Tramadol is converted in the liver by an enzyme. In some people, there is a certain variant of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, it is more likely to experience severe side effects.
You should stop taking the medicine and immediately contact your doctor if you experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
If any of the above situations have applied to you in the past or apply to you while taking Padolten, you should inform your doctor. Your doctor will then decide whether you should continue taking this medicine.
If you experience any of the following symptoms while taking Padolten, you should tell your doctor or pharmacist: excessive tiredness, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience such symptoms, you should contact your doctor, who will decide whether you need hormone replacement therapy.
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. If you experience any symptoms of this syndrome with a severe course, you should immediately seek medical attention (see section 4 "Possible side effects").
Tolerance, dependence and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can lead to the medicine becoming less effective (the patient becomes accustomed to the medicine, which is called tolerance). Repeated use of Padolten can also lead to the development of dependence, abuse and addiction, which can result in life-threatening overdose. The risk of these side effects may increase with the dose and duration of use.
Dependence can make it difficult for the patient to control the dose of the medicine or how often it is taken.
The risk of dependence is different for different people. The risk of dependence on Padolten may be higher if:

• you or someone in your family has ever abused or been dependent on alcohol, prescription drugs or illegal drugs ("addiction");
• you smoke;
• you have ever had mood disorders (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental illnesses.

If you experience any of the following symptoms while taking Padolten, it may indicate dependence:

• you need to take the medicine for longer than your doctor recommended
• you need to take a higher dose than recommended
• you use the medicine for reasons other than those recommended, such as "to calm down" or "to help you sleep"
• you have made repeated, unsuccessful attempts to stop or control the use of the medicine
• after stopping the medicine, you feel unwell and feel better after taking it again ("withdrawal symptoms").

If you experience any of these symptoms, you should talk to your doctor to discuss the best course of treatment, including when to stop the medicine and how to do it safely (see section 3 "Stopping Padolten").

Children

Use in children under 12 years of age is not recommended.
Use in children with breathing difficulties:
Tramadol is not recommended for use in children with breathing difficulties, as symptoms of tramadol toxicity may be exacerbated in them.

Other medicines and Padolten

You should tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

Important: the medicine contains paracetamol and tramadol. You should tell your doctor if you are taking other medicines that contain paracetamol or tramadol, to avoid exceeding the maximum daily doses.

Padolten must notbe taken at the same time as monoamine oxidase inhibitors (MAOIs) (see "When not to take Padolten").
It is not recommended to take Padolten with the following medicines:

• carbamazepine (a medicine commonly used to treat epilepsy or certain types of pain, such as severe facial pain, called trigeminal neuralgia),
• buprenorphine, nalbuphine or pentazocine (opioid painkillers). The pain-relieving effect may be weakened.

You should inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic) due to a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

The risk of side effects is higher if you are taking:

• triptans (used for migraine) or selective serotonin reuptake inhibitors "SSRIs" (used for depression). If you experience disorientation, anxiety, fever, sweating, uncoordinated movements of the limbs or eyes, or uncontrolled muscle twitching or diarrhea, you should contact your doctor.
• other painkillers, such as morphine and codeine (also in cough medicines), baclofen (a muscle relaxant), blood pressure-lowering medicines, or medicines used to treat allergies. You may feel drowsy or faint. If you experience these symptoms, you should inform your doctor.
• concomitant use of Padolten and sedatives, such as benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible. If your doctor has prescribed Padolten with sedatives, your doctor should limit the dose and duration of concomitant treatment. You should inform your doctor about all sedatives you are taking and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the possibility of these subjective and objective symptoms. If you experience such symptoms, you should contact your doctor.
• gabapentin or pregabalin for the treatment of epilepsy or nerve pain (neuropathic pain).
• medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may be higher if you are taking Padolten. Your doctor will decide whether Padolten is suitable for you.
• certain antidepressants - Padolten may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• warfarin or phenprocoumon (blood thinners). The effectiveness of these medicines may change, and bleeding may occur. Any cases of prolonged or unexpected bleeding should be reported to your doctor immediately.

The effectiveness of Padolten may be affected by concomitant use of:

• metoclopramide, domperidone or ondansetron (used to treat nausea and vomiting),
• cholestyramine (a cholesterol-lowering medicine).

Your doctor will indicate which medicines can be safely taken with Padolten.

Padolten with food, drink and alcohol

Padolten may cause drowsiness. As alcohol can increase drowsiness, you should avoid drinking alcohol while taking Padolten.

Pregnancy, breastfeeding and fertility

Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
As the medicine contains tramadol, it is contraindicated during pregnancy. If you become pregnant during treatment with Padolten, you should consult your doctor before taking any further doses.
Breastfeeding
Tramadol passes into breast milk. Therefore, you should not take more than one dose of Padolten while breastfeeding. If you take more than one dose of Padolten, you should stop breastfeeding.
Based on human experience, it is suggested that tramadol does not affect fertility in women or men. There are no data on the effect of the combination of tramadol and paracetamol on fertility.
You should ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Padolten may cause drowsiness, which can affect your ability to drive or use machines safely.

Padolten contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is essentially sodium-free.

3. How to take Padolten

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from taking Padolten, when and for how long you should take it, when you should contact your doctor and when you should stop taking it (see also section 2).
Padolten should be taken for as short a time as possible.
Use in children under 12 years of age is not recommended.
The dose will be adapted to the intensity of the pain and the individual response of the patient to treatment. You should take the smallest dose that relieves the pain.
If your doctor has not prescribed otherwise, the recommended initial dose of Padolten is 2 tablets for adults and adolescents aged 12 and over.
If necessary, you can take further doses as directed by your doctor. There must be at least a 6-hour interval between doses.

