Tramadol Viatris 100 mg/ml oral solution drops EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol Viatris 100 mg/ml oral drops solution EFG

tramadol hydrochloride

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, and you should not give it to other people, 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 Tramadol Viatris is and what it is used for
2. What you need to know before taking Tramadol Viatris
3. How to take Tramadol Viatris
4. Possible side effects
5. How to store Tramadol Viatris
6. Contents of the pack and other information

1. What Tramadol Viatris is and what it is used for

Tramadol – the active substance in this medicine – is an analgesic belonging to the opioid group that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol is used to treat moderate to severe pain in adults and in children from 3 years of age.

2. What you need to know before taking Tramadol Viatris

Do not take Tramadol Viatris

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6).
• in cases of acute intoxication caused by alcohol, sleeping medications, painkillers, or other psychotropic medicines (medicines that affect mood and emotions).
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (a type of medicine used to treat depression), or if you have taken them within the last 14 days before starting treatment with this medicine (see “Other medicines and Tramadol Viatris”).
• if you have epilepsy and your seizures are not adequately controlled by treatment.
• for the treatment of withdrawal syndrome.
• in children under 3 years of age.

Warnings and precautions

Talk to your doctor before starting to take Tramadol Viatris

• if you have disorders of consciousness (if you feel you might faint);
• if you are in shock (a sign of this condition may be cold sweating);
• if you have increased intracranial pressure (for example, after a head injury or brain diseases);
• if you have difficulty breathing;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you have depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol Viatris”);
• if you have liver or kidney disease.

Sleep-related breathing disorders

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

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

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

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the maximum recommended daily dose (400 mg).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the drug (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of this medicine may also lead to dependence, abuse, and addiction, which could result in 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 loss of control over the amount of medicine you need 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 this medicine may be higher if:

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

If you notice any of the following symptoms while using this medicine, 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 those 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 using 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 Tramadol Viatris).

Also inform your doctor if any of these problems occur during treatment with this medicine or if you have ever experienced them.

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 contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

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

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

Other medicines and Tramadol Viatris

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

Concomitant treatment with tramadol and MAO inhibitors (a type of medicine used to treat depression) should be avoided.

The effect and duration of pain relief from tramadol may be reduced if you take medicines containing:

• Carbamazepine (for epileptic seizures).
• Ondansetron (to prevent nausea).

Your doctor will advise you whether you should take this medicine and at what dose.

The risk of adverse effects increases:

• if you are taking this medicine simultaneously with other painkillers such as morphine and codeine (even when used for cough treatment) and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.

The concomitant use of tramadol with sedatives or medicines for insomnia (such as benzodiazepines) 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 tramadol 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 symptoms listed above. Inform your doctor if you experience any of these symptoms:

• if you are taking medicines that may lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. Your doctor will advise you whether tramadol is suitable for you;
• if you are taking gabapentin or pregabalin to treat epilepsy or nerve-related pain (neuropathic pain);
• if you are taking medicines for depression. Tramadol may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”);
• if you are taking coumarin anticoagulants (blood-thinning medicines) such as warfarin while taking tramadol. The effect of these medicines on blood clotting may be affected, leading to bleeding;
• if you are taking medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (such as, for example, ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).

Taking Tramadol Viatris with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effects may be intensified. Food does not affect the action of tramadol.

Children and adolescents

Use in children with respiratory problems:

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

In particular, the first administration of tramadol in children should be performed under strict medical supervision.

Monitor the child, especially during the first administration. If warning signs occur (such as altered consciousness, constricted pupils, vomiting, seizures, very slow breathing...), call a doctor immediately or contact an emergency service (see section “If you take more Tramadol Viatris than you should”).

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.

There is very limited information available on the safety of tramadol in pregnant women. Therefore, you should not take this medicine if you are pregnant.

Chronic treatment during pregnancy may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or if you take tramadol more than once, you must stop breastfeeding.

Based on human experience, tramadol is not considered to affect fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or use machines during treatment with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel drowsy, 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.

Tramadol Viatris contains ethanol, sucrose, and propylene glycol

This medicine contains 161.8 mg of ethanol (alcohol) per ml, equivalent to 0.16 g per 40 drops. The amount in 1 ml of this medicine corresponds to 4 ml of beer or 1.7 ml of wine.

The small amount of alcohol contained in this medicine will not have notable effects.

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine. It may cause dental caries.

This medicine contains 124.5 mg of propylene glycol per ml of oral solution, equivalent to 100 mg/ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.

3. How to take Tramadol Viatris

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

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from the use of Tramadol Viatris, 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).

The recommended dose, unless your doctor has given you different instructions, is:

Adults and adolescents over 12 years of age

Normally, the recommended dose of tramadol hydrochloride is 50–100 mg every 4–6 hours. The dose of tramadol per administration should not exceed 100 mg.

