Pontalsic 37.5 mg/325 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pontalsic 37.5 mg/325 mg film-coated tablets

Tramadol hydrochloride/Paracetamol

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pontalsic is and what it is used for

Pontalsic is a combination of two analgesics, tramadol and paracetamol, which work together to relieve pain.

Pontalsic is indicated for the symptomatic treatment of moderate to severe pain, whenever your doctor considers that the combination of tramadol and paracetamol is necessary.

Pontalsic should only be used by adults and adolescents over 12 years of age.

2. What you need to know before taking Pontalsic

Do not take Pontalsic

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6);
• if you have taken any medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may alter mood and emotions) in cases of acute alcohol intoxication;
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease) or have taken them within the last 14 days before starting treatment with Pontalsic;
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled by your current treatment.

Warnings and precautions

Talk to your doctor before taking Pontalsic if

• you are taking other medicines containing paracetamol or tramadol;
• you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• you have kidney problems;
• you have severe breathing difficulties, for example asthma or serious lung conditions;
• you have epilepsy or have previously experienced seizures or convulsions;
• you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Taking Pontalsic with other medicines”);
• you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• you are dependent on any other medicine used for pain relief, for example morphine;
• you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• you are due to undergo anesthesia. Inform your doctor or dentist that you are taking Pontalsic.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (your body gets used to it, known as pharmacological tolerance). Repeated use of Pontalsic may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over how much medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Pontalsic may be higher if:

• you or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs (“addiction”);
• you are a smoker;
• you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

If you notice any of the following symptoms while using Pontalsic, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than prescribed, for example, “to feel calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking the medicine, and feel better once you take it again (“withdrawal effects”).

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you stop taking Pontalsic).

During treatment with Pontalsic, inform your doctor immediately if:

you have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and being sick (vomiting).

Sleep-related breathing disorders

Pontalsic contains an active substance belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).

The risk of experiencing central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnea.

There is a low risk of developing serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Consult a doctor immediately if you experience any symptoms associated with this serious condition (see section 4 “Possible side effects”).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

If you develop or have previously experienced any of these problems while taking Pontalsic, please inform your doctor. He or she will decide whether you should continue taking this medicine.

Children and adolescents

Use in children with breathing problems:

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Inform your doctor if you experience any of the following symptoms while taking Pontalsic:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Taking Pontalsic with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Important: This medicine contains paracetamol and tramadol. Inform your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily dose.

Pontalsic must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Pontalsic”).

The use of Pontalsic is not recommended if you are being treated with:

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

Inform your doctor or pharmacist if you are taking:

flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that must be treated urgently (see section 2). Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.

The risk of adverse effects increases if you are taking:

• triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.
• other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines to lower blood pressure, or medicines for allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of Pontalsic and sedative medicines such as benzodiazepines or other sedatives or medicines that affect respiratory activity (e.g., opioids) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with sedative medicines, your doctor will limit the dose and duration of concomitant treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

• medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Pontalsic simultaneously with these medicines. Your doctor will advise whether Pontalsic is suitable for you.
• medicines for the treatment of depression. Pontalsic may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”).
• warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics).
• medicines for treating psychiatric disorders (antipsychotics or neuroleptics).
• muscle relaxants.
• medicines for treating Parkinson’s disease.

The effectiveness of Pontalsic may be altered if you also take:

• metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• colestyramine (a medicine that lowers blood cholesterol).

Your doctor will know which medicines are safe to use with Pontalsic.

Taking Pontalsic with food and alcohol

Pontalsic may make you feel drowsy. Alcohol may increase drowsiness; therefore, it is recommended not to drink alcohol while taking Pontalsic.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because Pontalsic contains tramadol, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant while taking Pontalsic, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take Pontalsic more than once during breastfeeding, or if you take Pontalsic more than once, you must stop breastfeeding.

Based on human experience, there is no suggestion that tramadol affects fertility in men and women. There are no data available on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines

Ask your doctor if you can drive or operate machinery while taking Pontalsic. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Pontalsic contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free.”

3. How to take Pontalsic

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using Pontalsic, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

You should take Pontalsic for the shortest time 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 your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used.

Unless otherwise prescribed by your doctor, the recommended starting dose for adults and adolescents over 12 years of age is 2 tablets.

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 8 Pontalsic tablets per day.

Do not take Pontalsic more frequently than instructed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slow. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with Pontalsic is not recommended. If you have moderate liver or kidney impairment, your doctor may recommend prolonging the dosing intervals.

