DOLERGOT DUO 37.5 mg/325 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dolergot DUO 37.5 mg/325 mg film-coated tablets EFG

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Dolergot DUO is and what it is used for

Dolergot DUO is a combination of two pain relievers, tramadol and paracetamol, which work together to relieve pain.

This medicine is indicated for the treatment of moderate to severe pain, only when your doctor considers that a combination of tramadol and paracetamol is necessary.

Dolergot DUO should only be used by adults and adolescents over 12 years of age with a minimum body weight of 40 kg.

2. What you need to know before you take Dolergot DUO

Do not take Dolergot DUO

• 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 intoxication.
• If you are taking sleeping pills, strong pain relievers, or other psychotropic medicines (medicines that can alter mood and emotions).
• If you are taking MAO inhibitors (certain medicines used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Dolergot DUO.
• If you have severe liver disease.
• If you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dolergot DUO

• If you are taking other medicines that contain paracetamol or tramadol.
• If you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may be a sign of 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.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Dolergot DUO")
• If you have recently suffered a head injury, shock, or severe headaches associated with vomiting.
• If you are dependent on any other medicine used for pain relief (e.g., morphine).
• If you are taking other medicines for pain relief that contain buprenorphine, nalbuphine, or pentazocine.
• If you are going to be anesthetized. Tell your doctor or dentist that you are using Dolergot DUO.

Respiratory disorders related to sleep

This medicine contains an active substance that belongs to the opioid group. Opioids can cause sleep-related breathing problems, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).

The risk of central sleep apnea depends on the dose of opioids. Your doctor may consider reducing the total dose of opioids if you suffer from central sleep apnea.

There is a slight risk of suffering from a serotonin syndrome that may appear after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

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

If you have experienced any of the above points in the past or experience them while taking Dolergot DUO, please make sure to inform your doctor. The doctor will decide whether to continue or not with this treatment.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (you get used to it, which is known as tolerance). Repeated use of Dolergot DUO can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may increase with a higher dose and longer use.

Dependence or addiction can make you feel that you no longer control the amount of 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 Dolergot DUO if:

• You or someone in your family has abused or been dependent 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 been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Dolergot DUO, it could be a sign 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 calm down" 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 you feel better when you take it again ("withdrawal effect")

If you observe any of these signs, talk to your doctor so that they can indicate the best treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, If you stop taking Dolergot DUO).

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Dolergot DUO: 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 any of these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

Other medicines and Dolergot DUO

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Do not take Dolergot DUO with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Dolergot DUO").

Dolergot DUO is contraindicated if you are being treated with:

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

Please inform your doctor or pharmacist if you are taking:

• Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap that occurs when the acidity of the blood increases) that must be treated urgently and may occur particularly in case of severe renal or hepatic insufficiency, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used, especially if you are taking the maximum daily dose of paracetamol for a longer period. Metabolic acidosis with high anion gap is a serious disease that requires urgent treatment.
• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain). The risk of side 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 limb or eye movements, or diarrhea, you should call your doctor.
• If you are taking other pain relievers such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), certain medicines to lower blood pressure, or medicines for allergy treatment. You may feel drowsy or dizzy. If this happens, consult your doctor.

The effectiveness of Dolergot DUO may be altered if you also take:

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

Your doctor will indicate which medicines are safe to use with Dolergot DUO

Dolergot DUO with food and alcohol

Do not drink alcohol while taking this medicine, as it can make you feel drowsy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Dolergot DUO while pregnant or breastfeeding.

Consult your doctor if you become pregnant during treatment withthis medicineand before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or if you take Dolergot DUO more than once, you should interrupt breastfeeding.

Based on human experience, it is not suggested that tramadol affects fertility in men and women. There are no data available on the influence of the combination of tramadol and paracetamol on fertility.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

If you feel drowsy while taking Dolergot DUO, do not drive or use tools or machinery.

This medicine can affect your ability to drive, as it can make you feel sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you

Dolergot DUO contains sodium

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

3. How to take Dolergot DUO

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The dose must be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used.

You should take this medicine for the shortest time necessary and not for longer than indicated by your doctor.

Adults and adolescents over 12 years of age and with a minimum body weight of 40 kg:

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age and with a minimum body weight of 40 kg is 2 tablets. If necessary, you can take additional doses, as recommended by your doctor.

The shortest interval between doses must be at least 6 hours.

This medicine is not suitable for patients with a body weight below 40 kg.

Do not take more than 8 Dolergot DUO tablets per day.

Children under 12 years of age

Do not give this medicine to children under 12 years of age.

Elderly patients

In elderly patients (over 75 years of age), the elimination of tramadol may be delayed. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney failure/patients on dialysis:

If you have severe liver or kidney disease, treatment with Dolergot DUO is not recommended. If you have mild or moderate liver or kidney disease, your doctor may prolong the dosing intervals.