You should not take more than 8 coated tablets of Padolten per day.

You should not take Padolten more often than your doctor has told you to.
Elderly patients
In elderly patients (over 75 years), the elimination of tramadol may be delayed. In these patients, your doctor may recommend prolonging the dosing interval.
Severe liver or kidney disease (failure)/dialysis patients
Patients with severe liver or kidney failure should not take Padolten.
In cases of mild or moderate impairment, your doctor may recommend prolonging the dosing interval.
Method of administration
The tablets should be taken orally.
The tablets should be swallowed whole, without crushing or chewing, with a sufficient amount of water.
If you think that the effect of Padolten is too strong (e.g. you feel increased drowsiness or have difficulty breathing) or too weak (i.e. it does not relieve the pain sufficiently), you should contact your doctor.

Overdose of Padolten

You should immediately contact your doctor or pharmacist, even if you feel well. There is a risk of liver damage, which may become apparent later.

Missed dose of Padolten

If you miss a dose, it is likely that the pain will return. You should not take a double dose to make up for the missed dose, but take the next tablet at the usual time.

Stopping Padolten

You should not stop taking this medicine suddenly without your doctor's advice. If you want to stop taking the medicine, you should discuss it with your doctor, especially if you have been taking it for a long time.
Your doctor will advise you on when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms).
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should stop taking the medicine and contact your doctor immediately. Do not take the medicine again.
Rare (may affect up to 1 in 1000 people):

• skin rash, allergic reaction with sudden swelling of the face and neck, difficulty breathing or low blood pressure and fainting.

Other reported side effects include:

Very common (may affect more than 1 in 10 people):

• nausea,
• dizziness, drowsiness.

Common (may affect up to 1 in 10 people):

• vomiting, gastrointestinal disorders (constipation, bloating, diarrhea), abdominal pain, dry mouth,
• itching, excessive sweating (hyperhidrosis),
• headache, tremor,
• confusion, sleep disturbances, mood changes (anxiety, nervousness, euphoria).

Uncommon (may affect up to 1 in 100 people):

• increased heart rate or blood pressure, heart rhythm disorders,
• tingling, numbness or prickling sensation in the limbs, ringing in the ears, involuntary muscle contractions,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not there), temporary memory problems,
• breathing difficulties,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g. rashes, hives),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare (may affect up to 1 in 1000 people):

• seizures, difficulty coordinating movements,
• transient loss of consciousness (fainting),
• dependence,
• delirium,
• blurred vision,
• pupil constriction (miosis),
• pupil dilation (mydriasis),
• speech disorders.

Unknown (frequency cannot be estimated from the available data):

• low blood sugar (hypoglycemia),
• serotonin syndrome, whose symptoms may include changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination and (or) gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "Important information before taking Padolten").

The following side effects have been reported by people taking medicines that contain only tramadol or only paracetamol.
However, if you experience any of these symptoms while taking Padolten, you should report them to your doctor:

• frequency unknown (cannot be estimated from the available data): a serious condition that can cause the blood to become more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).
• feeling of fainting when standing up from a lying or sitting position, slow heartbeat, fainting, changes in appetite, muscle weakness, slower or shallower breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• taking paracetamol alone or paracetamol in combination with the antibiotic flucloxacillin may cause blood and fluid disorders (metabolic acidosis with anion gap), when the acidity of the blood increases.
• concomitant use of Padolten with blood thinners (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any cases of prolonged or unexpected bleeding should be reported to your doctor immediately.
• rare cases of severe skin reactions have been reported after taking paracetamol.
• rare cases of respiratory depression have been reported during tramadol treatment.

  Reporting side effects

  If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Padolten

  The medicine should be kept out of the sight and reach of children.
  The medicine should be stored in a safe place, where other people cannot access it. It can cause serious harm and be fatal for people it has not been prescribed for.
  Do not take this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.
  The container should be discarded 50 days after first opening.
  The medicine does not require any special storage conditions.
  Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the pack and other information

  What Padolten contains

  • The active substances of the medicine are tramadol hydrochloride and paracetamol. Each coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
  • The medicine also contains: Kollicoat IR [copolymer of methacrylic acid and ethyl acrylate], maize starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, magnesium stearate; Tablet coating: Opadry II Beige 85F97409: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

  What Padolten looks like and contents of the pack

  Padolten coated tablets are peach-colored, capsule-shaped, with the imprint "T37.5" on one side and "A325" on the other side.
  Padolten is available in cartons containing blisters of 10, 20, 30, 60 or 90 tablets, and in containers of 10 tablets and 100 tablets.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Teva Pharmaceuticals Polska Sp. z o.o.
  ul. Emilii Plater 53
  00-113 Warsaw, Poland
  tel.: (22) 345 93 00

  Manufacturer

  Teva Operations Poland Sp. z o.o.
  ul. Mogilska 80
  31-546 Krakow
  Pliva Hrvatska d.o.o.
  Prilaz baruna Filipovića 25,
  10000 Zagreb
  Croatia

  This medicinal product is authorized in the Member States of the European Economic Area under the following names:

  Belgium
  Tramadol/Paracetamol Teva 37,5 mg/325 mg filmomhulde tabletten
  France
  TRAMADOL/PARACETAMOL TEVA
  Slovenia
  Tramadol/Paracetamol Teva 37.5 mg/325 mg film-coated tablets
  Spain
  Tramadol/Paracetamol Teva 37.5 mg/325 mg film-coated tablets
  Netherlands
  Tramadol HCl/Paracetamol 37,5/325 mg Teva
  Poland
  Padolten
  United Kingdom (Northern Ireland) Tramadol hydrochloride/Paracetamol
  Date of last revision of the leaflet:January 2025