Method of administration

Pontalsic is available as tablets for oral administration.

The tablets must be swallowed whole with sufficient liquid. They must not be broken or chewed.

If you feel that the effect of Pontalsic is too strong (e.g. you feel very drowsy or have difficulty breathing) or too weak (e.g. you do not get adequate pain relief), inform your doctor.

If you take more Pontalsic than you should

If you have taken more Pontalsic than you should, even if you feel well, contact your doctor or pharmacist immediately.

After taking very high doses, symptoms such as pupil constriction, vomiting, low blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may progress to respiratory arrest and death may occur. In such a case, call a doctor immediately!

An overdose of paracetamol may cause nausea and vomiting. There is a risk of serious liver damage, which may only become apparent later. Severe cases may lead to liver failure, brain disorders, coma, or death.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Pontalsic

If you forget to take a dose of Pontalsic, your pain may return. Do not take a double dose to make up for missed doses; simply continue taking the tablets as usual.

If you stop taking Pontalsic

You should not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking the medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• nausea,
• dizziness, drowsiness.

Common: may affect up to 1 in 10 people:

• vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being “on a high” all the time).

Uncommon: may affect up to 1 in 100 people:

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• tingling sensation, numbness or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or sensing something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stools,
• skin reactions (e.g. rashes, urticarial rash),
• increased liver enzyme values,
• presence of albumin in urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare: may affect up to 1 in 1,000 people:

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope),
• drug dependence,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known:

• decrease in blood sugar levels (hypoglycaemia).

The following adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Pontalsic, you must inform your doctor:

• Dizziness upon standing up after lying down or sitting, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.

• The use of Pontalsic together with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes may occur, indicating allergic reactions that may present as sudden swelling of the face and neck, shortness of breath, drop in blood pressure, and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You must not take this medicine again.

In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult for you to stop taking it.

Occasionally, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience digestive and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Pontalsic, please consult your doctor.

Frequency not known: hiccups.

Serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you need to know before taking Pontalsic”).

In exceptional cases, blood tests may reveal certain abnormalities, for example low platelet count, which may result in nosebleeds or bleeding gums.

Very rarely, serious skin reactions have been reported with paracetamol.

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) has been reported in patients with severe illness using paracetamol (see section 2), with unknown frequency.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pontalsic

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pontalsic

• The active substances are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components (excipients) are:

Tablet core: powdered cellulose, pregelatinized corn starch, sodium starch glycolate (type A), corn starch, magnesium stearate.

Film coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), propylene glycol (E1520), talc.

Appearance of the product and contents of the pack

Pontalsic film-coated tablets are pale yellow tablets marked with the manufacturer's logo ? on one side and "T5" on the other.

Pontalsic film-coated tablets are packed in blisters.

Available in pack sizes of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.

Only certain pack sizes may be marketed.

Pontalsic film-coated tablets are also available in packs of 2x1, 10x1, 20x1, 30x1, 40x1, 50x1, 60x1, 70x1, 80x1, 90x1 or 100x1 tablets in single-dose precut blister packs.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Grünenthal Pharma, S.A.
Doctor Zamenhof, 36 - 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH
Zieglerstrasse 6 - D-52078 Aachen, Germany

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

Germany	Zaldiar 37.5 mg/325 mg Film-coated tablets
Austria	Zaldiar 37.5 mg/325 mg Film-coated tablets
Belgium	Zaldiar 37.5 mg / 325 mg, film-coated tablets / filmomhulde tabletten
	Pontalsic 37.5 mg / 325 mg, film-coated tablets / filmomhulde tabletten
Slovenia	Zaldiar 37.5 mg/325 mg filmsko obložene tablete
Spain	Zaldiar 37.5 mg/325 mg film-coated tablets
	Pontalsic 37.5 mg/325 mg film-coated tablets
France	Zaldiar 37.5 mg/325 mg, film-coated tablet
	Ixprim 37.5 mg/325 mg, film-coated tablet
Greece	ZALDIAR
Netherlands	Zaldiar 37.5 mg/325 mg, filmomhulde tabletten
Hungary	Zaldiar 37.5 mg/325 mg filmtabletta
Ireland	Ixprim 37.5 mg/325 mg, film-coated tablets
Luxembourg	Zaldiar 37.5 mg / 325 mg, comprimés pelliculés
Portugal	Zaldiar 37.5 mg/325 mg film-coated tablets
United Kingdom	Tramacet 37.5 mg/325 mg, film-coated tablets

Date of the most recent review of this leaflet: December 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/