Method of administration:

Tablets for oral administration.

They should be swallowed whole with sufficient liquid.

They should not be broken or chewed.

If you think the effect of this medicine is too strong (e.g., you feel very drowsy or have difficulty breathing) or too weak (e.g., you do not have adequate pain relief), tell your doctor.

If you take more Dolergot DUO than you should

If you take more doses than you should, consult your doctor immediately, even if you feel well. This is because a high dose of paracetamol can cause serious liver damage that may appear over time.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dolergot DUO

If you forget to take a dose of this medicine, it is likely that the pain will return.

Do not take a double dose to make up for forgotten doses; simply continue taking the tablets as usual.

If you stop taking Dolergot DUO

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

People may:

• feel agitated, nervous, anxious, or tremulous.
• be hyperactive.
• have difficulty sleeping.
• have digestive and intestinal disorders.

Very few people may also have:

• panic attacks.
• hallucinations, unusual perceptions such as itching, tingling, and numbness.
• ringing in the ears.

Consult your doctor if you experience any of these symptoms after stopping treatment with this medicine. For more information on other side effects, see section 4.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious. Consult your doctor immediately if you experience any of the following:

• In rare cases, skin rashes, indicating allergic reactions that can manifest through sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.
• Prolonged and unexpected bleeding, when using this medicine with anticoagulants (e.g., warfarin, phenprocoumon).

If any of the adverse effects mentioned below worsen, consult your doctor or pharmacist immediately.

Very common: may affect more than 1 in 10 people

• Nausea,
• Dizziness, drowsiness.

Common: may affect 1 in 10 people

• Vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth,
• Itching, increased sweating (hyperhidrosis),
• Headache, agitation,
• Confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling "high" all the time).

Uncommon: may affect 1 in 100 people

• Increased pulse or increased blood pressure, heart rhythm and frequency disorders,
• Feeling of tingling, numbness, or pinching sensation in the limbs, ringing in the ears, involuntary muscle spasms,

Depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss,

• Difficulty breathing,
• Difficulty swallowing, blood in the stool,
• Skin reactions (e.g., rashes, urticaria),
• Increased liver enzyme values,
• Presence of albumin in the urine, difficulty or pain when urinating
• Chills, hot flashes, chest pain.

Rare: may affect 1 in 1,000 people

• Seizures, difficulties in carrying out coordinated movements, transient loss of consciousness (syncope),
• Dependence on the medicine,
• Delirium,
• Blurred vision, pupil constriction (miosis),
• Speech disorders,
• Excessive dilation of the pupils (mydriasis).

Frequency not known:cannot be estimated from the available data:

• Decrease in blood sugar levels (hypoglycemia)

Additionally, the following adverse effects have been reported by people who have taken medicines containing only tramadol or only paracetamol:

• Feeling of dizziness when standing up after lying down or sitting, low heart rate, fainting,
• Changes in appetite,
• Muscle weakness, slower or weaker breathing,
• Changes in mood, changes in activity, changes in perception,
• Worsening of asthma,
• Nasal or gum bleeding, which can result in a low platelet count,
• In very rare cases, serious skin reactions have been reported with paracetamol,
• In rare cases, respiratory depression has been reported with tramadol,
• Hiccup (frequency not known).

In rare cases, using a medicine like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they suddenly stop treatment. They may feel agitated, anxious, nervous, or trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have 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 this medicine, please consult your doctor.

Serotonin syndrome, which can manifest through changes in mental state (e.g., agitation, hallucinations, coma), and other effects, such as fever, increased 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 "What you need to know before taking Dolergot DUO").

In exceptional cases, blood tests may reveal certain anomalies, such as a low platelet count, which can result in nasal or gum bleeding.

If you experience any adverse effect, consult your doctor or pharmacist. This includes any possible adverse effect that does not appear in the prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dolergot DUO

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

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal to people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the packaging and blister, after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofDolergot DUO

The active ingredients 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: pregelatinized starch, powdered cellulose, sodium carboxymethyl starch type A (potato), cornstarch, magnesium stearate, Opadry yellow 15B32209.

Coating film (Opadry yellow 15B32209): hypromellose, Titanium dioxide E171, polyethylene glycol 400, yellow iron oxide E172, polysorbate 80.

Product Appearance and Package Contents

Dolergot DUO are pale yellow, biconvex, capsule-shaped film-coated tablets, approximately 15.5 mm x 6.4 mm in size, marked with "C8" on one side and plain on the other.

Blister pack of 60 tablets (PVC/Aluminum)

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

OPKO Health Spain S.L.U

Plaza Europa 13-15, 08908

L'Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer:

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

08040 Barcelona,

Spain.

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

Denmark: Tramadolhydrochlorid/Paracetamol Opko

Spain: Dolergot DUO 37,5 mg/ 325 mg film-coated tablets EFG

Date of the last revision of this prospectus: February 2024

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