Padolten

Patient Information Leaflet

Padolten, 37.5 mg + 325 mg, film-coated tablets
Tramadoli hydrochloridum + Paracetamolum
Please read the entire leaflet before taking this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if needed.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents:

1. What Padolten is and what it is 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 Padolten is and what it is used for

Padolten is a combination medicine containing two analgesic agents – tramadol and paracetamol – which work together to relieve pain.
Padolten is indicated for the treatment of moderate to severe pain, when a doctor has determined that combined treatment with tramadol and paracetamol is necessary.
Padolten should only be used in adults and adolescents aged 12 years and older.

2. Important information before using Padolten

When not to use Padolten

• if the patient is allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6);
• in cases of acute intoxication with alcohol, hypnotics, analgesics or other psychotropic agents (medicines affecting mood and emotions);
• if the patient is currently taking monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression or Parkinson's disease) or has taken them within 14 days before starting treatment with Padolten;
• if the patient has severe liver failure;
• in patients with epilepsy that is not controlled by treatment.

Warnings and precautions
Before starting to take Padolten, discuss the following with your doctor:

• if the patient is simultaneously taking other medicines containing paracetamol or tramadol;
• if the patient has liver disorders or liver disease, or if yellowing of the eyes or skin occurs. These symptoms may indicate jaundice or biliary tract disorders;
• if the patient has kidney function disorders;
• in patients with serious respiratory disorders, e.g. asthma or severe lung diseases;
• if the patient has epilepsy or has previously experienced seizures;
• if the patient has recently suffered a head injury, concussion, or experienced severe headaches accompanied by vomiting;
• if the patient is dependent on any drugs, including analgesics such as morphine;
• if the patient is taking other analgesics containing buprenorphine, nalbuphine or pentazocine;
• if the patient is due to undergo anaesthesia. Inform the doctor or dentist about taking Padolten;
• if the patient suffers from depression and is taking antidepressant medicines, as some of them may interact with tramadol (see "Other medicines and Padolten").

During treatment with Padolten, immediately inform the doctor if:

• the patient has serious illnesses, including severe kidney function disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (an abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly for prolonged periods or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Breathing disorders during sleep:
Padolten may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).
Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact a doctor. The doctor may consider reducing the dose.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, the risk of severe adverse effects is higher.
Treatment must be discontinued and medical advice sought immediately if the patient experiences any of the following adverse effects: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
If any of the above situations have occurred in the patient’s past or occur during treatment with Padolten, the patient should inform the doctor. The doctor will then decide whether the patient should continue treatment with this medicine.
If any of the following symptoms occur during treatment with Padolten, inform the doctor or pharmacist: excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact the doctor, who will decide whether hormone replacement therapy is necessary.
When tramadol is taken alone or in combination with certain antidepressants, there is a small risk of developing serotonin syndrome. If the patient experiences any symptoms of severe serotonin syndrome, immediate medical advice should be sought (see section 4 "Possible side effects").

Tolerance, dependence and abuse
This medicine contains tramadol, an opioid medicine. Repeated use of opioids may result in reduced effectiveness (the patient becomes accustomed to the medicine, known as tolerance). Repeated use of Padolten may also lead to dependence, misuse and abuse, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of use.
Dependence may cause the patient to lose control over the dose or frequency of medicine intake.
The risk of dependence varies among individuals. The risk of dependence on Padolten may be higher if:

• the patient or a family member has ever misused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction");
• the patient smokes tobacco;
• the patient has ever had mood disorders (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur during treatment with Padolten, this may indicate dependence:

• the patient needs to take the medicine longer than prescribed by the doctor;
• the patient needs to take a higher dose than recommended;
• the patient uses the medicine for reasons other than prescribed, e.g. "to calm down" or "to help sleep";
• the patient has made repeated unsuccessful attempts to stop or control medicine use;
• after stopping the medicine, the patient feels unwell and feels better after taking the medicine again ("withdrawal effects").

If any of these symptoms occur, talk to the doctor to discuss the best treatment approach, including when and how to discontinue Padolten safely (see section 3. "Stopping Padolten treatment").

Children
Use of Padolten in children under 12 years of age is not recommended.
Use in children with respiratory disorders:
Tramadol is not recommended in children with respiratory disorders, as symptoms of tramadol toxicity may be more severe in them.

