Clanderón 37.5 mg/325 mg effervescent tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Clanderon 37.5 mg/325 mg effervescent tablets EFG

Tramadol hydrochloride / Paracetamol

Read the entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Clanderon is and what it is used for

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

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

Clanderon should only be used by adults and children over 12 years of age.

2. What you need to know before taking Clanderon

Do not take Clanderon

• If you are allergic to tramadol, paracetamol, or any of the other components of this medicine (listed in section 6);
• if you have taken any medicines for insomnia, analgesics, 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 if you have taken them within the last 14 days before starting treatment with Clanderon;
• 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 Clanderon

• if you are taking other medicines containing paracetamol or tramadol;
• if 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;
• if you have kidney problems;
• if you have severe breathing difficulties, for example asthma or severe lung problems;
• if you have epilepsy or have had seizures or convulsions;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Clanderon”);
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other pain-relief medicines, for example morphine;
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anaesthetized. Tell your doctor or dentist that you are using Clanderon.

During treatment with tramadol/paracetamol, 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 at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

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

Sleep-related breathing disorders

Clanderon may cause sleep-related breathing disorders such as central 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, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

There is a small risk of developing serotonin syndrome after taking tramadol, particularly when used in combination with certain antidepressants or with tramadol alone.

Contact a doctor immediately if you experience any symptoms related to this serious condition (see section 4 “Possible side effects”).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation in 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.

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 (you become tolerant to it). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have previously had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking tramadol/paracetamol, it could indicate that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine for reasons other than those prescribed, for example, “to stay calm” or “to sleep”.
• You have repeatedly tried and failed to stop or control the use of the medicine.
• When you stop taking the medicine, you feel unwell, and feel better when you take it again (“withdrawal effect”).

If you notice any of these signs, talk to your doctor so they can advise you on the best treatment approach, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, “If you stop taking tramadol/paracetamol”).

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 or pharmacist if you experience any of the following symptoms while taking Clanderon:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor; he/she will decide whether you need hormonal supplementation.

Other medicines and Clanderon

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.

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

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

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as intense facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (see section 2).

The risk of adverse effects is increased:

• 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 limb or eye movements, uncontrollable muscle contractions, or diarrhea, contact your doctor.
• if you are taking other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines to lower blood pressure, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• if you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain).
• the concomitant use of tramadol/paracetamol and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, 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 dose and duration of concomitant treatment should be limited. Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosing 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.
• if you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol/paracetamol simultaneously with these medicines. Your doctor will advise whether tramadol/paracetamol is suitable for you.
• if you are taking medicines for depression. Tramadol/paracetamol may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• If you are taking warfarin or fenprocoumon (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.

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

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

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

Taking Clanderon with food, drinks, and alcohol

Clanderon may make you feel drowsy. Alcohol may increase this drowsiness, so it is recommended not to drink alcohol while taking Clanderon.

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

Breastfeeding

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

Based on human experience, tramadol is not thought to affect 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 whether you can drive or use machines during treatment with tramadol/paracetamol. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Use in athletes

This medicine may result in a positive doping test.

Clanderon contains sodium

This medicine contains 178.11 mg of sodium (main component of table/cooking salt) per effervescent tablet. This corresponds to 9.11% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need 2 or more effervescent tablets daily for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to take Clanderon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what to expect from the use of tramadol/paracetamol, when and for how long you should take it, when you should contact your doctor, and when you should discontinue it (see also section 2).

You should take Clanderon for the shortest time possible.

Use in children under 12 years of age is not recommended.

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 effervescent tablets.

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

Do not take more than 8 Clanderon tablets per day.

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

Elderly patients

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

Patients with hepatic or renal impairment/patients on dialysis

If you suffer from severe liver or kidney disease, treatment with tramadol/paracetamol is not recommended. If you have moderate liver or kidney impairment, your doctor may extend the dosing intervals.

Method of administration

The effervescent tablets are administered orally.

The effervescent tablets should be taken dissolved in a glass of water. The effervescence must have ceased before ingesting the medication.

If you feel that the effect of Clanderon 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 Clanderon than you should

If you have taken more Clanderon than you should, even if you feel well, consult your doctor or pharmacist immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Clanderon

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

If you stop taking Clanderon

Do not stop taking this medicine suddenly unless instructed by your doctor. 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 discontinue treatment, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further questions about the use of 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,
• difficulty breathing,
• difficulty swallowing, blood in stools,
• skin reactions (e.g. rashes, urticaria),
• 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: cannot be estimated from available data:

• decrease in blood sugar levels (hypoglycaemia).

The following adverse effects have been reported in individuals taking medicines containing tramadol only or paracetamol only. However, if you experience any of these symptoms while taking Clanderon, you should 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, mood changes, changes in activity, changes in perception, worsening of asthma.

• The use of tramadol/paracetamol 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 manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens, stop treatment and consult your doctor immediately. You must not take this medicine again.

• Frequency not known (frequency cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

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

Rarely, individuals 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 gastrointestinal 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 Clanderon, please consult your doctor.

Frequency not known:

• hiccups
• serotonin syndrome, which may present as 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 starting to take Clanderon").

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.

Rare cases of depression have been reported with tramadol.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clanderon

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

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or even be fatal to people for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the carton, aluminum strip, or at the bottom of the tablet container after EXP. The expiry date refers to the last day of the month indicated.

Tablet packaging in coated aluminum strips: Store below 25°C

Tablet packaging in tablet containers: Store below 30°C

Shelf life after first opening: 9 months, without exceeding the expiry date.

Keep in the original container to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clanderon effervescent tablets

• The active substances are tramadol hydrochloride and paracetamol.

Each effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components (excipients) are:

povidone (PVK-90), maltodextrin, sodium saccharin dihydrate, orange flavour, anhydrous citric acid, anhydrous monosodium citrate, sodium bicarbonate, copovidone, acesulfame potassium, PEG 6000.

Appearance of the product and contents of the pack:

Clanderon effervescent tablets EFG are presented as effervescent tablets of white or almost white colour.

The effervescent tablets are packaged in aluminium blisters or in tablet containers.

Aluminium blister packs: packs containing 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 effervescent tablets.

Tablet containers: packs containing 10, 16, 20, 25, 30, 40, 50, 60, 70, 80, 90 and 100 effervescent tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer:

Laboratorios Medicamentos Internacionales S.A. (Medinsa)

C/ Solana No. 26

28850 Torrejón de Ardoz

Madrid, SPAIN

Or

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Date of latest revision of this leaflet: June 2025

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/