The dose should be adjusted according to the intensity of pain and your individual sensitivity. The lowest effective dose that provides pain relief should normally be used. Do not take more than 160 drops per day, equivalent to 400 mg of tramadol hydrochloride (i.e., 4 doses of 40 drops in 24 hours), unless otherwise directed by your doctor.

For dose adjustment in drops, refer to the following equivalence table:

Equivalence table showing the number of drops corresponding to the mg content of tramadol hydrochloride

Number of drops	Tramadol hydrochloride content
5 drops	12.5 mg
10 drops	25 mg
15 drops	37.5 mg
20 drops	50 mg
25 drops	62.5 mg
30 drops	75 mg
35 drops	87.5 mg
40 drops	100 mg

Children

For children over 3 years of age, the recommended dose is 1 mg of tramadol hydrochloride per kg of body weight.

Doses should not exceed 2 mg of tramadol hydrochloride per kg of body weight per administration.

The usual recommended and maximum doses per administration, according to body weight, are as follows:

Child's weight	Child's age (approximate)	Usual dose by child's weight and per administration (in drops*)	Maximum dose by child's weight and per administration (in drops*)
15 kg-20 kg	3 - 5 years	5 drops	10 drops
20 kg-25 kg	5 - 8 years	5 drops	15 drops
25 kg-35 kg	8 - 11 years	10 drops	20 drops
35 kg-37 kg	11 years	15 drops	25 drops
37 kg-44 kg	11 - 13 years	15 drops	30 drops
44 kg-45 kg	>13 years	15 drops	35 drops

*Always round the number of drops down to the next lower whole number.

The lowest effective dose that provides pain relief should be used. Daily doses must not exceed 8 mg of tramadol hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride, whichever is lower.

• 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 this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the dosing intervals.

How and when to take Tramadol Viatris

Administer orally.

The solution may be diluted in a sugared solution or a small amount of liquid.

You may take the medicine either on an empty stomach or with food.

For how long should you take Tramadol Viatris?

This medicine should not be administered for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor you at short, regular intervals (and if necessary with treatment interruptions) to determine whether treatment with this medicine and at what dose should continue.

If you feel the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Tramadol Viatris than you should

If you have taken an extra dose by mistake, you will generally not experience negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, symptoms such as pupillary constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, reduced level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest can occur. In such a case, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine's package leaflet to the healthcare professional.

If you forget to take Tramadol Viatris

If you forget to take the medicine, your pain may return. Do not take a double dose to make up for missed doses. Simply continue taking tramadol as you have been doing.

If you stop taking Tramadol Viatris

If you interrupt or stop treatment with this medicine too soon, your pain is likely to return. If you wish to discontinue treatment due to adverse effects, consult your doctor.

You must not stop taking this medicine suddenly unless your doctor tells you to do so. If you wish to stop taking your 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).

Generally, adverse effects do not commonly occur when tramadol treatment is stopped. However, on rare occasions, individuals who have been taking this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (depersonalization), changes in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, consult your doctor.

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.

You must consult your doctor immediately if you experience symptoms of an allergic reaction, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, rash, and difficulty breathing.

The most common adverse effects during treatment with tramadol are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect 1 in 10 people

• Headache, numbness.
• Fatigue.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong heartbeats and rapid heartbeat, feeling dizzy or fainting). These adverse effects may occur particularly in patients who are standing up or performing physical exertion.
• Nausea (feeling like vomiting), gastrointestinal discomfort (e.g., feeling of pressure in the stomach, bloating), diarrhoea.
• Skin reactions (e.g., itching, rash).

Rare: may affect 1 in 1000 people

• Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after using high doses of tramadol or when taken simultaneously with another medicine that may trigger them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological disturbances may occur after treatment with tramadol. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These may manifest as mood changes (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• May lead to drug dependence. If treatment is abruptly discontinued, withdrawal syndrome may occur (see “If you stop taking Tramadol Viatris”).
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• Cases of worsening asthma have been reported; however, it has not been established whether they were caused by tramadol. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increase in liver enzymes.

Frequency not known: cannot be estimated from available data

• Decrease in blood sugar levels.
• 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 taking Tramadol Viatris”).

Reporting of adverse effects

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

5. Storage of Tramadol Viatris

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. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Tramadol Viatris

• The active substance is tramadol hydrochloride.

One millilitre of solution contains 100 mg of tramadol hydrochloride as the active substance. 40 drops equal 1 millilitre.

• The other components are: potassium sorbate (E-202), ethanol (20% V/V), propylene glycol (E-1520), sucrose, polysorbate 80, pipermin oil, purified water.

Appearance of the medicine and contents of the container

Clear, colourless to pale yellow solution presented in 10 ml and 30 ml bottles with a dropper.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Temmler Pharma GmbH.

Temmlerstraße, 2

35039 Marburg, Hessen

Germany

Further information on this medicine is available upon request from the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.

C/General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent revision of this leaflet: May 2024

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