Other medicines and Padolten
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Important: Padolten contains paracetamol and tramadol. Inform the doctor if the patient is taking other medicines containing paracetamol or tramadol to avoid exceeding the maximum daily doses.
Padolten must not be used simultaneously with monoamine oxidase inhibitors (MAOIs) (see section "When not to use Padolten").
Use of Padolten with the following medicines is not recommended:

• carbamazepine (a medicine commonly used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia);
• buprenorphine, nalbuphine or pentazocine (opioid analgesics). Pain relief may be reduced.

Inform the doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic) due to a serious blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

The risk of adverse effects is higher if the patient is taking:

• triptans (used for migraine) or selective serotonin reuptake inhibitors (SSRIs) (used for depression). If the patient experiences confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrolled muscle twitching or diarrhoea, contact the doctor.
• other analgesics such as morphine and codeine (also in cough suppressants), baclofen (a muscle relaxant), antihypertensive medicines, or antihistamines. The patient may experience drowsiness or fainting. Inform the doctor if these symptoms occur.
• simultaneous use of Padolten and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, combined use should only be considered when no other treatment options are available. If the doctor has prescribed Padolten together with sedatives, the doctor should limit the dose and duration of combined treatment. Inform the doctor about all sedative medicines being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform family members or friends about the possibility of experiencing the above-mentioned subjective and objective symptoms. If such symptoms occur, contact the doctor.
• gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).
• medicines that may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may be higher if the patient is taking Padolten simultaneously. The doctor will decide whether Padolten is suitable for the patient.
• certain antidepressants – Padolten may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• warfarin or phenprocoumon (anticoagulants). The effectiveness of these medicines may change, leading to bleeding. Any episodes of prolonged or unexpected bleeding should be reported to the doctor immediately.

The effectiveness of Padolten may be altered when taken simultaneously with:

• metoclopramide, domperidone or ondansetron (used to treat nausea and vomiting);
• cholestyramine (a medicine that lowers blood cholesterol levels).

The treating doctor will advise which medicines can be safely used together with Padolten.

Padolten with food, drink and alcohol
Padolten may cause drowsiness. Since alcohol may increase drowsiness, alcohol consumption should be avoided during treatment with Padolten.

Pregnancy, breastfeeding and effects on fertility
Pregnancy
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Because Padolten contains tramadol, it is contraindicated during pregnancy. If pregnancy is diagnosed during treatment with Padolten, consult the doctor before taking further doses.

Breastfeeding
Tramadol passes into breast milk. Therefore, no more than a single dose of Padolten should be taken during breastfeeding. If the patient takes more than one dose of Padolten, breastfeeding must be discontinued.
Based on human experience, tramadol is not expected to affect fertility in women or men. There are no data on the effect of the combination of tramadol and paracetamol on fertility.
Before using any medicine, consult a doctor or pharmacist.

Driving and operating machinery
Padolten may cause drowsiness, which may affect the ability to drive safely or operate tools and machinery.

Padolten contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is considered to be essentially "sodium-free".

3. How to use Padolten

This medicine should always be used exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what effects to expect from using Padolten, when and for how long it should be taken, when to contact the doctor, and when it should be discontinued (see also section 2).
Padolten should be used for as short a duration as possible.
Use of this medicine is not recommended in children under 12 years of age.
The dose should be adjusted according to the intensity of pain and the individual patient's response to treatment. The lowest effective dose that relieves pain should be taken.
Unless otherwise directed by the doctor, the recommended initial dose of Padolten is 2 tablets for adults and adolescents aged 12 years and older.
If needed, additional doses may be taken according to the doctor's instructions. There must be an interval of at least 6 hours between doses.
Do not take more than 8 coated tablets of Padolten per day.
Do not take Padolten more frequently than directed by the doctor.

Elderly patients
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. In these patients, the doctor may recommend extending the time interval between doses.

Severe liver or kidney disease (failure)/dialysis patients
Patients with severe liver and/or kidney failure should not take Padolten.
In cases of mild or moderate impairment, the doctor may recommend extending the intervals between doses.

Method of administration
The tablets should be taken orally.
Tablets should be swallowed whole, without crushing or chewing, with an adequate amount of water.
If the patient feels that the effect of Padolten is too strong (e.g. experiences increased drowsiness or has breathing difficulties) or too weak (i.e. does not relieve pain adequately), they should contact the doctor.

Taking more than the recommended dose of Padolten
Seek immediate medical advice from a doctor or pharmacist, even if the patient feels well.
There is a risk of liver damage, which may manifest later.

Missed dose of Padolten
If a dose is missed, pain may return. Do not take a double dose to make up for the missed dose. Instead, take the next tablet at the usual time.

Stopping treatment with Padolten
Do not suddenly stop taking this medicine without medical advice. If the patient wishes to discontinue treatment, this should be discussed with the doctor, especially if the medicine has been taken for a prolonged period.
The doctor will advise when and how to stop taking the medicine; this may involve gradually reducing the dose to reduce the likelihood of withdrawal symptoms.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following adverse reactions, treatment must be discontinued and
medical advice must be sought immediately. The medicine must not be taken again.

Rare (may occur in less than 1 in 1,000 people):

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

Other reported adverse reactions include:
Very common (may occur in more than 1 in 10 people):

• nausea,
• dizziness, drowsiness.

Common (may occur in less than 1 in 10 people):

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

Uncommon (may occur in less than 1 in 100 people):

• increased heart rate or blood pressure, disturbances in heart function or rhythm,
• tingling, numbness or stiffness of 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 stool,
• skin reactions (e.g. rashes, urticaria),
• increased liver enzyme levels,
• presence of albumin in urine, difficulty or pain when passing urine,
• chills, hot flushes, chest pain.

Rare (may occur in less than 1 in 1,000 people):

• seizures, difficulty with coordination,
• transient loss of consciousness (fainting),
• dependence,
• delirium,
• blurred vision,
• constriction of pupils (miosis),
• excessive dilation of pupils (mydriasis),
• speech disturbances.

Unknown frequency (cannot be estimated from available data):

• decreased blood sugar levels (hypoglycaemia),
• serotonin syndrome, which may present with changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 "Important information before taking Padolten").

The following adverse reactions have been reported in individuals taking medicines containing tramadol only or paracetamol only.
However, if any of these symptoms occur during treatment with Padolten, they should be reported to a doctor:

• frequency unknown (cannot be estimated from available data): a serious condition that may cause blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).
• feeling faint when standing up from lying or sitting position, slow heartbeat, fainting, changes in appetite, muscle weakness, slower or shallower breathing, mood changes, changes in activity, perceptual disturbances, worsening of asthma.
• taking paracetamol alone or paracetamol in combination with the antibiotic flucloxacillin may cause disturbances in blood and body fluids (metabolic acidosis with anion gap) when blood plasma acidity increases.
• concomitant use of Padolten with blood-thinning medicines (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any prolonged or unexpected bleeding should be immediately reported to a doctor.
• in rare cases: skin rash indicating an allergic reaction, which may present with sudden swelling of the face and neck, breathing difficulties, drop in blood pressure, and fainting. If any of these symptoms occur, treatment must be stopped immediately and medical advice must be sought without delay. The medicine must not be restarted.

In rare cases, use of medicines such as tramadol may lead to drug dependence, making discontinuation difficult.
Rarely, individuals taking tramadol long-term may feel unwell after abrupt discontinuation of treatment. They may experience agitation, anxiety, nervousness or tremor. They may become hyperactive, have difficulty sleeping, and experience stomach or digestive disturbances. In very few individuals, panic attacks, hallucinations, unusual sensations such as itching, tingling and numbness, and ringing in the ears may occur. If any of these symptoms are experienced after stopping Padolten, medical advice should be sought.

Frequency unknown: hiccups.
In exceptional cases, blood count results may be abnormal, e.g. indicating low platelet count, which may result in nosebleeds or bleeding gums.
In very rare cases, severe skin reactions have been reported following paracetamol use.
In rare cases, respiratory depression has been reported during tramadol use.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Padolten

Keep this medicine out of sight and reach of children.
This medicine should be stored in a safe place inaccessible to others. It may cause serious harm and can be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the outer carton and blister after the word "EXP". The expiry date refers to the last day of the specified month.
Dispose of the container 50 days after first opening.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Padolten contains

• The active substances are: tramadol hydrochloride and paracetamol. Each coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• Other ingredients are: Kollicoat IR [polyethylene glycol-grafted polyvinyl alcohol copolymer], pregelatinized corn starch, microcrystalline cellulose, sodium carboxymethyl starch, hydroxypropyl cellulose, magnesium stearate;
  Tablet coating: Opadry II Beige 85F97409 colouring agent: polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, 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-coloured, capsule-shaped tablets, with the imprint "T37.5" on one side and "A325" on the other side.
Padolten is available in cardboard boxes containing blisters of 10, 20, 30, 60 or 90 tablets, as well as in containers containing 10 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Kraków, Poland
Pliva Hrvatska d.o.o.
Prilaz baruna Filipovića 25,
10000 Zagreb, Croatia

This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following names:
Belgium: Tramadol/Paracetamol Teva 37.5 mg/325 mg film-coated tablets
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